TELMISARTAN 20 mg Tabletka

Treść ulotki

1. Telmisartan Pensa 20 mg tablets, 40 mg tablets, 80 mg tablets
   1. What is Telmisartan pensa and what it is used for
   2. What you need to know before taking Telmisartan pensa
   3. How to take Telmisartan pensa
   4. Possible side effects
   5. How to store Telmisartan pensa
   6. Contents of the pack and other information

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

Telmisartan

Generic medicine
Contents of this leaflet

• 1. What Telmisartan Pensa is and what it is used for
• 2. What you need to know before you take Telmisartan Pensa
• 3. How to take Telmisartan Pensa
• 4. Possible side effects
• 5. How to store Telmisartan Pensa
• 6. Contents of the pack and other information

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

Telmisartan pensabelongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance present in the body that causes constriction of blood vessels, increasing blood pressure. Telmisartan blocks this effect of angiotensin II, so that blood vessels and blood pressure are lowered.

Telmisartan pensais used for the treatment of essential hypertension (high blood pressure) in adults. 'Essential' means that the high blood pressure is not caused by other conditions. Hypertension, if left untreated, can damage blood vessels in many organs, which can sometimes cause heart attack, heart failure or kidney failure, stroke or blindness. There are usually no symptoms of high blood pressure before damage occurs. Therefore, it is important to measure blood pressure regularly to check if it is within the normal range.

Telmisartan Pensais also used to reduce cardiovascular events (e.g. heart attack or stroke) in adults who are at risk because they have a reduced or blocked blood supply to the heart or legs, or have had a stroke or a high risk of diabetes. Your doctor can tell you if you are at high risk of such events.

2. What you need to know before taking Telmisartan pensa

Do not takeTelmisartan pensa

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6). Read this leaflet carefully before you start taking this medicine as it containsimportant 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

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• if you are pregnant for more than 3 months (it is best to avoid taking Telmisartan pensain early pregnancy - see the section “Pregnancy”).
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, 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 suffer from or have ever suffered from any of the following conditions or
diseases:

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

Talk to 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” (for example 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 what is stated under "Do not take Telmisartan Pensa".
• if you are taking digoxin

You must tell your doctor if you think you may be (or might become) pregnant. Telmisartan pensais not
recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it can cause serious harm to the baby if taken during this
period (see the section “Pregnancy”).
In case of surgery or administration of anesthetics, you must inform your doctor
that you are taking Telmisartan pensa.

Telmisartan pensamay be less effective in lowering blood pressure in patients of
black race.

Children and adolescents
The use of Telmisartan pensa is not recommendedin children and adolescents under the age of
18 years.

Other medicines andTelmisartan pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might
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take any other medicines. Your doctor may need to change 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 especially true for the medicines listed below taken at the same time as

Telmisartan pensa:

• Medicines containing lithium to treat some types of depression.
• Medicines that can increase the levels of potassium 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, for example, aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
• Diuretics, especially if taken in high doses with Telmisartan pensa,can lead to excessive loss of body water and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not take Telmisartan Pensa" and "Warnings and precautions”).
• Digoxin.

The effect of Telmisartan pensamay be reduced if taken with NSAIDs (non-steroidal anti-inflammatory drugs, for example aspirin or ibuprofen) or corticosteroids.

Telmisartan pensacan increase the hypotensive effect of other medicines used to treat
high blood pressure or medicines with a potential hypotensive effect (e.g. baclofen,
amifostine).
In addition, low blood pressure can be worsened by alcohol, barbiturates, narcotics or
antidepressants. You may experience dizziness when standing up. You should contact your
doctor if you need to change the dose of other medicines while taking Telmisartan

pensa.

Pregnancy, breastfeeding and fertility
Pregnancy
You must tell your doctor if you think you may be (or might become) pregnant. Usually your doctor will
advise you to stop taking Telmisartan pensabefore starting a
pregnancy or as soon as you find out you are pregnant and will advise you
to take another medicine instead of Telmisartan pensa. Telmisartan pensais not
recommended in early pregnancy and must not be taken if you are more than 3 months pregnant, as it can cause serious harm to the baby if taken after the third month of
pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding. Telmisartan pensais not
recommended for women who are breastfeeding and your doctor may choose another treatment
if you wish to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
Some patients may experience dizziness or drowsiness while taking Telmisartan

pensa. If you feel dizzy or tired, do not drive vehicles or use machines.

3. How to take Telmisartan pensa

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Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
The recommended dose of Telmisartan pensais one tablet a day. Try to take the
tablet at the same time each day.
You can take Telmisartan pensawith or without food. The tablets must be swallowed with
a little water or other non-alcoholic beverage. It is important to take Telmisartan pensaevery
day until your doctor tells you otherwise. If you have the impression that the effect of

Telmisartan pensais too strong or too weak, consult your doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of Telmisartan pensafor most
patients is one 40 mg tablet once a day to control blood
pressure over a 24-hour period. Your doctor may have recommended a lower dose of one
20 mg tablet per day. Telmisartan pensacan be used in association with diuretics
such as hydrochlorothiazide, which has been shown to have an additive effect with Telmisartan pensain
reducing blood pressure.
For the reduction of cardiovascular events, the usual dose of Telmisartan pensais one
80 mg tablet once a day. At the beginning of preventive therapy 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
a day.

If you take moreTelmisartan pensathan you should
If you accidentally take too many tablets, contact your doctor, pharmacist, or the
emergency room of the nearest hospital.

If you forget to takeTelmisartan pensa
If you forget to take a dose, do not worry. Take it as soon as you remember, then
continue as before. If you do not take the tablet one day, take the normal dose the next
day. Do not take a double dose to make up for a missed dose.
If you have any doubts 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 everyone will experience them.

Some side effects may be serious and require immediate medical attention
You should immediately see a doctor if you experience any of the following symptoms:
Sepsis * (often called "blood poisoning" is a serious infection with 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 the patient should stop taking the product and consult
their doctor immediately. If these effects are not treated they can be fatal.

Possible side effects ofTelmisartan pensa:
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for the reduction of 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), decreased red blood cells (anemia), high potassium levels,
difficulty sleeping, feeling sad (depression), fainting (syncope),
feeling of spinning (dizziness), slow heartbeat (bradycardia), low blood pressure
(hypotension) in patients treated for high blood pressure, dizziness when standing up
(orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort,
swelling, vomiting, itching, increased sweating, drug rash, back pain,
muscle cramps, muscle pain (myalgia), impaired kidney function including acute
renal failure, chest pain, feeling of weakness and increased creatinine levels in
the blood.
Rare side effects (may affect up to 1 in 1,000 people):
Sepsis * (often called "blood poisoning" is a serious infection with inflammatory response throughout the body that can lead to death), increased white blood cells
(eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic
reaction), allergic reaction (e.g. skin rash, itching, difficulty breathing,
wheezing, swelling of the face or low blood pressure), low blood sugar levels
(in diabetic patients), feeling of anxiety, drowsiness, changes in vision, fast
heartbeat (tachycardia), dry mouth, stomach pain, changes in taste

(dysgeusia), altered liver function (Japanese patients are more likely to
have this side effect), rapid swelling of the skin and mucous membranes which can also
lead to death (angioedema, even with fatal outcome), eczema (skin disorder),
skin redness, urticaria, severe skin rash, joint pain (arthralgia),
pain in the extremities, tendon pain, flu-like disorders, decreased hemoglobin
(a blood protein), increased uric acid levels, increased 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) **.
* The event may have occurred by chance or may be related to a currently
unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during
the intake of telmisartan. However, it is not known whether telmisartan was the cause.
If you experience any side effect, including those not listed in this leaflet, tell your
doctor or pharmacist.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can
contribute to providing 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 which is 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 particular storage conditions.
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Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What the medicine containsTelmisartan pensa
The active ingredient 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 ofTelmisartan Pensaand contents of the pack

20 mg:
round tablet, slightly biconvex white or almost white, with T20 inscribed on one side.

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

80 mg:
oval tablet, slightly biconvex, white or almost white, scored on both sides and
with T80 imprinted on one side. The tablet can be divided into two equal doses.
Telmisartan pensa tablets are available in packs of 28 tablets.

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

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 authorised in the Member States of the European Economic Area with the
following names:
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