Telmisartan 40 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Telmark 40 mg film-coated tablets EFG

telmisartan

Read the entire leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet as 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, since it could harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Telmark is and what it is 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, thereby increasing your blood pressure. Telmark blocks the effect of angiotensin II, allowing blood vessels to relax and reducing your blood pressure.

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

Untreated high blood pressure can damage blood vessels in various organs and may lead, in some cases, to heart attacks, heart or kidney failure, strokes, or blindness. High blood pressure generally does not cause symptoms before such damage occurs. Therefore, it is important to measure your blood pressure regularly to ensure it remains within the normal range.

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

2. What you need to know before taking Telmark

Do not take Telmark

• 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. (It is better to avoid taking Telmark also during the early stages of pregnancy – see section “Pregnancy”).
• 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 impaired kidney function and are being treated for high blood pressure with medicines containing aliskiren.

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

Warnings and precautions

Tell your doctor before starting Telmark if you are suffering from 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 (retention of water and salts 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

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), particularly if you have kidney problems related to diabetes.

• aliskiren.

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

• if you are taking digoxin.

If you are pregnant (or suspect you might be), you must inform your doctor. Use of Telmark is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to the baby if taken during this period (see section “Pregnancy”).

If you are undergoing surgery or anaesthesia, 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 diarrhoea 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 use in 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 need to take any other medicines.

Your doctor may need to adjust the dose of these medicines or take other precautions. In some cases, you may need to stop taking one of the medicines. This particularly applies to the following medicines when taken together with Telmark:

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

The effect of Telmark may be reduced when taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids.

Telmark may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or of medicines with potential to lower blood pressure (e.g. baclofen, amifostine). In addition, 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 breast-feeding

Pregnancy

If you are pregnant (or suspect you might be), you must inform your doctor. Your doctor will advise you to stop taking Telmark before becoming pregnant or as soon as pregnancy occurs and will recommend an alternative antihypertensive medicine. Telmark is not recommended during early pregnancy and must not be used from the third month of pregnancy onwards, as it may cause serious harm to your baby when used from that stage.

Breast-feeding

Inform your doctor if you are planning to start or are currently breast-feeding. Telmark is not recommended for women who are breast-feeding, and your doctor should choose an alternative treatment for you if you plan to breast-feed, especially if the newborn or infant is premature.

Driving and using machines

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

Telmark contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him 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

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

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

For the treatment of high blood pressure, the usual dose of Telmark for most patients is 40 mg once daily, 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 may be used in combination with diuretics such as hydrochlorothiazide, which has been shown to exert an additive blood pressure-lowering effect with Telmark.

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

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

In case of overdose or accidental ingestion, contact your doctor, pharmacist, or the Toxicology Information Service immediately at phone number 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine packaging and leaflet 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 miss a 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, this medicine can cause adverse effects, although not everyone will experience them.

Some adverse effects can be serious and require immediate medical attention:

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

Sepsis * (often called "blood poisoning", a serious infection with a systemic inflammatory response), rapid swelling of the skin and mucous membranes (angioedema). These adverse effects are rare (may affect up to 1 in 1,000 patients) but are extremely serious, and patients must stop taking this medicine and seek immediate medical advice. If these effects are not treated immediately, they may be fatal.

Possible adverse effects of Telmark:

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

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

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

Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), deficiency in red blood cells (anaemia), elevated potassium levels, difficulty sleeping, feeling of sadness (depression), fainting (syncope), sensation of movement (vertigo), 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, back pain, muscle cramps, muscle pain (myalgia), kidney failure including acute renal failure, chest pain, feeling of weakness, and increased blood creatinine levels.

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

Sepsis * (often called "blood poisoning", a serious infection with a systemic inflammatory response that may 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, facial swelling or low blood pressure), low blood glucose levels (in diabetic patients), feeling of anxiety, drowsiness, vision problems, increased heart rate (tachycardia), dry mouth, abdominal discomfort, altered taste (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this adverse effect), rapid swelling of the skin and mucous membranes that may be fatal (angioedema including fatal outcome), eczema (a skin disease), skin redness, hives (urticaria), severe drug-induced skin 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 patients):

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

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

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

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

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

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse 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 stated on the packaging after "CAD". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature. Store in the original packaging to protect it from moisture. Remove Telmark tablets from the blister pack immediately before use.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Telmark

The active substance is telmisartan. Each tablet contains 40 mg of telmisartan.

The other components 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 contents of the container

Telmark is a yellow, film-coated, capsule-shaped tablet, marked with a 40´ on one side and a T´ on the other.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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

Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:

Glenmark Farmacéutica, S.L.U.
C/ Retama 7, 7th floor
28045 Madrid
Spain

This medicinal product is authorized in the European Economic Area countries under the following names:

Sweden: Telmark 40 mg filmdragerade tabletter
Slovakia: Telmark 40 mg filmom obalené tablety
Spain: Telmark 40 mg comprimidos recubiertos con película EFG
Finland: TELMARK 40 mg tabletti, kalvopäällysteinen

Date of the most recent review of this leaflet: March 2025.

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