TELMISARTAN ALMUS 80 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Almus 80 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Telmisartan Almus 80 mg and what is it used for
2. What you need to know before you take Telmisartan Almus 80 mg
3. How to take Telmisartan Almus 80 mg
4. Possible side effects
5. Storage of Telmisartan Almus 80 mg
6. Contents of the pack and other information

1. What is Telmisartan Almus 80 mg and what is it used for

Telmisartan Almus belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body which causes your blood vessels to narrow, thus increasing your blood pressure. Telmisartan Almus blocks the effect of angiotensin II, so that the blood vessels relax and blood pressure is reduced.

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

"Essential" means that the high blood pressure is not caused by any other condition.

High blood pressure, if not treated, can damage blood vessels in various organs, which could lead, in some cases, to heart attack, heart failure, kidney failure, stroke, or blindness. Usually, there are no symptoms to indicate high blood pressure before damage occurs. Thus, it is important to regularly measure blood pressure to verify if it is within the normal range.

Telmisartan Almus is also usedto reduce cardiovascular events (e.g., heart attack or stroke) in patients 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 suffering from diabetes. Your doctor will inform you if you have a high risk of suffering these events.

2. What you need to know before you take Telmisartan Almus 80 mg tablets

Do not take Telmisartan 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 at the start of your pregnancy – see section pregnancy-)
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with bile drainage from the liver and gallbladder) or any other serious liver disease.
• if you have diabetes or kidney impairment and are treated with a blood pressure-lowering medicine containing aliskiren.

If your case is any of the above, inform your doctor or pharmacist before taking Telmisartan Almus.

Warnings and precautions

Consult your doctor if you are suffering or have ever suffered from any of the following disorders 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 an imbalance of various minerals in the blood).
• Low blood pressure (hypotension), which may likely occur if you are dehydrated (excessive water loss from the body) or have salt deficiency due to treatment with diuretics, low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Consult your doctor before starting to take Telmisartan 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), especially if you have kidney problems related to diabetes.
  • aliskiren.

Your doctor may check your kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals.

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

See also the information under the heading “Do not take Telmisartan Almus”.

• if you are taking digoxin.

If you are pregnant, think you may be pregnant, or are planning to have a baby, inform your doctor.

Telmisartan Almus is not recommended during the first trimester of pregnancy (first 3 months) and must not be taken during the second and third trimesters of pregnancy (from the 4th month onwards) as it may cause serious harm to your baby, see section pregnancy.

In case of surgery or anesthesia, inform your doctor that you are taking Telmisartan Almus.

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

Children and adolescents

Telmisartan Almus is not recommended for children and adolescents up to 18 years.

Using Telmisartan Almus with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to modify your dose and/or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially applicable to the following medicines when taken together with Telmisartan Almus:

• Medicines containing lithium for treating some types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, 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 Almus, may cause excessive water loss 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 Telmisartan Almus” and “Warnings and precautions”).
• Digoxin.

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

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

Additionally, the decrease in blood pressure may be aggravated by alcohol, barbiturates, narcotics, or antidepressants. You may notice this effect as dizziness when standing up. You should consult your doctor if you need to adjust the dose of your other medicines while taking Telmisartan Almus.

Pregnancy and breastfeeding

Pregnancy

You should inform your doctor if you are pregnant, think you might be pregnant, or are planning to have a baby. Your doctor will normally advise you to stop taking Telmisartan Almus before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Telmisartan Almus. Telmisartan Almus is not recommended during the first trimester of pregnancy (first 3 months) and must not be taken during the second and third trimesters of pregnancy (from the 4th month onwards) as it may cause serious harm to your baby.

Breastfeeding

Inform your doctor if you are about to start or are already breastfeeding, as Telmisartan Almus is not recommended for use during breastfeeding. Your doctor may decide to prescribe a different treatment for you if you want to breastfeed, especially if your baby is a newborn or premature.

Driving and using machines

Some people may feel dizzy or tired when taking Telmisartan Almus. If you feel dizzy or tired, do not drive or use machines.

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

3. How to take Telmisartan Almus 80 mg tablets

Follow exactly the instructions of your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartan Almus is one tablet per day. Try to take the tablet at the same time each day. You can take Telmisartan Almus 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 Almus every day until your doctor tells you to stop. If you think that the effect of Telmisartan Almus is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartan Almus for most patients is 40 mg once a day 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. Telmisartan Almus can be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect with Telmisartan Almus.

For the reduction of cardiovascular events, the usual daily dose of Telmisartan Almus is one 80 mg tablet. At the start of preventive treatment with Telmisartan Almus 80 mg, blood pressure should be frequently monitored.

If your liver is not working properly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartan Almus 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 medicine and the amount ingested).

If you forget to take Telmisartan Almus

If you forget to take 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 forgotten doses.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

Sepsis* (often called “blood infection”, a serious infection that involves an inflammatory reaction of the whole body), rapid swelling of the skin and mucous membranes (angioedema); these side effects are rare (may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking the medicine and see their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartan Almus:

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

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

Uncommon 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), high potassium levels, difficulty falling asleep (insomnia), feeling sad (depression), fainting (syncope), feeling of losing balance (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness when standing up (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal discomfort, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, and symptoms of weakness and high creatinine levels in the blood.

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

Sepsis* (often called “blood infection”, a serious infection that involves an inflammatory reaction of the whole body 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 disturbance, increased heart rate (tachycardia), dry mouth, stomach upset, taste disturbance (dysgeusia), abnormal liver function (Japanese patients show a greater tendency to experience this side effect), sudden swelling of the skin and mucous membranes (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, pain in the tendons, pseudo-influenza disease, decrease in hemoglobin (a blood protein), increased blood levels of uric acid, increased liver enzymes, or creatine phosphokinase in the blood.

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

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

Side effects of unknown frequency (cannot be estimated from the available data):

Intestinal angioedema: inflammation in the intestine presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea has been reported after the use of similar products.

• This may have been a chance finding or be related to a currently unknown mechanism.

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmisartan Almus 80 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 carton and blister after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan Almus

• The active substance is telmisartan. One 80 mg tablet of Telmisartan Almus contains 80 mg of telmisartan.
• The other ingredients are povidone, meglumine, sodium hydroxide, mannitol, crospovidone, and magnesium stearate.

Appearance of the product and pack contents

Telmisartan Almus is a tablet.

Telmisartan Almus 80 mg: white, oblong tablets with “LC” engraved on one side.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Pharmaceutical, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 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 last revision of this leaflet:March2025

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