CONSTELLA must not be used in children under 6 years of age and is not recommended for use in children and adolescents between 6 and 18 years of age. The safety and efficacy of CONSTELLA in children and adolescents (less than 18 years of age) have not been established.

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

• You have any other medical conditions.
• You are pregnant, think you may be pregnant, or plan to become pregnant. It is not known if CONSTELLA will harm your unborn baby.
• You are breast-feeding or planning to breastfeed. It is not known if CONSTELLA passes into your breast milk. Talk with your doctor about the best way to feed your baby, if you take CONSTELLA.
• You are taking or planning to take any other medicines, including prescription and non-prescription drugs, vitamins and herbal supplements.

The most common side effects reported with CONSTELLA are:

• Diarrhea
• Passing gas
• Abdominal (stomach-area) pain
• Swelling, or a feeling of fullness or pressure in your abdomen (bloating)
• Nausea
• Vomiting

Some side effects can be serious.

Mild to moderate diarrhea often begins within the first two weeks of taking CONSTELLA. Stop taking CONSTELLA and call your doctor right away if you get severe diarrhea (for example persistent watery stools) during treatment with CONSTELLA.

Call your doctor or go to the nearest hospital emergency room right away, if you develop unusual or severe abdominal pain.

This is not a complete list of side effects. If you have other unexpected side effects, side effects that bother you or do not go away, contact your doctor or pharmacist.

As very little linaclotide is absorbed from the intestines, no drug interaction studies have been conducted with CONSTELLA.

Your doctor or pharmacist can tell you if it is safe to take CONSTELLA with your other medicines. Do not start or stop any medicine while taking CONSTELLA without talking to your healthcare provider first.

Usual adult dose:

• Take CONSTELLA exactly as your doctor tells you to take it.
• Take CONSTELLA one time each day on an empty stomach, at least 30 minutes before your first meal of the day.
• Swallow the capsule whole with water. Do not break the capsule apart or chew it.

If no improvement in symptoms is seen within 6 weeks, contact your doctor.

Overdose:

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

Missed dose:

If you miss a dose of CONSTELLA, just skip that dose. Do not take two capsules to make up the missed dose. Instead, wait until the next time you are supposed to take it and then take your normal dose on an empty stomach, at least 30 minutes before your first meal of the day.

Don’t use VIGAMOX if you have a fungal or viral eye infection. This medicine is used only to treat bacterial infections.

Before taking VIGAMOX, tell your doctor if you have allergies to any medicines, especially other antibiotics.

VIGAMOX is intended for use in the eyes. Don’t swallow or inject VIGAMOX.

Also, tell your healthcare provider if you wear contact lenses before taking VIGAMOX. You’ll have to take out your lenses before using the medicine, and you may have to leave them out until your eye heals.

Don’t use this medicine for a shorter or longer amount of time than your doctor prescribes.

Taking VIGAMOX for longer periods of time may cause a secondary infection. Stopping the drug too soon may cause a return of the infection.

Tell your healthcare provider if your condition doesn’t improve after seven days of using VIGAMOX.

Pregnancy and VIGAMOX

It’s not known whether VIGAMOX will harm an unborn baby.

Don’t use this medicine without first talking to your doctor if you’re pregnant or plan to become pregnant.

It’s also not known whether the drug passes into breast milk or could hurt a breastfeeding baby. Talk to your doctor before breastfeeding while taking VIGAMOX.

Common Side Effects of VIGAMOX

Common side effects of VIGAMOX in the eyes include:

• Burning
• Stinging
• Itching
• Dryness
• Redness
• Irritation
• Tearing
• Blurred vision

Serious Side Effects of VIGAMOX

Tell your doctor right away if you experience any signs of an allergic reaction while using VIGAMOX. These may include:

• Severe itching or rash
• Swelling of the face, tongue, or throat
• Dizziness
• Trouble breathing

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

• Other eye drops or eye medicines
• Other antibiotics

VIGAMOX and Other Interactions

Use caution when driving or performing other activities that require alertness, as VIGAMOX can cause blurred vision.

The recommended dose of VIGAMOX for adults and children at least 1 year old is one drop in the affected eye, three times a day, for seven days.

Apply light pressure to the inside corner of the eye after administering each drop of VIGAMOX. This will prevent the liquid from draining down the tear duct.

Follow the instructions on the prescription label carefully when taking this medicine. Don’t take more or less VIGAMOX than is prescribed by your doctor.

Be sure to wash your hands before using the eye drops.

The VIGAMOX dropper is sterile. Don’t place it on any surface, including the eyes or hands. If the dropper becomes contaminated with bacteria or other organisms, it could cause an infection.

If you’re using other eye drops, wait at least five minutes before applying them.

Don’t use the medicine if it’s discolored or has particles in it.

VIGAMOX Overdose

An overdose of VIGAMOX isn’t likely to be life-threatening.

However, if you suspect an overdose or accidently swallow the drops, contact a poison control center or emergency room immediately.

Missed Dose of VIGAMOX

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

However, skip the missed dose if it’s almost time for your next scheduled dose.

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

You should not use this medication if you are allergic to DANOCRINE, or if you have porphyria, a history of stroke or blood clot, or severe problems with your heart, liver, or kidney. You also should not take DANOCRINE if you are pregnant or breast-feeding, if you have breast or uterine cancer, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

DANOCRINE can harm an unborn baby or cause vaginal birth defects in a newborn female infant. Do not use if you are pregnant.

You may need to have a negative pregnancy test before starting this treatment.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment with DANOCRINE.

Your medication needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you. Do not change your medication dose or schedule without your doctor's advice.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve or if they get worse during treatment.

Call your doctor at once if you have a serious side effect such as sudden numbness or weakness, problems with vision or speech, chest pain, sudden cough, or wheezing, swelling, rapid weight gain, feeling short of breath, ringing in your ears, dizziness, nausea, pain behind your eyes, stomach pain and loss of appetite, dark urine, or jaundice (yellowing of the skin or eyes).

You should not use this medication if you are allergic to DANOCRINE, or if you have:

• severe heart disease, a history of stroke or blood clot;
• severe kidney disease;
• severe liver disease;
• a hormone-related cancer such as breast or uterine cancer;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• abnormal vaginal bleeding that has not been checked by a doctor; or
• if you are pregnant or breast-feeding.

To make sure you can safely take DANOCRINE, tell your doctor if you have any of these other conditions:

• heart disease, high blood pressure, coronary artery disease, congestive heart failure;
• high cholesterol or triglycerides;
• a history of breast cancer;
• diabetes;
• hypoparathyroidism, or low levels of calcium in your blood;
• a seizure disorder;
• kidney or liver disease; or
• migraine headaches.

FDA pregnancy category X. This medication can harm an unborn baby or cause vaginal birth defects in a newborn female infant. Do not use DANOCRINE if you are pregnant. Stop taking DANOCRINE and tell your doctor right away if you become pregnant during treatment.

You may need to have a negative pregnancy test before starting this treatment.

Use a barrier form of birth control (such as a condom or diaphragm with spermicide). Hormonal contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment with DANOCRINE .

DANOCRINE can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using DANOCRINE.

Taking DANOCRINE to treat endometriosis may increase your risk of ovarian cancer.

In rare cases, danazol can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness (especially on one side of the body), confusion, problems with speech or balance;
• severe headache, ringing in your ears, dizziness, nausea, vomiting, vision problems, pain behind your eyes;
• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• pain, swelling, warmth, or redness in one or both legs;
• swelling or rapid weight gain, especially in your face and midsection;
• bloody, black, or tarry stools;
• cough up blood or vomit that looks like coffee grounds; or
• upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• acne or other skin problems, increased sweating;
• increased hair growth or hair loss;
• breast changes;
• decreased amount of semen released during sex;
• hoarse or deepened voice, sore throat;
• flushing (warmth, redness, or tingly feeling);
• changes in your menstrual periods;
• unusual vaginal bleeding or spotting;
• vaginal dryness, discomfort, or itching.

Tell your doctor about all other medicines you use, especially:

• carbamazepine (Carbatrol, Equetro, Tegretol);
• cyclosporine (Gengraf, Neoral, Sandimmune);
• insulin or oral diabetes medications;
• tacrolimus (Prograf);
• a blood thinner such as warfarin (Coumadin, Jantoven); or
• cholesterol lowering medicines such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Mevacor, Altoprev, Advicor), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin, Juvisync).

This list is not complete and other drugs may interact with danazol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Women who take danazol to treat endometriosis or fibrocystic breast disease should start the medication during a menstrual period.

Danazol is usually given for 6 to 9 months to treat fibrocystic breast disease or endometriosis. To prevent attacks of hereditary angioedema, you may need to use the medication long-term. Follow your doctor's instructions.

Your medication needs may change if you become ill, have a fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you. Do not change your medication dose or schedule without your doctor's advice.

Use danazol regularly to get the most benefit. Try not to miss any doses. Get your prescription refilled before you run out of medicine completely.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve or if they get worse during treatment.

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

An overdose of danazol is not expected to produce life threatening symptoms. However, long term use of high doses can lead to symptoms such as weight gain, increased acne or facial hair, menstrual problems, or breast changes.

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.

Call your doctor for instructions if you have missed doses for more than 2 days in a row.

This medicine should be used at the lowest dose and for the shortest time suitable for your condition. Talk to your doctor if you have any concerns about your treatment.

Tell any doctor, dentist, pharmacist or health care professional that you see, that you are taking this medicine. This is especially important if you are planning to have heart surgery.

Do NOT drink alcohol while taking this medication. You would be more likely to get stomach problems.

Fertility may be decreased. The use of VIMOVO is not recommended in women trying to get pregnant.

Tell your doctor or pharmacist about symptoms that may be a sign of a more serious problem in your stomach or intestine such as:

• trouble swallowing.
• unplanned weight loss.
• vomiting blood or food.
• black (blood-stained) stools.
• you have heart bypass surgery (planning to have or recently had).
• you have severe, uncontrolled heart failure.
• you have bleeding in the brain or other bleeding disorders.
• you are pregnant (after 28 weeks of pregnancy).
• you are currently breastfeeding (or planning to breastfeed).
• you are allergic to ASA (Acetylsalicylic Acid), other NSAIDs, naproxen, esomeprazole, substituted benzimidazoles or other ingredients of VIMOVO
• you have an active ulcer.
• you have active bleeding from the stomach or gut.
• you have inflammatory bowel disease (Crohn’s Disease or Ulcerative Colitis).
• you have liver disease (active or severe).
• you have kidney disease (severe or worsening).
• you have high potassium in the blood.

Patients who took a drug in the same class as VIMOVO after a type of heart surgery (coronary artery bypass grafting (CABG)) were more likely to have heart attacks, strokes, blood clots in the leg(s) or lung(s), and infections or other complications than those who did NOT take that drug. VIMOVO must not be used after recent CABG.

VIMOVO should NOT be used in patients under 18 years of age.

If you take antibiotics while taking VIMOVO: If you experience symptoms such as severe (bloody or repeated watery) diarrhea, with or without fever, abdominal pain or tenderness, you may have bowel inflammation caused by a bacterial infection (Clostridium difficile). If this happens, stop taking the drug combination and call your healthcare professional immediately.

Long-term use of PPIs, like esomeprazole, may interfere with the absorption of Vitamin B12 from the diet. This may cause a shortage of Vitamin B12 in your body. Talk to your doctor about this risk.

Long-term use of PPIs may lead to low blood magnesium in some people. When blood magnesium is lower than normal, it may also lead to low blood calcium and low blood potassium.

Using PPIs for a long time (every day for a year or longer) may increase risks of broken bones of the hip, wrist or spine. Talk to your doctor about this risk.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

VIMOVO may cause some side effects, especially if you use it for a long time or take large doses. When these side effects occur, you may need to see a health care provider. These are not all the possible side effects you may feel when taking VIMOVO. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

VIMOVO may cause you to become drowsy or tired. Be careful about driving or doing activities that require you to be alert. If you become drowsy, dizzy or light-headed after taking VIMOVO, do NOT drive or use machines.

VIMOVO may cause you to become more sensitive to sunlight. Sunlight or sunlamps may cause sunburn, skin blisters, skin rash, redness, itching or discolouration, or vision changes. If you have a reaction from the sun, check with your health care provider.

Stomach upset is a common problem with NSAIDs, such as naproxen. The esomeprazole in VIMOVO helps to reduce this side effect. However, side effects, usually mild, have been reported with esomeprazole use. These side effects may not be caused by esomeprazole in your case, but only a doctor can assess this. If these become bothersome (or last more than 1-2 days), discuss with your doctor.

Common:

• Nausea.
• Stomach upset.
• Diarrhea.
• Headache.

Uncommon:

• Dry mouth.
• Dizziness.
• Insomnia.
• Feeling of burning/prickliness/numbing.
• Swelling of extremities.
• Feeling sleepy.
• Feeling like you or your surroundings are moving (vertigo).

Rare:

• Taste disorders.
• Nervousness.
• Hair loss.
• Increased sweating.

Stopping VIMOVO after taking it for a long time may cause your stomach to increase acid production. This may cause stomach symptoms. Carefully follow your doctor’s instructions when stopping VIMOVO.

NOT a complete list

• Acetylsalicylic Acid (ASA) or other NSAIDs (e.g. celecoxib, diclofenac, ibuprofen, indomethacin, ketorolac, meloxicam, naproxen).
• Antacids.
• Antidepressants (Selective Serotonin Reuptake Inhibitors (SSRIs), e.g. citalopram, fluoxetine, paroxetine, sertraline).
• Blood pressure medications (ACE (angiotensin converting enzyme) inhibitors, e.g. enalapril, lisinopril, perindopril, ramipril) or ARBs (angiotensin II receptor blockers, e.g. candesartan, irbesartan, losartan, valsartan).
• Blood thinners (e.g. warfarin, ASA, clopidogrel).
• Corticosteroids (including glucocorticoids e.g. prednisone).
• Cyclosporin.
• Digoxin.
• Diuretics (e.g. furosemide, hydrochlorothiazide).
• Erlotinib (or any other anticancer drug from the same class).
• Lithium.
• Methotrexate.
• Oral contraceptives.
• Oral hypoglycemics (diabetes medications).
• Tacrolimus.

Your health care provider may prescribe low-dose ASA (acetylsalicylic acid) as a blood thinner to reduce your risk of having a heart attack or stroke while you are taking VIMOVO. Take only the amount of ASA prescribed by your health care provider. The beneficial effects of VIMOVO apply whether you take ASA or not.

Studies with esomeprazole have shown that blood levels of some drugs may be influenced if taken at the same time as drugs used to prevent fungal infections (itraconazole, ketoconazole, voriconazole), anxiety (diazepam), epilepsy (phenytoin), drugs to speed up stomach emptying (cisapride†), poor circulation in the legs (cilostazol†), heart problems (digoxin), treatment for tuberculosis (rifampin), St John’s Wort (Hypericum perforatum) or a certain type of anticancer drug (erlotinib or any other anticancer drug from the same class). However, none of these interactions have been shown to change the effectiveness of esomeprazole or the other drug.

Drugs used to prevent blood clotting (warfarin or coumarin derivatives, clopidogrel) have been reported to interact with esomeprazole. Speak to your doctor or pharmacist if you are taking any of these drugs as monitoring may be required when you start or stop taking VIMOVO. Use of VIMOVO with clopidogrel should be avoided.

Esomeprazole may decrease the effectiveness of some drugs used for HIV treatment. Atazanavir and nelfinavir should not be used with VIMOVO.

Carefully follow your health care provider’s directions on how to take VIMOVO.

Do NOT take more of it.

Do NOT take it more often.

Do NOT take it for a longer period of time than your health care provider recommends.

If possible, you should take the lowest dose of this medication for the shortest time period. Taking too much VIMOVO may increase your chances of unwanted and sometimes dangerous side effects, especially if you are elderly, have other diseases or take other medications.

This medication has been prescribed specifically for you. Do NOT give it to anyone else. It may harm them, even if their symptoms seem to be similar to yours.

• VIMOVO should be taken at least 30 minutes before a meal.
• The tablets should be swallowed whole with water.
• Do not chew, split or crush them.

Overdose

If you think you have taken too much VIMOVO, 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 of VIMOVO, take the dose as soon as possible. Then go back to your regular schedule. If you remember your missed dose close to the time of your next dose, do not take the missed dose. Do not double dose. Just take the next dose on time.

Serious Warnings and Precautions

A rare bowel condition called ʺfibrosing colonopathyʺ, where your gut is narrowed, has been reported in patients with cystic fibrosis taking high doses of pancreatic enzymes. As a precaution, consult your doctor if you experience any unusual abdominal symptoms or any change in abdominal symptoms, especially if you are taking more than 10 000 units of lipase/kg body weight/day or more than 4 000 units of lipase/gram fat intake.

Talk to your doctor about all the drugs you are taking before taking VIOKACE.

Talk to your doctor before taking this medicine if you are pregnant, might become pregnant, or are breast-feeding. Your doctor will decide if you should take VIOKACE and at which dose.

Potential Viral Exposure from the Product Source: The pancreas glands used to make VIOKACE and other pancreatic enzyme products come from pigs used for food. These pigs may carry viruses. When VIOKACE is made several steps are taken to reduce the risk of viruses being spread, including their destruction and testing for specific viruses. The risk of infections caused by these or other unknown or novel viruses cannot be totally ruled out. However, there have not been any cases reported where infection of patients has occurred.

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

• You are allergic to pork (pigs) products
• You have a history of intestinal blockage of your intestines or scarring or thickening of your bowel wall (fibrosing colonopathy)
• You have any other medical conditions
• You are pregnant or might become pregnant
• You are breast-feeding or plan to breast-feed

Common Side Effects of VIOKACE

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

• Headache
• Cough or sore throat
• Dizziness
• Nausea or upset stomach
• Nosebleed
• Neck pain
• Feeling full after eating a small amount of food
• Constipation
• Diarrhea
• Greasy stools
• Heartburn
• Gas
• Sore mouth or tongue
• Irritation around the rectum
• Weight loss

Serious Side Effects of VIOKACE

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, or throat)
• Hoarseness
• Severe nausea or vomiting
• Severe or unusual stomach pain
• Difficulty having bowel movements
• Pain or swelling in your joints, especially in your big toe

There are no known drug interactions with VIOKACE.

Before taking VIOKACE tablets make sure you tell your doctor and pharmacist all the medications (including those without prescription) you are taking.

Do not switch VIOKACE with any other pancreatic enzyme product without first talking to your doctor.

Always take VIOKACE with a meal or a snack and enough liquid to swallow VIOKACE completely. This will allow the enzymes to mix thoroughly with the food and digest it as it passes through the gut. If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose.

Usual dose:

Your dose is measured in ‘lipase units’. Lipase is one of the enzymes in VIOKACE. Different strengths of pancreatic enzymes may contain different amounts of lipase.

Your doctor should also prescribe a medicine for you called a proton pump inhibitor (PPI) to decrease stomach acid. VIOKACE should be taken with a PPI to help prevent VIOKACE from breaking down in your stomach.

Your doctor will adjust your dose to suit you. It will depend on:

• your illness
• your weight
• your diet
• how much fat is in your stools

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.

If you know or suspect that you have taken more of this product than you normally do, or notice any unusual symptoms, contact your doctor or nearest hospital emergency department immediately. Ensure that you are adequately hydrated during this time by drinking plenty of fluids.

Extremely high doses of pancreatic enzymes have sometimes caused too much uric acid in the urine (hyperuricosuria) and in the blood (hyperuricaemia).

Missed dose:

If a dose of this medication has been missed, take your next dose at the usual time, with your next meal. Do not try to make up for the dose that you have missed.