Package Insert: Information for the User

Telmisartán Almus 40 mg Tablets EFG

Read this package insert carefully before taking this medicine, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

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

“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 blood pressure regularly to verify if it is within the normal range.

Telmisartán Almusis also used toreduce cardiovascular events (e.g., heart attacks or strokes) 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 developing diabetes. Your doctor will inform you if you have an elevated risk of experiencing these events.

Do not take Telmisartán Almus

• 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 also at the beginning of your pregnancy – see pregnancy section)
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and the gallbladder) or any other severe liver disease.
• if you have diabetes or kidney failure and are being treated with a blood pressure lowering medicine that contains aliskirén.

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

Warnings and precautions

Consult your doctor if you are suffering or have ever suffered from any of the following conditions or diseases:

• Kidney diseases or kidney transplant.
• Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
• Liver disease.
• Heart problems.
• Elevated aldosterone levels (retention of water and salts in the body along with imbalance of several minerals in the blood).
• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of water from the body) or have a salt deficiency due to diuretic treatment, low-salt diet, diarrhea, or vomiting.
• Elevated potassium levels in the blood.
• Diabetes.

Consult your doctor before starting to take 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
  • aliskirén

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

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea 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 pregnant, if you suspect you may be, or if you plan to become pregnant, you must inform your doctor.

Telmisartán Almus is not recommended for use at the beginning of pregnancy (first 3 months) and should not be administered at all from the third month of pregnancy because it may cause serious harm to your baby, see pregnancy section.

Inform your doctor of any surgery or anesthesia that you are undergoing while taking Telmisartán Almus.

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

Children and adolescents

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

Use of Telmisartán Almus 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 adjust your dose and/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 Telmisartán Almus:

• Medicines containing lithium for treating certain types of depression.
• Medicines that can 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. ciclosporin or tacrolimus), and the antibiotic trimetoprim.
• Diuretics, especially if taken in high doses with Telmisartán Almus, may cause excessive loss of water from the body and lower blood pressure (hypotension).
• ACE inhibitors or aliskirén (see also the information under the headings “Do not take Telmisartán Almus” and “Warnings and precautions”.
• Digoxina

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

Telmisartán Almus may increase the effect of other medicines used to treat high blood pressure or of medicines that may potentially lower blood pressure (e.g. baclofeno, amifostina).

Additionally, the decrease in blood pressure may be exacerbated 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 Telmisartán Almus.

Pregnancy and breastfeeding

Pregnancy

You must inform your doctor if you are pregnant, if you suspect you may be, or if you plan to become pregnant. Your doctor will usually advise you to stop taking Telmisartán Almus before becoming pregnant or as soon as you become pregnant, and will recommend taking another medicine instead of Telmisartán Almus. Telmisartán Almus is not recommended for use at the beginning of pregnancy, and should not be administered at all from the third month of pregnancy because it may cause serious harm to your baby when administered from that time.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as Telmisartán Almus 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 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”.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Telmisartán Almus is one tablet per day. Try to take the tablet at the same time every day. You can take Telmisartán Almus with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take Telmisartán Almus every day until your doctor tells you otherwise. If you estimate 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 a day to control blood pressure over 24 hours. However, your doctor may sometimes recommend a lower dose, 20 mg, or a higher dose, 80 mg. Telmisartán Almus can be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additional blood pressure-lowering effect with Telmisartán Almus.

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

If your liver does not function correctly, the usual dose should not exceed 40 mg once a day.

If you take more Telmisartán 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 medication 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 day, take your usual dose the next day. Do not take a double dose to compensate for the missed doses.

If you have any other questions about the use of this product, 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 severe 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 Almus Possible Side Effects:

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

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

Infrequent 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 a loss of balance (vertigo), 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 (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 levels (a blood protein), increased blood uric acid levels, increased liver enzymes or creatine phosphokinase in the 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(cannot be estimated from available data):

Intestinal angioedema: intestinal inflammation has been reported, presenting 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 of 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 theSpanish System for Pharmacovigilance of Medicines for Human Use (Website: www.notificaRAM.es).By reporting side effects, you can contribute to providing more information on the safety of the medicine.

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

Do not use this medicationafter the expiration date that appears on the packaging and the blister pack 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 in the trash. Dispose of the 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 the packaging and medications you no longer need.By doing so, you will help protect the environment.

Telmisartan Almus Composition

• The active ingredient is telmisartan. A 40 mg Telmisartan Almus tablet 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 packaging

Telmisartan Almus are tablets.

Telmisartan Almus 40 mg: are 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 some package sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder :

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible Manufacturer:

Laboratorios LICONSA, S.A.

Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), SPAIN

Last review date of this leaflet : March 2025

The 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/.