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 Medication, 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 medication 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, tell your 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 medications such as Olimestra. To help lower blood pressure, your doctor may also recommend lifestyle changes (e.g., weight loss, smoking cessation, reduced alcohol consumption, and reduced salt intake in the diet). Your doctor may also encourage regular physical exercise, such as walking or swimming.
It is essential to follow your doctor's recommendations.

2. Important Information Before Taking Olimestra

When Not to Take Olimestra:

• after the third month of pregnancy (you should also avoid taking Olimestra during early pregnancy - see section "Pregnancy");

Warnings and Precautions

Before taking Olimestra, 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, such as 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 Olimestra".
Tell your doctor if you 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 levels of potassium in the blood,
• adrenal gland problems.

Contact your doctor if you experience severe, persistent diarrhea that causes significant weight loss. 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 Olimestra, discuss it with your doctor. Your doctor will decide on further treatment. Do not stop taking Olimestra on your own.
As with any blood pressure medication, excessive blood pressure lowering in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will carefully monitor your blood pressure.
You must inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Olimestra during early pregnancy. You must not take Olimestra after the third month of pregnancy, as it may seriously harm your baby (see section "Pregnancy").

Children and Adolescents

Studies have been conducted on the use of olmesartan medoxomil in children and adolescents. For more information, contact your 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

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take:

• Other blood pressure-lowering medicines, as they may increase the effect of Olimestra. Your doctor may recommend a dose change and/or take other precautions if you are 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 thinner). 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 effects of lithium. 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) taken with Olimestra may increase the risk of kidney failure. The effect of Olimestra may be reduced by NSAIDs.
• Colesevelam hydrochloride (a cholesterol-lowering medicine), as it may reduce the effect of Olimestra. Your 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 much.
Black Patients
As with similar medicines, the blood pressure-lowering effect of Olimestra may be slightly less in black patients.

Olimestra with Food and Drink

Olimestra can be taken with or without food.

Pregnancy and Breastfeeding

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.
Pregnancy
You must inform your doctor about pregnancy, suspected pregnancy, or planned pregnancy. Your doctor will usually recommend stopping Olimestra before becoming pregnant or as soon as pregnancy is detected and will prescribe another medicine. It is not recommended to take Olimestra during early pregnancy. You must not take Olimestra after the third month of pregnancy, as it may seriously harm your baby.
Breastfeeding
Inform your doctor about breastfeeding or intending to breastfeed. It is not recommended to take Olimestra during breastfeeding. Your doctor may choose another medicine if you intend 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, do not drive or operate machinery until these symptoms have resolved. Consult your doctor.

Olimestra Contains Lactose

If you know you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to Take Olimestra

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

Adults

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

Children and Adolescents

The recommended starting dose is 10 mg once daily. If blood pressure control is not adequate, your 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. Swallow the tablet with a sufficient amount of liquid (e.g., a glass of water). If possible, take the medicine at the same time each day, e.g., during breakfast.

Taking More Than the Recommended Dose of Olimestra

If you have taken more than the recommended dose of Olimestra or if a child has accidentally taken the medicine, seek medical advice immediately and take the package leaflet with you to the doctor or hospital.

Forgetting to Take a Dose of Olimestra

If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

Stopping Treatment with Olimestra

It is important to continue taking Olimestra for as long as your doctor recommends.
If you have any further questions on the use of this product, ask your 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 affect up to 1 in 1000 people), the following allergic reactions have been reported, which can affect the whole body:

During treatment with Olimestra, facial swelling, mouth and/or throat swelling with itching and rash may occur. If you experience these symptoms, stop taking Olimestra and contact your doctor immediately.
Rarely (but more frequently in elderly people), 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 you experience these symptoms, stop taking Olimestra, contact your doctor immediately, and lie down.
Frequency not known: if you experience yellowing of the eyes, dark urine, itching of the skin, even if you started taking Olimestra much earlier, contact your doctor immediately, who will assess the symptoms and decide how to continue blood pressure treatment.
The following are other known side effects of Olimestra:

Common side effects (may affect up to 1 in 10 people):
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.
Abnormal laboratory 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 affect up to 1 in 100 people):
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, skin eruptions (hives), skin bumps (papules), angina pectoris (chest pain or discomfort).
Abnormal laboratory test results have also been observed, including decreased platelet count (thrombocytopenia).
Rare side effects (may affect up to 1 in 1000 people):
Lack of energy, muscle cramps, kidney problems, kidney failure, intestinal angioedema: intestinal swelling with symptoms such as stomach pain, nausea, vomiting, and diarrhea.
Abnormal laboratory 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, side effects are similar to those reported in adults. However, dizziness and headache are more frequent in children, while nosebleeds are a common side effect that occurs only in children.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects 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
You can also report side effects 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 Olimestra

Keep this medicine out of the 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.
There are no special storage precautions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. 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.
• The other ingredients are:
• tablet core: microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, 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 convex film-coated tablets, with the inscription S1 on one side; tablet diameter: 6.5 mm.
20 mg: white, round, slightly convex film-coated tablets, with the inscription S2 on one side; tablet diameter: 8 mm.
40 mg: white, oval, convex film-coated tablets, with the inscription 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 Medicinal Product 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