STIOLTO RESPIMAT is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

Olodaterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Use only the prescribed dose of this medicine, and do not use it for longer than your doctor recommends. Follow all patient instructions for safe use.

You should not use this medicine if you are allergic to olodaterol, tiotropium, or ipratropium (Atrovent, Combivent, DuoNeb). STIOLTO RESPIMAT is for use only in people with COPD and should not be used to treat asthma.

Olodaterol may increase the risk of death in people with asthma, but the risk in people with COPD is not known. Talk with your doctor about your individual risks and benefits of using this medicine.

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

• heart disease, coronary artery disease, or high blood pressure;
• epilepsy or other seizure disorder;
• a thyroid disorder;
• glaucoma;
• enlarged prostate;
• kidney disease;
• a food allergy; or
• bladder obstruction or other urination problems.

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 STIOLTO RESPIMAT passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

STIOLTO RESPIMAT is not approved for use by anyone younger than 18 years old.

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

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine;
• new or worsening COPD symptoms;
• painful or difficult urination;
• blurred vision, tunnel vision, eye pain, or seeing halos around lights;
• severe headache, pounding in your neck or ears;
• fast or irregular heartbeats; or
• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common side effects may include:

• stuffy nose, sinus pain;
• cough; or
• back pain.

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

Avoid getting this medicine in your eyes.

Do not use a second long-acting inhaled bronchodilator such as arformoterol (Brovana), albuterol (Combivent, DuoNeb), formoterol (Foradil, Perforomist, Symbicort), olodaterol (Striverdi), or salmeterol (Serevent, Advair) unless your doctor has told you to.

This medicine may cause dizziness and blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

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

• atropine;
• bladder or urinary medicines such as darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin;
• cold or allergy medicine that contains an antihistamine;
• medication for Parkinson's disease;
• medication to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome; or
• other bronchodilators such as aclidinium (Tudorza), ipratropium (Atrovent, Combivent), tiotropium (Spiriva), or umeclidinium (Incruse Ellipta).

This list is not complete. Other drugs may interact with STIOLTO RESPIMAT, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

The usual dose of this medicine is 2 inhalations once per day. Use the medicine at the same time each day, and not more than once in a 24-hour period. Using too much of this medicine can cause life-threatening side effects.

STIOLTO RESPIMAT is not a rescue medicine. It will not work fast enough to treat a COPD flare-up. Your doctor may prescribe a fast-acting inhalation medicine to treat a bronchospasm attack.

Tell your doctor if any of your medicines seem to stop working as well in controlling your symptoms.

This medicine comes with patient instructions for safe and effective use, and directions for priming the inhaler device. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Use only the inhaler device provided with your medicine or you may not get the correct dose. Use the new inhaler each time you get your prescription refilled.

Call your doctor right away if you feel that this medicine is not working as well as usual, or if you think you need to use more than usual. An increased need for medication could be an early sign that your condition is getting worse.

COPD is usually treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

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

Seek emergency medical attention or call the Poison Help line.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Do not use more than two inhalations every 24 hours.

Stay under a doctor's care when taking STRIBILD. Do not change your treatment or stop treatment without first talking with your doctor.

Take STRIBILD every day exactly as your doctor prescribed it. Follow the directions from your doctor, exactly as written on the label. Set up a dosing schedule and follow it carefully.

When your STRIBILD supply starts to run low, get more from your doctor or pharmacy. This is very important because the amount of virus in your blood may increase if the medicine is stopped for even a short time. If STRIBILD is not taken regularly, as prescribed, the virus may develop resistance to STRIBILD and become harder to treat.

Only take medicine that has been prescribed specifically for you. Do not give STRIBILD to others or take medicine prescribed for someone else. Do not use if seal over bottle opening is broken or missing.

Usual adult dose:

• The usual dose of STRIBILD is one tablet orally (by mouth) once a day, preferably at the same time each day. Swallow with plenty of water.
• Take STRIBILD with food. Taking STRIBILD with food helps get the right amount of medicine in your body.

Overdose:

In case of drug overdose, contact your healthcare practitioner (e.g. doctor), hospital emergency department or regional poison control centre, even if there are no symptoms.

Missed dose:

It is important that you do not miss any doses. If you miss a dose of STRIBILD and it is less than 12 hours from the time you usually take STRIBILD, then take the dose. If more than 12 hours has passed from the time you usually take STRIBILD, then wait until the next scheduled daily dose. Do not take more than 1 dose of STRIBILD in a day. Do not take 2 doses at the same time. Call your doctor or pharmacist if you are not sure what to do.

The common side effects of STRIBILD are:

• Diarrhea
• Nausea
• Headache

Additional side effects may include:

• Depression
• Vomiting
• Tiredness
• Stomach pain
• Upset stomach
• Gas
• Dizziness
• Trouble sleeping
• Abnormal dreams
• Serious kidney problems
• Rash
• Suicidal ideation (suicidal thoughts) and suicide attempt (in patients who have had depression or previous mental health problems). If you have these thoughts, contact your doctor.

Other common side effects reported for EMTRIVA and VIREAD are:

• Allergic reaction (including skin rash, redness, irritation, swelling of the face, lips, tongue or throat)
• Pancreatitis (inflammation of the pancreas)
• Shortness of breath
• Skin discoloration (small spots or freckles)
• Sinusitis (inflammation of the sinuses)
• Nasopharyngitis (inflammation of the nasal cavity and throat area)
• Somnolence (feeling sleepy)
• Upper respiratory tract infection
• Back pain
• Weakness
• Pain

Changes in body fat have been seen in some patients taking antiretroviral therapy. These changes may include increased amounts of fat in the upper back and neck (“buffalo hump”), breast, and around the trunk. Loss of fat from the legs, arms and face may also happen. The cause and long term health effects of these conditions are not known at this time.

Changes in your immune system (Immune Reconstitution Inflammatory Syndrome) can happen when you start taking HIV medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time, or you could develop an autoimmune disease in which your immune system reacts against your own body (e.g. Graves' disease (which affects the thyroid gland), Guillain-Barré syndrome (which affects the nervous system) or polymyositis (which affects the muscles) and it may develop at any time, sometimes months later after the start of HIV therapy). Sometimes symptoms can be severe, so if you develop high temperature (fever), joint or muscle pain, redness, rash, swelling or fatigue, or any new symptoms, contact your doctor right away.

Tell your doctor if you have any side effect that bothers you or that does not go away.

• In animal studies, tenofovir DF, a component of STRIBILD, caused harm to the bones of animals. If you notice bone pain, suffer a bone fracture, or other bone problem, consult your doctor. If you have bone problems, you may wish to discuss calcium and/or vitamin D supplementation with your doctor. The effect of supplementation with calcium and/or vitamin D is unknown.

• Patients who experience dizziness, trouble concentrating or drowsiness should avoid driving or operating machinery.

• If you have advanced HIV infection (AIDS) and have an infection, you may develop symptoms of infection and inflammation or worsening of the symptoms of an existing infection once treatment with STRIBILD is started. These symptoms may indicate that your body's improved immune system is fighting infection. If you notice signs of inflammation or infection, tell your doctor at once.

BEFORE you use STRIBILD (elvitegravir/cobicistat/emtricitabine/tenofovir DF) talk to your doctor or pharmacist:

If you are pregnant or plan to become pregnant: It is not known if STRIBILD can harm your unborn child.

Pregnancy Registry. There is a pregnancy registry for women who take antiviral medicines during pregnancy. This registry collects information about your health and your baby's health. If you become pregnant while taking STRIBILD, talk with your doctor about taking part in this registry.

If you are breast-feeding or plan to breast-feed: Do not breast-feed if you have HIV because of the chance of passing the HIV virus to your baby. Two of the components of STRIBILD, emtricitabine and tenofovir DF, can be passed to your baby in your breast milk and may cause harm to your baby. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby.

If you have other medical conditions: Let your doctor know if you have other medical conditions, especially liver problems (including hepatitis B or C virus) infection, kidney problems, or have or are at risk for bone disease or bone related problems or pancreatitis (inflammation of the pancreas).

If you are taking other medicines: Some medicines can interact when taken together, including prescription and non-prescription medicines, herbal products and dietary supplements.

Drugs that should not be taken with STRIBILD:

• alfuzosin hydrochloride (Xatral)
• astemizole (Hismanal) or terfenadine (Seldane)
• cisapride (Prepulsid)
• carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
• ergot-containing medicines: dihydroergotamine, ergonovine, ergotamine, methylergonovine, such as Cafergot, Migranal, D.H.E. 45, Ergotrate, Methergine, Migergot, Ergomar, and others.
• lovastatin (Advicor, Altoprev*, Mevacor)
• midazolam (Versed), when taken by mouth
• phenobarbital (Luminal)
• phenytoin (Dilatin, Phenytek)
• pimozide (Orap)
• rifampin (Rifadin, Rifamate, Rifater, Rofact)
• salmeterol (Advair, Serevent)
• sildenafil (Revatio), when used for treating lung problems
• simvastatin (Simcor, Vytorin*, Zocor)
• St. John's wort (Hypericum perforatum) or products containing St. John's wort
• triazolam (Halcion)

If you are taking STRIBILD, you should not take:

• Do not take STRIBILD if you are on other medications that may affect your kidneys and have not discussed this with your doctor.
• Any other medicines to treat HIV infection.
• Other medicines that contain tenofovir (ATRIPLA, COMPLERA, VIREAD, TRUVADA).
• Other medicines that contain emtricitabine or lamivudine (Combivir, EMTRIVA, 3TC or Heptovir, Kivexa, Trizivir)
• ritonavir (Kaletra, Norvir)
• adefovir (HEPSERA)
• ledipasvir/sofosbuvir (HARVONI)

Also tell your doctor if you take:

• An antacid medicine that contains aluminum, magnesium hydroxide, or calcium carbonate. Take antacids at least 2 hours before or after you take STRIBILD.
• Antidepressants such as trazodone
• Antifungals such as ketaconazole (Nizoral), itraconazole (Sporanox) and voriconazole (Vfend)
• Antiarrhythmics such as amiodarone (Cordarone), flecainide (Tambacor) and quinidine (Neudexta)
• Antibacterials such as clarithromycin (Biaxin) and telithromycin (Ketek)
• Antimycobacterials such as rifabutin (Mycobutin)
• Anticoagulants such as warfarin (Coumadin)
• Antigout (colchicine)
• Antipsychotics such as quetiapine (Seroquel)
• Beta-blockers such as metoprolol (Lopresor) and timolol
• Calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem), and felodipine
• Corticosteroids systemic such as dexamethasone and fluticasone (Flonase)
• Endothelial receptor antagonists such as bosentan (Tracleer)
• Hormonal contraceptives such as norgestimate/ethinyl estradiol
• Immunosuppressants such as cyclosporine (Neoral), sirolimus (Rapamune) and tacrolimus (Prograf)
• Neuroleptics such as risperidone (Risperdal) and perphenazine (Trilafon)
• PDE-5 Inhibitors such as sildenafil (Viagra), tadalafil (Cialis, Adcirca), and vardenafil (Levitra)
• Sedative/hypnotics such as diazepam (Valium), flurazepam and buspirone

These are not all the medicines that may cause problems if you take STRIBILD. Be sure to tell your doctor about all the medicines you take.

Keep a complete list of all the prescription and nonprescription medicines as well as any herbal medicines that you are taking, how much you take and how often you take them. Make a new list when medicines or herbal medicines are added or stopped, or if the dose changes. Give copies of this list to all your doctors and pharmacists every time you visit them or fill a prescription. This will give your doctor a complete picture of the medicines you use. Then he or she can decide the best approach for the situation.

You shouldn’t take STROMECTOL if you’re allergic to STROMECTOL or any ingredients in the drug.

Talk to your doctor before taking STROMECTOL if you have asthma or a skin condition called onychodermatitis.

Pregnancy and STROMECTOL

STROMECTOL has not been well studied in pregnant humans.

Before taking STROMECTOL, talk to your doctor about whether the drug benefits outweigh the potential risks to your unborn baby.

Whether or not STROMECTOL is for mothers who are breastfeeding has not been determined.

Tell your doctor if you’re pregnant, planning a pregnancy, or breastfeeding before taking STROMECTOL.

STROMECTOL for Dogs and Cats

Veterinarians often prescribe STROMECTOL (under the brand names Heartgard, Ivomec, Iverhart, and others) for dogs and cats.

The drug is used to treat parasitic infections such as heartworm, mange, and ear mites.

Low doses of STROMECTOL are generally considered safe for animals.

However, STROMECTOL is not suitable for all dogs. Some carry a mutated gene (MDR-1) that makes the dog especially sensitive to STROMECTOL toxicity.

In dogs with this mutation, STROMECTOL can pass into the brain and nervous system with deadly consequences.

There are some dog breeds that are more sensitive to STROMECTOL than others. These include Australian and German Shepherds; English, Old English, and Shelton Sheepdogs; Syke Terriers; and Collies.

However, your dog's breed is not necessarily a guarantee that there will or will not be a problem with STROMECTOL.

Common Side Effects of STROMECTOL

The side effects vary depending on the form you’re using. They include the following:

• Itching and rash
• Swelling
• Headache
• Joint pain
• Pink eye, inflammation of the eyes or discomfort
• Dizziness and a drop in blood pressure upon standing
• Racing heart beat
• Changes in liver function tests

Cream and lotion formulations of STROMECTOL may cause your skin to itch or burn.

Serious Side Effects of STROMECTOL

The following side effects generally apply to STROMECTOL tablets (Stromectol):

• Sudden drop in blood pressure and dizziness upon standing
• Life-threatening skin reactions
• Seizures
• Asthma flare-up
• Changes in vision, including loss of vision
• Liver infection

Tell your doctor and pharmacist all the medications you’re taking.

This includes prescriptions and over-the-counter medications, vitamins and other dietary supplements (nutritional shakes, protein powders, etc.), herbal remedies, and illegal and recreational drugs.

Ask your doctor about taking Stromectol with warfarin (Coumadin, Jantoven), since Stromectol may increase the side effects of the blood thinner.

STROMECTOL and Alcohol

You should avoid or limit drinking alcohol while taking STROMECTOL, because the combination may increase your risk of serious side effects of the drug.  

STROMECTOL and Grapefruit Juice

Grapefruit juice slows down how quickly the body is able to break down STROMECTOL, which could cause blood levels of the drug to become dangerously high.

Do not consume grapefruit or grapefruit juice while you’re taking STROMECTOL.

Be sure to wash your hands thoroughly after you’ve applied either product to your skin.

STROMECTOL Overdose

If you think you might have taken or applied too much STROMECTOL, contact an emergency room at 911 or a poison control center right away.

Missed Dose of STROMECTOL

If you miss a dose of STROMECTOL or an application, try to take it or apply it as soon as you remember.

If it’s almost time for the next dose, skip the missed dose and take your next dose at the regular time. Don't double your dose.

The typical oral dose for adults with chest pain or high blood pressure ranges from 120 milligrams (mg) to 540 mg a day.

The immediate release tablets are typically given up to four times a day.

The extended-release formula is given once a day and should not be crushed or chewed.

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

Missed Dose of TIAZAC

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

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

Do not "double up" to make up for a missed one.

Common Side Effects

TIAZAC can cause side effects. You should tell your doctor if the following symptoms are severe or do not go away:

• Flushing
• Headache
• Dizziness or lightheadedness
• Slow heartbeat
• Weakness
• Vomiting
• Constipation
• Diarrhea
• Nasal congestion
• Cough

Serious Side Effects

TIAZAC can cause serious side effects. You should call your doctor immediately if you experience:

• Swelling of the face, lips, tongue, eyes, hands, arms, feet, lower legs, or ankles
• Fainting
• Breathing or swallowing difficulties
• Yellowing of the skin or eyes (jaundice)
• Rash
• Nausea
• Unusual bleeding or bruising
• Extreme fatigue
• Lack of energy
• Loss of appetite
• Pain in the upper right part of the stomach
• Increase in frequency or severity of chest pain
• Flu-like symptoms

TIAZAC may prevent chest pain if taken regularly, but it does not stop chest pain once it starts.

TIAZAC controls high blood pressure and chest pain, but it does not cure them.

It may take up to two weeks for you to experience the full benefit of this medicine.

Your doctor will likely start you on a low dose of TIAZAC and then gradually increase your dose.

Your blood pressure and pulse will be checked regularly while taking TIAZAC to determine your response to the drug.

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

• A heart attack
• Any condition that causes food to move more slowly through your digestive system
• Low blood pressure
• Heart, liver, or kidney disease

You should also tell your doctor if you plan to have any type of surgery, including dental surgery.

Pregnancy and TIAZAC

There are not adequate studies to show that this drug is safe in pregnant women.

TIAZAC is excreted in breast milk, so women should not take it while breastfeeding.

Many medications can interact with TIAZAC.

Tell your doctor about all prescription, non-prescription, illegal, recreational, herbal, nutritional, or dietary drugs you are taking, especially:

• Atazanavir (Reyataz)
• Beta blockers such as atenolol (Tenormin), labetalol (Trandate), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• Buspirone (BuSpar)
• Benzodiazepines such as midazolam (Versed) and triazolam (Halcion)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Digoxin (Lanoxin, Lanoxicaps)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Rifampin (Rifadin, Rifamate, Rifater, Rimactane)
• Lovastatin (Altoprev, Mevacor, Advicor)
• Quinidine (Quinidex)

Other TIAZAC Interactions

Grapefruit and grapefruit juice may interact with TIAZAC. Your doctor may advise you to follow a low-sodium diet while taking TIAZAC.

This medication may impair your thinking and reaction time. Be especially careful when driving or performing any activity that may require you to be alert.

You should also try to avoid exposure to sunlight or tanning beds. TIAZAC can increase your skin's sensitivity to light and you may develop sunburns more easily.

RIFADIN comes as oral capsules or in solution for intravenous use.

For treating adults with TB, RIFADIN should be taken once daily with a full glass of water, either an hour before a meal or two hours afterward.

The initial phase of treatment requires it to be taken with isoniazid and pyrazinamide, for two months. A fourth drug, either streptomycin or ethambutol, may also be necessary.

Following this initial course, doctors prescribe another four months of treatment with RIFADIN and isoniazid.

If you are taking RIFADIN, you must complete the treatment course, even if you feel better. Completing the treatment ensures that the bacteria causing the infection are completely eradicated and don't become resistant.

The drug is taken twice daily for two days to treat N. meningitidis infection in adults.

RIFADIN Overdose

Symptoms of overdose include:

• Nausea and vomiting
• Abdominal pain
• Severe itching
• Headache
• Increased lethargy
• Unconsciousness
• Jaundice and liver enlargement

Children who overdose may also experience facial sweating and some life-threatening symptoms, including low blood pressure, irregular heartbeat, seizures, and heart attacks.

Contact a poison control center or emergency room if you suspect you have taken too much RIFADIN. Call 911 if a person has collapsed or isn't breathing.

Missed Dose of RIFADIN

Missing a dose of RIFADIN can increase your risks of developing low blood platelet counts and a hypersensitivity to the drug in your kidneys.

Take the missed dose as soon as you remember it. But if it's almost time for your next dose, skip the missed dose and call your doctor.

Common Side Effects of RIFADIN:

• Heartburn
• Upset stomach and cramps
• Gas
• Diarrhea
• Headache
• Drowsiness
• Fatigue
• Dizziness
• Inability to concentrate
• Confusion and behavioral changes
• Muscular weakness, pain in your arms or legs, and generalized numbness
• Vision changes
• Painful or irregular menstruation
• Flushing and itchiness
• Lack of coordination

Severe Side Effects of RIFADIN

Contact your doctor if you experience any of the following:

• Fever
• Loss of appetite
• Malaise
• Nausea and vomiting
• Darkened urine
• Jaundice (yellowing of the skin and eyes)
• Pain or swelling of your joints

Rare Side Effects of RIFADIN:

The following side effects have been reported but are rare:

• Myopathy (muscular disease)
• Psychosis
• Adrenal insufficiency (inadequate amounts of steroid hormones in people with compromised adrenal glands)
• Kidney issues
• Hepatitis (liver inflammation, usually caused by a viral infection) and abnormal liver function

You shouldn't take the RIFADIN if you are hypersensitive to it, any of its components, or related antibiotics (rifamycins).

Some antiviral medications reduce the effectiveness of RIFADIN, including:

• Darunavir (Prezista)
• Atazanavir (Reyataz)
• Fosamprenavir (Lexiva)
• Saquinavir (Invirase)
• Tipranavir (Aptivus)

Taking RIFADIN with ritonavir-boosted saquinavir (Invirase), an HIV-antiviral drug, could increase your risk of severe liver damage.

Your doctor will not prescribe RIFADIN if you have symptoms of meningitis. That's because the medication increases your risk of rapidly developing a resistant strain of the bacteria causing the infection.

Before taking RIFADIN, tell your doctor if you have ever had liver problems or liver disease, any condition that affects your adrenal glands, porphyria (disorders that mainly cause nerve or skin problems), or diabetes.

RIFADIN may cause your urine, sweat, tears, and mucus to turn reddish. This is a harmless side effect, but it can permanently stain rigid or extended-wear contact lenses.

Pregnancy and RIFADIN

RIFADIN is an FDA Pregnancy Category C Drug, meaning research in animals indicates it can be harmful to a developing baby, but human studies are lacking.

It should only be used during pregnancy if the potential benefits outweigh the risk to the fetus. You should tell your doctor if you are pregnant or plan to become pregnant while taking this medication.

Because RIFADIN is excreted in human breast milk and animal studies have shown that the drug has the potential to cause tumors to form, you shouldn't take it if you are breastfeeding.

RIFADIN can decrease the effectiveness and reliability of hormonal contraceptives, including birth control pills, patches, rings, implants, and injections. Talk to your doctor about the most effective contraceptive to use while you are taking RIFADIN.

You should always tell your doctor about any prescription, non-prescription, illegal, and recreational drugs; herbal remedies; and nutritional and dietary supplements you're taking, since RIFADIN may interact with a wide range of drugs, including the following types of medications:

• Antacids
• Anticonvulsants
• Antiarrhythmic medications
• Anticoagulants
• Antifungals
• Barbiturates
• Calcium-channel blockers
• Antibiotics
• Corticosteroids
• Cardiac glycosides
• Hypoglycemic agents including sulfonylureas
• Narcotic painkillers
• Progestins
• Tricyclic antidepressants

RIFADIN also interacts with the following drugs:

• Atovaquone-Proguanil (Malarone)
• Digitoxin (Lanoxin)
• Cyclosporine (Restasis) Clofibrate
• Dapsone
• Diazepam (Valium)
• Haloperidol (Haldol)
• Halothane (Fluothane)
• Isoniazid (Laniazid, Nydrazid, and others; in Rifamate, IsonaRif, and Rifater)
• Levothyroxine (Synthroid)
• Methadone
• Probenecid (Benemid and Probalan, in Proben-C and Colbenemid)
• Quinine
• Sulfasalazine (Azulfidine)
• Tacrolimus (Prograf, Advagraf)
• Theophylline (Theo-24)
• Zidovudine (Retrovir)

RIFADIN and Alcohol

Drinking alcohol while taking RIFADIN may increase your risk of liver damage.

RIFADIN and Other Interactions

RIFADIN may produce false-positive results in urine screening tests for opiates. It can interfere with other laboratory tests, too, including blood folate and vitamin B12 tests, and liver and gallbladder function tests.

Always take Surgam exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Surgam can cause side effects, although not everybody gets them.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because Surgam can affect the way some other medicines work.

Also some medicines can affect the way Surgam works.

In particular, tell your doctor if you are taking any of the following:

• Other non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen, celecoxib, etodolac or meloxicam
• Water tablets (diuretics) such as spironolactone, triamterene or amiloride used to increase the flow of your water (urine)
• Antibiotics such as quinolone, sulphonamides or aminoglycosides (for infections)
• Corticosteroids such as prednisolone (for inflammation, allergies or some types of cancer)
• Medicines for lowering your blood sugar such as medicines for diabetes
• Medicines for lowering your blood pressure (antihypertensives)
• Medicines called ‘cardiac glycosides’ such as digoxin (for heart failure)
• Medicine to stop your blood clotting such as heparin, warfarin, clopidogrel or triclopidine
• Medicine to dissolve blood clots such as streptokinase, altepase, reteplase or tenecteplase
• Ciclosporin – used after an organ transplantation to help prevent rejection
• Medicines for depression such as fluoxetine, sertraline, citalopram or paroxetine
• Mifepristone - for terminating a pregnancy. It is important not to use Surgam for at least 8–12 days after taking Mifepristone
• Lithium - for some types of mental illness
• Phenytoin - for epilepsy
• Methotrexate - for some types of cancer
• Probenecid - used with a medicine called cidofovir to stop kidney damage
• Tacrolimus - used after an organ transplant
• Zidovudine - an antiviral drug

Please tell your doctor if you are taking any of these medicines.

If you have chronic hepatitis C, taking PROMACTA with ribavirin and interferon treatment can increase your risk of liver problems. Call your doctor at once if you have signs of liver problems: nausea, upper stomach pain, confusion, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

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

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

• liver disease (unless you are being treated for hepatitis C);
• kidney disease;
• high levels of platelets in your blood;
• a blood cancer or bone marrow disorder;
• if you have ever had cataracts or a blood clot;
• if your spleen has been removed; or
• if you are of East Asian descent (Chinese, Japanese, Taiwanese, or Korean).

Taking PROMACTA may increase your risk of developing blood cancers, especially if you have myelodysplastic syndrome (also called "preleukemia"). Talk with your doctor if you have concerns about this risk.

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

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of PROMACTA on the baby.

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

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

You could develop a blood clot if your platelet count gets too high while you are using PROMACTA. Call your doctor or get emergency medical help 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 stomach--severe stomach pain, vomiting, diarrhea;
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

If you have chronic hepatitis C, taking PROMACTA with ribavirin and interferon treatment can increase your risk of liver problems. Call your doctor at once if you have signs of liver problems:

• nausea, upper stomach pain, loss of appetite;
• confusion, tired feeling; or
• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Also call your doctor at once if you have:

• vision changes, eye pain, or seeing halos around lights;
• flu symptoms such as fever, cough, sore throat, headache, body aches, tired feeling;
• increased or frequent need to urinate;
• pain or burning when you urinate; or
• pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin.

Common side effects may include:

• nausea, vomiting, diarrhea, stomach pain;
• cold symptoms such as stuffy nose, sneezing;
• flu symptoms;
• mouth pain;
• muscle pain, back pain;
• itching, tingling, or burning under your skin;
• skin rash; or
• abnormal liver function tests.

Avoid taking other medicines within 4 hours before or 2 hours after you take PROMACTA. This includes antacids, vitamins, mineral supplements, or any other product that contains aluminum, calcium, iron, magnesium, selenium, or zinc.

Avoid all dairy products or products that contain calcium (including fortified fruit juice) for at least 4 hours before or 2 hours after you take PROMACTA.

Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

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

• a blood thinner (warfarin, Coumadin, Jantoven); or
• cholesterol medication--atorvastatin, ezetimibe, fluvastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin.

This list is not complete. Other drugs may interact with PROMACTA, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

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

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

Take PROMACTA on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not crush an PROMACTA tablet. Swallow the tablet whole with a full glass of water.

Do not take this medication with milk.

Follow all instructions for mixing PROMACTA oral suspension. Mix the oral suspension powder only with water. Use the dosing syringe to measure the water and to give the correct dose.

You will need frequent blood tests to check your liver function. Your eyes may also need to be checked for signs of cataract formation.

Taking PROMACTA long-term can cause harmful effects on your bone marrow that may result in serious blood cell disorders.

It may take up to 4 weeks of taking this medicine before it is completely effective in preventing bleeding episodes. Keep taking the medication as directed and tell your doctor if you have any bruising or bleeding episodes after 4 weeks of treatment.

If you take PROMACTA with other medicines to treat chronic hepatitis C, tell your doctor if you stop using any of your other hepatitis medicines.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture-absorbing preservative. After mixing PROMACTA oral suspension, store the liquid at room temperature and use it within 30 minutes.

After you stop taking PROMACTA, your risk of bleeding may be even higher than it was before you started treatment. Be extra careful to avoid cuts or injury for at least 4 weeks after you stop taking PROMACTA. Your blood will need to be tested weekly during this time.

Seek emergency medical attention or call the Poison Help line.

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.