Elestar Hct

Patient Information Leaflet: Important 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

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, tell your 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 pack 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 channel blockers, which also lower 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.

The combination of these substances lowers 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 already taking a combination of olmesartan medoxomil and hydrochlorothiazide and amlodipine as separate tablets or a combination of olmesartan medoxomil and amlodipine and hydrochlorothiazide as separate tablets.

2. Important information before taking Elestar HCT

When not to take Elestar HCT

• if you are allergic to olmesartan medoxomil, amlodipine or calcium channel blockers (dihydropyridine derivatives), hydrochlorothiazide or sulfonamide derivatives, or any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, consult your doctor before taking Elestar HCT.
• in case of severe kidney problems.
• if you have diabetes or kidney problems and are treated with a blood pressure-lowering medicine containing aliskiren.
• if you have low levels of potassium, sodium, high levels of calcium, or high levels of uric acid in the blood (with symptoms of gout or kidney stones), which cannot be treated.
• after the third month of pregnancy (you should also avoid taking Elestar HCT during early pregnancy - see "Pregnancy and breastfeeding").
• in case of severe liver problems, if bile flow is disturbed or bile flow from the gallbladder is blocked (e.g., by gallstones), or if you have jaundice (yellowing of the skin and eyes).
• in case of inadequate blood supply to the tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat, or shock (including cardiogenic shock, i.e., shock caused by severe heart problems).
• in case of very low blood pressure.
• in case of narrowing or blockage of the blood flow from the heart. This can be caused by narrowing of the blood vessels or heart valves (aortic stenosis).
• in case of weakened heart function after a heart attack (acute myocardial infarction). Weakened heart function can cause shortness of breath or swelling of the feet and ankles.

Do not take Elestar HCT if any of the above situations apply to you.

Warnings and precautions

Before taking Elestar HCT, discuss it with your doctor or pharmacist.
Tell your doctorif you are taking any of the following medicines for high blood pressure:

• an angiotensin-converting enzyme (ACE) inhibitor (e.g., enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium) in the blood.
See also "When not to take Elestar HCT".
Tell your doctorif you have any of the following conditions:

• Kidney problems or 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 levels of potassium 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 after exposure to sunlight or UV radiation;
• If you have had skin cancer or if an unexpected skin change occurs during treatment. Long-term treatment with hydrochlorothiazide may increase the risk of certain types of skin cancer and lip cancer (non-melanoma skin cancer). During treatment with Elestar HCT, protect your skin from sunlight and UV radiation;
• If you have had breathing or lung problems after taking hydrochlorothiazide. If you experience severe shortness of breath or difficulty breathing after taking Elestar HCT, seek medical help immediately.

Consult your doctorif you experience any of the following symptoms:

• Prolonged, severe diarrhea that causes significant weight loss. Your 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 of the eye (excessive fluid accumulation between the choroid and sclera) or increased pressure in 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 you experience abdominal pain, nausea, vomiting, or diarrhea after taking Elestar HCT, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Elestar HCT on your 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 heart attack or stroke. Therefore, your doctor will monitor your blood pressure carefully in such patients.
Elestar HCT may increase lipid levels and uric acid levels in the blood (a cause of gout - a painful swelling of the joints). Your doctor will likely recommend periodic blood tests to check these levels.
Taking Elestar HCT may affect the electrolyte balance in your body. Your doctor will likely recommend periodic blood tests to check electrolyte levels. Symptoms of electrolyte disturbances include thirst, dry mouth, muscle pain or cramps, fatigue, low blood pressure (hypotension), weakness, apathy, fatigue, drowsiness, or restlessness, nausea, vomiting, decreased urine output, rapid heartbeat. If you experience such symptoms, inform your doctor.
Stop taking Elestar HCT before parathyroid function tests.
Inform your doctor if you 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 baby (see "Pregnancy and breastfeeding").

Children and adolescents (under 18 years)

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

Elestar HCT and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take:

• Other blood pressure-lowering medicines- may enhance the effect of Elestar HCT.
• ACE inhibitors or aliskiren- your doctor may recommend a dose change and/or take other precautions (see also "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, your 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) - may weaken the effect of Elestar HCT. Your doctor may recommend taking Elestar HCT at least 4 hours before taking cholestyramine hydrochloride.
• Some antacids(medicines used to treat indigestion or heartburn), as the effect of Elestar HCT may be slightly reduced.
• Some muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic medicines, such as atropine and bipiperidine.

