Leaflet: information for the user

Telmisartan pensa 40 mg tablets EFG

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

• Keep this leaflet, as you may need to read it again.

If you have any questions, ask yourdoctor, or pharmacist.

• This medicine has been prescribedonlyfor you, and do not give it to other people even ifthey havethe same symptomsas you,as it may harm them.
• If you experience any side effects,consult your doctor, or pharmacist,evenifthey are not listed in this leaflet. See section 4.

1. What isTelmisartan Pensaand what it is used for

2. What you need to know before you start takingTelmisartan Pensa

3. How to takeTelmisartan Pensa

4. Possible side effects

5. Storage ofTelmisartan Pensa

6. Contents of the pack and additional information

Telmisartán Pensa belongs to a class of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to constrict, thereby increasing your blood pressure. Telmisartán Pensa blocks the effect of angiotensin II, causing your blood vessels to relax and your blood pressure to decrease.

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 cause.

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 renal failure, strokes, or blindness. Generally, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to measure your blood pressure regularly to verify if it is within the normal range.

Telmisartán Pensa is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in adults with a high 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 developing diabetes. Your doctor will inform you if you have a high risk of experiencing these events.

Do not take Telmisartán Pensa:

• if you are allergic to the active ingredient or to any of the other components of this medication (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is better to avoid taking Telmisartán Pensa at the beginning of your 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 medication that contains aliskiren

Inform your doctor or pharmacist before taking Telmisartán Pensa if your case is any of the above.

Warnings and precautions

Consult your doctor if you are experiencing or have ever experienced 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.
• Elevated aldosterone levels (water and salt retention in the body along with mineral imbalance 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 diuretic treatment, low-salt diet, diarrhea, or vomiting.
• Elevated potassium levels in the blood.
• Diabetes.

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

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

Your doctor may monitor your renal function, blood pressure, and 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 diarrhea after taking telmisartán. Your doctor will decide whether to continue treatment. Do not stop taking telmisartán on your own.

Inform your doctor if you think you may be pregnant (or could be). Telmisartán Pensa is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy at any rate, as it may cause serious harm to your baby when administered from that point onwards (see Pregnancy section).

In the event of surgery or anesthesia, inform your doctor that you are taking Telmisartán Pensa.

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

Children and adolescents

Telmisartán Pensa is not recommended for use in children and adolescents under 18 years.

Use of Telmisartán Pensa with other medications

Inform your doctor or pharmacistifyou are using, have used recentlyor may have to use any other medication.

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

In some cases, you may need to stop taking one of the medications. This applies especially to the following medications when taken with Telmisartán Pensa:

• Medications containing lithium for treating certain types of depression.
• Medications that can increase potassium levels in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics, ACEIs, angiotensin II receptor antagonists, NSAIDs (e.g. aspirin or ibuprofen), heparin (a blood thinner), immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially if taken in high doses with Telmisartán Pensa, may cause excessive water loss from the body and lower blood pressure (hypotension).
• ACEIs or aliskiren (see also the information under the headings “Do not take Telmisartán Pensa” and “Warnings and precautions”)
• Digoxin

The effect of Telmisartán Pensa may be reduced when you use NSAIDs (e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartán Pensa may increase the hypotensive effect of other medications used to treat high blood pressure or medications that may potentially lower blood pressure (e.g. baclofen, amifostine).

Additionally, blood pressure may be lowered further 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 medications while taking Telmisartán Pensa.

Pregnancy,lactationand fertility

Pregnancy

If you are pregnant, think you may be pregnant, or intend to become pregnant, consultyour doctor or pharmacist before using this medication.Your doctor will usually advise you to stop taking Telmisartán Pensa before becoming pregnant or as soon as you become pregnant, and recommend taking another medication instead of Telmisartán Pensa. Telmisartán Pensa is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy at any rate, as it may cause serious harm to your baby when administered from that point onwards.

Lactation

If you are planning to breastfeed or are breastfeeding, consultyour doctor or pharmacist before using this medicationas Telmisartán Pensa is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machinery

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

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take Telmisartán Pensa every day until your doctor tells you otherwise. If you estimate 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 a day, to control blood pressure over 24 hours. Your doctor has recommended a lower dose, one 20 mg tablet per day. Telmisartán Pensa can also be used in association with diuretics such as hydrochlorothiazide, which has been shown to exert an additional blood pressure-lowering effect with telmisartán.

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

If your liver does not function correctly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartán Pensa than you should

If you accidentally take too many tablets, consult your doctor, pharmacist immediately, or call the Toxicological Information Service. Phone 91 562 04 20, or go to the nearest hospital emergency department, indicating the medication and the amount ingested.

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 a dose, take your usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, Telmisartán Pensa can cause side effects, although not everyone will experience them.

Some side effects can be severe and require immediate medical attention:

If you experience any of the following symptoms, you should visit your doctor immediately:

Sepsis* (often called "blood infection," it is a severe infection that involves a systemic inflammatory reaction), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (can affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and visit their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartán Pensa:

Frequent side effects(can affect up to 1 in 10 people):

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

Infrequent side effects(can 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), elevated potassium levels, difficulty falling asleep (insomnia), feeling sad (depression), fainting (syncope), feeling of loss of balance (dizziness), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug-induced rash, back pain, muscle cramps, muscle pain (myalgia), renal insufficiency including acute renal failure, chest pain, feeling weak and elevated creatinine levels in blood.

Rare side effects(can affect up to 1 in 1,000 people)

Sepsis* (often called "blood infection," it is a severe infection that involves a systemic inflammatory reaction and can cause death), increased 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 anxious, drowsiness, vision changes, increased heart rate (tachycardia), dry mouth, stomach discomfort, taste alterations (dysgeusia), abnormal liver function (Japanese patients are more prone to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (a skin alteration), skin redness, hives (urticaria), severe drug-induced rash, joint pain (arthralgia), pain in the limbs, tendon pain, pseudogripal disease, decreased hemoglobin (a blood protein), elevated uric acid levels in blood, elevated liver enzymes or creatine phosphokinase in blood.

Very rare side effects(can affect up to 1 in 10,000 people)

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

Frequency "unknown":

Intestinal angioedema: intestinal inflammation 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 related to an unknown mechanism.

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

Reporting of side effects:

If you experience side effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging and/or blister after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash.Deposit the packaging and medications you no longer need at the SIGRE collection pointof the pharmacy. In case of doubtask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Telmisartan Pensa Composition

• The active ingredient 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 content of the packaging

The 40 mg tablets are white or almost white, oblong, slightly biconvex, scored on both faces, and have the inscription T40 on one face.

The tablet can be divided into equal doses.

Telmisartan Pensa is presented in packs of 28 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for Manufacturing

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 with the following names:

Spain: Telmisartán Pensa 40 mg Tablets EFG

Italy: Telmisartan Pensa 40 mg tablets

Portugal: Telmisartan toLife

Last review date of this prospectus: February 2025

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/