TELMISARTAN COMBIX 20 mg TABLETS

Introduction

Package Leaflet: Information for the Patient

Telmisartan Combix 20 mg Tablets EFG

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package 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 taking Telmisartan Combix
3. How to take Telmisartan Combix
4. Possible side effects
5. Storage of Telmisartan Combix
6. Package contents and additional information

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

Telmisartan Combix belongs to a class of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes your blood vessels to narrow, increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, so your blood vessels relax and your blood pressure decreases.

Telmisartan is used to treat essential hypertension (high blood pressure). "Essential" means that high blood pressure is not due to any other cause.

High blood pressure, if left untreated, can damage blood vessels in various organs, which can lead to heart attacks, heart failure, or kidney failure, strokes, or blindness in some cases. Generally, no symptoms of high blood pressure appear before damage occurs. Therefore, it is essential to regularly check your blood pressure to see 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 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 Telmisartan Combix

Do not take Telmisartan Combix

• if you are allergic to telmisartan or any of the other ingredients of this medication (listed in section 6).
• if you are pregnant for more than 3 months. (In any case, it is best to avoid taking this medication 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 medication that contains aliskiren.

If your case is any of the above, inform your doctor or pharmacist before taking Telmisartan Combix.

Warnings and precautions

Consult your doctor 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 water loss from the body) or have a salt deficiency due to treatment with diuretics, a low-salt diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.

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

• if you are taking any of the following medications 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 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 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, inform your doctor. Telmisartan is not recommended during the first trimester of pregnancy (the first 3 months) and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby, see section Pregnancy.

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

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

Children and adolescents

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

Using Telmisartan Combix with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication. 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 medications. This is especially applicable to the following medications when taken with telmisartan:

• Medications containing lithium to treat certain types of depression.
• Medications that may increase potassium levels in the blood, such as potassium-containing 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 when taken in high doses with telmisartan, may cause excessive water loss 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 NSAIDs (non-steroidal anti-inflammatory drugs, e.g., aspirin or ibuprofen) or corticosteroids.

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

Using Telmisartan Combix with food and drinks

You can take Telmisartan Combix with or without food.

Pregnancy and breastfeeding

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

Pregnancy

You should inform your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. Your doctor will usually advise you to stop taking telmisartan before becoming pregnant or as soon as you become pregnant and recommend an alternative blood pressure medication. Telmisartan is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy, as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are breastfeeding, as telmisartan is not recommended for women who are breastfeeding, and your doctor may decide to prescribe a more suitable treatment if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

Some people may 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 certain sugars, consult with them before taking Telmisartan Combix.

3. How to take Telmisartan Combix

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

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 other non-alcoholic drink. It is essential that you take telmisartan every day until your doctor tells you to stop. If you think the effect of telmisartan is too strong or too weak, tell 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 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 monitored frequently.

If your liver is not functioning correctly, the usual dose should not exceed 40 mg once daily.

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 medication and the amount ingested, or go to the nearest emergency department.

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 continue as before. If you do not take your tablet one day, take your usual dose the next day. Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone 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 severe 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 extremely serious, and patients should stop taking the medication 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 the reduction of cardiovascular events.

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 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, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medications), 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 severe infection that involves an inflammatory reaction of the whole body and can cause death), increased certain 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 changes, 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), skin redness, 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 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 with symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported after the use of similar products.

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

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Telmisartan Combix

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

No special storage conditions are required.

Do not use this medication after the expiration date stated on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of via wastewater or household waste. Return the packaging and any unused medication to the pharmacy's SIGRE collection point. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Telmisartan Combix

• The active ingredient is telmisartan. Each tablet contains 20 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 package contents

Tablets, round, flat, with beveled edges, light brown speckled to brown speckled in color, with the engraving "20" on one side and smooth on the other.

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

Telmisartan Combix is available in packages 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 the last revision of this package leaflet: February 2025.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.