Telmisartan Combix 80 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Telmisartan Combix 80 mg tablets EFG

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

Leaflet contents

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

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

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

Telmisartán 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 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 is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in adults who are at risk because their blood flow to the heart or legs is reduced or blocked, 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 experiencing these events.

2. What you need to know before taking Telmisartán Combix

Do not take Telmisartán Combix

• if you are allergic to telmisartan or to 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 an antihypertensive medicine containing aliskiren.

If any of the above apply to you, inform your doctor or pharmacist before taking Telmisartán Combix.

Warnings and precautions

Consult your doctor if you are currently suffering from, or have ever had, 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 (retention of water and salts 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 treatment, low-salt diet, diarrhoea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Consult your doctor or pharmacist before starting to take Telmisartán Combix:

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
  • an angiotensin-converting enzyme (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.

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 monotherapy without medical advice.

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

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 three months), and must not be used from the third month of pregnancy onwards as it may cause severe harm to your baby – see Pregnancy section.

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

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

Children and adolescents

Use of telmisartan is not recommended in children and adolescents under 18 years of age.

Taking Telmisartán Combix with other medicines

Inform 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 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. ciclosporin 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 (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Telmisartán Combix” and “Warnings and precautions”).

The effect of telmisartan may be reduced when taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.

Telmisartan may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure.

Taking Telmisartán Combix with food and drink

You may take Telmisartán Combix with or without food.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

You must inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Your doctor will generally advise you to stop taking telmisartan before becoming pregnant or as soon as pregnancy occurs, 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 severe harm to your baby when used from that stage.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as telmisartan is not recommended for breastfeeding women. Your doctor may decide to prescribe a treatment more suitable if you intend to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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

Telmisartán Combix contains lactose and sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking Telmisartán Combix.

3. How to take Telmisartán Combix

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

The recommended dose is one tablet daily. Try to take the tablet at the same time each day. Telmisartan may be taken 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 every day until your doctor tells you otherwise. If you think 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 daily, to control blood pressure over 24 hours. However, your doctor may recommend a lower dose, one 20 mg tablet, or a higher dose, one 80 mg tablet. Telmisartan may also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect with telmisartan.

For reduction of cardiovascular events, the usual daily dose of telmisartan is one 80 mg tablet. At the start of preventive treatment with Telmisartán Combix 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 Combix than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital emergency department.

If you forget to take Telmisartán Combix

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 may 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 severe infection involving a systemic inflammatory response), 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 Combix:

Frequent 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), reduced red blood cells (anemia), elevated potassium levels, difficulty sleeping (insomnia), feeling of sadness (depression), fainting (syncope), dizziness, 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, 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, symptoms of weakness, and elevated blood creatinine levels.

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

Sepsis* (commonly called "blood infection", a severe infection involving a systemic inflammatory response that 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, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach discomfort, abnormal liver function (Japanese patients show a higher tendency to experience this adverse effect), sudden swelling of the skin and mucous membranes that 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, pseudoinfluenza illness, decrease in haemoglobin (a blood protein), increased blood levels of uric acid, increased blood levels of liver enzymes or creatine phosphokinase.

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 it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Telmisartán Combix

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

No special storage conditions are required.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Package contents and additional information

Composition of Telmisartán Combix

• The active substance is telmisartan. Each tablet contains 80 mg of telmisartan.
• The other components (excipients) are: monohydrate lactose, sorbitol (E420i), meglumine, povidone K-25, sodium stearyl fumarate, sodium hydroxide (E524), magnesium stearate (E470b), and red iron oxide (E172).

Appearance of the product and contents of the pack

Tablets, oblong, biconvex, mottled light brown to mottled brown, engraved with “80” on one side and smooth on the other.

Standard and single-dose aluminum-aluminum blisters (OPA/Al/PVC-Aluminum).

Telmisartán Combix is available in packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223– Pozuelo de Alarcon (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

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 Medical Devices (AEMPS) http://www.aemps.gob.es/.