TELMISARTAN 80MG GLENMARK GENERICS FILM-COATED TABLETS

Active substance: TELMISARTAN

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Package leaflet: Information for the user
Telmisartan 20mg Glenmark Generics film-coated tablet
Telmisartan 40mg Glenmark Generics film-coated tablet
Telmisartan 80mg Glenmark Generics 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.
What is in this leaflet:
1. What Telmisartan Glenmark Generics is and what it is used for
2. What you need to know before you take Telmisartan Glenmark
Generics
3. How to take Telmisartan Glenmark Generics
4. Possible side effects
5. How to store Telmisartan Glenmark Generics
6. Contents of the pack and other information
1. What Telmisartan Glenmark Generics is and what it is used
for
Telmisartan Glenmark Generics 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 Generics blocks the effect of angiotensin II so that the
blood vessels relax, and your blood pressure is lowered.
Telmisartan Glenmark Generics 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 Generics 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. Before you take Telmisartan Glenmark Generics
Do not take Telmisartan Glenmark Generics
• 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 Generics 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 any of the above applies to you, tell your doctor or pharmacist
before taking Telmisartan Glenmark Generics
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.
You must tell your doctor if you think you are (or might become)
pregnant. Telmisartan Glenmark Generics 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 Generics.
Telmisartan Glenmark Generics may be less effective in lowering
the blood pressure in black patients.
Children and adolescents
The use of Telmisartan Glenmark Generics in children and
adolescents up to the age of 18 years is not recommended.
Other medicines and Telmisartan Glenmark Generics
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 Generics:
• 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 Generics, may lead to excessive
loss of body water and low blood pressure (hypotension).
The effect of Telmisartan Glenmark Generics may be reduced when
you take NSAIDs (non steroidal anti-inflammatory medicines, e.g.
aspirin or ibuprofen) or corticosteroids.
Telmisartan Glenmark Generics may increase the blood pressure
lowering effect of other medicines used to treat high blood pressure.
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 Generics 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 Generics.
Telmisartan Glenmark Generics 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 Generics 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
Generics. If you feel dizzy or tired, do not drive or operate machinery.
Telmisartan Glenmark Generics contains lactose.
If you are intolerant to some sugars, consult your doctor before
taking Telmisartan Glenmark Generics.
3. How to take Telmisartan Glenmark Generics
Always take Telmisartan Glenmark Generics exactly as your doctor
has told you. Check with your doctor or pharmacist if you are not
sure.
The recommended dose of Telmisartan Glenmark Generics is one
tablet a day. Try to take the tablet at the same time each day.
You can take Telmisartan Glenmark Generics with or without food.
The tablets should be swallowed with some water or other nonalcoholic drink. It is important that you take Telmisartan Glenmark
Generics every day until your doctor tells you otherwise. If you have
the impression that the effect of Telmisartan Glenmark Generics 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 Generics 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 Generics
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
Generics.
For reduction of cardiovascular events, the usual dose of
Telmisartan Glenmark Generics is one 80 mg tablet once a day. At
the beginning of the preventive therapy with Telmisartan Glenmark
Generics 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 Generics 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 Generics
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 Generics
Do not stop taking Telmisartan Glenmark Generics 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 Generics
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.
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 Generics:
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, 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.
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet.
5. How to store Telmisartan Glenmark Generics
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 Generics 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 Generics looks like and contents
of the pack
Telmisartan 20mg Glenmark Generics 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 Generics 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 Generics 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 Generics 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 Generics (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 Generics (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 September 2012.      

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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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