Oral form: Oral FLOXIN contains a black-box warning because it may raise your risk of developing tendonitis (swelling of a tendon, the tissue that connects a bone to a muscle) or a tendon rupture.

This risk can happen to anyone but is greatest in people over age 60. Tell your doctor if you've ever had:

• A kidney, heart, or lung transplant

• Kidney disease

• A joint or tendon condition, such as rheumatoid arthritis

Also, let your doctor know if you participate in regular physical activity, or if you take any oral or injectable steroid medicines.

Tell your doctor right away if you experience any of the following symptoms while taking FLOXIN:

• Pain, swelling, tenderness, stiffness, or difficulty moving a muscle

• Feeling or hearing a snap or pop in the tendon area

• Inability to move or put weight on an affected area

• Bruising after an injury to your tendon area

The risk of tendonitis or a tendon rupture is higher both during your treatment with FLOXIN, and for several months after you stop the therapy.

Oral FLOXIN also contains a black-box warning because it can worsen muscle weakness, and cause severe breathing difficulties or death, in people with myasthenia gravis (a disorder of the nervous system).

Tell your doctor if you have myasthenia gravis before taking oral FLOXIN.

Also, let your doctor know if you have, or have ever had:

• Prolonged QT interval (a condition that can cause irregular heartbeat, fainting, or sudden death)

• An irregular or slow heartbeat

• Chest pain

• Nerve problems

• Seizures

• Low levels of potassium in your blood

• Liver disease

• Cerebral arteriosclerosis (narrowing of blood vessels in or near the brain)

• Allergies to medications (especially other antibiotics)

Oral FLOXIN can cause nerve damage that may not go away after you stop taking the medicine. Call your doctor immediately if you notice any of the following symptoms:

• Numbness

• Tingling pain

• Burning in the arms or legs

• Change in your ability to feel pain, cold, heat, or a light touch

This medicine shouldn't be given to children under 18.

Common Side Effects of FLOXIN

Oral form: Tell your doctor if any of the following side effects of become severe or don't go away:

• Nausea, mild diarrhea, constipation, gas, or vomiting

• Stomach pain or cramps

• Loss of appetite

• Change in ability to taste food

• Headache

• Dry mouth

• Dizziness

• Excessive tiredness

• Pain, swelling, or itching of the vagina

Ear drops: Tell your doctor know if any of the following side effects become severe or don't go away:

• Ear pain or itching

• Changes in taste

• Dizziness

Eye drops: Tell your doctor if any of the following side effects become severe or don't go away:

• Blurred vision

• Burning, itching, stinging, redness, or discomfort in the eye

• Dry eyes, eye pain, or tearing

• Sensitivity to sunlight

Serious Side Effects of FLOXIN

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

• Severe diarrhea

• Confusion or hallucinations

• Nightmares or difficulty sleeping

• Depression, anxiety, or suicidal thoughts

• Uncontrollable shaking of a part of the body

• Restlessness

• Vision changes

• Fever

• Skin peeling or blistering

• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, throat, feet, ankles, or lower legs)

• Hoarseness

• Fast heartbeat

• Fainting

• Loss of consciousness

• Dark-colored urine, or a decrease in the amount of urine produced

• Yellowing of the skin or eyes (jaundice)

• Seizures

• Unusual bleeding or bruising

• Joint or muscle pain

Ear drops: Tell your doctor right away if you experience any of the following serious side effects:

• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, throat, feet, ankles, or lower legs)

Eye drops: Tell your doctor right away if you experience any of the following serious side effects:

• Signs of an infection, which may include fever, chills, or sore throat

• Severe itching

• Loss of consciousness

• Severe sensitivity to light

• Signs of an allergic reaction (may include hives, rash, itching, chest tightness, or swelling of the face, lips, tongue, or throat)

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

• Other antibiotics

• Antacids containing aluminum, calcium, or magnesium (includes Maalox, Mylanta, Tums, and others)

• Anticoagulants (blood thinners) such as Coumadin or Jantoven (warfarin)

• Certain antidepressants

• Antipsychotics (drugs to treat mental illness)

• Tagamet (Cimetidine)

• Gengraf, Neoral, or Sandimmune (cyclosporine)

• Videx (didanosine)

• Diuretics (water pills)

• Insulin and oral medications for diabetes

• Certain drugs for irregular heartbeat, such as quinidine, Cordarone (amiodarone), Procanbid (procainamide), or Betapace, Betapace AF, or Sorine (sotalol)

• Nonsteroidal anti-inflammatory drugs (NSAIDs), such as Advil or Motrin (ibuprofen) or Aleve (naproxen)

• Probalan (probenecid) or Col-Probenecid (colchicine and probenecid)

• Carafate (sucralfate)

• Supplements or multivitamins containing iron or zinc

• Elixophyllin, Theo-24, or Uniphyl (theophylline)

FLOXIN and Other Interactions

Oral FLOXIN may cause dizziness or lightheadedness, and eye drops may cause blurred vision.

Don't drive or operate machinery until you know how this medicine affects you.

The drug may also make your skin more sensitive to the sun.

Avoid unnecessary exposure to sunlight, and wear sunglasses, sunscreen, and protective clothing when outdoors.

Caffeine from coffee and other caffeinated beverages may interact with how FLOXIN eye drops work.

Talk to your doctor about how much caffeine is safe to consume while taking this medicine.

Oral form: Oral FLOXIN comes as a tablet. It's typically taken by mouth twice a day, for three days to six weeks.

The medicine can be taken with or without food. Try to take it around the same time each day.

Your dose and length of treatment will depend on the type of infection you have.

Follow the instructions on your prescription label carefully. Don't take more or less FLOXIN than is recommended.

Be sure to drink plenty of water while taking oral FLOXIN.

Ear drops: FLOXIN ear drops come as a liquid drop to apply to the opening of the ear canal. They're usually taken once or twice a day, for 7 to 14 days.

Try to use take medicine around the same time each day.

Use FLOXIN ear drops exactly as directed. Don't take more or less of the medicine than is prescribed by your doctor.

Don't use FLOXIN ear drops in your eyes.

Eye drops: FLOXIN eye drops come as a liquid drop to apply to the eye. They're usually taken in the affected eye four or more times a day.

Wash your hands before and after taking FLOXIN eye drops. Try to take them around the same time each day.

Follow the instructions on your product label carefully when using the drops.

Remove your contact lenses before taking FLOXIN eye drops. You can put them back in 10 minutes after you give yourself a dose.

Don't swallow FLOXIN eye drops.

FLOXIN Overdose

Symptoms of an FLOXIN overdose may include:

• Dizziness

• Drowsiness

• Nausea

• Hot and cold flashes

• Slurred speech

• Confusion

• Numbness or swelling of the face

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

You can get in touch with a poison control center.

Missed Dose of FLOXIN

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

But if it's almost time for your next dose, skip the missed dose and continue with your regular medication schedule.

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

Don't take more than two doses of oral FLOXIN in one day.

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Your steroid medication needs may change if you have unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using FLORINEF.

Do not stop using FLORINEF suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking steroid medication.

Store FLORINEF at room temperature away from moisture and heat.

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include swelling, weight gain, feeling short of breath, confusion, uneven heart rate, increased thirst or urination, leg discomfort, and muscle pain or weakness.

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• problems with your vision;

• swelling, rapid weight gain, feeling short of breath;

• severe depression, unusual thoughts or behavior, seizure (convulsions);

• bloody or tarry stools, coughing up blood;

• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• sleep problems (insomnia), mood changes;

• acne, dry skin, thinning skin, bruising or discoloration;

• slow wound healing;

• increased sweating;

• headache, dizziness, spinning sensation;

• nausea, stomach pain, bloating; or

• changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist).

You should not use this medication if you are allergic to FLORINEF, or if you have a fungal infection anywhere in your body.

Before taking FLORINEF, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are taking FLORINEF. Vaccines may not work as well while you are taking a steroid.

Do not stop using FLORINEF suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

You should not use this medication if you are allergic to FLORINEF, or if you have a fungal infection anywhere in your body.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking this medication, tell your doctor about any illness or infection you have had within the past several weeks.

Other medical conditions you should tell your doctor about before taking FLORINEF include:

• liver disease (such as cirrhosis);

• kidney disease;

• a thyroid disorder;

• diabetes;

• a history of malaria;

• tuberculosis;

• osteoporosis;

• a muscle disorder such as myasthenia gravis;

• glaucoma or cataracts;

• herpes infection of the eyes;

• stomach ulcers, ulcerative colitis, or diverticulitis;

• depression or mental illness;

• congestive heart failure; or

• high blood pressure

If you have any of these conditions, you may need a dose adjustment or special tests to safely take FLORINEF.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

Do not receive a "live" vaccine while you are being treated with FLORINEF. Vaccines may not work as well while you are taking a steroid.

There are many other medicines that can interact with steroids. Below is only a partial list of these medicines:

• aspirin (taken on a daily basis or at high doses);

• amphotericin B (Fungizone);

• a diuretic (water pill);

• digoxin (digitalis, Lanoxin);

• phenytoin (Dilantin);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• birth control pills or hormone replacement therapy;

• a blood thinner such as warfarin (Coumadin);

• insulin or diabetes medications you take by mouth;

• an anabolic steroid such as oxymetholone (Anadrol-50), nandrolone (Durabolin, others), and others; or

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton).

This list is not complete and there may be other drugs that can interact with FLORINEF. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Usual dose:

The starting dose: 240 mg given as two injections of 120 mg each.

The maintenance dose: 80 mg given once a month. The maintenance dose is usually given one month after the starting dose.

The injected liquid forms a gel from which a continuous release of FIRMAGON takes place over a period of one month.

How is FIRMAGON used?

The powder and solvent are mixed and injected by your doctor or a nurse in your abdominal region.

FIRMAGON must be injected under the skin (subcutaneously) ONLY. The site of injection is likely to vary within the abdominal region.

Make sure your injection site is free of any pressure from belts, waistbands or other types of clothing.

Always remind your doctor or nurse to set up an appointment for your next injection.

Monitoring and testing while taking FIRMAGON:

You will be checked regularly by your doctor while you are taking FIRMAGON, to monitor side effects and to check your response to therapy. Blood tests may be ordered by your doctor.

Overdose:

If you think you were given more FIRMAGON than required, talk to your doctor or nurse, or contact poison control centre immediately.

Missed dose:

If you missed an injection at the usual time and/or if you believe your monthly dose of FIRMAGON has been forgotten, talk to your doctor or nurse.

Common side effects with FIRMAGON include injection site reactions (e.g. pain, redness, node or hardness, and/or swelling), hot flashes, weight gain, increase in blood liver enzymes, high blood pressure, back pain, increase in blood cholesterol, nausea, tiredness, chills, constipation, dizziness and anemia.

Injection site reactions have occurred, usually with the first dose and become less with subsequent doses. These reactions are usually mild and resolve after a few days.

Less common side effects include: weakness, fever or flu-like illness, sweating, bone pain, headache, trouble sleeping. Frequent passage of small amount of urine and urge to urinate.

Uncommon side effects include loss of sex drive, impotence, decrease in testicular size, breast swelling and diarrhea.

FIRMAGON may induce thinning of the bone (osteoporosis), and/or a change in heart rhythm (QT prolongation). QT prolongation symptoms include sensation of skipped heart beats or rapid or forceful beats, shortness of breath, chest discomfort and fainting.

Contact your doctor immediately if you experience any of the following symptoms: severe back pain, severe hot flashes, heavy sweating, severe pain in the chest or abdomen, abnormal swelling, weakness, persistent nausea or vomiting, or rapid heart beat.

Serious Warnings and Precautions

FIRMAGON should be prescribed by a doctor experienced in the use of hormonal therapy in prostate cancer and administered (given) under his/her supervision.

FIRMAGON has not been studied in patients with severe liver impairment or in patients with severe kidney impairment.

Possible serious side effects of FIRMAGON include:

• QT prolongation (changes in heart rhythm)
• Osteoporosis (thinning of the bone)

BEFORE you use FIRMAGON talk to your doctor or pharmacist if you:

• are taking medicines that affect the heart rhythm
• have any heart problems such as abnormal heartbeat (arrhythmias)
• have problems with the balance of your body salts or electrolytes, such as sodium, potassium, calcium and magnesium
• have kidney or liver problems
• have diabetes mellitus (sugar diabetes). Worsening or onset of diabetes may occur. If you have diabetes, you may have to measure blood glucose more frequently
• have bone problems. The use of FIRMAGON may result in loss of mineral from bone, some of which may not be reversible
• have anemia (low red blood cell count)

FIRMAGON may cause the body to produce anti-degarelix antibody. There is no indication that this impacts the safety and efficacy of FIRMAGON treatment.

FIRMAGON may cause dizziness. Do not drive a car or operate machinery until you know how the drug affects you.

FIRMAGON is not indicated for use in women and children.

Tell your doctor and pharmacist if you are taking or have taken any medicines for your heart such as:

• antiarrhythmics (e.g. quinidine, disopyramide, procainamide, amiodarone, sotalol, dofetilide, ibutilide, flecainide, propafenone)

Or other medicines which can have an effect on heart rhythm such as:

• antipsychotics (e.g. chlorpromazine)
• antidepressants (e.g. amitriptyline, nortriptyline)
• opioids (e.g. methadone)
• macrolide antibiotics and analogues (e.g. erythromycin, clarithromycin, azithromycin)
• quinolone antibiotics (e.g. moxifloxacin)
• pentamidine
• antimalarials (e.g. quinine)
• azole antifungals
• cisapride
• 5-hydroxytryptamine (5-HT3) receptor antagonists (e.g. ondansetron)
• beta-2 adrenoceptor agonists (e.g. salbutamol)

Tell your doctor if you are taking or have recently taken, or are planning to take any other medicines, including non-prescription drugs such as vitamins and herbal supplements.

You should start taking ELLA during the first 7 days of your menstrual period.

A single treatment course is three months of continuous use.

You should wait two menstrual cycles before starting the next treatment cycle of ELLA.

The tablet should be swallowed with water and may be taken with or without food.

Always take ELLA exactly as your healthcare professional has told you. Never take more than prescribed.

Usual adult dose:

The usual dose of ELLA is one 5 mg tablet per day, taken by mouth.

Treatment should be started when menstruation has occurred:

• The first treatment course should be started within the first 7 days of menstruation.
• Subsequent treatment courses should start, at earliest, during the first week of the second menstruation following completion of the previous treatment course.

Overdose:

Warning: If you think you have taken too much ELLA, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose, take it as soon as you remember. However, if it is time for your next tablet, skip the missed tablet and take only a single tablet as usual. Do not take a double dose to make up for a forgotten tablet.

These are not all the possible side effects you may feel when taking ELLA. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• headache
• breast pain, tenderness and/or discomfort
• vaginal discharge
• pelvic pain
• nausea
• fatigue
• acne
• obesity
• feeling like you are spinning and/or loss of balance (vertigo)
• hair loss

When you use ELLA, you will find that this usually leads to a big drop, or even a stop, in the bleeding of your periods within the first few days. If you keep bleeding a lot or have any unexpected or unusual bleeding, tell your healthcare professional.

The lining of the uterus may thicken or change as a result of taking ELLA. These changes return to normal after treatment stops and your periods restart. If you take ELLA for more than one treatment cycle your healthcare professional may recommend a yearly ultrasound of your uterus, once your period returns, to monitor these changes.

ELLA should not be taken by children under 18 years of age.

The following may interact with ELLA:

• Phenytoin, phenobarbital, carbamazepine, oxcarbazepine, fosphenytoin, primidone (drugs to treat epilepsy)
• Ritonavir, efavirenz, nevirapine (drug to treat HIV infections)
• Rifampicin, telithromycin, clarithromycin, erythromycin, rifabutin (antibiotics)
• Ketoconazole (except shampoo), itraconazole (drugs to treat fungal infections)
• St John’s wort (a herbal treatment for depression)
• Nefazodone (drug to treat depression)
• Hormonal methods of birth control (such as “the pill”)

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

The RAZADYNE ER extended-release capsule is usually taken once per day in the morning. Follow your doctor's instructions.

The RAZADYNE short-acting tablet or the oral solution (liquid) are usually given two times per day, with meals. Follow your doctor's instructions.

The extended-release capsule works best if you take it with food.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Take RAZADYNE with a full glass of water. Drink 6 to 8 full glasses of water each day to keep from getting dehydrated while taking this medication.

If you need surgery, tell the surgeon ahead of time that you are using RAZADYNE. You may need to stop using the medicine for a short time.

If you have stopped taking RAZADYNE for any reason, talk with your doctor before you start taking it again. You may need to restart the medication at a lower dose.

Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

Seek emergency medical attention or call the Poison Help line.

Overdose symptoms may include severe nausea, vomiting, stomach cramps, muscle weakness or spasm, watery eyes, drooling, increased urination or bowel movements, sweating, slow heart rate, feeling light-headed or fainting, and seizure (convulsions).

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 take extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain, slow heart rate;
• little or no urinating;
• blood in your urine;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
• a light-headed feeling, like you might pass out; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• nausea, vomiting, diarrhea, loss of appetite;
• headache, dizziness;
• depression; or
• weight loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

You should not use RAZADYNE if you are allergic to it.

To make sure RAZADYNE is safe for you, tell your doctor if you have:

• urination problems;
• heart disease or a heart rhythm disorder;
• a history of stomach ulcer or bleeding;
• seizures or epilepsy;
• kidney disease;
• liver disease; or
• a history of asthma or chronic obstructive pulmonary disease (COPD).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether RAZADYNE passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Tell your doctor about all your current medicines and any you start or stop using, especially:

• bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
• bronchodilators such as aclidinium, ipratropium, or tiotropium;
• cold or allergy medicine that contains an antihistamine;
• medication for Parkinson's disease; or
• medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome.

This list is not complete. Other drugs may interact with RAZADYNE, including prescription and over-the-counter medicines, vitamins, and herbal products.