TELMISARTAN PENSA 20 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Pensa 20 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet.

Contents of the package leaflet:

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

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

Telmisartan 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, thus increasing your blood pressure. Telmisartan Pensa blocks the effect of angiotensin II, so that your blood vessels relax and your blood pressure is reduced.

Telmisartan Pensa is used to treat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by any other condition.

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. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly measure your blood pressure to check if it is within the normal range.

Telmisartan Pensa is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in adults at risk because their blood supply to the heart or legs is reduced or blocked, or they have had a stroke or have a high risk of suffering from diabetes. Your doctor will inform you if you have a high risk of suffering from these events.

2. What you need to know before you take Telmisartan Pensa

Do not take Telmisartan Pensa

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant for more than 3 months. (In any case, it is better to avoid taking Telmisartan Pensa also at the beginning of your pregnancy - see 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 severe liver disease.
• if you have diabetes or kidney failure and are being treated with a blood pressure-lowering medicine that contains aliskiren.

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

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 levels of aldosterone (water and salt retention in the body along with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension) that 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 levels of potassium in the blood.
• Diabetes.

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

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• • an angiotensin-converting enzyme inhibitor (ACE inhibitor) (e.g., enalapril, lisinopril, ramipril), especially 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 Telmisartan Pensa".

• if you are taking digoxin.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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). It is not recommended to use Telmisartan Pensa at the beginning of pregnancy and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from that time (see section Pregnancy).

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

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

Children and adolescents

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

Use of Telmisartan Pensa with other medicines

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

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

In some cases, you may need to stop taking one of the medicines. This is especially applicable to the following medicines when taken at the same time as Telmisartan Pensa:

• Medicines containing lithium for treating some types of depression.
• Medicines that can 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 (a medicine to prevent blood clotting), immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses together with Telmisartan Pensa, can cause excessive water loss from the body and lower blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan Pensa" and "Warnings and precautions")
• Digoxin.

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

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

Additionally, the decrease in blood pressure may be enhanced 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 Telmisartan Pensa.

Pregnancy, breast-feeding, 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. In general, your doctor will advise you to stop taking Telmisartan Pensa before you become pregnant or as soon as you find out you are pregnant, and will recommend that you take another medicine instead of Telmisartan Pensa. It is not recommended to use Telmisartan Pensa at the beginning of pregnancy and in no case should it be administered from the third month of pregnancy, as it may cause serious harm to your baby when administered from that time.

Breast-feeding

If you are about to start or are already breast-feeding, consult your doctor or pharmacist before using this medicine, as it is not recommended to administer Telmisartan Pensa to women during this period. Your doctor may decide to administer a treatment that is more suitable if you want to breast-feed, especially to newborns or premature babies.

Driving and using machines

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

3. How to take Telmisartan Pensa

Follow exactly the instructions of your doctor or pharmacist for taking this medicine. If you are unsure, consult your doctor or pharmacist again.

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

The tablets should be swallowed with a little water or other non-alcoholic drink. It is important that you take Telmisartan Pensa every day until your doctor tells you to stop. If you think that the effect of Telmisartan Pensa is too strong or too weak, talk to 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 a day, to control blood pressure over 24 hours. Your doctor has recommended a lower dose, one 20 mg tablet per day. Telmisartan Pensa can also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect with telmisartan.

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

If your liver is not working properly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartan Pensa than you should

If you accidentally take too many tablets, consult your doctor, pharmacist, or call the Toxicology Information Service. Telephone 91 562 04 20, or go to the Emergency Department of the nearest hospital, indicating the medicine and the amount taken.

If you forget to take Telmisartan Pensa

If you forget to take a dose, do not worry. Take it as soon as you remember on the same day. 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan Pensa can cause side effects, although not everybody gets them.

Some side effects can 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 serious 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 medicine and see their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartan Pensa:

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

Low blood pressure (hypotension) in users treated for cardiovascular event reduction.

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 falling asleep (insomnia), feeling sad (depression), fainting (syncope), feeling of loss of balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing up (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, stomach discomfort, abdominal distension, vomiting, itching, increased sweating, drug-induced exanthema, back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, feeling 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 serious infection that involves an inflammatory reaction of the whole body and can cause death), increased white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., exanthema, itching, difficulty breathing, wheezing, facial swelling, or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, drowsiness, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach upset, taste disturbance (dysgeusia), abnormal liver function (Japanese patients show a greater tendency to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug-induced exanthema, joint pain (arthralgia), pain in the limbs, pain in the tendons, pseudogripal illness, decrease in 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 people)

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

Frequency "not known":

Intestinal angioedema: inflammation in the intestine has been reported, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

• This may have been a chance finding or be related to a mechanism that is currently not known.

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

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan Pensa

• The active substance is telmisartan. Each tablet contains 20 mg of telmisartan.
• The other ingredients are mannitol, meglumine, povidone (K-29/32), sodium hydroxide, magnesium stearate.

Appearance of the product and pack contents

The 20 mg tablets are white or almost white, round, slightly biconvex with the inscription T20 on one side.

Telmisartan Pensa is available in packs of 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 medicine is authorized in the Member States of the European Economic Area under the following names:

Spain:Telmisartán Pensa 20 mg Comprimidos EFG

Italy:Telmisartan Pensa 20 mg compresse

Portugal:Telmisartan to Life

Date of last revision of this package leaflet: February 2025

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