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TELMISARTAN ZENTIVA 40MG TABLETS

Active substance(s): TELMISARTAN / TELMISARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Telmisartan 20mg Tablets
Telmisartan 40mg Tablets
Telmisartan 80mg Tablets
Telmisartan
Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask 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 signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What telmisartan is and what it is used for
2. What you need to know before you take telmisartan
3. How to take telmisartan
4. Possible side effects
5. How to store telmisartan
6. Contents of the pack and other information

1. What telmisartan is and what it is used for
The name of your medicine is Telmisartan 20mg, 40mg or 80mg Tablets (called telmisartan
throughout this leaflet).
Telmisartan belongs to a class of medicines known as angiotensin II receptor antagonists.
Angiotensin II is a substance produced in your body which causes your blood vessels to
narrow, thus increasing your blood pressure. Telmisartan blocks the effect of angiotensin II so
that the blood vessels relax, and your blood pressure is lowered.
Telmisartan is used to treat essential hypertension (high blood pressure) in adults.
‘Essential’ means that the high blood pressure is not caused by any other condition.
High blood pressure, if not treated, can damage blood vessels in several organs, which could
lead sometimes to heart attack, heart or kidney failure, stroke, or blindness. There are usually
no symptoms of high blood pressure before damage occurs. Thus it is important to regularly
measure blood pressure to verify if it is within the normal range.
Telmisartan is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adults
who are at risk because they have a reduced or blocked blood supply to the heart or legs, or
have had a stroke or have high risk diabetes. Your doctor can tell you if you are at high risk
for such events.

2. What you need to know before you take telmisartan
Do not take Telmisartan

if you are allergic to telmisartan or any of the other ingredients of this medicine (listed
in section 6).

if you are more than 3 months pregnant. (It is also better to avoid telmisartan in early
pregnancy – see pregnancy section.)

if you have severe liver problems such as cholestasis or biliary obstruction (problems
with drainage of the bile from the liver and gall bladder) or any other severe liver
disease.

if you have diabetes or impaired kidney function and you are treated with a blood
pressure lowering medicine containing aliskiren.
If any of the above applies to you, tell your doctor or pharmacist before taking telmisartan.
Warnings and precautions
Talk to your doctor or pharmacist before taking telmisartan.
Talk to your doctor if you are suffering or have ever suffered from any of the following
conditions or illnesses:









Kidney disease or kidney transplant
Renal artery stenosis (narrowing of the blood vessels to one or both kidneys)
Liver disease
Heart trouble
Raised aldosterone levels (water and salt retention in the body along with imbalance of
various blood minerals)
Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss
of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt
diet, diarrhoea, or vomiting
Elevated potassium levels in your blood
Diabetes

Talk to your doctor before taking telmisartan
 if you are taking digoxin
 if you are taking any of the following medicines used to treat high blood pressure or
heart disorders:
 an ACE-inhibitor (for example enalapril, lisinopril, ramipril) in particular if you
have diabetes-related kidney problems.
 aliskiren
 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 information under the heading “Do not take telmisartan”.
You must tell your doctor if you think you are (or might become) pregnant. Telmisartan is not
recommended in early pregnancy, and must not be taken if you are more than 3 months
pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy
section).
In case of surgery or anaesthesia, you should tell your doctor that you are taking telmisartan.

Telmisartan may be less effective in lowering the blood pressure in black patients.
Children and adolescents
The use of telmisartan in children and adolescents up to the age of 18 years is not
recommended.
Other medicines and telmisartan
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines. Your doctor may need to changeyour dose and/or to take other precautions. In
some cases you may have to stop taking one of the medicines. This applies especially to the
medicines listed below taken at the same time with telmisartan:







Lithium containing medicines to treat some types of depression.
Medicines that may increase blood potassium levels such as salt substitutes containing
potassium, potassium-sparing diuretics (certain 'water tablets'), angiotensin II receptor
antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or
ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the
antibiotic trimethoprim.
Diuretics ('water tablets'), especially if taken in high doses together with telmisartan
may lead to excessive loss of body water and low blood pressure (hypotension).
An ACE-inhibitor or aliskiren (used to treat high blood pressure) (see also information
under the headings “Do not take telmisartan” and “Warnings and precautions”).
Digoxin

The effect of telmisartan may be reduced when you take NSAIDs (non-steroidal antiinflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Telmisartan may increase the blood pressure lowering effect of other medicines used to treat
high blood pressure or of medicines with blood pressure lowering potential (e.g. baclofen,
amifostine). Furthermore, low blood pressure may be aggravated by alcohol, barbiturates,
narcotics or antidepressants. You may notice this as dizziness when standing up. You should
consult with your doctor if you need to adjust the dose of your other medicines while taking
telmisartan.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have
a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy:
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will
normally 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 is not recommended in early pregnancy, and must not be taken when more than
3 months pregnant, as it may cause serious harm to your baby if used after the third month of
pregnancy.
Breast-feeding:
Tell your doctor if you are breast-feeding or about to start breast-feeding. Telmisartan is not
recommended for mothers who are breast-feeding, and your doctor may choose another

treatment for you if you wish to breast-feed, especially if your baby is new born, or was born
prematurely.
Driving and using machines
Some people feel dizzy or tired when taking telmisartan.. If you feel dizzy or tired, do not
drive or operate machinery.
Telmisartan contains sorbitol.
If you have been told by your doctor that you have an intolerance to some sugars, contact
your doctor before taking this medicinal product.

