TELMISARTAN DR REDDYS 80 MG TABLETS

Active substance: TELMISARTAN

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Telmisartan 20 mg, 40 mg, 80 mg 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.
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
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 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 any of the above applies to you, tell your doctor or pharmacist before taking Telmisartan.
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 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 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:
 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)
 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).
The effect of Telmisartan may be reduced when you take NSAIDs (non steroidal anti-inflammatory
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.
Telmisartan with food and drink
You can take Telmisartan with or without food. Swallow the tablets with some water or other nonalcoholic drink.
Pregnancy and breastfeeding
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.
Breastfeeding:
Tell your doctor if you are breastfeeding or about to start breastfeeding. Telmisartan is not
recommended for mothers who are breastfeeding, and your doctor may choose another treatment for
you if you wish to breastfeed, especially if your baby is newborn, 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.
3. How to take Telmisartan
Always take Telmisartan exactly as your doctor 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 this medicine 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 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 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.
For reduction of cardiovascular events: The usual dose of Telmisartan is one 80 mg tablet once a
day. At the beginning of the preventive therapy with Telmisartan 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 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 forgotten individual doses.
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", which is a severe infection with whole-body
inflammatory response). Signs are: rapid breathing and fast heart rate, fever or low body
temperature, confusion, disorientation, agitation and low blood pressure
 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 product and see their doctor immediately. If these effects are not treated they
could be fatal.
Possible side effects of Telmisartan:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet.
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
 increased level of creatinine in the blood.
Rare side effects (may affect up to 1 in 1,000 people):
 sepsis* (often called "blood poisoning", which is a severe infection with whole-body
inflammatory response which can lead to death). Signs are: rapid breathing and fast heart rate,
fever or low body temperature, confusion, disorientation, agitation and low blood pressure

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
 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 extremities, 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
Keep 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 contains
The active substance is telmisartan. Each 20 mg tablet contains 20 mg telmisartan. Each 40 mg tablet
contains 40 mg telmisartan. Each 80 mg tablet contains 80 mg telmisartan.
The other ingredients are meglumine, sodium hydroxide, povidone, polysorbate, mannitol (E421) and
magnesium stearate.
What Telmisartan looks like and contents of the pack
Telmisartan 20 mg are white to off-white, uncoated, round, flat face bevelled edge tablets with ‘T’ and
‘L’ debossed on either side of the break line on one side and ‘20’ debossed on the other side.
Telmisartan 40 mg are white to off-white, uncoated, modified capsule shaped tablets with ‘T’ and ‘L’
debossed on either side of the break line on one side and ‘40’ debossed on the other side.
Telmisartan 80 mg are white to off-white, uncoated, modified capsule shaped tablets with ‘T’ and ‘L’
debossed on either side of the break line on one side and ‘80’ debossed on the other side.
The break line is to help break the tablet for ease of swallowing and not to divide into equal doses.
Telmisartan 20 mg is available in blisters packs containing 28 tablets.
Telmisartan 40 mg is available in blisters packs containing 28, 56, or 98 tablets.
Telmisartan 80 mg is available in blisters packs containing 28, 56, or 98 tablets.
Not all pack sizes may be available in your country.
Marketing Authorisation Holder and Manufacturer
Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United
Kingdom
This leaflet was last revised in 04/2013

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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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