TELMISARTAN 20 mg Tabletki Powlekane

Treść ulotki

1. Telmisartan EG 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets
   1. What is Telmisartan EG and what is it used for
   2. What you need to know before taking Telmisartan EG
   3. How to take Telmisartan EG
   4. POSSIBLE SIDE EFFECTS
   5. How to store Telmisartan EG
   6. Content of the pack and other information

Telmisartan EG 20 mg film-coated tablets, 40 mg film-coated tablets, 80 mg film-coated tablets

Generic medicine

Read this leaflet carefully before taking this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Telmisartan EG is and what it is used for
• 2. What you need to know before you take Telmisartan EG
• 3. How to take Telmisartan EG
• 4. Possible side effects
• 5. How to store Telmisartan EG
• 6. Contents of the pack and other information

1. What is Telmisartan EG and what is it used for

Telmisartan EG belongs to a class of medicines known as angiotensin II receptor antagonists. Angiotensin II is a substance produced in your body that causes blood vessels to constrict, thereby increasing blood pressure. Telmisartan EG blocks the effect of angiotensin II, causing blood vessels to relax and thus reducing blood pressure.
Telmisartan EG is used for the treatment of essential hypertension (high blood pressure).
“Essential” means that the high blood pressure is not caused by other conditions.
High blood pressure, if left untreated, can damage blood vessels in many organs, which can sometimes cause heart attack, heart failure or kidney failure, stroke or blindness. Normally, high blood pressure does not give symptoms before such damage occurs. Therefore, it is important to have your blood pressure measured regularly to check if it is within the normal range.

Telmisartan EG is also usedto reduce cardiovascular events (e.g. heart attack or stroke) in
patients who are at risk because their blood supply to the heart or legs is reduced or blocked or
have had a stroke or have high-risk diabetes. Your doctor can tell you if you are at high risk
of these events.

2. What you need to know before taking Telmisartan EG

Do not take Telmisartan EG
if you are allergic to telmisartan or any of the other ingredients of this medicine (listed in
section 6).
if you are pregnant for more than 3 months (it is best to avoid taking Telmisartan EG even in the
early stages of pregnancy - see the Pregnancy section).
if you suffer from severe liver problems such as cholestasis or biliary obstruction (problems with the
drainage of bile from the liver and gallbladder) or any other serious liver disease.
if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that
lowers your blood pressure, containing aliskiren.
If any of these conditions apply to you, tell your doctor before taking Telmisartan EG.

Warnings and precautions
Tell your doctor if you suffer from 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 of one or both kidneys).
Liver diseases.
Heart problems.
Increased levels of aldosterone (retention of water and salt in the body with an imbalance of various minerals
in the blood).
Low blood pressure (hypotension), which is more likely to occur if you are dehydrated
(excessive loss of water from the body) or have a salt deficiency due to diuretic
therapy (“diuretics”), a low-salt diet, diarrhea or vomiting.
High levels of potassium in the blood.
Diabetes.

Talk to your doctor, pharmacist or nurse before taking Telmisartan EG
If you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney
problems related to diabetes.
aliskiren.
The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also what is stated under "Do not take Telmisartan EG”.
You should tell your doctor if you think you may be pregnant (or if there is a possibility of becoming
pregnant). Telmisartan EG is not recommended in the early stages of pregnancy and should not be taken
after the third month of pregnancy as it can cause serious harm to the baby if taken during that period
(see the section relating to pregnancy).
In case of surgery or administration of anesthetics, you must inform your doctor that you are
taking Telmisartan EG.

Children and adolescents
The use of Telmisartan EG in children and adolescents up to 18 years of age is not recommended.
Like all other angiotensin II receptor antagonists, Telmisartan EG may be less effective
in lowering blood pressure in black patients.

Other medicines and Telmisartan EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The doctor may decide to change the dose of these other medicines or take other precautions. In
some cases it may be necessary to stop taking one of these medicines. This applies especially to the medicines listed below, taken simultaneously with Telmisartan EG:
Medicines containing lithium to treat some types of depression.
Medicines that can increase potassium levels in the blood such as potassium-containing salt substitutes, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists,
NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen), heparin,
immunosuppressants (e.g. cyclosporine or tacrolimus) and the antibiotic trimethoprim.
Diuretics, especially if taken at high doses with Telmisartan EG, can induce excessive
loss of body water and low blood pressure (hypotension).
If you are taking an ACE inhibitor or aliskiren (see also what is stated under: "Do not take
Telmisartan EG" and "Warnings and precautions”).
As with other medicines that lower blood pressure, the effect of Telmisartan EG may be
reduced when taking NSAIDs (non-steroidal anti-inflammatory drugs, e.g. aspirin or ibuprofen) or
corticosteroids.
Telmisartan EG may increase the effect of other medicines used to lower blood pressure

Telmisartan EG with food
Telmisartan EG can be taken with or without food.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
As a rule, your doctor will advise you to stop taking Telmisartan EG before you start trying to
become pregnant or as soon as you know you are pregnant and will advise you to take another medicine
instead of Telmisartan EG. Telmisartan EG is not recommended in the early stages of pregnancy and should not be
taken after the third month of pregnancy as it can cause serious harm to the baby if taken during that
period.
Breastfeeding
Telmisartan EG is not recommended during breastfeeding and your doctor may choose another treatment
for you if you wish to breastfeed, especially if your baby is newly born or premature.

Driving and operating machinery
There is no information on the effect of Telmisartan EG on the ability to drive or operate
machinery. Some patients may experience dizziness or drowsiness during treatment
for hypertension. If you experience these effects, do not drive or operate machinery.

Telmisartan EG contains lactose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before
taking this medicine.

3. How to take Telmisartan EG

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
doubts, consult your doctor or pharmacist.
The recommended dose of Telmisartan EG is one tablet a day. Try to take the
tablet at the same time each day. You can take Telmisartan EG with or without food. The tablets
should be swallowed with a little water or other non-alcoholic beverages. It is important that you take
Telmisartan EG every day unless your doctor instructs otherwise. If you feel that
the effect of Telmisartan EG is too strong or too weak, talk to your doctor or pharmacist.
For the treatment of high blood pressure, the recommended dose of Telmisartan EG for
most patients is one 40 mg tablet a day to control blood pressure for
a period of 24 hours. However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose
of 80 mg.
Alternatively, Telmisartan EG can also be used in combination with diuretics (tablets that
promote diuresis), such as hydrochlorothiazide, for which an additive effect has been demonstrated with
the association with Telmisartan EG in terms of blood pressure reduction.
For the reduction of cardiovascular events, the recommended dose of Telmisartan EG is one tablet of
80 mg once a day. At the beginning of preventive therapy with Telmisartan EG 80 mg, blood
pressure should be checked frequently.
If your liver is not functioning properly, the usual dose of 40 mg per
day should not be exceeded.

If you take more Telmisartan EG than you should
If you accidentally take too many tablets, seek immediate medical advice from your doctor, pharmacist or
go to the nearest emergency room.

If you forget to take Telmisartan EG
If you forget to take a dose, do not worry. Take it as soon as you remember and then continue as usual.
If you miss a dose for one day, take your normal dose the next day. Do not take a double
dose to make up for a missed dose.

If you stop taking Telmisartan EG
Do not stop treatment with Telmisartan EG without first consulting your doctor.
You may need to take medicines to control your blood pressure for the rest of your
life. If you stop treatment with Telmisartan EG, your blood pressure will return within a few days to pre-
treatment levels.
If you have any further questions about the use of this medicine, ask your doctor, pharmacist or
nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Some side effects may be serious and require immediate medical attention:
Seek medical attention immediately if you experience any of the following symptoms:
Sepsis* (often called “blood poisoning”, is a serious infection that causes an inflammatory response
throughout the body), rapid swelling of the skin and mucous membranes (angioedema), severe allergic
reaction (anaphylactic reaction), allergic reaction (e.g. skin rashes, itching, difficulty
breathing, wheezing, swelling of the face or low blood pressure); these side effects are rare
(may affect up to 1 in 1000 patients) but are extremely serious and patients should
stop taking the medicine and seek medical attention immediately. If these effects are not
treated they can be fatal.

