Package Leaflet: Information for the User

Telmisartán Teva-ratiopharm 80 mg Tablets EFG

telmisartán

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

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

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

3. How to take Telmisartán Teva-ratiopharm

4. Possible side effects

5. Storage of Telmisartán Teva-ratiopharm

6. Contents of the pack and additional information

Telmisartán belongs to a class of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to constrict, thereby increasing blood pressure. Telmisartán blocks the effect of angiotensin II, causing blood vessels to relax and reducing blood pressure.

Telmisartán Teva-ratiopharm tablets are used

totreat essential hypertension (high blood pressure) in adults. “Essential” means that the high blood pressure is not due to any other cause.

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 renal failure, stroke, or blindness. Generally, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to measure blood pressure regularly to verify if it is within the normal range.

Telmisartán 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 have an elevated risk of experiencing these events.

Do not take Telmisartán Teva-ratiopharm

• if you are allergic to telmisartán 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 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 other severe liver disease.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskirén.

Inform your doctor or pharmacist before taking Telmisartán Teva-ratiopharm if your case is any of the above.

Warnings and precautions

Consult your doctor if you are experiencing or have ever experienced 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 aldosterone levels (water and salt retention in the body along with mineral imbalance in the blood).
• low blood pressure (hypotension) that may occur if you are dehydrated (excessive loss of water from the body) or have a salt deficiency due to diuretic treatment, low-salt diet, diarrhea, 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):

• a renin-angiotensin-aldosterone system (RAAS) inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskirén

Your doctor may monitor your kidney function, blood pressure, and 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 digoxina.

If you are pregnant (or may become pregnant), inform your doctor. Telmisartán Teva-ratiopharm is not recommended at the beginning of pregnancy, and it should not be administered if you are more than 3 months pregnant because it may cause serious harm to your baby (see Pregnancy section).

Inform your doctor if you are undergoing surgery or anesthesia that you are taking Telmisartán Teva-ratiopharm.

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

Children and adolescents

Telmisartán Teva-ratiopharm is not recommended for use in children and adolescents until 18 years old.

Use of Telmisartán Teva-ratiopharm with other medicines

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine. 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 applies especially to the following medicines when taken with Telmisartán Teva-ratiopharm:

• medicines containing lithium for treating certain types of depression.
• medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, RAAS inhibitors, angiotensin II receptor antagonists, nonsteroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., ciclosporin or tacrolimus), and the antibiotic trimetoprim.
• diuretics, especially if taken in high doses with Telmisartán Teva-ratiopharm, may cause excessive loss of water from the body and lower blood pressure (hypotension).
• if you are taking an RAAS inhibitor or aliskirén (see also the information under the headings “Do not take Telmisartán Teva-ratiopharm” and “Warnings and precautions”).
• digoxina.

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

The effect of Telmisartán Teva-ratiopharm may be reduced when you use NSAIDs (e.g., aspirin or ibuprofen) or corticosteroids.

Telmisartán Teva-ratiopharm may increase the hypotensive effect of other medicines for treating high blood pressure or medicines that may lower blood pressure (e.g., baclofeno, amifostina).

Additionally, blood pressure may be lowered further by alcohol, barbiturates, narcotics, or antidepressants. You may notice this as dizziness that occurs when standing up. You should consult your doctor if you need to adjust the dose of your other medicines while taking Telmisartán Teva-ratiopharm, tablets.

Pregnancy and breastfeeding

Pregnancy

You should 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 recommend taking another antihypertensive medicine instead of Telmisartán Teva-ratiopharm. Telmisartán Teva-ratiopharm is not recommended at the beginning of pregnancy, and it should not be administered if you are more than 3 months pregnant because 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 plan to start. Telmisartán 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 operating machinery

Some people may 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 mml of sodium (23 mg) per tablet, i.e., essentially “sodium-free”.

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

In case of doubt, consult your doctor or pharmacist again.

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

You can take Telmisartán Teva-ratiopharm with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to 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 a day, to control blood pressure over 24 hours.

Telmisartán Teva-ratiopharm 80 mg tablets

However, in some cases, 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 that have demonstrated an additive effect on blood pressure reduction with Telmisartán Teva-ratiopharm.

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

If your liver does not function correctly, the usual dose should not exceed 40 mg once a day.

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

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 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 usual dose the next day.Do nottake a double dose to compensate for the missed doses.

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

Like all medicines, telmisartan can cause side effects, although not everyone will experience them.

Some side effects can be severe and require immediate medical attention:

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

Sepsis* (often referred to as "blood infection," it is a severe infection that involves a systemic inflammatory reaction), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (they may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medication and visit their doctor immediately. If these side effects are not treated, they can be fatal.

Telmisartan Teva-ratiopharm side effects:

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

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

Infrequent 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), elevated potassium levels, difficulty falling asleep (insomnia), feeling of sadness (depression), fainting (syncope), feeling of loss of balance (dizziness), 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, diarrhea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug-induced rash (skin reaction to medication), back pain, muscle cramps, muscle pain (myalgia), renal insufficiency including acute renal failure, chest pain, symptoms of weakness, and elevated creatinine levels in blood.

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

Sepsis* (often referred to as "blood infection," it is a severe infection that involves a systemic inflammatory reaction 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 of anxiety, drowsiness, vision alteration, increased heart rate (tachycardia), dry mouth, stomach discomfort, altered taste (dysgeusia), abnormal liver function (Japanese patients are more prone to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (skin alteration), skin reddening, hives (urticaria), severe drug-induced rash, joint pain (arthralgia), pain in limbs, tendon pain, pseudogripal disease, decreased hemoglobin (a blood protein), increased uric acid levels in blood, increased liver enzymes or creatine phosphokinase in blood.

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

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

Frequency "unknown" (it is not possible to estimate the frequency from available data):

Intestinal angioedema: intestinal swelling has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using similar products.

* This may have been a coincidental finding or related to an unknown mechanism.

currently.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the carton after “CAD”.

The expiration date is the last day of the month indicated.

Container

Period of validity after the first opening: 6 months.

This medication does not require special storage conditions.

Medicines should not be thrown into the drains or trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of the pharmacy.In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Telmisartán Teva-ratiopharm 80 mg tablets Composition

- The active ingredient is telmisartán.

Cada tablet contains 80 mg of telmisartán.

- The other components are:

Manitol, meglumina, sorbitol (E420), povidona (K-90), sodium hydroxide, hypromelosa, and magnesium stearate.

Appearance of the product and contents of the packaging

Telmisartán Teva-ratiopharm 80 mg tablets are white or off-white, oblong tablets with a notch on one face.

The tablet can be divided into two equal halves.

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

HDPE bottle with a white PP cap

Packaging size:

100 tablets

500 tablets (only for hospital use).

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Teva Pharma, S.L.U.

C/ Anabel Segura 11,

Edificio Albatros B, 1st floor,

28108 Alcobendas, Madrid

Spain

Responsible 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

Last review date of this leaflet: December 2020

"Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)"

You can access detailed and updated information on this medicine by scanning the QR code included in the carton with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/72787/P_72787.html

QR code + URL