PATIENT INFORMATION LEAFLET

Telmisartán NORMON 80 mg tablets EFG

Telmisartán

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 your doctor or pharmacist.

- This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What isTelmisartánNORMONand what it is used for

2.What you need to know before starting to take TelmisartánNORMON

3.How to take TelmisartánNORMON

4.Possible side effects

5.Storage of TelmisartánNORMON

6.Contents of the pack and additional information

Telmisartán NORMON 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 NORMON blocks the effect of angiotensin II, causing blood vessels to relax and reducing blood pressure.

Telmisartán NORMON is used totreat essential hypertension (high blood pressure) in adults. “Essential” means that the high blood pressure is not due to any other cause.

Untreated high blood pressure 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 regularly measure blood pressure to verify if it is within the normal range.

Telmisartán NORMON is also used toreduce 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 NORMON

• If you are allergic to telmisartan or 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 best to avoid taking this medication also 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 insufficiency and are being treated with a blood pressure medication that contains aliskiren.

Inform your doctor or pharmacist before starting to take Telmisartán NORMON if your case is any of the above.

Warnings and precautions

Consult your doctor before starting to take Telmisartán NORMON 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 blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• Elevated aldosterone levels (retention of water and salts in the body along with imbalance of several minerals in the blood).
• Low blood pressure (hypotension) that may occur if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic treatment, low-salt diet, diarrhea, or vomiting.
• Elevated potassium levels in the blood.
• Diabetes.

Consult your doctor before starting to take Telmisartán NORMON.

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 NORMON”.

• If you are taking digoxin.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartán NORMON. Your doctor will decide whether to continue treatment. Do not stop taking Telmisartán NORMON in monotherapy.

Inform your doctor if you think you are (or could become) pregnant. Telmisartán NORMON is not recommended for use at the beginning of pregnancy and should not be administered if you are more than 3 months pregnant because it may cause severe damage to your baby if used at this stage (see Pregnancy section).

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

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

Children and adolescents

Telmisartán NORMON is not recommended for use in children and adolescents up to 18 years old.

Taking Telmisartán NORMON with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor may need to adjust the dose of these other medications 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 NORMON:

• Medications containing lithium for treating certain types of depression.
• Medications that may 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, immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially if taken in high doses with Telmisartán NORMON, may cause excessive loss of water from the body and low blood pressure (hypotension).
• If you are taking an ACEI or aliskiren (see also the information under the headings “Do not take Telmisartán NORMON” and “Warnings and precautions”).
• Digoxin.

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

Telmisartán NORMON may increase the effect of other medications used to treat high blood pressure or medications that may potentially lower blood pressure (e.g. baclofen, amifostine). Additionally, the decrease in blood pressure may be exacerbated by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. Consult your doctor if you need to adjust the dose of other medications while taking Telmisartán NORMON.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are (or could become) pregnant. Your doctor will usually advise you to stop taking Telmisartán NORMON before becoming pregnant or as soon as you know you are pregnant, and recommend taking another antihypertensive medication instead. Telmisartán NORMON is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy, as it may cause severe damage to your baby if used at this stage.

Breastfeeding

Inform your doctor if you are planning to start breastfeeding or are breastfeeding. Telmisartán NORMON is not recommended for use in breastfeeding mothers, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and operating machinery

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

Telmisartán NORMON contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially “sodium-free”.

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

The recommended dose of Telmisartán NORMON is one tablet per day. Try to take the tablet at the same time every day. You can take Telmisartán NORMON with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take Telmisartán NORMON every day until your doctor tells you otherwise. If you estimate that the effect of Telmisartán NORMON is too strong or too weak, inform your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartán NORMON for most patients is one 40 mg tablet once a day, to control blood pressure over 24 hours. However, your doctor may recommend a lower dose, 20 mg, or a higher dose, 80 mg, at times. Telmisartán NORMON can also be used in association with diuretics such as hydrochlorothiazide, which has been shown to have an additional blood pressure-lowering effect with Telmisartán NORMON.

For the reduction of cardiovascular events, the usual dose of Telmisartán NORMON is one 80 mg tablet once a day. At the beginning of preventive treatment with Telmisartán NORMON 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 NORMON than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately, or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Telmisartán NORMON

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 nottake 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, this medicine may cause side effects, although not everyone will experience them.

Some side effects can be serious 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) and rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (they may 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.

Telmisartán NORMON side effects

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

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

Infrequent side effects(may 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 of sadness (depression), fainting (syncope), feeling of loss of balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients 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 exanthema (skin reaction to medications), back pain, muscle cramps, muscle pain (myalgia), renal insufficiency including acute renal failure, chest pain, feeling of weakness and elevated creatinine levels in blood.

Rare side effects(may 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 may cause death), increased certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. exanthema, itching, difficulty breathing, cough, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling of anxiety, drowsiness, vision alteration, increased heart rate (tachycardia), dry mouth, stomach discomfort, taste alteration (dysgeusia), abnormal liver function (Japanese patients are more prone to experience this side effect), sudden swelling of the skin and mucous membranes that may cause death (angioedema including fatal outcome), eczema (skin alteration), skin redness, hives (urticaria), severe drug-induced exanthema, joint pain (arthralgia), pain in the extremities, tendon pain, pseudogripal disease, decreased hemoglobin levels (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase levels in blood.

Very rare side effects (may 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

* This may have been a chance finding or related toacurrently 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a side effect that does 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.

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

Do not use this medication after the expiration date that appears on the packaging afterCAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Telmisartan NORMON Composition

The active ingredient is telmisartan.

The other components are povidone, meglumine, sodium hydroxide, mannitol, crospovidone, and magnesium stearate.

Product appearance and packaging content

They are white, elongated tablets, with the code LC engraved on one face.

Each tablet contains 80 mg of telmisartan.

Telmisartan NORMON 80 mg is presented in blisters (aluminum/aluminum) containing 28 tablets.

Marketing Authorization Holder

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres cantos – Madrid (SPAIN)

Responsible for Manufacturing

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Industrial Estate Miralcampo

19200 Azuqueca de Henares (Guadalajara), SPAIN

or

Laboratorios NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres cantos – Madrid (SPAIN)

Last review date of this leaflet:February 2025

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