Telmisartan Tecnigen 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Telmisartán Tecnigen 40 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 as 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 side effects, talk to your doctor or pharmacist, even if they are side effects 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 your blood vessels to relax and your blood pressure to decrease.

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, which 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, or who have had a stroke, or who are 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 components 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 renal impairment 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

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

Inform 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 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 levels of potassium 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.

Consult 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 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. 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.

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

Inform 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 need to stop taking one of the medicines. This particularly applies to the following medicines when taken together with telmisartan:

• Medicines containing lithium used to treat certain types of depression.
• Medicines that may increase blood potassium levels such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II 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 if taken in high doses together with telmisartan, may cause excessive loss of body water and lead to low 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

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 is confirmed, and will recommend an alternative antihypertensive treatment. Use of 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 stage.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as telmisartan is not recommended for use in women during this period. Your doctor may decide to prescribe a treatment more suitable for you if you intend 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 may feel dizzy or tired while receiving treatment for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartan Tecnigen contains sorbitol

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Telmisartán Tecnigen

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

The usual dose of telmisartan is one tablet per day. Try to take the tablet at the same time each day. You may take telmisartan with or without food. The tablets should be swallowed with a little water or another non-alcoholic drink. It is important that you take telmisartan every day unless your doctor tells you otherwise. If you think that the effect of telmisartan is too strong or too weak, tell 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 exert 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. At the start of 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 do not take your tablet 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 produce adverse effects, although not everyone will experience them.

These adverse effects may occur with different frequencies defined below:

• 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 severe infection involving an inflammatory response throughout the body), 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 (vertigo), 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 severe infection involving an inflammatory response throughout the body and which may result in death), 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, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach discomfort, abnormal liver function**, sudden swelling of the skin and mucous membranes which may be fatal (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, 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 symptoms such as abdominal pain, nausea, vomiting, and diarrhoea following use of similar products.

• In a long-term study involving 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 related to a mechanism currently unknown.

** Most cases of abnormal liver function and liver disorders reported during 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 may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products. 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 refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of containers and unused medicines at the SIGRE Point located at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused containers and medicines. 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 40 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 medicine and contents of the pack

Telmisartan Tecnigen 40 mg are white or slightly beige, round, biconvex 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 review of this leaflet: March 2026

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