TELMISARTAN TEVA PHARMA 20 mg TABLETS

Introduction

Leaflet: information for the user

Telmisartan Teva Pharma 20mg Tablets EFG

Telmisartan

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What is Telmisartan Teva Pharma and what is it used for
2. What you need to know before taking Telmisartan Teva Pharma
3. How to take Telmisartan Teva Pharma
4. Possible side effects

5 Storage of Telmisartan Teva Pharma

1. Package contents and additional information

1. What is Telmisartan Teva Pharma and what is it used for

Telmisartan Teva Pharma belongs to a group of medications known as angiotensin II receptor antagonists.

Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, increasing your blood pressure. Telmisartan Teva Pharma blocks the effect of angiotensin II, so that your blood vessels relax and your blood pressure decreases.

Telmisartan Teva Pharma is used to treat essential hypertension (high blood pressure). "Essential" means that 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 kidney failure, strokes, or blindness. Generally, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to regularly check your blood pressure to see if it is within the normal range.

Telmisartan Teva is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in patients at risk because their blood supply to the heart or legs is reduced or blocked, or they have suffered a stroke or are at high risk of developing diabetes. Your doctor will inform you if you are at high risk of experiencing these events.

2. What you need to know before taking Telmisartan Teva Pharma

Do not take Telmisartan Teva Pharma

• if you are allergic to telmisartan or any of the other components of this medication (listed in section 6).
• if you are pregnant for more than 3 months (It is also recommended to avoid taking Telmisartan Teva Pharma at the start of 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 medications that lower blood pressure containing aliskiren.

If your case is any of the above, inform your doctor or pharmacist before taking Telmisartan Teva Pharma.

Warnings and precautions

Consult your doctor if you are suffering or have ever suffered from any of the following disorders 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), which may occur if you are dehydrated (excessive water loss from the body) or have a salt deficiency due to treatment with diuretics, low-salt diet, diarrhea, or vomiting
• High potassium levels in the blood
• Diabetes

Consult your doctor before taking Telmisartan Teva Pharma:

• if you are taking digoxin.
• if you are taking any of the following medications used to treat high blood pressure:

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals.

See also information under the heading "Do not take Telmisartan Teva Pharma".

If you think you may be pregnant (or could be), you must inform your doctor. Telmisartan Teva Pharma is not recommended at the start of pregnancy and should not be taken after the third month of pregnancy because it may cause serious harm to your baby (see pregnancy section).

In case of surgery or anesthesia, inform your doctor that you are taking Telmisartan Teva Pharma.

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

Children and adolescents

The use of Telmisartan Teva Pharma is not recommended in children and adolescents up to 18 years.

Other medications and Telmisartan Teva

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. Your doctor may need to change the dose of these medications or take other precautions. In some cases, you may need to stop taking one of the medications. This is especially applicable to the following medications when taken with Telmisartan Teva Pharma:

• Medications containing lithium for treating certain types of depression.
• Medications that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE 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 when taken in high doses with Telmisartan Teva Pharma, can cause excessive water loss from the body and lower blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also information under the heading "Do not take Telmisartan Teva Pharma" and "Warnings and precautions").
• Digoxin.

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

Telmisartan Teva Pharma may increase the blood pressure-lowering effect of other medications used to treat high blood pressure.

If you have a condition called "orthostatic hypotension" (a drop in blood pressure when standing up from a sitting or lying position, resulting in dizziness or fainting), your condition may worsen if you take Telmisartan Teva Pharma in combination with:

• Other medications used to treat high blood pressure
• Baclofen (a muscle relaxant)
• Amifostine (a protective medication during radiation therapy for cancer treatment)
• Alcohol
• Barbiturates (strong sleeping pills)
• Narcotics (strong painkillers)
• Antidepressants

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you may be pregnant (or could be). Your doctor will usually advise you to stop taking Telmisartan Teva Pharma before becoming pregnant or as soon as you become pregnant and recommend taking another medication instead of Telmisartan Teva Pharma. Telmisartan Teva Pharma is not recommended at the start of pregnancy and should not be taken after the third month of pregnancy because it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are breastfeeding. Telmisartan Teva Pharma is not recommended for women who are breastfeeding, and your doctor may decide to prescribe another treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and using machines

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

Telmisartan Teva Pharma contains sorbitol.

This medication contains 21.4 mg of sorbitol in each tablet.

Telmisartan Teva Pharma contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially "sodium-free".

3. How to take Telmisartan Teva Pharma

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartan Teva is one tablet per day. Try to take the tablet at the same time each day. You can take Telmisartan Teva Pharma with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential that you take Telmisartan Teva Pharma every day until your doctor tells you otherwise. If you think the effect of Telmisartan Teva Pharma is too strong or too weak, tell your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan Teva Pharma for most patients is 40 mg once daily to control blood pressure over 24 hours. Your doctor has recommended a lower dose of one 20 mg tablet daily. Alternatively, Telmisartan Teva Pharma may be used in combination with diuretics such as hydrochlorothiazide, which have been shown to have an additive blood pressure-lowering effect with Telmisartan Teva Pharma.

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

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

If you take more Telmisartan Teva Pharma than you should

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

If you forget to take Telmisartan Teva Pharma

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. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Some side effects may 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 severe 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 medication and see their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartan

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

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

Uncommon side effects (may affect up to 1 in 100 patients):

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 spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, difficulty breathing, 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 severe 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 changes, increased heart rate (tachycardia), dry mouth, stomach upset, abnormal liver function (more likely in Japanese patients), sudden swelling of the skin and mucous membranes that can cause death (angioedema, including fatal outcome), hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, pseudogripal illness, decreased 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 patients):

Progressive lung tissue scarring (interstitial lung disease)**

*This may have been an isolated incident or related to a currently unknown mechanism.

**Cases of progressive lung tissue scarring have been reported during telmisartan treatment. However, it is not known if telmisartan was the cause.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Telmisartan Teva Pharma

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister after "EXP". The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Container contents and additional information

Composition of Telmisartan Teva Pharma

• The active ingredient is telmisartan. Each Telmisartan Teva Pharma tablet contains 20 mg of telmisartan.
• The other ingredients are microcrystalline cellulose (Avicel PH 102), sodium glycolate starch (Type A), poloxamers, meglumine, povidone (PVP K-30), sorbitol (E420), magnesium stearate.

Appearance of the product and container contents

Telmisartan Teva Pharma 20 mg tablets are white to off-white, oval-shaped tablets; one side of the tablet is engraved with the number “93”. The other side of the tablet is engraved with the number “7458”.

Telmisartan Teva Pharma is supplied in aluminum-aluminum blisters with a separable sheet of precut unit doses and aluminum-aluminum blisters of precut unit doses containing 14, 28, 30, 40, 56, 60, 84, 90, 98, 100 tablets per blister pack, although only some pack sizes may be marketed.

Please note that the instructions for removing the tablet from the blister strip are given on the outer packaging of the blisters with a separable sheet.

Telmisartan Teva Pharma is also supplied in aluminum-aluminum blisters of pack size 28 and 30 tablets

Marketing authorization holder and manufacturer

The marketing authorization holder is:

Teva B.V.

Swensweg 5

2031GA Haarlem

Netherlands

The manufacturer is:

TEVA Pharmaceutical Works Private Limited Company

H-4042 Debrecen,

Pallagi út 13,

Hungary

Or:

Pharmachemie B.V.

Swensweg 5,

2031 GA, Haarlem,

Netherlands

Or:

TEVA Santé SA,

Rue Bellocier,

89100 Sens,

France

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the last revision of this leaflet:{month/year}.

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/.