TELMISARTAN TEVA-RATIOPHARM 40 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Teva-ratiopharm 40 mg Tablets EFG

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, even if they have the same symptoms as you, as it may harm them.

if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the pack and other information

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

1. What is Telmisartan Teva-ratiopharm and what is it used for

Telmisartan 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. Telmisartan blocks the effect of angiotensin II, so that the blood vessels relax and your blood pressure is reduced.

Telmisartan Teva-ratiopharm tablets are 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 uncontrolled, can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or kidney failure, stroke, 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.

Telmisartan Teva-ratiopharm tablets are 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 are at high risk of having these events.

2. What you need to know before you take Telmisartan Teva-ratiopharm

Do not take Telmisartan Teva-ratiopharm

• 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 Telmisartan Teva-ratiopharm at the start of your pregnancy - see section Pregnancy).
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any severe liver disease.
• if you have diabetes or kidney problems and are being treated with a blood pressure medicine containing aliskiren.

If any of the above apply to you, tell your doctor or pharmacist before taking Telmisartan Teva-ratiopharm.

Warnings and precautions

Tell your doctor 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 water loss 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 taking Telmisartan Teva-ratiopharm:

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

• 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 headings “Do not take Telmisartan Teva-ratiopharm” and “Warnings and precautions”.

• if you are taking digoxin.

If you are pregnant (or might become pregnant), tell your doctor. It is not recommended to take Telmisartan Teva-ratiopharm at the start of pregnancy, and it must not be taken if you are more than 3 months pregnant, 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 Telmisartan Teva-ratiopharm.

Telmisartan Teva-ratiopharm may be less effective in lowering blood pressure in black patients.

Children and adolescents

Telmisartan Teva-ratiopharm is not recommended for use in children and adolescents up to 18 years.

Using Telmisartan Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use 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 at the same time as Telmisartan Teva-ratiopharm:

• Medicines containing lithium for treating some types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-salt substitutes, potassium-sparing diuretics, ACE inhibitors (angiotensin-converting enzyme 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 if taken in high doses with Telmisartan Teva-ratiopharm, may cause excessive water loss from the body and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take Telmisartan Teva-ratiopharm” and “Warnings and precautions”).
• Digoxin.

If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartan Teva-ratiopharm, talk to your doctor. Your doctor will decide what treatment to follow. Do not stop taking Telmisartan Teva-ratiopharm on your own.

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

Telmisartan Teva-ratiopharm 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 increased by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness when standing up. You should consult your doctor if you need to adjust the dose of your other medicines while taking Telmisartan Teva-ratiopharm tablets.

Pregnancy and Breastfeeding

Pregnancy

You should inform your doctor if you are pregnant (or might become pregnant). Your doctor will normally advise you to stop taking Telmisartan Teva-ratiopharm before you become pregnant or as soon as you know you are pregnant, and will advise you to take another blood pressure medicine instead of Telmisartan Teva-ratiopharm. It is not recommended to take Telmisartan Teva-ratiopharm at the start of pregnancy, and it must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby when administered from the third month of pregnancy.

Breastfeeding

Inform your doctor if you are breastfeeding or about to start breastfeeding. Telmisartan Teva-ratiopharm is not recommended for women who are breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Some people may feel dizzy or tired when taking Telmisartan Teva-ratiopharm. If you feel dizzy or tired, do not drive or use machines.

Telmisartan Teva-ratiopharm tablets contain:

Sorbitol

Telmisartan Teva-ratiopharm 40 mg tablets EFG

This medicine contains 19.20 mg of sorbitol in each tablet.

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

3. How to take Telmisartan Teva-ratiopharm

Take Telmisartan Teva-ratiopharm exactly as your doctor has told you.

If you are not sure, ask your doctor or pharmacist.

The recommended dose of Telmisartan Teva-ratiopharm is one tablet per day. Try to take the tablet at the same time each day.

You can take Telmisartan Teva-ratiopharm with or without food. The tablets should be swallowed with a little water or another non-alcoholic drink. It is important that you take Telmisartan Teva-ratiopharm every day until your doctor tells you to stop. If you feel that the effect of Telmisartan Teva-ratiopharm is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan Teva-ratiopharm for most patients is one 40 mg tablet once a day, to control blood pressure over 24 hours.

For Telmisartan Teva-ratiopharm 40 mg tablets

However, in some cases, your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Telmisartan Teva-ratiopharm may be used in combination with diuretics that have been shown to have an additive blood-pressure-lowering effect with Telmisartan Teva-ratiopharm.

For the reduction of cardiovascular events, the usual dose of Telmisartan Teva-ratiopharm is one 80 mg tablet once a day. At the start of preventive treatment with Telmisartan Teva-ratiopharm, blood pressure should be checked frequently.

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

If you take more Telmisartan Teva-ratiopharm tablets than you should

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service, telephone: 91 562 04 20, stating the medicine and the amount taken.

If you forget to take Telmisartan Teva-ratiopharm tablets

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. Donot take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, telmisartan 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 Telmisartan Teva-ratiopharm:

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 potassium levels, 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 (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, symptoms of weakness, and high creatinine levels 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, facial swelling, 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), reddening of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, tendon pain, 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) **.

Frequency “not known” (cannot be estimated from the available data):

Intestinal angioedema: the occurrence of swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported after using similar products.

• This may have been a chance finding or related to a currently 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, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan Teva-ratiopharm

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 shown.

Bottle

Shelf-life after first opening: 6 months.

This medicine does not require any special storage conditions.

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

6. Container Content and Additional Information

Composition of Telmisartan Teva-ratiopharm 40 mg EFG Tablets

• The active ingredient is telmisartan.

Each tablet contains 40 mg of telmisartan.

• The other components are:

Mannitol, meglumine, sorbitol (E420), povidone (K-90), sodium hydroxide, hypromellose, and

magnesium stearate.

Appearance of the Product and Container Content

Telmisartan Teva-ratiopharm 40 mg tablets are white or almost white, oblong tablets with a score line on one side.

The tablet can be divided into two equal halves.

Telmisartan Teva-ratiopharm 40 mg tablets are available in packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, and 100 tablets.

Bottle (HDPE) with white cap (PP)

Container size:

100 tablets

500 tablets (only for hospital use).

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Teva Pharma, S.L.U.

Anabel Segura 11,

Albatros Building B, 1st floor,

28108 Alcobendas, Madrid

Spain

Manufacturer

Merckle GmbH, Ludwig-Merckle-Strasse 3,

89143 Blaubeuren, Germany

Or

Teva Pharmaceutical Works Private Limited Company

Pallagi str. 13.

H-4042, Debrecen

Hungary

Or

Teva Operations Poland Sp. z o.o.

ul. Mogilska 80., Krakow

31-546 Poland

Date of Last Revision of this Leaflet: December 2020

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/”

You can access detailed and updated information about this medicinal product by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72786/P_72786.html

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