Read the Patient Information Leaflet if available from your pharmacist before you start using tolterodine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually twice a day.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day. The dosage is based on your medical condition (especially kidney and liver disease), response to treatment, and other medicationsyou may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Ask your doctor or pharmacist for more details.

Do not increase your dose or take this medication more often than directed. Your condition will not improve any faster and your risk of serious side effects may be increased.

Tell your doctor if your condition persists or worsens.

Dry mouth, dry eyes, headache, constipation, stomach upset/pain, dizziness, drowsiness, tiredness, or blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using this drug, consult your pharmacist for help in selecting a laxative (such as a stimulant-type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: visionchanges, severe stomach/abdominal pain, trouble urinating, signs of kidney infection(such as burning/painful urination, lower back pain, fever).

Get medical help right away if you have any very serious side effects, including: fast/slow/irregular heartbeat, severe dizziness, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking tolterodine, tell your doctor or pharmacist if you are allergic to it; or to fesoterodine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems emptying your bladder (urinary retention, bladder outflow obstruction), severe blockage of stomach/intestines (gastric retention), glaucoma, stomach/intestinal disease (such as ulcerative colitis, slowed movement of stomach/intestines), severe constipation, kidney disease, liver disease, a certain muscle disease (myasthenia gravis).

Tolterodine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using tolterodine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using tolterodine safely.

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above), drowsiness, confusion, constipation, or trouble urinating. Drowsiness and confusion can increase the risk of falling.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: anticholinergic drugs (such as atropine, scopolamine), other antispasmodic drugs (such as dicyclomine, propantheline), certain anti-Parkinson's drugs (such as benztropine, trihexyphenidyl), belladonna alkaloids, potassium tablets/capsules, pramlintide.

Many drugs besides tolterodine may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, macrolide antibiotics (such as erythromycin), among others.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

You will take your first pill on the first day of your period or on the first Sunday after your period begins. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medicine. Follow your doctor's instructions.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not take one pill daily. Get your prescription refilled before you run out of pills completely.

The 28-day-birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.

You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Use a back-up birth control if you are sick with severe vomiting or diarrhea.

If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medicine for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.

While taking birth control pills, you will need to visit your doctor regularly.

Follow the patient instructions provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. Missing a pill increases your risk of becoming pregnant.

If you miss one active pill, take two pills on the day you remember. Then take one pill per day for the rest of the pack.

If you miss two active pills in a row in Week 1 or 2, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.

If you miss two active pills in a row in Week 3, throw out the rest of the pack and start a new pack the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss three active pills in a row in Week 1, 2, or 3, throw out the rest of the pack and start a new pack on the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new pack that day.

If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss a reminder pill, throw it away and keep taking one reminder pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.

Stop using birth control pills and call your doctor at once if you have:

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--severe stomach pain, fever, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• a change in the pattern or severity of migraine headaches;
• swelling in your hands, ankles, or feet;
• a breast lump; or
• symptoms of depression--sleep problems, weakness, tired feeling, mood changes.

Common side effects may include:

• light vaginal bleeding or spotting;
• nausea (especially when you first start taking this medicine), vomiting, bloating;
• changes in weight or appetite;
• breast tenderness or swelling;
• freckles or darkening of facial skin, increased hair growth, loss of scalp hair;
• headache; or
• vaginal itching or discharge.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take birth control pills if you smoke and are over 35 years old.

Taking birth control pills can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight. Your risk of stroke or blood clot is highest during your first year of taking birth control pills. Your risk is also high when you restart birth control pills after not taking them for 4 weeks or longer.

Do not use if you are pregnant. Stop taking this medicine and tell your doctor if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills.

You should not take birth control pills if you have:

• untreated or uncontrolled high blood pressure;
• heart disease (coronary artery disease, uncontrolled heart valve disorder, history of heart attack, stroke, or blood clot);
• a blood-clotting disorder or circulation problems;
• problems with your eyes, kidneys or circulation caused by diabetes;
• a history of hormone-related cancer such as breast or uterine cancer;
• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease or liver cancer;
• severe migraine headaches (with aura, numbness, weakness, or vision changes);
• a history of jaundice caused by pregnancy or birth control pills; or
• if you smoke and are over 35 years old.

To make sure birth control pills are safe for you, tell your doctor if you have:

• high blood pressure, varicose veins;
• high cholesterol or triglycerides;
• a history of depression;
• underactive thyroid, gallbladder disease;
• seizures or epilepsy;
• a history of irregular menstrual cycles;
• tuberculosis; or
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram.

The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breast feeding a baby.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.

Many drugs can interact with birth control pills and make them less effective, which may result in pregnancy. DESOGEN can also affect blood levels of certain other drugs, making them less effective or increasing side effects. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

DEPO-MEDROL is to be given to you as an injection to the joint (intra-articular or intra-synovial injection), or into a muscle (intramuscular injection) by your health care provider. The dose of DEPO-MEDROL will depend on your condition and how severe it is.

When your condition has improved, your dose will be reduced gradually.

DEPO-MEDROL should not be stopped abruptly.

Overdose:

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

DEPO-MEDROL may hide symptoms of infections, may cause latent infections to become active, and may induce infections by normally inoffensive organisms due to lowered body resistance.

Potential side effects with DEPO-MEDROL include:

Allergic Reactions:

• anaphylaxis (a severe, life-threatening allergic reaction)
• cardiac arrest
• bronchospasm (narrowing of the airway)

Cardiovascular:

• heart failure
• heart attack
• arrhythmia (irregular heartbeat)
• high and low blood pressure
• blood clots
• thrombophlebitis (vein inflammation)

Dermatologic:

• thin fragile skin
• impaired wound healing
• swelling
• ecchymosis (spots caused by ruptured blood vessels)
• petechiae (reddish spot containing blood that appears in skin)
• stretch marks
• dry, scaly skin
• rash
• redness
• itching
• acne
• increased sweating
• injection site reaction
• lightening or darkening of an area of skin
• abscess
• suppressed reaction to skin tests
• thinning hair

Endocrine and Metabolism:

• development of Cushingoid state (abnormal bodily condition caused by excess corticosteroids)
• moon face (enlargement of chin and forehead)
• weight gain
• abnormal fat deposits
• suppression of pituitary-adrenal axis (a condition that could lead to disabling the body’s responses to physiological stress such as severe infections or trauma)
• suppression of growth in children
• abnormal hair growth
• new symptoms of diabetes

Gastrointestinal:

• stomach ulcer
• stomach bleeding
• inflammation of the pancreas and esophagus
• perforation of the bowel
• nausea
• vomiting or altered sense of taste (with rapid administration of large doses)
• abdominal pain
• bloating
• diarrhea
• indigestion
• bowel/bladder dysfunction
• increased appetite
• peritonitis

Hematology:

• above normal white blood cell count
• above normal cholesterol or triglycerides

Hepatic:

• enlarged liver

Musculoskeletal:

• loss of muscle mass
• muscle weakness
• muscle pain
• malaise (feeling of general discomfort or uneasiness)
• osteoporosis
• pathological fractures
• vertebral compression fractures
• tendon rupture, (particularly of the Achilles tendon)
• Charcot joint disease (neuropathic arthropathy)
• pain and inflammation of the tissues surrounding the injection site
• joint pain

Neurologic:

• seizures
• headache
• vertigo
• pain and tenderness
• impaired sensation, strength, and reflexes
• sensation of tingling, tickling, prickling, or burning of a person's skin
• amnesia
• dizziness

Ophthalmologic:

• cataracts
• increased intraocular pressure
• glaucoma
• bulging of the eye
• blindness

Psychiatric:

• depression
• emotional instability
• euphoria (intense feelings of well-being, elation, happiness, excitement and joy)
• insomnia
• mood swings
• personality changes
• thoughts of suicide
• delusion
• hallucination
• confusion
• schizophrenia
• anxiety

Sexual Function/Reproduction:

• menstrual irregularities
• increased or decreased motility and number of sperm

Other:

• hiccups, fatigue, irritability, swelling

DEPO-MEDROL with preservative benzyl alcohol is not recommended for injection into the joint (intra-synovial or intra-articular injection).

Before taking DEPO-MEDROL, talk to your doctor if you have:

• an infection (such as herpes simplex, chicken pox, tuberculosis, threadworm);
• recently had myocardial infarction (heart attack);
• thromboembolic disorders (bleeding or blood clotting problems);
• brittle bone (osteoporosis);
• high blood pressure;
• water retention (oedema);
• seizures (fits);
• thyroid problems;
• muscle pain or weakness (such as myasthenia gravis);
• skin cancer (Kaposi's sarcoma);
• heart problems such as heart failure;
• certain eye diseases such as glaucoma, cataracts; herpes infection;
• kidney disease;
• liver disease such as cirrhosis;
• certain mental or mood conditions (such as depression);
• stomach or gut problems (ulcer, ulcerative colitis);
• low potassium or calcium;
• Cushing's disease (caused by an excess of cortisol hormone);
• weak immune response;
• high blood sugar.

Before you have any operation, tell your doctor, dentist or anesthetist that you are taking DEPO-MEDROL.

Pregnancy and breast feeding:

You must tell your doctor if you are pregnant, think you might be pregnant or are trying to become pregnant as this medicine could slow the baby's growth.

You should also tell your doctor if you are breast feeding as small amounts of corticosteroid medicines may get into breast milk.

Children:

Corticosteroids can affect growth in children.

DEPO-MEDROL with preservative benzyl alcohol is not recommended to be used in infants since benzyl alcohol has been reported to cause “gasping syndrome” that may result in death.

Before taking DEPO-MEDROL talk to your doctor about all your other medications, including those you bought without prescription, herbal or natural products. The following may interact with DEPO-MEDROL:

• drugs to treat glaucoma and epilepsy such as acetazolamide
• drugs to prevent or alleviate nausea and vomiting such as aprepitant or fosaprepitant
• drugs to treat cancer such as aminoglutethimide or cyclophosphamide
• drugs to “thin” the blood; anticoagulants such as acenocoumarol, phenindione and warfarin
• drugs to treat myasthenia gravis (a muscle condition) such as distigmine and neostigmine
• antibiotics and antifungals (such as ketoconazole, itraconazole, amphotericin B, erythromycin, clarithromycin, troleandomycin, rifampicin and rifabutin)
• aspirin and non-steroidal anti-inflammatory medicines (also called NSAIDs) such as ibuprofen
• drugs to treat epilepsy such as barbiturates, carbamazepine, phenytoin and primidone
• drugs for heartburn and acid indigestion such as cimetidine
• cyclosporine
• drugs for heart problems or high blood pressure such as calcium channel blockers, digoxin and diltiazem
• water pills (diuretics)
• hormone replacement therapy or hormonal oral contraceptives
• drugs to treat HIV infections such as indinavir or ritonavir
• pancuronium or vecuronium—or other medicines called neuromuscular blocking agents which are used in some surgical procedures
• tacrolimus—used following an organ transplant to prevent rejection of the organ
• vaccines—tell your doctor or nurse if you have recently had, or are about to have any vaccination.
• drugs to treat diabetes
• drugs to treat tuberculosis
• drugs to treat high cholesterol (cholestyramine)
• aromatase inhibitors (drugs to treat breast or ovarian cancer)
• immunosuppressants (drugs that suppress or reduce the strength of the body's immune system

Do not drink grapefruit juice while taking DEPO-MEDROL.

Driving and Using Machines:

DEPO-MEDROL may cause dizziness, vertigo, vision problems and fatigue. If you experience these side effects you should not drive or operate machinery.

DEPAKOTE Withdrawal

Do not stop taking DEPAKOTE without talking to your healthcare provider first. Stopping a seizure medication like DEPAKOTE suddenly can cause serious withdrawal symptoms or other problems.  In a patient who has epilepsy, quitting abruptly can cause seizures that will not stop (status epilepticus).

DEPAKOTE Overdose

If you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.  Do not "double up" on this medication to make up for a missed dose.

Because one of the risks of this drug is an increase in the chance of liver damage, you should be on the lookout for these symptoms:

• Nausea
• Vomiting that does not go away
• Loss of appetite
• Pain the in the right side of your stomach
• Dark urine
• Swelling of your face, hands, arms, feet, and legs
• Yellowing of your skin or eyes (jaundice)

 DEPAKOTE can cause suicidal thoughts or actions. Call your doctor right away if you have any of these symptoms, especially if they are new:

• Thoughts of suicide or dying
• Attempts to commit suicide
• A depression that is new or getting worse
• Anxiety that is new or getting worse
• Feeling agitated or restless
• Panic attacks
• Trouble sleeping (insomnia)

This drug may cause life-threatening pancreatitis. Get emergency attention if you develop:

• Nausea
• Vomiting
• Abdominal pain, especially pain that radiates to the back or that feels worse after eating
• Tenderness when pressing on the stomach

Encephalopathy, a severe (sometimes fatal) brain disorder is a rare but possible side effect of this drug, especially in patients with certain metabolic disorders (urea cycle disorders).

Tell your doctor immediately if you develop unexplained weakness, vomiting, or sudden mental/mood changes like confusion.

Nausea is quite common when taking this medication. Between 10 and 20 percent of people who take DEPAKOTE report being nauseous at some point.

Common side effects of DEPAKOTE include:

• Diarrhea
• Dizziness
• Blurred or double vision
• Memory impairment
• Ringing in the ears
• Shakiness or unsteadiness (tremors)
• Somnolence (excessive sleepiness)
• Hair loss
• Irregular or painful menstrual periods
• Weight gain

Serious side effects of DEPAKOTE include:

• Chest pain
• Easy bruising or unexplained bleeding
• Irregular heartbeat
• Swelling of hands or deet
• Nystagmus (involuntary eye movement)
• Feeling cold or shivering
• Rapid breathing or loss of consciousness

Seek immediate medical attention if you develop signs of a serious allergic reaction to this medication:

• Rash
• Itching
• Swelling (especially in the face, tongue, or throat)
• Severe dizziness
• Trouble breathing

The FDA requires DEPAKOTE to carry a black-box warning because it can cause serious liver damage that could be fatal, especially in children younger than 2.  The risk of this happening is higher in the first six months of taking the drug. In some cases liver damage continued even after patients stopped taking DEPAKOTE .

There is an additional black-box warning linking DEPAKOTE to cases of life-threating pancreatitis.  In some cases, patients who developed pancreatitis rapidly went from initial symptoms to death, so getting medical treatment quickly is essential.

If you develop abdominal pain, nausea, vomiting, and a stomach that is tender to the touch, call 911 immediately.

Pancreatitis was reported in people who took this drug for a short time as well as in those who took it for years.

You should not take DEPAKOTE if you have a history of liver disease, a urea cycle disorder, or a genetic disorder such as Alpers' disease (a progressive degenerative disease of the central nervous system that occurs mostly in infants and children), or Alpers-Huttenlocher syndrome (the formal name for Alper's Disease).

DEPAKOTE and Pregnancy

The FDA warns DEPAKOTE can harm an unborn baby. Women who take this medication while pregnant could give birth to a child with serious birth defects.  The most common are those that affect the brain and spinal cord, particularly spina bifida or neural tube defects. These defects occur in one or two babies out of 100 that are exposed to DEPAKOTE before birth. Unfortunately, these defects can develop in the very first month of pregnancy, before you even know you are pregnant.

Studies also show if you take DEPAKOTE during pregnancy, your child is at risk for having a lower IQ. The FDA warns that women who take this drug should use effective birth control to prevent pregnancy. DEPAKOTE passes into breast milk. There have not been reports of harm to breastfeeding infants, but talk to your doctor about any risks to your child before you begin breastfeeding.

Drinking alcohol could increase nervous system side effects of DEPAKOTE like drowsiness, dizziness, difficulty concentrating, and impaired judgment.

Avoid alcohol altogether or limit how much you drink while taking this medication.

DEPAKOTE and Drug Interactions

The following drugs could interact moderately with DEPAKOTE:

• Carbamazepine (Tegretol)
• Salicylates (Doans Pills)
• Topiramate (Topamax and Topamax Sprinkle)
• Rifampin (Rifadin)
• Warfarin (Coumadn)
• Amitriptyline (Elavil)
• Clomipramine (Anafranil)
• Nortriptyline (Pamelor)
• Rufinamide (Banzel)
• Lorazepam (Ativan)
• Felbamate (Felbatol)

In addition, certain anticonvulsants, barbiturates, and hydantoins could interact with DEPAKOTE.

In some cases, the effect of a barbiturate could increase to toxic levels while the potency of DEPAKOTE could decrease, making the medicine ineffective.

You should always tell your healthcare professional about all prescription, non-prescription, over-the-counter, illegal and recreational drugs, herbal remedies, nutritional and dietary supplements, and any other drugs and treatments you are taking.

DEPAKOTE Withdrawal

Do not stop taking DEPAKOTE without talking to your healthcare provider first. Stopping a seizure medication like DEPAKOTE suddenly can cause serious withdrawal symptoms or other problems.  In a patient who has epilepsy, quitting abruptly can cause seizures that will not stop (status epilepticus).

DEPAKOTE Overdose

If you miss a dose, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose.  Do not "double up" on this medication to make up for a missed dose.

Because one of the risks of this drug is an increase in the chance of liver damage, you should be on the lookout for these symptoms:

• Nausea
• Vomiting that does not go away
• Loss of appetite
• Pain the in the right side of your stomach
• Dark urine
• Swelling of your face, hands, arms, feet, and legs
• Yellowing of your skin or eyes (jaundice)

 DEPAKOTE can cause suicidal thoughts or actions. Call your doctor right away if you have any of these symptoms, especially if they are new:

• Thoughts of suicide or dying
• Attempts to commit suicide
• A depression that is new or getting worse
• Anxiety that is new or getting worse
• Feeling agitated or restless
• Panic attacks
• Trouble sleeping (insomnia)

This drug may cause life-threatening pancreatitis. Get emergency attention if you develop:

• Nausea
• Vomiting
• Abdominal pain, especially pain that radiates to the back or that feels worse after eating
• Tenderness when pressing on the stomach

Encephalopathy, a severe (sometimes fatal) brain disorder is a rare but possible side effect of this drug, especially in patients with certain metabolic disorders (urea cycle disorders).

Tell your doctor immediately if you develop unexplained weakness, vomiting, or sudden mental/mood changes like confusion.

Nausea is quite common when taking this medication. Between 10 and 20 percent of people who take DEPAKOTE report being nauseous at some point.

Common side effects of DEPAKOTE include:

• Diarrhea
• Dizziness
• Blurred or double vision
• Memory impairment
• Ringing in the ears
• Shakiness or unsteadiness (tremors)
• Somnolence (excessive sleepiness)
• Hair loss
• Irregular or painful menstrual periods
• Weight gain

Serious side effects of DEPAKOTE include:

• Chest pain
• Easy bruising or unexplained bleeding
• Irregular heartbeat
• Swelling of hands or deet
• Nystagmus (involuntary eye movement)
• Feeling cold or shivering
• Rapid breathing or loss of consciousness

Seek immediate medical attention if you develop signs of a serious allergic reaction to this medication:

• Rash
• Itching
• Swelling (especially in the face, tongue, or throat)
• Severe dizziness
• Trouble breathing

The FDA requires DEPAKOTE to carry a black-box warning because it can cause serious liver damage that could be fatal, especially in children younger than 2.  The risk of this happening is higher in the first six months of taking the drug. In some cases liver damage continued even after patients stopped taking DEPAKOTE .

There is an additional black-box warning linking DEPAKOTE to cases of life-threating pancreatitis.  In some cases, patients who developed pancreatitis rapidly went from initial symptoms to death, so getting medical treatment quickly is essential.

If you develop abdominal pain, nausea, vomiting, and a stomach that is tender to the touch, call 911 immediately.

Pancreatitis was reported in people who took this drug for a short time as well as in those who took it for years.

You should not take DEPAKOTE if you have a history of liver disease, a urea cycle disorder, or a genetic disorder such as Alpers' disease (a progressive degenerative disease of the central nervous system that occurs mostly in infants and children), or Alpers-Huttenlocher syndrome (the formal name for Alper's Disease).

