Telmisartan Genoptim

Leaflet attached to the packaging: patient information

Telmisartan Genoptim, 40 mg, tablets

Telmisartan Genoptim, 80 mg, tablets

Telmisartan

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, 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, or nurse. See section 4.

Table of contents of the leaflet:

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

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

Telmisartan Genoptim 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 constrict, leading to an increase in blood pressure. Telmisartan Genoptim blocks the action of angiotensin II, causing blood vessels to relax and blood pressure to decrease.
Telmisartan Genoptim is usedto 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 can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, or kidney disease, stroke, or vision loss. Most often, before the above complications appear, no symptoms of high blood pressure are observed. Therefore, it is essential to regularly measure blood pressure to check if it is within the normal range.
Telmisartan Genoptim is also usedto reduce the frequency of cardiovascular events (such as heart attack or stroke) in adults at risk, i.e., those with reduced blood flow to the heart or legs, those who have had a stroke, or those with diabetes.
The doctor will inform the patient if they belong to the risk group for these disorders.

2. Important information before taking Telmisartan Genoptim

When not to take Telmisartan Genoptim

• after the third month of pregnancy (you should also avoid taking Telmisartan Genoptim in early pregnancy - see "Pregnancy");

If any of the above conditions apply to you, inform your doctor or pharmacist before taking Telmisartan Genoptim.

Warnings and precautions

Before starting to take Telmisartan Genoptim, discuss it with your doctor or pharmacist if you have or have had any of the following conditions or diseases:

• kidney disease or kidney transplant;
• renal artery stenosis (narrowing of the blood vessels supplying one or both kidneys);
• liver disease;
• heart disease;
• increased aldosterone levels (water and sodium retention in the body, accompanied by electrolyte disturbances);
• low blood pressure (hypotension), which is more likely if you are dehydrated (excessive water loss from the body) or have a low sodium level due to the use of diuretics, a low-sodium diet, diarrhea, or vomiting;
• high potassium levels in the blood;
• diabetes.

Before starting to take Telmisartan Genoptim, discuss it with your doctor:

• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if you have kidney problems related to diabetes;
• aliskiren. Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also "When not to take Telmisartan Genoptim" and "Warnings and precautions".

Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant. It is not recommended to take Telmisartan Genoptim in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby (see "Pregnancy").
In case of planned surgery or anesthesia, inform your doctor that you are taking Telmisartan Genoptim.
Telmisartan Genoptim may be less effective in lowering blood pressure in black patients.
If you experience stomach pain, nausea, vomiting, or diarrhea after taking Telmisartan Genoptim, discuss it with your doctor. The doctor will decide on further treatment. Do not stop taking Telmisartan Genoptim on your own.

Children and adolescents

Telmisartan Genoptim should not be used in children and adolescents under 18 years of age.

Telmisartan Genoptim and other medicines

Tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take. Your doctor may recommend changing the dose of these medicines or taking other precautions. In some cases, it may be necessary to stop taking one of the medicines. This is especially true for the following medicines taken with Telmisartan Genoptim:

• lithium preparations used to treat certain types of depression;
• medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive agents (e.g., cyclosporine or tacrolimus), and the antibiotic trimethoprim;
• diuretics, especially when taken in high doses with Telmisartan Genoptim, as they can lead to significant water loss and low blood pressure (hypotension);
• ACE inhibitors or aliskiren (see also "When not to take Telmisartan Genoptim" and "Warnings and precautions");
• digoxin.

The effect of Telmisartan Genoptim may be weakened when taken with non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen) or corticosteroids.
Telmisartan Genoptim may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure or medicines that can lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be further reduced by: alcohol, barbiturates, opioids, or antidepressants. The symptom is dizziness when standing up.
If you need to adjust the dose of another medicine you are taking while taking Telmisartan Genoptim, consult your doctor.

Telmisartan Genoptim with food and drink

Telmisartan Genoptim can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy
Tell your doctor if you are pregnant, think you may be pregnant, or plan to become pregnant.
Usually, the doctor will recommend stopping Telmisartan Genoptim before planned pregnancy or immediately after pregnancy is confirmed and recommend another medicine instead of Telmisartan Genoptim. It is not recommended to take Telmisartan Genoptim in early pregnancy and should not be taken after the third month of pregnancy, as it may seriously harm the baby if taken after 3 months of pregnancy.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It is not recommended to take Telmisartan Genoptim while breastfeeding. The doctor may recommend other treatment if you want to breastfeed, especially if you are breastfeeding a newborn or premature baby.

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.

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

3. How to take Telmisartan Genoptim

Always take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.
Try to take the tablet at the same time every day.
Telmisartan Genoptim can 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 your doctor tells you to stop. If you feel that the effect of Telmisartan Genoptim is too strong or too weak, talk to your doctor or pharmacist.
In the treatment of high blood pressure, the usual dose of Telmisartan Genoptim is one 40 mg tablet once a day, which provides 24-hour blood pressure control. In some cases, your doctor may recommend a lower dose of 20 mg per day (such a dose cannot be obtained with Telmisartan Genoptim tablets - other medicines should be used) or a higher dose of 80 mg per day.
Telmisartan Genoptim can also be given in combination with a diuretic (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 a day. At the beginning of treatment, blood pressure should be monitored frequently.
In patients with kidney problems, the usual dose should not exceed 40 mg once a day.

Taking a higher dose of Telmisartan Genoptim than recommended

If you accidentally take too many tablets, contact your doctor or go to the emergency department of the nearest hospital immediately.

Missing a dose of Telmisartan Genoptim

If you miss a dose, take it as soon as you remember, and then continue taking the medicine as scheduled. If you do not take the tablet during the day, take the usual dose the next day. Do not take a double dose to make up for the missed dose.
If you have any further doubts about taking the 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 may require immediate

medical attention.If you experience any of the following symptoms, contact your doctor immediately:

• sepsis* (often referred to as blood poisoning, a severe infection with an inflammatory reaction throughout the body),
• sudden swelling of the skin and mucous membranes (angioedema). These side effects are rare (may occur in up to 1 in 1000 patients), but they are extremely severe, and if they occur, you should stop taking the medicine and contact your doctor immediately. If these symptoms are not treated, they may be fatal.

Possible side effects of Telmisartan Genoptim:

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), reduced red blood cell count (anemia), high potassium levels in the blood, insomnia, low mood (depression), fainting, spinning sensation (peripheral vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for high blood pressure, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, stomach pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle spasms, muscle pain, kidney problems, including acute kidney failure, chest pain, feeling weak, and increased creatinine levels in the blood.
Rare side effects (may occur in up to 1 in 1000 patients):
Sepsis* (often referred to as blood poisoning, a severe infection with an inflammatory reaction throughout the body, which can be fatal), increased white blood cell count (eosinophilia), low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reactions (e.g., rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in patients with diabetes), feeling anxious, drowsiness, vision disturbances, rapid heart rate (tachycardia), dry mouth, gastritis, taste disturbances, liver problems (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which can also be fatal (angioedema), skin rash, skin redness, hives, severe skin rash, toxic skin damage, joint pain, limb pain, tendon pain, flu-like symptoms, decreased hemoglobin levels (a protein in the blood), increased uric acid levels in the blood, increased liver enzyme activity or creatine phosphokinase in the blood.
Very rare side effects (may occur in up to 1 in 10,000 patients):
Progressive scarring of lung tissue (interstitial lung disease)**
*This side effect may occur randomly or be related to an unknown mechanism.
**During treatment with telmisartan, cases of progressive scarring of lung tissue have been reported. It is not known whether telmisartan causes this.
Frequency not known (frequency cannot be estimated from the available data):
Angioedema of the intestine - after using similar products, angioedema occurred in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance 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.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Telmisartan Genoptim

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month.
The batch number (Lot) on the blister means the batch number.
There are no special precautions for storing the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Telmisartan Genoptim contains

The active substance of the medicine 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, oblong tablets with "LC" embossed on one side of the tablet.
Telmisartan Genoptim, 80 mg, tablets are white, oblong tablets with "LC" embossed on one side of the tablet.
Telmisartan Genoptim is available in a pack containing 28 or 56 tablets in an aluminum/aluminum blister pack.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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

Date of last revision of the leaflet: