TELMISARTAN KERN PHARMA 80 mg TABLETS

Introduction

Package Leaflet: Information for the User

Telmisartan Kern Pharma 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Telmisartan Kern Pharma and what is it used for

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

Telmisartan is used totreat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not caused by any other condition.

High blood pressure, if not treated, can damage the blood vessels in various organs, which can lead, in some cases, to heart attacks, heart failure, or renal failure, strokes, or blindness. Usually, there are no symptoms to indicate high blood pressure before damage occurs. Therefore, it is important to regularly check your blood pressure to verify if it is within the normal range.

Telmisartan is also used toreduce cardiovascular events (e.g., heart attacks or strokes) in adults 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 from these events.

2. What you need to know before you take Telmisartan Kern Pharma

Do not take Telmisartan Kern Pharma

• 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 recommended to avoid taking this medicine at the start of pregnancy - see section Pregnancy)
• if you have severe hepatic impairment (e.g., cholestasis or biliary obstruction) or any other severe hepatic disease.
• if you have diabetes or kidney impairment and are treated with a blood pressure lowering medicine containing aliskiren.

If any of the above applies to you, inform your doctor or pharmacist before taking this medicine

Warnings and precautions

Consult your doctor before taking this medicine 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 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) that may 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 taking telmisartan:

• if you are taking any of the following medicines used to treat high blood pressure:

• 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. See also the information under the headings "Do not take Telmisartan Kern Pharma" and "Warnings and precautions"

• if you are taking digoxin

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

You must inform your doctor if you think you are (or might become) pregnant. It is not recommended to take telmisartan at the start of pregnancy and it should not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if taken at this stage (see section Pregnancy).

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

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

Children and adolescents

The use of telmisartan is not recommended in children and adolescents up to 18 years old.

Using Telmisartan Kern Pharma 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 the dose of these other medicines 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:

• Medicines containing lithium for treating certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially when taken in high doses together with telmisartan, 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 Kern Pharma" and "Warnings and precautions").
• Digoxin

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

Telmisartan may increase the blood pressure-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 reduction in blood pressure may be enhanced 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.

Taking Telmisartan Kern Pharma with food and drink

You can take telmisartan with or without food.

Pregnancy and breast-feeding

Pregnancy

You must inform your doctor if you think you are (or might become) pregnant. In general, your doctor will advise you to stop taking telmisartan before you become pregnant or as soon as you know you are pregnant, and will recommend that you take another medicine instead. It is not recommended to use telmisartan at the start of pregnancy and it should not be taken after the third month of pregnancy, as it may cause serious harm to your baby if taken after this time.

Breast-feeding

Inform your doctor if you are breast-feeding or about to start breast-feeding. It is not recommended to take telmisartan while breast-feeding, and your doctor may choose another treatment that is more suitable for you if you want to breast-feed, especially if your baby is newborn or premature.

Driving and using machines

Some people may experience side effects such as fainting or a feeling of spinning (vertigo) when taking telmisartan. If you experience these side effects, do not drive or use machines.

Telmisartan Kern Pharma contains sorbitol

Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars, or have been diagnosed with a rare genetic disorder called hereditary fructose intolerance (HFI), in which the patient cannot break down fructose, consult your doctor before taking this medicine.

Telmisartan Kern Pharma contains sodium

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

3. How to take Telmisartan Kern Pharma

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

The recommended dose is one tablet per day. Try to take the tablet at the same time each day. You can take this medicine with or without food. The tablets should be swallowed with a little water or other non-alcoholic drink. It is important that you take telmisartan every day until your doctor tells you to stop. If you think that the effect of telmisartan is too strong or too weak, talk to your doctor or pharmacist.

For the treatment of high blood pressure, the usual dose of telmisartan for most patients is one 40 mg tablet 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 can also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect with this medicine.

For the reduction of cardiovascular events, the usual dose of this medicine is one 80 mg tablet once a day. At the start of preventive treatment with telmisartan 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 Kern Pharma than you should

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or the nearest emergency service or call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Telmisartan 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 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 other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan Kern Pharma 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:

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, 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, feeling weak, 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 white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., drug rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, drowsiness, vision disturbance, rapid heart rate (tachycardia), dry mouth, abdominal discomfort, taste disturbance (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this side effect), sudden swelling of the skin and mucous membranes that can cause death (angioedema including fatal outcome), eczema (a skin disorder), skin redness, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in the limbs, tendon pain, pseudo-influenza, decrease in hemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase in the blood, low sodium levels.

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

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 mechanism currently not known.

** Cases of progressive scarring of lung tissue have been reported during treatment with telmisartan. However, it is not known whether telmisartan was the cause.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Telmisartan Kern Pharma

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

No special storage conditions are required.

Store in the original package to protect from moisture.

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Return any unused medicine to your pharmacist. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmisartan Kern Pharma

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

Appearance and packaging

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

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of last revision of this leaflet: June 2025.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) www.aemps.gob.es