Telmisartan egis

Package leaflet: Information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.
Telmisartan EGIS
80 mg, coated tablets
Telmisartanum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet:

1. What Telmisartan EGIS is and what it is used for
2. What you need to know before taking 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 group of medicines called angiotensin II receptor antagonists.
Angiotensin II is a substance produced by the body that causes blood vessels to narrow, leading to
increased blood pressure. Telmisartan EGIS blocks the action of angiotensin II, allowing blood
vessels to relax and blood pressure to decrease.
Telmisartan EGIS is used to treat essential hypertension (high blood pressure) in adults. The term
"essential" means that high blood pressure is not caused by another disease.
Untreated high blood pressure may damage blood vessels in various organs and, in some cases,
may lead to heart attack, heart or kidney failure, stroke or loss of vision. Often, there are no
symptoms of high blood pressure before these complications occur. Therefore, it is important
to measure blood pressure regularly to ensure it remains within normal limits.
Telmisartan EGIS is also used to reduce the risk of cardiovascular events (such as heart attack
or stroke) in patients at high risk, such as those with reduced blood flow to the heart or legs, those
who have had a stroke, or those with diabetes.
Your doctor will inform you whether you belong to a high-risk group for such conditions.

2. Important information before using Telmisartan EGIS

When not to use Telmisartan EGIS

• if the patient is allergic to telmisartan or to any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy. Use of Telmisartan EGIS should also be avoided in early pregnancy (see section "Pregnancy");
• if the patient has severe liver problems such as cholestasis or biliary obstruction (problems with bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above situations apply to the patient, inform the doctor or pharmacist before taking Telmisartan EGIS.

Warnings and precautions

Before starting to take Telmisartan EGIS, discuss this with your doctor or pharmacist.

Inform your doctor if the patient has or has had any of the following conditions or diseases:

• kidney disease or status post kidney transplant;
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys);
• liver disease;
• heart problems;
• elevated aldosterone levels (retention of water and salt in the body, accompanied by imbalances in various blood mineral levels);
• low blood pressure (hypotension), particularly if the patient is dehydrated or has salt depletion due to diuretic therapy, low-salt diet, diarrhoea, or vomiting;
• increased potassium levels in the blood;
• diabetes;
• if the patient is taking any of the following medicines used to treat high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems related to diabetes;
  • aliskiren.

The treating doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals.

See also information under the heading "When not to use Telmisartan EGIS".

Before taking Telmisartan EGIS, inform the doctor:

• if the patient is taking digoxin.

Inform the doctor if pregnancy is suspected or planned. Use of Telmisartan EGIS is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy").

If undergoing surgery or anaesthesia, inform the doctor about taking Telmisartan EGIS.

Like other medicines in the angiotensin II receptor antagonist group, Telmisartan EGIS may be less effective in lowering blood pressure in patients of black race.

Children and adolescents

Use of Telmisartan EGIS is not recommended in the treatment of children and adolescents under 18 years of age.

Telmisartan EGIS and other medicines

Tell your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. The doctor may need to adjust the dose and/or take other precautions. In some cases, discontinuation of one of the medicines may be necessary. This particularly applies to concomitant use of Telmisartan EGIS with the following medicines:

• lithium preparations, used in the treatment of certain types of depression;
• medicines that may increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics, angiotensin II receptor antagonists, NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen), heparin, immunosuppressive medicines (e.g. cyclosporine or tacrolimus), and the antibiotic trimethoprim;
• diuretics (water tablets), especially when used in high doses together with Telmisartan EGIS, as they may lead to significant fluid loss and low blood pressure (hypotension);
• if the patient is taking an ACE inhibitor or aliskiren (see also information under the headings "When not to use Telmisartan EGIS" and "Warnings and precautions");
• digoxin.

As with other blood pressure-lowering medicines, the effect of Telmisartan EGIS may be reduced when taken together with NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen) or corticosteroids.

Telmisartan EGIS may enhance the blood pressure-lowering effect of other medicines used to treat hypertension or medicines that may cause low blood pressure (e.g. baclofen, amifostine). In addition, alcohol, barbiturates, narcotics, or antidepressants may further lower blood pressure. Symptoms include dizziness upon standing.

If dose adjustment of another medicine taken during Telmisartan EGIS treatment is needed, consult your doctor.

Telmisartan EGIS with food and drink

The patient may take Telmisartan EGIS with or without food.

Pregnancy and breastfeeding

Pregnancy

During pregnancy, breastfeeding, or if pregnancy is suspected or planned, consult a doctor or pharmacist before using this medicine.

Usually, the doctor will recommend stopping Telmisartan EGIS before planned pregnancy or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Use of Telmisartan EGIS is not recommended in early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child if used after the third month.

Breastfeeding

Inform the doctor if the patient is breastfeeding or intends to breastfeed. Telmisartan EGIS is not recommended for use in breastfeeding women. The doctor may choose a different treatment if the patient wishes to breastfeed, especially if the baby is a newborn or premature.

Driving and operating machinery

Some patients may experience dizziness or fatigue while taking Telmisartan EGIS. If dizziness or fatigue occurs, do not drive or operate machinery.

Telmisartan EGIS contains lactose and sodium

If the doctor has informed the patient of an intolerance to certain sugars, the patient should consult the doctor before taking this medicine.

The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Telmisartan EGIS

This medicine should always be taken as directed by your doctor. If in doubt, consult your
doctor or pharmacist.
The recommended dose of Telmisartan EGIS is one tablet per day. Try to take the tablet at the
same time each day.
Telmisartan EGIS may be taken with food or independently of meals. Tablets should be
swallowed with water or another non-alcoholic drink.
It is important to take Telmisartan EGIS every day, unless otherwise instructed by your doctor.
If you feel that the effect of Telmisartan EGIS is too strong or too weak, consult your doctor or
pharmacist.
For the treatment of hypertension, the usual recommended dose for most patients is one
40 mg tablet of Telmisartan EGIS once daily, which provides blood pressure control for over
24 hours. Your doctor may recommend a lower dose of one 20 mg tablet per day or a higher
dose of one 80 mg tablet per day.
(Since a 20 mg dose cannot be achieved with Telmisartan EGIS, your doctor may prescribe
another telmisartan-containing medicine for this purpose.)
Telmisartan EGIS may also be given in combination with a diuretic (water tablet) such as
hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmisartan EGIS.
To reduce the risk of cardiovascular events, the recommended dose of Telmisartan EGIS is
one 80 mg tablet once daily. At the beginning of treatment with the 80 mg dose of
Telmisartan EGIS, blood pressure should be monitored frequently.
In patients with impaired liver function, the recommended dose must not exceed 40 mg once
daily.
Taking more Telmisartan EGIS than recommended
If too many tablets are taken by mistake, contact your doctor or pharmacist or go to the nearest
hospital emergency department immediately.
Missing a dose of Telmisartan EGIS
If you miss a dose, do not worry. Take it as soon as you remember, then continue taking the
medicine as before. If a tablet is not taken during the whole day, take your usual dose the next
day. Do not take a double dose to make up for a missed dose.
Stopping Telmisartan EGIS
Do not stop taking Telmisartan EGIS without consulting your doctor.
Medicines used to treat high blood pressure may need to be taken for life. If you stop taking
Telmisartan EGIS, your blood pressure will return to its pre-treatment level within a few days.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Some adverse reactions may be serious and may require immediate medical attention:
Seek immediate medical advice if any of the following symptoms occur:
sepsis* (commonly known as "blood poisoning", a severe infection causing systemic inflammatory response), sudden swelling of the skin and mucous membranes (angioedema). These are rare (may occur in up to 1 in 1,000 people) but extremely serious adverse reactions, and patients must immediately stop taking the medicine and contact a doctor. If these adverse reactions are not treated, they may result in death.

Possible adverse reactions associated with the use of Telmisartan EGIS
Common adverse reactions (may occur in up to 1 in 10 patients):
low blood pressure (hypotension) in patients treated to reduce the frequency of cardiovascular events.

Uncommon adverse reactions (may occur in up to 1 in 100 patients):
urinary tract infections, upper respiratory tract infections (e.g. sore throat, sinusitis, common cold), reduced number of red blood cells (anaemia), high potassium levels in plasma, difficulty falling asleep, low mood (depression), fainting, sensation of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for hypertension, dizziness upon standing (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, drug rash, back pain, muscle cramps, muscle pain, kidney dysfunction, including acute kidney failure, chest pain, feeling of weakness, and increased blood creatinine levels.

Rare adverse reactions (may occur in up to 1 in 1,000 patients):
sepsis* (commonly known as "blood poisoning", a severe infection causing systemic inflammatory response, potentially leading to death), increased number of a certain type of white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, breathing difficulties, wheezing, facial swelling or low blood pressure), low blood pressure (in patients with diabetes), feeling of restlessness, drowsiness, visual disturbances, rapid heart rate (tachycardia), dryness of the oral mucosa, gastritis, taste disturbances, liver function disorders (Japanese patients are more susceptible to this adverse reaction), sudden swelling of the skin and mucous membranes, which may also lead to death (angioedema, including fatal cases), skin eruptions (skin disease), redness of the skin, urticaria, severe drug rash, joint pain, limb pain, tendon pain, influenza-like symptoms, decreased haemoglobin concentration (a protein in the blood), increased uric acid levels, increased activity of liver enzymes or creatine phosphokinase in blood.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Progressive fibrosis of the lung alveoli (interstitial lung disease)**
* The event may be coincidental or related to a currently unknown mechanism.
** Cases of interstitial lung disease have been reported in temporal association with telmisartan use. However, a causal relationship has not been established.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309; website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Telmisartan EGIS

Keep in the original packaging to protect from moisture.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the pack and other information

What Telmisartan EGIS contains
The active substance is telmisartan. Each coated tablet contains 80 mg of telmisartan.
The other ingredients are:
sodium hydroxide,
povidone 25,
meglumine,
lactose monohydrate,
crospovidone,
yellow iron oxide (E 172),
magnesium stearate.
Coating:
hypromellose,
titanium dioxide (E 171),
macrogol 400,
talc,
yellow iron oxide (E 172).

What Telmisartan EGIS looks like and contents of the pack
Telmisartan EGIS 80 mg tablets: yellow, capsule-shaped, film-coated tablets, embossed with the code "80" on one side and "T" on the other.
Telmisartan EGIS is available in aluminium/aluminium blister packs containing 28 tablets.

For further detailed information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in the Czech Republic, the country of export:
Egis Pharmaceuticals PLC
Keresztúri út 30-38.
1106 Budapest
Hungary

Manufacturer:
Glenmark Pharmaceuticals s.r.o.
City Tower, Hvězdova 1716/2b, 140 78 Prague 4, Czech Republic
Egis Pharmaceuticals PLC
Bökényföldi út 118-120., 1165 Budapest, Hungary

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Relabelled and repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw

Marketing Authorisation Number in the Czech Republic, the country of export: 58/501/12-C
Parallel Import Licence Number: 437/15

This medicinal product is authorised in the European Economic Area (EEA) Member States under the following names:
Bulgaria: Telmisartan EGIS 80mg filmirani tabletki
Czech Republic: Telmisartan EGIS
Hungary: Telmisartan EGIS 80mg filmtabletta
Poland: Telmisartan EGIS
Slovakia: Telmisartan EGIS 80mg