Package leaflet: Information for the user

Elestar, 20 mg+5 mg, film-coated tablets
Elestar, 40 mg+5 mg, film-coated tablets
Elestar, 40 mg+10 mg, film-coated tablets
Olmesartanum medoxomilum + Amlodipinum
Please read this leaflet carefully before taking this medicine, because it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

What Elestar is and what it is used for
What you need to know before taking Elestar
How to take Elestar
Possible side effects
How to store Elestar
Contents of the pack and other information

1. What Elestar is and what it is used for

Elestar contains two active substances: olmesartan medoxomil and amlodipine (in the form of
besylate). Both of these 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 channel blockers. Amlodipine inhibits calcium entry into the walls of blood vessels, preventing their constriction and thereby lowering blood pressure.

The combined action of both substances helps prevent blood vessel constriction, resulting in reduced vessel tension and lower blood pressure.
Elestar is used to treat arterial hypertension in patients whose blood pressure is not sufficiently controlled with olmesartan medoxomil alone or amlodipine alone.

2. Important information before using Elestar

When not to use Elestar

if the patient is allergic to olmesartan medoxomil, amlodipine, or any other calcium channel blocker of the dihydropyridine class, or to any of the other ingredients of this medicine (listed in section 6). If allergy is suspected, consult a doctor before taking Elestar
after the third month of pregnancy. (Elestar should also be avoided during early pregnancy – see section "Pregnancy and breastfeeding")
if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren
in case of severe liver problems, 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 very low blood pressure
in case of inadequate blood flow to tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat (shock, including cardiogenic shock caused by severe heart problems)
in case of impaired blood outflow from the heart (e.g. due to aortic valve stenosis)
in case of weakened heart function (causing shortness of breath or peripheral edema) following a heart attack.

Warnings and precautions
Before starting treatment with Elestar, discuss it with your doctor or pharmacist.
Tell your doctor if the patient is taking any of the following medicines used for treating high blood pressure:

angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney problems 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".
Tell your doctor if any of the following conditions are present:

Kidney problems or status after kidney transplant
Liver disease
Heart failure or heart valve or myocardial disorders
Severe vomiting, diarrhea, treatment with high doses of diuretics ("water pills"), or a low-salt diet
Increased blood potassium levels
Adrenal gland disorders (hormone-producing glands located above the kidneys)

Contact your doctor if the patient develops severe, persistent diarrhea leading to significant weight loss. The doctor will assess symptoms and decide how to continue antihypertensive treatment.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Elestar, discuss this with the doctor. The doctor will decide on further treatment. Do not stop taking Elestar on your own.
As with other blood pressure-lowering medicines, excessive reduction in blood pressure in patients with heart or brain circulation disorders may lead to heart attack or stroke. Your doctor will recommend careful blood pressure monitoring in such patients.
Inform your doctor if you suspect (or are planning) pregnancy. Elestar is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnancy and breastfeeding").
Children and adolescents (under 18 years of age)
Elestar is not recommended for use in children and adolescents under 18 years of age.
Elestar and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take. This includes especially the following medicines:

Other blood pressure-lowering medicines – may enhance the effect of Elestar.
ACE inhibitors or aliskiren – your doctor may recommend dose adjustment and/or additional precautions (see also sections "When not to use Elestar" and "Warnings and precautions").
Potassium supplements, potassium-containing salt substitutes, diuretics ("water pills"), or heparin (a blood thinner used to prevent blood clots) – concomitant use with Elestar may increase blood potassium levels.
Lithium (used to treat mood disorders and certain types of depression) – concomitant use with Elestar may increase lithium toxicity. If lithium treatment is necessary, your doctor will recommend monitoring blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other signs of inflammation, including joint inflammation), taken together with Elestar, may increase the risk of kidney failure. NSAIDs may also reduce the effectiveness of Elestar.
Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels) – possible reduction in Elestar's effectiveness. Your doctor may recommend taking Elestar at least 4 hours before taking colesevelam hydrochloride.
Certain antacids (medicines used for indigestion or heartburn) – may slightly reduce the effectiveness of Elestar.
Medicines used to treat HIV/AIDS infections (e.g. ritonavir, indinavir, nelfinavir) or fungal infections (e.g. ketoconazole, itraconazole).
Diltiazem, verapamil (medicines used for heart rhythm disorders and high blood pressure).
Rifampicin, erythromycin, clarithromycin (antibiotics), medicines used for tuberculosis or other infections.
St. John's wort (Hypericum perforatum), a herbal preparation.
Dantrolene (administered intravenously in severe body temperature disorders).
Simvastatin used to reduce blood cholesterol and fat (triglyceride) levels.
Tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine used to control immune system reactions, allowing the body to accept a transplanted organ.

Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken, or plans to take.
Taking Elestar with food and drink
Elestar can be taken with or without food. Swallow the tablet with liquid (e.g. a glass of water). If possible, take the prescribed dose at the same time every day, for example during breakfast.
Patients taking Elestar should not consume grapefruit juice or grapefruit, as these may increase blood levels of the active substance amlodipine, potentially leading to unpredictable intensification of Elestar's blood pressure-lowering effect.
Elderly patients
In patients over 65 years of age, the doctor will monitor blood pressure after each dose increase to ensure that blood pressure does not drop too much.
Black patients
As with other similar blood pressure-lowering medicines, Elestar may be somewhat less effective in black patients.
Pregnancy and breastfeeding
Pregnancy
Inform your doctor if you suspect or are planning pregnancy. Your doctor will usually recommend stopping Elestar before planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Elestar is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.
If pregnancy occurs while taking Elestar, contact your doctor immediately.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Small amounts of amlodipine have been shown to pass into human milk. Elestar is not recommended during breastfeeding, especially when nursing a newborn or preterm infant. Your 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 taking this medicine.
Driving and operating machinery
Antihypertensive medicines may cause drowsiness, nausea, dizziness, or headache. 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. it is considered "sodium-free".

3. How to take Elestar

This medicine should always be taken as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.

The recommended dose is one tablet per day.
Tablets 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 with grapefruit juice.
If possible, take the recommended dose at the same time each day, for example during breakfast.

Taking more Elestar than recommended
Taking more tablets than recommended may cause excessive lowering of blood pressure,
manifesting as dizziness and increased or decreased heart rate.
If you take more than the recommended dose, or if a child accidentally swallows the medicine,
seek immediate medical attention from your 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.

Missed dose of Elestar
If you miss a dose, take your usual dose the next day. Do not take a double dose to make up for
a missed dose.

Stopping Elestar
It is important to continue taking Elestar until your doctor advises you to stop.
If you have any further doubts about using 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 of the medicine, although not common, may be severe:
During treatment with Elestar, allergic reactions may occur, which may affect the whole body,
with facial swelling, swelling of the oral cavity and (or) larynx, accompanied by itching and rash. In such
a case, Elestar must be discontinued and medical advice must be sought immediately.
In susceptible individuals, taking Elestar may cause excessive lowering of blood pressure,
including as a result of an allergic reaction. This may cause severe dizziness or
fainting. In such a case, Elestar must be discontinued, a doctor must be notified immediately and
the patient must remain in a lying position.
Frequency not known: if yellowing of the whites of the eyes, dark urine, or skin itching occurs, even
if Elestar administration started significantly earlier, medical advice must be sought immediately,
so that the physician can assess the symptoms and decide how to continue treatment for
hypertension.
Other possible adverse reactions of Elestar:
Common (may occur in fewer than 1 in 10 people):
Dizziness, headache, swelling of the ankles, feet, legs, hands or arms, fatigue.
Uncommon (may occur in fewer than 1 in 100 people):
Dizziness upon standing, lack of energy, tingling or numbness of hands or feet, vertigo, awareness of heartbeat,
increased heart rate, low blood pressure with symptoms such as dizziness, feeling of "emptiness" in the head, difficulty
breathing, cough, nausea, vomiting, indigestion, diarrhoea, constipation, dryness of the oral mucosa,
abdominal pain, skin rash, cramps, pain in hands and legs, back pain, increased urge to urinate, reduced sexual performance,
inability to achieve or maintain erection, weakness.
The following laboratory test changes have also been observed: increased or decreased blood potassium concentration, increased creatinine concentration, increased uric acid concentration, increased activity of liver enzymes (gamma-glutamyltransferase).
Rare (may occur in fewer than 1 in 1000 people):
Hypersensitivity to the medicine, fainting, flushing and sensation of warmth in the face, red itchy lumps (urticaria), facial swelling.
Adverse reactions observed during administration of olmesartan medoxomil alone or amlodipine alone, but not observed during administration of Elestar or observed with higher frequency during monotherapy:
Olmesartan medoxomil
Common (may occur in fewer than 1 in 10 people):
Bronchitis; sore throat; nasal congestion or runny nose; cough; abdominal pain; gastroenteritis; diarrhoea; indigestion; nausea; joint or bone pain; back pain; presence of blood in urine; urinary tract infection; chest pain; influenza-like symptoms; pain. Blood test changes – increased blood lipid concentration (elevated triglycerides), increased blood urea or uric acid concentration, increased liver enzyme activity and muscle function parameters.
Uncommon (may occur in fewer than 1 in 100 people):
Decreased platelet count, which may lead to easy bruising or prolonged bleeding time; sudden allergic reaction affecting the whole body and causing difficulty breathing, as well as sudden drop in blood pressure which may even lead to fainting (anaphylactic reaction); angina pectoris (chest pain or discomfort, known as angina attack); itching; skin eruptions; allergic skin rash; urticarial rash; facial swelling; muscle pain; malaise.
Rare (may occur in fewer than 1 in 1000 people):
Swelling of the face, oral cavity and (or) larynx; acute kidney failure and kidney function disorders; lethargy; intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.
Amlodipine
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):
Abdominal pain; nausea; ankle swelling; drowsiness; flushing and sensation of warmth in the face; visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhoea; constipation; indigestion; cramps, weakness; difficulty breathing.
Uncommon (may occur in fewer than 1 in 100 people):
Difficulty falling asleep, sleep disturbances; mood changes, including anxiety; depression; irritability; chills; altered taste; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); heart rhythm disorders; nasal congestion or runny nose; hair loss; blue or purple spots on the skin due to small haemorrhages (purpura); skin discoloration; excessive sweating; skin eruptions; itching; red itchy lumps (urticaria); joint or muscle pain; urinary disorders; need to urinate at night; increased urge to urinate; breast enlargement in men; chest pain; pain, malaise; weight gain or weight loss.
Rare (may occur in fewer than 1 in 1000 people):
Disorientation.
Very rare (may occur in fewer than 1 in 10,000 people):
Decreased white blood cell count, which may increase the risk of infections; decreased platelet count, which may lead to easy bruising or prolonged bleeding time; increased blood glucose concentration; increased muscle tone or increased resistance to passive movement (hypertonia); tingling or numbness of hands or feet; myocardial infarction; vasculitis; hepatitis or pancreatitis; gastric mucosal inflammation; gingival hyperplasia; increased liver enzyme activity; jaundice (yellowing of the skin and eyes); increased photosensitivity; allergic reactions: itching, rash, facial swelling, swelling of the oral cavity and (or) larynx with accompanying itching and rash, severe skin reactions including intense skin rash, urticaria, redness of the entire skin surface, severe skin itching, blistering, skin peeling and skin swelling, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening.
Frequency not known (cannot be estimated from available data):
Tremor, postural rigidity, facial mask-like expression, slowed movements and dragging of legs while walking, unsteady gait.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Elestar

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton following EXP.
The expiry date refers to the last day of the stated month.
No special storage conditions apply for this medicine.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Elestar contains
The active substances are olmesartan medoxomil and amlodipine (as besylate).
Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
Each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
Each tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).
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 (E171).
Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), iron oxide yellow (E172).
Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172).

What Elestar looks like and contents of the pack
Elestar 20 mg + 5 mg are white, round, film-coated tablets marked with "C73" on one side.
Elestar 40 mg + 5 mg are cream-coloured, round, film-coated tablets marked with "C75" on one side.
Elestar 40 mg + 10 mg are brown-red, round, film-coated tablets marked with "C77" on one side.
Film-coated Elestar tablets are available in blisters OPA/Aluminium/PVC/Aluminium in packs containing 14, 28, 56, 98 film-coated tablets per pack, and 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 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
Laboratorios Menarini, S.A.
Alfonso XII, 587
08918 Badalona (Barcelona), Spain
Fine Foods & Pharmaceuticals NTM S.p.A.
Via Grignano, 43
24041 - Brembate (BG), Italy

For further information regarding 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 following names in the Member States of the European Economic Area:
Austria: Amelior 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Belgium: Forzaten 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Bulgaria: Tespadan 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Cyprus: Orizal 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Czech Republic: Sintonyn 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Estonia: Sanoral 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
France: Axeler 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Greece: Orizal 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Spain: Balzak 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Netherlands: Belfor 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Ireland: Konverge 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Lithuania: Sanoral 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Latvia: Sanoral 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Luxembourg: Forzaten 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Malta: Konverge 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Germany: Vocado 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Poland: Elestar 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Portugal: Zolnor 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Romania: Inovum 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Slovenia: Olectan 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Slovakia: Folgan 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Hungary: Duactan 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg
Italy: Bivis 20 mg+5 mg, 40 mg+5 mg, 40 mg+10 mg