Telmisartan Kern Pharma 80 mg tablets EFG

Package leaflet: Information for the user

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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you. It may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Telmisartan belongs to a class of medicines known as angiotensin II receptor blockers. Angiotensin II is a substance produced in your body that causes narrowing of your blood vessels, thereby increasing your blood pressure. Telmisartan blocks the effect of angiotensin II, allowing blood vessels to relax and resulting in lower blood pressure.

Telmisartan is used to treat essential hypertension (high blood pressure) in adults. "Essential" means that the high blood pressure is not due to any other underlying cause.

If left untreated, high blood pressure can damage blood vessels in various organs, potentially leading in some cases to heart attacks, heart or kidney failure, strokes, or blindness. High blood pressure generally does not cause symptoms until organ damage occurs. Therefore, it is important to measure your blood pressure regularly to ensure it remains within the normal range.

Telmisartan is also used to reduce cardiovascular events (e.g., heart attacks or strokes) in adults who are at risk due to reduced or blocked blood flow to the heart or legs, those who have had a stroke, or those at high risk of developing diabetes. Your doctor will inform you if you are at high risk of such events.

2. What you need to know before taking Telmisartán Kern Pharma

Do not take Telmisartán Kern Pharma

• if you are allergic to telmisartan or to 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 during early 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 blood pressure-lowering medicine containing aliskiren.

If any of the above apply to you, inform your doctor or pharmacist before starting to take this medicine.

Warnings and precautions

Talk to your doctor before taking this medicine if you are suffering from or have ever had 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 imbalance of several blood minerals).
• Low blood pressure (hypotension), which may occur if you are dehydrated (excessive loss of body water) or have salt depletion due to diuretic treatment, low-salt diet, diarrhoea or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Talk to your doctor before starting telmisartan:

• 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.

• aliskiren

Your doctor may monitor your kidney function, blood pressure and blood electrolyte levels (e.g. potassium) at regular intervals. See also information under the heading “Do not take Telmisartán Kern Pharma”.

• if you are taking digoxin.

Talk to your doctor if you experience abdominal pain, nausea, vomiting or diarrhoea after taking this medicine. Your doctor will decide whether to continue treatment. Do not stop taking telmisartan monotherapy without medical advice.

You must inform your doctor if you think you are (or may become) pregnant. Use of telmisartan is not recommended during early pregnancy and must not be given after the third month of pregnancy because it may cause serious harm to your baby if used at this stage (see Pregnancy section).

If you are undergoing surgery or anaesthesia, inform your doctor that you are taking telmisartán.

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

Children and adolescents

The use of telmisartan is not recommended in children and adolescents under 18 years of age.

Taking Telmisartán Kern Pharma with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might need to take any other medicines. Your doctor may need to adjust 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 important for the following medicines when taken together with telmisartan:

• Medicines containing lithium used to treat certain types of depression.
• Medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
• Diuretics, especially if taken at high doses together with telmisartan, may cause excessive loss of body water and low blood pressure (hypotension).
• If you are taking an angiotensin-converting enzyme inhibitor (ACE inhibitor) or aliskiren (see also information under the headings “Do not take Telmisartán Kern Pharma” and “Warnings and precautions”).
• Digoxin.

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

Telmisartan may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or of medicines that may potentially lower blood pressure (e.g. baclofen, amifostine). In addition, the reduction in blood pressure may be worsened by alcohol, barbiturates, narcotics or antidepressants. You may notice this effect as dizziness upon standing. Consult your doctor if you need to adjust the dose of any of your other medicines while taking telmisartan.

Taking Telmisartán Kern Pharma with food and drink

You may take telmisartan with or without food.

Pregnancy and breastfeeding

Pregnancy

Inform your doctor if you think you are (or may become) pregnant. Your doctor will usually advise you to stop taking telmisartan before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Use of telmisartan is not recommended during early pregnancy and must not be administered from the third month of pregnancy onwards, as it may cause serious harm to your baby if used from this stage.

