Elestar Hct

Leaflet attached to the packaging: patient information

Elestar HCT, 20 mg + 5 mg + 12.5 mg, film-coated tablets

Elestar HCT, 40 mg + 5 mg + 12.5 mg, film-coated tablets

Elestar HCT, 40 mg + 10 mg + 12.5 mg, film-coated tablets

Elestar HCT, 40 mg + 5 mg + 25 mg, film-coated tablets

Elestar HCT, 40 mg + 10 mg + 25 mg, film-coated tablets

Olmesartan medoxomil + Amlodipine + Hydrochlorothiazide

You should carefully read the contents of this 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 you need to.
• If you have 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 as yours.
• If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Elestar HCT and what is it used for

Elestar HCT contains three active substances called olmesartan medoxomil, amlodipine (as besylate) and hydrochlorothiazide. All three substances help to lower high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists, which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called calcium antagonists. It also lowers blood pressure by relaxing blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which lower blood pressure by removing excess fluid from the body through the urine.

The action of these substances results in a decrease in blood pressure. Elestar HCT is used to treat high blood pressure:

• in adult patients whose blood pressure is not adequately controlled by the combination of olmesartan medoxomil and amlodipine taken as a two-component product, or
• in patients who are taking a combination product containing olmesartan medoxomil and hydrochlorothiazide and amlodipine in a separate preparation or a combination product containing olmesartan medoxomil and amlodipine and hydrochlorothiazide in a separate preparation.

2. Important information before taking Elestar HCT

When not to take Elestar HCT

• after the third month of pregnancy (the patient should also avoid taking Elestar HCT in early pregnancy - see "Pregnancy and breastfeeding").

Elestar HCT should not be taken if any of the above situations apply to the patient.

Warnings and precautions

Before starting treatment with Elestar HCT, the patient should discuss it with their doctor or pharmacist.
The patient should tell their doctorif they are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme (ACE) inhibitor (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems 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 section "When not to take Elestar HCT".
The patient should tell their doctorif they have any of the following conditions:

• Kidney problems or a history of kidney transplant;
• Liver disease;
• Heart failure or problems with heart valves or heart muscle;
• Severe vomiting, diarrhea, treatment with high doses of diuretics or a low-salt diet;
• High potassium levels in the blood;
• Adrenal gland problems (glands that produce hormones, located above the kidneys);
• Diabetes;
• Systemic lupus erythematosus (an autoimmune disease);
• Allergy or asthma;
• Skin reactions, such as sunburn or rash caused by sunlight or artificial light (solarium);
• If the patient has a history of skin cancer or if an unexpected skin change occurs during treatment. Treatment with hydrochlorothiazide, especially in high doses and for a long time, may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Elestar HCT, the patient should protect their skin from sunlight and UV radiation;
• If the patient has a history of breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If the patient experiences severe shortness of breath or difficulty breathing after taking Elestar HCT, they should seek medical help immediately.

The patient should contact their doctorif they experience any of the following symptoms:

• Severe, persistent diarrhea that causes significant weight loss. The doctor may assess the symptoms and decide how to continue blood pressure treatment.
• Blurred vision or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure inside the eye - they can occur within a few hours to a few weeks after taking Elestar HCT. If left untreated, they can cause permanent vision loss

If the patient experiences stomach pain, nausea, vomiting or diarrhea after taking Elestar HCT, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Elestar HCT on their own.
As with other blood pressure-lowering medicines, excessive lowering of blood pressure in patients with circulatory problems in the heart or brain may lead to a heart attack or stroke. Therefore, the doctor will recommend careful monitoring of blood pressure in such patients.
Elestar HCT may increase lipid and uric acid levels in the blood (a cause of gout - a painful swelling of the joints). The doctor will likely recommend periodic blood tests to check these levels.
Taking Elestar HCT may affect the patient's electrolyte balance. The doctor will likely recommend periodic blood tests to check electrolyte levels. Symptoms of electrolyte disturbances include: thirst, dryness of the mucous membranes, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, decreased urine output, rapid heartbeat. If such symptoms occur, the patient should inform their doctor.
Elestar HCT should be discontinued before parathyroid function tests are performed.
The patient should inform their doctor if they suspect or plan to become pregnant. It is not recommended to take Elestar HCT during pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").

