PRITOR 80 mg TABLETS

Introduction

Package Leaflet: Information for the User

Pritor 80 mg Tablets

telmisartan

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Pritor and what is it used for
2. What you need to know before you take Pritor
3. How to take Pritor
4. Possible side effects
5. Storage of Pritor
6. Contents of the pack and other information

1. What is Pritor and what is it used for

Pritor belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, thus increasing your blood pressure. Pritor blocks the effect of angiotensin II, so that your blood vessels relax and your blood pressure is reduced.

Pritor is used totreat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by any other condition.

High blood pressure, if left untreated, can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or kidney failure, strokes, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly measure your blood pressure to check if it is within the normal range.

Pritor is also used toreduce cardiovascular events (e.g., heart attacks or strokes) in adults at risk because their blood supply to the heart or legs is reduced or blocked, or they have had a stroke or have a high risk of developing diabetes. Your doctor will inform you if you have a high risk of developing these events.

2. What you need to know before you take Pritor

Do not take Pritor

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking this medicine also at the start of your pregnancy - see section Pregnancy).
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other severe liver disease.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Pritor.

Warnings and precautions

Tell your doctor before starting treatment with Pritor if you are suffering from or have ever suffered from any of the following conditions or diseases:

• Kidney disease or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• High levels of aldosterone (water and salt retention in the body along with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension) that may occur if you are dehydrated (excessive loss of water from the body) or have low salt levels due to treatment with diuretics, low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Tell your doctor before starting treatment with Pritor:

• if you are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the information under the heading "Do not take Pritor".

• if you are taking digoxin.

If you are pregnant, think you may be pregnant, or are planning to become pregnant, tell your doctor. Pritor is not recommended during the first three months of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby, see section Pregnancy.

In case of surgery or anesthesia, inform your doctor that you are taking Pritor.

Pritor may be less effective in lowering blood pressure in black patients.

Children and adolescents

Pritor is not recommended for use in children and adolescents under 18 years.

Other medicines and Pritor

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change the dose of these medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially applicable to the following medicines when taken with Pritor:

• Medicines containing lithium for treating certain types of depression.
• Medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with Pritor, can cause excessive loss of water from the body and lower blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Pritor" and "Warnings and precautions").
• Digoxin.

The effect of Pritor may be reduced when you use NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen) or corticosteroids.

Pritor may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may potentially lower blood pressure (e.g., baclofen, amifostine).

Additionally, the reduction in blood pressure may be enhanced by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. You should consult your doctor if you need to adjust the dose of your other medicines while taking Pritor.

Pregnancy and breastfeeding

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking Pritor before you become pregnant or as soon as you know you are pregnant, and will advise you to take another medicine to treat your high blood pressure. Pritor is not recommended during the first three months of pregnancy and should not be taken after the third month of pregnancy as it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding. It is not recommended to take Pritor while breastfeeding. Your doctor may decide to give you a different treatment that is more suitable if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

Some people feel dizzy or tired when taking Pritor. If you feel dizzy or tired, do not drive or use machines.

Pritor contains sorbitol

This medicine contains 337.28 mg of sorbitol in each tablet. Sorbitol is a source of fructose. If your doctor has told you that you have an intolerance to some sugars, or you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder, in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Pritor contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Pritor

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet per day. Try to take the tablet at the same time each day. You can take Pritor with or without food. The tablets should be swallowed with a little water or other non-alcoholic drink. It is important that you take Pritor every day until your doctor tells you to stop. If you feel that the effect of Pritor is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Pritor for most patients is one 40 mg tablet once a day, to control blood pressure over 24 hours. However, your doctor may sometimes recommend a lower dose of 20 mg or a higher dose of 80 mg. Pritor can also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect with Pritor.

For the reduction of cardiovascular events, the usual daily dose of Pritor is one 80 mg tablet. At the start of treatment with Pritor 80 mg, blood pressure should be monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once a day.

If you take more Pritor than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or the nearest hospital emergency department immediately.

If you forget to take Pritor

If you forget to take a dose, do not worry. Take it as soon as you remember and then continue as before. If you do not take your tablet one day, take your normal dose the next day. Do not take a double dose to make up for a forgotten dose.

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

4. Possible side effects

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

Some side effects can be serious and require immediate medical attention

If you experience any of the following symptoms, you should see your doctor immediately:

Sepsis* (often called "blood infection", a serious infection that involves an inflammatory reaction of the whole body), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Pritor

Common side effects (may affect up to 1 in 10 people)

Low blood pressure (hypotension) in users treated for cardiovascular event reduction.

Uncommon side effects (may affect up to 1 in 100 people)

Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cells (anemia), high levels of potassium, difficulty falling asleep (insomnia), feeling sad (depression), fainting (syncope), feeling of losing balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing up (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash (reaction of the skin to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney problems including acute kidney failure, chest pain, symptoms of weakness, and high levels of creatinine in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

Sepsis* (often called "blood infection", a serious infection that involves an inflammatory reaction of the whole body and can cause death), increased certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, drowsiness, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach upset, taste disturbance (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, pain in the tendons, pseudo-influenza, decrease in hemoglobin (a blood protein), increased blood levels of uric acid, increased liver enzymes or creatine phosphokinase in the blood.

Very rare side effects (may affect up to 1 in 10,000 people)

Progressive scarring of lung tissue (interstitial lung disease) **.

• This may have been a chance finding or be related to an unknown mechanism.

** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pritor

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month.

This medicine does not require any special storage conditions. Store in the original package to protect from moisture. Take your Pritor tablet out of the blister pack just before you take it.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Additional Information

Pritor Composition

The active ingredient is telmisartan. Each tablet contains 80 mg of telmisartan.

The other components are povidone (K25), meglumine, sodium hydroxide, sorbitol (E420), and magnesium stearate.

Product Appearance and Package Contents

Pritor 80 mg are white, oblong tablets with the code “52H” engraved.

Pritor is available in blister packs containing 14, 28, 30, 56, 90, 98, or 280 tablets, or in single-dose blisters containing 28 x 1 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Bayer AG

51368 Leverkusen

Germany

Manufacturer

Bayer AG

Kaiser-Wilhelm-Allee

51368 Leverkusen

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder.

Date of the last revision of this leaflet: {MM/AAAA}.

Other sources of information

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.