TELMISARTAN TECNIGEN 40 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Telmisartan Tecnigen 40 mg Tablets EFG

Telmisartan

Read the 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, pharmacist, or nurse.
• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet:

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

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

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

Telmisartan Tecnigen is used totreat essential hypertension (high blood pressure). "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 Tecnigen is also used toreduce cardiovascular events (e.g., heart attacks or strokes) in patients 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 developing diabetes. Your doctor will inform you if you have a high risk of developing these events.

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

Do not take Telmisartan Tecnigen

• if you are allergic to telmisartan 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 this medicine during the first trimester of 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 impairment and are being treated with a blood pressure-lowering medicine containing aliskiren

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

Warnings and precautions

Consult your doctor or pharmacist before starting treatment with Telmisartan Tecnigen

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, a low-salt diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.
• 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

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.

Your doctor may check 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 TecniGen”

If you are pregnant, think you may be pregnant, or are planning to become pregnant, tell your doctor. It is not recommended to take telmisartan during the first trimester of pregnancy (first 3 months) and in any case, it should not be taken after the third month of pregnancy because it may cause serious harm to your baby, see section Pregnancy.

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

Telmisartan is not recommended for children and adolescents up to 18 years of age.

As with other angiotensin II receptor antagonists, telmisartan may be less effective in lowering blood pressure in black patients.

Taking Telmisartan Tecnigen with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. 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 together with telmisartan:

• Medicines containing lithium for treating certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses together with telmisartan, 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 TecniGen” and “Warnings and precautions”)

As with other blood pressure-lowering medicines, the effect of telmisartan may be reduced when you use NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen) or corticosteroids.

Telmisartan may increase the blood pressure-lowering effect of other medicines used to treat high blood pressure.

Using Telmisartan Tecnigen with food, drinks, and alcohol

You can take telmisartan with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking telmisartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine to treat your high blood pressure. It is not recommended to take telmisartan during the first trimester of pregnancy and in any case, it should not be taken after the third month of pregnancy because it may cause serious harm to your baby.

Breastfeeding

Tell your doctor if you are breastfeeding or about to start breastfeeding. It is not recommended to take telmisartan while breastfeeding, and your doctor may prescribe a different treatment if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

Driving and using machines

No information is available on the effect of telmisartan on the ability to drive or use machines. Some people may feel dizzy or tired when taking blood pressure-lowering medicines. If you feel dizzy or tired, do not drive or use machines.

Telmisartan Tecnigen contains sorbitol

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

3. How to take Telmisartan Tecnigen

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The usual dose of telmisartan is one tablet a day. Try to take the tablet at the same time each day. You can take telmisartan with or without food. The tablets should be swallowed with a little water or another non-alcoholic drink. It is important to take telmisartan every day to control your blood pressure. If you think that the effect of telmisartan is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of telmisartan for most patients is 40 mg once daily to control blood pressure over a 24-hour period. However, your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Telmisartan 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 is 80 mg. At the start of preventive treatment with telmisartan 80 mg, blood pressure should be monitored frequently.

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

If you take more Telmisartan Tecnigen than you should

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

If you forget to take Telmisartan Tecnigen

If you forget to take a dose, do not worry. Take it as soon as you remember and then continue as before.

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 a forgotten dose.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

These side effects may occur with the following frequencies:

• very common: may affect more than 1 in 10 people
• common: may affect up to 1 in 10 people
• uncommon: may affect up to 1 in 100 people
• rare: may affect up to 1 in 1,000 people
• very rare: may affect up to 1 in 10,000 people

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

If you experience any of the following symptoms, you should contact your doctor immediately: sepsis* (often referred to as "blood infection," a severe infection that involves an inflammatory reaction of the whole body), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare but extremely serious, and you should stop taking the medicine and contact your doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartan Tecnigen:

Common side effects may include:

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

Uncommon side effects may include:

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 losing 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, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, symptoms of weakness, and high creatinine levels in the blood

Rare side effects may include:

Sepsis* (often referred to as "blood infection," a severe 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., rash, itching, difficulty breathing, wheezing, low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach upset, abnormal liver function**, 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 rash, joint pain (arthralgia), pain in the limbs, pain in the tendons, pseudo-influenza, decrease in hemoglobin (a blood protein), increased uric acid levels in the blood, increased liver enzymes or creatine phosphokinase in the blood.

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.

• In a long-term study involving more than 20,000 patients, there were more patients treated with telmisartan who developed sepsis compared to patients who did not receive telmisartan.

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

** Most cases of abnormal liver function and liver disorder from post-marketing experience with telmisartan were in Japanese patients. Japanese patients are more likely to experience these side effects.

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. 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. Website: www.notificaRAM.es.

5. Storage of Telmisartan Tecnigen

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 after "EXP". The expiry date refers to the last day of the month shown.

No special storage conditions are required. You should keep your medicine in the original packaging to protect it from moisture.

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 Tecnigen

• The active substance is telmisartan. Each tablet contains 40 mg of telmisartan.
• The other ingredients (excipients) are: microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, sodium starch glycolate (potato starch), sorbitol (E420), magnesium stearate, purified water, and ethanol.

Appearance of the product and pack contents

Telmisartan Tecnigen 40 mg are white or slightly beige, round, biconvex tablets without a score.

Telmisartan Tecnigen is available in blister packs containing 28 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

Manufacturer:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande,

No 2 Abrunheira, Sintra,

Portugal

Date of last revision of this leaflet:February 2025

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