Telmisartan Pensa 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Telmisartan Pensa 40 mg tablets EFG

Read the entire 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 questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Telmisartan Pensa is 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

1. What Telmisartán Pensa is and what it is used for

Telmisartán Pensa 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, thereby increasing your blood pressure. Telmisartán Pensa blocks the effect of angiotensin II, allowing your blood vessels to relax and reducing your blood pressure.

Telmisartán Pensa is used to treat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not due to any other identifiable cause.

If left untreated, high blood pressure can damage blood vessels in various organs, which may lead, in some cases, to heart attacks, heart or kidney failure, strokes, or blindness. High blood pressure generally does not cause symptoms before damage occurs. Therefore, it is important to measure your blood pressure regularly to ensure it remains within the normal range.

Telmisartán Pensa is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in adults who are at risk because their blood supply to the heart or legs is reduced or blocked, or who have had a stroke, or who have a high risk of developing diabetes. Your doctor will inform you if you are at high risk of experiencing such events.

2. What you need to know before starting to take Telmisartán Pensa

Do not take Telmisartán Pensa:

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking Telmisartán Pensa also during early 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 a blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, inform your doctor or pharmacist before taking Telmisartán Pensa.

Warnings and precautions

Consult your doctor if you are currently suffering from, or have ever 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.
• High levels of aldosterone (water and salt retention in the body along with imbalance of several blood minerals).
• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to treatment with diuretics, a low-salt diet, diarrhoea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Consult your doctor or pharmacist before starting to take Telmisartán Pensa:

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
  • aliskiren

Your doctor may monitor 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 Pensa”.

• if you are taking digoxin.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhoea after taking telmisartan. Your doctor will decide whether to continue treatment. Do not stop taking telmisartan on your own.

Inform your doctor if you think you are pregnant (or might be). Telmisartán Pensa is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when administered from that time onward (see Pregnancy section).

If you are undergoing surgery or anaesthesia, inform your doctor that you are taking Telmisartán Pensa.

Telmisartán Pensa may be less effective in lowering blood pressure in black patients.

Children and adolescents

The use of Telmisartán Pensa is not recommended in children and adolescents under 18 years of age.

Use of Telmisartán Pensa with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Your doctor may need to adjust your dose and/or take other precautions:

In some cases, you may have to stop taking one of the medicines. This particularly applies to the following medicines when taken together with Telmisartán 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, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin (a medicine to prevent blood clotting), immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken at high doses together with Telmisartán Pensa, may cause excessive loss of body water and lower blood pressure (hypotension).
• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Telmisartán Pensa” and “Warnings and precautions”).
• Digoxin.

The effect of Telmisartán Pensa may be reduced when used with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartán Pensa may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or of medicines that may potentially reduce blood pressure (e.g. baclofen, amifostine).

In addition, the reduction in blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. You should consult your doctor if you need to adjust the dose of your other medicines while taking Telmisartán Pensa.

Pregnancy, breastfeeding, and fertility

Pregnancy

If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Generally, your doctor will advise you to stop taking Telmisartán Pensa before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative medicine. Telmisartán Pensa is not recommended during early pregnancy and must not be administered from the third month of pregnancy onward, as it may cause serious harm to your baby when given from that time onward.

Breastfeeding

If you are planning to breastfeed or are currently breastfeeding, consult your doctor or pharmacist before using this medicine, as Telmisartán Pensa is not recommended for women during this period. Your doctor may choose a treatment more suitable for you if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and use of machines

Some people feel dizzy or tired when taking Telmisartán Pensa. If you feel dizzy or tired, do not drive or operate machinery.

3. How to take Telmisartán Pensa

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartán Pensa is one tablet daily. Try to take the tablet at the same time each day.

The tablets should be swallowed with a small amount of water or another non-alcoholic drink. It is important that you take Telmisartán Pensa every day until your doctor tells you otherwise. If you think that the effect of Telmisartán Pensa is too strong or too weak, inform your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartán 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, one 20 mg tablet daily. Telmisartán Pensa may also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to exert an additive blood pressure-lowering effect with telmisartan.

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

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

If you take more Telmisartán Pensa than you should

If you accidentally take too many tablets, contact your doctor, pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, or go to the nearest hospital emergency department, indicating the medicine and the amount taken.

If you forget to take Telmisartán Pensa

If you forget to take a dose, do not worry. Take it as soon as you remember on the same day. If you miss your tablet for 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, Telmisartán Pensa may produce adverse effects, although not everyone experiences them.

Some adverse effects can be serious and require immediate medical attention:

If you experience any of the following symptoms, you must see your doctor immediately:

Sepsis* (commonly called “blood infection”)—a serious infection involving an inflammatory response throughout the entire body; rapid swelling of the skin and mucous membranes (angioedema). These adverse effects are rare (may affect up to 1 in 1,000 people), but are extremely serious. Patients must stop taking the medicine and see their doctor immediately. If these adverse effects are not treated, they may be fatal.

Possible adverse effects of Telmisartán Pensa:

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

Low blood pressure (hypotension) in patients treated for the reduction of cardiovascular events.

Uncommon adverse effects (may affect up to 1 in 100 people):

Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduction in red blood cells (anemia), elevated potassium levels, difficulty sleeping (insomnia), feeling of sadness (depression), fainting (syncope), dizziness, sensation of loss of balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness upon standing (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug-induced rash, back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute renal failure, chest pain, feeling of weakness, and elevated blood creatinine levels.

Rare adverse effects (may affect up to 1 in 1,000 people):

Sepsis* (commonly called “blood infection”)—a serious infection involving an inflammatory response throughout the entire body, which may be fatal; increase in 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 of anxiety, drowsiness, visual disturbances, increased heart rate (tachycardia), dry mouth, stomach discomfort, taste disturbances (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this adverse effect), sudden swelling of the skin and mucous membranes which may be fatal (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, tendon pain, flu-like illness, decrease in hemoglobin (a blood protein), increased blood levels of uric acid, increased liver enzymes or creatine phosphokinase in blood.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Progressive fibrosis of lung tissue (interstitial lung disease) **.

Frequency “not known”:

Intestinal angioedema: intestinal inflammation has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

• This may have been an incidental finding or related to a mechanism currently unknown.

** Cases of progressive fibrosis of lung tissue have been reported during treatment with telmisartan. However, it is unknown whether telmisartan was the cause.

Reporting of adverse effects:

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan Pensa

Keep this medicine out of 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 the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartán Pensa

• The active substance is telmisartan. Each tablet contains 40 mg of telmisartan.
• The other components are mannitol, meglumine, povidone (K-29/32), sodium hydroxide, magnesium stearate.

Appearance of the product and contents of the pack

The 40 mg tablets are white or almost white, oblong, slightly biconvex, scored on both sides, with the inscription T40 on one side.

The tablet can be divided into equal doses.

Telmisartán Pensa is available in packs containing 28 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

or

Ferrer Internacional, S.A.

Joan Buscallà, 1-9

08173 St. Cugat del Vallés (Barcelona)

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

Spain: Telmisartán Pensa 40 mg Comprimidos EFG

Italy: Telmisartan Pensa 40 mg compresse

Portugal: Telmisartan toLife

Date of the most recent revision of the summary: March 2026

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/