Olimestra

Package Leaflet: Information for the Patient

Olimestra, 10 mg, film-coated tablets

Olimestra, 20 mg, film-coated tablets

Olimestra, 40 mg, film-coated tablets

Olmesartan medoxomil

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a 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 not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Olimestra and what is it used for

Olimestra belongs to a group of medicines called angiotensin II receptor antagonists. It lowers blood pressure by relaxing blood vessels.
Olimestra is used to treat high blood pressure (hypertension) in adults and in children and adolescents from 6 to less than 18 years of age. Hypertension can cause damage to blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this can lead to heart attack, heart or kidney failure, stroke, or blindness.
Hypertension usually does not cause any symptoms. Monitoring blood pressure allows prevention of these damages.
Hypertension can be controlled by taking medicines such as Olimestra. To help lower blood pressure, the doctor may also recommend lifestyle changes (e.g., weight loss, quitting smoking, reducing alcohol consumption, and reducing salt intake). The doctor may also encourage the patient to engage in regular physical activity, such as walking or swimming.
It is essential to follow the doctor's recommendations.

2. Important information before taking Olimestra

When not to take Olimestra:

• if the patient is allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6);
• after the third month of pregnancy (Olimestra should also be avoided in early pregnancy - see section "Pregnancy");
• if the patient has jaundice (yellowing of the skin and eyes) or if bile secretion from the gallbladder is impaired (bile flow from the gallbladder is blocked, e.g., by gallstones);
• if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions

Before starting Olimestra, the patient should discuss it with their doctor or pharmacist.
The patient should tell their doctorif they are taking any of the following medicines for high blood pressure:

• an angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, ramipril, especially if the patient has kidney problems related to diabetes,
• aliskiren.

The doctor may recommend regular monitoring of kidney function, blood pressure, and electrolyte levels (e.g., potassium).
See also the section "When not to take Olimestra".
The patient should tell their doctor if they have any of the following health problems:

• kidney disease,
• liver disease,
• heart failure, valve problems, or heart muscle problems,
• severe vomiting, diarrhea, taking high doses of diuretics, or a low-salt diet,
• high potassium levels in the blood,
• adrenal gland problems.

The patient should contact their doctor if they experience severe, persistent diarrhea that causes significant weight loss. The doctor will assess the symptoms and decide how to continue blood pressure treatment.
If the patient experiences stomach pain, nausea, vomiting, or diarrhea after taking Olimestra, they should discuss it with their doctor. The doctor will decide on further treatment. The patient should not stop taking Olimestra on their own.
As with any blood pressure-lowering medicine, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, the doctor will carefully monitor the patient's blood pressure.
The patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. Olimestra should not be taken during pregnancy. Olimestra should not be taken after the third month of pregnancy, as it may seriously harm the baby (see section "Pregnancy").

Children and adolescents

Studies have been conducted on the use of olmesartan medoxomil in children and adolescents. For more information, the patient should contact their doctor. Olimestra is not recommended for children under 6 years of age. Olimestra should not be used in children under 1 year of age.

Olimestra and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take:

• Other blood pressure-lowering medicines, as they may enhance the effect of Olimestra. The doctor may recommend a dose change and/or take other precautions if the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to take Olimestra" and "Warnings and precautions").
• Potassium supplements, salt substitutes containing potassium, diuretics, or heparin (a blood-thinning medicine). Taking these medicines with Olimestra may increase potassium levels in the blood.
• Lithium salts (a medicine used to treat mood changes and some types of depression). Taking lithium with Olimestra may increase the toxic effect of lithium. If lithium is necessary, the 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) taken with Olimestra may increase the risk of kidney failure. The effect of Olimestra may be reduced by NSAIDs.
• Colesevelam hydrochloride (a medicine that lowers cholesterol levels in the blood), as it may reduce the effect of Olimestra. The doctor may recommend taking Olimestra at least 4 hours before taking colesevelam hydrochloride.
• Certain antacids (medicines used to neutralize stomach acid), as they may slightly reduce the effect of Olimestra.

Elderly patients
In patients over 65 years of age, whose dose is increased to 40 mg per day, the doctor will recommend regular monitoring of blood pressure to ensure that it does not drop too low.
Black patients
As with similar medicines, the blood pressure-lowering effect of Olimestra may be slightly weaker in black patients.

Olimestra with food and drink

Olimestra can be taken with or without food.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
The patient must inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Olimestra before becoming pregnant or as soon as pregnancy is confirmed and prescribe another medicine. Olimestra should not be taken during early pregnancy. Olimestra should not be taken after the third month of pregnancy, as it may seriously harm the baby.
Breastfeeding
The patient should inform their doctor about breastfeeding or intending to breastfeed. Olimestra is not recommended during breastfeeding. The doctor may choose another medicine if the patient intends to breastfeed, especially if breastfeeding a newborn or premature baby.

Driving and using machines

During treatment for high blood pressure, drowsiness or dizziness may occasionally occur. In such cases, the patient should not drive or operate machinery until these symptoms have resolved. The patient should consult their doctor.

Olimestra contains lactose

If the patient knows they have an intolerance to some sugars, they should contact their doctor before taking this medicine.

3. How to take Olimestra

This medicine should always be taken exactly as the doctor or pharmacist has told the patient. In case of doubt, the patient should consult their doctor or pharmacist.

Adults

The recommended starting dose is 10 mg once daily. If blood pressure control is not adequate, the doctor may increase the dose to 20 mg or 40 mg once daily or prescribe additional medicines.

Children and adolescents

The recommended starting dose is 10 mg once daily. If blood pressure control is not adequate, the doctor may increase the dose to 20 mg or 40 mg once daily. In children with a body weight below 35 kg, the dose should not exceed 20 mg once daily.
In patients with mild to moderate kidney disease, the dose should not exceed 20 mg once daily.
Tablets can be taken with or without food. The tablet should be swallowed with a sufficient amount of liquid (e.g., a glass of water). If possible, the medicine should be taken at the same time every day, e.g., during breakfast.

Taking a higher dose of Olimestra than recommended

In case of taking a higher dose than recommended or accidental ingestion by a child, the patient should immediately consult a doctor or the emergency department of the nearest hospital and take the package leaflet with them.

Missing a dose of Olimestra

If the patient has missed a dose, they should take the next dose at the usual time the next day. The patient should not take a double dose to make up for the missed dose.

Stopping Olimestra treatment

It is essential to take Olimestra for as long as the doctor recommends.
In case of further doubts about taking this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Olimestra can cause side effects, although not everybody gets them.
Although rare, the following side effects may be serious:
Rarely (may occur in less than 1 in 1000 patients), the following allergic reactions have been reported, which can affect the whole body:
During Olimestra treatment, facial swelling, mouth and/or throat swelling with itching and rash may occur. If these symptoms occur, the patient should stop taking Olimestra and immediately consult their doctor.
Rarely (but more frequently in elderly patients), Olimestra may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This can lead to severe dizziness or fainting. If these symptoms occur, the patient should stop taking Olimestra, immediately consult their doctor, and lie down.
Frequency not known: if yellowing of the whites of the eyes, dark urine, itching of the skin occurs, even if Olimestra treatment was started much earlier, the patient should immediately consult their doctor, who will assess the symptoms and decide how to continue hypertension treatment.
Other known side effects of Olimestra are listed below:
Common side effects (may occur in less than 1 in 10 patients):
Dizziness, headache, nausea, indigestion, diarrhea, stomach pain, gastritis, fatigue, sore throat, runny nose or stuffy nose, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain, bone or joint pain, urinary tract infections, swelling of the ankles, feet, legs, hands, or arms, blood in the urine.
Abnormalities in blood test results have also been observed, including increased levels of fats (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased levels of urea in the blood, increased liver enzyme activity, and increased muscle enzyme activity.
Uncommon side effects (may occur in less than 1 in 100 patients):
Anaphylactic reactions, which can affect the whole body and cause difficulty breathing, as well as a sudden drop in blood pressure, which can lead to fainting, dizziness of vestibular origin, vomiting, weakness, malaise, muscle pain, skin rash, allergic dermatitis, itching, rash (skin eruptions), skin bumps (blisters), angina pectoris (chest pain or discomfort).
In blood test results, a decrease in the number of blood cells called platelets (thrombocytopenia) has been observed.
Rare side effects (may occur in less than 1 in 1000 patients):
Lack of energy, muscle cramps, kidney problems, kidney failure, intestinal angioedema: swelling in the intestine with symptoms such as stomach pain, nausea, vomiting, and diarrhea.
Abnormalities in blood test results have also been observed, including increased levels of potassium (hyperkalemia) and increased levels of substances related to kidney function.

Children and adolescents

In children, similar side effects to those reported in adult patients occur.
However, dizziness and headache are more common in children, while nosebleeds are a common side effect that occurs only in children.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist. 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:
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 Olimestra

The medicine should be stored 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 month.
No special precautions for storage are necessary.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Olimestra contains

• The active substance is olmesartan medoxomil. Each film-coated tablet contains 10 mg, 20 mg, or 40 mg of olmesartan medoxomil.
• Other ingredients are:
• tablet core: microcrystalline cellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate;
• tablet coating: Opadry II 85F28751 II HP white, containing titanium dioxide (E 171), talc, macrogol 3000, partially hydrolyzed polyvinyl alcohol. See section 2 "Olimestra contains lactose".

What Olimestra looks like and contents of the pack

10 mg: white, round, slightly biconvex film-coated tablets with the imprint S1 on one side; tablet diameter: 6.5 mm.
20 mg: white, round, slightly biconvex film-coated tablets with the imprint S2 on one side; tablet diameter: 8 mm.
40 mg: white, oval, biconvex film-coated tablets with the imprint S3 on one side; tablet dimensions: 13 mm x 8 mm.
Packaging: 28, 30, 56, or 60 film-coated tablets in blisters in a cardboard box.

Marketing authorization holder and manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8000 Novo mesto, Slovenia

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:20.03.2025