ELESTAR HCT

Package leaflet: Information for the patient

Warning! Keep the leaflet. Information on the immediate packaging in a foreign language.
Elestar HCT (Sanoral HCT)
40 mg + 5 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 so that you can read it again if necessary.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Elestar HCT is and what it is used for
2. What you need to know 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 the tension in blood vessels.
• Amlodipine belongs to a group of medicines called calcium channel blockers. It also lowers blood pressure by reducing the tension in blood vessels.
• Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics (water pills). Hydrochlorothiazide lowers 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 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 fixed combination containing olmesartan medoxomil and hydrochlorothiazide along with amlodipine as a separate preparation, or a fixed combination 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 aliskiren-containing antihypertensive medication.
• 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 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 blood outflow from the heart. This may result from narrowing of blood vessels or heart valves (aortic stenosis).
• in case 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 treatment with 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 electrolyte levels (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 affecting heart valves or heart muscle;
• Severe vomiting, diarrhea, treatment with high doses of diuretics ("water pills") or a low-salt diet;
• Increased potassium levels in the blood;
• Adrenal gland disorders (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 (e.g. solarium);
• If the patient has previously had skin cancer or develops unexpected skin changes during treatment. Treatment with hydrochlorothiazide, especially at 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 or lung problems (including pneumonia or fluid accumulation in the lungs) after taking hydrochlorothiazide. If the patient develops severe shortness of breath or difficulty breathing after taking Elestar HCT, seek immediate medical help.

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

• Severe, persistent diarrhea leading to significant weight loss. The doctor will assess the symptoms and decide how to continue antihypertensive treatment.
• Vision disturbances 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 a few hours to several weeks after taking Elestar HCT. If untreated, they may lead to permanent vision loss.

If the patient develops abdominal pain, nausea, vomiting or diarrhea after taking Elestar HCT, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Elestar HCT on your own.
As with other antihypertensive 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 monitoring of blood pressure 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 your doctor.
Discontinue Elestar HCT before undergoing parathyroid function tests.
Inform your 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 antihypertensive 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 (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 medicine used to treat depression.
• Cisapride – a medicine stimulating gastrointestinal motility.
• Diphenhydramine – a medicine used in slow heart rate and to reduce 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 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, used to relieve pain, swelling and other inflammatory symptoms, including joint inflammation), when taken with Elestar HCT, may increase the risk of kidney failure. NSAIDs may reduce the effectiveness of Elestar HCT. High-dose salicylate use may increase central nervous system toxicity.
• Sedatives, tranquilizers and antidepressants taken with Elestar HCT may cause sudden drop in blood pressure upon standing.
• Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels) – may reduce the effectiveness of Elestar HCT. The doctor may recommend taking Elestar HCT at least 4 hours before colesevelam hydrochloride.
• Certain antacids (used for indigestion or heartburn), as they may slightly reduce the effectiveness of Elestar HCT.
• Certain muscle relaxants such as baclofen and tubocurarine.
• Anticholinergic medicines such as atropine and biperiden.
• Calcium supplements.
• Dantrolene (administered intravenously in severe temperature disorders).
• Simvastatin – used to lower blood cholesterol and fat (triglyceride) levels.
• Medicines used to control the body's immune response (such as tacrolimus, sirolimus, temsirolimus, everolimus and cyclosporine), which help the body accept a transplanted organ.

Also, tell your doctor or pharmacist about any of the following medicines currently or recently taken, or planned for use:

• 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 antihypertensive 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 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 lowering blood lipid levels such as cholestyramine and colestipol.
• Medicines lowering 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, potentially leading to unpredictable intensification of the antihypertensive 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 blood pressure does not drop too much.
Pregnancy and breastfeeding
Pregnancy
Inform your 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 your doctor immediately.
Breastfeeding
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. Use of Elestar HCT during breastfeeding is not recommended. The doctor may recommend an alternative medicine.
If you are pregnant, breastfeeding, think you may be pregnant or are planning to have a baby, consult your 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 subside. Consult your doctor for advice.
This medicine contains less than 1 mmol (23 mg) of sodium per coated tablet, i.e. it 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 used exactly as directed by your doctor or pharmacist. If you are unsure,
please consult your doctor or pharmacist.

• The recommended dose of Elestar HCT is one tablet daily.
• The tablet can be taken with or without food. Swallow the tablet whole 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, rapid or slow heartbeat.
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 caused by fluid accumulation in the lungs (pulmonary oedema) may occur up to 24–48 hours after taking the medicine.

If you forget to take 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 how to use this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects are often mild and do not require discontinuation of the medicine.
The following adverse effects 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 throat, 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, dark urine, or skin itching occurs, 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 high blood pressure.
Elestar HCT is a combination of three active substances. The information below refers to adverse
effects reported so far during treatment with the fixed-combination medicine Elestar HCT (in addition
to those mentioned above), as well as adverse effects observed with individual substances alone or
when two substances are used together.
For assessing the frequency of adverse effects, the following classification is used:
frequent, uncommon, rare, very rare.
Other possible adverse effects of Elestar HCT:
If the following adverse effects 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; 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; facial flushing and
feeling of warmth; cough; dryness of the oral mucosa; muscle weakness; inability to achieve or
maintain erection.
Other adverse effects observed during treatment with individual substances alone or two
substances together:
The following adverse effects 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; presence of
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; anaphylactic
reactions; marked loss of appetite (anorexia); sleep disturbances; irritability; mood changes, including
anxiety; low mood or depression; chills; sleep disorders; 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 disorders; 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; decreased 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;
restless movement; 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, cold 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; angioneurotic intestinal oedema: intestinal
swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Very rare (may occur in fewer than 1 in 10000 people):
Increased muscle tension; numbness of hands or feet; myocardial infarction; inflammation of the
gastric mucosa; gum enlargement; 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 uvea, the vascular layer 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).
Tremor, rigidity, mask-like facial expression, slowed movements, shuffling gait, unsteady gait.
Malignant skin and lip tumours (non-melanoma skin cancers).
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or
nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug
Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
02 - 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps provide more information on the safety of the medicine.

5. How to store Elestar HCT

Keep this medicine out of 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 you no longer use. Such measures will 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 (as amlodipine
besilate) and hydrochlorothiazide.
Each tablet contains 40 mg of olmesartan medoxomil, 5 mg of amlodipine (as amlodipine
besilate) and 12.5 mg of hydrochlorothiazide.
The other ingredients are:
Tablet core: pregelatinized corn 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).

What Elestar HCT looks like and contents of the pack
Elestar HCT 40 mg + 5 mg + 12.5 mg, film-coated tablets:
Light yellow, round, film-coated tablets, 9.5 mm in diameter, marked with "C53" on one side.
Elestar HCT film-coated tablets are available in OPA/Aluminum/PVC/Aluminum blisters, in packs containing 28 film-coated tablets per blister.
For more detailed 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

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

Marketing Authorisation Number in Latvia, country of export: 11-0037
Parallel Import Licence Number: 345/25

This medicine is authorised for marketing in the Member States of the European Economic Area under the following names:
Austria: Amelior plus HCT, 40 mg + 5 mg + 12.5 mg
Belgium: Forzaten/HCT, 40 mg + 5 mg + 12.5 mg
Bulgaria: Tespadan HCT, 40 mg + 5 mg + 12.5 mg
Cyprus: Orizal plus, 40 mg + 5 mg + 12.5 mg
Czech Republic: Sintonyn Combi, 40 mg + 5 mg + 12.5 mg
Estonia: Sanoral HCT, 40 mg + 5 mg + 12.5 mg
Germany: Vocado HCT, 40 mg + 5 mg + 12.5 mg
Greece: Orizal plus, 40 mg + 5 mg + 12.5 mg
Hungary: Duactan HCT, 40 mg + 5 mg + 12.5 mg
Ireland: Konverge Plus, 40 mg + 5 mg + 12.5 mg
Latvia: Sanoral HCT, 40 mg + 5 mg + 12.5 mg
Lithuania: Sanoral HCT, 40 mg + 5 mg + 12.5 mg
Luxembourg: Forzaten/HCT, 40 mg + 5 mg + 12.5 mg
Netherlands: Belfor HCT, 40 mg + 5 mg + 12.5 mg
Malta: Konverge Plus, 40 mg + 5 mg + 12.5 mg
Poland: Elestar HCT, 40 mg + 5 mg + 12.5 mg
Portugal: Zolnor HCT, 40 mg + 5 mg + 12.5 mg
Romania: Inovum HCT, 40 mg + 5 mg + 12.5 mg
Slovakia: Folgan HCT, 40 mg + 5 mg + 12.5 mg
Slovenia: Olectan HCT, 40 mg + 5 mg + 12.5 mg
Spain: Balzak plus, 40 mg + 5 mg + 12.5 mg