Telmisartan + hydrochlorothiazide genoptim

Package leaflet: information for the patient

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
Telmisartanum + Hydrochlorothiazidum
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else even if their symptoms are similar.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

Telmisartan + HCT Genoptim is a combination medicine containing two active substances – telmisartan and hydrochlorothiazide – in a single 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 that causes narrowing of blood vessels, thereby increasing blood pressure. Telmisartan blocks the action of angiotensin II, resulting in relaxation of blood vessels and lowering of blood pressure.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics. It increases urine production, which leads to lowering of blood pressure.

Untreated high blood pressure may damage blood vessels in various organs and may lead to heart attack, heart or kidney failure, stroke, or loss of vision. Often, there are no symptoms of high blood pressure before such complications occur. Therefore, it is important to measure blood pressure regularly to ensure it remains within normal limits.

Telmisartan + HCT Genoptim 40 mg + 12.5 mg and 80 mg + 12.5 mg is used in the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with telmisartan alone.
Telmisartan + HCT Genoptim 80 mg + 25 mg is used in the treatment of high blood pressure (essential hypertension) in adults whose blood pressure is not sufficiently controlled with Telmisartan + HCT Genoptim 80 mg + 12.5 mg, or in adults whose blood pressure has been controlled with a combination of telmisartan and hydrochlorothiazide given as separate medicines.

2. Important information before using Telmisartan + HCT Genoptim

When not to use 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 to other sulfonamide-derived drugs;
• after the third month of pregnancy (the use of Telmisartan + HCT Genoptim should also be avoided in early pregnancy - see section "Pregnancy");
• if the patient has severe liver disease, such as biliary obstruction or bile duct stenosis (impaired bile flow from the liver and gallbladder), or any other severe liver disease;
• if the patient has severe kidney disease;
• if the physician has diagnosed low blood potassium levels or high blood calcium levels that do not improve with treatment;
• if the patient has diabetes or kidney dysfunction 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 + HCT Genoptim.
Warnings and precautions
Inform your doctor if the patient has or has had any of the following
conditions or diseases:

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

Before starting treatment with Telmisartan + HCT Genoptim, discuss the following with your 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,

especially if the patient has kidney dysfunction related to diabetes;

• aliskiren. The doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium). See also the section “When not to use Telmisartan + HCT Genoptim”.
  • if the patient is taking digoxin.

Inform the doctor if the patient is pregnant, suspects pregnancy, or is planning pregnancy. Use of
Telmisartan + HCT 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”).
Treatment with hydrochlorothiazide may lead to electrolyte imbalance in the body.
Typical symptoms of water and electrolyte imbalance include: dryness of the oral mucosa,
weakness, lethargy, drowsiness, restlessness, muscle pain or cramps, nausea, vomiting, muscle fatigue, and
abnormally rapid heartbeat (faster than 100 heartbeats per minute). If any
of these symptoms occur, inform the doctor.
Also inform the doctor if photosensitivity of the skin occurs,
manifesting as sunburn (e.g. redness, itching, swelling, blistering) appearing more quickly than usual.
If a surgical procedure or anaesthesia is planned, inform the doctor
about taking Telmisartan + HCT Genoptim.
Telmisartan + HCT Genoptim may be less effective in lowering blood pressure in individuals of Black race.
If abdominal pain, nausea, vomiting,
or diarrhoea occur after taking Telmisartan + HCT Genoptim, discuss this with the doctor. The doctor will
decide on further treatment. Do not
make independent decisions about stopping Telmisartan + HCT Genoptim.
Children and adolescents
Telmisartan + HCT Genoptim is not recommended for use in children and adolescents under 18 years of age.
Telmisartan + HCT Genoptim and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has 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 + HCT Genoptim with the following medicines:

• lithium preparations, used to treat certain types of depression;

• medicines associated with low blood potassium levels (hypokalaemia), such as other diuretics (water pills), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (adrenocorticotropic hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat oral ulcers), sodium benzylpenicillin (an antibiotic), salicylic acid and its derivatives;

• medicines that may increase blood potassium levels, such as potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, ACE inhibitors, cyclosporine (an immunosuppressant), and other medicines, e.g. sodium heparin (an anticoagulant);

• medicines whose effects are influenced by changes in blood potassium levels, such as cardiac medicines (e.g. digoxin), medicines used to control heart rhythm (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used to treat psychiatric disorders (e.g. thioridazine, chlorpromazine, levomepromazine), and other medicines, e.g. certain antibiotics (sparfloxacin,
  pentamidine) or certain medicines used to treat allergic reactions (terfenadine);

• antidiabetic medicines (insulin or oral medicines such as metformin);

• cholestyramine and colestipol, used to reduce blood lipid levels;

• medicines that increase blood pressure, e.g. noradrenaline;

• muscle relaxants, e.g. tubocurarine;

• calcium supplements and (or) vitamin D;

• anticholinergic medicines (used to treat various disorders, e.g. painful intestinal spasms, bladder spasms, asthma, motion sickness, muscle spasms, Parkinson's disease, and as adjuncts during anaesthesia), e.g. atropine and biperiden;

• amantadine (used to treat Parkinson's disease and to treat and prevent certain viral diseases);

• other medicines used to treat hypertension, corticosteroids, painkillers (such as non-steroidal anti-inflammatory drugs - NSAIDs), medicines used to treat cancer, gout, or arthritis;

• ACE inhibitors or aliskiren (see also sections “When not to use Telmisartan + HCT Genoptim” and “Warnings and precautions”).

Telmisartan + HCT 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, alcohol, barbiturates, opioids, or antidepressants may further reduce
blood pressure. Symptoms include dizziness upon standing. If dose adjustment of another medicine taken by the patient during treatment with Telmisartan + HCT
Genoptim is needed, consult the doctor.
NSAIDs (non-steroidal 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 may be taken with or without food.
Alcohol consumption should be avoided during treatment with Telmisartan + HCT Genoptim. Alcohol may
exacerbate the lowering of blood pressure and increase the risk of dizziness or fainting.
Pregnancy, breastfeeding, and fertility
Pregnancy
Inform the doctor if the patient is pregnant, suspects pregnancy, or is planning pregnancy. The doctor will usually recommend
discontinuing Telmisartan + HCT Genoptim before a planned pregnancy or immediately after
confirming pregnancy and will recommend an alternative medicine instead of Telmisartan + HCT Genoptim. Use of Telmisartan + HCT Genoptim is not recommended during 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 if the patient is breastfeeding or intends to breastfeed.
Use of Telmisartan + HCT Genoptim is not recommended during breastfeeding. The doctor may recommend
alternative treatment if the patient wishes to breastfeed.
Driving and operating machinery
Some patients taking Telmisartan + HCT Genoptim may experience dizziness or
fatigue. In such cases, do not drive or operate machinery.
Telmisartan + HCT Genoptim contains sugar (lactose).
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should contact
the doctor before taking Telmisartan + HCT Genoptim.
Telmisartan + HCT Genoptim contains sodium.
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Telmisartan + HCT Genoptim

Telmisartan + HCT Genoptim must always be taken according to the doctor's instructions.
If in doubt, consult your doctor or pharmacist.
The recommended dose of Telmisartan + HCT Genoptim is one tablet daily. Try to take the tablet at
the same time each day. Telmisartan + HCT Genoptim may be taken with or between meals. Swallow the
tablet with water or a non-alcoholic drink. It is important to take Telmisartan + HCT Genoptim every day,
unless otherwise advised by your doctor.
If the patient has impaired liver function, the daily dose must not exceed 40 mg of telmisartan and
12.5 mg of hydrochlorothiazide.
Taking more than the recommended dose of Telmisartan + HCT Genoptim
Taking more tablets than recommended may cause low blood pressure and increased heart rate.
Slowed heart rate, dizziness, vomiting, and worsening kidney function, including kidney failure, have also been reported.
Due to the presence of hydrochlorothiazide, marked lowering of blood pressure and decreased blood potassium levels may occur,
leading to nausea, drowsiness, and muscle cramps, and/or rhythm disturbances, particularly when used concomitantly with drugs such as
digitalis glycosides or certain antiarrhythmic medications. Seek immediate medical advice or go to the nearest hospital emergency department.
Missing a dose of Telmisartan + HCT Genoptim
If a dose is missed, take it as soon as you remember, then resume your regular dosing schedule. However, if more than 12 hours have passed,
skip the missed dose and take your next dose at the usual time. Do not take a double dose to make up for a missed dose.
If you have any further questions 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 will experience them.
Some adverse reactions may be serious and may require immediate
medical attention.
If any of the following symptoms occur, contact your doctor immediately:

• Septicaemia* (often called blood poisoning, a severe infection causing a systemic inflammatory response),
• Sudden swelling of the skin and mucous membranes (angioedema),
• Blistering and peeling of the outer layers of skin (toxic epidermal necrolysis).
  The above adverse reactions are rare (occurring in less than 1 in 1,000 patients) or of unknown frequency (toxic epidermal necrolysis), but are extremely serious. If they occur, discontinue the medicine immediately and contact your doctor without delay. If left untreated, these symptoms may result in death. An increased incidence of septicaemia has been observed in individuals receiving telmisartan as monotherapy; however, it cannot be excluded in patients treated with Telmisartan + HCT Genoptim.

Possible adverse reactions of Telmisartan + HCT Genoptim:
Common adverse reactions (may occur in less than 1 in 10 patients):
dizziness
Uncommon adverse reactions (may occur in less than 1 in 100 patients):
decreased blood potassium levels, anxiety, fainting, tingling and numbness (paraesthesia), sensation of spinning (vestibular dizziness), increased heart rate (tachycardia), heart rhythm disturbances, low blood pressure, sudden drop in blood pressure upon standing, shortness of breath, diarrhoea, dryness of the oral mucosa, bloating, back pain, muscle cramps, muscle pain, erectile dysfunction (inability to achieve or maintain erection), chest pain, increased blood uric acid levels
Rare adverse reactions (may occur in less than 1 in 1,000 patients):
lung inflammation (bronchitis), activation or worsening of systemic lupus erythematosus (a disease in which the body is attacked by its own immune system, causing joint pain, skin rashes and fever), sore throat, sinusitis, feeling of sadness (depression), difficulty falling asleep (insomnia), visual disturbances, breathing difficulties, abdominal pain, constipation, bloating (dyspepsia), nausea/vomiting, inflammation of the gastric mucosa, liver function abnormalities (more frequent in patients of Japanese origin), skin redness (flushing), allergic reactions such as itching or rash, increased sweating, urticaria, joint pain and limb pain, muscle cramps, flu-like symptoms, pain, low sodium levels, increased creatinine levels, increased blood activity of liver enzymes or creatine phosphokinase

Adverse reactions reported for individual components may also occur during treatment with Telmisartan + HCT Genoptim, even if they were not observed in clinical studies of the product.

Telmisartan
In patients receiving telmisartan alone, the following additional adverse reactions have been observed:
Uncommon adverse reactions (may occur in less than 1 in 100 patients):
upper respiratory tract infection (e.g. sore throat, sinusitis, common cold), urinary tract infections, decreased number of red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney function impairment, including acute renal failure, fatigue, cough
Rare adverse reactions (may occur in less than 1 in 1,000 patients):
low platelet count (thrombocytopenia), increased number of certain white blood cells (eosinophilia), severe allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug eruption), low blood glucose levels (in patients with diabetes), gastritis, skin rash (dermatosis), joint degeneration, tendonitis, decreased haemoglobin concentration (a blood protein), drowsiness
Very rare adverse reactions (may occur in less than 1 in 10,000 patients):
progressive fibrosis of lung tissue (interstitial lung disease)**
*This phenomenon may be coincidental or related to a mechanism not yet understood.
**Cases of progressive fibrosis of lung tissue temporally associated with telmisartan use have been reported. However, a causal relationship has not been established.

Hydrochlorothiazide
In patients receiving hydrochlorothiazide alone, the following additional adverse reactions have been observed:
Common adverse reactions (may occur in less than 1 in 10 patients):
nausea, low blood magnesium levels
Rare adverse reactions (may occur in less than 1 in 1,000 patients):
decreased platelet count, increasing the risk of bleeding or bruising (small purple-red skin lesions or lesions in other tissues caused by haemorrhage), high blood calcium levels, headache
Very rare adverse reactions (may occur in less than 1 in 10,000 patients):
increased pH (acid-base imbalance) due to low blood chloride levels
Adverse reactions with unknown frequency (frequency cannot be estimated from available data):
sialadenitis, decreased number (or even absence) of certain blood cells, including low numbers of red and white blood cells, severe allergic reactions (e.g. hypersensitivity, anaphylactic reactions), decreased or loss of appetite, restlessness, sensation of "emptiness" in the head, blurred vision or yellow vision, worsening of vision and eye pain due to elevated pressure (possible symptoms of fluid accumulation in the uvea—the membrane surrounding the eye—or excessive fluid accumulation between the choroid and sclera—acute myopia or acute angle-closure glaucoma), vasculitis (necrotizing vasculitis), pancreatitis, gastritis, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a disease mimicking systemic lupus erythematosus, in which the body is attacked by its own immune system), skin disorders such as cutaneous vasculitis, increased sensitivity to sunlight, rash, skin redness, blistering of the lips, eyes or oral mucosa, skin peeling, fever (possible symptoms of erythema multiforme), fatigue, kidney inflammation or kidney function disturbances, presence of glucose in urine (glucosuria), fever, electrolyte imbalance, high blood cholesterol levels, decreased blood volume, increased blood glucose levels, difficulty controlling blood/urine glucose levels (in patients with diagnosed diabetes) or blood lipids.
Frequency not known (frequency cannot be estimated from available data):
Intestinal angioedema – 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 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, PL-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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Telmisartan + HCT Genoptim

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister after the abbreviation
EXP and on the cardboard box after “Expiry date (EXP)”. The expiry date refers to the last
day of the stated month.
The batch number marked as LOT on the blister indicates the manufacturing batch.
No special temperature storage requirements.
Store in the original packaging to protect from moisture and light.
Medicines must 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 packaging and other information

What Telmisartan + HCT Genoptim contains
The active substances in this 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, monohydrate lactose, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch, yellow iron oxide (E 172).
Telmisartan + HCT Genoptim 80 mg + 12.5 mg: mannitol, povidone (K 25), crospovidone, magnesium stearate, meglumine, sodium hydroxide, monohydrate lactose, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch, red iron oxide (E 172).
Telmisartan + HCT Genoptim 80 mg + 25 mg: mannitol, povidone (K 25), crospovidone, magnesium stearate, meglumine, sodium hydroxide, monohydrate lactose, microcrystalline cellulose, hypromellose, sodium carboxymethyl starch, 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, two-layer tablets.
Telmisartan + HCT Genoptim 80 mg + 12.5 mg tablets are red-white, round, two-layer tablets.
Telmisartan + HCT Genoptim 80 mg + 25 mg tablets are yellow-white, round, two-layer tablets.

Telmisartan + HCT Genoptim is available in aluminium/aluminium blisters containing 28, 56, and 84 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 Warszawa
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