Package Insert: Information for the Patient

Telmisartán Cinfa 20 mg Tablets EFG

Read this entire 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 only for you, and you should not give it 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.

Telmisartan cinfa 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 constrict, thereby increasing your blood pressure.

Telmisartan cinfa blocks the effect of angiotensin II, causing your blood vessels to relax and your blood pressure to decrease.

Telmisartan is used totreat essential hypertension (high blood pressure) in adults. “Essential” means that the 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, in some cases, to heart attacks, heart failure, or renal failure, strokes, or blindness. Generally, there are no symptoms of high blood pressure before damage occurs. Therefore, it is essential to measure your blood pressure regularly to verify if it is within the normal range.

Telmisartan is also used toreduce 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 developing diabetes. Your doctor will inform you if you have an elevated risk of experiencing these events.

Do not take telmisartan cinfa

Inform your doctor or pharmacist before taking telmisartan if your case is any of the above.

Warnings and precautions

Consult your doctor or pharmacist before starting to take telmisartan 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 sodium deficiency due to diuretic treatment, low-sodium diet, diarrhea, or vomiting.
• Elevated potassium levels in the blood.
• Diabetes.

Consult your doctor before starting to take telmisartan.

• 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 electrolyte levels in the blood (e.g. potassium) at regular intervals. See also the information under the heading “Do not take telmisartan cinfa”.

• If you are taking digoxin.

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.

If you are pregnant, if you suspect you may be pregnant, or if you plan to become pregnant, inform your doctor. Telmisartan is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered at all after the third month of pregnancy because it may cause serious harm to your baby, see Pregnancy section.

Inform your doctor if you are undergoing surgery or anesthesia, as you are taking telmisartan.

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

Children and adolescents

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

Taking telmisartan cinfa with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine. Your doctor may need to change the dose of these medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This applies especially to the following medicines when taken with telmisartan:

• Medicines containing lithium for treating 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 (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 lower blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information under the headings “Do not take telmisartan cinfa” and “Warnings and precautions”).
• Digoxin.

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

Telmisartan may increase the hypotensive effect of other medicines used to treat high blood pressure or of medicines that may potentially lower blood pressure (e.g. baclofen, amifostine).

Additionally, blood pressure may be lowered further by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. Consult your doctor if you need to adjust the dose of your other medicines while taking telmisartan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you 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, if you suspect you may be pregnant, or if you 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 taking another antihypertensive medicine instead. Telmisartan is not recommended for use at the beginning of pregnancy and should not be administered at all after the third month of pregnancy because it may cause serious harm to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as telmisartan is not recommended for use during this period. Your doctor may decide to administer a more suitable treatment if you want to breastfeed, especially for 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.

Telmisartan cinfa contains lactose

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

Telmisartan cinfa contains sodium

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

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. 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 telmisartan with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take telmisartan every day until your doctor tells you otherwise. If you estimate 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 a day, to control blood pressure over 24 hours. Your doctor has recommended a lower dose, one 20 mg tablet per day. Telmisartan can also be used in association with diuretics such as hydrochlorothiazide, which has been shown to exert an additional blood pressure-reducing effect with telmisartan.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take telmisartan cinfa

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 tablet, take your usual dose the next day.Do nottake 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 (can affect up to 1 in 1,000 people) but are 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.

Telmisartan side effects

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

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

Rare side effects(can 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 sad (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, cough, 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 blood creatinine levels.

Rare side effects(can affect up to 1 in 1,000 people)

Sepsis* (often called "blood infection," it is a severe infection that involves a systemic inflammatory reaction 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, facial swelling or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, drowsiness, vision changes, increased heart rate (tachycardia), dry mouth, stomach discomfort, taste alterations (dysgeusia), abnormal liver function (Japanese patients are more prone to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (skin alteration), skin redness, hives (urticaria), severe drug-induced rash, joint pain (arthralgia), pain in the extremities, tendon pain, pseudogripal disease, decreased hemoglobin (a blood protein), elevated blood uric acid levels, elevated liver enzymes or creatine phosphokinase in blood.

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

Side effects of 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.

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

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.

This medication does not require special storage conditions.

Medications should not be disposed of through drains or trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Telmisartan cinfa composition

Product appearance and packaging content

Telmisartan cinfa 20 mg are white, cylindrical, biconvex, non-scored tablets marked with the code “T20”.

They are presented in Aluminio/Aluminio blisters.

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

Only some package sizes may be commercially marketed.

Marketing authorization holder and responsible manufacturer

Cinfa, S.A. Laboratories

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:February 2025

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

You can access detailed and updated information on this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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