Telmisartan viatris

Package leaflet: Information for the user

Telmisartan Mylan, 40 mg, tablets
Telmisartan Mylan, 80 mg, tablets
Telmisartanum
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Telmisartan Mylan is and what it is used for
2. What you need to know 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 Telmisartan Mylan is and what it is used for

Telmisartan Mylan contains the active substance 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 increased blood pressure. Telmisartan Mylan blocks the effect 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 high blood pressure is not caused by another disease.
Untreated high blood pressure may damage blood vessels in various organs and, in some cases, may lead to heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before these complications occur. Therefore, it is important to measure your blood pressure regularly to ensure it remains within normal limits.
Telmisartan Mylan is also used to reduce the risk of heart attack or stroke in adults at high risk, such as those who have reduced blood flow to the heart or legs, who have had a stroke, or who have organ damage due to diabetes.
Your doctor will inform you whether you belong to this high-risk group.

2. What you need to know before taking Telmisartan Mylan

Do not 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 using Telmisartan Mylan during early pregnancy – see section "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 the above apply to you, please inform your doctor or pharmacist before taking Telmisartan Mylan.

Warnings and precautions

Please inform your doctor if you have or have had any of the following conditions or diseases:

• kidney disease or status post kidney transplant
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys)
• liver disease
• heart problems
• low blood pressure (hypotension), especially if you are dehydrated or have low salt levels due to diuretics, a low-salt diet, diarrhoea, or vomiting
• fluid and salt retention accompanied by imbalances in blood mineral levels (e.g. increased aldosterone levels)
• increased potassium levels in the blood
• diabetes

Before starting Telmisartan Mylan, discuss with your doctor or pharmacist if you are taking:

• digoxin
• any of the following medicines used to treat high blood pressure:
  • ACE inhibitors (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems due to diabetes
  • aliskiren

Your doctor may regularly monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also information in the section: "Do not take Telmisartan Mylan".

If you are of Black race, Telmisartan Mylan may be less effective in lowering blood pressure, as is the case with all other angiotensin II receptor antagonists used in Black patients.

Please inform your doctor if you suspect or are planning pregnancy. Telmisartan Mylan is not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").
If you are scheduled for surgery or anaesthesia, inform your doctor that you are taking Telmisartan Mylan.

Children and adolescents
Telmisartan Mylan is not recommended for use in children and adolescents under 18 years of age.

Telmisartan Mylan and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take.
Your doctor may decide to adjust the dose of these medicines or take other precautions. In some cases, one of the medicines may need to be discontinued. This particularly applies when taking the following medicines together with Telmisartan Mylan:

• Lithium preparations (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, angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressive medicines (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim
• Diuretics (water tablets), e.g. furosemide, hydrochlorothiazide, amiloride, especially when taken in high doses together with Telmisartan Mylan, as they may lead to significant fluid loss and low blood pressure (hypotension)
• As with other blood pressure-lowering medicines, the effectiveness of Telmisartan Mylan may be reduced when taken with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid 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 radiotherapy), or antidepressant tablets
• ACE inhibitors or aliskiren (see also information in sections: "Do not take Telmisartan Mylan" and "Warnings and precautions")
• Digoxin

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

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

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you suspect or are planning pregnancy.
Your doctor will usually advise stopping telmisartan before planning pregnancy or immediately after confirming pregnancy and will recommend an alternative medicine. Telmisartan Mylan is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used after 3 months of pregnancy.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Telmisartan is not recommended for breastfeeding mothers. Your doctor may choose an alternative treatment if you wish to breastfeed, especially if this involves feeding newborns or preterm infants.

Driving and using machines
Some patients being treated for 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 of sodium (23 mg) per tablet, i.e. it is considered "sodium-free".

3. How to use Telmisartan Mylan

This medicine should always be used exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
The recommended dose of Telmisartan Mylan depends on the reason for which the medicine is being used.
The medicine should be taken 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 ensures blood pressure control for 24 hours. However, your 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 may also be given in combination with a diuretic (water tablet),
such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of telmisartan.
For reducing 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, you should consult your doctor or pharmacist.
Telmisartan Mylan is available in two strengths: 40 mg and 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
Tablets should be swallowed whole with water or another non-alcoholic drink.
Telmisartan Mylan may be taken with or without food.
Patients with liver function disorders
In patients with impaired liver function, the recommended dose should not exceed 40 mg once daily.
Patients with kidney function disorders
If you have kidney problems, you should consult your doctor. Your doctor may prescribe a lower starting dose of 20 mg daily.
Taking more Telmisartan Mylan than recommended
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 heartbeat, and kidney problems.
Missing a dose of Telmisartan Mylan
If you miss a dose, take it as soon as you remember, then continue taking the medicine as prescribed.
If you miss a day's dose, take your normal dose the next day.
Do not take a double dose to make up for a missed dose.
Stopping Telmisartan Mylan
Before stopping Telmisartan Mylan, you should consult your doctor.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should contact your doctor immediately if any of the following symptoms occur,
as, if untreated, they may become life-threatening:

• Septicaemia* (often called "blood poisoning", a severe infection with a systemic inflammatory response)
• Severe allergic reaction with symptoms such as: rash, itching, difficulty breathing, wheezing, facial swelling, or low blood pressure (anaphylactic reaction)
• Sudden swelling of the skin, face, lips, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema)
• Severe skin reactions, which may include blistering and peeling of the skin (toxic skin reaction)
• Difficulty passing urine, nausea, vomiting, shortness of breath, swelling of legs, ankles or feet (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 occur in 1 out of 10 patients):

• Low blood pressure (hypotension) in patients treated to reduce the risk of cardiovascular events such as heart attack or stroke
  Uncommon (may occur in up to 1 out of 100 patients):

• Upper respiratory tract infections, e.g. sore throat, common cold, sinusitis causing pain, high temperature and tenderness

• Urinary tract infections, including cystitis

• Decrease in red blood cells (anaemia), which may cause pale skin, weakness and shortness of breath

• High potassium levels in blood tests

• Depression

• Difficulty sleeping

• Sensation of spinning (vertigo)

• 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, diarrhoea, indigestion, bloating or vomiting

• Rash, itchy skin

• Excessive sweating

• Back pain, muscle pain, muscle cramps

• Weakness

• Increased creatinine levels in blood tests
  Rare (may occur in up to 1 out of 1000 patients):

• Decrease in platelets, which increases the risk of bleeding and bruising

• Increase in certain white blood cells (eosinophilia) seen in blood tests

• Feeling of restlessness

• Vision disturbances (blurred vision)

• Fast heart rate (tachycardia)

• Dry mouth

• Taste disturbances

• Liver function abnormalities**

• Skin inflammation, characterised by itching and rash, often with blisters (eczema), skin redness

• Joint pain, limb pain, tendon pain

• Influenza-like symptoms

• Increased levels of certain enzymes in blood (such as liver enzymes or creatine kinase) seen in blood tests

• Low blood sugar (in patients with diabetes)

• Decreased haemoglobin (blood protein) levels seen in blood tests

• Increased uric acid levels seen in blood tests

• Drowsiness

• Stomach discomfort

*In a long-term study involving over 20,000 patients, septicaemia occurred more frequently
in patients treated with telmisartan compared to those not receiving telmisartan.
This may be coincidental or related to a currently unknown mechanism.
** Most cases of abnormal liver function and liver disorders
reported during the post-marketing period occurred in patients from Japan.
Japanese patients have a higher likelihood of experiencing these adverse effects.
*** Cases of interstitial lung disease temporally associated with telmisartan use have been reported.
However, a causal relationship has not been established.
Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions
of the Office for Registration 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
Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Telmisartan Mylan

Keep the 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 the specified month.
Store in the original packaging to protect from light.
Do not use Telmisartan Mylan if a change in the colour of the tablets is observed.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures 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, embossed with the code 'TN40' on one side and 'M' on the other side.
80 mg: White to off-white, oval, biconvex tablets, embossed with the code 'TN80' on one side and 'M' on the other side.
Telmisartan Mylan is available in OPA/Aluminium/PVC/Aluminium blister packs containing 28 tablets.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturers
McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate
Grange Road, Dublin 13
Ireland
Mylan Hungary Kft.
H-2900 Komárom
Mylan utca 1
Hungary

For further information about this medicinal product and its brand names in the Member States of the European Economic Area, please contact the representative of the Marketing Authorisation Holder:
Mylan Healthcare Sp. z o.o.
Tel: +48 22 546 64 00