Breastfeeding

Inform your doctor if you are breastfeeding or plan to breastfeed. Telmisartan is not recommended for women who are breastfeeding, and your doctor may choose another treatment more suitable for you if you wish to breastfeed, especially if your baby is newborn or premature.

Driving and using machines

Some people may experience adverse effects such as fainting or dizziness (vertigo) when taking telmisartan. If you experience these adverse effects, do not drive or operate machinery.

Telmisartán 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 certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which patients cannot break down fructose, consult your doctor (or your child’s doctor) before taking this medicine.

Telmisartán 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 Telmisartán Kern Pharma

Follow exactly the administration instructions for this medicine as indicated by your doctor. If in 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 may take this medicine with or without food. Swallow the tablets with a little water or other non-alcoholic drink. It is important that you take telmisartán every day until your doctor tells you otherwise. If you think 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 once daily, 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. Telmisartán may also be used in combination with diuretics such as hydrochlorothiazide, which has been shown to exert 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 daily. At the beginning of preventive treatment with telmisartán 80 mg, blood pressure should be monitored frequently.

If your liver is not functioning properly, the usual dose should not exceed 40 mg once daily.

If you take more Telmisartán Kern Pharma than you should

In case of overdose or accidental ingestion, contact your doctor, pharmacist, nearest emergency service immediately, or call the Toxicology Information Service at phone number: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget 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 dose one day, take your normal dose the next day. Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, Telmisartán Kern Pharma may cause adverse effects, although not everyone experiences them.

Some adverse effects may be serious and require immediate medical attention

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

Sepsis* (commonly known as "blood infection", a severe infection causing a systemic inflammatory response throughout the body), rapid swelling of the skin and mucous membranes (angioedema); these adverse effects are rare (may affect up to 1 in 1,000 people) but are extremely serious, and patients must stop taking the medicine and see their doctor immediately. If these adverse effects are not treated, they may be fatal.

Possible adverse effects of Telmisartán:

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

Low blood pressure (hypotension) in patients treated for reduction of cardiovascular events.

Uncommon adverse effects (may affect up to 1 in 100 people)

Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduced red blood cells (anaemia), elevated potassium levels, difficulty sleeping (insomnia), feeling of sadness (depression), fainting (syncope), sensation 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, cough, abdominal pain, diarrhoea, stomach pain, abdominal distension, vomiting, itching, increased sweating, drug rash (skin reaction to medicines), back pain, muscle cramps, muscle pain (myalgia), renal failure including acute renal failure, chest pain, feeling of weakness, elevated blood creatinine levels, dizziness.

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

Sepsis* (commonly known as "blood infection", a severe infection causing a systemic inflammatory response throughout the body which may result in death), increased levels of 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, visual disturbances, increased heart rate (tachycardia), dry mouth, abdominal discomfort, taste disturbances (dysgeusia), abnormal liver function (Japanese patients show a higher tendency to experience this adverse effect), sudden swelling of the skin and mucous membranes which may be fatal (angioedema including fatal outcome), eczema (a skin disorder), redness of the skin, hives (urticaria), severe drug rash, joint pain (arthralgia), limb pain, tendon pain, flu-like illness, decreased haemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or creatine phosphokinase in blood, low sodium levels.

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

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

Adverse effects with unknown frequency

Intestinal angioedema: intestinal inflammation has been reported with symptoms such as abdominal pain, nausea, vomiting and diarrhoea following the use of similar products.

• This may have been an incidental finding or related to a mechanism currently unknown.

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

Reporting of adverse effects

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

5. Storage of Telmisartan Kern Pharma

Keep this medicine out of 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 medicine after the expiry date stated on the packaging after “EXP”. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Telmisartán Kern Pharma

• The active substance 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.

Appearance of the product and contents of the pack

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

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

Only some 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 the most recent revision of this leaflet: March 2026.

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