TELMISARTAN COMBIX 80 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Telmisartan Combix 80 mg Tablets EFG

Read this package leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this package 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 Package Leaflet

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

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

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

Telmisartan is used to treat essential hypertension (high blood pressure). "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 measure your blood pressure to check if it is within the normal range.

Telmisartan 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 inform you if you have a high risk of suffering from these events.

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

Do not take Telmisartan Combix

• 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 the drainage of bile from the liver and gallbladder) or any other severe liver disease.
  • if you have diabetes or kidney impairment and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan Combix.

Warnings and precautions

Tell your doctor if you are suffering from 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 (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 low salt levels due to treatment with diuretics, low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Tell your doctor or pharmacist before starting to take Telmisartan Combix:

• 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.

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

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

If you are pregnant, think you may be pregnant, or plan to become pregnant, tell your doctor. It is not recommended to use telmisartan at the start of pregnancy (first 3 months) and in no case should it be administered from the third month of pregnancy as it may cause serious harm to your baby, see section Pregnancy.

In case of surgery or anesthesia, tell your doctor that you are taking telmisartan.

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

Children and adolescents

The use of telmisartan is not recommended in children and adolescents up to 18 years.

Using Telmisartan Combix with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines. Your doctor may need to modify your dose and/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:

• 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 medicines (e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporin or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses together with telmisartan, 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 Combix” and “Warnings and precautions”).

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

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

Using Telmisartan Combix with food and drink

You can take Telmisartan Combix with or without food.

Pregnancy and breast-feeding

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

Pregnancy

You should inform your doctor if you are pregnant, think you might be pregnant, or are planning to become pregnant. Your doctor will normally advise you to stop taking telmisartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine to treat your high blood pressure. It is not recommended to use telmisartan during the first 3 months of pregnancy and in no case should it be administered after the third month of pregnancy as it may cause serious harm to your baby.

Breast-feeding

Inform your doctor if you are going to start or are already breast-feeding, as it is not recommended to take telmisartan while breast-feeding, and your doctor may decide to give you a different treatment, especially if you are breast-feeding a newborn or premature baby.

Driving and using machines

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

Telmisartan Combix contains lactose and sorbitol.If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking Telmisartan Combix.

3. How to take Telmisartan Combix

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The recommended dose is one tablet per day. Try to take the tablet at the same time each day. You can take telmisartan with or without food. The tablets should be swallowed with a little water or another non-alcoholic drink. It is important that you take telmisartan every day until your doctor tells you to stop. If you think that the effect of telmisartan is too strong or too weak, talk to 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 a 24-hour period. However, your doctor may recommend a lower dose, one 20 mg tablet, or a higher dose, one 80 mg tablet. Telmisartan 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.

For the reduction of cardiovascular events, the usual daily dose of telmisartan is one 80 mg tablet. At the start of preventive treatment with Telmisartan Combix 80 mg, blood pressure should be frequently monitored.

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

If you take more Telmisartan Combix than you should

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

If you forget to take Telmisartan Combix

If you forget to take a dose, do not worry. Take it as soon as you remember and then continue as before. If you do not take your tablet one day, take your normal dose the next day. Do not take a double dose to make up for forgotten doses.

If you have any further questions on 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), 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 see their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartan Combix:

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 cells (anemia), high potassium levels, difficulty falling asleep (insomnia), feeling sad (depression), fainting (syncope), feeling of losing 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, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, symptoms 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 cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach upset, 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, pseudogrippal illness, decrease in hemoglobin (a blood protein), increased blood levels of uric acid, increased liver enzymes or 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 presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported with the use of similar products.

• This may have been a chance finding or be related to a mechanism currently not known.

** 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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan 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 carton after EXP. The expiry date refers to the last day of the month shown.

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 Combix

• The active substance is telmisartan. Each tablet contains 80 mg of telmisartan.
• The other ingredients (excipients) are: lactose monohydrate, 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 pack contents

Tablets are oblong, biconvex, light brown speckled to brown speckled in color, with the engraving “80” on one side and smooth on the other.

Aluminum-aluminum (OPA/Al/PVC-Aluminum) standard and monodose blisters.

Telmisartan Combix is available in packs of 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 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 Health Products (AEMPS) http://www.aemps.gob.es/.