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TELMISARTAN 80MG GLENMARK FILM-COATED TABLETS

Active substance(s): TELMISARTAN

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Package leaflet: Information for the user
Telmisartan 20mg Glenmark film-coated tablet
Telmisartan 40mg Glenmark film-coated tablet
Telmisartan 80mg Glenmark film-coated tablet
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 Glenmark is and what it is used for
2. What you need to know before you take Telmisartan Glenmark
3. How to take Telmisartan Glenmark
4. Possible side effects
5. How to store Telmisartan Glenmark
6. Contents of the pack and other information
1. What Telmisartan Glenmark is and what it is used for
Telmisartan Glenmark 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 Glenmark blocks
the effect of angiotensin II so that the blood vessels relax, and your
blood pressure is lowered.
Telmisartan Glenmark 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 Glenmark 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
Glenmark
Do not take Telmisartan Glenmark
• if you are allergic (hypersensitive) 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 Glenmark in early pregnancy – see pregnancy
section.)
• if you have severe liver problems such as cholestasis or biliary
obstruction (problems with the 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 Glenmark
Warnings and precautions
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 Glenmark:
• if you are taking any of the following medicines used to treat
high blood pressure:
– 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 Glenmark”.
• if you are taking digoxin.
You must tell your doctor if you think you are (or might become)
pregnant. Telmisartan Glenmark 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 Glenmark.
Telmisartan Glenmark may be less effective in lowering the blood
pressure in black patients.
Children and adolescents
The use of Telmisartan Glenmark in children and adolescents up to
the age of 18 years is not recommended.
Other medicines and Telmisartan Glenmark
Tell your doctor or pharmacist if you are taking, have recently taken
or might take any other medicines. Your doctor may need to change
the dose of these other medicines or 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 Glenmark:
• 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’), ACE inhibitors, 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 Glenmark, may lead to excessive loss
of body water and low blood pressure (hypotension).
• If you are taking an ACE-inhibitor or aliskiren (see also
information under the headings “Do not take Telmisartan
Glenmark” and “Warning and precautions”).
• Digoxin
The effect of Telmisartan Glenmark may be reduced when you take
NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or
ibuprofen) or corticosteroids.
Telmisartan Glenmark 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 medicine while
taking Telmisartan Glenmark.
Pregnancy and breast-feeding
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 Glenmark before you become pregnant or as soon
as you know you are pregnant and will advise you to take another
medicine instead of Telmisartan Glenmark. Telmisartan Glenmark 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 breastfeeding. Telmisartan Glenmark 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 newborn,
or was born prematurely.
Driving and using machines
Some people feel dizzy or tired when taking Telmisartan Glenmark.
If you feel dizzy or tired, do not drive or operate machinery.
Telmisartan Glenmark contains lactose.
If you are intolerant to some sugars, consult your doctor before
taking Telmisartan Glenmark.
3. How to take Telmisartan Glenmark
Always take Telmisartan Glenmark exactly as your doctor has told
you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Telmisartan Glenmark is one tablet

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 but are
extremely serious and patients should stop taking the product and
see their doctor immediately. If these effects are not treated they
could be fatal.
Possible side effects of Telmisartan Glenmark:
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in users treated for reduction of
cardiovascular events.
Uncommon side effects (may affect up to 1 to 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 side effects (may affect up to 1 in 1,000 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), upset stomach, dry mouth, taste disturbance
(dysgeusia), abnormal liver function(Japanese patients are more

likely to experience these 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 side effects (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 not 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
website 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 Glenmark
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 after “EXP”. The expiry date refers to the last day of
that month.
This medicine does not require any special storage conditions.
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 Glenmark contains
The active substance is telmisartan, each tablet contains
20mg/40mg/80mg telmisartan.
The other ingredients are: sodium hydroxide, povidone (K-25),
meglumine, lactose monohydrate, crospovidone, ferric oxide
yellow (E172), magnesium stearate.
The film-coating contains: hypromellose, titanium dioxide (E171),
macrogol-400, talc, ferric oxide yellow (E172).
What Telmisartan Glenmark looks like and contents of the
pack
Telmisartan 20mg Glenmark film-coated tablets are yellow, circular
shaped film coated tablets with ‘20’ engraved on one side and ‘T’
engraved on the other side.
Telmisartan 40mg Glenmark film-coated tablets are yellow,
capsule shaped film coated tablets with ‘40’ engraved on one side
and ‘T’ engraved on the other side.
Telmisartan 80mg Glenmark film-coated tablets are yellow,
capsule shaped film coated tablets with ‘80’ engraved on one side
and ‘T’ engraved on the other side.
Telmisartan Glenmark is available in blister packs containing 14,
15, 28, 30, 56, 60, 84, 90 or 98 tablets.
Not all pack sizes may be marketed in your country.
Marketing Authorisation Holder
Glenmark Pharmaceuticals Europe Limited
Laxmi House,
2 B Draycott Avenue,
Kenton, Middlesex
HA3 0BU,
United Kingdom
Manufacturers
Glenmark Pharmaceuticals sro
Fibichova 143,
566 17 Vysoké Mýto,
Czech Republic
Glenmark Pharmaceuticals Europe Limited
Building 2, Croxley Green Business Park,
Croxley Green, Hertfordshire, WD18 8YA
United Kingdom
Tillomed Laboratories Limited,
3 Howard Road, Eaton Socon, St Neots, Cambridgeshire,
PE19 8ET
This leaflet was last revised in November 2014.

PE185870713-1 UK

a day. Try to take the tablet at the same time each day. You
can take Telmisartan Glenmark with or without food. The tablets
should be swallowed with some water or other non-alcoholic drink.
It is important that you take Telmisartan Glenmark every day until
your doctor tells you otherwise. If you have the impression that the
effect of Telmisartan Glenmark is too strong or too weak, talk to
your doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of
Telmisartan Glenmark for most patients is one 40 mg tablet
once a day to control blood pressure over the 24-hour period.
However sometimes your doctor may recommend a lower dose
of 20 mg or a higher dose of 80 mg. Telmisartan Glenmark may
also 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 Glenmark.
For reduction of cardiovascular events, the usual dose of
Telmisartan Glenmark is one 80 mg tablet once a day. At the
beginning of the preventive therapy with Telmisartan Glenmark 80
mg, blood pressure should be frequently monitored.
If your liver is not working properly, the usual dose should not
exceed 40 mg once daily.
If you take more Telmisartan Glenmark 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 Glenmark
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 forgotten individual doses.
If you stop taking Telmisartan Glenmark
Do not stop taking Telmisartan Glenmark without talking to your
doctor.
Medicines for high blood pressure may need to be taken for the
rest of your life. If you stop taking Telmisartan Glenmark your
blood pressure will return to the level it was before treatment in
a few days.
If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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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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