Children and adolescents (under 18 years)

Elestar HCT is not recommended for children and adolescents under 18 years of age.

Elestar HCT and 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:

• Other blood pressure-lowering medicines- may enhance the effect of Elestar HCT.
• ACE inhibitors or aliskiren- the doctor may recommend a dose change and/or take other precautions (see also the sections "When not to take Elestar HCT" and "Warnings and precautions").
• Lithium(a medicine used to treat mood disorders and some types of depression) - taking it with Elestar HCT may increase lithium toxicity. If lithium is necessary, the doctor will recommend monitoring lithium levels in the blood.
• Diltiazem, verapamil, medicines used to treat heart rhythm disorders and high blood pressure.
• Rifampicin, erythromycin, clarithromycin, tetracycline or sparfloxacin, antibiotics used to treat tuberculosis and other infections.
• St. John's Wort(Hypericum perforatum), a herbal medicine used to treat depression.
• Cisapride, a medicine that stimulates gastrointestinal motility.
• Difemanil, a medicine used in case of slow heart rate and reducing sweating.
• Halofantrine, a medicine used to treat malaria.
• Winkamine administered intravenously, a medicine used to improve cerebral circulation.
• Amantadine, a medicine used to treat Parkinson's disease.
• Potassium supplements, salt substitutes containing potassium, diuretics(diuretics), heparin(thins blood and prevents clotting), ACE inhibitors (lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), sodium penicillin G (sodium salt of benzylpenicillin, an antibiotic), some painkillers, such as acetylsalicylic acid or salicylates. Taking these medicines with Elestar HCT may cause changes in potassium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs)(medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis), taken with Elestar HCT, may increase the risk of kidney failure. NSAIDs may weaken the effect of Elestar HCT. With high doses of salicylates, toxic effects on the central nervous system may be enhanced.
• Sedatives, tranquilizers and antidepressantstaken with Elestar HCT may cause a sudden drop in blood pressure when standing up.
• Cholestyramine hydrochloride(a medicine that lowers cholesterol levels in the blood) - possible weakening of the effect of Elestar HCT. The doctor may recommend taking Elestar HCT at least 4 hours before taking cholestyramine hydrochloride.
• Certain antacids(medicines used for indigestion or heartburn), as the effect of Elestar HCT may be slightly reduced.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and bipiperidine.

Calcium supplements.

• Dantrolene(administered by infusion in case of severe body temperature disorders).
• Simvastatin, used to lower cholesterol and fat (triglyceride) levels in the blood.
• Medicines used to control the body's immune response(such as tacrolimus, sirolimus, temsirolimus, everolimus and cyclosporine), which allow the body to accept a transplanted organ.

The patient should also tell their doctor or pharmacist about any other medicines they are currently taking or have recently taken, as well as any medicines they plan to take:

• Medicines used in certain mental disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyanemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol.
• Medicines used in case of low blood sugar(e.g. diazoxide) or blood pressure-lowering medicines(e.g. beta-blockers, methyldopa), as Elestar HCT may affect the action of these medicines.
• Medicines used to treat heart rhythm disorders, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or erythromycin administered by injection.
• Medicines used to treat HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir).
• Medicines used to treat fungal infections(e.g. ketoconazole, itraconazole, amphotericin).
• Medicines used in heart disorders, such as quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, bepridil or digitalis.
• Anticancer medicines, such as amifostine, cyclophosphamide, methotrexate.
• Medicines that increase blood pressure and heart contractility, such as noradrenaline.
• Medicines used in gout, such as probenecid, sulfinpyrazone and allopurinol.
• Medicines that lower lipid levels in the blood, such as cholestyramine and colestipol.
• Medicines that lower blood sugar levels, such as metformin or insulin.

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.

Taking Elestar HCT with food and drink

Elestar HCT can be taken with or without food.
Patients taking Elestar HCT should not consume grapefruit juice or grapefruits, as they may increase the levels of the active substance amlodipine in the blood, which can lead to unpredictable enhancement of the blood pressure-lowering effect of Elestar HCT.
The patient should be cautious when drinking alcohol while taking Elestar HCT, as it may cause dizziness or fainting in some people. If such symptoms occur, the patient should not consume alcohol.

Elderly patients

In patients over 65 years of age, the doctor will monitor blood pressure during each dose increase to ensure that it does not drop too low.

Pregnancy and breastfeeding

Pregnancy
The patient should inform their doctor if they suspect or plan to become pregnant. The doctor will usually recommend stopping Elestar HCT before a planned pregnancy or as soon as pregnancy is confirmed, and will recommend taking a different medicine instead of Elestar HCT. It is not recommended to take Elestar HCT during pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").
If the patient becomes pregnant while taking Elestar HCT, they should immediately consult their doctor.
Breastfeeding
The patient should inform their doctor if they are breastfeeding or plan to breastfeed. It has been shown that small amounts of amlodipine and hydrochlorothiazide pass into human milk. It is not recommended to take Elestar HCT during breastfeeding. The doctor may recommend taking a different medicine.
If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

During treatment for high blood pressure, drowsiness, nausea, dizziness or headache may occur. In such cases, the patient should not drive or operate machinery until the symptoms have resolved. The patient should consult their doctor for advice.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means that it is essentially "sodium-free".

3. How to take Elestar HCT

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

• The recommended dose of Elestar HCT is one tablet per day.
• The tablet can be taken with or without food. The tablet should be swallowed with a liquid (e.g. a glass of water). The tablets should not be chewed. Elestar HCT should not be taken with grapefruit juice.
• If possible, the patient should take the daily dose at the same time every day, e.g. during breakfast.

Taking a higher dose of Elestar HCT than recommended

If the patient takes more tablets than recommended, they may experience excessive lowering of blood pressure with symptoms such as dizziness, rapid or slow heartbeat.
If the patient takes a higher dose than recommended or if a child accidentally swallows any amount of the medicine, they should immediately consult a doctor or the emergency department of the nearest hospital, taking the medicine packaging or this leaflet with them.
Even 24-48 hours after taking the medicine, shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Elestar HCT

If the patient misses a dose, they should take their usual dose the next day. They should not take a double dose to make up for the missed dose.

Stopping treatment with Elestar HCT

It is important to continue taking Elestar HCT until the doctor recommends stopping it.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Elestar HCT can cause side effects, although not everybody gets them.
Side effects are usually mild and do not require discontinuation of the medicine.

The following side effects may be serious, but they are rare:

During treatment with Elestar HCT, allergic reactions with swelling of the face, mouth and/or throat, with accompanying itching and rash, may occur. In such cases, the patient should stop taking Elestar HCT and immediately consult their doctor.

Elestar HCT

People who are prone to dizziness or fainting may experience severe dizziness or fainting due to excessive lowering of blood pressure when taking Elestar HCT. In such cases, the patient should stop taking Elestar HCT, immediately consult their doctor and remain in a lying position.
Frequency unknown: if the patient experiences yellowing of the whites of the eyes, dark urine, itching of the skin, even if they started taking Elestar HCT much earlier, they should immediately consult their doctor,who will assess the symptoms and decide how to continue treating high blood pressure.
Elestar HCT is a combination of three active substances. The following information refers to side effects that have been reported so far during treatment with the combination product Elestar HCT (in addition to those listed above) and those side effects that have been observed with the individual substances or with the combination of two substances:
The frequency of side effects is defined as follows:
common, uncommon, rare, very rare.

Other possible side effects of Elestar HCT:

If the patient experiences the following side effects, they are usually mild and do not require discontinuation of treatment.
Common(may occur in less than 1 in 10 people):
Upper respiratory tract infection; sore throat, nose; urinary tract infection; dizziness of central origin; headache; palpitations; low blood pressure; nausea; diarrhea; constipation; cramps; joint swelling; increased urine output; feeling of weakness; swelling around the ankles; feeling of fatigue; abnormal laboratory test results.
Uncommon(may occur in less than 1 in 100 people):
Dizziness when standing up; dizziness of labyrinthine origin; rapid heartbeat; fainting; flushing and feeling of warmth in the face; cough; dryness of the mucous membranes; muscle weakness; impotence.

Other side effects observed with individual substances or with the combination of two substances:

The following side effects may occur during treatment with Elestar HCT, even if they have not been reported so far:
Very common(may occur in at least 1 in 10 people):
Edema (fluid retention in the body).
Common(may occur in less than 1 in 10 people):
Bronchitis; gastrointestinal infection; vomiting; increased blood sugar levels; presence of sugar in the urine; confusion; drowsiness; visual disturbances (including double vision and blurred vision); runny or stuffy nose; sore throat; difficulty breathing; cough; abdominal pain; heartburn; discomfort in the stomach; bloating; back pain; musculoskeletal pain; joint pain; presence of blood in the urine; flu-like symptoms; chest pain; pain.
Uncommon(may occur in less than 1 in 100 people):
Decreased platelet count, which can cause easy bruising or prolonged bleeding; anaphylactic reactions; significant loss of appetite (anorexia); sleep disturbances; irritability; mood changes, including anxiety; depression; chills; sleep disturbances; taste disturbances; loss of consciousness; numbness; tingling; tinnitus (ringing in the ears); angina pectoris (chest pain or discomfort, known as angina attack); arrhythmias; rash; hair loss; allergic skin rash; redness of the skin; purple spots on the skin due to small blood vessel bleeding (purpura); skin discoloration; red, itchy bumps (hives); increased sweating; itching; skin rashes; skin reactions to light, such as sunburn or rash caused by sunlight or artificial light (solarium); muscle pain; difficulty urinating; nocturia; breast enlargement in men; decreased libido; facial swelling; malaise; weight gain or loss; fatigue.
Rare(may occur in less than 1 in 1000 people):
Swelling and pain in the salivary glands; decreased white blood cell count, which can increase the risk of infections; low red blood cell count (anemia); bone marrow damage; restlessness; apathy; seizures; yellow vision; dry eyes; blood clots (thrombosis, embolism); fluid accumulation in the lungs; pneumonia; inflammation of blood vessels and small blood vessels in the skin; pancreatitis; jaundice; acute gallbladder inflammation; symptoms of systemic lupus erythematosus, such as rash, joint pain, cold hands and fingers; severe skin reactions, including intense skin rash, hives, redness of the skin, severe itching, blistering and peeling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), which can be life-threatening; movement disorders; acute kidney failure; non-infectious kidney inflammation; kidney dysfunction, fever; intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhea.
Very rare (may occur in less than 1 in 10,000 people):
Muscle stiffness; numbness or tingling in the hands or feet; heart attack; stomach inflammation; gum hypertrophy; intestinal obstruction; liver inflammation; acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).
Frequency not known(cannot be estimated from the available data):
Blurred vision or eye pain due to increased pressure (possible symptoms of fluid accumulation in the vascular layer surrounding the eye - excessive fluid accumulation between the choroid and sclera - or acute angle-closure glaucoma) .
Worsening of vision or eye pain (possible symptoms of acute angle-closure glaucoma) .
Tremors, stiffness, mask-like face, slow movements and shuffling gait.
Malignant skin tumors and lip tumors (non-melanoma skin cancer).

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Elestar HCT

The medicine should be stored out of sight and reach of children.
Do not take this medicine after the expiry date stated on the carton and blister after the abbreviation EXP. The expiry date refers to the last day of the month stated.
There are no special precautions for storing the medicine.
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 packaging and other information

What Elestar HCT contains

The active substances of Elestar HCT are olmesartan medoxomil, amlodipine (as besylate) and hydrochlorothiazide.
Each tablet contains 20 mg of olmesartan medoxomil, 5 mg of amlodipine (as besylate) and 12.5 mg of hydrochlorothiazide.
Each tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as besylate) and 12.5 mg of hydrochlorothiazide.
Each tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as besylate) and 12.5 mg of hydrochlorothiazide.
Each tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as besylate) and 25 mg of hydrochlorothiazide.
Each tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (as besylate) and 25 mg of hydrochlorothiazide.
The other ingredients are:
Tablet core: cornstarch, microcrystalline cellulose, colloidal anhydrous silica, sodium croscarmellose, magnesium stearate.
Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172) (only in 20 mg + 5 mg + 12.5 mg, 40 mg + 10 mg + 12.5 mg, 40 mg + 10 mg + 25 mg film-coated tablets), black iron oxide (E 172) (only in 20 mg + 5 mg + 12.5 mg film-coated tablets).

What Elestar HCT looks like and contents of the pack

Elestar HCT, 20 mg + 5 mg + 12.5 mg, film-coated tablets:
Light orange, round, 8 mm diameter film-coated tablet with the inscription C51 on one side.
Elestar HCT, 40 mg + 5 mg + 12.5 mg, film-coated tablets:
Light yellow, round, 9.5 mm diameter film-coated tablet with the inscription C53 on one side.
Elestar HCT, 40 mg + 10 mg + 12.5 mg, film-coated tablets:
Gray-red, round, 9.5 mm diameter film-coated tablet with the inscription C55 on one side.
Elestar HCT, 40 mg + 5 mg + 25 mg, film-coated tablets:
Light yellow, oval, 15 x 7 mm film-coated tablet with the inscription C54 on one side.
Elestar HCT, 40 mg + 10 mg + 25 mg, film-coated tablets:
Gray-red, oval, 15 x 7 mm film-coated tablet with the inscription C57 on one side.
Elestar HCT film-coated tablets are available in laminated polyamide / aluminum / polyvinyl chloride / aluminum blisters:

• in packs containing 14, 28, 56, 98 film-coated tablets in blisters
• in packs containing 10 x 1, 50 x 1 or 500 x 1 film-coated tablets in perforated blisters.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Menarini International Operations Luxembourg S.A.
1 Avenue de la Gare
L-1611 Luxembourg
Luxembourg
Manufacturer:
Daiichi Sankyo Europe GmbH
Luitpoldstrasse 1
85276 Pfaffenhofen, Ilm
Germany
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany
Menarini - Von Heyden GmbH
Leipziger Strasse 7-13,

• 01097 – Dresden Germany

For more information about this medicine, the patient should contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: + 48 22 566 21 00
Fax: + 48 22 566 21 01

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria: Amelior plus HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Belgium: Forzaten/HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Bulgaria: Tespadan HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Cyprus: Orizal plus, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Czech Republic: Sintonyn Combi, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Estonia: Sanoral HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Germany: Vocado HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Greece: Orizal plus, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Hungary: Duactan HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Ireland: Konverge Plus, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Latvia: Sanoral HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Lithuania: Sanoral HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Luxembourg: Forzaten/HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Netherlands: Belfor HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Malta: Konverge Plus, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Poland: Elestar HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Portugal: Zolnor HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Romania: Inovum HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Slovakia: Folgan HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Slovenia: Olectan HCT, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Spain: Balzak plus, 20 mg + 5 mg + 12.5 mg; 40 mg + 5 mg + 12.5 mg; 40 mg + 10 mg + 12.5 mg; 40 mg + 5 mg + 25 mg; 40 mg + 10 mg + 25 mg
Date of last revision of the leaflet:01/2025