Elestar hct

Poland
Brand name Elestar hct
Form tablets, film-coated
Active substance / Dosage
Prescription type Prescription only
ATC code
Registration number 100264368
Manufacturer Berlin-Chemie AG
Elestar hct tablets, film-coated

Package leaflet: Information for the patient

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

  • Keep this leaflet, so that you can read it again if necessary.
  • If you have any doubts, please consult your doctor or pharmacist.
  • This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
  • If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

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

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

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

The combined effect of these substances results in reduced blood pressure.
Elestar HCT is used to treat high blood pressure:

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

2. Important information before using Elestar HCT

When not to use Elestar HCT

  • if the patient is allergic to olmesartan medoxomil, amlodipine or a calcium channel blocker (dihydropyridine derivatives), hydrochlorothiazide or substances similar to hydrochlorothiazide (sulfonamides), or any of the other ingredients of this medicine (listed in section 6). If an allergic reaction is suspected, consult a doctor before taking Elestar HCT.
  • in cases of severe kidney function disorders.
  • if the patient has diabetes or kidney function disorders and is being treated with a blood pressure-lowering medicine containing aliskiren.
  • if there is low potassium, low sodium, high calcium, or high uric acid levels in the blood (with symptoms of gout or kidney stones) that are unresponsive to treatment.
  • after the 3rd month of pregnancy (use of Elestar HCT should also be avoided in early pregnancy – see section “Pregnancy and breastfeeding”).
  • in cases of severe liver disorders, if bile excretion is impaired or bile flow from the gallbladder is blocked (e.g. by gallstones), or if jaundice (yellowing of the skin and eyes) is present.
  • in cases of inadequate blood supply to 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 cases of very low blood pressure.
  • in cases of narrowing or blockage of blood outflow from the heart. This may result from narrowing of blood vessels or heart valves (aortic stenosis).
  • in cases of weakened heart function following a heart attack (acute myocardial infarction). Weakened heart function may cause shortness of breath or swelling of the feet and ankles.

Do not use Elestar HCT if any of the above conditions apply to the patient.
Warnings and precautions
Before starting Elestar HCT, discuss this with your doctor or pharmacist.
Tell your doctor if the patient is taking any of the following medicines used to treat high blood pressure:

  • angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney disorders related to diabetes.
  • aliskiren.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood levels of electrolytes (e.g. potassium).
See also the section “When not to use Elestar HCT”.
Tell your doctor if any of the following conditions are present:

  • Kidney disorders or status post kidney transplant;
  • Liver disease;
  • Heart failure or disorders of heart valves or heart muscle;
  • Severe vomiting, diarrhoea, treatment with high doses of diuretics (water pills), or a low-salt diet;
  • Increased potassium levels in the blood;
  • Disorders of the adrenal glands (hormone-producing glands located above the kidneys);
  • Diabetes;
  • Systemic lupus erythematosus (an autoimmune disease);
  • Allergy or bronchial asthma;
  • Skin reactions such as sunburn or rash following exposure to sunlight or artificial UV light (solarium);
  • If the patient previously had skin cancer or develops an unexpected skin lesion during treatment. Treatment with hydrochlorothiazide, especially in high doses over a prolonged period, may increase the risk of certain types of non-melanoma skin cancer and lip cancer. While taking Elestar HCT, protect the skin from sunlight and UV radiation;
  • If the patient previously experienced breathing or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If severe shortness of breath or breathing difficulties occur after taking Elestar HCT, seek immediate medical help.

Contact your doctor if the patient experiences any of the following symptoms:

  • Severe, persistent diarrhoea leading to significant weight loss. The doctor will assess the symptoms and decide how to continue antihypertensive treatment.
  • Vision impairment or eye pain. These may be symptoms of fluid accumulation in the vascular layer surrounding the eye (excessive fluid accumulation between choroid and sclera) or increased intraocular pressure. These may occur from several hours to several weeks after taking Elestar HCT. If untreated, they may lead to permanent vision loss.

If the patient experiences abdominal pain, nausea, vomiting, or diarrhoea after taking Elestar HCT, discuss this with the doctor. The doctor will decide on further treatment. Do not independently decide to stop taking Elestar HCT.
As with other blood pressure-lowering medicines, excessive lowering of blood pressure in patients with circulatory disorders of the heart or brain may lead to heart attack or stroke. Therefore, the doctor will recommend careful blood pressure monitoring in such patients.
Elestar HCT may increase blood levels of lipids and uric acid (causing gout – painful joint swelling). The doctor will likely recommend periodic blood tests to monitor these levels.
Use of Elestar HCT may affect the patient’s electrolyte balance. The doctor will likely recommend periodic blood tests to monitor electrolyte levels. Symptoms of electrolyte imbalance include: thirst, dryness of the oral mucosa, muscle pain or cramps, muscle weakness, low blood pressure (hypotension), fatigue, apathy, tiredness, drowsiness or restlessness, nausea, vomiting, reduced urine output, rapid heartbeat. If such symptoms occur, inform the doctor.
Stop taking Elestar HCT before undergoing parathyroid function tests.
Inform the doctor if pregnancy is suspected (or planned). Use of Elestar HCT is not recommended in early pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section “Pregnancy and breastfeeding”).
Children and adolescents (under 18 years of age)
Use of Elestar HCT is not recommended in children and adolescents under 18 years of age.
Elestar HCT and other medicines
Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take:

  • Other blood pressure-lowering medicines – may enhance the effect of Elestar HCT.
  • ACE inhibitors or aliskiren – the doctor may recommend dose adjustment and/or additional precautions (see also sections “When not to use Elestar HCT” and “Warnings and precautions”).
  • Lithium (a medicine used to treat mood disorders and certain types of depression) – concomitant use with Elestar HCT may increase lithium toxicity. If lithium must be taken, the doctor will recommend monitoring lithium blood levels.
  • Diltiazem, verapamil, medicines used to treat heart rhythm disorders and hypertension.
  • 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 stimulating gastrointestinal motility.
  • Diphenhydramine, a medicine used for slow heart rate and reducing sweating.
  • Halofantrine, a medicine used to treat malaria.
  • Vincamine administered intravenously, a medicine used to improve cerebral circulation.
  • Amantadine, a medicine used in Parkinson’s disease.
  • Potassium supplements, potassium-containing salt substitutes, diuretics (water pills), heparin (thins blood and prevents clots), ACE inhibitors (lower blood pressure), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (used to treat oral and gastric ulcers), sodium G penicillin (sodium salt of benzylpenicillin, an antibiotic), certain painkillers such as acetylsalicylic acid or salicylates. Concomitant use of these medicines with Elestar HCT may alter blood potassium levels.
  • Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other inflammatory symptoms, including joint inflammation), taken together with Elestar HCT, may increase the risk of kidney failure. NSAIDs may reduce the effectiveness of Elestar HCT. High-dose salicylates may intensify toxic effects on the central nervous system.
  • Sedatives, tranquilizers, and antidepressants taken together with Elestar HCT may cause sudden lowering of blood pressure upon standing.
  • Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels) – possible reduction in the effectiveness of Elestar HCT. The doctor may recommend taking Elestar HCT at least 4 hours before colesevelam 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 biperiden.
  • Calcium supplements.
  • Dantrolene (administered by infusion in severe body temperature disorders).
  • Simvastatin, used to reduce blood cholesterol and fat (triglyceride) levels.
  • Medicines used to control immune system responses (such as tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine), which help the body accept a transplanted organ.

Also, inform your doctor or pharmacist if you are currently or recently taking, or plan to take, any of the following medicines:

  • Medicines used for certain psychiatric disorders, such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol, or haloperidol.
  • Medicines used for low blood sugar (e.g. diazoxide) or blood pressure-lowering medicines (e.g. beta-blockers, methyldopa), as Elestar HCT may affect their action.
  • Medicines used to treat heart rhythm disorders, such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide, or intravenous erythromycin.
  • Medicines used for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir).
  • Medicines used to treat fungal infections (e.g. ketoconazole, itraconazole, amphotericin).
  • Medicines used for 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 contractile heart function, such as noradrenaline.
  • Medicines used for gout, such as probenecid, sulfinpyrazone, and allopurinol.
  • Medicines that reduce blood lipid levels, such as cholestyramine and colestipol.
  • Medicines that reduce blood sugar levels, such as metformin or insulin.

Tell your doctor or pharmacist about all medicines currently or recently taken, as well as any medicines the patient plans to take.
Taking Elestar HCT with food and drink
Elestar HCT can be taken during meals or independently of meals.
Patients taking Elestar HCT should not consume grapefruit juice or grapefruits, as they may increase blood levels of the active substance – amlodipine – potentially causing unpredictable intensification of the blood pressure-lowering effect of Elestar HCT.
Exercise caution when drinking alcohol while taking Elestar HCT, as some people may experience fainting or dizziness. If such symptoms occur, do not consume alcohol.
Elderly patients
In patients over 65 years of age, the doctor will monitor blood pressure with each dose increase to ensure that blood pressure is not lowered excessively.
Pregnancy and breastfeeding
Pregnancy
Inform the doctor if pregnancy is suspected (or planned). The doctor will usually recommend discontinuing Elestar HCT before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Use of Elestar HCT is not recommended during pregnancy and must not be used after the 3rd month of pregnancy, as it may seriously harm the unborn child.
If pregnancy occurs while taking Elestar HCT, consult the doctor immediately.
Breastfeeding
Inform the doctor if breastfeeding or planning to breastfeed. Small amounts of amlodipine and hydrochlorothiazide have been shown to pass into human milk. Use of Elestar HCT during breastfeeding is not recommended. The doctor may recommend an alternative medicine.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
Driving and operating machinery
During treatment for high blood pressure, drowsiness, nausea, dizziness, or headache may occur. In such cases, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. the medicine is considered “sodium-free”.

3. How to use Elestar HCT

This medicine should always be used as directed by a doctor or pharmacist. If in doubt,
consult a doctor or pharmacist.

  • The recommended dose of Elestar HCT is one tablet per day.
  • The tablet may be taken with or without food. Swallow the tablet with liquid (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 each day, for example during breakfast.

Taking more Elestar HCT than recommended
If you take more tablets than recommended, excessive lowering of blood pressure may occur,
with symptoms such as dizziness, increased or slowed heart rate.
If you take more than the recommended dose or if a child accidentally swallows any amount of the medicine,
seek immediate medical advice from a doctor or the nearest hospital emergency department,
taking the medicine pack or this leaflet with you.
Breathlessness due to fluid accumulation in the lungs (pulmonary oedema) may occur up to 24–48 hours
after taking the medicine.
If you miss a dose of Elestar HCT
If you miss a dose, take your usual dose the next day. Do not take a double dose to make up for
the missed dose.
Stopping Elestar HCT
It is important to continue taking Elestar HCT until your doctor advises you to stop.
If you have any further doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
Adverse reactions are often mild and do not require discontinuation of the medicine.
The following adverse reactions may be serious, although they do not occur frequently:
During treatment with Elestar HCT, allergic reactions may occur, including swelling of the face,
oral cavity and (or) larynx, accompanied by itching and rash. In such a case, discontinue Elestar HCT
immediately and contact your doctor without delay.
In susceptible individuals, severe dizziness or fainting may occur due to excessive lowering of
arterial blood pressure during treatment with Elestar HCT. In such a case, discontinue Elestar HCT,
contact your doctor immediately, and remain in a lying position.
Frequency unknown: if yellowing of the whites of the eyes occurs, dark urine, or skin itching, even if
Elestar HCT treatment was initiated significantly earlier, seek immediate medical advice. The
doctor will assess the symptoms and decide how to continue antihypertensive treatment.
Elestar HCT is a combination of three active substances. The following information refers to
adverse reactions reported so far during treatment with the fixed combination Elestar HCT (in
addition to those mentioned above), as well as adverse reactions observed with individual
substances alone or when two substances are used together.
For the purpose of assessing the frequency of adverse reactions, the following classification is used:
common, uncommon, rare, very rare.
Other possible adverse reactions of Elestar HCT:
If the following adverse symptoms occur, they are often mild and do not require interruption of
treatment.
Common (may occur in fewer than 1 in 10 people):
Upper respiratory tract infection; sore throat, nasal pain; urinary tract infection; central dizziness;
headache; palpitations; low blood pressure; nausea; diarrhoea; constipation; cramps; joint swelling;
increased urination; feeling of weakness; swelling around the ankles; feeling of fatigue; abnormal
laboratory test results.
Uncommon (may occur in fewer than 1 in 100 people):
Dizziness upon standing; labyrinthine dizziness; increased heart rate; fainting; flushing and feeling
of warmth in the face; cough; dryness of the oral mucosa; muscle weakness; inability to achieve or
maintain erection.
Other adverse reactions observed during treatment with individual substances alone or two
substances together:
The following adverse reactions 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):
Oedema (fluid retention in the body).
Common (may occur in fewer than 1 in 10 people):
Bronchitis; stomach and intestinal infection; vomiting; increased blood glucose; glucose in urine;
confusion; drowsiness; visual disturbances (including double vision and blurred vision); nasal discharge
or nasal congestion; sore throat; breathing difficulties; cough; abdominal pain; heartburn;
discomfort in the stomach; bloating; bone or joint pain; back pain; skeletal pain; presence of blood in
urine; influenza-like symptoms; chest pain; pain.
Uncommon (may occur in fewer than 1 in 100 people):
Decreased platelet count, which may lead to easy bruising or prolonged bleeding time; anaphylactic
reactions; marked loss of appetite (anorexia); sleep disorders; irritability; mood changes, including
anxiety; low mood or depression; chills; sleep disturbances; taste disturbances; loss of consciousness;
reduced sense of touch; tingling sensation; worsening of myopia; ringing in the ears (tinnitus);
angina pectoris (chest pain or discomfort, known as angina attack); heart rhythm disturbances; rash;
hair loss; allergic dermatitis; skin redness; purple skin spots due to small haemorrhages (purpura);
skin discoloration; red, itchy lumps (urticaria); increased sweating; itching; skin eruptions; photosensitivity
reactions such as sunburn or rash; muscle pain; difficulty in passing urine; need to pass urine at night;
breast enlargement in men; reduced libido; facial swelling; malaise; weight gain or weight loss;
exhaustion.
Rare (may occur in fewer than 1 in 1000 people):
Swelling and tenderness of the salivary glands; decreased white blood cell count, which may increase
susceptibility to infections; low red blood cell count (anaemia); bone marrow damage; motor restlessness;
feeling of lack of interest (apathy); seizures; yellow vision; dry eyes; blood clots (thrombosis, embolism);
fluid accumulation in the lungs; lung inflammation; inflammation of blood vessels and small blood
vessels of the skin; pancreatitis; yellowing of the skin and eyes; acute cholecystitis; symptoms of systemic
lupus erythematosus such as rash, joint pain, coldness of hands and fingers; severe skin reactions,
including intense skin rash, urticaria, redness of the entire body, severe itching, blistering, skin peeling
and swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis),
sometimes life-threatening; movement disorders; acute kidney failure; non-infectious kidney
inflammation; impaired kidney function, fever; angioedema of the intestine: intestinal swelling with
symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Very rare (may occur in fewer than 1 in 10,000 people):
Increased muscle tone; numbness of hands or feet; myocardial infarction; inflammation of the gastric
mucosa; gum hypertrophy; intestinal obstruction; hepatitis; acute respiratory failure (symptoms include
severe shortness of breath, fever, weakness and confusion).
Frequency unknown (cannot be estimated from available data):
Visual impairment or eye pain due to elevated pressure (possible symptoms of fluid accumulation in
the vascular layer surrounding the eye – excessive fluid accumulation between the choroid and the
sclera – or acute angle-closure glaucoma).
Worsening of vision or eye pain (possible symptoms of acute angle-closure glaucone).
Tremor, postural rigidity, facial masking, slowed movements and dragging of the legs while walking,
unsteady gait.
Malignant skin and lip tumours (non-melanoma skin cancers).
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
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.
By reporting adverse reactions, additional information on the safety of the medicine can be collected.

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 stated on the outer carton and
blister after the abbreviation EXP. The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer in use. This will help protect
the environment.

6. Contents of the pack and other information

What Elestar HCT contains
The active substances in this medicine 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: pregelatinized starch, corn starch, microcrystalline cellulose, colloidal anhydrous 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 coated tablets 20 mg + 5 mg + 12.5 mg, 40 mg + 10 mg + 12.5 mg, 40 mg + 10 mg + 25 mg), black iron oxide (E 172) (only in coated tablets 20 mg + 5 mg + 12.5 mg).

What Elestar HCT looks like and contents of the pack
Elestar HCT, 20 mg + 5 mg + 12.5 mg, coated tablets:
Light orange, round, 8 mm in diameter, film-coated tablet with the marking C51 on one side.

Elestar HCT, 40 mg + 5 mg + 12.5 mg, coated tablets:
Light yellow, round, 9.5 mm in diameter, film-coated tablet with the marking C53 on one side.

Elestar HCT, 40 mg + 10 mg + 12.5 mg, coated tablets:
Grey-red, round, 9.5 mm in diameter, film-coated tablet with the marking C55 on one side.

Elestar HCT, 40 mg + 5 mg + 25 mg, 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, coated tablets:
Grey-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 blisters made of polyamide/aluminium/polyvinyl chloride/aluminium:

  • Packs containing 14, 28, 56, or 98 film-coated tablets in blisters
  • 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Menarini International Operations Luxembourg S.A.
1 Avenue de la Gare
L-1611 Luxembourg
Luxembourg

Manufacturers:
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 further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Tel. + 48 22 566 21 00
Fax: + 48 22 566 21 01

This medicinal product is authorised in the European Economic Area countries 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