TELMISARTAN EGIS 40MG FILM-COATED TABLETS

Active substance: TELMISARTAN

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Package leaflet: Information for the user
Telmisartan EGIS 40mg film-coated 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
In this leaflet:
1.
What Telmisartan EGIS is and what it is used for
2.
What you need to know before you take Telmisartan EGIS
3.
How to take Telmisartan EGIS
4.
Possible side effects
5.
How to store Telmisartan EGIS
6.
Contents of the pack and other information

1.

What Telmisartan Egis is and what it is used for

Telmisartan EGIS 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 EGIS blocks the effect of angiotensin II so that the blood vessels relax, and
your blood pressure is lowered.
Telmisartan EGIS 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 EGIS is also used to reduce cardiovascular events (i.e. heart attack or stroke) in adult patients
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 EGIS

Do not take Telmisartan EGIS
 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 EGIS 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 EGIS.

Warnings and precautions
Talk to your doctor or pharmacist before taking Telmisartan EGIS
Please tell 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 EGIS 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 EGIS.
As with all other angiotensin II receptor antagonists, Telmisartan EGIS may be less effective in lowering the
blood pressure in black patients.
Children and adolescents
The use of Telmisartan EGIS in children and adolescents up to the age of 18 years is not recommended.
Other medicines and Telmisartan EGIS
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines,
including medicines obtained without a prescription. 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 EGIS:





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 EGIS may lead to
excessive loss of body water and low blood pressure (hypotension).

As with other blood pressure lowering medicines, the effect of Telmisartan EGIS may be reduced when you
take NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen) or corticosteroids.
Telmisartan EGIS may increase the blood pressure lowering effect of other medicines used to treat high
blood pressure.
Telmisartan EGIS with food and drink
You can take Telmisartan EGIS with or without food.
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 EGIS before you become pregnant or as soon as you know you are

pregnant and will advise you to take another medicine instead of Telmisartan EGIS.
Telmisartan EGIS 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 EGIS 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
No information is available on the effect of Telmisartan EGIS on the ability to drive or operate machinery.
Some people feel dizzy or tired when they are treated for high blood pressure. If you feel dizzy or tired, do
not drive or operate machinery.
Telmisartan EGIS contains lactose.
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 EGIS

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if
you are not sure.
The recommended dose of Telmisartan EGIS is one tablet a day. Try to take the tablet at the same time
each day.
You can take Telmisartan EGIS with or without food. The tablets should be swallowed with some water or
other non-alcoholic drink.
It is important that you take Telmisartan EGIS every day until your doctor tells you otherwise.
If you have the impression that the effect of Telmisartan EGIS is too strong or too weak, talk to your doctor
or pharmacist.
For the treatment of high blood pressure, the usual dose of Telmisartan EGIS 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 EGIS 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 EGIS.
For reduction of cardiovascular events, the usual dose of Telmisartan EGIS is one 80 mg tablet once a day.
At the beginning of the preventive therapy with Telmisartan EGIS 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 EGIS 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 EGIS
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 stop taking Telmisartan EGIS
Do not stop taking Telmisartan EGIS 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 EGIS 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.
Common side effects (may affect up to 1 in 10 people) may include:
Low blood pressure (hypotension) in users treated for reduction of cardiovascular events.
Uncommon side effects (may affect up to 1 to 100 people) may include:
Upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold).
Urinary tract infections, deficiency in red blood cells (anaemia), high potassium levels, feeling sad
(depression), fainting (syncope), difficulty falling asleep, feeling of spinning (vertigo), slow heart rate
(bradycardia), low blood pressure (hypotension), in users treated for high blood pressure, dizziness or
standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in
the abdomen, bloating, vomiting, increased sweating, itching, drug rash, muscle pain (myalgia), back pain,
muscle cramps, kidney impairment including acute kidney failure, and 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) may include:
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**, severe drug rash, hives (urticaria),
redness of skin, rapid swelling of the skin and mucosa which can also lead to death (angioedema also with
fatal outcome), eczema (a skin disorder), joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness,
increased levels of uric acid, hepatic enzymes or creatine phosphokinase in the blood and decreased
haemoglobin (a blood protein).
Very rare side effects (may affect up to 1 in 10,000 people) may include:
Progressive scarring of lung tissue (interstitial lung disease)***.
* In a long-term study involving more than 20,000 patients, more patients treated with telmisartan

experienced sepsis compared with patients who received no telmisartan. The event may have happened
by chance or could be related to a mechanism currently not known.
** Most cases of abnormal liver function and liver disorder from post-marketing experience with
telmisartan occurred in Japanese patients. Japanese patients are more likely to experience this side effect.
*** 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 side effects not listed in this
leaflet.

5.

How to store Telmisartan EGIS

Store in the original package in order to protect from moisture.
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.
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 EGIS 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 EGIS looks like and contents of the pack
Telmisartan EGIS 40 mg are yellow, capsule shaped film coated tablets with ‘40’ engraved on one side and
‘T’ engraved on the other side.
Telmisartan EGIS 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 and Manufacturer
Marketing Authorisation Holder
EGIS Pharmaceuticals PLC
H-1106 Budapest, Keresztúri út 30-38.
Hungary

Manufacturer
Tillomed Laboratories Limited.
3 Howard Road. Eaton Socon ST Neots,
Cambridgeshire. PE19 3 ET.
United Kingdom
Glenmark Pharmaceuticals sro.
City Tower, Hvezdova 1716/2B,
Prague 4, CZ-140 78,
Czech Republic
Glenmark Generics (Europe) Limited.
Building 2, Croxley Green Business Park, Hatters Lane, Croxley Green,
Hertfordshire, WD18 8YR,
United Kingdom
EGIS Pharmaceuticals PLC
H-1106, Budapest, Keresztúri út 30-38,
Hungary.
For any information about this medicine, please contact the local representative of the Marketing
Authorisation Holder.
This medicinal product is authorised in the Member States of the EEA under the following names:
Great Britain
Bulgaria:
Czech Republic:
Hungary:
Lithuania:
Latvia:
Poland:
Romania:
Slovak republic:

Telmisartan EGIS 40mg film-coated tablets
Telmisartan EGIS 40mg филмирани таблетки
Telmisartan EGIS 40mg
Telmisartan EGIS 40mg filmtabletta
Telmisartan EGIS 40mg plėvele dengtos tabletės
Telmisartan EGIS 40mg apvalkotās tabletes
Telmisartan EGIS
Telmisartan EGIS 40mg comprimate filmate
Telmisartan EGIS 40mg

This leaflet was last revised in {03/2013}.
POM
PL 0325/0024

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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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