How it is taken:

• Do not break,crush, chew or cut MYFORTIC tablets. Do not take any tablets that are broken or split. The tablets should be swallowed whole with plenty of water.
• Space your two doses of MYFORTIC as evenly as you can throughout the day leaving about 12 hours between each dose.
• Try to take your doses at the same times each day. This will help keep a constant amount of drug in your body so it can continue to protect your transplanted organ. Taking your medicine at the same time each day will also help you remember each dose.
• MYFORTIC should be taken on an empty stomach, one hour before or two hours after food intake.
• Vomiting or diarrhea may prevent MYFORTIC from being taken up into your body. Always call your doctor if you have either of these episodes.
• Your doctor has decided the dose of MYFORTIC you should take based on your medical condition and response to the drug. Follow your doctor's instruction carefully. Do not take any more or any less of the drug than your doctor has told you. Do not change the dose on your own, no matter how you are feeling.

How long is treatment continued:

• Treatment will continue for as long as you need immunosuppression to prevent you from rejecting your transplanted kidney.

Overdose:

In case of drug overdosage, contact a healthcare professional (e.g. doctor), hospital emergency department or regional Poison Control Centre, even if there are no symptoms.

Missed dose:

• Missing even a few doses of MYFORTIC may lead to rejection of your transplanted kidney. That is why it is so important to take each dose of MYFORTIC as prescribed.
• If you have trouble remembering doses, or if you are uncertain about how to take them talk to your doctor, nurse or pharmacist and be sure to discuss any concerns you have about taking the drug as prescribed.
• If you ever do miss a dose of MYFORTIC, do not double dose or catch up on your own; instead call your doctor or pharmacist right away for advice. It is also a good idea to ask your doctor ahead of time what to do about missed doses.
• Never allow your medication to run out between refills. Plan to order your refills about one week ahead of time. That way you will always have a supply in case the pharmacy is closed or out of the drug. Also be sure to take enough medication with you when you go on a holiday.

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

Some effects could be serious:

• If you have symptoms of infection including fever, chills, sweating, fatigue, drowsiness, or lack of energy. If you are taking MYFORTIC you may be more susceptible to infections than usual. These may affect various body systems, the most common being the urinary tract, the respiratory tract and the skin.
• If you experience vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and muscle weakness, these can be the signs and symptoms of an infection of the brain called progressive multifocal leukoencephalopathy.
• If you have enlarged glands, new or enlarging skin growths, or a change in an existing mole. As can happen in patients taking immunosuppressive medication a very small number of MYFORTIC patients have developed cancer of the skin or lymph nodes.
• If you experience unusual tiredness, headache, shortness of breath with exercise or at rest, dizziness, chest pain, looking pale. These are all symptoms of anaemia (decrease in red blood cells).

If you experience any of these, tell your doctor straight away.

Other side effects may include:

Very common side effects (>1 in 10 patients).

• diarrhea
• low level of white blood cells
• reduced level of calcium in the blood , sometimes leading to cramps, (hypocalcemia)
• muscle weakness, muscle spasms, abnormal heart rhythm (possible symptoms of low level of potassium in the blood) (hypokalemia)
• abnormal blood test results (high level of uric acid in the blood) (hyperuricemia)
• headache, dizziness (possible symptoms of high blood pressure) (hypertension)
• dizziness, light-headedness (possible symptoms of low blood pressure) (hypotension)

Common side effects (≤10 in every 100 patients).

• bleeding or bruising more easily than normal (signs of low level of blood platelets—thrombocytopenia)
• muscle spasms, abnormal heart rhythm (possible symptoms of high level of potassium in the blood) (hyperkalemia)
• abnormal blood test results (low level of magnesium in the blood) (hypomagnesemia)
• excessive emotional distress, troubled (symptoms of anxiety)
• dizziness
• headache
• cough
• headache, dizziness, possibly with nausea (possible symptoms of severe high blood pressure) (aggravated hypertension)
• shortness of breath, laborated breathing (possible symptoms of dyspnea or dyspnea exertional)
• pain (e.g. in the abdomen, stomach, or joints)
• constipation
• indigestion
• flatulence
• loose stools
• nausea
• vomiting
• tiredness
• fever
• abnormal results of liver or kidney test
• pain in joint (arthralgia)
• weakness (asthenia)
• muscle pain (myalgia)
• swollen hands, ankles or feet (possible symptoms of edema peripheral)

Uncommon side effects (<1 in 100 patients).

