Package Insert: Information for the Patient

Telmisartán Tecnigen 80 mg Tablets EFG

Telmisartán

Read this entire package insert carefully before starting to take this medication because it contains important information for you

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist even if they are not listed in this package insert. See section 4.

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

Telmisartán Tecnigen is used totreat essential hypertension (elevated blood pressure). “Essential” means that the elevated blood pressure is not due to any other cause.

Elevated 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 elevated blood pressure before damage occurs. Therefore, it is essential to measure blood pressure regularly to verify if it is within the normal range.

Telmisartán 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 an elevated risk of experiencing these events.

Do not take Telmisartán Tecnigen

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Telmisartán Tecnigen

Inform your doctor if you are suffering or have ever suffered from any of the following conditions or diseases:

- an angiotensin-converting enzyme inhibitor (ACEI) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskirén

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 in monotherapy.

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

See also the information under the heading “Do not take Telmisartán TecniGen”

If you are pregnant, if you suspect you may be, or if you plan to become pregnant, inform your doctor. Telmisartán is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered after the third month of pregnancy because it may cause serious harm to your baby, see Pregnancy section.

Inform your doctor if you are undergoing surgery or anesthesia that you are taking telmisartán.

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

Like other angiotensin II receptor antagonists, telmisartán may be less effective in reducing blood pressure in patients of black race.

Taking Telmisartán Tecnigen with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased 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 medications. This applies especially to the following medications when taken with telmisartán:

Like other medications that lower blood pressure, the effect of telmisartán may be reduced when you use NSAIDs (e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartán may increase the hypotensive effect of other medications used to treat high blood pressure.

Telmisartán Tecnigen with food, drinks, and alcohol

You can take telmisartán with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be, or if you plan to become pregnant. Your doctor will usually advise you to stop taking telmisartán before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Telmisartán is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy because it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding because telmisartán is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for newborns or premature babies.

Driving and operating machinery

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

Telmisartán Tecnigen contains sorbitol

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the administration instructions for this medication as indicated 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 every day. You can take telmisartan with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take telmisartan every day until your doctor tells you otherwise. If you estimate 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 a day, to control blood pressure over 24 hours. However, your doctor may sometimes recommend a lower dose, 20 mg, or a higher dose, 80 mg. Telmisartan can also be used in association with diuretics such as hydrochlorothiazide, which has been shown to have an additional 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 beginning of preventive treatment with telmisartan 80 mg, blood pressure should be monitored frequently.

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

If you take more Telmisartán Tecnigen than you should

If you accidentally take too many tablets, consult your doctor, pharmacist, or the nearest hospital emergency service immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication 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 continue as before.

If you miss a tablet, take your usual dose the next day. Do not take a double dose to compensate for the missed dose.

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

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

These side effects can occur at different frequencies, as defined below:

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* (frequently 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 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 Tecnigen:

Common side effectsmay include:

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

Uncommon side effectsmay include:

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 of sadness (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 (orthostatic hypotension), difficulty breathing, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug-induced rash (skin reaction to medications), back pain, muscle cramps, muscle pain (myalgia), renal insufficiency including acute renal failure, chest pain, symptoms of weakness, and elevated creatinine levels in blood

Rare side effectsmay include:

Sepsis* (frequently 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 of anxiety, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach discomfort, abnormal liver function**, sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (skin alteration), skin redness, hives (urticaria), severe drug-induced rash, joint pain (arthralgia), pain in the limbs, tendon pain, pseudogripal disease, decrease in hemoglobin (a blood protein), increased uric acid levels in blood, increased liver enzymes or creatine phosphokinase in blood.

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

* In a long-term study, which includes more than 20,000 patients, there were more patients treated with telmisartan who suffered from sepsis compared to patients who did not receive telmisartan.

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

** Most cases of abnormal liver function and liver disorder from post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients show a greater tendency to experience these side effects.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use. Website: www.notificaRAM.es.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the carton after “CAD”. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of the containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medications. By doing so, you will help protect the environment.

Telmisartan Tecnigen Composition

• The active ingredient is telmisartan. Each tablet contains 80 mg of telmisartan.
• The other components (excipients) are: microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, sodium starch glycolate (potato starch), sorbitol (E420), magnesium stearate, purified water, and ethanol.

Product appearance and packaging contents

Telmisartan Tecnigen 80 mg are white or slightly beige, oval-shaped, and unnotched tablets.

Telmisartan Tecnigen is available in blister packs containing 28 tablets.

Marketing Authorization Holder and Responsible for Manufacturing:

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, nº 13. 3ºD

28108 - Alcobendas (Madrid)

Responsible for Manufacturing:

Laboratorios Alter, S.A.

Mateo Inurria, 30

28036 Madrid

ATLANTIC PHARMA - PRODUÇOES FARMACEUTICAS, S.A.

Rua da Tapada Grande,

No 2 Abrunheira, Sintra,

Portugal

Last review date of this leaflet:February 2025

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