Package leaflet: Information for the patient

Telmisartan Genoptim, 40 mg, tablets
Telmisartan Genoptim, 80 mg, tablets
Telmisartanum
Please read the entire leaflet carefully before taking the medicine, as it contains
important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
Consult your doctor or pharmacist if you have any doubts.
This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, 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, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

What Telmisartan Genoptim is and what it is used for
Important information before taking Telmisartan Genoptim
How to take Telmisartan Genoptim
Possible side effects
How to store Telmisartan Genoptim
Contents of the pack and other information

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

Telmisartan Genoptim belongs to a group of medicines known as 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 Genoptim blocks the action of angiotensin II, allowing blood vessels to relax and thereby lowering blood pressure.

Telmisartan Genoptim 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 the normal range.

Telmisartan Genoptim is also used to reduce the frequency of cardiovascular events (such as heart attack or stroke) in adults at high risk, i.e., those who have reduced blood flow to the heart or legs, who have had a stroke, or who have been diagnosed with diabetes.

Your doctor will inform you whether you belong to this high-risk group.

2. Important information before using Telmisartan Genoptim

When not to use Telmisartan Genoptim

if the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
after the third month of pregnancy (Telmisartan Genoptim should also be avoided during early pregnancy - see section "Pregnancy");
if the patient has severe liver disease, such as biliary obstruction or bile duct narrowing (impaired 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 conditions apply to the patient, inform the doctor or
pharmacist before taking Telmisartan Genoptim.
Warnings and precautions
Before starting Telmisartan Genoptim, discuss with the doctor or
pharmacist if the patient has or has had any of the following conditions or
diseases:

kidney disease or history of kidney transplant;
renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys);
liver disease;
heart disease;
elevated aldosterone levels (retention of water and sodium in the body, accompanied by electrolyte imbalances);
low blood pressure (hypotension), which is more likely if the patient is dehydrated (excessive loss of water from the body) or has sodium deficiency due to diuretic use, low-sodium diet, diarrhoea or vomiting;
increased potassium levels in the blood;
diabetes.

Before starting Telmisartan Genoptim, discuss with the doctor:

if the patient is taking any of the following medicines used to treat high blood pressure:
- angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, particularly if the patient has kidney problems related to diabetes;
- aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also section "When not to use Telmisartan Genoptim".
if the patient is taking digoxin.

Inform the doctor about pregnancy, suspected or planned pregnancy. Use of
Telmisartan Genoptim 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 undergoing surgery or anaesthesia, inform the doctor about taking Telmisartan Genoptim.
Telmisartan Genoptim may be less effective in lowering blood pressure in black patients.
If abdominal pain, nausea, vomiting or diarrhoea occur after taking Telmisartan Genoptim, discuss this with the doctor. The doctor will decide on further treatment. Do not
discontinue Telmisartan Genoptim without medical advice.
Children and adolescents
Telmisartan Genoptim is not recommended for use in children and adolescents under 18 years of age.
Telmisartan Genoptim and other medicines
Tell the doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take. The doctor may recommend
adjusting the dose of these medicines or taking other precautions. In some cases,
discontinuation of one of the medicines may be necessary. This particularly applies to concomitant use of Telmisartan Genoptim 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 (certain diuretics), ACE inhibitors, 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 Genoptim, as they may lead to significant fluid loss and low blood pressure (hypotension);
ACE inhibitors or aliskiren (see also sections "When not to use Telmisartan Genoptim" and "Warnings and precautions");
digoxin.

The effect of Telmisartan Genoptim may be reduced when used concomitantly with
NSAIDs (non-steroidal anti-inflammatory drugs, e.g. acetylsalicylic acid or ibuprofen) or
corticosteroids.
Telmisartan Genoptim may enhance the blood pressure-lowering effect of other
medicines used to treat hypertension or medicines that may lower blood pressure (e.g.
baclofen, amifostine). Additionally, low blood pressure may be further reduced by: alcohol,
barbiturates, opioids or antidepressants. Symptoms include dizziness upon standing.
If dose adjustment of another medicine taken by the patient is required during
treatment with Telmisartan Genoptim, consult the doctor.
Telmisartan Genoptim with food and drink
Telmisartan Genoptim can be taken with or without food.
Pregnancy, breastfeeding and fertility
Pregnancy
Inform the doctor about pregnancy, suspected or planned pregnancy.
The doctor will usually recommend stopping Telmisartan Genoptim before planning pregnancy
or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Use of Telmisartan Genoptim 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 3 months of pregnancy.
Breastfeeding
Inform the doctor about breastfeeding or intention to breastfeed. Use of Telmisartan Genoptim is not recommended during breastfeeding. The doctor may recommend alternative treatment if the patient wishes to breastfeed, especially when feeding a newborn or preterm infant.
Driving and using machines
Some patients taking Telmisartan Genoptim may experience dizziness or fatigue.
In such cases, do not drive or operate machinery.
Telmisartan Genoptim contains sodium.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. the medicine is considered "sodium-free".

3. How to use Telmisartan Genoptim

This medicine should always be taken as directed by the doctor. In case of doubt, consult
your doctor or pharmacist.
Try to take the tablet at the same time each day.
Telmisartan Genoptim may be taken with or without food. Swallow the tablet with water or another non-alcoholic drink. It is important to take Telmisartan Genoptim every day, unless otherwise advised by your doctor. If you feel that the effect of Telmisartan Genoptim is too strong or too weak, consult your doctor or pharmacist.
For the treatment of high blood pressure, the usual dose of Telmisartan Genoptim is one 40 mg tablet once daily for most patients, which provides 24-hour blood pressure control. In some cases, your doctor may recommend a lower dose of 20 mg per day (this dose cannot be achieved with Telmisartan Genoptim tablets – another medicine should be used) or a higher dose of 80 mg per day.
Telmisartan Genoptim may also be given in combination with a diuretic (water pill), such as hydrochlorothiazide, which enhances the blood pressure-lowering effect of Telmisartan Genoptim.
To reduce the frequency of cardiovascular events, the usual dose of Telmisartan Genoptim is one 80 mg tablet once daily. Blood pressure should be monitored frequently at the beginning of treatment.
In case of impaired liver function, the usual dose should not exceed 40 mg once daily.
Taking more Telmisartan Genoptim than prescribed
If too many tablets have been taken by mistake, contact your doctor immediately or go to the nearest hospital emergency department.
Missing a dose of Telmisartan Genoptim
If you miss a dose, take it as soon as you remember, and then continue taking the medicine according to your usual schedule. 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.
If you have any further doubts 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 experiences them.
Some adverse reactions may be serious and may require immediate medical attention. If any of the following symptoms occur,
you should contact your doctor immediately:

Septicaemia* (often called blood poisoning, a severe infection causing systemic inflammatory response),
Sudden swelling of the skin and mucous membranes (angioedema).
These adverse reactions are rare (may occur in up to 1 in 1,000 patients), but are extremely serious. If they occur, treatment with this medicine must be stopped immediately and medical advice sought without delay. If these symptoms are not treated, they may result in death.

Possible adverse reactions of Telmisartan Genoptim:
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), reduced number of red blood cells (anaemia), high potassium levels in plasma, difficulty falling asleep, low mood (depression), fainting, sensation of spinning (peripheral 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, discomfort in the abdominal cavity, bloating, vomiting, itching, excessive sweating, drug rash, back pain, muscle cramps, muscle pain, renal 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):
Septicaemia* (often called blood poisoning, a severe infection with systemic inflammatory response, which may lead to death), increased number of certain white blood cells (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g. rash, itching, breathing difficulties, wheezing, facial swelling or low blood pressure), low blood sugar levels (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 (occur more frequently in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which may also lead to death (angioedema, including fatal cases), skin rash (skin disease), redness of the skin, urticaria, severe drug rash, toxic skin damage, joint pain, limb pain, tendon pain, influenza-like symptoms, decreased haemoglobin concentration (a protein in the blood), increased blood uric acid levels, increased liver enzyme activity or increased creatine kinase levels in blood.

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):
Progressive fibrosis of lung tissue (interstitial lung disease)**
*This reaction may occur coincidentally or may be related to a currently unknown mechanism.
**Cases of progressive fibrosis of lung tissue have been reported during treatment with telmisartan. It is not known whether telmisartan is the cause.

Frequency not known (frequency cannot be estimated from available data):
Angioedema of the intestine – following administration of similar products, intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea has occurred.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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.
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Telmisartan Genoptim

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and the outer carton after the abbreviation EXP. The expiry date refers to the last day of the stated month.
The batch number marked as "Lot" on the blister refers to the batch number.
No special storage instructions apply to this medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. Such measures will help protect the environment.

6. Contents of the pack and other information

What Telmisartan Genoptim contains
The active substance is telmisartan.
Each 40 mg tablet contains 40 mg of telmisartan.
Each 80 mg tablet contains 80 mg of telmisartan.
The other ingredients are: sodium hydroxide, povidone (K 25), meglumine, mannitol, magnesium stearate and crospovidone.

What Telmisartan Genoptim looks like and contents of the pack
Telmisartan Genoptim 40 mg tablets are white, elongated tablets with "LC" embossed on one side.
Telmisartan Genoptim 80 mg tablets are white, elongated tablets with "LC" embossed on one side.
Telmisartan Genoptim is available in packs: aluminium/aluminium blisters containing 28 or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synoptis Pharma Sp. z o.o.
ul. Krakowiaków 65
02-255 Warsaw
Tel.: 22 321 62 40

Manufacturer
Laboratorios Liconsa, S.A.
Avenida Miralcampo, 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares, Guadalajara, Spain
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz