Elestar Hct

Leaflet accompanying 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 your 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 you experience any side effects, including those not listed in this leaflet, you should 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 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 increased urine production.

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 as separate tablets or a combination product containing 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 antagonists (dihydropyridine derivatives), hydrochlorothiazide or substances similar to hydrochlorothiazide (sulfonamides) or any of the other ingredients of this medicine (listed in section 6). If you suspect an allergy, consult your doctor before taking Elestar HCT.
• in case of severe kidney problems.
• if you have diabetes or kidney problems and are being 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) that do not respond to treatment.
• after the third month of pregnancy (you should also avoid taking Elestar HCT in early pregnancy - see "Pregnancy and breastfeeding").
• in case of severe liver problems, if bile secretion is impaired 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 insufficient 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 the result of 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.

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

Warnings and precautions

Before starting to take Elestar HCT, you should discuss it with your doctor or pharmacist.
You should tell your doctorif you are taking any of the following medicines for high blood pressure:

• an 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 the section "When not to take Elestar HCT".
You should tell your doctorif you have any of the following conditions:

• Kidney problems or a history of kidney transplant;
• Liver disease;
• Heart failure or heart valve problems or heart muscle problems;
• 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 caused by sunlight or artificial light (solarium);
• If you have a history of malignant skin tumor 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 malignant skin tumors and lip tumors (non-melanoma skin cancer). During treatment with Elestar HCT, you should protect your skin from sunlight and UV radiation;
• If you have a history of breathing or lung problems after taking hydrochlorothiazide (including pneumonia or fluid accumulation in the lungs). If you experience severe shortness of breath or difficulty breathing after taking Elestar HCT, you should seek medical attention immediately.

You should contact your doctorif you experience any of the following symptoms:

• Persistent, severe diarrhea that causes significant weight loss. Your doctor may assess the symptoms and decide how to continue the blood pressure-lowering 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 you experience abdominal pain, nausea, vomiting or diarrhea after taking Elestar HCT, you should discuss it with your doctor. Your doctor will decide on further treatment. You should not stop taking Elestar HCT on your own.
Like 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 recommend careful monitoring of blood pressure 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 determine these levels.
Taking Elestar HCT may affect the electrolyte balance in your body. Your doctor will likely recommend periodic blood tests to determine 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 you experience such symptoms, you should inform your doctor.
You should stop taking Elestar HCT before undergoing parathyroid function tests.
You should inform your doctor if you suspect (or plan) pregnancy. 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 of age)

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

Elestar HCT and other medicines

You should 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 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) - concomitant use 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 clot formation), ACE inhibitors (lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine used to treat mouth and stomach ulcers), sodium penicillin G (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 concomitantly with Elestar HCT, may increase the risk of kidney failure. NSAIDs may weaken the effect of Elestar HCT. When taking high doses of salicylates, the toxic effect on the central nervous system may be enhanced.
• Sedatives, tranquilizers and antidepressantstaken concomitantly 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. Your doctor may recommend taking Elestar HCT at least 4 hours before taking cholestyramine hydrochloride.
• Certain antacids(medicines used to treat indigestion or heartburn), as the effect of Elestar HCT may be slightly reduced.
• Certain muscle relaxants, such as baclofen and tubocurarine.
• Anticholinergic agents, 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 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.

You should 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 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.

You should 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 grapefruits, as they may cause an increase in the level of the active substance amlodipine in the blood, which may result in unpredictable enhancement of the blood pressure-lowering effect of Elestar HCT.
You should be cautious when drinking alcohol while taking Elestar HCT, as it may cause dizziness or fainting in some people. If such symptoms occur, you 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 much.

Pregnancy and breastfeeding

Pregnancy
You should inform your doctor if you suspect (or plan) pregnancy. 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 fetus (see "Pregnancy and breastfeeding").
If you become pregnant while taking Elestar HCT, you should consult your doctor immediately.
Breastfeeding
You should inform 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 are planning to have a baby, you should 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, you should not drive vehicles or operate machines until the symptoms have resolved. You should consult your doctor for advice.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. the medicine is considered "sodium-free".

3. How to take Elestar HCT

This medicine should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, you should consult your 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 daily dose should be taken at the same time every day, e.g. during breakfast.

Taking a higher dose of Elestar HCT than recommended

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 a higher dose than recommended or if a child accidentally swallows any amount of the medicine, you should immediately consult a doctor or the emergency department of the nearest hospital, taking the medicine packaging 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.

Missing a dose of Elestar HCT

If you miss a dose, you should take the usual dose the next day. You 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 your doctor recommends stopping it.
If you have any further doubts about taking this medicine, you should consult 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 usually mild and do not require discontinuation of the medicine.

The following side effects may be serious, although 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, you should stop taking Elestar HCT and contact your doctor immediately.

Elestar HCT.

Prone individuals may experience severe dizziness or fainting due to excessive lowering of blood pressure when taking Elestar HCT. In such cases, you should stop taking Elestar HCT, contact your doctor immediately and remain in a lying position.
Unknown frequency: if yellowing of the whites of the eyes, dark urine, itching of the skin occurs, even if Elestar HCT was started much earlier, you should contact your doctor immediately,who will assess the symptoms and decide how to continue the treatment of 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 individual substances or with two substances taken concomitantly.
To assess the frequency of side effects, the following classification is used:
common, uncommon, rare, very rare.

Other possible side effects of Elestar HCT:

If you experience 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 production; 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 on the face; cough; dryness of the mucous membranes; muscle weakness; inability to achieve or maintain an erection.

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

The following side effects may occur during treatment with Elestar HCT, even if they have not been observed 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; muscle or joint pain; uric acid in the urine; flu-like symptoms; chest pain; pain.
Uncommon(may occur in less than 1 in 100 people):
Swelling and pain in the salivary glands; decreased white blood cell count, which can increase the risk of infections; anemia (low red blood cell count); 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, finger and toe numbness; severe skin reactions, including intense skin rash, hives, redness of the skin, severe itching, blistering and peeling of the skin, and inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening; movement disorders; acute kidney failure; non-infectious kidney inflammation; kidney impairment, fever; intestinal edema: swelling in the intestine with symptoms such as abdominal pain, nausea, vomiting and diarrhea.
Very rare(may occur in less than 1 in 10,000 people):
High muscle tone; numbness of hands or feet; heart attack; stomach inflammation; thickening of the gums; 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 you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug 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

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month.
There are no special storage instructions for the medicine.
Medicines should not be disposed of via wastewater or household waste. You should ask your 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: maize starch, 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 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 detailed information on this medicine, you 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