Telmisartan Normon 80 mg tablets EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Telmisartan NORMON 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 or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if the effects are not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Telmisartán NORMON is and what it is used for

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

Telmisartán NORMON is used to treat essential hypertension (high blood pressure) in adults. "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 cause symptoms before such damage occurs. Therefore, it is important to measure your blood pressure regularly to ensure it remains within the normal range.

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

2. What you need to know before taking Telmisartán NORMON

Do not take Telmisartán NORMON

• 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 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 starting Telmisartán NORMON.

Warnings and precautions

Talk to your doctor before taking 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 the blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• High levels of aldosterone (fluid and salt retention in the body along with imbalance of several blood minerals).
• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have salt depletion due to diuretic therapy, low-salt diet, diarrhoea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Talk to your doctor before taking Telmisartán NORMON

• 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.

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 Telmisartán NORMON”.

• If you are taking digoxin.

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

You must inform your doctor if you think you are (or could become) pregnant. Use of Telmisartán NORMON is not recommended during early pregnancy and must not be given after the third month of pregnancy because it may cause severe harm to your baby if used at this stage (see Pregnancy section).

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

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

Children and adolescents

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

Taking Telmisartán NORMON with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines. Your doctor may need to adjust the dose of these other medicines 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 Telmisartán NORMON:

• 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 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 when taken at high doses together with Telmisartán NORMON, may cause excessive loss of body water and 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 Telmisartán NORMON” and “Warnings and precautions”).
• Digoxin.

The effect of Telmisartán NORMON may be reduced when you take NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartán NORMON may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may potentially lower blood pressure (e.g. baclofen, amifostine). In addition, blood pressure reduction may be worsened by alcohol, barbiturates, narcotics or antidepressants. You may notice this effect as dizziness upon standing. You should consult your doctor if you need dose adjustments of your other medicines while taking Telmisartán NORMON.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are (or could become) pregnant. Generally, your doctor will advise you to stop taking Telmisartán NORMON before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative antihypertensive medicine. Telmisartán NORMON is not recommended during early pregnancy and must not be administered after the third month of pregnancy, as it may cause severe harm to your baby when used from that point onward.

Breastfeeding

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

Driving and using machines

Some people feel dizzy or tired when taking Telmisartán NORMON. If you feel dizzy or tired, do not drive or use machines.

Telmisartán NORMON contains sodium

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

3. How to take Telmisartán NORMON

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

The recommended dose of Telmisartán NORMON is one tablet daily. Try to take the tablet at the same time each day. You may take Telmisartán NORMON with or without food. Tablets should be swallowed with a little water or another non-alcoholic drink. It is important that you take Telmisartán NORMON every day until your doctor tells you otherwise. If you think 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 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. Telmisartán NORMON may also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to exert an additive 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 daily. At the start of preventive treatment with Telmisartán NORMON 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 NORMON than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget 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 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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

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) and rapid swelling of the skin and mucous membranes (angioedema); these adverse effects are rare (may affect up to 1 in 1,000 people) but are 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 NORMON

Common adverse effects (may affect up to 1 in 10 people):

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

Uncommon adverse effects (may affect up to 1 in 100 people):

Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduction in 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, cough, abdominal pain, diarrhoea, stomach 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, feeling of weakness, elevated blood creatinine levels, and dizziness.

Rare adverse effects (may affect up to 1 in 1,000 people):

Sepsis* (commonly called "blood infection", a serious infection involving a systemic inflammatory response which 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, drowsiness, visual disturbances, increased heart rate (tachycardia), dry mouth, stomach discomfort, taste disturbances (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this adverse effect), 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), limb pain, tendon pain, flu-like illness, decrease in haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or increased creatine phosphokinase in blood.

Very rare adverse effects (may affect up to 1 in 10,000 people):

Progressive fibrosis of lung tissue (interstitial lung disease).**

Frequency “not known”:

Intestinal angioedema: intestinal inflammation has been reported with symptoms such as abdominal pain, nausea, vomiting, and diarrhoea following the use of similar products.

• This may have been an incidental finding or related to a mechanism currently unknown.

** Cases of progressive fibrosis of lung tissue have been reported during treatment with telmisartan. However, it is unknown whether telmisartan was the cause.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan NORMON

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, 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 NORMON

The active substance is telmisartan.

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

Appearance of the medicine and contents of the pack

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

Each tablet contains 80 mg of telmisartan.

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

Marketing Authorization Holder

LABORATORIOS NORMON, S.A.

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

Manufacturer

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), SPAIN

or

LABORATORIOS NORMON, S.A.

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

Date of the most recent revision of this leaflet: April 2026

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