DEPAKOTE and Pregnancy

The FDA warns DEPAKOTE can harm an unborn baby. Women who take this medication while pregnant could give birth to a child with serious birth defects.  The most common are those that affect the brain and spinal cord, particularly spina bifida or neural tube defects. These defects occur in one or two babies out of 100 that are exposed to DEPAKOTE before birth. Unfortunately, these defects can develop in the very first month of pregnancy, before you even know you are pregnant.

Studies also show if you take DEPAKOTE during pregnancy, your child is at risk for having a lower IQ. The FDA warns that women who take this drug should use effective birth control to prevent pregnancy. DEPAKOTE passes into breast milk. There have not been reports of harm to breastfeeding infants, but talk to your doctor about any risks to your child before you begin breastfeeding.

Drinking alcohol could increase nervous system side effects of DEPAKOTE like drowsiness, dizziness, difficulty concentrating, and impaired judgment.

Avoid alcohol altogether or limit how much you drink while taking this medication.

DEPAKOTE and Drug Interactions

The following drugs could interact moderately with DEPAKOTE:

• Carbamazepine (Tegretol)
• Salicylates (Doans Pills)
• Topiramate (Topamax and Topamax Sprinkle)
• Rifampin (Rifadin)
• Warfarin (Coumadn)
• Amitriptyline (Elavil)
• Clomipramine (Anafranil)
• Nortriptyline (Pamelor)
• Rufinamide (Banzel)
• Lorazepam (Ativan)
• Felbamate (Felbatol)

In addition, certain anticonvulsants, barbiturates, and hydantoins could interact with DEPAKOTE.

In some cases, the effect of a barbiturate could increase to toxic levels while the potency of DEPAKOTE could decrease, making the medicine ineffective.

You should always tell your healthcare professional about all prescription, non-prescription, over-the-counter, illegal and recreational drugs, herbal remedies, nutritional and dietary supplements, and any other drugs and treatments you are taking.

FELDENE comes as a tablet to take by mouth. It’s typically taken once or twice daily.

Take this medicine around the same time each day with a full glass of water.

You can take FELDENE with food if it upsets your stomach.

Follow the instructions on your prescription label carefully. Don’t take more or less FELDENE than your doctor recommends.

FELDENE Overdose

Symptoms of an overdose may include:

• Drowsiness
• Upset stomach or stomach pain
• Vomiting
• Lack of energy
• Bloody, black, or tarry stools
• Vomit that looks like coffee grounds
• Coma
• Breathing difficulties

If you suspect an overdose, contact a poison control center or emergency room immediately.

Missed Dose of FELDENE

If you miss a dose of FELDENE, take it as soon as you remember.

However, if it’s almost time for your next dose, skip the missed dose and continue on your regular medication schedule.

Don’t double up on doses to make up for a missed one.

Common Side Effects of FELDENE

Tell your doctor if any of the following side effects are severe or don’t go away:

• Diarrhea or constipation
• Gas
• Dizziness
• Ringing in the ears
• Headache

Serious Side Effects of FELDENE

Tell your doctor right away if you experience any of the symptoms listed in the FELDENE Warnings section above, or any of the following serious side effects:

• Vision problems
• Unexplained weight gain
• Joint pain
• Fever
• Blisters
• Rash, itching, or hives
• Difficulty breathing or swallowing
• Swelling of the face, eyes, lips, tongue, throat, arms, hands, feet, ankles, or lower legs
• Hoarseness
• Pale skin
• Excessive fatigue or lack of energy
• Fast heartbeat
• Unusual bleeding or bruising
• Upset stomach
• Loss of appetite
• Pain in the upper right part of the stomach
• Flu-like symptoms
• Yellowing of the eyes or skin
• Back pain
• Difficult or painful urination
• Discolored, cloudy, or bloody urine

FELDENE carries a black-box warning because it may increase the risk of heart attack or stroke in certain people.

This risk may be greater if you already have heart problems or if you take FELDENE for a long time.

Tell your doctor if you or anyone in your family has or has ever had:

• Heart disease
• A heart attack
• High blood pressure
• Diabetes
• High cholesterol

Don’t take FELDENE right before or right after bypass heart surgery.

Get emergency medical help right away if you experience any of the following symptoms while taking FELDENE:

• Shortness of breath
• Chest pain
• Weakness on one side of your body
• Slurred speech

This medicine also carries a black-box warning because it may increase your risk of developing stomach ulcers and bleeding. These problems can be serious and sometimes fatal.

Elderly people and those who take NSAIDs such as FELDENE for a long time have a greater risk of developing intestinal problems. Consuming alcohol may also increase your risk of stomach bleeding or ulcers.

Tell your doctor before starting FELDENE if you take any of the following medicines:

• Anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven)
• Aspirin
• Other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn)
• Oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)

Also, let your healthcare provider know if you have ever had ulcers, stomach bleeding, gastritis, or any bleeding problems.

Stop taking FELDENE right away and call your doctor if you experience:

• Stomach or abdominal pain
• Heartburn
• Vomit that looks like coffee grounds
• Bloody stools
• Black and tarry stools

Keep all appointments with your doctor and laboratory while taking FELDENE. Your doctor will want to carefully monitor your body’s response to the drug.

Before taking FELDENE, you should tell your doctor if you have or have ever had:

• Asthma
• Nasal polyps
• Swelling of the hands, feet, ankles, or lower legs
• Liver disease
• Kidney disease
• Stomach or bowel bleeding
• Low blood sodium levels
• A history of alcohol abuse
• Allergies to medications

Discuss the risks and benefits of using this medicine with your doctor if you’re over the age of 65. Older adults are more likely to experience serious side effects.

FELDENE will help control your symptoms, but it won’t cure your condition. It may take up to 12 weeks before you experience the full benefits of this drug.

Tell your doctor that you take FELDENE before any type of surgery, including dental procedures.

Pregnancy and FELDENE

FELDENE may harm an unborn baby. Don’t take this medicine without talking to a doctor if you’re pregnant or plan to become pregnant.

You especially shouldn’t take FELDENE during your last three months of pregnancy.

The medicine is found in breast milk and could hurt a nursing baby. Don’t take FELDENE while breastfeeding a baby.

FELDENE for Dogs

FELDENE is commonly used to manage pain in dogs.

It can also be combined with other drugs to treat a type of bladder cancer in dogs.

The medicine may have risks, so you should talk to your veterinarian before giving your pet FELDENE.

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you’re taking, especially those listed in the FELDENE Warnings section above, or any of the following:

• Angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• Diuretics (water pills)
• Lithium (Eskalith, Lithobid)
• Medications for diabetes
• Methotrexate (Rheumatrex)
• Phenytoin (Dilantin)

FELDENE and Other Interactions

FELDENE may cause dizziness or drowsiness.

Don’t drive or operate machinery until you know how this drug affects you.

FELDENE and Alcohol, Tobacco

Consuming alcohol or using tobacco products may raise the risk of developing serious side effects while taking FELDENE.

Talk to your doctor about these potential interactions.

Usual dose:

Follow all instructions given to you by your doctor or pharmacist carefully. Your doctor will explain when to start using ESTRADOT. ESTRADOT is used as continuous therapy. You will need to wear a patch all the time. The ESTRADOT patches are applied twice weekly on the same days of each week. Each patch should be worn continuously for 3 to 4 days.

It is important that you take your medication as your physician has prescribed. Do not discontinue or change your therapy without consulting your physician first.

What to do if the patch falls of:

Should a patch fall off in a very hot bath or shower, shake the water off the patch. Dry your skin completely and reapply the patch (to a different area of skin) and continue your regular schedule. Make sure you choose a clean, lotion-free area of the skin). If it still does not stick completely to your skin, then use a new patch. No matter what day this happens, go back to changing the patch on the same days as the initial schedule.

If hot baths, saunas or whirlpools are something you enjoy and you find that the patch is falling off, you may consider removing the patch temporarily while you are in the water. If you do remove the patch temporarily, the adhesive side of the patch should be placed on the protective liner that was removed when originally applying the patch. Wax paper may be used as an alternate to the liner. This prevents the contents of the patch from emptying by evaporation while you are not wearing it.

In addition to exposure to very hot water, there are some other causes for the patch failing to stick. If you are having patches fall off regularly, this could be happening as a result of:

• using any type of bath oil
• using soaps with a high cream content
• using skin moisturizers before applying the patch

Patch adhesion may be improved if you avoid using these products, and by cleansing the site of application with rubbing alcohol before you apply the patch.

What to do if your skin becomes red or irritated under or around the patch:

As with any product that covers the skin for a period of time (such as bandages), the ESTRADOT patch can produce some skin irritation in some women. This varies according to the sensitivity of each woman.

Usually this redness does not pose any health concern to you, but to reduce this problem, there are some things that you may do:

• Choose the buttock as the site of application
• Change the site of application of the ESTRADOT patch every time a new patch is applied, usually twice weekly

Experience with another matrix patch (VIVELLE) has shown that if you allow the patch to be exposed to the air for approximately 10 seconds after the protective liner has been removed, skin redness may not occur.

If redness and/or itching continues, you should consult your physician.

Overdose:

If more medication has been taken than what has been prescribed, remove the patch and contact either your doctor, hospital, or emergency department or poison control centre immediately.

Missed dose:

If you miss applying a patch, apply a new patch as soon as you remember. No matter what day that happens, go back to changing this patch on the same day as your initial schedule.

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

Check with your doctor as soon as possible if any of the following occur:

The most common adverse drug reactions (≥1%) are: swelling of the lower legs, ankles, fingers or abdomen due to fluid retention (oedema), change in weight, vaginal bleeding or spotting and changes in vaginal discharge, headache, depression, migraine, dizziness, nausea, abdominal pain and swelling, tender breasts and breast enlargement, and persistent or severe skin irritation, redness, rash or itching of the skin after the patch has been removed (signs of application site reaction includes bleeding, bruising, burning, discomfort, dryness, skin boils, edema, erythema, inflammation, irritation, pain, tiny solid skin bumps, rash, skin discolouration, skin pigmentation, swelling, hives, and blisters).

The less common adverse drug reactions (<1%) are: change in your sex drive, hair loss, excessive hairiness, vomiting, lump or mass in the breast (possible signs of breast cancer), fibroids (benign growths in the uterus) vaginal thrush (vaginal fungal infection with severe itching, vaginal discharge).

The adverse drug reactions with unknown frequency are: easy bruising, excessive nose bleeds, spotty darkening of the skin, particularly on the face or abdomen (chloasma), purple skin patches, acne, decline of memory or mental ability, rapid mood changes, contact lens discomfort, dry eyes, gall bladder disease (tendency to form gall stones), nervousness, back pain and pain in extremity, signs or symptoms that blood clots may have formed in your body (pains in the calves, thighs or chest, sudden shortness of breath, coughing blood or dizziness), increase in blood pressure, yellowing of the eyes or the skin, diarrhea, signs of an allergic reactions (sudden troubled breathing, tightness of the chest, general rash or itching), uncontrollable jerky movements (chorea), skin inflammation and rash (rash with painful red lumps, pain in joints and muscles swelling, blistering of lips, eyes, skin peeling) breast pain, irregular heavy vaginal bleeding or constant spotting (possible signs of endometrial hyperplasia), menstrual cramps, breast discharge, lumps in the breast (non-cancerous), hives, worsening of porphyria (a condition affecting the liver), and varicose veins.

Serious Warnings and Precautions

There is an increased risk of developing invasive breast cancer, heart attack, stroke and blood clots in both lungs and large veins with the use of estrogen plus progestin therapy.

There is an increased risk of stroke and blood clots in the large veins with the use of estrogen-alone therapy.

Estrogens with or without progestins should not be used for the prevention of heart disease or stroke.

Estrogens with or without progestins should be used at the lowest effective dose and for the shortest period of time possible. Regular medical follow-up is advised.

• Breast cancer
• The results of the WHI trial indicated an increased risk of breast cancer in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.
• The results of the WHI trial indicated no difference in the risk of breast cancer in postmenopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.
• Estrogens should not be taken by women who have a personal history of breast cancer.
• In addition, women with a family history of breast cancer or women with a history of breast lump, breast biopsies or abnormal mammograms (breast x-rays) should consult with their doctor before starting hormone replacement therapy.
• Women should have a mammogram before starting HRT and at regular intervals during treatment as recommended by their doctor.
• Regular breast examinations by a doctor and regular breast self-examination are recommended for all women. You should review technique for breast self-examination with your doctor.
• Overgrowth of the lining of the uterus and cancer of the uterus
• The use of estrogen-alone therapy by post menopausal women who still have a uterus increases the risk of developing endometrial hyperplasia (overgrowth of the lining of the uterus), which increases the risk of endometrial cancer (cancer of the lining of the uterus).
• If you still have your uterus, you should take a progestin medication (another hormone drug) regularly for a certain number of days of each month to reduce the risk of endometrial hyperplasia.
• You should discuss progestin therapy and risk factors for endometrial hyperplasia and endometrial carcinoma with your doctor. You should also report any unexpected or unusual vaginal bleeding to your doctor.
• If you have had your uterus removed, you are not at risk of developing endometrial hyperplasia or endometrial carcinoma. Progestin therapy is therefore not generally required in women who have had a hysterectomy.
• Ovarian cancer
• In some studies, the use of estrogen-alone and estrogen plus progestin therapies for 5 or more years has been associated with an increased risk of ovarian cancer.
• Heart disease and Stroke
• The results of the WHI trial indicated an increased risk of stroke and coronary heart disease in post-menopausal women taking combined estrogen plus progestin compared to women taking placebo.
• The results of the WHI trial indicated an increased risk of stroke, but no difference in the risk of coronary heart disease in post-menopausal women with prior hysterectomy taking estrogen alone compared to women taking placebo.
• Abnormal Blood Clotting
• The results of the WHI trial indicated an increased risk of blood clots in the lungs and large veins in post menopausal women taking combined estrogen plus progestin compared to women taking placebo.
• The results of the WHI trial indicated an increased risk of blood clots in the large veins, but no difference in the risk of blood clots in the lungs in post-menopausal women with prior hysterectomy taking estrogen-alone compared to women taking placebo.
• The risk of blood clots increases with age, if you or a family member has had blood clots, if you smoke or if you are severely overweight. The risk of blood clots is also temporarily increased if you are immobilized for long periods of time and following major surgery. You should discuss risk factors for blood clots with your doctor since blood clots can be life-threatening or cause serious disability.
• Gallbladder disease
• The use of estrogens by postmenopausal women has been associated with an increased the risk of gallbladder disease requiring surgery.
• Dementia
• The Women's Health Initiative Memory Study (WHIMS) was a substudy of the WHI trial and indicated an increased risk of dementia (loss of memory and intellectual function) in post-menopausal women age 65 and over taking oral combined estrogen plus progestin compared to women taking placebo.
• The WHIMS indicated no difference in the risk of dementia in post-menopausal women age 65 and over with prior hysterectomy taking oral estrogen-alone compared to women taking placebo.

Before you use ESTRADOT talk to your doctor or pharmacist if you:

• have a history of severe allergic reaction or intolerance to any medications or other substances
• have been told that you have a condition called hereditary angioedema of if you have had episodes of rapid swelling of the hands, feet, face, lips, eyes, tongue, throat (airway blockage) or digestive tract
• have a personal history of breast disease (including breast lumps) and/or breast biopsies, or a family history of breast cancer
• have experienced any unusual or undiagnosed vaginal bleeding
• have a history of uterine fibroids or endometriosis
• have a history of liver disease or liver tumours, jaundice (yellowing of the eyes and/or skin) or itching related to estrogen use or during pregnancy
• have a history of migraine headache
• have a history of high blood pressure
• have a personal or family history of blood clots, or a personal history of heart disease or stroke
• phlebitis (inflamed varicose veins)
• have a history of kidney disease or asthma
• have a history of bone disease (this includes certain metabolic conditions or cancers that can affect blood levels of calcium and phosphorus)
• have been diagnosed with diabetes
• have been diagnosed with porphyria (a disease of blood pigment)
• have been diagnosed with lupus
• gall bladder disease
• depression
• have been diagnosed with hearing loss due to otosclerosis
• epilepsy (seizures) or other neurological disorders
• have a history of high cholesterol or high triglycerides
• are pregnant or may be pregnant
• are breastfeeding
• have had a hysterectomy (surgical removal of the uterus)
• smoke
• are undergoing surgery or need long bed rest
• have had several miscarriages
• have hypothyroidism, a condition in which your thyroid gland fails to produce enough thyroid hormone and for which you are treated with thyroid hormone replacement therapy.

Ask your doctor and pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you are taking or have recently taken any other medications, including prescription medications, over-the-counter medications, vitamins or herbal products.

This particularly includes the following: anti-anxiety medicines (e.g. barbiturates, meprobamate), anti-epileptic medicines (e.g. phenobarbital, phenytoin or carbamazepine), an anti-inflammatory medicine called phenylbutazone, antibiotics and other anti-infective medicines (e.g. rifampicin, ketoconazole, erythromycin, rifabutin, nevirapine, efavirenz), and herbal medicines (e.g. St John's wort).

The following interactions with ethinyl estradiol-containing products (specifically, oral contraceptives) have been reported in the public literature. It is unknown whether such interactions occur with drug products containing other types of estrogens (like hormone replacement therapy): acetaminophen, vitamin C, aminoglutethimide with medroxyprogesterone acetate (MPA), atorvastatin, clofibric acid, cyclosporin, morphine, prednisolone, salicylic acid, temazepam, theophylline, and troglitazone.

These medicines may be affected by ESTRADOT or, conversely, they may affect how well ESTRADOT works. Your doctor may need to adjust the dose of your treatment.

Usual dose:

Take EMEND exactly as your physician has prescribed. The recommended dose of EMEND is one 125 mg capsule by mouth 1 hour before you start your chemotherapy treatment on Day 1 and one 80 mg capsule by mouth each morning for the 2 days following your chemotherapy treatment.

EMEND may be taken with or without food.

Overdose:

If you take more than the prescribed dosage, contact your physician immediately.

Missed dose:

Try to take EMEND as prescribed. However, if you miss a dose, contact your physician for further instructions.

Any medicine may have unintended or undesirable effects, so-called side effects.

Like all prescription drugs, EMEND may cause side effects.

The most common side effects included diarrhea, stomach pain, upset stomach, vomiting, dizziness, hiccups, fatigue, weakness, constipation, headache, hair loss, and loss of appetite.

Other side effects may also occur rarely, which include: anxiousness, fever with increased risk of infection, dry mouth, conjunctivitis (eye discharge and itching), excessive sweating, flushing, painful burning urination, muscle cramp or pain, taste disturbance, ringing in the ear (tinnitus), and low blood pressure.

The following side effects have been reported in general use with EMEND: Allergic reactions, which may be serious, and may include hives, rash and itching and cause difficulty in breathing or swallowing. If you have an allergic reaction, stop taking EMEND and call your physician right away.

Ask your physician or pharmacist for more information. Both have a more complete list of side effects. Tell your physician or pharmacist promptly about these or any other unusual symptoms.

Serious Warnings and Precautions

Drug interactions with:

• Medicines that are likely to be broken down mainly by the liver
• Warfarin
• Hormonal contraception (birth control medicines)

BEFORE you use EMEND talk to your physician or pharmacist if:

• you have any past or present medical problems
• you have liver problems
• you have any allergies
• you drive a car or operate machinery
• you are pregnant or plan to become pregnant
• you are breast-feeding or plan to breast-feed

Use in children:

EMEND should not be given to children under 18 years of age.

Use in the elderly:

No dosage adjustment is necessary.

Tell your physician about all medicines that you are taking or plan to take, even those you can get without a prescription or herbal products.

Your physician may check that your medicines are working properly together if you are taking other medicines such as:

• anti-anxiety drugs (such as alprazolam, midazolam)
• birth control medicines (which may not work as well)
• ketoconazole (an antifungal)
• rifampin (an antibiotic)
• paroxetine (a medicine used to treat a certain type of depression)
• diltiazem (a medicine used to treat high blood pressure)
• dexamethasone, methylprednisolone (steroid medicines used for a variety of conditions)
• warfarin (a blood thinner)
• tolbutamide (a medicine used to treat diabetes)
• phenytoin (a medicine used to treat seizures)
• some chemotherapy medications such as ifosfamide