Possible side effects of Telmisartan EG
Common side effects (may affect up to 1 in 10 people):
Low blood pressure (hypotension) in patients treated for cardiovascular events.
Uncommon side effects (may affect up to 1 in 100 people):
Urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis,
common cold), low red blood cell count (anemia), high potassium levels, difficulty falling
asleep, feeling sad (depression), fainting (syncope), feeling dizzy (vertigo), slowed heart
rate (bradycardia), low blood pressure (hypotension) in patients treated for hypertension,
dizziness upon standing up (orthostatic hypotension), shortness of breath, cough, abdominal
pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, increased sweating, drug
rash, back pain, muscle cramps, muscle pain (myalgia), impaired
kidney function including acute renal failure, chest pain, feeling weak, increased
creatinine levels in the blood.
Rare side effects (may affect up to 1 in 1000 people):
Increased certain types of white blood cells (eosinophilia), low platelet count (thrombocytopenia), low
blood sugar levels (in diabetic patients), anxiety, drowsiness, vision disturbances, fast heart
rate (tachycardia), dry mouth, stomach disorders, abnormal liver function (Japanese patients
are more likely to experience these side effects), eczema (a skin disease), skin redness, hives,
severe drug rash, joint pain (arthralgia), pain in the extremities, tendon pain, flu-like illness,
decreased hemoglobin (a blood protein), increased uric acid levels, increased liver enzymes or
creatine phosphokinase in the blood.
Very rare side effects (may affect up to 1 in 10,000)
Progressive scarring of lung tissue (interstitial lung disease)**
* The event may occur by chance or may be related to a currently unknown mechanism.
** Cases of progressive scarring of lung tissue have been reported during the intake of
telmisartan. However, it is not known whether telmisartan is the cause of this.
Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor, pharmacist or nurse. You can also report side effects directly through
the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side
effects you can help provide more information on the safety of this medicine.

5. How to store Telmisartan EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date indicated on the pack after the designation "EXP". The
expiry date refers to the last day of that month.
This medicine does not require special storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of the
medicines you no longer use. This will help protect the environment.

6. Content of the pack and other information

What Telmisartan EG contains

• The active ingredient is telmisartan, each tablet contains 20 mg/40 mg/80 mg of telmisartan.
• The other ingredients are: Sodium hydroxide Povidone (K-25) Meglumine Lactose monohydrate Crospovidone Yellow iron oxide (E172) Magnesium stearate

The tablet coating contains:
Hypromellose
Titanium dioxide (E171)
Macrogol-400
Talc
Yellow iron oxide (E172)

Description of the appearance of Telmisartan EG and content of the pack
Telmisartan EG is available in the form of film-coated tablets with a circular shape and yellow color
with "20" imprinted on one side and "T" imprinted on the other.
Telmisartan EG is available in the form of film-coated tablets with a capsule shape and yellow color
with "40" imprinted on one side and "T" imprinted on the other.
Telmisartan EG is available in the form of film-coated tablets with a capsule shape and yellow color
with "80" imprinted on one side and "T" imprinted on the other.
Telmisartan EG 20 mg is provided in blister packs containing 7, 10, 14, 15, 28, 30, 56, 60, 84, 90, 98, 112,
126, 140, 154, 168 or 182 tablets.
Telmisartan EG 40 mg is provided in blister packs containing 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98,
112, 126, 140, 154, 168 or 182 tablets.
Telmisartan EG 80 mg is provided in blister packs containing 7, 10, 14, 15, 28, 30, 50, 56, 60, 84, 90, 98,
112, 126, 140, 154, 168 or 182 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A. Via Pavia, 6 – 20136 Milan

Manufacturers
Glenmark Pharmaceuticals s.ro., Fibíchova 143, 56617 Vysoké Mýto (Czech Republic)
Tillomed Laboratories Ltd., 3 Howard Road, Easton Socon, St. Neots, Cambridgeshire, PE 198ET (United
Kingdom)
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
STADA Arzneimittel GmbH, Muthgasse 36, 1190 Vienna (Austria)
Clonmel Healthcare LTD, Waterford Road, Clonmel, Co. Tippery (Ireland)

This medicinal product is authorised in the Member States of the European Economic Area with the following
denominations:
UK Telmisartan Glenmark Generics20/40/80 mg film-coated tablets
AT Telmisartan STADA20/40/80 mg Filmtabletten
BE Telmisartan EG 20/40/80 mg filmomhulde tabletten
LU Telmisartan EG 20/40/80 mg comprimés pelliculés
BG Telmisartan STADA 20/40/80 mg Филмирана таблетка
DE Telmisartan STADA 20/40/80 mg Filmtabletten
DK Telmisartan STADA
ES Telmisartán STADA 20/40/80 mg comprimidos recubiertos con película EFG
FI Telmisartan STADA 20/40/80 mg Tabletti, kalvopäällysteinen
FR Telmisartan EG 20/40/80 mg comprimé pelliculé
IE Telmisartan Clonmel 20/40/80 mg film-coated tablets
IT Telmisartan EG 20/40/80 mg compresse rivestite con film
NL Telmisartan CF 20/40/80 mg filmomhulde tabletten
PT Telmisartan Ciclum
SE Telmisartan STADA 20/40/80 mg Filmdragerad tabletter