Elestar

Leaflet attached to 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, so you can read it again if you need to.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their 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 (in the form of 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 reducing the tension of blood vessels.
• Amlodipine belongs to a group of medicines called calcium antagonists. Amlodipine inhibits the penetration of calcium into the walls of blood vessels, preventing their constriction, and thus lowering blood pressure.

The action of both substances contributes to the inhibition of blood vessel constriction, resulting in a decrease in blood vessel tension and a decrease in blood pressure. Elestar is used to treat high blood pressure in patients whose blood pressure is not sufficiently controlled by taking only olmesartan medoxomil or only amlodipine.

2. Important information before taking Elestar

When not to take Elestar

• after the third month of pregnancy. (It is also recommended to avoid taking Elestar in early pregnancy - see section "Pregnancy and breastfeeding")

Warnings and precautions

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

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

Your doctor may recommend regular monitoring 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 a history of kidney transplantation;
• Liver disease;
• Heart failure or problems with heart valves or heart muscle;
• Severe vomiting, diarrhea, treatment with high doses of diuretics (diuretics) or a low-salt diet;
• Increased potassium levels in the blood;
• Adrenal gland disorders (hormone-producing glands located in the upper part of the kidneys).

If you experience severe, persistent diarrhea that causes significant weight loss, consult your doctor. The doctor will assess the symptoms and decide how to continue blood pressure treatment. If you experience abdominal pain, nausea, vomiting, or diarrhea after taking Elestar, discuss it with your doctor. The 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 a heart attack or stroke. Your doctor will recommend careful monitoring of blood pressure in such patients. If you suspect (or plan) pregnancy, do not take Elestar during early pregnancy and do not take it after 3 months of pregnancy, as it may seriously harm the fetus (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 now or have taken recently, as well as any medicines you 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 (diuretics), 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.
• Cholestyramine 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 cholestyramine hydrochloride.
• Certain antacids(medicines used for heartburn or acid reflux) - may slightly weaken the effect 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), used to treat 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 now or have taken recently, as well as any medicines you plan to take.

Taking Elestar with food and drink

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

Elderly patients

In patients over 65 years of age, during each dose increase, the doctor will monitor blood pressure to check if it has not decreased 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
Tell your doctor if you suspect (or plan) pregnancy. The doctor will usually recommend stopping Elestar before planned pregnancy or immediately after confirming pregnancy and will recommend taking another medicine instead of Elestar. It is not recommended to take Elestar during early pregnancy and it should not be taken after 3 months of pregnancy, as it may seriously harm the fetus.
If you become pregnant while taking Elestar, contact your doctor immediately.
Breastfeeding
Tell your doctor if you are breastfeeding or plan to breastfeed. It has been shown that small amounts of amlodipine pass into human milk. It is not recommended to take Elestar during breastfeeding, especially when breastfeeding a newborn or premature baby. The doctor may recommend taking another medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist 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 vehicles or operate machines until the symptoms have subsided. Consult your doctor for advice.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is "sodium-free".

3. How to take Elestar

Take this medicine always as directed by your doctor or pharmacist. If you are unsure, consult 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 liquid (e.g., a glass of water). Do not chew the tablets. Do not take Elestar with grapefruit juice.
• If possible, take the prescribed dose of Elestar every day at the same time, for example, 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.
Even 24-48 hours after taking the medicine, shortness of breath due to excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Elestar

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

Stopping Elestar treatment

It is essential to continue taking Elestar until your doctor recommends stopping it.
If you have any further doubts about taking this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Elestar can cause side effects, although not everybody gets them.
Side effects are often mild and do not require stopping the medicine.

The following side effects of Elestar, although rare, can 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 consult 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, consult your doctor immediately, and stay in a lying position.
Unknown frequency: if yellowing of the whites of the eyes occurs, dark urine, itching of the skin, even if Elestar was started much earlier, consult your doctor immediately,who will assess the symptoms and decide how to continue blood pressure treatment.

Other possible side effects of Elestar:

Common(may occur in less than 1 in 10 people):
Dizziness, headache, swelling of the ankles, feet, legs, hands, or arms, fatigue.
Uncommon(may occur in less than 1 in 100 people):
Dizziness when standing up, lack of energy, tingling or numbness of the hands or feet, vertigo, 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, abdominal pain, rash, 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 occur in less than 1 in 1000 people):
Hypersensitivity to the medicine, fainting, flushing and feeling of heat on the face, red, itchy bumps (hives), swelling of the face.
Side effects observed during treatment with only olmesartan medoxomil or only amlodipine, but not observed during treatment with Elestar or observed more frequently in monotherapy:

Olmesartan medoxomil

Common(may occur in less than 1 in 10 people):
Bronchitis; sore throat; runny nose or nasal congestion; cough; abdominal 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 in the blood, increased urea or uric acid levels in the blood, and increased liver enzyme and muscle function parameters.
Uncommon(may occur in less than 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 occur in less than 1 in 1000 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 abdominal pain, nausea, vomiting, and diarrhea.

Amlodipine

Very common(may occur in at least 1 in 10 people):
Swelling (fluid retention in the body).
Common(may occur in less than 1 in 10 people):
Abdominal pain; nausea; swelling of the ankles; feeling of sleepiness; flushing and feeling of heat on the face; visual disturbances (including double vision and blurred vision); palpitations; diarrhea; constipation; indigestion; cramps; weakness; breathing difficulties.
Uncommon(may occur in less than 1 in 100 people):
Difficulty sleeping, sleep disorders; mood changes, including anxiety; depression; irritability; chills; changes in taste; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); respiratory problems; hair loss; purple spots or patches on the skin due to small bleeding (purpura); skin discoloration; excessive sweating; skin rash; itching; red, itchy bumps (hives); joint or muscle pain; urinary disorders; need to urinate at night; increased urination; breast enlargement in men; chest pain; pain, malaise.
Rare(may occur in less than 1 in 1000 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 glucose levels in the blood; increased muscle tone or increased resistance to passive movement (hypertonia); tingling or numbness of the hands or feet; myocardial infarction; vasculitis; hepatitis or pancreatitis; gastritis; 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, blistering, and peeling of the skin, Stevens-Johnson syndrome, and toxic epidermal necrolysis, sometimes life-threatening.
Frequency not known(cannot be estimated from available data):
Tremor, stiffness, mask-like face, slow movements, and dragging of the feet when walking, unsteady gait.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Elestar

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after EXP.
The expiry date refers to the last day of the 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 that are no longer needed. This 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 (in the form of besylate).
Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (in the form of besylate).
Each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (in the form of besylate).
Each tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (in the form of besylate).
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/Aluminum/PVC/Aluminum 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
To obtain more detailed information on this medicine, contact the local representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
Phone: +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