PACKAGE LEAFLET: INFORMATION FOR THE USER

Telmisartan Pensa 20 mg tablets, 40 mg tablets, 80 mg tablets

Telmisartan
Equivalent medicine
Please read all of this leaflet carefully before you start taking this medicine, as 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

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

Telmisartan pensa belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance in the body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan blocks this effect of angiotensin II, allowing blood vessels to relax and blood pressure to decrease.
Telmisartan pensa 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 left untreated, hypertension can damage blood vessels in various organs and may eventually lead to heart attack, heart or kidney failure, stroke, or blindness. There are usually no symptoms of high blood pressure before such damage occurs. Therefore, it is important to regularly monitor your blood pressure to ensure it is within the normal range.
Telmisartan Pensa is also used to reduce cardiovascular events (e.g., heart attack or stroke) in adults who are at risk because they have reduced or blocked blood flow to the heart or legs, or who have had a stroke or are at high risk of diabetes. Your doctor can determine whether you are at high risk for such events.

2. What you should know before taking Telmisartan pensa

Do not take Telmisartan pensa

if you are allergic to telmisartan or to any of the excipients of this medicine (listed in section 6).
if you are more than 3 months pregnant (it is best to avoid taking Telmisartan pensa 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 serious 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 these apply to you, tell your doctor or pharmacist before taking
Telmisartan pensa.
Warnings and precautions
Tell your doctor if you have or have ever had any of the following conditions or
diseases:

Kidney problems or kidney transplant
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
Liver problems
Heart problems
High levels of aldosterone (retention of water and salt in the body with imbalance of various minerals in the blood)
Low blood pressure (hypotension), which is more likely if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic therapy ("diuretics"), low-salt diet, diarrhoea or vomiting
High potassium levels in the blood
Diabetes

Consult your doctor or pharmacist before taking Telmisartan Pensa

if you are taking any of the following medicines 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 blood electrolyte levels (e.g. potassium) at regular intervals. See also the section "Do not take Telmisartan Pensa".
- if you are taking digoxin

You must inform your doctor if you think you are (or could be) pregnant. Telmisartan pensa is not
recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken during this period (see section “Pregnancy”).
If you are undergoing surgery or receiving anaesthetics, you must inform your doctor that you are taking Telmisartan pensa.
Telmisartan pensa may be less effective in reducing blood pressure in black patients.
Children and adolescents
The use of Telmisartan pensa is not recommended in children and adolescents under 18 years of age.
Other medicines and Telmisartan pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Your doctor may need to adjust the dose of these other medicines or take other precautions.
In some cases, it may be necessary to stop taking one of the medicines.
This is particularly important for the following medicines taken concomitantly with Telmisartan pensa:

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 (some "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 when taken in high doses with Telmisartan pensa, may lead to excessive loss of body water and low blood pressure (hypotension).
- If you are taking an ACE inhibitor or aliskiren (see also the section: "Do not take Telmisartan Pensa" and "Warnings and precautions").
- Digoxin.

The effect of Telmisartan pensa may be reduced if taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.
Telmisartan pensa may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or of medicines with potential hypotensive effects (e.g. baclofen, amifostine).
In addition, low blood pressure may be worsened by alcohol, barbiturates, narcotics or antidepressants. Dizziness may occur when standing up. You should contact your doctor if you need to adjust the dose of other medicines while taking Telmisartan pensa.
Pregnancy, breast-feeding and fertility
Pregnancy
You must inform your doctor if you think you are (or could be) pregnant. Your doctor will normally advise you to stop taking Telmisartan pensa before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Telmisartan pensa. Telmisartan pensa is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to the unborn baby if taken after the third month of pregnancy.
Breast-feeding
Inform your doctor if you are breast-feeding or planning to breast-feed. Telmisartan pensa is not recommended for women who are breast-feeding, and your doctor may choose another treatment if you wish to breast-feed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Some patients may experience dizziness or drowsiness while taking Telmisartan pensa. If you feel dizzy or tired, do not drive or operate machinery.

3. How to take Telmisartan pensa

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Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose of Telmisartan pensa is one tablet daily. Try to take the
tablet at the same time each day.
You may take Telmisartan pensa with or without food. Swallow the tablets with
some water or another non-alcoholic drink. It is important to take Telmisartan pensa
every day until your doctor tells you otherwise. If you feel that the effect of
Telmisartan pensa is too strong or too weak, consult your doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of Telmisartan pensa for most
patients is one 40 mg tablet once daily to control blood pressure over 24 hours. Your doctor has recommended a lower dose of one 20 mg tablet per day. Telmisartan pensa may be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive effect with Telmisartan pensa in lowering blood pressure.
For the reduction of cardiovascular events, the usual dose of Telmisartan pensa is one 80 mg tablet once daily. At the beginning of preventive treatment with Telmisartan pensa 80 mg, 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 Telmisartan pensa than you should
If you accidentally take too many tablets, contact your doctor, pharmacist, or the nearest hospital emergency department immediately.
If you forget to take Telmisartan pensa
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 normal dose the next day. Do not take a double dose to make up for the missed dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects may be serious and require immediate medical treatment.
You must contact your doctor immediately if you experience any of the following symptoms:
Sepsis * (often called "blood poisoning" – a severe infection with an 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. You must stop taking this medicine and consult your doctor immediately. If these effects are not treated, they may be fatal.

Possible side effects of Telmisartan pensa:
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated to reduce cardiovascular events.

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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), reduced red blood cells (anaemia), high potassium levels, difficulty sleeping, feeling of sadness (depression), fainting (syncope), sensation of spinning (dizziness), slow heartbeat (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 of weakness, and increased blood creatinine levels.

Rare side effects (may affect up to 1 in 1,000 people):
Sepsis * (often called "blood poisoning" – a severe infection with an inflammatory response throughout the body that may lead to death), increase 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 of anxiety, drowsiness, vision disturbances, rapid heartbeat (tachycardia), dry mouth, stomach ache, taste disturbances (dysgeusia), changes in liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucous membranes which may also lead to death (angioedema, including fatal outcomes), eczema (skin disorder), skin redness, urticaria, severe skin rash, joint pain (arthralgia), pain in the extremities, tendon pain, influenza-like illness, decreased haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or increased creatine phosphokinase levels in the blood.

Very rare side effects (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease) **.

* The event may have occurred by chance or may be related to a mechanism currently unknown.
** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the website
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Telmisartan pensa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging and/or blister after "Exp.". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Telmisartan Pensa contains
The active substance is telmisartan.
Each tablet contains 20 mg of telmisartan.
Each tablet contains 40 mg of telmisartan.
Each tablet contains 80 mg of telmisartan.
The excipients are:
Mannitol, meglumine, povidone (K-29/32), sodium hydroxide, magnesium stearate.

Description of the appearance of Telmisartan Pensa and contents of the pack
20 mg:
Round, slightly biconvex, white or almost white tablet, engraved with "T20" on one side.

40 mg:
Oblong, slightly biconvex, white or almost white tablet, scored on both sides, with "T40" engraved on one side. The tablet can be divided into two equal doses.

80 mg:
Oblong, slightly biconvex, white or almost white tablet, scored on both sides, with "T80" engraved on one side. The tablet can be divided into two equal doses.

Telmisartan Pensa tablets are available in packs of 28 tablets.

Marketing Authorization Holder and Manufacturers
Marketing Authorization Holder
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano, Italy

Manufacturers responsible for batch release:
LABORATORIOS LESVI, S.L.
Avda. Barcelona, 69, 08970 Sant Joan Despí (Barcelona), Spain
FERRER INTERNACIONAL, S.A.
Joan Buscallà 1-9, 08173 St. Cugat del Vallés (Barcelona), Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

This patient information leaflet was last reviewed on
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