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 the 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 the above disorders.

2. Important information before taking Telmisartan Genoptim

When not to take Telmisartan Genoptim

• if the patient is allergic to telmisartan or any other ingredient of this medicine (listed in section 6);
• after the third month of pregnancy (it is also recommended to avoid taking Telmisartan Genoptim in early pregnancy - see "Pregnancy");
• if the patient has severe liver disease, such as bile stagnation or bile duct narrowing (disorders of bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.

If any of the above conditions apply to the patient, they should inform their doctor or pharmacist before taking Telmisartan Genoptim.

Warnings and precautions

Before starting Telmisartan Genoptim, the patient should discuss it with their doctor or pharmacist if they 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 the patient is dehydrated (excessive water loss from the body) or has a sodium deficiency due to the use of diuretics, a low-sodium diet, diarrhea, or vomiting;
• high potassium levels in the blood;
• diabetes.

Before starting Telmisartan Genoptim, the patient should discuss it with their doctor:

• if the patient is taking any of the following blood pressure-lowering medicines:
• angiotensin-converting enzyme (ACE) inhibitors, such as enalapril, lisinopril, ramipril, especially if the patient has kidney function disorders associated with diabetes;
• aliskiren. The 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".
• if the patient is taking digoxin.

The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Telmisartan Genoptim in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy").
In the case of planned surgery or anesthesia, the patient should inform their doctor about taking Telmisartan Genoptim.
Telmisartan Genoptim may be less effective in lowering blood pressure in black patients.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Telmisartan Genoptim, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Telmisartan Genoptim on their own.

Children and adolescents

Telmisartan Genoptim is not recommended for children and adolescents under 18 years of age.

Telmisartan Genoptim and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or plan to take. The 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 simultaneous use of Telmisartan Genoptim with the following medicines:

• lithium preparations used to treat certain types of depression;
• medicines that can increase potassium levels in the blood, such as potassium-containing salt substitutes, potassium-sparing diuretics (some diuretics), ACE inhibitors, angiotensin II receptor antagonists, non-steroidal anti-inflammatory drugs (NSAIDs, e.g., acetylsalicylic acid or ibuprofen), heparin, immunosuppressive drugs (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 from the body and decreased 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 hypertension or medicines that can lower blood pressure (e.g., baclofen, amifostine). Additionally, low blood pressure may be further decreased by: alcohol, barbiturates, opioids, or antidepressants. The symptom is dizziness when standing up.
If it is necessary to adjust the dose of another medicine taken by the patient while taking Telmisartan Genoptim, they should consult their doctor.

Telmisartan Genoptim with food and drink

Telmisartan Genoptim can be taken with or without food.

Pregnancy, breastfeeding, and fertility

Pregnancy
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy.
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 it should not be taken after the third month of pregnancy, as it may seriously harm the fetus if taken after 3 months of pregnancy.
Breastfeeding
The patient should tell their doctor about breastfeeding or planned breastfeeding. It is not recommended to take Telmisartan Genoptim during breastfeeding. The doctor may recommend alternative treatment if the patient wants to breastfeed, especially in the case of breastfeeding a newborn or premature baby.

Driving and using machines

Some patients taking Telmisartan Genoptim may experience dizziness or fatigue.
In such cases, the patient should not drive vehicles or operate machines.

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

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The patient should try to take the tablet at the same time every day.
Telmisartan Genoptim can be taken with or without food. The tablets should be swallowed with water or another non-alcoholic liquid. It is essential to take Telmisartan Genoptim every day, unless the doctor recommends otherwise. If the patient feels that the effect of Telmisartan Genoptim is too strong or too weak, they should consult their doctor or pharmacist.
In the treatment of hypertension, the usual dose of Telmisartan Genoptim is one 40 mg tablet per day for most patients, which provides 24-hour blood pressure control. In some cases, the doctor may recommend a lower dose of 20 mg per day (such a dose cannot be achieved with Telmisartan Genoptim tablets - another medicine 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 per day. At the beginning of treatment, blood pressure should be frequently monitored.
In patients with liver function disorders, the usual dose should not exceed 40 mg per day.

Taking a higher dose of Telmisartan Genoptim than recommended

If too many tablets are taken by mistake, the patient should immediately contact their doctor or go to the emergency department of the nearest hospital.

Missing a dose of Telmisartan Genoptim

If a dose is missed, the patient should take it as soon as they remember, and then continue taking the medicine as scheduled. If the tablet is not taken within a day, the patient should take the usual dose the next day. The patient should not take a double dose to make up for the missed dose.
If the patient has any further doubts about taking the medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan Genoptim can cause side effects, although not everybody gets them.

Some side effects may be serious and may require immediate

medical attention.If the patient experiences any of the following symptoms, they should immediately contact their doctor:

• 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, the patient should stop taking the medicine and immediately contact their doctor. If these symptoms are not treated, they can 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), decreased red blood cell count (anemia), high potassium levels in the blood, insomnia, depression, fainting, spinning sensation (peripheral vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in patients treated for hypertension, dizziness when standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhea, abdominal discomfort, bloating, vomiting, itching, excessive sweating, rash, back pain, muscle spasms, muscle pain, kidney function disorders, including acute kidney failure, chest pain, feeling of weakness, 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 lead to death), 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 of restlessness, drowsiness, vision disturbances, rapid heart rate (tachycardia), dryness of the mucous membranes of the mouth, gastritis, taste disturbances, liver function disorders (more common in patients of Japanese origin), sudden swelling of the skin and mucous membranes, which can also lead to death (angioedema, also fatal), skin rash, skin redness, hives, severe drug 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 is the cause.
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 abdominal pain, nausea, vomiting, and diarrhea.

Reporting side effects

If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should tell their doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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.
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Telmisartan Genoptim

The medicine should be stored out of 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 indicates the batch number.
There are no special precautions for storing the medicinal product.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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, elongated tablets with "LC" embossed on one side of the tablet.
Telmisartan Genoptim, 80 mg, tablets are white, elongated 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.
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: