Leaflet: information for the user

Telmark 80 mg film-coated tablets EFG

telmisartán

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

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

Telmark is used to treat essential hypertension (elevated blood pressure) in adults. “Essential” means that the elevated blood pressure is not due to any other cause.

Elevated 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 elevated blood pressure before damage occurs. Therefore, it is essential to measure blood pressure regularly to verify if it is within the normal range.

Telmark is also used to 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 developing diabetes. Your doctor will inform you if you have an elevated risk of experiencing these events.

Do not take Telmark

• if you areallergicto telmisartán or any of the other components of this medication (listed in section 6).
• if you aremore than 3 months pregnant. (It is better to avoid taking Telmark also at the beginning of your 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 kidney function deterioration and are being treated to lower blood pressure with medications containing aliskiren.

If you consider that any of the situations mentioned above affect you, consult your doctor or pharmacist before taking Telmark.

Warnings and precautions

Inform your doctor before starting to take Telmark 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 a salt deficiency due to diuretic treatment, low-salt diet, diarrhea, or vomiting.
• Elevated potassium levels in the blood.
• Diabetes.

Inform your doctor before taking Telmark:

• if you are taking any of the following medications 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 review your kidney function, blood pressure, and electrolyte levels (e.g. potassium) at regular intervals. See also the information in the heading “Do not take Telmark”.

• if you are taking digoxina.

If you are pregnant, (or if you suspect you may be), you must inform your doctor. Telmark is not recommended for use at the beginning of pregnancy and in no case should it be administered from the third month of pregnancy because it may cause serious damage to the baby if taken at this stage (see section “Pregnancy”).

In case ofsurgery or anesthesia, inform your doctor that you are taking Telmark.

Telmark may be less effective in reducing blood pressure in patients ofblack race.

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

Children and adolescents

Telmark is not recommended for use in children and adolescents until 18 years of age.

Other medications and Telmark

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. Your doctor may need to change the dose of these medications 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 Telmark:

• Medications containing lithium to treat some types of depression.
• Medications that can increase potassium levels in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor blockers, 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 Telmark, may cause excessive water loss from 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”).
• Digoxina.

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

Telmark may increase the hypotensive effect of other medications used to treat high blood pressure or medications with potential to lower blood pressure (e.g. baclofeno, amifostina). Additionally, low blood pressure may be worsened by alcohol, barbiturates, narcotics, or antidepressants. You may experience dizziness when standing up. Consult your doctor if you need to adjust the dose of another medication while taking Telmark.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant, (or if you suspect you may be), you must inform your doctor. Your doctor will advise you to stop taking Telmark before becoming pregnant or as soon as you become pregnant and recommend taking another antihypertensive medication instead. Telmark is not recommended for use at the beginning of pregnancy and in no case should it be administered from the third month of pregnancy because it may cause serious damage to the baby if taken at this stage.

Breastfeeding

Inform your doctor if you plan to start or are breastfeeding. Telmark is not recommended for women who are breastfeeding and your doctor should choose another treatment for you if you want to start breastfeeding, especially in newborns or premature babies.

Driving and operating machinery

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

Telmark contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Telmark contains sodium

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

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

The recommended dose of Telmark is one tablet per day. Try to take the tablet at the same time every day. You can take Telmark with or without food. The tablets should be swallowed whole with a little water or other non-alcoholic beverage. It is essential to take Telmark every day until your doctor tells you otherwise. If you think the effect of Telmark is too strong or too weak, inform 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, your doctor may sometimes 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 effect on reducing blood pressure with Telmark.

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

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

In case of overdose or accidental ingestion, consult your doctor, pharmacist, or the Toxicological Information Service immediately, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication 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 continue as before. If you miss a day, take your normal dose the next day.Do nottake a double dose to compensate for the missed doses.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

Seek immediate medical attention if you experience any of the following symptoms:

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

Possible side effects of Telmark:

Frequent side effects(can affect up to 1 in 10 patients):

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

Infrequent side effects(can affect up to 1 in 100 patients):

Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), anemia (deficiency in red blood cells), elevated potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of movement (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients with high blood pressure treatment, feeling dizzy when standing (orthostatic hypotension), difficulty breathing, cough, abdominal pain, diarrhea, abdominal cramps, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), renal insufficiency including acute renal failure, chest pain, feeling weak and increased creatinine levels in the blood.

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

Sepsis * (often called "blood poisoning," it is a severe infection with a systemic inflammatory response that can lead to 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 anxious, drowsiness, vision problems, rapid heart rate (tachycardia), dry mouth, abdominal discomfort,alterations in taste (dysgeusia),abnormal liver function (Japanese patients are more prone 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 medication, joint pain (arthralgia), pain in the limbs, tendon pain, pseudogripal disease, decreased hemoglobin levels (a protein in the blood), increased uric acid levels, increased liver enzymes or creatine phosphokinase in the blood, low sodium levels.

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

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

Frequency unknown(cannot be estimated from available data):

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

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

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

Reporting of side effects

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

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

Do not use this medication after the expiration date that appears on the box after “CAD”. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

Composition of Telmark

The active ingredient is telmisartán. Each tablet contains 80 mg of telmisartán.

The other components are:

Core:

Sodium hydroxide

Povidone (K-25)

Meglumine

Lactose monohydrate

Crospovidone

Yellow iron oxide (E172)

Magnesium stearate

Coating:

Hydroxypropyl methylcellulose

Titanium dioxide (E171)

Macrogol-400

Talc

Yellow iron oxide (E172)

Appearance of the product and contents of the package

Telmark are film-coated tablets, capsule-shaped, yellow in color, with an `80´ marked on one face and a `T´ marked on the other face.

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

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Glenmark Pharmaceuticals s.r.o.,

Hvezdova 1716/2b, 140 78 Praha 4,

Czech Republic

Responsible manufacturer

Glenmark Pharmaceuticals s.r.o.,

Fibichova, 143, 56617, Vysoke Myto

Czech Republic

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Viso Farmacéutica, S.L.U.

c/ Retama 7, 7ª Planta,

28045 Madrid,

Spain

This medicinal product is authorized in the member states of the European Economic Area with 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 tablets, film-coated

Last review date of this leaflet:March 2025.

Further detailed information about this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)