Elestar hct: detailed information

Patient Information Leaflet

Warning! Please keep this leaflet. The information on the immediate packaging is in a foreign language.
Elestar HCT (Sanoral HCT)
40 mg + 10 mg + 12.5 mg, film-coated tablets
Olmesartanum medoxomilum + Amlodipinum + Hydrochlorothiazidum
Elestar HCT and Sanoral HCT are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

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

Table of Contents

What Elestar HCT is and what it is used for
Important information before taking Elestar HCT
How to take Elestar HCT
Possible side effects
How to store Elestar HCT
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 components help lower high blood pressure.

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

The combined effect of these substances leads to a reduction in blood pressure.
Elestar HCT is used for the treatment of hypertension:

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 already taking a combination product containing olmesartan medoxomil and hydrochlorothiazide along with amlodipine as a separate preparation, or a combination product containing olmesartan medoxomil and amlodipine along 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 calcium channel blockers (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 case 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 do not respond 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 case 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 case 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 disorders).
in case of very low blood pressure.
in case of narrowing or blockage of the blood outflow tract from the heart. This may result from narrowing of blood vessels or heart valves (aortic stenosis).
in case of weakened heart function after 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 treatment with Elestar HCT, discuss it with your doctor or pharmacist.
Tell your doctor if the patient is taking any of the following medicines used
in the treatment of 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 after kidney transplantation;
Liver diseases;
Heart failure or disorders affecting heart valves or heart muscle;
Severe vomiting, diarrhoea, treatment with high doses of diuretics (water pills) or a low-salt diet;
Increased blood potassium levels;
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 after exposure to sunlight or artificial UV light (solarium);
If the patient previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially in high doses over a long 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 problems or lung disorders (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or breathing difficulties after taking Elestar HCT, seek immediate medical help.

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

Severe, persistent diarrhoea causing significant weight loss. The doctor may 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 – which may occur from a few hours to several weeks after taking Elestar HCT. If left untreated, these may lead to permanent vision loss.

If the patient develops abdominal pain, nausea, vomiting or diarrhoea after taking Elestar HCT, discuss this with the doctor. The doctor will decide on further treatment. Do not make independent decisions 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 lipid and uric acid levels (causing gout – painful joint swelling). The doctor will likely recommend periodic blood tests to monitor these levels.
Treatment with 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 fatigue, low blood pressure (hypotension), weakness, apathy, fatigue, drowsiness or restlessness, nausea, vomiting, reduced urine output, rapid heartbeat. If such symptoms occur, inform the doctor.
Discontinue 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 treatment is necessary, 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 remedy used to treat depression.
Cisapride – a medicine stimulating gastrointestinal motility.
Diphenhydramine – a medicine used in slow heart rate and reduced 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 (a blood thinner preventing clot formation), ACE inhibitors (blood pressure-lowering agents), laxatives, steroids, adrenocorticotropic hormone (ACTH), carbenoxolone (a medicine 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 cause changes in blood potassium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling and other inflammatory symptoms, including joint inflammation), when taken together with Elestar HCT, may increase the risk of kidney failure. NSAIDs may reduce the effectiveness of Elestar HCT. When high doses of salicylates are used, central nervous system toxicity may be intensified.
Sedatives, tranquilizers and antidepressants taken together with Elestar HCT may cause sudden drop in blood pressure upon standing.
Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels) – possible reduction in 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 intravenously in severe body temperature disorders).
Simvastatin – used to reduce cholesterol and fat (triglyceride) levels in the blood.
Medicines used to control immune system responses (such as tacrolimus, sirolimus, temsirolimus, everolimus and cyclosporine), which help the body accept a transplanted organ.

Also, tell your doctor or pharmacist about any current or recent use, or planned use of any of the following medicines:

Medicines used in certain psychiatric disorders such as thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, pimozide, sultopride, tiapride, droperidol or haloperidol.
Medicines used in low blood sugar (e.g. diazoxide) or medicines lowering high blood pressure (e.g. beta-blockers, methyldopa), because Elestar HCT may affect the action of these medicines.
Medicines used to treat heart rhythm disorders such as mizolastine, pentamidine, terfenadine, dofetilide, ibutilide or intravenous erythromycin.
Medicines used in 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 increasing blood pressure and heart contractility such as noradrenaline.
Medicines used in gout such as probenecid, sulfinpyrazone and allopurinol.
Medicines reducing blood lipid levels such as cholestyramine and colestipol.
Medicines reducing 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 with or without food.
Patients taking Elestar HCT should not consume grapefruit juice or grapefruits, as they may increase blood levels of the active substance – amlodipine, which could unpredictably intensify 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 does not drop too much.
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 instead of Elestar HCT. 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. It has been shown that small amounts of amlodipine and hydrochlorothiazide pass into human milk. Use of Elestar HCT is not recommended during breastfeeding. The doctor may recommend an alternative medicine.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning 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

Elestar HCT is available in the following strengths:
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.
This medicine should always be taken exactly as directed 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 daily.
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, the daily dose should be taken 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, rapid or slow heartbeat.
If you take more than the recommended dose, or if a child accidentally swallows any amount of this medicine, you should immediately go to a doctor or the nearest hospital emergency department, taking the medicine packaging or this leaflet with you.
Breathlessness caused by excess fluid accumulating 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 questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
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 due to excessive lowering of blood pressure may occur 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-coloured urine, or skin itching, even if treatment with Elestar HCT was initiated significantly earlier, seek medical advice
immediately. Your doctor will assess the symptoms and decide how to continue treatment for hypertension.

Elestar HCT is a combination of three active substances. The information below refers to adverse reactions reported so far during treatment with the fixed-combination medicine 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:
frequent, 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 discontinuation of
treatment.

Frequent (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; ankle swelling; 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; facial flushing and sensation of warmth; 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 frequent (may occur in at least 1 in 10 people):
Oedema (fluid retention in the body).

Frequent (may occur in fewer than 1 in 10 people):
Bronchitis; stomach and intestinal infection; vomiting; increased blood glucose levels; 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; gastric discomfort; bloating; bone or joint pain; back pain; musculoskeletal 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 touch sensation; 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 skin bumps (urticaria); increased sweating; itching; skin eruptions; photosensitivity reactions such as sunburn or rash; muscle pain; difficulty urinating; need to urinate 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 number of red blood cells (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; pneumonia; inflammation of blood vessels and small skin vessels; 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, generalized skin redness, severe itching, blister formation, 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 overgrowth; intestinal obstruction; hepatitis; acute respiratory failure (symptoms include severe shortness of breath, fever, weakness and confusion).

Frequency unknown (cannot be estimated from available data):
Impaired vision or eye pain due to elevated pressure (possible symptoms of fluid accumulation in the uvea surrounding the eye – excessive fluid accumulation between choroid and sclera – or acute angle-closure glaucoma).
Worsening of vision or eye pain (possible symptoms of acute angle-closure glau游戏副本

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 packaging. The expiry date refers to the last day of the stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Elestar HCT contains
The active substances in this medicine are olmesartan medoxomil, amlodipine (in the form of amlodipine besilate) and hydrochlorothiazide.
Each tablet contains 40 mg of olmesartan medoxomil, 10 mg of amlodipine (in the form of amlodipine besilate) and 12.5 mg of hydrochlorothiazide.
The other ingredients are:
Tablet core: pregelatinised starch, maize, 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).

What Elestar HCT looks like and contents of the pack
Elestar HCT 40 mg + 10 mg + 12.5 mg, film-coated tablets:
Grey-red, round, film-coated tablet with a diameter of 9.5 mm, marked with "C55" on one side.
Elestar HCT film-coated tablets are available in OPA/Aluminium/PVC/Aluminium blisters packed in cardboard boxes. The packs contain 28 film-coated tablets in blisters.
For further information, please contact the Marketing Authorisation Holder or the Parallel Importer.

Marketing Authorisation Holder in Latvia, country of export:
Menarini International Operations Luxembourg S.A.
1, Avenue de la Gare, L-1611, Luxembourg
Luxembourg

Manufacturer:
Berlin-Chemie AG
Glienicker Weg 125
12489 Berlin
Germany

Parallel Importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Poland

Marketing Authorisation Number in Latvia, country of export: 11-0035
Parallel Import Licence Number: 344/25

This medicine is authorised for sale in the European Economic Area countries under the following names:
Austria: Amelior plus HCT, 40 mg + 10 mg + 12.5 mg
Belgium: Forzaten/HCT, 40 mg + 10 mg + 12.5 mg
Bulgaria: Tespadan HCT, 40 mg + 10 mg + 12.5 mg
Cyprus: Orizal plus, 40 mg + 10 mg + 12.5 mg
Czech Republic: Sintonyn Combi, 40 mg + 10 mg + 12.5 mg
Estonia: Sanoral HCT, 40 mg + 10 mg + 12.5 mg
Germany: Vocado HCT, 40 mg + 10 mg + 12.5 mg
Greece: Orizal plus, 40 mg + 10 mg + 12.5 mg
Hungary: Duactan HCT, 40 mg + 10 mg + 12.5 mg
Ireland: Konverge Plus, 40 mg + 10 mg + 12.5 mg
Latvia: Sanoral HCT, 40 mg + 10 mg + 12.5 mg
Lithuania: Sanoral HCT, 40 mg + 10 mg + 12.5 mg
Luxembourg: Forzaten/HCT, 40 mg + 10 mg + 12.5 mg
Netherlands: Belfor HCT, 40 mg + 10 mg + 12.5 mg
Malta: Konverge Plus, 40 mg + 10 mg + 12.5 mg
Poland: Elestar HCT, 40 mg + 10 mg + 12.5 mg
Portugal: Zolnor HCT, 40 mg + 10 mg + 12.5 mg
Romania: Inovum HCT, 40 mg + 10 mg + 12.5 mg
Slovakia: Folgan HCT, 40 mg + 10 mg + 12.5 mg
Slovenia: Olectan HCT, 40 mg + 10 mg + 12.5 mg
Spain: Balzak plus, 40 mg + 10 mg + 12.5 mg