Telmisartan egis

Package leaflet: Information for the user

Telmisartan EGIS, 40 mg, film-coated tablets
Telmisartan EGIS, 80 mg, film-coated tablets
Telmisartanum
Please read all of this leaflet carefully before 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 a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this 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 blockers.
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, which 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
regularly measure blood pressure to ensure it remains within normal limits.
Telmisartan EGIS is also used to reduce the frequency of cardiovascular events (such as heart
attack or stroke) in patients at high risk, i.e., those who have reduced blood flow to the heart or
legs, who have had a stroke, or who have diabetes.
Your doctor will inform you whether you belong to a high-risk group for these conditions.

2. What you need to know before taking Telmisartan EGIS

Do not take Telmisartan EGIS if:

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

If any of the above apply to you, tell your doctor or pharmacist before taking Telmisartan EGIS.

Warnings and precautions

Talk to your doctor or pharmacist before starting Telmisartan EGIS.

Tell your doctor if you have or have had any of the following conditions or diseases:

• kidney disease or if you have had a kidney transplant;
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys);
• liver disease;
• heart problems;
• increased aldosterone levels (water and salt retention in the body, accompanied by imbalances in various blood minerals);
• low blood pressure (hypotension), especially if you are dehydrated or have low salt levels due to diuretic use, low-salt diet, diarrhea, or vomiting;
• high potassium levels in the blood;
• diabetes;
• if you are taking any of the following medicines for high blood pressure:
  • angiotensin-converting enzyme (ACE) inhibitors (e.g., enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes;
  • aliskiren.

Your doctor may monitor kidney function, blood pressure, and blood electrolyte levels (e.g., potassium) at regular intervals. See also information under the heading "Do not take Telmisartan EGIS if". Before taking Telmisartan EGIS, inform your doctor:

• if you are taking digoxin.

Tell your doctor if you suspect or are planning a pregnancy. Telmisartan EGIS is not recommended during 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 you experience abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartan EGIS, discuss this with your doctor. Your doctor will decide whether to continue treatment. Do not stop taking Telmisartan EGIS on your own.

If you are scheduled for surgery or anesthesia, inform your doctor that you are taking Telmisartan EGIS.

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

Children and adolescents

Telmisartan EGIS is not recommended for use in children and adolescents under 18 years of age.

Telmisartan EGIS with other medicines

Tell your doctor or pharmacist about all medicines you are currently taking, have recently taken, or plan to take. Your doctor may need to adjust the dose and/or take other precautions. In some cases, one of the medicines may need to be discontinued. This is especially important when taking Telmisartan EGIS together with the following medicines:

• lithium preparations, used to treat 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 blockers, NSAIDs (non-steroidal anti-inflammatory drugs such as acetylsalicylic acid or ibuprofen), heparin, immunosuppressive medicines (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim;
• diuretics (water tablets), especially when taken in high doses together with Telmisartan EGIS, as they may lead to significant fluid loss and low blood pressure (hypotension);
• if you are taking an ACE inhibitor or aliskiren (see also information under "Do not take Telmisartan EGIS if" and "Warnings and precautions");
• digoxin.

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

Telmisartan EGIS may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that may cause low blood pressure (e.g., baclofen, amifostine). In addition, low blood pressure may be further reduced by: alcohol, barbiturates, narcotics, or antidepressants. Dizziness upon standing may occur.

If dose adjustment of any other medicine you are taking is needed while on Telmisartan EGIS, consult your doctor.

Telmisartan EGIS with food and drink

You may take Telmisartan EGIS with or without food.

Pregnancy and breast-feeding

Pregnancy

During pregnancy, while breast-feeding, if you suspect you are pregnant, or if you are planning a pregnancy, consult your doctor or pharmacist before taking this medicine.

Usually, your doctor will advise stopping Telmisartan EGIS before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Telmisartan EGIS is not recommended during 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.

Breast-feeding

Tell your doctor if you are breast-feeding or intend to breast-feed. Telmisartan EGIS is not recommended for use in women who are breast-feeding. Your doctor may choose a different treatment if you wish to breast-feed, especially if your baby is a newborn or premature.

