Telmisartan TecniGen 80 mg tablets EFG

Package Leaflet: Information for the User

Introduction

Package leaflet: information for the patient

Telmisartán Tecnigen 80 mg tablets EFG

Telmisartan

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, pharmacist, or nurse.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Telmisartán Tecnigen is and what it is 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, thereby increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, allowing blood vessels to relax and reducing your blood pressure.

Telmisartán Tecnigen is used to treat essential hypertension (high blood pressure). "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 and may lead, in some cases, to heart attacks, heart or kidney failure, strokes, or blindness. High blood pressure generally does not produce symptoms before such damage occurs. Therefore, it is important to measure your blood pressure regularly to ensure it remains within the normal range.

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

2. What you need to know before taking Telmisartan Tecnigen

Do not take Telmisartan Tecnigen

• if you are allergic to telmisartan or to 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 better to avoid taking this medicine 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 Telmisartan Tecnigen.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Telmisartan Tecnigen.

Tell your doctor if you are suffering 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 levels of aldosterone (water and salt retention in the body along with imbalance of several minerals in the blood).

• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic treatment, low-salt diet, diarrhoea 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), particularly if you have kidney problems related to diabetes.

• aliskiren.

Talk to 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 when used as monotherapy.

Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals.

See also information under the heading “Do not take Telmisartan Tecnigen”.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor. The use of telmisartan is not recommended during early pregnancy (first 3 months), and in no case should it be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby – see Pregnancy section.

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

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

As with other angiotensin II receptor antagonists, telmisartan may be less effective in reducing 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 need to take any other medicines, including those obtained without a prescription. 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 especially applies to the following medicines when taken together with telmisartan:

• 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 receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken at high doses together with telmisartan, may cause excessive loss of body water and lower blood pressure (hypotension).
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Telmisartan Tecnigen” and “Warnings and precautions”).

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

Telmisartan may enhance the hypotensive effect of other medicines used to treat high blood pressure.

Use of Telmisartan Tecnigen with food, drinks and alcohol

You may take telmisartan with or without food.

Pregnancy, breastfeeding and fertility

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking telmisartan before becoming pregnant or as soon as pregnancy occurs, and will recommend an alternative antihypertensive medicine. Telmisartan 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.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed, as telmisartan is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

There is no information available on the effect of telmisartan on the ability to drive and use machines. Some people feel dizzy or tired when being treated for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan Tecnigen contains sorbitol

If your doctor has diagnosed you with an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Telmisartán Tecnigen

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

The usual dose of telmisartan is one tablet daily. Try to take the tablet at the same time each day. You may take telmisartan with or without food. Swallow the tablets with a little water or other non-alcoholic drink. It is important that you take telmisartan every day until your doctor tells you otherwise. If you think that the effect of telmisartan is too strong or too weak, inform your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of telmisartan for most patients is one 40 mg tablet once daily, to control blood pressure over 24 hours. However, your doctor may sometimes recommend a lower dose of 20 mg or a higher dose of 80 mg. Telmisartan may 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 one 80 mg tablet. When starting preventive treatment with telmisartan 80 mg, blood pressure should be monitored frequently.

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

If you take more Telmisartán Tecnigen than you should

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

If you forget to take Telmisartán 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 miss a dose one day, take your normal dose the next day. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

These adverse effects may occur with different frequencies defined as follows:

• 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 adverse effects may 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 a systemic inflammatory response), rapid swelling of the skin and mucous membranes (angioedema); these adverse effects are rare but extremely serious, and 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 Tecnigen:

Common adverse effects may include:

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

Uncommon adverse effects may include:

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

Rare adverse effects may include:

Sepsis* (commonly called “blood infection”, a serious infection involving a systemic inflammatory response that 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, visual disturbances, increased heart rate (tachycardia), dry mouth, stomach discomfort, abnormal liver function**, sudden swelling of the skin and mucous membranes that may be fatal (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, flu-like illness, decreased haemoglobin (a blood protein), increased blood levels of uric acid, increased liver enzymes or creatine phosphokinase in blood.

Frequency “not known”: Intestinal angioedema: intestinal inflammation has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhoea.

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

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

** Most cases of abnormal liver function and liver disorders reported in post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients appear to be more prone to experience these adverse effects.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human 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 stated on the carton after "EXP". The expiry date is the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 80 mg of telmisartan.
• The other components (excipients) are: microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, sodium starch glycolate from potato (potato starch), sorbitol (E420), magnesium stearate, purified water and ethanol.

Appearance of the medicinal product and contents of the pack

Telmisartan Tecnigen 80 mg are white or slightly beige, oblong tablets without a breakline.

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 the most recent revision of this leaflet: March 2026

Detailed and up-to-date 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/