TELMARK 80 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Telmark 80 mg Film-Coated Tablets EFG

telmisartan

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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

1. What is Telmark and what is it used for

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

Telmark is used to treatessential hypertension (high blood pressure) in adults. “Essential” means that the high blood pressure is not caused by any other condition.

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 kidney failure, strokes, or blindness. Usually, there are no symptoms of high blood pressure before damage occurs. Therefore, it is important to have your blood pressure checked regularly to see if it is within the normal range.

Telmark is also usedto reduce 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 Telmark

Do not take Telmark

• 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. (It is also better to avoid taking Telmark at the start of your pregnancy - see section “Pregnancy”).
• if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of bile from the liver and gallbladder) or any other serious liver disease.
• if you have diabetes or kidney impairment and are treated with aliskiren-containing medicines for high blood pressure.

If you think any of the above applies to you, consult your doctor or pharmacist before taking Telmark.

Warnings and precautions

Tell your doctor before starting treatment with Telmark if you have or have had any of the following conditions or illnesses:

• 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 loss of water from the body) or have low salt levels due to treatment with diuretics, low-salt diet, diarrhea, or vomiting.
• High levels of potassium in the blood.
• Diabetes.

Tell your doctor before taking Telmark:

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

• an ACE inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor should check your kidney function, blood pressure, and the amount of electrolytes (e.g., potassium) in your blood at regular intervals. See also the information in the heading “Do not take Telmark” and “Warnings and precautions”.

• if you are taking digoxin.

If you are pregnant (or think you might be), you should inform your doctor. Telmark is not recommended during the first trimester of pregnancy and should not be taken after the third month of pregnancy, 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 Telmark.

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

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

Children and adolescents

Telmark is not recommended for children and adolescents under 18 years of age.

Other medicines and Telmark

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Your doctor may need to change the dose of these medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This is especially true for the following medicines when taken with Telmark:

• 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 blockers, non-steroidal anti-inflammatory medicines (e.g., aspirin or ibuprofen), heparin, immunosuppressants (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim.
• Diuretics, especially if taken in high doses with Telmark, can cause excessive water loss in the body and a decrease in blood pressure (hypotension).
• If you are taking an ACE inhibitor or aliskiren (see also the information in the heading “Do not take Telmark” and “Warnings and precautions”).
• Digoxin.

The effect of Telmark may be reduced when you take non-steroidal anti-inflammatory medicines (e.g., aspirin or ibuprofen) or corticosteroids.

Telmark may increase the effect of other medicines used to treat high blood pressure or medicines with potential to lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may feel dizzy when standing up. Consult your doctor if you need to adjust the dose of another medicine while taking Telmark.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant (or think you might be), you should inform your doctor. Your doctor will advise you to stop taking Telmark before you become pregnant or as soon as you find out you are pregnant and recommend that you take another blood pressure medicine instead. Telmark should not be used during the first trimester of pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby when taken after this stage.

Breastfeeding

Tell your doctor if you are about to start or are already breastfeeding. Telmark is not recommended for women who are breastfeeding, and your doctor will choose another treatment for you if you want to breastfeed, especially newborns or premature babies.

Driving and using machines

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

Telmark contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult your doctor before taking this medicine.

Telmark contains sodium

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

3. How to take Telmark

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

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

For the treatment of high blood pressure, the usual dose of Telmark for most patients is 40 mg once a day to control blood pressure over 24 hours. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Telmark can be used in combination with diuretics such as hydrochlorothiazide, which has been shown to have an additive blood pressure-lowering effect with Telmark.

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

If you have accidentally taken more tablets than you should, talk to your doctor or pharmacist or go to the nearest hospital casualty department immediately.

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or the Toxicology Information Service (telephone: 91 562 04 20), stating the medicine and the amount taken. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you forget to take Telmark

If you forget to take a dose, do not worry. Take it as soon as you remember and then continue as before. If you do not take your tablet one day, take your normal dose the next day. Donot take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Some side effects can be serious and need immediate medical attention:

See your doctor immediately if you experience any of the following symptoms:

Sepsis* (often called “blood poisoning”, a serious infection with an inflammatory response throughout the body), rapid swelling of the skin and mucous membranes (angioedema), these side effects are rare (may affect up to 1 in 1,000 patients) but are extremely serious and patients should stop taking this medicine and see their doctor immediately. If these side effects are not treated immediately, they can be fatal.

Possible side effects of Telmark:

Common side effects (may affect up to 1 in 10 patients):

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

Uncommon side effects (may affect up to 1 in 100 patients):

Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), low red blood cell count (anemia), high potassium levels, difficulty sleeping, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, feeling dizzy when standing up (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, stomach pain, abdominal distension, vomiting, itching, increased sweating, skin rash, back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute kidney failure, chest pain, feeling weak, and increased creatinine levels in the blood.

Rare side effects (may affect up to 1 in 1,000 patients):

Sepsis* (often called “blood poisoning”, a serious infection with an inflammatory response throughout the body that can lead to death), increase in certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, drowsiness, vision problems, rapid heart rate (tachycardia), dry mouth, stomach upset, taste disturbances (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucous membranes that can lead to death (angioedema including fatal outcome), eczema (a skin disease), skin redness, hives (urticaria), severe skin rash caused by medicines, joint pain (arthralgia), limb pain, tendon pain, pseudo-influenza disease, decrease in hemoglobin (a blood protein), increase in uric acid levels, increase in liver enzymes or creatine phosphokinase in the blood, low sodium levels.

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

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

Frequency not known (cannot be estimated from the available data):

Intestinal angioedema: swelling in the intestine has been reported, which occurs with symptoms such as abdominal pain, nausea, vomiting, and diarrhea after taking similar products.

• This may have been an isolated incident or related to a currently unknown mechanism.

** Cases of progressive scarring of lung tissue have been detected during telmisartan intake. However, it is not known whether telmisartan was the cause of this.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency's Pharmacovigilance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Telmark

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

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 that month.

This medicine does not require any special storage conditions. Store in the original package to protect from moisture. Remove the Telmark tablets from the blister pack immediately before consumption.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Telmark

The active substance is telmisartan. Each tablet contains 80 mg of telmisartan.

The other ingredients are:

Core:

Sodium hydroxide

Povidone (K-25)

Meglumine

Lactose monohydrate

Crospovidone

Yellow iron oxide (E172)

Magnesium stearate

Coating:

Hypromellose

Titanium dioxide (E171)

Macrogol-400

Talc

Yellow iron oxide (E172)

Appearance of the product and pack contents

Telmark are film-coated tablets, capsule-shaped, yellow, with an “80” engraved on one face and a “T” engraved on the other face.

Telmark is available in blister packs containing 14, 15, 28, 30, 56, 60, 90, or 98 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b

140 78 Praha 4

Czech Republic

Manufacturer:

Glenmark Pharmaceuticals s.r.o.

Fibichova, 143

56617 Vysoke Myto

Czech Republic

You can obtain further information on this medicine from the representative of the marketing authorisation holder:

Glenmark Farmacéutica, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

Sweden: Telmark 80 mg film-coated tablets

Slovakia: Telmark 80 mg film-coated tablets

Spain: Telmark 80 mg film-coated tablets EFG

Finland: TELMARK 80 mg tablet, film-coated

Date of last revision of this leaflet:March 2025.

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