Calcium supplements.

• Dantrolene(given by infusion in case of severe temperature regulation disorders).
• Simvastatin, used to lower cholesterol and 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.

Also, tell your doctor or pharmacist about any medicines you are currently taking or have recently taken, as well as any medicines you 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 medicines that lower high blood pressure(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 given 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 rate, 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.

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you 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 grapefruit, as they may increase the levels of the active substance amlodipine in the blood, which may lead to unpredictable enhancement of the blood pressure-lowering effect of Elestar HCT.
Be careful when drinking alcohol while taking Elestar HCT, as it may cause dizziness or fainting in some people. If you experience such symptoms, do not drink alcohol.

Elderly patients

In patients over 65 years of age, the doctor will monitor blood pressure when increasing the dose to ensure that it does not drop too much.

Pregnancy and breastfeeding

Pregnancy
Tell your doctor if you suspect or plan to become pregnant. Your doctor will usually recommend stopping Elestar HCT before planned pregnancy or immediately after confirming pregnancy and 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 baby.
If you become pregnant while taking Elestar HCT, consult your doctor immediately.
Breastfeeding
Tell your doctor if you 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. Your doctor may recommend a different medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

3. How to take Elestar HCT

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

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

What to do if you take more Elestar HCT than you should

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

What to do if you forget to take Elestar HCT

If you forget to take a dose, take your normal dose the next day. Do not take a double dose to make up for a forgotten dose.

What to do if you stop taking Elestar HCT

It is important to continue taking Elestar HCT until your doctor tells you to stop.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

The following side effects can be serious, although they are rare:

During treatment with Elestar HCT, allergic reactions with swelling of the face, mouth, and/or throat, with itching and rash, may occur. Stop taking Elestar HCT and contact your doctor immediately.

Other possible side effects of Elestar HCT:

If you experience the following side effects, they are usually mild and do not require stopping treatment.
Common(may affect up to 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; ankle swelling; feeling of tiredness; abnormal laboratory test results.
Uncommon(may affect up to 1 in 100 people):
Dizziness when standing up; dizziness of labyrinthine origin; rapid heartbeat; fainting; flushing and feeling of warmth in the face; cough; dry mouth; muscle weakness; impotence.

Other side effects observed with individual substances or two substances taken together:

The following side effects may occur with Elestar HCT, although they have not been reported yet:
Very common(may affect more than 1 in 10 people):
Swelling (fluid retention in the body).
Common(may affect up to 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); nasal congestion; sore throat; difficulty breathing; cough; abdominal pain; heartburn; discomfort in the stomach; bloating; back pain; musculoskeletal pain; joint pain; blood in the urine; flu-like symptoms; chest pain; pain.
Uncommon(may affect up to 1 in 100 people):
Decreased number of platelets in the blood, which may cause easy bruising or prolonged bleeding; allergic reactions; significant loss of appetite (anorexia); sleep disturbances; irritability; mood changes, including anxiety; depression; chills; sleep disturbances; taste disturbances; loss of consciousness; decreased sensation; tingling; ringing in the ears (tinnitus); angina pectoris (pain or discomfort in the chest, known as angina attack); heart rhythm disorders; rash; hair loss; allergic skin inflammation; skin redness; purple spots on the skin due to small bleeding (purpura); skin discoloration; red, itchy bumps (hives); increased sweating; itching; skin rashes; skin reactions to light, such as sunburn or rash; muscle pain; difficulty urinating; need to urinate at night; breast enlargement in men; decreased libido; facial swelling; malaise; weight gain or loss; fatigue.
Rare(may affect up to 1 in 1,000 people):
Pain and swelling of the salivary glands; decreased number of white blood cells in the blood, which may increase the risk of infection; low number of red blood cells (anemia); bone marrow damage; restless movement; apathy; seizures; yellow vision or eye pain (possible symptoms of acute angle-closure glaucoma) .
Very rare(may affect up to 1 in 10,000 people):
Muscle stiffness; numbness or tingling of hands or feet; heart attack; stomach inflammation; 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 of 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 tumors of the skin and lips (non-melanoma skin cancer).

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your 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
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, you can help provide more information on the safety of this medicine.

5. How to store Elestar HCT

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 carton and blister after EXP. The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack 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, silicon dioxide, 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 marking 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 marking 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 marking 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 marking 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 marking 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 on this medicine, contact your 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