TELMISARTAN TEVA-RATIOPHARM 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Teva-ratiopharm 20 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, as it may harm them,

even if their symptoms are the same as yours.

• 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 Telmisartán Teva-ratiopharm and what is it used for
2. What you need to know before you take 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 further information

1. What is Telmisartán 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 your blood vessels relax and your blood pressure is reduced.

Telmisartán 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 untreated, 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.

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 a high risk of developing these events.

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

Do not take Telmisartán 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 recommended to avoid taking Telmisartán Teva-ratiopharm at the start 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 severe liver disease.
• if you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of these apply to you, tell your doctor or pharmacist before taking Telmisartán 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 aldosterone levels (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 a salt deficiency due to treatment with diuretics, a low-salt diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.

Tell 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), 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 Telmisartán Teva-ratiopharm"

• if you are taking digoxin.

If you are pregnant (or might become pregnant), tell your doctor. It is not recommended to take Telmisartán 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 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 in children and adolescents up to 18 years is not recommended.

Using Telmisartán 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 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-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory medicines (e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses with Telmisartán 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 Telmisartán Teva-ratiopharm" and "Warnings and precautions").
• Digoxin.

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 non-steroidal anti-inflammatory medicines (e.g., aspirin or ibuprofen) or corticosteroids.

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

Additionally, the decrease in blood pressure may be enhanced 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 Telmisartán 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 Telmisartán Teva-ratiopharm before you become pregnant or as soon as you know you are pregnant, and will advise you to take another blood pressure-lowering medicine instead of Telmisartán Teva-ratiopharm. It is not recommended to take Telmisartán 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 taken after the third month of pregnancy.

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 want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

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

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., it is essentially "sodium-free".

3. How to take Telmisartán Teva-ratiopharm

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

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

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

You can 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 to stop. If you feel that the effect of Telmisartán 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 Telmisartán Teva-ratiopharm for most patients is one 40 mg tablet once a day, to control blood pressure throughout the 24 hours.

For Telmisartán Teva-ratiopharm 20 mg tablets

Your doctor has recommended a lower dose, of one 20 mg tablet daily.

Telmisartán Teva-ratiopharm can also be used in combination with diuretics that 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 a day. At the start of preventive treatment with Telmisartán 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 Telmisartán Teva-ratiopharm tablets than you should

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

In case of overdose or accidental ingestion, consult 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 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 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 Telmisartán 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), anemia (low red blood cell count), high potassium levels, insomnia (difficulty sleeping), depression, syncope (fainting), vertigo (dizziness), bradycardia (slow heart rate), low blood pressure (hypotension) in users treated for high blood pressure, orthostatic hypotension (dizziness when standing up), shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash, 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), eosinophilia (an increase in certain white blood cells), thrombocytopenia (low platelet count), anaphylactic reaction (a severe allergic reaction), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, facial swelling, or low blood pressure), low blood sugar levels (in diabetic patients), anxiety, somnolence (drowsiness), vision disturbance, tachycardia (fast heart rate), dry mouth, stomach upset, taste disturbance (dysgeusia), abnormal liver function (Japanese patients show a greater 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), skin reddening, hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, pseudogrippal illness, decrease in hemoglobin (a blood protein), increase in blood uric acid levels, increase in 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: there have been reports of swelling in the intestines that present with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after using similar products.

• This may have been a chance finding or related to a mechanism that is currently

not known.

** 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 Telmisartán 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. Packaging Content and Additional Information

Composition of Telmisartan Teva-ratiopharm 20 mg EFG Tablets

• The active ingredient is telmisartan.

Each tablet contains 20 mg of telmisartan.

• The other ingredients are:

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

magnesium stearate.

Appearance of the Product and Packaging Content

Telmisartan Teva-ratiopharm 20 mg tablets are white or almost white, round, flat beveled edge, smooth on both sides.

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

Bottle (HDPE) with white cap (PP)

Package 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 B Building, 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/72785/P_72785.html

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