Package Insert: Information for the Patient

Telmisartán Combix 80 mg Tablets EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only and should not be given to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Telmisartán Combix belongs to a class of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body that causes the narrowing of blood vessels, thereby increasing blood pressure. Telmisartán blocks the effect of angiotensin II, causing blood vessels to relax and reducing blood pressure.

Telmisartán is used to treat essential hypertension (elevated blood pressure). “Essential” means that the elevated blood pressure is not due to any other cause.

Elevated blood pressure, if left untreated, can damage blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or renal failure, strokes, or blindness. Generally, there are no symptoms of elevated blood pressure before damage occurs. Therefore, it is essential to measure blood pressure regularly to verify if it is within the normal range.

Telmisartán is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in adults with a high 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 developing diabetes. Your doctor will inform you if you have a high risk of experiencing these events.

Do not take Telmisartán Combix

·If you are allergic to telmisartan or any of the other ingredients in this medication (listed in section 6).

·If you are more than 3 months pregnant. (In any case, it is best to avoid taking this medication at the beginning of your 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 kidney insufficiency 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 Telmisartán Combix.

Warnings and precautions

Consult your doctor 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 blood vessels to one or both kidneys).

·Liver disease.

·Heart problems.

·Elevated aldosterone levels (water and salt retention in the body along with mineral imbalance 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 diuretic treatment, low-salt diet, diarrhea, or vomiting.

·Elevated potassium levels in the blood.

·Diabetes.

Consult your doctor or pharmacist before starting to takeTelmisartán 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), particularly if you have kidney problems related to diabetes.

- aliskiren

Your doctor may need to monitor your kidney function, blood pressure, and 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 in monotherapy.

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, inform your doctor. It is generally recommended to stop taking telmisartan before becoming pregnant or as soon as you become pregnant, and to take another antihypertensive medication instead. Telmisartan is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy, as it may cause severe damage to your baby, see Pregnancy section.

Inform your doctor if you are undergoing surgery or anesthesia, as telmisartan may affect your blood pressure.

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

Children and adolescents

Telmisartan is not recommended for use in children and adolescents under 18 years of age.

Use of Telmisartán Combix with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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 applies especially to the following medications when taken with telmisartan:

·Lithium medications used to treat certain types of depression.

·Medications that can increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim.

·Diuretics, especially if taken in high doses 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 Telmisartán Combix” and “Warnings and precautions”).

The effect of telmisartan may be reduced when you use NSAIDs (e.g. aspirin or ibuprofen) or corticosteroids.

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

Use of Telmisartán Combix with food and beverages

You can take Telmisartán Combix with or without food.

Pregnancy and lactation

If you are pregnant, breastfeeding, or suspect you may be pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. It is generally recommended to stop taking telmisartan before becoming pregnant or as soon as you become pregnant, and to take another antihypertensive medication instead. Telmisartan is not recommended for use at the beginning of pregnancy and should not be administered after the third month of pregnancy, as it may cause severe damage to your baby, see Pregnancy section.

Lactation

Inform your doctor if you are breastfeeding or plan to breastfeed, as telmisartan is not recommended for use in lactating women and your doctor may decide to administer a different treatment if you want to breastfeed, especially in newborns or premature babies.

Driving and operating machinery

Some people may 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 told you that you have a certain sugar intolerance, consult with them before taking Telmisartán Combix.

Follow exactly the administration instructions for this medication as 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 every day. You can take telmisartán with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take telmisartán every day until your doctor tells you otherwise. If you estimate that the effect of telmisartán is too strong or too weak, inform your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of telmisartán for most patients is one 40 mg tablet once a day, 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. Telmisartán can also be used in association with diuretics such as hydrochlorothiazide, which has been shown to exert an additional blood pressure-lowering effect with telmisartán.

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

If your liver does not function correctly, the usual dose should not exceed one 40 mg tablet per day.

If you take more Telmisartán Combix than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Telephone 91 562 04 20, indicating the medication and the amount ingested, or go to the emergency service of the nearest hospital.

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, take your usual dose the next day. Do not take a double dose to compensate for the missed doses.

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

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

Some side effects can be serious and require immediate medical attention:

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

Sepsis* (often called "blood infection," it is a severe infection that involves a systemic inflammatory reaction), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare but extremely serious and patients should stop taking the medicine and visit their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartán Combix:

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

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

Rare 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), elevated potassium levels, difficulty falling asleep (insomnia), feeling of sadness (depression), fainting (syncope), feeling of loss of balance (dizziness), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing (orthostatic hypotension), difficulty breathing, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug-induced rash (skin reaction to medications), back pain, muscle cramps, muscle pain (myalgia), renal insufficiency including acute renal failure, chest pain, symptoms of weakness, and elevated creatinine levels in blood.

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

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

Unknown frequency

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

* This may have been a chance finding or related to an unknown mechanism.

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of the sight and reach of children.

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Telmisartan Combix Composition

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

Product appearance and packaging contents

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

Aluminum-aluminum blister packs (OPA/Al/PVC-Aluminum) standard and single-dose.

Telmisartan Combix is available in packs of 28 tablets.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Combix Laboratories, S.L.U.

C/ Badajoz 2, Building 2

28223– Pozuelo de Alarcon (Madrid)

Spain

Responsible 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

Last review date of this leaflet:February 2025.

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.