Telmisartan Viatris

Leaflet attached to the packaging: information for the user

Telmisartan Mylan, 40 mg, tablets

Telmisartan Mylan, 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.
• If you have any doubts, consult your doctor or pharmacist.
• 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Telmisartan Mylan and what is it used for

Telmisartan Mylan contains telmisartan, which 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 increased blood pressure. Telmisartan Mylan blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmisartan Mylan is used to treat essential hypertension (high blood pressure) in adults. The term "essential" means that the 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 failure, stroke, or vision loss. Most of the time, there are no symptoms of high blood pressure before these complications occur. Therefore, it is essential to regularly check blood pressure to ensure it is within the normal range.
Telmisartan Mylan is also used to reduce the risk of heart attack or stroke in adults at risk, i.e., those with reduced blood flow to the heart or legs, who have had a stroke, or who have organ damage caused by diabetes.
Your doctor will inform you if you are at risk of these disorders.

2. Important information before taking Telmisartan Mylan

When not to take Telmisartan Mylan

• after the third month of pregnancy (it is also recommended to avoid taking Telmisartan Mylan during early pregnancy - see "Pregnancy")

If any of these situations apply to the patient, they should inform their doctor or pharmacist before taking Telmisartan Mylan.

Warnings and precautions

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
• low blood pressure (hypotension), which is more likely if the patient is dehydrated or has low salt levels due to diuretics, low-salt diet, diarrhea, or vomiting
• fluid and salt retention in the body, accompanied by disturbances in the balance of various minerals in the blood (increased aldosterone levels)
• high potassium levels in the blood
• diabetes

Before starting Telmisartan Mylan, the patient should discuss the following with their doctor or pharmacist:

pharmacist:

• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if the patient has kidney problems caused by diabetes
• aliskiren

The doctor may check the patient's kidney function, blood pressure, and electrolyte levels (e.g., potassium) regularly.
See also the information in the section "When not to take Telmisartan Mylan".
If the patient is black, Telmisartan Mylan may be less effective in lowering blood pressure, as with all other angiotensin II receptor antagonists used in black patients.
The patient should inform their doctor if they suspect or plan to become pregnant. It is not recommended to take Telmisartan Mylan during early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy").
In case of planned surgery or anesthesia, the patient should inform their doctor about taking Telmisartan Mylan.
Children and adolescents
Telmisartan Mylan should not be taken by children and adolescents under 18 years of age.

Telmisartan Mylan with food, drink, and alcohol

Taking Telmisartan Mylan with alcohol may increase the blood pressure-lowering effect, which can cause dizziness and fainting, especially when changing position from sitting or lying down to standing.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient should inform their doctor if they suspect or plan to become pregnant.
Usually, the doctor will advise stopping telmisartan before planned pregnancy or as soon as pregnancy is detected and will prescribe another medicine instead of telmisartan. It is not recommended to take Telmisartan Mylan during early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken after 3 months of pregnancy.
Breastfeeding
The patient should tell their doctor if they are breastfeeding or plan to breastfeed. Telmisartan is not recommended for breastfeeding mothers. The doctor may choose another treatment if the patient wants to breastfeed, especially if it concerns breastfeeding newborns and premature babies.

Driving and using machines

Some patients treated for high blood pressure may experience dizziness or fatigue. If dizziness or fatigue occurs, the patient should not drive or operate machinery.

Telmisartan Mylan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which means it is considered "sodium-free".

3. How to take Telmisartan Mylan

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended dose of Telmisartan Mylan will depend on the reason for taking the medicine.
The medicine should be taken once a day, at the same time every day.
For the treatment of high blood pressure, the recommended dose of Telmisartan Mylan is 40 mg once daily, which provides 24-hour control of blood pressure. However, the doctor may prescribe a lower dose of 20 mg daily or a higher dose of 80 mg. For some patients, a daily dose of 20 mg may be sufficient.
Telmisartan Mylan can also be given in combination with a diuretic (such as hydrochlorothiazide), which enhances the blood pressure-lowering effect of telmisartan.
To reduce the risk of heart attack or stroke, the usual dose of Telmisartan Mylan is 80 mg once daily. Blood pressure should be monitored frequently at the start of treatment.
If the patient feels that the effect of Telmisartan Mylan is too strong or too weak, they should consult their doctor or pharmacist.
Telmisartan Mylan is available in 2 doses: 40 mg, 80 mg
Use in children and adolescents
Telmisartan Mylan should not be taken by children and adolescents under 18 years of age.

Method of administration

The tablets should be swallowed whole with water or another non-alcoholic liquid.
Telmisartan Mylan can be taken with or without food.

Patients with liver function disorders

In case of liver function disorders, the recommended dose should not exceed 40 mg once daily.

Patients with kidney function disorders

If the patient has kidney problems, they should consult their doctor. The doctor may prescribe a lower initial dose of 20 mg daily.

Taking a higher dose of Telmisartan Mylan than recommended

If the patient accidentally takes too many tablets, they should immediately contact their doctor or pharmacist or the nearest hospital emergency department.
Symptoms of overdose may include: low blood pressure, dizziness, rapid or slow heart rate, and kidney problems.

Missing a dose of Telmisartan Mylan

If a dose is missed, the patient should take it as soon as they remember, and then continue taking the medicine as scheduled. If a dose is missed for one day, the next day the patient should take the normal dose.
The patient should not take a double dose to make up for the missed dose.

Stopping Telmisartan Mylan

Before stopping Telmisartan Mylan, the patient should consult their doctor.
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, Telmisartan Mylan can cause side effects, although not everybody gets them.
The patient should immediately contact their doctor if they experience any of the following symptoms, as they can be serious and even life-threatening if left untreated:

• sepsis* (also known as "blood poisoning", a severe infection with a systemic inflammatory response)
• severe allergic reaction with symptoms such as rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure (anaphylactic reaction)
• sudden swelling of the skin, face, lips, tongue, or throat, which can cause difficulty swallowing or breathing (angioedema)
• severe skin reactions, which can include blistering and peeling of the skin (toxic skin reaction)
• difficulty urinating, nausea, vomiting, shortness of breath, swelling of the feet, ankles, or legs (including kidney failure)
• shortness of breath, dry or non-productive cough with weight loss due to progressive scarring of lung tissue (interstitial lung disease)***

Other possible side effects:
Common (may affect up to 1 in 10 people):

• low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events, such as heart attack or stroke
• infections of the upper respiratory tract, such as sore throat, cold, sinusitis, causing pain, high temperature, and tenderness
• urinary tract infections, including cystitis
• reduced red blood cell count (anemia), which can cause pale skin, weakness, and shortness of breath
• high potassium levels in the blood
• depression
• difficulty sleeping
• dizziness
• fainting
• dizziness, especially when standing up (orthostatic hypotension)
• slow heart rate (bradycardia)
• low blood pressure (hypotension) in patients treated for high blood pressure
• shortness of breath, chest pain
• cough
• abdominal pain, diarrhea, nausea, bloating, or vomiting
• rash, itching of the skin
• excessive sweating
• back pain, muscle pain, muscle spasms
• weakness
• increased creatinine levels in the blood, visible in blood test results
• Rare (may affect up to 1 in 1,000 people):
• reduced platelet count, which can increase the risk of bleeding and bruising
• increased white blood cell count (eosinophilia) visible in blood test results
• feeling of restlessness
• vision disturbances (impaired vision)
• rapid heart rate (tachycardia)
• dry mouth
• taste disturbances
• liver function disorders**
• skin inflammation, characterized by itching and rash, often with blisters (eczema), skin redness
• joint pain, limb pain, tendon pain
• flu-like symptoms
• increased levels of certain enzymes in the blood (such as liver enzymes or creatine phosphokinase) visible in blood test results
• low blood sugar levels (in patients with diabetes)
• reduced hemoglobin levels (a protein in the blood) visible in blood test results
• increased uric acid levels in the blood, visible in blood test results
• drowsiness
• discomfort in the stomach

*In a long-term study involving over 20,000 patients, sepsis occurred more frequently in patients treated with telmisartan compared to those who did not receive telmisartan. The event may be coincidental or related to an unknown mechanism.
**Most cases of abnormal liver function and liver disorders reported during the post-marketing period occurred in Japanese patients. Japanese patients have a higher likelihood of experiencing these side effects.
***Cases of interstitial lung disease have been reported in association with telmisartan. However, a causal relationship has not been established.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, 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, website: https://smz.ezdrowie.gov.pl. By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Telmisartan Mylan

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, carton, and bottle after EXP. The expiry date refers to the last day of the month.
Store in the original packaging to protect from light.
Do not use Telmisartan Mylan if the patient notices any change in the color of the tablets.
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 Telmisartan Mylan contains

• The active substance is telmisartan.
• Each tablet contains 40 mg or 80 mg of telmisartan.
• The other ingredients are magnesium stearate, povidone (K-30), meglumine, sodium hydroxide, and mannitol (E 421).

What Telmisartan Mylan looks like and contents of the pack

40 mg: White to off-white, oval, biconvex tablets, with the symbol 'TN40' embossed on one side and 'M' on the other side.
80 mg: White to off-white, oval, biconvex tablets, with the symbol 'TN80' embossed on one side and 'M' on the other side.
Telmisartan Mylan is available in blister packs of OPA/Aluminum/PVC/Aluminum, containing 28 tablets.

Marketing authorization holder and manufacturer:

Marketing authorization holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland
Manufacturer
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca1
Hungary
To obtain more detailed information on this medicine and its names in the Member States of the European Economic Area, the patient should contact the representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: +48 22 546 64 00

Date of last revision of the leaflet: