Telmisartan + Hct Genoptim

Leaflet attached to the packaging: patient information

Telmisartan + HCT Genoptim,40 mg + 12.5 mg, tablets
Telmisartan + HCT Genoptim,80 mg + 12.5 mg, tablets
Telmisartan + HCT Genoptim,80 mg + 25 mg, tablets
Telmisartan + Hydrochlorothiazide

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• 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, you should tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

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

Telmisartan + HCT Genoptim is a combination medicine that contains two active substances - telmisartan and hydrochlorothiazide in one tablet. Both substances help control high blood pressure.

• Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists. Angiotensin II is a substance produced in the body, causing blood vessels to narrow, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, resulting in the dilation of blood vessels and a decrease in blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It increases urine production, which leads to a decrease in blood pressure.

Untreated high blood pressure can cause damage to blood vessels in various organs, which can lead to heart attack, heart failure, or kidney failure, stroke, or vision loss. Most often, before the above complications occur, 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 + HCT Genoptim 40 mg + 12.5 mg and 80 mg + 12.5 mg is used

to treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled by telmisartan alone.
Telmisartan + HCT Genoptim 80 mg + 25 mg is usedto treat high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled by Telmisartan + HCT Genoptim 80 mg + 12.5 mg or in adults who have achieved blood pressure control while taking telmisartan and hydrochlorothiazide in separate medicines.

2. Important information before taking Telmisartan + HCT Genoptim

When not to take Telmisartan + HCT Genoptim

• if the patient is allergic to telmisartan or any of the other ingredients of this medicine (listed in section 6);
• if the patient is allergic to hydrochlorothiazide or other sulfonamide derivatives;
• after the third month of pregnancy (it is also recommended to avoid taking Telmisartan + HCT Genoptim in early pregnancy - see "Pregnancy");
• if the patient has severe liver disease, such as cholestasis or biliary obstruction (disorders of bile flow from the liver and gallbladder) or any other severe liver disease;
• if the patient has severe kidney disease;
• if the doctor has found low potassium or high calcium levels in the blood that do not improve with treatment;
• 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 + HCT Genoptim.

Warnings and precautions

The patient should inform their doctor if they have or have had any of the following conditions or diseases:

• low blood pressure (hypotension), which is more likely to occur if the patient is dehydrated (excessive water loss from the body), has a sodium deficiency due to the use of diuretics, follows a low-sodium diet, has diarrhea or vomiting, or is undergoing hemodialysis;
• kidney disease or post-kidney transplant;
• renal artery stenosis (narrowing of the blood vessels of one or both kidneys);
• liver disease;
• heart disease;
• diabetes;
• gout;
• increased aldosterone levels (water and sodium retention in the body, including electrolyte imbalance);
• systemic lupus erythematosus (also called lupus or SLE) - a disease in which the immune system attacks the body itself;
• hydrochlorothiazide may cause unusual reactions, characterized by worsening vision and eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive accumulation of fluid between the choroid and sclera) or increased intraocular pressure, which may occur within a few hours to a few weeks after taking Telmisartan + HCT Genoptim. If left untreated, they can lead to permanent vision loss.

Before starting Telmisartan + HCT Genoptim, the patient should discuss the following 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 related to diabetes;

• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood. See also the subsection "When not to take Telmisartan + HCT Genoptim".
• 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 + HCT Genoptim during pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy").
Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body. Typical symptoms of electrolyte imbalance include dryness of the mucous membranes, weakness, lethargy, drowsiness, restlessness, muscle pain, nausea, vomiting, fatigue, and irregular heartbeat (faster than 100 heartbeats per minute). If any of these symptoms occur, the patient should inform their doctor.
The patient should also inform their doctor about increased sensitivity of the skin to sunlight, in the form of sunburn (e.g., redness, itching, swelling, blistering) that appears more quickly than usual.
In the event of planned surgery or anesthesia, the patient should inform their doctor about taking Telmisartan + HCT Genoptim.
Telmisartan + HCT 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 + HCT Genoptim, they should discuss this with their doctor. The doctor will decide on further treatment. The patient should not stop taking Telmisartan + HCT Genoptim on their own.

Children and adolescents

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

Telmisartan + HCT Genoptim with other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they 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 discontinue one of the medicines. This applies especially to the simultaneous use of Telmisartan + HCT Genoptim with the following medicines:

• lithium preparations used to treat certain types of depression;
• medicines that can cause low potassium levels in the blood (hypokalemia), such as other diuretics, laxatives (e.g., castor oil), corticosteroids (e.g., prednisone), adrenocorticotropic hormone (ACTH), amphotericin (an antifungal medicine), carbenoxolone (used to treat stomach ulcers), benzylpenicillin sodium (an antibiotic), and salicylic acid and its derivatives;
• medicines that can increase potassium levels in the blood, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressive medicine), and other medicines, such as sodium heparin (an anticoagulant);
• medicines whose effects are influenced by changes in potassium levels in the blood, such as heart medicines (e.g., digoxin), medicines used to control heart rhythm (e.g., quinidine, disopyramide, amiodarone, sotalol), and medicines used to treat mental disorders (e.g., thioridazine, chlorpromazine, levomepromazine), as well as other medicines, such as certain antibiotics (sparfloxacin, pentamidine) or certain medicines used to treat allergic reactions (terfenadine);
• oral antidiabetic medicines (e.g., metformin);
• cholestyramine and colestipol, used to lower blood fat levels;
• medicines that increase blood pressure, such as noradrenaline;
• muscle relaxants, such as tubocurarine;
• calcium and/or vitamin D supplements;
• anticholinergic medicines (used to treat various disorders, such as painful intestinal contractions, bladder contractions, asthma, motion sickness, muscle contractions, Parkinson's disease, and as an adjunct during anesthesia), such as atropine and bipiperidine;
• amantadine (used to treat Parkinson's disease and to treat and prevent certain viral diseases);
• other medicines used to treat high blood pressure, corticosteroids, painkillers (such as nonsteroidal anti-inflammatory drugs - NSAIDs), anticancer medicines, gout, or arthritis;
• ACE inhibitors or aliskiren (see also subsections "When not to take Telmisartan + HCT Genoptim" and "Warnings and precautions").

Telmisartan + HCT Genoptim may enhance the blood pressure-lowering effect of other medicines used to treat high blood pressure 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. The symptom is dizziness when standing up. If necessary, the dose of another medicine taken by the patient during Telmisartan + HCT Genoptim treatment should be adjusted, and the patient should consult their doctor.
NSAIDs (nonsteroidal anti-inflammatory drugs, e.g., acetylsalicylic acid or ibuprofen) may weaken the effect of Telmisartan + HCT Genoptim.

Telmisartan + HCT Genoptim with food, drink, and alcohol

Telmisartan + HCT Genoptim can be taken with or without food.
The patient should avoid drinking alcohol while taking Telmisartan + HCT Genoptim. Alcohol may enhance the blood pressure-lowering effect and increase the risk of dizziness or fainting.

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 + HCT Genoptim before planned pregnancy or immediately after pregnancy is confirmed, and will recommend another medicine instead of Telmisartan + HCT Genoptim. It is not recommended to take Telmisartan + HCT Genoptim during 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 intending to breastfeed. It is not recommended to take Telmisartan + HCT Genoptim during breastfeeding. The doctor may recommend alternative treatment if the patient wants to breastfeed.

Driving and using machines

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

Telmisartan + HCT Genoptim contains sugar (lactose).

If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking Telmisartan + HCT Genoptim.

Telmisartan + HCT Genoptim contains sodium.

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

3. How to take Telmisartan + HCT Genoptim

Telmisartan + HCT Genoptim should always be taken as directed by the doctor.
In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Telmisartan + HCT Genoptim is one tablet per day. The patient should try to take the tablet at the same time every day. Telmisartan + HCT Genoptim can be taken with or without food. The tablets should be swallowed with water or a non-alcoholic beverage. It is essential to take Telmisartan + HCT Genoptim every day, unless the doctor recommends otherwise.
If the patient has liver function disorders, the daily dose should not exceed 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.

Taking a higher dose of Telmisartan + HCT Genoptim than recommended

After taking a higher dose of tablets than recommended, low blood pressure and rapid heartbeat may occur. Slow heart rate, dizziness, vomiting, and worsening kidney function, including kidney failure, have also been reported. Due to the presence of hydrochlorothiazide, significant low blood pressure and low potassium levels in the blood may occur, which can cause nausea, drowsiness, and muscle cramps, as well as (or) arrhythmias related to the simultaneous use of such medicines as digitalis glycosides or certain antiarrhythmic medicines. The patient should immediately consult their doctor or go to the emergency department of the nearest hospital.

Missing a dose of Telmisartan + HCT Genoptim

If a dose is missed, the patient should take it as soon as they remember, and then return to their usual dosing schedule. However, if more than 12 hours have passed, the patient should skip the missed dose and take the usual dose the next day. The patient should not take a double dose to make up for the missed dose.
In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Telmisartan + HCT 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 consult their doctor:

• sepsis* (often referred to as blood poisoning, being a severe infection with an inflammatory response of the whole body),
• sudden swelling of the skin and mucous membranes (angioedema),
• blistering and peeling of the skin (toxic epidermal necrolysis. The above side effects are rare (occurring in less than 1 in 1000 patients) or of unknown frequency (toxic epidermal necrolysis), but are extremely severe. If they occur, the patient should stop taking the medicine and immediately consult their doctor. If these symptoms are not treated, they can be fatal. An increased incidence of sepsis has been observed in patients taking telmisartan monotherapy, but it cannot be ruled out in the case of Telmisartan + HCT Genoptim.

Telmisartan + HCT Genoptim may cause the following side effects:

Common side effects (may occur in less than 1 in 10 patients):
dizziness
Uncommon side effects (may occur in less than 1 in 100 patients):
low potassium levels in the blood, anxiety, fainting, tingling or numbness (paresthesia), vertigo (dizziness of labyrinthine origin), rapid heartbeat (tachycardia), arrhythmias, low blood pressure, sudden drop in blood pressure when standing up, shortness of breath, diarrhea, dry mouth, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain an erection), chest pain, increased uric acid levels in the blood
Rare side effects (may occur in less than 1 in 1000 patients):
pneumonia (inflammation of the lungs), activation or exacerbation of systemic lupus erythematosus (a disease in which the immune system attacks the body itself, causing joint pain, skin rashes, and fever), sore throat, sinusitis, depression, insomnia, visual disturbances, breathing difficulties, abdominal pain, constipation, bloating (indigestion), nausea/vomiting, gastritis, abnormal liver function (more common in patients of Japanese origin), skin redness (rash), allergic reactions, such as itching or hives, increased sweating, urticaria, joint pain and limb pain, muscle cramps, flu-like symptoms, pain, low sodium levels, increased creatinine levels, increased liver enzyme activity or creatine phosphokinase in the blood
Side effects reported for individual components may also occur when taking Telmisartan + HCT Genoptim, even if they were not observed during clinical trials of the product.

Telmisartan

In patients taking telmisartan alone, the following additional side effects have been observed:

Uncommon side effects (may occur in less than 1 in 100 patients):
upper respiratory tract infection (e.g., sore throat, sinusitis, cold), urinary tract infections, low red blood cell count (anemia), high potassium levels, slow heart rate (bradycardia), kidney function disorders, including acute kidney failure, weakness, cough
Rare side effects (may occur in less than 1 in 1000 patients):
low platelet count (thrombocytopenia), increased white blood cell count (eosinophilia), severe allergic reaction (e.g., hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in patients with diabetes), gastritis, skin exfoliation (exfoliative dermatitis), joint degeneration, tendonitis, low hemoglobin levels (a protein in the blood), drowsiness
Very rare side effects (may occur in less than 1 in 10,000 patients):
progressive scarring of lung tissue (interstitial lung disease)**
*This phenomenon may be coincidental or related to a mechanism that has not yet been understood.
**Cases of progressive scarring of lung tissue have been reported in association with telmisartan, but a causal relationship has not been established.

Hydrochlorothiazide

In patients taking hydrochlorothiazide alone, the following additional side effects have been observed:

Common side effects (may occur in less than 1 in 10 patients):
nausea, low magnesium levels in the blood
Rare side effects (may occur in less than 1 in 1000 patients):
low platelet count, which increases the risk of bleeding or bruising (small, purple-red spots on the skin or in other tissues, caused by bleeding)
Very rare side effects (may occur in less than 1 in 10,000 patients):
increased blood pH (acid-base imbalance) due to low chloride levels in the blood
Side effects of unknown frequency (frequency cannot be estimated from available data):
pancreatitis, decreased appetite, restlessness, feeling of "emptiness" in the head, blurred vision or yellow vision, worsening vision and eye pain due to increased intraocular pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive accumulation of fluid between the choroid and sclera - acute glaucoma or angle-closure glaucoma), vasculitis (inflammation of blood vessels), pancreatitis, gastritis, jaundice (yellowing of the skin or eyes), systemic lupus erythematosus-like syndrome (a disease that mimics systemic lupus erythematosus, in which the body is attacked by its own immune system), skin disorders, such as vasculitis, increased sensitivity to sunlight, rash, redness of the skin, blistering on the lips, eyes, or mucous membranes, skin peeling, fever (possible symptoms of erythema multiforme), weakness, kidney inflammation or kidney function disorders, glucose in the urine (glycosuria), fever, electrolyte imbalance, high cholesterol levels in the blood, decreased blood volume, increased blood sugar levels, or difficulty controlling blood sugar levels/urine (in patients with diagnosed diabetes)
Frequency unknown (frequency cannot be estimated from available data):
Intestinal angioedema - 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 Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, PL-02 222 Warsaw
Phone: +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 + HCT Genoptim

The medicine should be stored out of sight and reach of children.
The patient should not take this medicine after the expiry date stated on the blister pack after the abbreviation EXP and on the carton after "Expiry date (EXP)". The expiry date refers to the last day of the month stated.
The abbreviation LOT on the blister pack indicates the batch number.
There are no special storage temperature requirements.
The medicine should be stored in its original packaging to protect it from moisture and light.
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 + HCT Genoptim contains

The active substances of the medicine are telmisartan and hydrochlorothiazide.
Each 40 mg + 12.5 mg tablet contains 40 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
Each 80 mg + 12.5 mg tablet contains 80 mg of telmisartan and 12.5 mg of hydrochlorothiazide.
Each 80 mg + 25 mg tablet contains 80 mg of telmisartan and 25 mg of hydrochlorothiazide.
The other ingredients are:
Telmisartan + HCT Genoptim 40 mg + 12.5 mg: mannitol, povidone (K 25), crospovidone, magnesium stearate, meglumine, sodium hydroxide, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium carboxymethylcellulose, yellow iron oxide (E 172).
Telmisartan + HCT Genoptim 80 mg + 12.5 mg: mannitol, povidone (K 25), crospovidone, magnesium stearate, meglumine, sodium hydroxide, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium carboxymethylcellulose, red iron oxide (E 172).
Telmisartan + HCT Genoptim 80 mg + 25 mg: mannitol, povidone (K 25), crospovidone, magnesium stearate, meglumine, sodium hydroxide, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium carboxymethylcellulose, yellow iron oxide (E 172).

What Telmisartan + HCT Genoptim looks like and contents of the pack

Telmisartan + HCT Genoptim 40 mg + 12.5 mg tablets are yellow-white, round, biconvex tablets.
Telmisartan + HCT Genoptim 80 mg + 12.5 mg tablets are red-white, round, biconvex tablets.
Telmisartan + HCT Genoptim 80 mg + 25 mg tablets are yellow-white, round, biconvex tablets.
Telmisartan + HCT Genoptim is available in a pack containing 28, 56, and 84 tablets.
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
Phone: 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: