Like all medicines, ISENTRESS can cause side effects, although not everybody gets them. In studies, side effects usually were mild and did not cause patients to stop taking ISENTRESS. The side effects reported in patients taking ISENTRESS were similar to side effects in patients treated with a tablet containing no medication (a placebo).

The most common side effects of ISENTRESS include:

• nausea

• headache

• diarrhea

• fever

• vomiting

• fatigue

• dizziness

• difficulty sleeping

• cough

• rash

• tiredness

• upper respiratory tract infection

• inflammation of the nasal passages and throat

• bronchitis

• back pain

• depression

Additionally, while the medicine has been on the market, some further reactions have occurred:

• Depression and suicidal thoughts have been reported. If you develop these feelings, discuss this with your physician.

• Other side effects that have been reported include low blood platelet count, clumsiness and lack of coordination, rash with or without an increase in some white blood cells, severe skin reaction, liver failure. If you develop any of these reactions, discuss with your physician.

In some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from opportunistic infections may occur when combination antiretroviral treatment is started. Tell your physician immediately if you notice any symptoms of infection.

Phenylketonuria (PKU). ISENTRESS Chewable Tablets contain phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU.

Contact your physician promptly if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS.

Contact your physician promptly if you develop a rash. Severe and life-threatening skin reactions and allergic reactions have been reported in some patients taking ISENTRESS.

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 physician right away.

Tell your physician if you develop any unusual side effect or if any known side effect does not go away or gets worse. For more information, ask your physician or pharmacist.

Tell your physician about all the medicines you take. Include the following:

• prescription medicines, including rifampin, which may interact with ISENTRESS

• non-prescription medicines including antacids. It is not recommended to take ISENTRESS with certain antacids containing aluminum and/or magnesium while others are acceptable (e.g. calcium carbonate, omeprazole, famotidine). If needed, talk to your physician about any other antacids you can take

• vitamins

• herbal supplements

Know the medicines you take.

• Keep a list of your medicines. Show the list to your physician and pharmacist when you get a new medicine.

Serious Warnings and Precautions

IRESSA should be prescribed by a health care professional experienced in the treatment and management of patients with cancer.

IRESSA should not be used in patients with EGFR mutation negative tumours.

IRESSA has not been studied in patients with severely reduced kidney function.

Isolated cases of liver failure have been reported in patients taking IRESSA, and some patients have died from this.

Gastrointestinal perforation (a hole through the wall of the stomach or intestine), including fatal cases, was reported in patients taking IRESSA.

Please inform your doctor if you are taking or have taken any medicines (including medicines taken some time ago), even those available over the counter. Your doctor especially needs to know if:

• You take any of the following medicines: phenytoin, carbamazepine, rifampicin, barbiturates, St John's Wort, itraconazole, ketoconazole, protease inhibitors (drugs to treat HIV/AIDS) or macrolide antibiotics such as erythromycin or clarithromycin. These medicines may affect the way IRESSA works. Your doctor should also know if you drink grapefruit juice.

• You take warfarin (to prevent blood-clots), as IRESSA may affect it. Your doctor may need to check your blood more often.

• You take any medicines which are used to help reduce stomach acid (e.g., ranitidine, sodium bicarbonate, proton-pump inhibitors).

Do not use IOPIDINE ophthalmic if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Before using IOPIDINE ophthalmic, tell your doctor if you have kidney or liver disease, heart disease, high blood pressure, or a history of fainting or low blood pressure. Also tell your doctor if you are using any medications to treat high blood pressure or a heart rhythm disorder.

You should not use this medication if you are allergic to IOPIDINE or to clonidine (Catapres).

Do not use IOPIDINE ophthalmic if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Before using IOPIDINE ophthalmic, tell your doctor if you have:

• kidney disease;
• liver disease;
• heart disease or high blood pressure;
• a history of fainting or low blood pressure.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use IOPIDINE ophthalmic.

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.

It is not known whether IOPIDINE ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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:

• slow or uneven heart rate;
• pounding heartbeats or fluttering in your chest;
• shallow breathing, feeling like you might pass out;
• severe swelling, redness, or discomfort in or around your eye;
• eye pain or increased watering; or
• numbness or tingly feeling in your hands or feet.

Less serious side effects may include:

• burning, itching, or dryness of your eyes;
• feeling like something is in your eye;
• blurred or dimmed vision;
• redness of the eye or eyelid;
• mildly swollen or puffy eyes;
• nausea, stomach pain, diarrhea;
• headache, sleep problems (insomnia);
• dry or stuffy nose, burning in your nose;
• a dry mouth; or
• unusual or unpleasant taste in your mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

Avoid using other medications in your eyes during treatment with IOPIDINE unless your doctor has told you to.

Before using IOPIDINE ophthalmic, tell your doctor if you are using any of the following medications:

• blood pressure medications; or
• heart rhythm medication.

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

This medication is usually given one hour before eye surgery and again right after surgery. Your doctor, nurse, or other healthcare professional will most likely give you this medication.

If you use IOPIDINE ophthalmic at home, use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Wash your hands before using the eye drops.

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using IOPIDINE before putting your contact lenses in.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
• Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
• Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Keep the eye drop pouches in their foil overwrap until you are ready to us the medication. Store at room temperature away from heat and moisture. Use each single-dose applicator only one time.

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

An overdose of IOPIDINE ophthalmic used in the eyes is not likely to produce life-threatening side effects, but overdose symptoms may include drowsiness, slow heart rate, and decreased body temperature.

Since IOPIDINE ophthalmic is usually given as needed by a healthcare professional, it is not likely that you will miss a dose.

If you are on a dosing schedule and you forget to use your medication, apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

• Take the dose prescribed for you by your healthcare professional. Your healthcare professional will prescribe the strength that is right for you.
• Take INVOKAMET twice a day with meals to lower your chance of having an upset stomach. Swallow the tablet whole.
• Your healthcare professional may prescribe INVOKAMET together with another medicine to help control your blood sugar.
• Always take INVOKAMET and all other medicines prescribed to you exactly as your healthcare professional has told you. Check with your doctor or pharmacist if you are not sure.

Overdose:

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

Missed Dose:

• If you forget to take a dose of INVOKAMET, take it as soon as you remember.
• However, if it is nearly time for the next dose, skip the missed dose.
• Do not take a double dose to make up for a forgotten dose.

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

Side effects may include:

• Changes in urination:
  • urinating more often or in larger amounts
  • an urgent need to urinate
  • a need to urinate at night
• Constipation, excess gas, abdominal discomfort
• Nausea, vomiting, diarrhea, indigestion, loss of appetite
• Changes in taste or a metallic taste
• Feeling thirsty
• Rash, hives
• Headache
• Fatigue

Diabetic Ketoacidosis (DKA) is a serious medical condition with normal or high blood glucose levels. Get medical help right away if you have any of the symptoms in the table below under DKA, even if your blood glucose levels are normal.

Tell your doctor if you are hospitalized for major surgery, serious infection or serious medical illness.

Increased need for lower leg or toe amputation (removal) especially if you are at high risk of heart disease. Talk to your doctor if you experience symptoms including leg pain, poor circulation, bluish, cold skin, and poor hair and toe nail growth. Good foot care is recommended.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Stop taking INVOKAMET and tell your healthcare professional if you get the following symptoms of lactic acidosis:

• You feel very weak and tired.
• You have unusual (not normal) muscle pain.
• You have trouble breathing or fast breathing.
• You have stomach pain with nausea and vomiting, or diarrhea.
• You feel cold, especially in your arms and legs.
• You feel dizzy or lightheaded.
• You feel unusual fatigue and drowsiness.
• You have a slow or irregular heartbeat.
• Your medical condition suddenly changes.
• You develop or experience a worsening of heart problems and particularly heart failure.

INVOKAMET is not recommended for use in patients under 18 years of age.

INVOKAMET will cause your urine to test positive for sugar (glucose).

Taking INVOKAMET increases your risk of breaking a bone. Talk to your doctor about factors that may increase your risk of bone fracture.

While taking INVOKAMET your healthcare professional may order blood tests to check your kidney function, blood fat levels (Low-Density Lipoprotein cholesterol or LDL-C), the amount of red blood cells in your blood (haematocrit), and potassium blood levels.

INVOKAMET may cause dizziness or light-headedness. DO NOT drive or use machines until you know how the medicine affects you.

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

The following may interact with INVOKAMET:

• digoxin, used to treat heart problems.
• furosemide or other diuretics (water pills), used to treat high blood pressure and other heart problems.
• insulin or a sulfonylurea (such as glimepiride, gliclazide, or glyburide), used to help control blood sugar.
• carbamazepine, phenytoin or phenobarbital, used to treat seizures.
• barbituates, used as sedatives and sleep-aids.
• efavirenz or ritonavir, used to treat HIV infection.
• rifampin, an antibiotic used to treat bacterial infections such as Tuberculosis.
• St. John’s wort, an herbal product used to treat depression.
• nifedipine, a calcium channel blocker used to treat heart problems.
• Angiotensin-Converting Enzyme (ACE) inhibitors, Angiotensin Receptor Blockers (ARB) used to treat high blood pressure.
• phenprocoumon and other drugs used prevent blood clots and thin the blood.
• birth control pills and other products containing estrogens.
• alcohol.

Your doctor and pharmacist will tell you how to take your medicine. Carefully follow the instructions given to you by your doctor and pharmacist.

INSPRA tablets may be taken with or after a meal or on an empty stomach. Swallow the tablets with a glass of water without chewing.

INSPRA is not recommended for children.

Usual dose:

The usual starting dose will depend on the potassium level in your body and your kidney condition which will be assessed by your doctor.

In people with normal or near normal kidney function, for heart failure the usual starting dose is one 25 mg tablet once daily, increasing to one 50 mg tablet once daily in about 4 weeks, as instructed by your doctor. For hypertension, the usual dose is 50 mg tablet once daily.

The maximum daily dose for heart failure is 50 mg and for hypertension, it is 100 mg.

Lower doses will be used in people with elevated potassium in the blood or weaker kidney function.

Blood potassium levels should be measured before starting INSPRA therapy, within the first week and at one month after the start of treatment or after a change in dose. The dose may be adjusted by your doctor, depending on the potassium levels in your blood. It is very important that you comply with your doctor's recommendations particularly regarding the laboratory test which may be prescribed.

It is important to keep taking INSPRA as prescribed unless your doctor tells you to stop your treatment.

Overdose:

If you take more INSPRA than you should, tell your doctor or pharmacist immediately.

If you think you have taken too much INSPRA contact your doctor, nurse, pharmacist, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed dose:

If you forget to take a tablet take it as soon as you remember. If it is almost time to take the next tablet, do not take the tablet you have missed. Instead, take the next tablet when it is due and afterwards, continue to take your tablets as your doctor has prescribed for you. Do not take a double dose to make up for the forgotten tablet.

Side effects may include headache. The most common side effects seen with INSPRA are related to increased blood potassium levels.

INSPRA can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.

BEFORE you use INSPRA tell your doctor or pharmacist if:

• you are pregnant or if you are planning to become pregnant. The effects of INSPRA have not been evaluated during pregnancy. Ask your doctor or pharmacist for advice before taking any medicine;
• you are breast-feeding or intend to breast-feed;
• you have kidney or liver disease;
• you are diabetic;
• you are taking lithium (usually given as a mood stabilizing medication);
• you are using potassium supplements or salt substitutes containing potassium.

Please contact your doctor if you are taking any of the above medicines, or have taken them in the past.

You may feel dizzy after taking this medicine. If this happens, tell your doctor about it and do not drive or operate machinery.

Do not use INSPRA if you:

• are hypersensitive (allergic) to INSPRA or to any of the other ingredients of INSPRA (see below for the nonmedicinal ingredients);
• have high levels of potassium in your blood;
• are taking potassium sparing diuretics (certain types of water tablets);
• have severe liver impairment;
• have heart failure and severe kidney impairment;
• have hypertension and moderate kidney impairment;
• are taking other medications that may affect the elimination of INSPRA, such as:
  • ritonavir or nelfinavir (antiviral medication for treating HIV);
  • clarithromycin, or telithromycin (antibiotics used to treat bacterial infections);
  • ketoconazole or itraconazole (medicines that are used to treat fungal infections);
  • nefazodone (used to treat depression);
  • potassium supplements.

Certain medications can affect the way that INSPRA is broken down by the body. Interaction with other drugs is possible. Please inform your doctor if you are taking any of the following medicines.

• ketoconazole, itraconazole or fluconazole (used to treat fungal infections);

• verapamil or diltiazem (used for heart problems and/or high blood pressure);

• digoxin or amiodarone (used to treat particular heart conditions including irregular heart rhythms);

• angiotensin converting enzyme inhibitors which are any medication with generic names ending with “pril” (used for high blood pressure or heart conditions);

• angiotensin II receptor antagonists, which are any medication with generic names ending with “sartan” (used for high blood pressure, or particular kidney conditions);

• potassium sparing diuretics (certain water tablets used to treat fluid retention)

• potassium supplements (salt tablets);

• herbal preparations containing large amounts of potassium (such as Noni fruit or juice, dandelion);

• saquinavir, ritonavir or nelfinavir (antiviral medication for treating HIV);

• erythromycin, clarithromycin, telithromycin, or rifampicin (antibiotics used to treat bacterial infections);

• lithium (usually given as a mood stabilizing medication);

• nefazodone and St John's Wort (used to treat depression);

• carbamazepine, phenytoin and phenobarbital (used to treat epilepsy);

• non-steroidal anti-inflammatory drugs (certain pain killers, such as ibuprofen and other pain relievers).

Tell your doctor or pharmacist if you are taking any other medications, including prescription, non-prescription and natural health products.

The usual recommended dose depends on the condition being treated as well as your kidney and liver function.

The dose range for treatment of high blood pressure is 1 mg to 5 mg once daily.

The dose range for congestive heart failure is 0.5 mg to 2.5 mg once daily.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

For the greatest benefit of this medication, INHIBACE should be taken at the same time each day, and may be taken with or without food.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• cough (dry, persistent)
• diarrhea
• dizziness
• drowsiness
• dry mouth
• headache
• nausea
• runny or stuffed-up nose
• unusual tiredness
• vomiting
• weakness (loss of energy)

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

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

• chest pain
• dizziness, lightheadedness, or fainting (signs of low blood pressure)
• increased or irregular heartbeat
• joint pain
• muscle cramps
• signs of anemia (low red blood cells; e.g., pale skin, unusual tiredness, or weakness)
• signs of breathing problems (e.g., pain when breathing, shortness of breath, troubled breathing, wheezing, tightness in chest, fast or irregular breathing)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
• signs of electrolyte imbalance (e.g., muscle pain or cramps, weakness, irregular heartbeat)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of kidney or urinary tract problems (e.g., difficulty urinating, pain when urinating, decreased amount of urine passed)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
• skin rash (with or without itching, fever, or joint pain)
• symptoms of lupus (e.g., fatigue, joint pain, butterfly-shaped rash on face, headaches, memory loss)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• difficulty swallowing or breathing (sudden)
• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of angioedema (e.g., swelling of face, mouth, hands, or feet)
• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
• signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
• symptoms of too much potassium in the body (e.g., muscle fatigue, weakness, difficulty moving, abnormal heart rhythms, nausea)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Do not take INHIBACE if you:

• are allergic to INHIBACE or any ingredients of this medication
• are allergic to any other angiotensin converting enzyme inhibitor (e.g., captopril, lisinopril, ramipril)
• are pregnant or plan to become pregnant
• are breast-feeding
• have a history of angioedema (a serious allergic reaction which causes the area around the throat and tongue to swell) after taking any ACE inhibitors
• have ascites (swollen abdomen due to liver problems)
• are taking aliskiren and
  • have diabetes
  • have kidney disease
  • are taking a medication in the class of angiotensin receptor blockers (e.g., irbesartan, losartan, valsartan)
  • are taking another angiotensin converting enzyme inhibitor (e.g., captopril, lisinopril, ramipril)
• have galactose intolerance (a rare hereditary condition)

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Angioedema: Angioedema is a serious allergic reaction that causes the area around the face, throat, and tongue to swell. It may occur with use of INHIBACE. If you experience swelling of the face, tongue, or throat, stop taking INHIBACE at once and get immediate medical attention. Do not take other ACE inhibitors in the future. If you have had angioedema caused by other substances, you may be at increased risk of angioedema while receiving INHIBACE.

Cough: ACE inhibitors such as this medication may cause you to develop a dry, persistent cough within hours of the first dose to weeks or months after starting therapy. The cough usually resolves within 4 weeks of stopping this medication. Talk to your doctor if you develop a persistent, intolerable cough.

Diabetes: INHIBACE may cause a decrease in blood sugar levels and increased effects from medications used to reduce blood glucose. You may find it necessary to monitor your blood sugar more frequently while using this medication.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced alertness: INHIBACE may cause drowsiness or dizziness, especially at the beginning of treatment or after a dose increase. This can affect your ability to drive or operate machinery. Avoid these and other hazardous tasks until you have determined how this medication affects you.

Fluid and electrolyte balance: Increases in blood levels of potassium occur for some people who take this medication. This rarely causes problems, but potassium levels should be monitored by your doctor. If you have kidney disease or diabetes, there is a higher risk of having increased blood potassium while taking INHIBACE. Discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Infection: INHIBACE can reduce the number of cells that fight infection in the body (white blood cells). This makes you more likely to experience infections.

Tell your doctor if you notice frequent signs of infection such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor should do blood tests periodically, to monitor the number of specific types of blood cells in your blood.

Kidney function: Changes in kidney function have been noticed in people with narrowed blood vessels in their kidneys, or those with severe congestive heart failure. The use of diuretics (water pills), non-steroidal anti-inflammatory drugs (NSAIDs), or aliskiren, may further increase risk of kidney problems in those at risk for this problem. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you have kidney function impairment you may require lower doses of this medication.

Let your doctor know if you notice any decreases in urine output or increases in the swelling of lower limbs, suggesting accumulation of fluid due to decreased urination.

Liver function: This medication may worsen liver disease or cause reduced liver function. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood pressure: Occasionally, blood pressure drops too low after taking INHIBACE. This usually happens after the first or second dose, or when the dose is increased. It is more likely to occur for people who take water pills or the medication aliskiren, have a salt-restricted diet, are on dialysis, are suffering from diarrhea or vomiting, or have been sweating excessively and not drinking enough liquids. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

To reduce the risk of dizziness, get up slowly from a lying or sitting position. If low blood pressure causes you to faint or feel lightheaded, contact your doctor.

Surgery: INHIBACE may interact with medications used during surgery. If you are scheduled for surgery, let your doctor know that you are taking this medication.

Pregnancy: Like other ACE inhibitors, INHIBACE may cause severe harm or death to an unborn baby and should not be used during pregnancy. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if INHIBACE passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of INHIBACE have not been established for children. Its use by this age group is not recommended.

Seniors: People over the age of 65 are more likely to experience the side effects of INHIBACE. If you are over the age of 65, your doctor may prescribe a lower dose of this medication.

There may be an interaction between INHIBACE and any of the following:

• aldesleukin
• aliskiren
• allopurinol
• alpha agonists (e.g., clonidine, methyldopa)
• alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
• amifostine
• angiotensin converting enzyme inhibitors (ACEIs; captopril, enalapril, ramipril)
• angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
• antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide, sodium bicarbonate)
• azathioprine
• barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
• beta-blockers (e.g., propranolol, metoprolol, sotalol)
• brimonidine
• calcium channel blockers (e.g., amlodipine, nifedipine, verapamil)
• cyclosporine
• diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
• dipyridamole
• diuretics (e.g., hydrochlorothiazide, furosemide, spironolactone, triamterene)
• eplerenone
• everolimus
• ginger
• ginseng
• grass pollen extract
• heparin
• iron dextran complex
• isosorbide dinitrate, isosorbide mononitrate
• licorice
• lithium
• low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• methylphenidate
• monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
• nonsteroidal anti-inflammatory medications (NSAIDs; e.g., ibuprofen, indomethacin, naproxen)
• phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
• potassium supplements
• quetiapine
• quinine
• rituximab
• salt substitutes that contain potassium
• sirolimus
• sodium phosphates
• temsirolimus
• tizanidine
• tolvaptan
• trimethoprim
• yohimbine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Always use INTELENCE exactly as your doctor has told you. You must check with your doctor if you are not sure.

Usual adult dose:

Take INTELENCE tablets every day exactly as prescribed by your doctor. The usual dose is 200 mg (one 200 mg tablet or two 100 mg tablets) of INTELENCE, twice daily every day. It may be easier to remember to take INTELENCE if you take them at the same time every day. If you have questions about when to take INTELENCE, your doctor can help you decide which schedule works for you.

You should always take INTELENCE following a meal. You should not take INTELENCE on an empty stomach. Taking INTELENCE on an empty stomach may lessen the effect of INTELENCE. Follow your doctor's advice on the type of meal you should be taking with INTELENCE.

Swallow the tablets whole with a liquid such as water. Do not use warm (>40°C) or carbonated beverages when taking INTELENCE tablet(s). Do not chew the tablets.

If you are unable to swallow the INTELENCE tablets whole, you may do the following:

• place the tablets in 5 mL (1 teaspoon) of water, or at least enough liquid to cover the medication,
• stir well until the water looks milky,
• if desired, add more water or alternatively orange juice or milk (do not place the tablets in orange juice or milk without first adding water),
• drink it immediately,
• rinse the glass several times with water, orange juice, or milk and completely swallow the rinse each time to make sure you take the entire dose.

Continue taking INTELENCE unless your doctor tells you to stop. Take the exact amount of INTELENCE that your doctor tells you to take, right from the very start. To help make sure you will benefit from INTELENCE, you must not skip doses or interrupt therapy. If you do not take INTELENCE as prescribed, the beneficial effects of INTELENCE may be reduced or even lost.

Instructions for proper use for children and adolescents (6 years to less than 18 years of age) and weighing at least 16 kg:

The doctor will work out the right dose based on the weight of the child. The doctor will inform you exactly how much INTELENCE the child should take.

Do not stop administering INTELENCE without talking to the child's doctor. The other HIV medicines used in combination with INTELENCE should be taken by the child as recommended by the child's doctor.

Overdose:

In case of drug overdose, contact a health care practitioner (doctor), hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed dose:

If you miss a dose of INTELENCE by more than 6 hours, wait and then take the next dose of INTELENCE at the regularly scheduled time. If you miss a dose of INTELENCE by less than 6 hours, take your missed dose of INTELENCE immediately, following a meal. Then take your next dose of INTELENCE at the regularly scheduled time.

If a dose of INTELENCE is skipped, do not double the next dose. Do not take more or less than your prescribed dose of INTELENCE at any one time.

Do not stop using INTELENCE without talking to your doctor first.

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

• have had or currently have liver problems, including hepatitis B and/or C.
• are pregnant or planning to become pregnant. It is not known if INTELENCE can harm your unborn baby. You and your doctor will need to decide if taking INTELENCE is right for you. If you take INTELENCE while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
• are breast-feeding or planning to breast-feed. Do not breast-feed if you are taking INTELENCE. You should not breast-feed if you have HIV because of the chance of passing HIV to your baby. Talk with your doctor about the best way to feed your baby.

A typical dose of INDOCIN for rheumatoid arthritis, osteoarthritis, or ankylosing spondylitis is 75 milligrams (mg) two or three times a day, but your doctor will try to find the lowest dose that works for you.

INDOCIN comes in regular capsules, extended-release capsules, liquid form, and suppositories.

Don't open or crush the extended-release capsules, and mix the liquid thoroughly. Take INDOCIN with food or after a meal.

Treatment for shoulder pain may continue for one or two weeks, but treatment for gout should stop as soon as pain goes away.

In 2014, the FDA approved a low-dose version of INDOCIN: 20-mg and 40-mg capsules sold under the brand name Tivorbex.

This version of the drug is made of smaller particles of INDOCIN that dissolve more quickly.

INDOCIN Overdose

An overdose of INDOCIN can cause nausea, vomiting, severe headache, dizziness, confusion, and tiredness.

Severe symptoms can include numbness, tingling, and seizure.

If you think you have taken an overdose, or if someone else may have overdosed on INDOCIN, call a poison control center..

Missed Dose of INDOCIN

Take INDOCIN exactly as directed by your doctor. Don’t take more or less.

If you miss a dose of INDOCIN, take the missed dose as soon as you remember.

But if it’s almost time for your next dose, skip the missed dose and continue your regular dosing schedule.

Don't double your dose to make up for the missed one.

Possible side effects of INDOCIN include:

• Nausea and vomiting
• Indigestion and stomachache
• Constipation
• Headache
• Dizziness
• Fatigue
• Sleepiness
• Depression
• Ringing in the ears

Serious side effects can occur with INDOCIN.

If you have any of these side effects, stop taking INDOCIN and call your doctor right away. For severe side effects, get emergency help, or call 911:

• Chest pain
• Wheezing or difficulty breathing
• Weakness on one side of the body
• Slurred speech
• Stomach pain
• Vomiting blood or something resembling coffee grounds
• Bloody diarrhea or tarry stools
• Unusual bleeding or bruising
• Skin rash or blistering
• Skin rash with fever
• Fatigue, nausea, yellowing of skin or eyes, dark-colored urine, and flu-like symptoms
• Swelling of the face, throat, tongue, or body
• Difficulty swallowing or talking
• Blurred vision

If you have any side effects from INDOCIN, let your doctor know.

People older than 65 are more prone to side effects of INDOCIN, including GI bleeding. If you are over 65, ask your doctor whether there are safer alternatives.

INDOCIN and other NSAIDs can cause heart attack and stroke.

These can occur without warning and can be fatal. This risk may increase if you take INDOCIN for a prolonged period of time.

You also may be at higher risk if you have a history of heart disease or high blood pressure. Taking INDOCIN may trigger high blood pressure or make it worse, and high blood pressure is a risk factor for stroke and heart attack.

INDOCIN and other NSAIDs may cause ulcers, perforations, and sudden bleeding in your stomach or intestine (known as gastrointestinal, or GI, bleeding).

This can occur at any time during treatment. You may be at higher risk for GI bleeding if you are elderly, drink a lot of alcohol, smoke, are in poor health, or take any blood-thinning medication.

You may also be at higher risk if you have a history of ulcers or GI bleeding.

About 1 percent of people who take INDOCIN every day for three to six months experience GI bleeding.

You should not take INDOCIN if you have asthma, nasal polyps, and an allergy to aspirin.

This triple combination -- known as ASA triad, aspirin triad, or Samter's triad -- can results in anaphylaxis, a potentially fatal allergic reaction.

Talk with your doctor about the warnings related to stroke, heart attack, GI bleeding, and anaphylaxis.

Tell your doctor about any history of heart disease, stroke, ulcers, or GI bleeding, including any family history of heart disease or stroke.

Ask your doctor how you will be checked for these conditions and any warning symptoms to watch for.

Use INDOCIN with caution if you have high blood pressure, heart failure, or edema (fluid retention), or if you have ever had a peptic ulcer.

You should not take INDOCIN for two weeks after having a type of heart bypass surgery called coronary artery bypass graft. Taking INDOCIN could increase your risk for stroke or heart attack after this surgery.

Before starting INDOCIN, also let your doctor know if you have any of these conditions:

• Kidney disease
• Liver disease
• Anemia
• Eye disease
• Depression
• Epilepsy
• Parkinson’s disease
• Abnormal bleeding
• Lung disease or asthma

INDOCIN and Pregnancy

INDOCIN is not safe to take during later stages of pregnancy because it may cause heart defects and other problems to a developing fetus.

Before taking INDOCIN, let your doctor know if you are pregnant or may become pregnant. And if you become pregnant while taking INDOCIN, tell your doctor right away.

INDOCIN is also unsafe to take while breastfeeding because it can pass into breast milk.

Children 14 years old and younger should not take INDOCIN.

Some drugs may affect the way INDOCIN works, and INDOCIN may affect other drugs you are taking.

It’s very important to let your doctor know about all drugs you take, including any other prescription drugs, over-the-counter medications, illegal or recreational drugs, herbal remedies, or supplements.

Types of drugs that are known to interact with INDOCIN include:

• Over-the-counter NSAIDs including Advil, Aleve, and Motrin
• Prescription NSAIDs, such as diflunisal (Dolobid) and naproxen (Naprosyn)
• Aspirin
• Angiotensin-converting enzyme (ACE) inhibitors for high blood pressure such as benazepril (Lotensin), captopril (Capoten), and enalapril (Vasotec)
• Beta blockers for high blood pressure, including atenolol (Tenormin), labetalol (Normodyne), and metoprolol (Lopressor, Toprol XL)
• Angiotensin receptor blockers (ARBs) for high blood pressure, such as candesartan (Atacand), eprosartan (Teveten), and irbesartan (Avapro)
• Oral corticosteroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
• Drugs used to treat rheumatoid arthritis, including methotrexate (Rheumatrex)
• Diuretics (water pills) such as triamterene (Dyrenium, in Dyazide)
• Blood thinners such as warfarin (Coumadin)
• The cardiac drug digoxin (Lanoxin)
• The bipolar disorder drug lithium (Eskalith, Lithobid)
• The gout treatment probenecid (Benemid)
• The seizure medication phenytoin (Dilantin)

Other INDOCIN Interactions

INDOCIN may cause drowsiness and headache, so don’t drive or do other activities that require careful attention until you know how INDOCIN affects you.

You shouldn’t drink alcohol while taking this medication because it can worsen the side effects of INDOCIN.