3. How to take telmisartan
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
The recommended dose of telmisartan is one tablet a day. Try to take the tablet at the same
time each day. You can take telmisartan with or without food. The tablets should be
swallowed with some water or other non-alcoholic drink. It is important that you take
telmisartan every day until your doctor tells you otherwise. If you have the impression that the
effect of telmisartan is too strong or too weak, talk to your doctor or pharmacist.
For treatment of high blood pressure, the usual dose of telmisartan for most patients is one
40mg tablet once a day to control blood pressure over the 24-hour period. However,
sometimes your doctor may recommend a lower dose of 20mg or a higher dose of 80mg.
Administration of 20mg dose can be achieved by halving 40mg tablet with break line.
Alternatively telmisartan may be used in combination with diuretics ('water tablets') such as
hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect
with telmisartan.
For reduction of cardiovascular events, the usual dose of telmisartan is one 80mg tablet once a
day. At the beginning of the preventive therapy with Telmisartan 80mg, blood pressure
should be frequently monitored.
If your liver is not working properly, the usual dose should not exceed 40mg once daily.
If you take more telmisartan than you should
If you accidentally take too many tablets, contact your doctor, pharmacist, or your nearest
hospital emergency department immediately.
If you forget to take telmisartan
If you forget to take a dose, do not worry. Take it as soon as you remember then carry on as
before. If you do not take your tablet on one day, take your normal dose on the next day. Do
not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some side effects can be serious and need immediate medical attention:
You should see your doctor immediately if you experience any of the following symptoms:
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory
response), rapid swelling of the skin and mucosa (angioedema); these side effects are rare
(may affect up to 1 in 1,000 people) but are extremely serious and patients should stop taking
the medicine and see their doctor immediately. If these effects are not treated they could be
fatal.
Possible side effects of telmisartan:
Common (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.
Uncommon (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses,
common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty
falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow
heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood
pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough,
abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased
sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment
including acute kidney failure, pain in the chest, feeling of weakness, and increased level of
creatinine in the blood.
Rare (may affect up to 1 in 1000 people):
Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory
response which can lead to death), increase in certain white blood cells (eosinophilia), low
platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic
reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood
pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired
vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia),
abnormal liver function (Japanese patients are more likely to experience this side effect),
rapid swelling of the skin and mucosa which can also lead to death (angioedema also with
fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash,
joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin
(a blood protein)increased levels of uric acid, increased hepatic enzymes or creatine
phosphokinase in the blood.
Very rare (may affect up to 1 in 10,000 people):
Progressive scarring of lung tissue (interstitial lung disease).**
* The event may have happened by chance or could be related to a mechanism currently not
known.
** Cases of progressive scarring of lung tissue have been reported during intake of
telmisartan. However, it is known whether telmisartan was the cause.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store telmisartan
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 carton/blister after EXP.
The expiry date refers to the last day of that month.
Store below 30°C. Store in the original package in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist
how to throw away medicines you no longer use. These measures will help protect the
environment.
6. Contents of the pack and other information
What telmisartan contains
The active substance is telmisartan.
Telmisartan 20mg: Each tablet contains 20mg telmisartan.
Telmisartan 40mg: Each tablet contains 40mg telmisartan.
Telmisartan 80mg: Each tablet contains 80mg telmisartan.
The other ingredients are meglumine, sorbitol (E420), sodium hydroxide, povidone,
magnesium stearate.
What telmisartan looks like and contents of the pack
Telmisartan 20mg tablets are off-white to yellowish round tablets with a diameter of 7mm.
Telmisartan 40mg tablets are off-white to yellowish, oblong biconvex tablets, scored on both
sides, 12mm long and 6mm wide. The tablet can be divided into equal halves.
Telmisartan 80mg tablets are off-white to yellowish, embossed “80” on one side, oblong
biconvex tablets, 16mm long and 8mm wide.
Pack sizes:
Telmisartan 20mg: 14, 28, 30, 56, 60, 84, 90, 98 and 100 tablets
Telmisartan 40mg: 14, 28, 30, 56, 60, 84, 90, 98, 100 and 280 tablets
Telmisartan 80mg: 14, 28, 30, 56, 60, 84, 90, 98, 100 and 280 tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturers

Zentiva k.s, U kabelovny 130, Dolní Mĕcholupy, 102 37 Prague 10, Czech Republic
or
S.C. Zentiva S.A., B-dul. Theodor Pallady nr.50, sector 3, Bucuresti, cod 032266, Romania
This leaflet was last revised in September 2014.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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