Elestar

Leaflet accompanying the packaging: 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

Olmesartan medoxomil + Amlodipine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of contents of the leaflet

• 1. What is Elestar and what is it used for
• 2. Important information before taking Elestar
• 3. How to take Elestar
• 4. Possible side effects
• 5. How to store Elestar
• 6. Contents of the pack and other information

1. What is Elestar and what is it used for

Elestar contains two active substances called olmesartan medoxomil and amlodipine (as besylate). Both of these substances help to lower high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists, which lower blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of medicines called calcium channel blockers. Amlodipine prevents calcium from entering the blood vessel walls, preventing them from narrowing and thus lowering blood pressure.

The action of both substances contributes to the relaxation of blood vessels, reducing blood pressure. Elestar is used to treat high blood pressure in patients whose blood pressure is not adequately controlled with olmesartan medoxomil or amlodipine alone.

2. Important information before taking Elestar

When not to take Elestar

• after the third month of pregnancy. (You should also avoid taking Elestar during early pregnancy - see section "Pregnancy and breastfeeding").

Warnings and precautions

Before taking Elestar, discuss it with your doctor or pharmacist. Tell your doctorif you are taking any of the following medicines for high blood pressure:

• an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), especially if you have kidney problems related to diabetes.
• aliskiren.

Your doctor may recommend regular checks of kidney function, blood pressure, and electrolyte levels (e.g. potassium) in the blood. See also the section "When not to take Elestar". Tell your doctorif you have any of the following conditions:

• Kidney problems or kidney transplant.
• Liver disease.
• Heart failure or heart valve problems or heart muscle problems.
• Severe vomiting, diarrhea, treatment with high doses of diuretics (water pills) or a low-salt diet.
• High potassium levels in the blood.
• Adrenal gland problems (glands that produce hormones, located on top of the kidneys).

If you experience severe, persistent diarrhea that causes significant weight loss, contact your doctor. Your doctor will assess the symptoms and decide how to continue blood pressure treatment. If you experience stomach pain, nausea, vomiting, or diarrhea after taking Elestar, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Elestar on your own. As with other blood pressure-lowering medicines, excessive lowering of blood pressure in patients with circulatory problems in the heart or brain may lead to heart attack or stroke. Your doctor will monitor your blood pressure closely in such patients. If you are pregnant or planning to become pregnant, inform your doctor. Elestar should not be taken during early pregnancy and should not be taken after the third month of pregnancy, as it may harm the baby (see section "Pregnancy and breastfeeding").

Children and adolescents (under 18 years of age)

Elestar should not be used in children and adolescents under 18 years of age.

Elestar and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take. This is especially important for the following medicines:

• Other blood pressure-lowering medicines- may enhance the effect of Elestar.
• ACE inhibitors or aliskiren- your doctor may recommend a dose change and/or take other precautions (see also sections "When not to take Elestar" and "Warnings and precautions").
• Potassium supplements, potassium-containing salt substitutes, diuretics (water pills), or heparin(a blood thinner that prevents blood clots). Taking these medicines with Elestar may increase potassium levels in the blood.
• Lithium(a medicine used to treat mood swings and some types of depression) - taking it with Elestar may increase lithium toxicity. If lithium is necessary, your doctor will recommend monitoring lithium levels in the blood.
• Non-steroidal anti-inflammatory drugs (NSAIDs)(medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis), taken with Elestar, may increase the risk of kidney failure. NSAIDs may weaken the effect of Elestar.
• Colesevelam hydrochloride(a medicine that lowers cholesterol levels in the blood) - may weaken the effect of Elestar. Your doctor may recommend taking Elestar at least 4 hours before taking colesevelam hydrochloride.
• Certain antacids (medicines used for heartburn or acid reflux)- may slightly weaken the effect of Elestar.
• Medicines used to treat HIV/AIDS (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(given by infusion in case of severe body temperature disorders).
• Simvastatinused to lower cholesterol and fat (triglycerides) levels in the blood.
• Tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporinused to control the immune system, allowing the body to accept a transplanted organ.

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.

Taking Elestar with food and drink

Elestar can be taken with or without food. Swallow the tablet with a drink of water (e.g. a glass of water). If possible, take the prescribed dose of Elestar at the same time every day, e.g. during breakfast. Patients taking Elestar should not consume grapefruit juice or grapefruit, as they may increase the levels of the active substance amlodipine in the blood, which may lead to unpredictable enhancement of the blood pressure-lowering effect of Elestar.

Elderly patients

In patients over 65 years of age, during each dose increase, the doctor will check blood pressure to ensure that it does not drop too much.

Black patients

Like other similar blood pressure-lowering medicines, Elestar may have a slightly weaker effect in black patients.

Pregnancy and breastfeeding

Pregnancy
Inform your doctor if you are pregnant or planning to become pregnant. Your doctor will usually recommend stopping Elestar before planned pregnancy or as soon as pregnancy is confirmed, and will recommend an alternative medicine. Elestar should not be taken during early pregnancy and should not be taken after the third month of pregnancy, as it may harm the baby. If you become pregnant while taking Elestar, contact your doctor immediately.
Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. It has been shown that small amounts of amlodipine pass into human milk. Elestar should not be taken during breastfeeding, especially during breastfeeding of newborns or premature babies. Your doctor may recommend an alternative medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

When taking blood pressure-lowering medicines, drowsiness, nausea, dizziness, or headache may occur. In such cases, do not drive or operate machinery until the symptoms have resolved. Consult your doctor for advice.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, i.e. it is essentially "sodium-free".

3. How to take Elestar

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

• The recommended dose is one tablet per day.
• Tablets can be taken with or without food. Swallow the tablet with a drink of water (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 every day, e.g. during breakfast.

Taking a higher dose of Elestar than recommended

Taking more tablets than recommended may cause excessive lowering of blood pressure, resulting in dizziness and rapid or slow heartbeat. If you take more than the recommended dose, or if a child accidentally swallows the medicine, go to your doctor or the emergency department of the nearest hospital immediately, taking the packaging or this leaflet with you.

Missing a 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 forgotten dose.

Stopping treatment with Elestar

It is important to continue taking Elestar until your doctor tells you to stop. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects are usually mild and do not require discontinuation of the medicine.

The following side effects of Elestar may be serious:

During treatment with Elestar, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth, and/or throat, accompanied by itching and rash. In such cases, stop taking Elestar and contact your doctor immediately.
In susceptible individuals, taking Elestar may cause excessive lowering of blood pressure, also due to an allergic reaction. This can cause severe dizziness or fainting. In such cases, stop taking Elestar, inform your doctor immediately, and remain lying down.
Frequency not known: if you experience yellowing of the whites of the eyes, dark urine, itching of the skin, even if you started taking Elestar much earlier, contact your doctor immediately,who will assess the symptoms and decide how to continue blood pressure treatment.

Other possible side effects of Elestar:

Common(may affect up to 1 in 10 people):
Dizziness, headache, swelling of the ankles, feet, legs, hands, or arms, fatigue.
Uncommon(may affect up to 1 in 100 people):
Dizziness when standing up, lack of energy, tingling or numbness of the hands or feet, dizziness of inner ear origin, palpitations, rapid heartbeat, low blood pressure with symptoms such as dizziness, feeling of "emptiness" in the head, difficulty breathing, cough, nausea, vomiting, indigestion, diarrhea, constipation, dryness of the mouth, stomach pain, rash, muscle cramps, pain in the arms and legs, back pain, increased urination, decreased sexual performance, inability to achieve or maintain an erection, weakness.
Changes in laboratory test results have also been observed: increased or decreased potassium levels in the blood, increased creatinine levels, increased uric acid levels, increased liver enzyme activity (gamma-glutamyltransferase).
Rare(may affect up to 1 in 1,000 people):
Hypersensitivity to the medicine, fainting, flushing and feeling of warmth in the face, red, itchy bumps (hives), swelling of the face.
Side effects observed during treatment with olmesartan medoxomil or amlodipine alone, but not observed during treatment with Elestar, or observed more frequently during monotherapy:

Olmesartan medoxomil

Common(may affect up to 1 in 10 people):
Bronchitis; sore throat; runny or stuffy nose; cough; stomach pain; flu-like symptoms; diarrhea; indigestion; nausea; back pain; blood in the urine; urinary tract infection; chest pain; flu-like symptoms; pain.
Changes in blood test results - increased triglyceride levels, increased urea or uric acid levels in the blood, and increased liver enzyme and muscle function parameters.
Uncommon(may affect up to 1 in 100 people):
Decreased platelet count, which can cause easy bruising or prolonged bleeding; sudden allergic reaction, which can affect the whole body and cause breathing difficulties, as well as a sudden drop in blood pressure, which can lead to fainting (anaphylactic reaction); angina pectoris (chest pain or discomfort); itching; skin rash; allergic skin rash; hives; swelling of the face; muscle pain; malaise.
Rare(may affect up to 1 in 1,000 people):
Swelling of the face, mouth, and/or throat; acute kidney failure and kidney problems; lethargy; intestinal angioedema: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.

Amlodipine

Very common(may affect more than 1 in 10 people):
Swelling (fluid retention in the body).
Common(may affect up to 1 in 10 people):
Abdominal pain; nausea; swelling of the ankles; feeling of tiredness; flushing and feeling of warmth in the face; visual disturbances (including double vision and blurred vision); palpitations; diarrhea; constipation; indigestion; muscle cramps; weakness; breathing difficulties.
Uncommon(may affect up to 1 in 100 people):
Sleep disorders, mood changes, including anxiety; depression; chills; changes in taste; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); runny or stuffy nose; hair loss; purple spots or patches on the skin due to small blood leaks (purpura); skin discoloration; excessive sweating; skin rash; itching; red, itchy bumps (hives); back pain; pain; weakness.
Rare(may affect up to 1 in 1,000 people):
Decreased white blood cell count, which can increase the risk of infections; decreased platelet count, which can cause easy bruising or prolonged bleeding; increased blood sugar levels; increased muscle tone or increased resistance to passive movement (hypertonia); tingling or numbness of the hands or feet; heart attack; blood vessel inflammation; liver or pancreas inflammation; stomach lining inflammation; gum hypertrophy; increased liver enzyme activity; yellowing of the skin and eyes; increased sensitivity to light; allergic reactions: itching, rash, swelling of the face, mouth, and/or throat with accompanying itching and rash, severe skin reactions, including intense skin rash, hives, flushing of the skin, severe itching of the skin, blistering, and peeling of the skin, inflammation of the mucous membranes (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening.
Frequency not known(cannot be estimated from the available data):
Tremor, stiffness, mask-like face, slow movements, and shuffling gait.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Elestar

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month. There are no special storage instructions 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. These measures will help protect the environment.

6. Contents of the pack and other information

What Elestar contains

The active substances of Elestar 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: maize starch, cornstarch, microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, magnesium stearate.
Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171).
Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), yellow iron oxide (E172).
Tablet coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172).

What Elestar looks like and contents of the pack

Elestar 20 mg + 5 mg are white, round, film-coated tablets with the inscription C73 on one side. Elestar 40 mg + 5 mg are cream-colored, round, film-coated tablets with the inscription C75 on one side. Elestar 40 mg + 10 mg are brown-red, round, film-coated tablets with the inscription C77 on one side. Elestar film-coated tablets are available in OPA/Aluminium/PVC/Aluminium blisters in packs containing 14, 28, 56, 98 film-coated tablets in blisters, and in packs containing 10 x 1, 50 x 1, or 500 x 1 film-coated tablets in blisters with perforation. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg.
Manufacturer:
Daiichi Sankyo Europe GmbH, Luitpoldstrasse 1, 85276 Pfaffenhofen, Ilm, Germany. Berlin-Chemie AG, Glienicker Weg 125, 12489 Berlin, Germany. Laboratorios Menarini, S.A., Alfonso XII, 587, 08918 Badalona (Barcelona), Spain. For further information on this medicine, contact your local representative of the marketing authorization 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 authorized in the Member States of the European Economic Area under the following names:

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.
Date of last revision of the leaflet:01/2025