Olimestra

Patient Information Leaflet

Olimestra 10 mg, film-coated tablets
Olimestra 20 mg, film-coated tablets
Olimestra 40 mg, film-coated tablets
Olmesartan medoxomil
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Olimestra is and what it is 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 Olimestra is and what it is 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 aged 6 to below 18 years. Hypertension may damage blood vessels in vital organs such as the heart, kidneys, brain, and eyes. In some cases, this may lead to heart attack, heart or kidney failure, stroke, or blindness.
Hypertension usually causes no symptoms. Monitoring blood pressure helps prevent such damage.
High blood pressure can be controlled with medicines such as Olimestra. To help lower blood pressure, your doctor may also recommend lifestyle changes (e.g. weight reduction, quitting smoking, reducing alcohol consumption, and decreasing dietary salt intake). Your doctor may also encourage regular physical activity, such as walking or swimming.
It is important to follow your doctor's advice.

2. Important information before using Olimestra

When not to use Olimestra:

• if the patient is allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6);
• after the 3rd month of pregnancy (Olimestra should also be avoided during early pregnancy – see section "Pregnancy");
• if the patient has jaundice (yellowing of the skin and eyes) or if bile excretion from the gallbladder is impaired (e.g. due to gallstones blocking bile flow);
• 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 treatment with Olimestra, discuss this with your doctor or pharmacist.

Tell your doctor if the patient is taking any of the following medicines used
for treating 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.

Your doctor may recommend regular monitoring of kidney function, blood pressure, and blood electrolyte levels (e.g. potassium).
See also the section "When not to use Olimestra".
Tell your doctor if the patient has any of the following health conditions:

• kidney disease,
• liver disease,
• heart failure, heart valve or heart muscle disorders,
• severe vomiting, diarrhoea, use of high doses of diuretics ("water pills") or a low-salt diet,
• high blood potassium levels,
• adrenal gland disorders.

Contact your doctor if the patient develops severe, persistent diarrhoea causing significant weight loss. Your doctor will assess the symptoms and decide how to continue blood pressure-lowering treatment.
If the patient experiences abdominal pain, nausea, vomiting or diarrhoea after taking Olimestra, discuss this with your doctor. Your doctor will decide on further treatment. Do not stop taking Olimestra on your own.

As with any medicine that lowers blood pressure, excessive lowering of blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will carefully monitor the patient's blood pressure.

Be sure to inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Olimestra is not recommended during early pregnancy. Olimestra must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child (see section "Pregnacy").

Children and adolescents
Studies on the use of olmesartan medoxomil in children and adolescents have been conducted. For additional information, consult your doctor. Olimestra is not recommended for children aged 1 to below 6 years. Olimestra must not be used in children under 1 year of age.

Olimestra with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines they plan to take:

• Other blood pressure-lowering medicines, as they may enhance the effect of Olimestra. Your doctor may recommend a dose adjustment and/or additional precautions if the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to use Olimestra" and "Warnings and precautions").
• Potassium supplements, potassium-containing salt substitutes, diuretics ("water pills") or heparin (a medicine that reduces blood clotting). Taking these medicines together with Olimestra may increase blood potassium levels.
• Lithium salts (a medicine used to treat mood disorders and certain types of depression). Taking lithium together with Olimestra may increase lithium's toxic effects. If lithium treatment is necessary, your doctor will recommend monitoring blood lithium levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling and other inflammatory symptoms, including joint inflammation) taken together with Olimestra may increase the risk of kidney failure. The effect of Olimestra may be reduced by NSAIDs.
• Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels), as it may reduce the effectiveness of Olimestra. Your doctor may recommend taking Olimestra at least 4 hours before taking colesevelam hydrochloride.
• Certain medicines that neutralize stomach acid (medicines used for indigestion), as they may slightly reduce the effectiveness of Olimestra.

Elderly patients
In patients over 65 years of age whose dose has been increased to 40 mg daily, your doctor will recommend regular blood pressure monitoring to ensure that blood pressure is not lowered excessively.

Black patients
As with similar medicines, the antihypertensive effect of Olimestra may be somewhat 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, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Pregnancy
Be sure to inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Your doctor will usually recommend stopping Olimestra before becoming pregnant or immediately after pregnancy is confirmed, and will prescribe an alternative medicine. Olimestra is not recommended during early pregnancy. Olimestra must not be taken after the 3rd month of pregnancy, as it may seriously harm the unborn child.

Breastfeeding
Inform your doctor if you are breastfeeding or plan to breastfeed. Olimestra is not recommended during breastfeeding. Your doctor may choose an alternative medicine if you plan to breastfeed, especially if breastfeeding a newborn or premature infant.

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 the patient knows they have been diagnosed with intolerance to certain sugars, they should contact their doctor before starting this medicine.

3. How to use Olimestra

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt,
you should consult your doctor or pharmacist.
Adults
The recommended starting dose is 10 mg once daily. However, if adequate blood pressure control is not achieved,
your 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. However, if adequate blood pressure control is not achieved,
your doctor may increase the dose to 20 mg or 40 mg once daily. In children with body weight below 35 kg,
the dose should not exceed 20 mg once daily.
In patients with mild to moderate renal impairment, the dose of this medicine should not exceed 20 mg
once daily.
The tablets may be taken with food or independently of meals. Swallow the tablet with an adequate amount
of liquid (e.g. a glass of water). If possible, take the medicine at the same time each day, for example with breakfast.
Taking more Olimestra than prescribed
If you take more medicine than prescribed, or if a child accidentally swallows the medicine,
seek immediate medical advice from a doctor or the nearest hospital emergency department,
and take the medicine packaging with you.
If you miss a dose of Olimestra
If you accidentally miss a dose, take the next dose the following day at your usual time.
Do not take a double dose to make up for a missed dose.
Stopping Olimestra
It is important to continue taking Olimestra for as long as your doctor recommends.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Although rare, the following adverse reactions may be serious:
In rare cases (may occur in fewer than 1 in 1,000 patients), the following allergic reactions affecting the whole body have been reported:
While using Olimestra, facial swelling, swelling of the oral cavity and (or) larynx, accompanied by itching and rash, may occur. If any of these symptoms occur, discontinue use of Olimestra immediately and contact your doctor without delay.
In rare cases (but somewhat 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 may lead to severe dizziness or fainting. If any of these symptoms occur, discontinue use of Olimestra immediately, contact your doctor without delay, and lie down.
Frequency unknown: if yellowing of the whites of the eyes, dark urine, or skin itching occur—even if Olimestra treatment was initiated significantly earlier—seek immediate medical advice. Your doctor will assess the symptoms and decide how to proceed with treatment for arterial hypertension.

The following are other known adverse reactions associated with Olimestra:

Common adverse reactions (may occur in fewer than 1 in 10 patients):
Dizziness, headache, nausea, indigestion, diarrhoea, stomach pain, inflammation of the mucous lining of the stomach and intestines, fatigue, sore throat, cold symptoms such as nasal congestion or runny nose, bronchitis, influenza-like symptoms, cough, pain, chest pain, back, bone or joint pain, urinary tract infection, swelling around the ankles, feet, legs, hands or arms, presence of blood in urine.

Certain abnormalities in blood test results have also been observed:
Increased levels of fats (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased blood urea nitrogen, increased activity of liver and muscle enzymes.

Uncommon adverse reactions (may occur in fewer than 1 in 100 patients):
Sudden allergic reactions affecting the whole body, which may cause breathing difficulties, as well as sudden drop in blood pressure potentially leading to fainting (anaphylactic reactions), vertigo, vomiting, weakness, malaise, muscle pain, skin rash, allergic dermatitis, itching, skin eruptions, skin nodules (blisters), angina pectoris (chest pain or discomfort).

Blood tests have also shown a decrease in the number of blood cells called platelets (thrombocytopenia).

Rare adverse reactions (may occur in fewer than 1 in 1,000 patients):
Lack of energy, muscle cramps, kidney dysfunction, kidney failure, intestinal angioedema: intestinal swelling with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Other blood test abnormalities observed include increased potassium levels (hyperkalemia) and increased levels of substances related to kidney function.

Children and adolescents
Children experience similar adverse reactions to those reported in adult patients. However, dizziness and headache occur more frequently in children, while nosebleeds are a common adverse reaction occurring only in children.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Olimestra

Keep this medicine 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 stated month.
No special storage instructions apply.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This helps protect the environment.

6. Contents of the packaging and other information

What Olimestra contains

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

What Olimestra looks like and contents of the pack
10 mg: white, round, slightly biconvex coated tablets, marked with the code S1 on one side; tablet diameter: 6.5 mm.
20 mg: white, round, slightly biconvex coated tablets, marked with the code S2 on one side; tablet diameter: 8 mm.
40 mg: white, oval, biconvex coated tablets, marked with the code S3 on one side; tablet dimensions: 13 mm x 8 mm.
Packs: 28, 30, 56 or 60 coated tablets in blister packs contained in a cardboard box.

Marketing Authorisation Holder and Manufacturer
KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8000 Novo mesto, Slovenia

This medicinal product is authorised in the Member States of the European Economic Area under the following names: