TELMISARTAN PENSA 80 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Pensa 80 mg Tablets EFG

Read all of this 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 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

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. Storing 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 the 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 check your blood pressure to see 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 tell 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 any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is recommended to avoid taking Telmisartan Pensa at the start of your 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 severe liver disease.
• if you have diabetes or kidney problems and are being treated with a blood pressure-lowering medicine that contains aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Pensa.

Warnings and precautions

Tell your doctor if you are suffering from or have ever suffered from 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 aldosterone levels (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 potassium levels in the blood.
• Diabetes.

Tell 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.

Tell 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.

Tell your doctor if you think you are pregnant (or might become pregnant). It is not recommended to use Telmisartan Pensa at the start 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, tell 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.

Using Telmisartan Pensa with other medicines

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

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 with Telmisartan Pensa:

• Medicines containing lithium for treating some types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-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 with Telmisartan Pensa, may cause excessive water loss from the body and low 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, 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. 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 start 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.

Breastfeeding

If you are about to start or are already breastfeeding, 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 breastfeed, especially 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 daily, to control blood pressure over 24 hours. Your doctor has recommended a lower dose, of one 20 mg tablet daily. 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 checked frequently.

If your liver is not working 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, consult your doctor, pharmacist, or call the Toxicology Information Service immediately. 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 need 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 cell count (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, abdominal 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 cell count (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), skin redness, hives (urticaria), severe drug-induced exanthema, joint pain (arthralgia), pain in the limbs, pain in the tendons, pseudo-influenza, decrease in hemoglobin (a blood protein), increased blood 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) **.

Frequency "not known":

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

• This may have been a chance finding or be related to a currently unknown mechanism.

** Cases of progressive scarring of lung tissue have been reported during the use of 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 leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing 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 carton 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. Ask your pharmacist how to dispose of medicines no longer required. These measures 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 80 mg of telmisartan.
• The other ingredients are mannitol, meglumine, povidone (K-29/32), sodium hydroxide, magnesium stearate.

Appearance of the product and contents of the pack

The 80 mg tablets are white or almost white, oblong, slightly biconvex, scored on both sides, and have the inscription T80 on one side.

The tablet can be divided into equal doses.

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 80 mg Tablets EFG

Italy:Telmisartan Pensa 80 mg compresse

Portugal:Telmisartan toLife

Date of last revision of this leaflet: February 2025

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