ELESTAR 20 mg/5 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: information for the user
2. Elestar, 20 mg+5 mg, film-coated tablets
3. Elestar, 40 mg+5 mg, film-coated tablets
4. Elestar, 40 mg+10 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
5. What is Elestar and what is it used for
6. Important information before taking Elestar
   1. When not to take Elestar
   2. Warnings and precautions
   3. Children and adolescents (under 18 years of age)
   4. Elestar and other medicines
   5. Taking Elestar with food and drink
   6. Elderly patients
   7. Black patients
   8. Pregnancy and breastfeeding
   9. Driving and using machines
7. How to take Elestar
   1. Taking a higher dose of Elestar than recommended
   2. Missing a dose of Elestar
   3. Stopping treatment with Elestar
8. Possible side effects
   1. The following side effects of Elestar, although not common, can be serious:
   2. Other possible side effects of Elestar:
   3. Olmesartan medoxomil
   4. Amlodipine
   5. Reporting side effects
9. How to store Elestar
10. Contents of the pack and other information
    1. What Elestar contains
    2. What Elestar looks like and contents of the pack
    3. Marketing authorization holder and manufacturer
    4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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 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 narrowing, and thus lowering blood pressure.

The action of both substances contributes to the inhibition of vasoconstriction, resulting in a decrease in vascular tension and 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. (You should also 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 post-kidney transplant;
• 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 problems (glands that produce hormones, located in the upper part 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 abdominal 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. Like 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 and inform your doctor. It is not recommended to take Elestar in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously 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(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) - possible weakening of 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 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. You should swallow the tablet with a liquid (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 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 check blood pressure to see if it has dropped 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. Your doctor will usually recommend stopping Elestar before planned pregnancy or as soon as pregnancy is confirmed, and will recommend taking another medicine instead of Elestar. It is not recommended to take Elestar in early pregnancy and it should not be taken after the third month of pregnancy, as it may seriously harm the baby.
If you become pregnant while taking Elestar, contact your doctor immediately.
Breastfeeding
Tell your doctor if you are breastfeeding or planning 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 if you are breastfeeding a newborn or premature baby. Your doctor may recommend taking another medicine.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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, you may experience drowsiness, nausea, dizziness, or headache. In this case, 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, which means 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. The tablet should be swallowed 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 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 tablets than recommended or if a child accidentally swallows the medicine, go to your doctor or the emergency department of the nearest hospital immediately, taking the medicine packaging or this leaflet with you.
Even 24-48 hours after taking the medicine, shortness of breath due to excess fluid accumulation in the lungs (pulmonary edema) may occur.

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 the missed 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 about taking this medicine, ask 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 discontinuation of the medicine.

The following side effects of Elestar, although not common, 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 this case, stop taking Elestar and contact your doctor immediately.
In susceptible individuals, taking Elestar may cause excessive lowering of blood pressure, also as a result of an allergic reaction. This can cause severe dizziness or fainting. In this case, stop taking Elestar, inform 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, 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 labyrinthine origin, awareness of heartbeat, 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 mucous membranes of the mouth, abdominal pain, skin rash, cramps, pain in the hands and feet, 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 heat in 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 affect up to 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 levels of fats (excess triglycerides in the blood), increased levels of urea or uric acid in the blood, and increased activity of liver enzymes 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 sudden drop in blood pressure, which can lead to fainting (anaphylactic reaction); angina pectoris (pain or discomfort in the chest, known as angina attack); itching; skin rash; allergic skin rash; 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 abdominal 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 sleepiness; flushing and feeling of heat in the face, visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhea; constipation; indigestion; cramps, weakness; breathing difficulties.
Uncommon(may affect up to 1 in 100 people):
Difficulty sleeping, sleep disturbances; mood changes, including anxiety; depression; chills; change in taste; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (pain or discomfort in the chest); nasal congestion or runny nose; 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); pain in the joints or muscles; urinary problems; need to urinate at night; increased urination; breast enlargement in men; chest pain; pain, malaise.
Rare(may affect up to 1 in 1,000 people):
Disorientation.
Very rare(may affect up to 1 in 10,000 people):
Decreased white blood cell count, which can increase the risk of infection; 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; 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 of the skin, blistering, and peeling of the skin, Stevens-Johnson syndrome, and 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 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 that month.
There are no special precautions for storing the 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 (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).
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, 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