Telmisartan CINFA 20 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

telmisartán cinfa 20 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What telmisartán cinfa is and what it is used for

telmisartán cinfa 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 cinfa blocks the effect of angiotensin II, allowing your blood vessels to relax and reducing your blood pressure.

Telmisartán is used to treat essential hypertension (high blood pressure) in adults. "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, which 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 at risk because of reduced or blocked blood flow to the heart or legs, or who have had a stroke, or who have a high risk of developing diabetes. Your doctor will inform you if you are at high risk of such events.

2. What you need to know before taking telmisartán cinfa

Do not take telmisartán cinfa

• If you are allergic to telmisartán 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 during early pregnancy as well – 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.

Warnings and precautions

Consult your doctor or pharmacist before starting telmisartán cinfa if you currently have 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 (fluid and salt retention 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 therapy, low-salt diet, diarrhea, or vomiting.
• High potassium levels in the blood.
• Diabetes.

Consult your doctor before starting telmisartán 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), 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. See also the information under the heading “Do not take telmisartán cinfa”.

• If you are taking digoxin.

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

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, inform your doctor. Use of telmisartán is not recommended during the first trimester of pregnancy (first 3 months), and must not be used from the third month of pregnancy onward, as it may cause severe harm to your baby – see Pregnancy section.

If you are undergoing surgery or anesthesia, inform your doctor that you are taking telmisartán.

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

Children and adolescents

The use of telmisartán is not recommended in children and adolescents under 18 years of age.

Taking telmisartán cinfa 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 the dose of these medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially important for the following medicines when taken together with telmisartán:

• Medicines containing lithium used to treat certain types of depression.
• Medicines that may increase potassium levels in the blood, 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. cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially if taken at high doses together with telmisartán, may cause excessive fluid loss and low blood pressure (hypotension).
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take telmisartán cinfa” and “Warnings and precautions”).
• Digoxin.

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

Telmisartán may enhance 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).

In addition, the reduction in blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness upon standing. Consult your doctor if dose adjustments of your other medicines are needed while taking telmisartán.

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

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 telmisartán before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Telmisartán is not recommended during early pregnancy and must not be used from the third month of pregnancy onward, as it may cause severe harm to your baby when used from that time.

Breastfeeding

Inform your doctor if you are planning to breastfeed or are currently breastfeeding, as telmisartán is not recommended for women during this period. Your doctor may choose a more suitable treatment if you intend to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

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

telmisartán cinfa contains lactose

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

telmisartán cinfa contains sodium

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially “sodium-free”.

3. How to take telmisartan cinfa

Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. 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. 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 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. Your doctor has prescribed a lower dose of one 20 mg tablet daily. Telmisartan may also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to exert an additive blood pressure-lowering effect with telmisartan.

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

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to take telmisartan cinfa

If you miss 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. 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 can 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 visit your doctor immediately:

Sepsis* (often called “blood infection”, a serious infection involving a systemic inflammatory response); rapid swelling of the skin and mucous membranes (angioedema); these adverse effects are rare (may affect up to 1 in 1,000 people) but are extremely serious, and patients must stop taking the medicine and visit their doctor immediately. If these adverse effects are not treated, they may be fatal.

Possible adverse effects of telmisartan

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), decreased 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, cough, abdominal pain, diarrhea, stomach discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney 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* (often called “blood infection”, a serious infection involving a systemic inflammatory response that may result in death), 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, drowsiness, visual disturbances, increased heart rate (tachycardia), dry mouth, stomach discomfort, taste disturbances (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this adverse effect), sudden swelling of the skin and mucous membranes which 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, flu-like illness, decreased hemoglobin (a blood protein), increased blood levels of uric acid, increased liver enzymes or creatine phosphokinase in blood.

Very rare adverse effects (may affect up to 1 in 10,000 people)
Progressive fibrosis of lung tissue (interstitial lung disease)**.

Adverse effects of unknown frequency:
Intestinal angioedema: intestinal inflammation has been reported with similar products, presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea.

• 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 telmisartan cinfa

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

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

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point located at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of telmisartan cinfa

• The active substance is telmisartán. Each tablet contains 20 mg of telmisartán.
• The other components are: sodium hydroxide, mannitol (E-421), povidone PVPK25, meglumine, kollidon CL, direct compression lactose, and magnesium stearate.

Appearance of the product and contents of the pack

telmisartán cinfa 20 mg are white, cylindrical, biconvex, unmarked tablets bearing the code “T20”.

They are presented in aluminum/aluminum blisters.

Each pack contains 28 or 98 tablets (clinical pack).

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: March 2026

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77604/P_77604.html

QR code to: https://cima.aemps.es/cima/dochtml/p/77604/P_77604.html