Package Insert: Information for the User

Telmisartán Kern Pharma 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 for you and should not be given to others, even if they have the same symptoms of the disease, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist or nurse, even if they are not listed in this package insert.Seesection4.

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

Telmisartán is used totreat essential hypertension (high blood pressure). “Essential” means that 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 regularly measure blood pressure to verify if it is within the normal range.

Telmisartán is also used toreduce cardiovascular events (e.g., heart attacks or strokes) inadultswith a high 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 a high risk of experiencing these events.

Do not take Telmisartán Kern Pharma

• if you are allergic to telmisartán or any of the other components of this medication (listed in section 6)
• if you are more than 3 months pregnant. (In any case, it is better 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 insufficiency and are being treated with a medication to lower blood pressure that contains aliskirén.

Inform your doctor or pharmacist before taking Telmisartán Kern Pharma 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 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 starting to take telmisartán:

• if you are taking any of the following medications used to treat high blood pressure (hypertension):

- an angiotensin-converting enzyme inhibitor (ACEI) (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.

- aliskirén

Your doctor may monitor your renal 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 Kern Pharma”

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

If you are pregnant, if you suspect you may be pregnant, 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 from the third month of pregnancy because it may cause serious harm 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 until 18 years old.

Use of Telmisartán Kern Pharma with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. 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 medications. This applies especially to the following medications when taken with telmisartán:

• Medications containing lithium for treating some types of depression.
• Medications that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACEIs, 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).
• If you are taking an ACEI or aliskirén (see also the information under the headings “Do not take Telmisartán Kern Pharma” and “Warnings and precautions”.

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

Telmisartán may increase the effect of other medications used to treat high blood pressure.

Taking Telmisartán Kern Pharma with food and drink

You can take Telmisartán Kern Pharma with or without food.

Pregnancy and lactation

Pregnancy

Inform your doctor if you are pregnant, if you suspect you may be pregnant, 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 from the third month of pregnancy because it may cause serious harm to your baby when administered from that point onwards.

Lactation

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 in newborns or premature babies.

Driving and operating machinery

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

Telmisartán Kern Pharma contains sorbitol

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking Telmisartán Kern Pharma.

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

The usual dose of Telmisartán is one tablet per day. Try to take the tablet at the same time every day. You can take Telmisartán with or without food. The tablets should be swallowed with a little water or other non-alcoholic beverage. It is essential to take Telmisartán every day until your doctor tells you otherwise. If you estimate that the effect of Telmisartán is too strong or too weak, inform your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of Telmisartán for most patients is one 40 mg tablet per day, to control blood pressure over 24 hours. However, your doctor may recommend a lower dose, 20 mg, or a higher dose, 80 mg, at times. Telmisartán can also be used in association with diuretics such as hydrochlorothiazide, which has been shown to have an additive effect in reducing blood pressure with Telmisartán.

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

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

If you take more Telmisartán Kern Pharma 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 forgot to take Telmisartán Kern Pharma

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, Telmisartán Kern Pharma may cause side effects, although not everyone will experience them.

Some side effects may be severe and require immediate medical attention:

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

Sepsis* (often referred to as "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 medication and visit their doctor immediately. If these side effects are not treated, they can be fatal.

Possible side effects of Telmisartán:

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

Low blood pressure (hypotension) in patients 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 of sadness (depression), fainting (syncope), feeling of loss of balance (dizziness), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness upon standing (orthostatic hypotension), difficulty breathing, 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 referred to as "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 of anxiety, drowsiness, vision disturbance, increased heart rate (tachycardia), dry mouth, stomach discomfort, abnormal liver function (Japanese patients are more prone to experiencing 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 limbs, tendon pain, pseudogripal disease, decreased hemoglobin (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) **.

Side effects of unknown frequency

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.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

Store in the original packaging to protect it from moisture.

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.

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 Kern Pharma Composition

• The active ingredient is telmisartan. Each tablet contains 80 mg of telmisartan.
• The other components are povidone, sorbitol (E420), sodium hydroxide, meglumine, anhydrous colloidal silica, and magnesium stearate.

Product appearance and packaging content

White, slightly yellowish round tablets. They are presented in aluminum/aluminum blisters in packs of 28 tablets.

Telmisartan Kern Pharma is also available in 40 mg tablets in packs of 28 tablets.

Only some packaging sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Last review date of this leaflet: February 2025.

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