Telmisartan Almus 40 mg tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Telmisartán Almus 40 mg tablets EFG

Read all of this leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet; 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 this leaflet

1. What Telmisartán Almus 40 mg is and what it is used for
2. What you need to know before taking Telmisartán Almus 40 mg
3. How to take Telmisartán Almus 40 mg
4. Possible adverse effects
5. How to store Telmisartán Almus 40 mg
6. Contents of the pack and other information

1. What Telmisartán Almus 40 mg is and what it is used for

Telmisartán Almus 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 blood pressure. Telmisartán Almus blocks the effect of angiotensin II, allowing blood vessels to relax and reducing blood pressure.

Telmisartán Almus is used to treat essential hypertension (high blood pressure).

"Essential" means that the high blood pressure is not due to any other underlying 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 Almus 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 such events.

2. What you need to know before taking Telmisartán Almus 40 mg tablets

Do not take Telmisartán Almus

• 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 kidney failure and are being treated with a blood pressure-lowering medicine containing aliskiren.

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

Warnings and precautions

Talk to your doctor if you are suffering from 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 (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 deficiency due to diuretic treatment, low-salt diet, diarrhoea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Talk to your doctor before starting Telmisartán Almus:

• 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.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking Telmisartán Almus. Your doctor will decide whether to continue treatment. Do not stop taking Telmisartán Almus on your own.

See also the information under the heading "Do not take Telmisartán Almus."

• if you are taking digoxin.

If you are pregnant, suspect you may be pregnant, or plan to become pregnant, you must inform your doctor.

The use of Telmisartán Almus 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 serious harm to your baby; see pregnancy section.

If you are undergoing surgery or anaesthesia, inform your doctor that you are taking Telmisartán Almus.

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

Children and adolescents

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

Taking Telmisartán Almus with other medicines

Tell 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 your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This particularly applies to the following medicines when taken together with Telmisartán Almus:

• 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 Almus, may cause excessive loss of body water and lead to 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 Almus" and "Warnings and precautions").
• Digoxin

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

Telmisartán Almus may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or of 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 when standing up. You should consult your doctor if dose adjustments of your other medicines are needed while taking Telmisartán Almus.

Pregnancy and breast-feeding

Pregnancy

Inform your doctor if you are pregnant, suspect you may be pregnant, or plan to become pregnant. Generally, your doctor will advise you to stop taking Telmisartán Almus before becoming pregnant or as soon as pregnancy is confirmed, and will recommend an alternative medicine. The use of Telmisartán Almus is not recommended during early pregnancy, and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that time.

Breast-feeding

Inform your doctor if you are planning to start or are currently breast-feeding, as Telmisartán Almus is not recommended for women during this period. Your doctor may decide to prescribe a treatment more suitable if you wish to breast-feed, especially if the infant is a newborn or premature.

Driving and using machines

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

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially "sodium-free".

3. How to take Telmisartán Almus 40 mg tablets

Follow exactly the instructions for use of this medicine as given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartán Almus is one tablet daily. Try to take the tablet at the same time each day. You may take Telmisartán Almus with or without food. Tablets should be swallowed with a little water or other non-alcoholic drink. It is important that you take Telmisartán Almus every day until your doctor tells you otherwise. If you think that the effect of Telmisartán Almus is too strong or too weak, inform your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartán Almus for most patients is 40 mg once daily to control blood pressure over 24 hours. However, your doctor may sometimes recommend a lower dose of 20 mg or a higher dose of 80 mg. Telmisartán Almus may be used in combination with diuretics such as hydrochlorothiazide, which has been shown to exert an additive blood pressure-lowering effect with Telmisartán Almus.

For reduction of cardiovascular events, the usual daily dose of Telmisartán Almus is one 80 mg tablet. At the start of preventive treatment with Telmisartán Almus 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 Almus than you should

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

If you forget to take Telmisartán Almus

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 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 product, 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); 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 Almus:

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 (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, 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, and elevated blood creatinine levels.

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 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 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 (angioedema, including fatal outcomes), 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 (cannot be estimated from available data):

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

• 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 can also report them directly via the Spanish Pharmacovigilance System for Human Medicines (Website: www.notificaRAM.es). By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan Almus 40 mg

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

Do not use this medicine after the expiry date which is stated on the outer packaging and blister after "EXP". The expiry date refers to 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 empty containers and unused medicines at a SIGRE point located at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan Almus

• The active substance is telmisartan. One 40 mg tablet of Telmisartan Almus contains 40 mg of telmisartan.
• The other components are povidone, meglumine, sodium hydroxide, mannitol, crospovidone and magnesium stearate.

Appearance of the product and contents of the pack

Telmisartan Almus are tablets.

Telmisartan Almus 40 mg: white, oblong tablets with the letters “LC” engraved on one side.

Telmisartan Almus is available in blister packs containing 14, 28, 30, 56, 84, 90 or 98 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Telephone: 93 739 71 80

Email: [email protected]

Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), SPAIN

Date of the most recent revision of this leaflet: February 2026

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