Telmisartan Teva-Ratiopharm 40 mg tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people,

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

• If you experience any side effects, talk to your doctor or pharmacist, even if they are

side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Telmisartan Teva-ratiopharm is and what it is used for
2. What you need to know before taking Telmisartan Teva-ratiopharm
3. How to take Telmisartan Teva-ratiopharm
4. Possible side effects
5. How to store Telmisartan 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 your blood pressure to decrease.

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 regularly check your blood pressure 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 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 diabetes. Your doctor will inform you if you are at high risk of 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 better to avoid taking Telmisartán Teva-ratiopharm at the beginning of 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 other severe liver disease.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Consult your doctor if you are currently 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 to one or both kidneys).
• Liver disease.
• Heart problems.
• High levels of aldosterone (retention of water and salts 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 potassium levels in the blood.
• Diabetes.

Consult 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 the 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. Taking Telmisartán Teva-ratiopharm is not recommended during early pregnancy, and must not be used after 3 months of pregnancy as it may cause serious harm to your baby (see section Pregnancy).

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

Inform your doctor or pharmacist if you are using, have recently used, or might need to use 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 potassium levels in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE 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 to your doctor. Your doctor will decide on the appropriate 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 of medicines that may potentially lower blood pressure (e.g. baclofen, amifostine).

In addition, the reduction in blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness when standing up. Consult your doctor if you need to adjust the dose 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 pregnancy is confirmed, and will recommend an alternative antihypertensive medicine instead of Telmisartán Teva-ratiopharm. Telmisartán Teva-ratiopharm is not recommended during early pregnancy and must not be used after 3 months 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 40 mg film-coated tablets

This medicine contains 19.20 mg of sorbitol per 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 instructions for using Telmisartán Teva-ratiopharm as 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 little 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 40 mg tablets

However, on some occasions your doctor may recommend a lower dose of 20 mg or a higher dose up to 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 reduction of cardiovascular events, the usual dose of Telmisartán Teva-ratiopharm is one 80 mg tablet once daily. At the beginning 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: 91 562 04 20, indicating the medication 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 day, take your normal dose the next day. Do not take a double dose to make up for forgotten 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 referred to as "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. 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 Telmisartán 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), reduced 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, abdominal 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, symptoms of weakness, and elevated blood creatinine levels.

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

Sepsis* (commonly referred to as "blood infection", a severe infection involving a systemic inflammatory response that may be fatal), 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 disturbances, increased heart rate (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), abnormal liver function (Japanese patients appear to be more prone to 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 creatine phosphokinase in blood.

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 presenting symptoms such as abdominal pain, nausea, vomiting and diarrhoea have been reported with similar products.

• This may have been an incidental 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 type of 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 System for Pharmacovigilance of 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 sight and reach of children.

Do not use this medicine after the expiry date stated on the carton after “EXP”. The expiry date refers to the last day of the month indicated.

Vial

Validity period 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 you are unsure, ask your pharmacist how to properly 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 40 mg tablets EFG

• The active substance is telmisartan.

Each tablet contains 40 mg of telmisartan.

• The other components are:

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

magnesium stearate.

Appearance of the product and contents of the pack

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 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.

HDPE bottle with white PP cap

Pack sizes:

100 tablets

500 tablets (for hospital use only)

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 revision of this summary: December 2020

“Detailed and up-to-date information on this medicine 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 about this medicine by scanning with your mobile phone (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/72786/P_72786.html

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