Telmizek

Leaflet attached to the packaging: information for the user

Telmizek, 40 mg, tablets

Telmizek, 80 mg, tablets

Telmisartan

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Telmizek and what is it used for
• 2. Important information before taking Telmizek
• 3. How to take Telmizek
• 4. Possible side effects
• 5. How to store Telmizek
• 6. Contents of the packaging and other information

1. What is Telmizek and what is it used for

Telmizek belongs to a group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that causes blood vessels to constrict, leading to an increase in blood pressure. Telmizek blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmizek is used to treat essential hypertension (high blood pressure). The term "essential" means that high blood pressure is not caused by another disease.
Untreated high blood pressure can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, or kidney disease, stroke, or vision loss. Most of the time, before these complications occur, no symptoms of high blood pressure are observed. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range.
Telmizek is also used to reduce the frequency of cardiovascular events (such as heart attack or stroke) in patients at risk, i.e., those with reduced blood flow to the heart or legs, those who have had a stroke, or those with diabetes. The doctor will inform the patient if they are at risk of these disorders.
2.

Important information before taking Telmizek

When not to take Telmizek

• If the patient is allergic to telmisartan or any other ingredient of this medicine

(listed in section 6);
After the third month of pregnancy. (It is also recommended to avoid taking Telmizek in early pregnancy - see section "Pregnancy");

• If the patient has severe liver dysfunction, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder) or any other severe liver disease;
• If the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, they should inform their doctor or pharmacist before taking Telmizek.

Warnings and precautions

If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Telmizek, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Telmizek on their own.
The patient should inform their doctor if they have or have had any of the following conditions or diseases:

• kidney disease or kidney transplant,
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys),
• liver disease,
• heart problems,
• high aldosterone levels (water and salt retention in the body, accompanied by mineral balance disorders),
• low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive water loss from the body) or has a salt deficiency due to the use of diuretics, a low-salt diet, diarrhea, or vomiting,
• high potassium levels in the blood,
• diabetes,

Before starting Telmizek, the patient should discuss it with their doctor:

• If the patient is taking any of the following medicines for high blood pressure:
• angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes,
• aliskiren. The doctor may monitor kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood at regular intervals.
• If the patient is taking digoxin.

The patient should inform their doctor if they suspect or plan to become pregnant. It is not recommended to take Telmizek in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see section "Pregnancy").
In case of planned surgery or anesthesia, the patient should inform their doctor about taking Telmizek.
Telmizek may be less effective in lowering blood pressure in black patients.

Children and adolescents

Telmizek is not recommended for use in children and adolescents under 18 years of age.

Telmizek and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking or have recently taken, as well as any medicines they plan to take.
The doctor may decide to change the dose of these medicines or take other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines taken with Telmizek:

• lithium preparations used to treat certain types of depression,
• medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive drugs (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim,
• diuretics, especially when taken in high doses with Telmizek, as they can lead to significant water loss and low blood pressure (hypotension),
• if the patient is taking an ACE inhibitor or aliskiren (see also the information under the heading "When not to take Telmizek" and "Warnings and precautions"),
• digoxin.

Telmizek's effect may be reduced when taken with NSAIDs or corticosteroids.
Telmizek may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can cause low blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be further reduced by: alcohol, barbiturates, narcotics, or antidepressants. The symptom is dizziness when standing up. If necessary, the patient should consult their doctor about adjusting the dose of another medicine they are taking while taking Telmizek.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor if they suspect or plan to become pregnant.
Usually, the doctor will recommend stopping Telmizek before planned pregnancy or as soon as pregnancy is confirmed and will recommend another medicine instead of Telmizek. It is not recommended to take Telmizek in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken after 3 months of pregnancy.
Breastfeeding
The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Telmizek is not recommended during breastfeeding. The doctor may choose another treatment during breastfeeding, especially in the period of breastfeeding newborns and premature babies.

Driving and using machines

Some patients taking Telmizek may experience dizziness or fatigue. In such cases, they should not drive or operate machines.

Telmizek contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose (40 mg or 80 mg), which means the medicine is considered "sodium-free".