• cyst containing lymph fluid
• difficulty in sleeping
• shakiness
• lung congestion
• shortness of breath
• belching; bad breath
• bowel obstruction
• inflammation of the oesophagus
• bloody or black stools
• tongue discoloration
• dry mouth
• heartburn; inflammation of the gums
• inflammation of the lining of the abdominal cavity
• flu-like symptoms
• swelling of ankles and feet
• loss of appetite
• hair loss
• bruise of the skin
• acne
• fast heart beat; discharge of the eye with itching, redness and swelling
• vision blurred
• kidney disorders
• abnormal narrowing of the tube through which urine passes to the outside of the body
• cough, difficulty breathing, painful breathing (possible symptoms of interstitial lung disease including fatal pulmonary fibrosis)

Other side effect with frequency not known

(Frequency cannot be estimated from the available data)

• rash
• fever, sore throat, frequent infections (possible symptoms of lack of white cells in the blood) (agranulocytosis)

Additional side effects have been reported with the class of drugs to which MYFORTIC belongs.

• inflammation of the colon or of the oesophagus
• abdominal pain
• vomiting
• loss of appetite
• nausea
• inflammation of the pancreas
• intestinal perforation;
• stomach or intestine bleeding
• stomach pain with or without bloody or black stools
• bowel obstruction
• serious infections
• reduction in the number of specific white blood cells or of all blood cells

If any of these affects you, tell your doctor. However, do not stop your medicines unless you have discussed this with your doctor first.

Do not take MYFORTIC if you are allergic (hypersensitive) to mycophenolic acid, mycophenolate sodium or mycophenolate mofetil or to any of the other ingredients of MYFORTIC (see below).

If you think you may be allergic, ask your doctor for advice.

Serious Warnings and Precautions

• MYFORTIC may increase your risk of infection and development of cancer of the lymphoid tissues (called lymphoma) and other cancers.
• MYFORTIC will only be prescribed for you by a doctor with experience in transplantation medicine.
• Female users of childbearing potential must use contraception. Use of MYFORTIC during pregnancy is associated with increased risks of pregnancy loss and congenital malformations.

Follow your doctor's instructions carefully. They may differ from the general information contained in this leaflet.

• For Female Patients:
  • MYFORTIC causes fetal malformations and pregnancy loss, including spontaneous abortion. Therefore, MYFORTIC should not be used in pregnant women unless clearly necessary. Should you become pregnant while on therapy with MYFORTIC, inform your doctor at once. You will want to discuss the possible benefits and risks of continuing with this drug.
  • Women of childbearing potential should have a negative serum (blood) or urine pregnancy test within 1 week prior to beginning therapy. Effective contraception must be used before beginning MYFORTIC therapy, during therapy, and for 6 weeks following discontinuation of therapy.
  • Effective contraception must be used before beginning MYFORTIC therapy, during therapy, and for 6 weeks following discontinuation of therapy, even where there has been a history of infertility, unless due to hysterectomy. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method. If pregnancy does occur during treatment, the patient should inform the physician immediately, and should discuss the potential risk to the fetus with him/her.
  • MYFORTIC should not be used while breast-feeding, or up to 6 weeks after you have stopped therapy. MYFORTIC may pass into breast milk and may harm your baby.
• MYFORTIC may reduce the effectiveness of vaccinations and the use of live attenuated vaccines should be avoided. Discuss it with your doctor before you get any vaccinations or immunizations.
• If you are a sexually active man, you should use condoms during treatment with MYFORTIC and for 13 weeks after stopping the treatment. Your partner should also use effective contraception during your treatment and for 13 weeks after you have stopped MYFORTIC. Tell your doctor straight away if your partner becomes pregnant while you are taking MYFORTIC.

• Tell all health professionals you see (doctors, dentists, nurses, pharmacists) that you are taking MYFORTIC.
• Do not take any other drugs without asking your doctor or pharmacist first. This includes anything you can buy off the shelf such as over-the-counter medicines (e.g. antacids) and natural health products.

Drugs that may interact with MYFORTIC include:

• Immunosuppressive agents other than cyclosporine or corticosteroids (e.g. azathioprine, mycophenolate mofetil, tacrolimus).
• Cholestyramine (a medicine used to treat high blood cholesterol levels).
• Acyclovir (a medicine used to treat herpes infection).
• Gancyclovir (a medicine used to treat cytomegalovirus (CMV) infection).
• Non-prescription medications, including antacids or any natural health product.

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

MYDRIACYL EYE DROPS are most often used only in a doctor's office during an eye examination. Instructions are provided below for giving yourself the medication if your doctor has prescribed it for home use.

Wash your hands before using the eye drops.

If you wear contact lenses, remove them before applying MYDRIACYL EYE DROPS. Ask your doctor if contact lenses can be reinserted after putting in the eye drops. MYDRIACYL EYE DROPS may contain a preservative (benzalkonium chloride) that may cause discoloration of contact lenses.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid. 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.

Store the drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

Rinse your eye with water and seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a MYDRIACYL EYE DROPS overdose may include headache, fast heartbeat, dry mouth and skin, unusual drowsiness, and warmth or redness under your skin.

Since MYDRIACYL EYE DROPS are usually given only during an eye exam, it is not likely that you will be on a dosing schedule.

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.

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

• fast or uneven heart rate;
• hallucinations or unusual behavior (especially in children); or
• stomach bloating or discomfort.

Less serious side effects may be more likely to occur, such as:

• blurred vision;
• eye sensitivity to sunlight;
• stinging and burning; or
• swelling of the eyelids.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

MYDRIACYL EYE DROPS may cause blurred vision, or make your eyes very sensitive to light. Be careful if you drive, operate machinery, or do anything else that requires you to see clearly. These effects can last for up to 24 hours.

Protect your eyes if you go outdoors into sunlight after using MYDRIACYL EYE DROPS.

Unless your doctor tells you to, avoid using other eye drops or ointment until the effects of MYDRIACYL EYE DROPS have worn off.

Do not use this medication if you are allergic to MYDRIACYL EYE DROPS, or if you have untreated glaucoma.

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.

MYDRIACYL EYE DROPS can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

• It is very important to take MYCOBUTIN exactly as your healthcare professional has told you to. Never change the dose by yourself. Do not stop taking MYCOBUTIN unless your healthcare professional tells you to because your infection could return.
• Take this drug at the same time every day.
• Swallow the MYCOBUTIN capsules (pills) whole with a drink of water.

Usual Dose:

• Take two MYCOBUTIN capsules (pills) by mouth once a day.
• If you have nausea, feel sick to your stomach, or throw up you can take one capsule (pill) by mouth twice a day. In this case, take with food.

Overdose:

If you think you have taken too much MYCOBUTIN, 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, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for a missed dose.

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

The most common side effect of MYCOBUTIN is a change in the colour of your urine from yellow to brown-orange. Colour changes like this may also affect bowel movements, spit, sweat, tears or skin. If you wear contact lenses, they may be permanently stained.

Other side effects include:

• A drop in the number of white blood cells (these fight infections).
• Skin rashes
• Stomach problems like upset stomach, burping, passing gas, nausea (feeling sick to your stomach), vomiting (throwing up) and belly pain.
• Ask your healthcare professional about how to tell if you have Mycobacterium avium complex (MAC) disease and/or TB.
• Let your healthcare professional know if you get any of these side effects and symptoms.

If you notice symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal (belly) pain, or tenderness, you may have Clostridium difficile colitis (C. difficile—bowel inflammation). If this occurs, stop taking MYCOBUTIN and contact your healthcare professional immediately.

Do not use Mycobutin if 

• If you are allergic (hypersensitive) to this drug.
• If you are allergic to any of the other ingredients in MYCOBUTIN
• If you are allergic to any drug containing rifamycin.

The following may interact with MYCOBUTIN:

• Drugs to treat diabetes
• Painkillers like acetylsalicylic acid (ASA) and others
• Narcotics, including methadone
• Blood thinners (anticoagulants) like warfarin
• Steroids (to treat inflammation or allergy) like prednisolone
• Drugs to suppress the immune system like cyclosporine (ciclosporin) and tacrolimus
• Drugs for heart conditions like quinidine or digitalis (digoxin is okay)
• Drugs to treat skin infections or pneumonia like dapsone
• Drugs to treat epilepsy or seizures like phenytoin (Dilantin)
• Drugs to treat fungal infections like fluconazole, itraconazole, posaconazole, voriconazole, ketoconazole and miconazole
• Drugs to treat viral infections like indinavir, saquinavir, ritonavir or amprenavir, fosamprenavir/ritonavir, lopinavir/ritonavir and tipranavir/ritonavir
• The anti-HIV drug called delviradine
• The antibiotic drug called clarithromycin
• Birth control pills that have ethinyl estradiol and/or norethindrone. (These drugs may not be as effective if you are on MYCOBUTIN and your healthcare professional may recommend a different kind or an additional kind of birth control.)

This medicine is to be administered only by or under the immediate supervision of your doctor.

A nurse or other trained health professional will give you this medicine. Hyaluronic acid knee injections, as you'd expect, medicine is given as a shot into your knee joint. It may take more than one injection for the pain to go away.

You will receive a series of monovisc injections of this medicine one week apart for a total of three or four injections.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Difficulty with moving
• muscle pain or stiffness
• pain in the joints

Less common

• Swelling or redness in the joints

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects of these monovisc injections not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Do not strain your knee joint for two days after receiving this medicine. Avoid activities such as jogging, soccer, tennis, heavy lifting, or standing on your feet for a long time.

Temporary pain or swelling in the knee joint may occur after receiving hyaluronic acid injection. Call your doctor if the pain or swelling in the knee persists or becomes worse after receiving this medicine.

Do not use this medicine with disinfectants containing quaternary ammonium salts (e.g., benzalkonium chloride). This may prevent hyaluronic acid injection from working properly.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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

The dosage is based on your medical condition and response to treatment.

Antacids containing aluminum or magnesium can decrease the absorption of fosinopril. If you are taking an antacid that contains aluminum or magnesium, take it at least 2 hours before or 2 hours after taking this product.

Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick.

For the treatment of high blood pressure, it may take several weeks before you get the full benefit of this medication. For the treatment of heart failure, it may take weeks to months before you get the full benefit of this medication. Tell your doctor if your condition does not improve or if it worsens (such as your blood pressure readings remain high or increase).

Dizziness or lightheadedness may occur as your body adjusts to the medication. Dry cough may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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

Tell your doctor right away if any of these unlikely but serious side effects occur: fainting, symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat).

Although fosinopril may be used to prevent kidney problems or treat people who have kidney problems, it may also rarely cause serious kidney problems or make them worse. Your doctor will check your kidney function while you are taking fosinopril. Tell your doctor right away if you have any signs of kidney problems such as a change in the amount of urine.

This drug may rarely cause serious (possibly fatal) liver problems. Tell your doctor right away if you notice any of the following rare but serious side effects: yellowing eyes/skin, dark urine, severe stomach/abdominal pain, persistent nausea/vomiting.

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

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

In the US -

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

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

Before taking fosinopril, tell your doctor or pharmacist if you are allergic to it; or to other ACE inhibitors (such as benazepril); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: history of an allergic reaction which included swelling of the face/lips/tongue/throat (angioedema), blood filtering procedures (such as LDLapheresis, dialysis), high level of potassium in the blood.

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

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Too much sweating, diarrhea, or vomiting may cause loss of too much body water (dehydration) and increase your risk of lightheadedness. Report prolonged diarrheaor vomiting to your doctor. Be sure to drink enough fluids to prevent dehydrationunless your doctor directs you otherwise.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This product may increase your potassium levels. Before using potassium supplements or salt substitutes that contain potassium, consult your doctor or pharmacist.

Older adults may be more sensitive to the side effects of this drug, including dizziness and increases in potassium level.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Consult your doctor for more details. (See also Warning section.)

This medication passes into breast milk. Consult your doctor before breast-feeding.

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

Some products that may interact with this drug include: aliskiren, certain drugs that weaken the immune system/increase the risk of infection (such as everolimus, sirolimus), lithium, drugs that may increase the level of potassium in the blood (such as ARBs including losartan/valsartan, birth control pills containing drospirenone), sacubitril.

Check the labels on all your medicines (such as cough-and-cold products, diet aids, or NSAIDs such as ibuprofen, naproxen) because they may contain ingredients that could increase your blood pressure or worsen your heart failure. Ask your pharmacist for more details.

Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day) should be continued. Consult your doctor or pharmacist for more details.

A very serious reaction may occur if you are getting injections for bee/wasp stingallergy (desensitization) and are also taking fosinopril. Make sure all your doctors know which medicines you are using.

This medication may interfere with certain laboratory tests (including digoxin levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

For oral administration.

To be taken preferably with or after food.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Adults

A single daily dose of 20mg Mobiflex should be taken at the same time each day. Mobiflex Tablets are for oral administration with water or other fluid.

Higher doses should be avoided as they do not usually achieve significantly greater therapeutic effect but may be associated with a higher risk of adverse events.

In acute musculoskeletal disorders treatment should not normally be required for more than 7 days, but in severe cases it may be continued up to a maximum of 14 days.

Elderly

The elderly are at increased risk of the serious consequences of adverse reactions. They are also more likely to be receiving concomitant medication or to have impaired hepatic, renal or cardiovascular function. If an NSAID is considered necessary the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Children

There are insufficient data to make a recommendation for administration of Mobiflex to children.

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

• Disturbances of the gut such as indigestion, diarrhoea, constipation, nausea, vomiting, wind or abdominal pain.
• Loss of appetite.
• Mouth ulcers.
• Ulceration or bleeding in the stomach or intestines.
• Sensation of spinning (vertigo).
• Sensation of ringing, or other noise in the ears (tinnitus).
• Retention of water in the body tissues, resulting in swelling (oedema).
• Increase in blood pressure.
• Blurred vision.
• Swollen eyes or eye irritation.
• Dizziness.
• Headache.
• Drowsiness.
• Difficulty sleeping (insomnia).
• Depression.
• Nervousness.
• Confusion.
• Hallucinations.
• Pins and needles sensations.
• Inflammation of the pancreas (pancreatitis).
• Hypersensitivity reactions such as narrowing of the airways (bronchospasm), swelling of the lips, throat and tongue (angioedema), severe skin rashes or anaphylactic shock.
• Kidney, liver or blood disorders.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

• This medicine may mask the signs and symptoms of infection, such as fever and inflammation. This may make you think mistakenly that an infection is getting better when it isn't, or that an infection is less serious than it is. For this reason you should tell your doctor if you get an infection while you are taking this medicine.
• Your doctor will prescribe you the lowest effective dose of this medicine for the shortest possible time necessary to relieve your symptoms. This is to minimise the chances of any side effects, particularly those mentioned below. It is important not to exceed the prescribed dose.
• NSAIDs can occasionally cause serious side effects on the gut, such as ulceration, bleeding or perforation of the stomach or intestinal lining. This type of side effect is more likely to occur in elderly people and in people taking high doses of the medicine. The risk can also be increased by taking certain other medicines (see end of factsheet). It is important that these people, as well as people with a history of disorders affecting the stomach or intestines, are closely monitored by a doctor while taking this medicine. If your doctor thinks you are at high risk of side effects on the gut you may be prescribed an additional medicine to help protect your gut. All people taking this medicine should stop treatment and consult their doctor immediately if they experience any sign of bleeding from the stomach or intestine during treatment, for example vomiting blood and/or passing black/tarry/bloodstained stools.
• Non-steroidal anti-inflammatory drugs such as this one may be associated with a small increase in the risk of experiencing a heart attack or stroke, although tenoxicam may have a lower risk than some other NSAIDs. Any risk is more likely with high doses and prolonged treatment. If you have heart problems, have ever had a stroke, or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.
• Very rarely, NSAIDS may cause serious blistering or peeling skin reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis). For this reason, you should stop taking this medicine and consult your doctor if you get a skin rash or sores inside your mouth while taking this medicine. This side effect is very rare, but if it occurs, is most likely to happen in the first month of treatment.
• If you have cirrhosis of the liver, heart failure or kidney disease, you are on a low sodium diet, or you are taking diuretic medicines, your kidney function should be assessed before starting and regularly throughout treatment with this medicine.
• During long-term treatment with this medicine you should have regular check-ups with your doctor so that you can be monitored for possible side effects of the medicine. This might include routine blood tests to monitor your kidney function, liver function and levels of blood components, particularly if you are elderly.

Use with caution in

• Elderly people.
• History of disorders affecting the stomach or intestines.
• Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
• Kidney disease.
• Liver disease.
• Heart failure.
• High blood pressure (hypertension).
• Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina or history of heart attack.
• Disease of the blood vessels in and around the brain (cerebrovascular disease), eg history of stroke or mini-stroke (TIA).
• Poor circulation in the arteries of the legs or feet (peripheral arterial disease).
• Raised levels of fats such as cholesterol in the blood (hyperlipidaemia).
• Diabetes.
• Smokers.
• People with blood clotting problems or taking anticoagulant medicines.
• History of asthma.
• History of allergies.
• Diseases affecting connective tissue, eg systemic lupus erythematosus.

Not to be used in

• People in whom aspirin or other NSAIDs, eg diclofenac, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema).
• People with an active peptic ulcer or a history of peptic ulcer, bleeding in the gut or severe stomach inflammation (gastritis).
• Severe heart failure.
• Mobiflex tablets are not recommended for children.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

Tenoxicam should not be used in combination with painkilling doses of aspirinor any other NSAID taken by mouth, eg ibuprofen, as this increases the risk of side effects on the stomach and intestines. Selective inhibitors of cyclo-oxgenase 2 such as celecoxib or etoricoxib should also be avoided for the same reason.

There may be an increased risk of ulceration or bleeding from the gut if tenoxicam is taken with corticosteroids such as prednisolone.

There may also be an increased risk of bleeding from the gut if tenoxicam is taken with the following medicines:

• anti-blood-clotting (anticoagulant) medicines such as warfarin
• anti-platelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, clopidogrel, dipyridamole
• dabigatran
• erlotinib
• selective serotonin re-uptake inhibitors (SSRIs) antidepressants, eg fluoxetine, paroxetine, citalopram
• venlafaxine.

Tenoxicam may enhance the effect of blood-thinning or anti-clotting medicines (anticoagulants) such as warfarin. As this may increase the risk of bleeding, people taking tenoxicam with an anticoagulant medicine should be closely monitored by their doctor.

There may be an increased risk of side effects on the kidneys if tenoxicam is used with any of the following medicines:

• ACE inhibitors, eg enalapril
• angiotensin II receptor antagonists, eg losartan
• ciclosporin
• diuretics, eg furosemide
• tacrolimus.

Tenoxicam may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, including the following:

• ACE inhibitors such as captopril
• angiotensin II receptor antagonists, eg losartan
• beta-blockers such as propranolol
• diuretics such as furosemide.

Tenoxicam may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines. People using tenoxicam with any of these should be closely monitored by their doctor:

• digoxin
• lithium
• methotrexate.

If this medicine is used in combination with quinolone antibiotics, such as ciprofloxacin or norfloxacin, there may be an increased risk of seizures (fits). This may occur in people with or without a previous history of epilepsy or convulsions.

Other medicines containing the same active ingredient

Tenoxicam tablets and injection are also available without a brand name, ie as the generic medicine.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Use MIRVASO topical once per day, unless your doctor tells you otherwise.

Apply a pea-sized amount of this medicine to each affected area of the face (forehead, nose, chin, and each cheek). Try not to get any of the medicine near your eyes or on your lips.

Do not use this medicine on open wounds or on sunburned, windburned, dry, chapped, or irritated skin.

Wash your hands after applying this medicine.

Store at room temperature away from moisture and heat.

Keep this medicine out of the reach of children. MIRVASO topical can cause serious medical problems in a child who accidentally swallows the medicine. Seek emergency medical attention if this happens.

An overdose of MIRVASO topical is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line if anyone has accidentally swallowed the medication.

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

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

Stop using MIRVASO topical and call your doctor at once if you have:

• severe skin redness, burning, or other irritation.

Common side effects may include:

• mild skin redness or burning;
• flushing (warmth, redness, or tingly feeling).

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

You should not use this medicine if you are allergic to brimonidine.

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

• coronary artery disease or circulation problems;
• heart disease or a blood vessel disorder;
• Raynaud's syndrome (numbness or cold feeling in your hands or feet);
• depression;
• low blood pressure;
• an autoimmune disorder called Sjogren's syndrome;
• a build-up of scar tissue on your skin (scleroderma); or
• if you take a heart or blood pressure medication.

FDA pregnancy category B. MIRVASO topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether MIRVASO topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not take by mouth. MIRVASO topical is for use only on the skin of your face. Avoid getting this medicine in your eyes or mouth.

It is not likely that other drugs you take orally or inject will have an effect on topically applied MIRVASO. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

The amount of MINIPRESS you take will depend on your doctor's instructions. A typical dosing schedule may look like this:

For high blood pressure:

• Adults: Start with 0.5-1 milligrams (mg), two or three times a day. Then, your doctor will slowly increase your dose to 6-15 mg, divided into two or three doses a day. However, the total daily dose is usually not more than 20 mg.
• Children: The dose will be based on body weight. The usual dose is 50-400 micrograms per kilogram of body weight a day. This is typically divided into two or three doses.

MINIPRESS Overdose

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

Missed Dosage

If you miss a dose of MINIPRESS, take it as soon as you remember. If it is close to the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not "double up" and take more than one dose at a time.

Common Side Effects of MINIPRESS:

Some less serious side effects of MINIPRESS include:

• Weakness
• Tiredness
• Dizziness
• Nausea

Serious Side Effects of MINIPRESS:

You should call your doctor if you experience any of the following serious side effects:

• Fast or pounding heartbeat or fluttering in your chest
• Feeling like you might pass out
• Trouble breathing
• Swelling in the hands, ankles, or feet
• An erection that is painful or lasts four or more hours

You may feel dizzy when you first start MINIPRESS, since it lowers blood pressure. This effect usually stops once your body gets used to the medication. Try not to stand up too quickly.

Older patients may be more sensitive to the side effects of MINIPRESS, especially dizziness and fainting, which can increase the risk of falling.

Before taking this drug, you should tell your doctor if you have a history of the following conditions:

• Heart problems
• Low blood pressure
• Kidney disease
• Narcolepsy
• Prostate cancer

You should tell your doctor that you are taking this medication before having surgery, including eye surgery.

Don't stop taking MINIPRESS without first consulting your physician. Because some conditions may worsen when the medication is stopped abruptly, your dose may need to be gradually decreased.

Pregnancy and MINIPRESS

MINIPRESS should only be used during pregnancy if absolutely necessary. The drug passes through breast milk.

Some drugs that may interact with MINIPRESS include:

• Beta blockers, such as atenolol (Tenormin), metoprolol (Toprol-XL), propranolol (Inderal)
• Verapamil (Calan)
• Erectile dysfunction or pulmonary hypertension meds
• Antihistamines, such as diphenhydramine (llermax, Banophen, Benadryl)
• Anti-seizure drugs, such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol)
• Drugs for sleep or anxiety, such as alprazolam (Niravam, Xanax, Xanax XR), diazepam (Valium), zolpidem (Ambien)
• Muscle relaxants
• Narcotic pain relievers (such as codeine)
• Psychiatric meds, such as chlorpromazine (Thorazine), risperidone (Risperdal), amitriptyline (Elavil), trazodone (Desyrel)

Check the labels on all of your medications because they may contain ingredients that can increase your blood pressure or cause a fast heartbeat. This drug may also interfere with certain lab tests, so you should tell laboratory personnel you are taking MINIPRESS.

You should also discuss all prescription, non-prescription, illegal, recreational, herbal, nutritional or dietary drugs you are taking with your doctor.

MINIPRESS and Other Interactions

This drug may impair your vision and make you dizzy or drowsy. Do not drive, use machinery, or perform any other activity that requires alertness until you are sure you can do so safely. You should also limit your alcohol intake while taking MINIPRESS.

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

Take MIDAMOR with food.

Your doctor may recommend you eat certain foods or take supplements to keep your potassium from getting too low. Follow the diet and medication plan created for you by your doctor or nutrition counselor.

While using MIDAMOR, you will need frequent blood tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using MIDAMOR. You may need to stop taking MIDAMOR at least 3 days before having a glucose tolerance test.

Store at room temperature away from moisture, heat, or freezing temperatures.

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.

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

Stop taking MIDAMOR and call your doctor at once if you have:

• increased thirst, decreased urination;
• heavy sweating, or hot and dry skin;
• tremors, confusion, loss of consciousness;
• jaundice (yellowing of the skin or eyes);
• high potassium--tiredness, numbness or tingling, slow or unusual heart rate, muscle weakness or limp feeling; or
• low levels of sodium in the body--headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common side effects may include:

• nausea, stomach pain, gas, loss of appetite;
• headache; or
• rash.

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

You should not use MIDAMOR if you have kidney problems, if you are unable to urinate, or if you have high levels of potassium in your blood. Do not use potassium supplements or other diuretics while you are taking MIDAMOR.

MIDAMOR can raise the levels of potassium in your blood. You will need frequent blood tests while taking this medicine.

Call your doctor right away if you have unusual tiredness, numbness or tingling, slow heartbeats, muscle weakness or limp feeling.

You should not use MIDAMOR if you are allergic to it, or if:

• you have kidney disease or are unable to urinate;
• you have problems with your kidneys caused by diabetes;
• you have high potassium levels (hyperkalemia);
• you take a potassium supplement; or
• you take another potassium-sparing diuretic such Moduretic, spironolactone, or triamterene.

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

• diabetes;
• heart disease;
• breathing problems;
• cirrhosis or other liver disease;
• if you are on a low-salt diet; or
• if you are severely ill or debilitated.

MIDAMOR is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether MIDAMOR passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking MIDAMOR.

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Drinking alcohol with this medicine can cause side effects.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

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

• lithium;
• medicine to prevent organ transplant rejection--cyclosporine, tacrolimus;
• an ACE inhibitor (angiotensin converting enzyme)--benazepril, captopril, enalapril, fosinipril, lisinopril, moexipril, perindopril, quinapril, ramipril, or trandolapril;
• heart or blood pressure medication--azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, valsartan; or
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

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