Driving and using machines

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

Telmisartan EGIS contains lactose and sodium

If your doctor has informed you of an intolerance to certain sugars, consult your doctor before taking this medicinal product.

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

3. How to take Telmisartan EGIS

This medicine should always be taken according to your doctor's instructions. If in doubt, consult
your doctor or pharmacist.
The recommended dose of Telmisartan EGIS is one tablet daily. Try to take the tablet at the same
time each day.
Telmisartan EGIS may be taken with food or independently of meals. Swallow the tablet 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 arterial hypertension, the 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 prescribe a lower dose of one 20 mg tablet daily or a higher dose of
one 80 mg tablet daily.
(Since a 20 mg dose cannot be achieved with Telmisartan EGIS, your doctor may prescribe a
different 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 frequency 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 prescribed
If you accidentally take too many tablets, contact your doctor or pharmacist or 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 prescribed. If the missed tablet is not taken during the same day, take your usual
dose the next day. Do not take a double dose to make up for a missed dose.
Stopping treatment with 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 the rest of your 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 how to use this medicine, consult 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 may be serious and require immediate medical attention:
Seek immediate medical advice if you experience any of the following symptoms:
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 side effects, and
patients must stop taking the medicine immediately and contact their doctor. If these side effects
are not treated, they may result in death.
Possible side effects associated with the use of Telmisartan EGIS:
Common side effects (may occur in up to 1 in 10 patients):
low blood pressure (hypotension) in patients treated to reduce the frequency of cardiovascular
events.
Uncommon side effects (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
sleeping, 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 renal failure, chest pain,
feeling of weakness, and increased blood creatinine levels.
Rare side effects (may occur in up to 1 in 1,000 patients):
sepsis* (commonly known as "blood poisoning", a severe infection causing systemic
inflammatory response, which may lead 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
anxiety, 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 effect), sudden swelling of the skin and mucous membranes, which
may also lead to death (angioedema, including fatal cases), skin eruptions (skin disease),
erythema, 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 liver enzyme or creatine phosphokinase activity in blood, low sodium levels.
Very rare side effects (may occur in up to 1 in 10,000 patients):
Progressive fibrosis of the lung alveoli (interstitial lung disease)**
Frequency not known (frequency cannot be estimated from the available data):
Angioedema of the intestine – after administration of similar products, intestinal swelling has
occurred with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
* The event may be coincidental or related to a currently unknown mechanism.
** Cases of interstitial lung disease temporally associated with telmisartan use have been
reported. However, a causal relationship has not been established.

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

5. How to store Telmisartan EGIS

Store in the original packaging to protect from moisture.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
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. This 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 40 mg or 80 mg of telmisartan.

The other ingredients are:
sodium hydroxide,
povidone (K-25),
meglumine,
lactose monohydrate,
crospovidone,
iron oxide yellow (E 172),
magnesium stearate.
Coating:
hypromellose,
titanium dioxide (E 171),
macrogol 400,
talc,
iron oxide yellow (E 172)

What Telmisartan EGIS looks like and contents of the pack
Telmisartan EGIS 40 mg tablets: yellow, film-coated, capsule-shaped tablets with the imprint “40” on one side and “T” on the other side.
Telmisartan EGIS 80 mg tablets: yellow, film-coated, capsule-shaped tablets with the imprint “80” on one side and “T” on the other side.
Telmisartan EGIS is available in aluminium/aluminium blister packs containing 14, 15, 28, 30, 56, 60, 84, 90 or 98 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Egis Pharmaceuticals PLC
Keresztúri út 30-38, 1106 Budapest
Hungary

Manufacturer
Glenmark Pharmaceuticals s.r.o.
Fibichova 143, 566 17 Vysoké Mýto
Czech Republic
Egis Pharmaceuticals PLC
Bökényföldi út 118-120, 1165 Budapest
Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Czech Republic: Telmisartan EGIS
Hungary: Telmisartan EGIS 20mg/40mg/80mg filmtabletta
Poland: Telmisartan EGIS
Slovakia: Telmisartan EGIS 20mg/40mg/80mg