3. How to take Telmizek

Telmizek should always be taken as directed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose is one tablet per day. The patient should try to take the tablet at the same time every day. Telmizek can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic liquid. It is essential to take Telmizek every day, unless the doctor recommends otherwise. If the patient feels that the effect of Telmizek is too strong or too weak, they should consult their doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Telmizek is one 40 mg tablet per day, which provides 24-hour blood pressure control. The doctor may recommend a lower dose of 20 mg per day or a higher dose of 80 mg per day.
Telmizek can also be given in combination with a diuretic, such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmizek.
To reduce the frequency of cardiovascular events, the usual dose of Telmizek is one 80 mg tablet per day. At the beginning of treatment, blood pressure should be frequently monitored.
In case of liver dysfunction, the usual dose should not exceed 40 mg per day.

Taking a higher dose of Telmizek than recommended

If the patient accidentally takes too many tablets, they should immediately contact their doctor, pharmacist, or the nearest hospital emergency department.

Missing a dose of Telmizek

If a dose is missed, the patient should take it as soon as they remember, and then continue taking the medicine as scheduled. If the tablet is not taken within a day, the patient should take the usual dose the next day. Do nottake a double dose to make up for the missed dose.

Stopping Telmizek

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

Some side effects may be serious and require immediate medical attention.

If the patient experiences any of the following symptoms, they should immediately contact their doctor:
Septicemia* (often referred to as blood poisoning, a severe infection with an inflammatory reaction throughout the body), sudden swelling of the skin and mucous membranes (angioedema).
These side effects are rare (may occur in up to 1 in 1000 patients), but they are extremely serious, and the patient should stop taking the medicine and immediately contact their doctor. If these symptoms are not treated, they can be fatal.

Possible side effects of Telmizek:

Common side effects (may occur in up to 1 in 10 patients):
Low blood pressure (hypotension) in patients being treated to reduce the frequency of cardiovascular events.
Uncommon side effects (may occur in up to 1 in 100 patients):
Urinary tract infections, upper respiratory tract infections (e.g., sore throat, sinusitis, common cold), decreased red blood cell count (anemia), high potassium levels in the blood, insomnia, depression, fainting, dizziness (peripheral vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients being treated for high blood pressure, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, stomach pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle cramps, muscle pain, kidney problems, including acute kidney failure, chest pain, feeling of weakness, and increased creatinine levels in the blood.
Rare side effects (may occur in up to 1 in 1000 patients):
Septicemia* (often referred to as blood poisoning, a severe infection with an inflammatory reaction throughout the body, which can be fatal), increased white blood cell count (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in patients with diabetes), restlessness, drowsiness, vision disturbances, rapid heart rate (tachycardia), dry mouth, gastritis, taste disturbances, liver problems (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which can also be fatal (angioedema), skin eruptions (skin disease), skin redness, hives, severe drug rash, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (a protein in the blood), increased uric acid levels, increased liver enzyme activity or creatine phosphokinase in the blood.
Very rare side effects (may occur in up to 1 in 10,000 patients):
Progressive scarring of the lung tissue (interstitial lung disease)**
Frequency not known (frequency cannot be estimated from the available data):
Angioedema of the intestine - after using similar products, angioedema occurred in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.
*The event may be coincidental or related to an unknown mechanism.
**There have been reports of interstitial lung disease associated with telmisartan. However, a causal relationship has not been established.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, e-mail: https://smz.ezdrowie.gov.pl .
Reporting side effects can help gather more information on the safety of the medicine.
5.

How to store Telmizek

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister pack, or bottle after "EXP". The expiry date refers to the last day of the month.
Aluminium/Aluminium blisters: Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Telmizek contains

• The active substance of Telmizek is telmisartan. Each tablet contains 40 mg or 80 mg of telmisartan.
• The other ingredients are: magnesium stearate, croscarmellose sodium, mannitol (E 421), povidone (K-29/32), potassium hydroxide.

What Telmizek looks like and contents of the pack

Telmizek 40 mg: white, oval, biconvex tablets with a score line and logo T on one side. The tablet can be divided into two halves.
Telmizek 80 mg: white, oval, biconvex tablets with logo T1 on one side.
Telmizek is available in Aluminium/Aluminium blisters containing 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

Manufacturer

Actavis Ltd
BLB016 Bulebel Industrial Estate
Zejtun ZTN 3000
Malta
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów

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

{Poland }
{Telmizek}

Date of last revision of the leaflet:

March 2025