Telmisartan Alter 20 mg tablets EFG

Patient Information Leaflet

Introduction

Package Leaflet: Information for the Patient

Telmisartán Alter 20 mg Tablets EFG

Read this entire leaflet carefully before you start taking this medicine, as 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. Do 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 reactions, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Telmisartán Alter is and what it is used for

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

Telmisartán Alter is used to treat essential hypertension (high blood pressure). "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, potentially leading, in some cases, to heart attacks, heart or kidney failure, strokes, or blindness. High blood pressure generally does not produce symptoms before such damage occurs. Therefore, it is important to measure your blood pressure regularly to ensure it remains within the normal range.

Telmisartán Alter is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in patients at risk due to reduced or blocked blood flow to the heart or legs, those who have had a stroke, or those at high risk of developing diabetes. Your doctor will inform you if you are at high risk of experiencing such events.

2. What you need to know before taking Telmisartán Alter

Do not take Telmisartán Alter

• 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 during early 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 renal impairment and are being treated with an antihypertensive medicine containing aliskiren.

If any of the above applies to you, inform your doctor or pharmacist before taking Telmisartán Alter.

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Telmisartán Alter.

Talk to 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 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 treatment, low-salt diet, diarrhoea or vomiting.
• High potassium levels in the blood.
• Diabetes.

Talk to your doctor before taking Telmisartán Alter:

• if you are taking any of the following medicines used to treat high blood pressure (hypertension):
• an angiotensin-converting enzyme (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 information under the heading “Do not take Telmisartán Alter”.

• if you are taking digoxin.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Telmisartán Alter. Your doctor will decide whether to continue treatment. Do not stop taking Telmisartán Alter when used as monotherapy.

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

If you are undergoing surgery or anaesthesia, 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 under 18 years of age.

Taking Telmisartán Alter 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 telmisartan:

• 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 when taken in high doses together with telmisartan, may cause excessive fluid loss and low blood pressure (hypotension).
• If you are taking an angiotensin-converting enzyme (ACE) inhibitor or aliskiren (see also information under the headings “Do not take Telmisartán Alter” and “Warnings and precautions”).
• Digoxin.

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

Telmisartan 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, blood pressure reduction may be aggravated 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, 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 telmisartan before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative antihypertensive medicine. Telmisartan is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause severe harm to your baby when administered from that time.

Breastfeeding

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

Driving and using machines

There is no available information on the effect of telmisartan on the ability to drive and use machines. Some people feel dizzy or tired while receiving treatment for high blood pressure. If you feel dizzy or tired, do not drive or use machines.

Telmisartán Alter contains sorbitol

This medicine contains sorbitol. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Telmisartán Alter

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

The recommended dose of telmisartan is one tablet daily. Try to take the tablet at the same time each day. Telmisartan may be taken 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 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 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 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 Telmisartán Alter than you should

If you accidentally take too many tablets, contact your doctor, pharmacist, or the nearest hospital emergency department immediately, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Telmisartán Alter

If you forget to take a dose, do not worry. Take it as soon as you remember and then continue as before.

If you miss a dose 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 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 see your doctor immediately:

Sepsis* (commonly called "blood infection", a severe infection involving a systemic inflammatory response throughout the body), 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 see their doctor immediately. If these adverse effects are not treated, they may be fatal.

Possible adverse effects of Telmisartán Alter:

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), reduced red blood cells (anaemia), elevated potassium levels, difficulty sleeping (insomnia), feeling of sadness (depression), fainting (syncope), 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, diarrhoea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), renal failure including acute renal failure, chest pain, symptoms of weakness, elevated blood creatinine levels and dizziness.

Rare adverse effects (may affect up to 1 in 1,000 people):

Sepsis* (commonly called "blood infection", a severe infection involving a systemic inflammatory response throughout the body which may be fatal), 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 disturbance, 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, decrease in haemoglobin (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)**.

• 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.

Frequency not known (cannot be estimated from available data):

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

Reporting of adverse effects

If you experience any 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 Telmisartán Alter

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 refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect from moisture. Remove your telmisartan tablet from the blister pack immediately before taking it.

Medicines must not be disposed of via wastewater or household waste. Return any unused medicines and their packaging to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan Alter

• The active substance is telmisartan. Each tablet contains 20 mg of telmisartan.
• The other components are microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, sodium carboxymethylstarch (type A) (from potato), sorbitol (E420) and magnesium stearate.

Appearance of the product and contents of the pack

Telmisartan Alter 20 mg are white or slightly beige, round, biconvex tablets without a break line.

Telmisartan Alter is available in blister packs containing 28 tablets.

Marketing Authorization Holder and Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

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 Medical Devices (AEMPS) http://www.aemps.gob.es/.