TELMISARTAN 80 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Telmisartan Mylan, 40 mg, tablets
3. Telmisartan Mylan, 80 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for you.
   2. Table of Contents of the Package Leaflet:
4. What is Telmisartan Mylan and what is it used for
   1. Important information before taking Telmisartan Mylan
   2. When not to take Telmisartan Mylan
   3. Warnings and precautions
   4. Tell your doctor if you have or have had any of the following conditions or diseases:
   5. Before taking Telmisartan Mylan, discuss with your doctor or pharmacist:
   6. Telmisartan Mylan with other medicines
   7. Telmisartan Mylan with food, drink, and alcohol
   8. Pregnancy and breastfeeding
   9. Driving and using machines
   10. Telmisartan Mylan contains sodium
5. How to take Telmisartan Mylan
   1. Method of administration
   2. Patients with liver problems
   3. Patients with kidney problems
   4. Taking more than the recommended dose of Telmisartan Mylan
   5. Missing a dose of Telmisartan Mylan
   6. Stopping treatment with Telmisartan Mylan
   7. Reporting side effects
6. How to store Telmisartan Mylan
7. Contents of the pack and other information
   1. What Telmisartan Mylan contains
   2. What Telmisartan Mylan looks like and contents of the pack
   3. Marketing authorisation holder and manufacturer:
   4. Mylan Healthcare Sp. z o.o.
   5. Date of last revision of the leaflet:

Package Leaflet: Information for the User

Telmisartan Mylan, 40 mg, tablets

Telmisartan Mylan, 80 mg, tablets

Telmisartan

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

• You should keep this leaflet, so you can read it again later.
• If you have any doubts, consult 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 symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 pack 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 narrow, leading to an increase in 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 condition.
Untreated high blood pressure can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, kidney failure, stroke, or vision loss. Most people with high blood pressure do not experience any symptoms before these complications occur. Therefore, it is important 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 kidney damage caused by diabetes.
Your doctor will inform you if you are at risk of these conditions.

2. Important information before taking Telmisartan Mylan

When not to take Telmisartan Mylan

• if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6)
• after the third month of pregnancy (you should also avoid taking Telmisartan Mylan during early pregnancy - see "Pregnancy")
• if you have severe liver problems, such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder) or any other severe liver disease
• if you have diabetes, impaired kidney function, or are being treated with a blood pressure-lowering medicine containing aliskiren

If any of these conditions apply to you, inform your doctor or pharmacist before taking Telmisartan Mylan.

Warnings and precautions

Tell your doctor if you 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 you are dehydrated or have low salt levels due to diuretic use, 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 taking Telmisartan Mylan, discuss with your doctor or pharmacist:

if you are taking digoxin:

• if you are taking any of the following medicines for high blood pressure:
• ACE inhibitors (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems caused by diabetes
• aliskiren

Your doctor may check your 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 you are black, Telmisartan Mylan may be less effective in lowering your blood pressure, as with all other angiotensin II receptor antagonists in black patients.
Tell your doctor if you are planning 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 harm the baby (see "Pregnancy").
If you are scheduled for surgery or anesthesia, inform your doctor that you are taking Telmisartan Mylan.
Children and adolescents
Telmisartan Mylan should not be used in children and adolescents under 18 years of age.

Telmisartan Mylan with other medicines

Tell your doctor or pharmacist about all the medicines you are taking, have recently taken, or plan to take.
Your 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 Telmisartan Mylan:

• Lithium preparations (used to treat certain types of depression)
• Medicines that may increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (e.g., aspirin or ibuprofen), heparin, immunosuppressive agents (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim
• Diuretics (e.g., furosemide, hydrochlorothiazide, amiloride), especially when taken in high doses with Telmisartan Mylan, as they may lead to significant water loss and low blood pressure (hypotension)
• As with other blood pressure-lowering medicines, the effectiveness of Telmisartan Mylan may be reduced when taken with non-steroidal anti-inflammatory drugs (e.g., aspirin or ibuprofen) or corticosteroids
• Other medicines used to treat high blood pressure, strong painkillers, barbiturates (used to treat epilepsy), baclofen (used to treat cerebral palsy and multiple sclerosis), amifostine (used to prevent fever and infections in patients receiving chemotherapy and radiation therapy), or antidepressants
• ACE inhibitors or aliskiren (see also the information in the sections "When not to take Telmisartan Mylan" and "Warnings and precautions")
• Digoxin

Telmisartan Mylan may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure.

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 you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you are planning to become pregnant.
Normally, your doctor will advise you to stop taking telmisartan before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of telmisartan.
Telmisartan Mylan should not be taken during early pregnancy and must not be taken after the third month of pregnancy, as it may harm the baby, if taken after 3 months of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed.
Telmisartan is not recommended for mothers who are breastfeeding. Your doctor may choose another treatment if you want to breastfeed, especially if you are breastfeeding newborns or premature babies.

Driving and using machines

Some patients with high blood pressure may experience dizziness or fatigue. If you experience dizziness or fatigue, do not drive or operate machinery.

Telmisartan Mylan contains sodium

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

3. How to take Telmisartan Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose of Telmisartan Mylan will depend on the reason for taking the medicine.
Take the medicine once daily, at the same time each 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, your doctor may recommend a lower dose of 20 mg once 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 taken in combination with a diuretic (e.g., 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 beginning of treatment.
If you feel that the effect of Telmisartan Mylan is too strong or too weak, talk to your doctor or pharmacist.
Telmisartan Mylan is available in 2 strengths: 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

Swallow the tablets whole with water or another non-alcoholic drink.
Telmisartan Mylan can be taken with or without food.

Patients with liver problems

In patients with liver problems, the recommended dose should not exceed 40 mg once daily.

Patients with kidney problems

If you have kidney problems, consult your doctor. Your doctor may prescribe a lower initial dose of 20 mg once daily.

Taking more than the recommended dose of Telmisartan Mylan

If you accidentally take too many tablets, contact your doctor or pharmacist immediately or go to the nearest hospital emergency department.
Symptoms of overdose may include: low blood pressure, dizziness, fast or slow heart rate, and kidney problems.

Missing a dose of Telmisartan Mylan

If you miss a dose, take it as soon as you remember, then continue taking your medicine as usual. If you miss a dose one day, take your normal dose the next day.
Do not take a double dose to make up for a missed dose.

Stopping treatment with Telmisartan Mylan

Before stopping treatment with Telmisartan Mylan, consult your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Seek immediate medical attention if you experience any of the following symptoms, as they can be life-threatening if left untreated:

• Septicaemia* (also known as "blood poisoning", a severe infection with an inflammatory response affecting the whole body)
• 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 hands (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 being treated for cardiovascular events, such as heart attack or stroke
• Upper respiratory tract infections, such as sore throat, cold, sinusitis, causing pain, high temperature, and tenderness
• Urinary tract infections, including cystitis
• Decreased red blood cell count (anaemia), which can cause pale skin, weakness, and shortness of breath
• High potassium levels in the blood, visible in blood test results
• Depression
• Difficulty sleeping
• Dizziness
• Fainting
• Dizziness when standing up (orthostatic hypotension)
• Slow heart rate (bradycardia)
• Low blood pressure (hypotension) in patients being 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):
• Decreased platelet count, which can increase the risk of bleeding and bruising
• Increased levels of certain white blood cells (eosinophilia), visible in blood test results
• Feeling anxious
• Vision disturbances (impaired vision)
• Fast 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 (e.g., liver enzymes or creatine phosphokinase), visible in blood test results
• Low blood sugar levels (in patients with diabetes)
• Decreased 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 you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Telmisartan Mylan

Keep this medicine out of the 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 that month.
Store in the original package to protect from light.
Do not use Telmisartan Mylan if you notice a change in the color of the tablets.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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/Aluminium/PVC/Aluminium, containing 28 tablets.

Marketing authorisation holder and manufacturer:

Marketing authorisation 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 authorized names in the Member States of the European Economic Area, contact the representative of the marketing authorisation holder:

Mylan Healthcare Sp. z o.o.

Phone: +48 22 546 64 00

Date of last revision of the leaflet: