Telmisartan Mylan: detailed information

Patient Information Leaflet

Telmisartan Mylan 20 mg tablets, 40 mg tablets, 80 mg tablets

telmisartan
Generic Medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

What Telmisartan Mylan is and what it is used for
What you need to know before taking Telmisartan Mylan
How to take Telmisartan Mylan
Possible side effects
How to store Telmisartan Mylan
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 class of medicines known as “angiotensin II receptor blockers”. Angiotensin II is a substance produced by the body that causes blood vessels to narrow, thereby increasing blood pressure. Telmisartan Mylan blocks the effect of angiotensin II, so that blood vessels relax and blood pressure is lowered.
Telmisartan Mylan is used to treat essential hypertension (high blood pressure) in adults. “Essential” means that the hypertension is not caused by other conditions.
If hypertension is not treated, it may damage blood vessels in certain organs, which can lead to heart attack, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms until such damage occurs. Therefore, it is important to have your blood pressure checked regularly to ensure it is within the normal range.
Telmisartan Mylan is also used to reduce the risk of heart attack or stroke in adults who are at risk because they have reduced or blocked blood flow to the heart or legs, have had a previous stroke, or have organ damage caused by diabetes. Your doctor may tell you if you are at high risk for these events.

2. What you need to know before taking Telmisartan Mylan

Do not take Telmisartan Mylan:

if you are allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6)
if you are more than three months pregnant (it is better to avoid Telmisartan Mylan even in the early stages of 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 mellitus or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply to you, talk to your doctor or pharmacist before taking
Telmisartan Mylan.
Warnings and precautions
Tell your doctor if you currently have or have previously had any of the following conditions or diseases:

if you have kidney disease or have had a kidney transplant
if you have renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
if you have any liver disease
if you have heart problems
if you have low blood pressure (hypotension), which is more likely if you have excessive fluid loss from the body (dehydration), low salt levels due to taking diuretics or following a low-salt diet, or if you have diarrhoea or vomiting
if you have fluid and salt retention in the body together with changes in various blood minerals (increased aldosterone levels)
if you have high levels of potassium in the blood
if you have diabetes.

Talk to your doctor or pharmacist before taking Telmisartan Mylan:

if you are being treated with digoxin
if you are taking any of the following medicines used to treat high blood pressure:
- an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes
- aliskiren.

Contact your doctor if, after taking Telmisartan Mylan, you experience abdominal pain, nausea, vomiting,
or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking
Telmisartan Mylan on your own.
Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium)
in your blood at regular intervals.
See also the section “Do not take Telmisartan Mylan”.
If you are of Black origin: as with all other angiotensin II receptor blockers, Telmisartan Mylan may be
less effective in lowering blood pressure in Black patients.
You must inform your doctor if you think you are pregnant (or might become pregnant). Telmisartan Mylan is
not recommended during early pregnancy and must not be taken after the third month of pregnancy, as it may
cause serious harm to the unborn baby if used during this period (see section “Pregnancy”).
If you are due to have surgery or to receive an anaesthetic, you must inform your doctor that you are
taking Telmisartan Mylan.
Children and adolescents
The use of Telmisartan Mylan is not recommended in children and adolescents under 18 years of age.
Other medicines and Telmisartan Mylan
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Your doctor may need to adjust the dose of these medicines and/or take other precautions. In some cases,
one of the other medicines may need to be discontinued. This particularly applies to the following
medicines when taken together with Telmisartan Mylan:

Lithium (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 (some diuretics), ACE inhibitors, angiotensin II receptor blockers, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin, immunosuppressants (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim
Diuretics, e.g. furosemide, hydrochlorothiazide, amiloride; especially if taken at high doses together with Telmisartan Mylan, they may lead to excessive fluid loss and low blood pressure (hypotension)
As with other blood pressure-lowering medicines, the effect of Telmisartan Mylan may be reduced if you take NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or corticosteroids
Other medicines used to treat high blood pressure, strong painkillers, barbiturates (for epilepsy), baclofen (used to treat cerebral palsy and multiple sclerosis), amifostine (used to prevent fever and infections in patients receiving chemotherapy or radiotherapy), or medicines for depression
If you are taking an ACE inhibitor or aliskiren (see also sections “Do not take Telmisartan Mylan” and “Warnings and precautions”)
Digoxin.

Telmisartan Mylan may enhance the antihypertensive effect of other medicines used to treat high
blood pressure.
Telmisartan Mylan and alcohol
Telmisartan Mylan, when taken together with alcohol, may increase the blood pressure-lowering effect,
which may cause dizziness, lightheadedness, and weakness, especially when rising from a sitting or
lying position.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding,
please consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you are pregnant (or might become pregnant). Your doctor will
normally advise you to stop taking telmisartan before pregnancy or as soon as pregnancy is diagnosed, and
will recommend an alternative medicine. Telmisartan is not recommended during early pregnancy and must
not be taken after the third month of pregnancy, as it may cause serious harm to the unborn baby after this
time.
Breastfeeding
Inform your doctor if you are breastfeeding or about to start breastfeeding. Telmisartan is not recommended
for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to
breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
Some patients may experience adverse effects such as fainting or dizziness (vertigo) when being treated
for high blood pressure. If you experience these adverse effects, do not drive or operate machinery.
Telmisartan Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Telmisartan Mylan

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of Telmisartan Mylan depends on why it has been prescribed for you. You should take your dose once daily, at the same time each day.
For the treatment of hypertension, the recommended dose is 40 mg once daily 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. A daily dose of 20 mg may be sufficient for some patients.
Telmisartan Mylan may also be used in combination with diuretics such as hydrochlorothiazide, which has shown an additive effect in lowering blood pressure when used together with Telmisartan Mylan.
To reduce the risk of heart attack or stroke, the recommended dose is 80 mg once daily. After starting treatment, blood pressure should be monitored frequently.
If you feel that the effect of Telmisartan Mylan is too strong or too weak, talk to your doctor or pharmacist.
The medicine is available in 3 strengths:
20 mg, 40 mg and 80 mg.

Use in children and adolescents
Children and adolescents under 18 years of age must not take Telmisartan Mylan.

Method of administration
Swallow the tablets whole with water or other non-alcoholic beverages.
Telmisartan Mylan may be taken with or without food.

Patients with liver problems
If your liver function is impaired, the recommended dose should not exceed 40 mg once daily.

Patients with kidney problems
If you have kidney problems, talk to your doctor. Your doctor may prescribe a reduced starting dose of 20 mg daily.

If you take more Telmisartan Mylan than you should
If you accidentally take too many tablets, contact your doctor, pharmacist or the nearest hospital emergency department immediately.
Signs to watch for include low blood pressure, dizziness, increased or decreased heart rate, and kidney problems.

If you forget to take Telmisartan Mylan
If you forget to take your tablet, don't worry. Take it as soon as you remember, then continue as before.
If you miss a dose for one day, take your usual dose the next day. Do not take a double dose to make up for a missed dose.

If you stop taking Telmisartan Mylan
If you wish to stop taking this medicine, discuss it with your doctor.
If you have any 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 everyone gets them.
Some side effects may be serious and require immediate medical treatment.
You must go to the doctor immediately if you experience any of the following symptoms, as they may be fatal if untreated:

Sepsis* (often called "blood infection", a severe infection with an inflammatory response throughout the body)
Severe allergic reaction with symptoms such as rash, itching, difficulty breathing, wheezing, facial swelling or low blood pressure (anaphylactic reaction)
Rapid swelling of the skin, face, lips, mouth, tongue or throat that may cause difficulty breathing or swallowing (angioedema)
Severe skin reactions, with blistering and peeling of the skin (toxic skin reaction)
Problems urinating associated with tiredness, feeling unwell, shortness of breath and swelling of legs, ankles or feet (renal impairment including kidney failure)
Shortness of breath with dry or non-productive cough and 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 cardiovascular events, such as heart attack or stroke.

Uncommon (may affect up to 1 in 100 people):

Upper respiratory tract infections (e.g. sore throat, common cold, inflammation and swelling of the sinuses causing pain, high fever, sensitivity)
Urinary tract infections, including bladder inflammation
Lack of red blood cells (anaemia), which may make the skin pale and cause weakness and shortness of breath
High potassium levels, which may be detected by blood tests
Feeling of sadness (depression)
Difficulty falling asleep
Sensation of dizziness (vertigo)
Fainting (syncope)
Dizziness or lightheadedness, especially when standing up (orthostatic hypotension)
Slow heart rate (bradycardia)
Low blood pressure (hypotension) in patients treated for high blood pressure
Shortness of breath and chest pain
Cough
Stomach pain, diarrhoea, indigestion, bloating or vomiting
Skin rash, itching
Increased sweating
Back pain, muscle pain (myalgia), spasms
Weakness
Increased levels of a substance called creatinine in the blood, which may be detected by blood tests.

Rare (may affect up to 1 in 1,000 people):

Decrease in the number of platelets, increasing the risk of bleeding or bruising
Increase in certain white blood cells (eosinophilia), which may be detected by blood tests
Feeling of anxiety
Visual disturbances (vision changes)
Increased heart rate (tachycardia)
Dry mouth
Altered taste (dysgeusia)
Liver function abnormalities **
Skin inflammation with itching and rash, often with blistering (eczema), skin redness, urticaria
Joint pain (arthralgia), limb pain or tendon pain
Influenza-like symptoms (influenza-like illness)
Increased levels of certain enzymes in the blood (such as liver enzymes or creatine phosphokinase), which may be detected by blood tests
Decreased blood sugar levels (in diabetic patients)
Decreased haemoglobin (a blood protein), which may be detected by blood tests
Increased uric acid levels, which may be detected by blood tests
Drowsiness
Stomach disorders
Low sodium levels.

Frequency not known (cannot be estimated from available data):

Intestinal angioedema: after use of similar products, swelling in the intestine has been reported, presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

* In a long-term study involving over 20,000 patients, a higher number of patients treated with telmisartan developed sepsis compared to patients who did not receive telmisartan. This event may be coincidental or may be related to a currently unknown mechanism.
** Most cases of abnormal liver function and liver disorders observed in post-marketing experience with telmisartan occurred in Japanese patients. Japanese patients are more likely to experience this adverse effect.
*** Cases of progressive scarring of lung tissue have been reported during telmisartan use. However, it is not known whether telmisartan is the cause.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
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 which is stated on the blister and outer carton after "Exp.".
The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not use this medicine if you notice any discolouration of the tablets.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Telmisartan Mylan contains

The active substance is telmisartan.
Each tablet contains 20 mg, 40 mg, or 80 mg of telmisartan.
The other components are: magnesium stearate, povidone, meglumine, sodium hydroxide, and mannitol (E421).

Description of the appearance of Telmisartan Mylan and contents of the pack
20 mg: White to off-white, round, flat tablets with bevelled edges, marked “TN” above “20” on one side and “M” on the other side.
40 mg: White to off-white, oblong tablets with sides curving outwards, marked “TN40” on one side and “M” on the other side.
80 mg: White to off-white, oblong tablets with sides curving outwards, marked “TN80” on one side and “M” on the other side.
Telmisartan Mylan is available in blister packs containing 28 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milan, Italy

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

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Telmisartan Mylan Generics 20 mg, 40 mg, 80 mg Tabletten
Italy: Telmisartan Mylan