Patient Information Leaflet

Telmisartan Zentiva 20 mg tablets, 40 mg tablets, 80 mg tablets

Equivalent medicinal product
Please read all of this leaflet carefully before 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. Do not pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Telmisartan Zentiva is and what it is used for
What you need to know before taking Telmisartan Zentiva
How to take Telmisartan Zentiva
Possible side effects
How to store Telmisartan Zentiva
Contents of the pack and other information

1. What Telmisartan Zentiva is and what it is used for

Telmisartan Zentiva belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan Zentiva blocks the action of angiotensin II, helping blood vessels to relax and thereby lowering blood pressure.

Telmisartan Zentiva is used to treat essential hypertension (high blood pressure) in adults. 'Essential' means that the high blood pressure is not caused by other conditions.

If untreated, high blood pressure can damage blood vessels in various organs and may eventually lead to heart attack, heart or kidney failure, stroke, or blindness. Usually, there are no symptoms of high blood pressure before such damage occurs. Therefore, it is important to have your blood pressure checked regularly to ensure it remains within the normal range.

Telmisartan Zentiva is also used to reduce cardiovascular events (such as heart attack or stroke) in adult patients who are at risk because they have reduced or blocked blood flow to the heart or legs, have had a stroke, or are at high risk of developing diabetes. Please consult your doctor if you are at high risk of these events.

2. What you should know before taking Telmisartan Zentiva

Do not take Telmisartan Zentiva

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 three months pregnant. (It is better to avoid Telmisartan Zentiva even in the early stages of pregnancy – see Pregnancy section.)
If you have a serious liver problem such as cholestasis or biliary obstruction (conditions affecting bile flow from the liver and gallbladder) or any other severe liver disease.
If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the conditions listed above apply to you, contact your doctor or
pharmacist before taking Telmisartan Zentiva.
Warnings and precautions
Talk to your doctor or pharmacist before taking Telmisartan Zentiva.
Speak with your doctor if you have or have 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;
Elevated levels of aldosterone (water and salt retention in the body with disruption of the balance of various minerals in the blood);
Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have a salt deficiency caused by diuretic therapy, a low-salt diet, diarrhoea, or vomiting;
High levels of potassium in the blood;
Diabetes.

Talk to your doctor before taking Telmisartan Zentiva:

if you are taking digoxin;
if you are taking any of the following medicines used to treat high blood pressure:
- an "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 the amount of
electrolytes (e.g., potassium) in your blood at regular intervals.
See also the section "Do not take Telmisartan Zentiva".
You must talk to your doctor if you think you are pregnant or could become pregnant.
Telmisartan Zentiva is not recommended during early pregnancy and must not be taken
after 3 months of pregnancy, as it may cause serious harm to your baby if used during this
stage of pregnancy (see Pregnancy section).
If you are undergoing surgery or anaesthesia, you must inform your doctor that you are taking
Telmisartan Zentiva.
Telmisartan Zentiva may be less effective in lowering blood pressure in Black patients.
Children and adolescents
The use of Telmisartan Zentiva is not recommended in children and adolescents under 18
years of age.
Other medicines and Telmisartan Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other
medicines. Your doctor may consider it necessary to adjust the dose and/or take other precautions. In some cases, it may be necessary to discontinue one of these medicines. This is particularly relevant when taking the following medicines at the same time as Telmisartan Zentiva:

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, 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 in high doses together with Telmisartan Zentiva, may lead to excessive loss of body water and cause low blood pressure (hypotension).
An ACE inhibitor or aliskiren (see also sections: "Do not take Telmisartan Zentiva" and "Warnings and precautions").
Digoxin.

The effect of Telmisartan Zentiva may be reduced when taken with NSAIDs (non-steroidal
anti-inflammatory drugs, e.g., aspirin or ibuprofen) or corticosteroids.
Telmisartan Zentiva 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, low blood pressure may be worsened by alcohol, barbiturates, narcotics, or
antidepressants. You may notice this as dizziness when standing up. You should consult your
doctor if a dose adjustment of other medicines is needed while taking
Telmisartan Zentiva.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Pregnancy:
You must inform your doctor if you are pregnant (or could become pregnant). Your doctor will
typically advise you to stop taking Telmisartan Zentiva before becoming pregnant or as soon as
you know you are pregnant and will recommend alternative treatment.
Telmisartan Zentiva is not recommended during early pregnancy and must not be taken after
3 months of pregnancy, as it may cause serious harm to your baby if used beyond the third
month of pregnancy.
Breastfeeding:
Talk to your doctor if you are breastfeeding or plan to breastfeed. Telmisartan Zentiva is not
recommended for women who are breastfeeding, and your doctor may choose another
treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.
Driving and using machines
Some people may experience dizziness or fatigue when taking Telmisartan Zentiva. If you
experience dizziness or feel tired, do not drive or operate machinery.
Telmisartan Zentiva contains sorbitol.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before
taking this medicine.

3. How to take Telmisartan Zentiva

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Telmisartan Zentiva is one tablet daily. Try to take the tablet at the same time each day. You may take Telmisartan Zentiva with or without food.
The tablets should be swallowed with water or another non-alcoholic drink. It is important that you take Telmisartan Zentiva every day unless your doctor tells you otherwise. If you think that the effect of Telmisartan Zentiva is too strong or too weak, speak to your doctor or pharmacist.
Other dosage strengths are available: Telmisartan Zentiva 20 mg, Telmisartan Zentiva 40 mg, or Telmisartan Zentiva 80 mg.

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

Telmisartan Zentiva 40 mg:
For the treatment of high blood pressure, the usual dose of Telmisartan Zentiva for many patients is one 40 mg tablet once daily to control blood pressure over 24 hours. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. A dose of 20 mg can be achieved by splitting the 40 mg tablet along the break line. Alternatively, Telmisartan Zentiva may be used in combination with diuretics such as hydrochlorothiazide, which has demonstrated an additive effect with Telmisartan Zentiva in lowering blood pressure.

Telmisartan Zentiva 80 mg:
For the treatment of high blood pressure, the usual dose of Telmisartan Zentiva for most patients is one 40 mg tablet once daily to control blood pressure over a 24-hour period. However, your doctor may sometimes recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Telmisartan Zentiva may be used in combination with diuretics such as hydrochlorothiazide, which has shown an additive effect in lowering blood pressure when used with Telmisartan Zentiva.
For reduction of cardiovascular events, the usual dose of Telmisartan Zentiva is one 80 mg tablet once daily. During the initial phase of preventive treatment with Telmisartan Zentiva 80 mg, blood pressure should be monitored frequently.

If you have impaired liver function, the usual dose of 40 mg once daily should not be exceeded.

If you take more Telmisartan Zentiva than you should
If you accidentally take too many tablets, contact your doctor or pharmacist immediately or go to the nearest hospital.

If you forget to take Telmisartan Zentiva
If you forget to take a dose, do not worry. Take it as soon as you remember, then continue as before. If you miss a dose one day, take your usual dose the next day. Do not take a double dose to make up for the forgotten dose.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Some side effects can be serious and require immediate medical treatment:
You must immediately contact your doctor if you experience any of the following symptoms:
Sepsis* (often called "blood poisoning", it is a severe infection with a widespread inflammatory response throughout the 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 must stop taking the medicine and seek immediate medical attention. If these effects are not treated, they may be fatal.
Possible side effects with Telmisartan Zentiva:
Common (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated to reduce cardiovascular events.
Uncommon (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), deficiency of red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), sensation of spinning (dizziness), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, chest pain, feeling weak, and increased blood creatinine levels.
Rare (may affect up to 1 in 1,000 people):
Sepsis* (often called "blood poisoning", it is a severe infection with a widespread inflammatory response throughout the body, which may lead to death), increases in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. skin rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, drowsiness, visual disturbances, rapid heartbeat (tachycardia), dry mouth, stomach discomfort, taste disturbance (dysgeusia), altered liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucous membranes which may also be fatal (angioedema, including fatal outcomes), eczema (a skin disorder), skin redness, urticaria, severe drug rash, joint pain (arthralgia), limb pain, tendon pain, influenza-like illness, decreased haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase in the blood.
Very rare (may affect up to 1 in 10,000 people):
Progressive fibrosis of lung tissue (interstitial lung disease).**
*The event may be coincidental or related to a mechanism currently unknown.
**Cases of progressive fibrosis of lung tissue have been reported during telmisartan administration. However, it is not known whether telmisartan was the cause.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects contributes to providing more information on the safety of this medicine.

5. How to store Telmisartan Zentiva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton/blister after
EXP. The expiry date refers to the last day of that month.
Store below 30°C. Keep in the original packaging to
protect the medicine from moisture.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Telmisartan Zentiva contains
The active substance is telmisartan.
Telmisartan Zentiva 20 mg: each tablet contains 20 mg of telmisartan.
Telmisartan Zentiva 40 mg: each tablet contains 40 mg of telmisartan.
Telmisartan Zentiva 80 mg: each tablet contains 80 mg of telmisartan.
The other components are meglumine, sorbitol (E420), sodium hydroxide, povidone, magnesium stearate.

Description of the appearance of Telmisartan Zentiva and package contents
Telmisartan Zentiva 20 mg tablets are whitish-yellow, round tablets with a diameter of 7 mm.
Telmisartan Zentiva 40 mg tablets are whitish-yellow, oblong biconvex tablets with a break line on both sides, 12 mm long and 6 mm wide. The tablets can be divided into two equal doses.
Telmisartan Zentiva 80 mg tablets are whitish-yellow, oblong biconvex tablets with "80" engraved on one side, 16 mm long and 8 mm wide.

Pack sizes:
Telmisartan Zentiva 20 mg: 14, 28, 30, 56, 60, 84, 90, 98 and 100 tablets
Telmisartan Zentiva 40 mg: 14, 28, 30, 56, 60, 84, 90, 98, 100 and 280 tablets
Telmisartan Zentiva 80 mg: 14, 28, 30, 56, 60, 84, 90, 98, 100 and 280 tablets
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Zentiva Italia S.r.l.
Viale Bodio 37/B
20158 Milan, Italy

Responsible manufacturers for batch release
S.C. ZENTIVA S.A.
B-dul. Theodor Pallady nr.50,
sector 3, Bucharest, cod 032266 – Romania
Zentiva k.s,
U kabelovny 130,
Dolní Měcholupy,
10237 Prague 10, Czech Republic

This medicinal product is authorised in the European Economic Area countries
under the following names:

| Country | Name | |------------------------|-----------------------------------------------| | Czech Republic | Telmisartan Zentiva 20 mg, tablety | | United Kingdom | Telmisartan 20 / 40 / 80 mg Tablets | | Germany | Telmisartan Zentiva 20 / 40 / 80 mg Tabletten | | France | TELMISARTAN ZENTIVA 20 / 40 / 80 mg, comprimé | | Portugal, Italy, Poland, Slovakia, Slovenia | Telmisartan Zentiva | | Romania | Telmisartan Zentiva 20 mg comprimate | | Slovenia | Telmisartan Zentiva 20 / 40 / 80 mg tablete |