Olmesartan lek-am

Package leaflet: Information for the patient

Olmesartan LEK-AM, 20 mg, film-coated tablets
Olmesartan LEK-AM, 40 mg, film-coated tablets
Olmesartanum medoxomilum

Please read this leaflet carefully before taking the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual only. Do not pass it on to others. The medicine may harm other people, 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.

Leaflet contents

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

1. What Olmesartan LEK-AM is and what it is used for

Olmesartan LEK-AM belongs to a group of medicines called angiotensin II receptor antagonists.
The medicine lowers blood pressure by dilating blood vessels.
Olmesartan LEK-AM is used in the treatment of high blood pressure, i.e. hypertension, in adults.
Hypertension may damage blood vessels in 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. It is important to monitor blood pressure regularly to prevent complications.
Hypertension can be controlled with medicines such as Olmesartan LEK-AM. To help lower blood pressure, your doctor may also recommend lifestyle changes (e.g. weight reduction, quitting smoking, reducing alcohol intake, and decreasing salt consumption in the diet).
Your doctor may also encourage you to engage in regular physical activity, such as walking or swimming. It is important to follow your doctor's advice.

2. Important information before taking Olmesartan LEK-AM

When not to use Olmesartan LEK-AM:

• 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 (Olmesartan LEK-AM should also be avoided during early pregnancy - see section "Pregnancy and breastfeeding");
• if the patient develops yellowing of the skin or eyes (jaundice) or impaired bile flow from the gallbladder (biliary obstruction, e.g. due to 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 Olmesartan LEK-AM, discuss this with your doctor.
Inform your doctor if the patient is taking any of the following medicines used to treat 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 Olmesartan LEK-AM".
Inform your doctor if the patient has:

• kidney disease,
• liver disease,
• heart failure, heart valve disorders, 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 leading to a significant decrease in body weight. Your doctor will assess the symptoms and decide how to continue blood pressure-lowering treatment.
As with any medicine that lowers blood pressure, excessive reduction in blood pressure in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, your doctor will recommend regular blood pressure monitoring.
Inform your doctor if the patient is pregnant, suspects pregnancy, or is planning pregnancy. Use of Olmesartan LEK-AM is not recommended during early pregnancy. Olmesartan LEK-AM must not be taken after the 3rd month of pregnancy, as it may cause serious harm to the unborn child (see section "Pregnancy and breastfeeding").
Like other medicines in the class of angiotensin II receptor antagonists, Olmesartan LEK-AM may be less effective in lowering blood pressure in black patients.
Elderly patients
In patients over 65 years of age whose dose has been increased to 40 mg daily, the doctor will recommend regular blood pressure monitoring to ensure that blood pressure is not reduced excessively.
Children and adolescents
Olmesartan LEK-AM is not recommended for use in children and adolescents under 18 years of age.
Olmesartan LEK-AM and other medicines
Tell your doctor or pharmacist about any medicines the patient is currently taking, has recently taken, or might take in the future.
In particular, inform your doctor if the patient is taking any of the following medicines:

• other blood pressure-lowering medicines, as they may enhance the effect of Olmesartan LEK-AM – your doctor may recommend a dose adjustment and/or additional precautions, especially if the patient is taking an ACE inhibitor or aliskiren (see also sections "When not to use Olmesartan LEK-AM" and "Warnings and precautions");
• potassium supplements, potassium-containing salt substitutes, potassium-sparing diuretics, or heparin (a medicine that reduces blood clotting) – taking these together with Olmesartan LEK-AM may increase blood potassium levels;
• lithium (a medicine used to treat mood disorders and certain types of depression) – taking lithium together with Olmesartan LEK-AM may increase lithium's toxic effects; if lithium treatment is necessary, your doctor will monitor blood lithium levels;
• non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) – when taken together, there may be an increased risk of kidney impairment, and the effect of Olmesartan LEK-AM may be reduced by NSAIDs;
• colesevelam hydrochloride (a medicine that lowers blood cholesterol levels) – this may reduce the effect of Olmesartan LEK-AM; your doctor may recommend taking Olmesartan LEK-AM at least 4 hours before taking colesevelam hydrochloride;
• certain medicines that neutralize stomach acid (used for indigestion) – these may slightly reduce the effect of Olmesartan LEK-AM.

Olmesartan LEK-AM with food and drink
Olmesartan LEK-AM may 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
Inform your doctor if the patient is pregnant, suspects pregnancy, or is planning pregnancy. Your doctor will usually recommend stopping Olmesartan LEK-AM before becoming pregnant or as soon as pregnancy is confirmed, and will prescribe an alternative medicine. Use of Olmesartan LEK-AM is not recommended during early pregnancy. Olmesartan LEK-AM must not be taken after the 3rd month of pregnancy, as it may be highly harmful to the unborn child.
Breastfeeding
Inform your doctor if the patient is breastfeeding or intends to breastfeed. Olmesartan LEK-AM is not recommended during breastfeeding. Your doctor may recommend an alternative medicine, especially if the patient is breastfeeding a newborn or a premature infant.
Driving and operating machinery
During treatment for high blood pressure, drowsiness or dizziness may occur. In such cases, do not drive or operate machinery until these symptoms subside. Consult your doctor.
Olmesartan LEK-AM contains lactose
If the patient has been previously diagnosed with an intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to take Olmesartan LEK-AM

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
The recommended starting dose is 10 mg once daily. This dose cannot be achieved with Olmesartan LEK-AM tablets – other medicines with appropriate strength should be used. However, if adequate blood pressure control is not achieved, your doctor may increase the dose to 20 mg or 40 mg once daily, or recommend additional medicines.
In patients with mild to moderate kidney disease, the dose of this medicine must not exceed 20 mg once daily.
The tablets can be taken with or without food. Swallow the tablet with a sufficient amount of liquid (e.g. a glass of water). Try to take the medicine at the same time each day, for example during breakfast.
Taking more Olmesartan LEK-AM than prescribed
If you take more tablets than prescribed, or if a child accidentally swallows the medicine, seek immediate medical advice from your doctor or the nearest hospital emergency department, and bring the medicine packaging with you.
Missing a dose of Olmesartan LEK-AM
If you miss a dose, take the next dose the following day at your usual time. Do not take a double dose to make up for the missed dose.
Stopping Olmesartan LEK-AM
If you stop taking Olmesartan LEK-AM, your blood pressure may rise again. Do not discontinue treatment without consulting your doctor first.
If you have any further questions regarding 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.
Adverse reactions are usually mild and do not require discontinuation of treatment.
Some symptoms may be severe and may require immediate medical attention.
In rare cases (in fewer than 1 in 1000 people), the following systemic
allergic reactions have been reported:

• swelling of the face, mouth and (or) throat, accompanied by itching and rash – if such symptoms occur in a patient, discontinue Olmesartan LEK-AM and contact a doctor immediately,
• excessive drop in blood pressure in susceptible individuals or as a result of an allergic reaction (slightly more common in elderly patients), with severe dizziness or fainting – if such symptoms occur in a patient, discontinue Olmesartan LEK-AM, contact a doctor immediately and lie down.

Frequency unknown: if yellowing of the whites of the eyes, dark urine, or skin itching occur, even
if treatment with Olmesartan LEK-AM was started significantly earlier, medical advice must be sought immediately, so that the doctor can assess the symptoms and decide how to continue
treatment for hypertension.

The following adverse reactions have been reported during treatment with Olmesartan LEK-AM:
Common adverse reactions (may occur in fewer than 1 in 10 patients):
Central dizziness, headache, nausea, indigestion, diarrhoea, stomach pain,
gastritis and enteritis, fatigue, sore throat, cold symptoms or nasal congestion, bronchitis,
influenza-like symptoms, cough, pain, chest pain, back pain, bone or
joint pain, urinary tract infection, swelling around ankles, feet, legs, hands or arms, presence of blood
in urine.

Some abnormalities in blood test results have also been observed:
Increased levels of fats (hypertriglyceridaemia), increased levels of uric acid
(hyperuricaemia), increased blood urea levels, increased activity of liver
and muscle enzymes.

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

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 1000 patients):
Lack of energy, muscle cramps, kidney function disorders, kidney failure.

Some abnormalities in blood test results have also been observed, including increased potassium levels (hyperkalaemia) and increased levels of substances related to kidney function.

Very rare adverse reactions (may occur in fewer than 1 in 10,000 patients):
Celiac disease-type enteropathy.

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 of 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 to provide more information on the safety of the medicine.

5. How to store Olmesartan LEK-AM

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and blister pack after "EXP". The expiry date refers to the last day of the stated month.
No special storage conditions are required for this medicine.
Medicines should not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the packaging and other information

What Olmesartan LEK-AM contains

• The active substance is olmesartan medoxomil. Each coated tablet contains 20 mg or 40 mg of olmesartan medoxomil.
• The other ingredients are: tablet core: monohydrate lactose 80, monohydrate lactose 200, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, hydroxypropyl cellulose, magnesium stearate; tablet coating Opadry II white 33G28684: hypromellose (6cP), titanium dioxide (E171), monohydrate lactose, polyethylene glycol 3350, triacetin.

What Olmesartan LEK-AM looks like and contents of the pack
Olmesartan LEK-AM, 20 mg: white or almost white, oval coated tablets, with a smooth surface, free from discolorations and damage.
Olmesartan LEK-AM, 40 mg: white or almost white, oval coated tablets, with a smooth surface, free from discolorations and damage, embossed with the mark "LEKAM".
Blisters OPA/Aluminium/PVC/Aluminium containing 10 or 14 coated tablets are placed in a cardboard box.
The pack contains 28, 30, 56, 60 or 90 coated tablets.

Marketing Authorisation Holder and Manufacturer
Pharmaceutical Company LEK-AM Sp. z o.o.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
Tel.: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106
28.02.2022