TELMISARTAN NORMON 80 mg TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Telmisartan NORMON 80 mg tablets EFG

Telmisartan

Read all of this 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Telmisartan 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, thus increasing your blood pressure. Telmisartan NORMON blocks the effect of angiotensin II, so that your blood vessels relax and your blood pressure is reduced.

Telmisartan NORMON is used to treat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by any other condition.

High blood pressure, if left untreated, can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or kidney failure, strokes, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to regularly check your blood pressure to see if it is within the normal range.

Telmisartan NORMON is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in adults 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 suffering from diabetes. Your doctor will tell you if you have a high risk of suffering from these events.

2. What you need to know before you take Telmisartan NORMON

Do not take Telmisartan 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 at the start of your pregnancy - see section Pregnancy).
• 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 that contains aliskiren.

If your case is any of the above, inform your doctor or pharmacist before starting to take Telmisartan NORMON.

Warnings and precautions

Consult your doctor before starting to take Telmisartan NORMON if you are suffering or have ever suffered from any of the following disorders 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 aldosterone levels (water and salt retention in the body along with an imbalance of various minerals in the blood).
• Low blood pressure (hypotension) that may occur if you are dehydrated (excessive loss of water from the body) or have a salt deficiency due to treatment with diuretics, low-salt diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.

Consult your doctor before starting to take Telmisartan 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), especially if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also the information under the headings "Do not take Telmisartan NORMON" and "Warnings and precautions".

• If you are taking digoxin.

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

You must inform your doctor if you think you are (or might become) pregnant. It is not recommended to use Telmisartan NORMON at the start of pregnancy and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage (see section Pregnancy).

In case of surgery or anesthesia, inform your doctor that you are taking Telmisartan NORMON.

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

Children and adolescents

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

Taking Telmisartan NORMON with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change the dose of these other medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially applicable to the following medicines when taken together with Telmisartan NORMON:

• Medicines containing lithium for treating some types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, 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 NORMON, may cause excessive loss of water from the body and low blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings "Do not take Telmisartan NORMON" and "Warnings and precautions").
• Digoxin.

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

Telmisartan NORMON may increase 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). 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. You should consult your doctor if you need to adjust the dose of your other medicines while taking Telmisartan NORMON.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you think you are (or might become) pregnant. In general, your doctor will advise you to stop taking Telmisartan NORMON before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another blood pressure-lowering medicine instead. It is not recommended to use Telmisartan NORMON at the start of pregnancy and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at this stage.

Breastfeeding

Inform your doctor if you are about to start breastfeeding or are breastfeeding. It is not recommended to take Telmisartan NORMON if you are breastfeeding, and your doctor may choose another treatment for you if you want to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

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

Telmisartan NORMON contains sodium

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

3. How to take Telmisartan NORMON

Follow exactly the instructions of administration of this medicine indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartan NORMON is one tablet per day. Try to take the tablet at the same time each day. You can take Telmisartan NORMON with or without food. The tablets should be swallowed with a little water or other non-alcoholic drink. It is important that you take Telmisartan NORMON every day until your doctor tells you to stop. If you think that the effect of Telmisartan NORMON is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan NORMON 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 of 20 mg or a higher dose of 80 mg. Telmisartan NORMON can also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect with Telmisartan NORMON.

For the reduction of cardiovascular events, the usual dose of Telmisartan NORMON is one 80 mg tablet once a day. At the start of preventive treatment with Telmisartan NORMON 80 mg, blood pressure should be checked frequently.

If your liver is not working properly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartan NORMON than you should

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

If you forget to take Telmisartan NORMON

If you forget to take a dose, do not worry. Take it as soon as you remember and continue as before.

If you do not take your tablet one day, take your normal dose the next day. Donottake a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and require immediate medical attention

If you experience any of the following symptoms, you should see your doctor immediately:

Sepsis* (often called "blood infection", a serious infection that involves an inflammatory reaction of the whole body) and rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartan NORMON

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

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

Uncommon 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 cell count (anemia), high potassium levels, difficulty falling asleep (insomnia), feeling sad (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 up (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash (reaction of the skin to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, feeling of weakness, and high creatinine levels in the blood.

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

Sepsis* (often called "blood infection", a serious infection that involves an inflammatory reaction of the whole body and can cause death), increased white blood cell count (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 anxious, drowsiness, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach upset, taste disturbance (dysgeusia), abnormal liver function (Japanese patients show a greater tendency to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, pain in the tendons, pseudo-influenza disease, decrease in hemoglobin (a blood protein), increased uric acid levels, increased liver enzymes, or increased creatine phosphokinase in the blood.

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

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

Frequency "not known":

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

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

** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan NORMON

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan NORMON

The active substance is telmisartan.

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

Appearance of the product and pack contents

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 available in blister packs (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 last revision of this leaflet:February 2025

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