Telmisartan Teva-Ratiopharm 80 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Telmisartán Teva-ratiopharm 80 mg tablets EFG

telmisartan

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people,

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

• If you experience any adverse effects, consult your doctor or pharmacist, even if they are

effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Telmisartán Teva-ratiopharm is and what it is 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, thereby increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, allowing your blood vessels to relax and thereby reducing your blood pressure.

Telmisartán Teva-ratiopharm tablets are used

to treat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not due to any other identifiable cause.

If left untreated, high blood pressure can damage blood vessels in various organs, which may lead, in some cases, to heart attacks, heart or kidney failure, stroke, or blindness. High blood pressure generally does not cause symptoms before such damage occurs. Therefore, it is important to have your blood pressure measured regularly to ensure it remains within the normal range.

Telmisartán Teva-ratiopharm tablets are also used

to reduce cardiovascular events (e.g., heart attacks or strokes) in adults who are at risk due to reduced or blocked blood flow to the heart or legs, or who have had a stroke, or who have a high risk of developing diabetes. Your doctor will inform you if you are at high risk of experiencing such events.

2. What you need to know before taking Telmisartán Teva-ratiopharm

Do not take Telmisartán Teva-ratiopharm

• if you are allergic to telmisartan or to 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 best to avoid taking Telmisartán Teva-ratiopharm at the beginning of your pregnancy – see Pregnancy section).
• 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 renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor if you are suffering from or have ever had any of the following conditions or diseases:

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

Talk to your doctor before taking Telmisartán 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), particularly if you have kidney problems related to diabetes.

• aliskiren

Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also information under the heading “Do not take Telmisartán Teva-ratiopharm”.

• if you are taking digoxin.

If you are pregnant (or may become pregnant), you must inform your doctor. The use of Telmisartán Teva-ratiopharm is not recommended during early pregnancy and must not be used after the third month of pregnancy because it may cause serious harm to your baby (see Pregnancy section).

If you are undergoing surgery or anaesthesia, inform your doctor that you are taking Telmisartán Teva-ratiopharm.

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

Children and adolescents

The use of Telmisartán Teva-ratiopharm is not recommended in children and adolescents under 18 years of age.

Taking Telmisartán Teva-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Your doctor may need to adjust 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 important for the following medicines when taken together with Telmisartán Teva-ratiopharm:

• Medicines containing lithium used to treat certain types of depression.
• Medicines that may increase blood potassium levels such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors (angiotensin-converting enzyme inhibitors), angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially if taken at high doses together with Telmisartán Teva-ratiopharm, may cause excessive loss of body water and lead to low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also information under the headings “Do not take Telmisartán Teva-ratiopharm” and “Warnings and precautions”).
• Digoxin.

If you experience abdominal pain, nausea, vomiting, or diarrhoea after taking Telmisartán Teva-ratiopharm, speak with your doctor. Your doctor will decide on the appropriate course of treatment. Do not stop taking Telmisartán Teva-ratiopharm on your own.

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

Telmisartán Teva-ratiopharm may enhance 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).

In addition, low blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness upon standing. Consult your doctor if you need dose adjustments of your other medicines while taking Telmisartán Teva-ratiopharm tablets.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you are pregnant (or may become pregnant). Your doctor will usually advise you to stop taking Telmisartán Teva-ratiopharm before becoming pregnant or as soon as you know you are pregnant, and will recommend another antihypertensive medicine instead of Telmisartán Teva-ratiopharm. The use of Telmisartán Teva-ratiopharm is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may cause serious harm to your baby when administered from the third month of pregnancy onwards.

Breastfeeding

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

Driving and using machines

Some people feel dizzy or tired when taking Telmisartán Teva-ratiopharm. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartán Teva-ratiopharm tablets contain:

Sorbitol

Telmisartán Teva-ratiopharm 20 mg tablets EFG

This medicine contains 9.60 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 Telmisartán Teva-ratiopharm

Follow exactly the administration instructions for Telmisartán Teva-ratiopharm given by your doctor.

If in doubt, consult your doctor or pharmacist again.

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

You may take Telmisartán Teva-ratiopharm with or without food. The tablets should be swallowed with a small amount of water or another non-alcoholic drink. It is important that you take Telmisartán Teva-ratiopharm every day until your doctor tells you otherwise. If you feel that the effect of Telmisartán Teva-ratiopharm is too strong or too weak, inform your doctor or pharmacist.

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

For Telmisartán Teva-ratiopharm 80 mg tablets

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

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

If your liver is not functioning properly, the usual dose should not exceed 40 mg once daily.

If you take more Telmisartán 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 at telephone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take Telmisartán Teva-ratiopharm tablets

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

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

4. Possible adverse effects

Like all medicines, telmisartan may cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious and require immediate medical attention:

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

Sepsis* (commonly called "blood infection", a severe infection involving a systemic inflammatory response), rapid swelling of the skin and mucous membranes (angioedema); these adverse effects are rare (may affect up to 1 in 1,000 people) but are extremely serious, and patients must stop taking the medicine and see their doctor immediately. If these adverse effects are not treated, they may be fatal.

Possible adverse effects of Telmisartan Teva-ratiopharm:

Frequent adverse effects (may affect up to 1 in 10 people):

Low blood pressure (hypotension) in patients treated for reduction of cardiovascular events.

Uncommon adverse 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 (anaemia), elevated potassium levels, difficulty sleeping (insomnia), feeling of sadness (depression), fainting (syncope), sensation of loss of balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness upon standing (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhoea, stomach discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), renal impairment including acute renal failure, chest pain, weakness symptoms, and elevated blood creatinine levels.

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

Sepsis* (commonly called "blood infection", a serious infection involving a systemic inflammatory response that may result in death), increase in 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 of anxiety, drowsiness, visual disturbance, increased heart rate (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this adverse effect), sudden swelling of the skin and mucous membranes which may be fatal (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, flu-like illness, decreased haemoglobin (a blood protein), increased blood levels of uric acid, increased liver enzymes or blood creatine phosphokinase.

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

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

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

Intestinal angioedema: cases of intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea have been reported after using similar products.

• This may have been a coincidental finding or related to a mechanism currently unknown.

** Cases of progressive fibrosis of lung tissue have been reported during treatment with telmisartan. However, it is unknown whether telmisartan was the cause.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 indicated.

Vial

Shelf life after first opening: 6 months.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan Teva-ratiopharm 80 mg tablets EFG

• The active substance is telmisartan.

Each tablet contains 80 mg of telmisartan.

• The other components are:

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

magnesium stearate.

Appearance of the medicinal product and contents of the pack

Telmisartan Teva-ratiopharm 80 mg tablets are white or almost white, oblong tablets with a score line on one side.

The tablet can be divided into equal halves.

Telmisartan Teva-ratiopharm 80 mg tablets are available in packs of 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and multipacks containing 98 tablets (2 packs of 49).

Bottle (HDPE) with white cap (PP)

Pack sizes:

100 tablets

500 tablets (for hospital use only).

Only some pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11,

Edificio Albatros 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 the most recent review of this leaflet: December 2020

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.es/”

You can access detailed and up-to-date information on this medicinal product by scanning with your mobile smartphone the QR code included in the packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72787/P_72787.html

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