Package Insert: Information for the Patient

Telmisartán Alter 80 mg Tablets EFG

Read this 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 even if they 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.

Telmisartán belongs to a class of medications 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 blocks the effect of angiotensin II, causing blood vessels to relax and reducing blood pressure.

Telmisartán Alter is used totreat essential hypertension (elevated blood pressure). “Essential” means that the elevated blood pressure is not due to any other cause.

Elevated 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 elevated blood pressure before damage occurs. Therefore, it is essential to measure blood pressure regularly to verify if it is within the normal range.

Telmisartán Alter is 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 Alter

• if you are allergic to telmisartán or any of the other ingredients of this medication (listed in section 6).
• if you are more than 3 months pregnant. (In any case, it is best to avoid taking this medication also at the beginning of your 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 medication to lower blood pressure that contains aliskirén.

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

Warnings and precautions

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

Consult your doctor if you are experiencing or have ever experienced 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 imbalance of several minerals in the blood).
• Low blood pressure (hypotension) that may occur if you are dehydrated (excessive loss of water from the body) or have salt deficiency due to diuretic treatment, low-salt diet, diarrhea, or vomiting.
• Elevated potassium levels in the blood.
• Diabetes.

Consult your doctor before taking Telmisartán Alter:

• if you are taking any of the following medications 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. See also the information under the heading “Do not take Telmisartán Alter”.

• if you are taking digoxina.

Consult your doctor if you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartán Alter. Your doctor will decide whether to continue treatment. Do not stop taking Telmisartán Alter in monotherapy.

If you are pregnant, if you suspect you may be, or if you plan to become pregnant, inform your doctor. Telmisartán 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 severe damage to your baby, see Pregnancy section.

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

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

Children and adolescents

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

Taking Telmisartán Alter with other medications

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

• Medications containing lithium for treating certain types of depression.
• Medications 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. ciclosporin or tacrolimus), and the antibiotic trimetoprim.
• Diuretics, especially if taken in high doses with telmisartán, 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 Alter” and “Warnings and precautions”).
• Digoxina.

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

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

Additionally, blood pressure may be further decreased 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 medications while taking telmisartán.

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 medication.

Pregnancy

You should 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 before becoming pregnant or as soon as you become pregnant, and recommend taking another antihypertensive medication instead. Telmisartán 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 severe damage to your baby when administered from that point onwards.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding, as telmisartán 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

No information is available on the effect of telmisartán on the ability to drive and operate machinery. Some people may feel dizzy or tired when being treated for high blood pressure. If you feel dizzy or tired, do not drive or operate machinery.

Telmisartán Alter contains sorbitol

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

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 telmisartan 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 per 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. Telmisartan can also be used in association with diuretics such as hydrochlorothiazide, which has been shown to have an additional 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 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 Telmisartán Alter than you should

If you accidentally take too many tablets, consult your doctor, pharmacist, or the nearest hospital emergency service immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication 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 continue as before.

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

If you have any doubts 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 (they may 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.

Possible side effects of Telmisartán Alter:

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

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

Infrequent 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), elevated potassium levels, difficulty falling asleep (insomnia), feeling sad (depression), fainting (syncope), feeling of 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 creatinine levels in blood.

Rare side effects(may 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, cough, 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 levels (a blood protein), increased uric acid levels in blood, increased liver enzymes or creatine phosphokinase in blood.

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

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

* This may have been a chance finding or related to an unknown mechanism currently.

**There have been reported cases of progressive fibrosis of lung tissue during telmisartan use. However, it is unknown if telmisartan was the cause.

Unknown frequency(cannot be estimated from available data):

Intestinal angioedema: there have been reported cases of intestinal inflammation presenting symptoms such as abdominal pain, nausea, vomiting, and diarrhea after use of similar products.

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 theSpanish 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 any special storage temperature. Store in the original packaging to protect it from moisture. Remove your telmisartan tablet from the blister pack just before taking it.

Medications should not be disposed of through drains or trash. Deposit 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 Alter Composition

• The active ingredient is telmisartan. Each tablet contains 80 mg of telmisartan.
• The other components are microcrystalline cellulose, sodium hydroxide, meglumine, povidone K30, carboxymethylamidone sodium (type A) (from potato), sorbitol (E420), and magnesium stearate.

Appearance of the product and content of the packaging

Telmisartan Alter 80 mg are white or slightly beige, oval-shaped, unnotched tablets.

Telmisartan Alter is available in blister packs containing 28 tablets.

Marketing Authorization Holder and Responsible Manufacturer

Laboratorios Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review date of this leaflet: February 2025

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