Olmesartan Lek-am

Leaflet attached to the packaging: patient information

Olmesartan LEK-AM, 20 mg, film-coated tablets

Olmesartan LEK-AM, 40 mg, film-coated tablets

Olmesartan medoxomil

It is essential to carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Olmesartan LEK-AM and what is it 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 packaging and other information

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

Olmesartan LEK-AM belongs to a group of medicines called angiotensin II receptor antagonists.
The medicine lowers blood pressure by widening the blood vessels.
Olmesartan LEK-AM is used to treat high blood pressure, also known as hypertension, in adults. 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. It is essential to monitor blood pressure to prevent damage.
Hypertension can be controlled by taking medicines such as Olmesartan LEK-AM. 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 in the diet).
The doctor may also encourage the patient to engage in regular physical activity, such as walking or swimming. It is crucial to follow the doctor's recommendations.

2. Important information before taking Olmesartan LEK-AM

When not to take 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 third month of pregnancy (it is also recommended to avoid taking Olmesartan LEK-AM in early pregnancy - see subsection "Pregnancy and breastfeeding");
• if jaundice (yellowing of the skin and eyes) or obstruction of bile flow from the gallbladder (bile duct obstruction, e.g., due to gallstones) occurs;
• 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 to take Olmesartan LEK-AM, the patient should discuss it with their doctor.
The patient should tell their doctor if they are taking any of the following medicines used to treat high blood pressure:

• an angiotensin-converting enzyme (ACE) inhibitor, such as enalapril, lisinopril, or 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) in the blood.
See also the subsection "When not to take Olmesartan LEK-AM".
The patient should inform their doctor if they have:

• kidney disease,
• liver disease,
• heart failure, valve problems, or heart muscle disease,
• severe vomiting, diarrhea, or taking high doses of diuretics (water pills) or a low-salt diet,
• high levels of potassium 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 may assess the symptoms and decide how to continue blood pressure treatment.
As with any blood pressure-lowering medicine, excessive blood pressure reduction in patients with impaired blood flow to the heart or brain may lead to heart attack or stroke. Therefore, the doctor will recommend regular blood pressure monitoring.
The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Olmesartan LEK-AM in early pregnancy. The patient should not take Olmesartan LEK-AM after the third month of pregnancy, as it may harm the baby (see subsection "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 of the medicine is increased to 40 mg per day, the doctor will recommend regular blood pressure monitoring to ensure that the blood pressure does not drop too low.

Children and adolescents

Olmesartan LEK-AM is not recommended for children and adolescents under 18 years of age.

Olmesartan LEK-AM and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
In particular, the patient should inform their doctor about taking any of the following medicines:

• other blood pressure-lowering medicines, as they may enhance the effect of Olmesartan LEK-AM - the doctor may recommend a dose change and/or take other precautions, especially if the patient is taking an ACE inhibitor or aliskiren (see also subsections "When not to take Olmesartan LEK-AM" and "Warnings and precautions");

potassium supplements, salt substitutes containing potassium, potassium-sparing diuretics, or heparin (a blood-thinning medicine) - taking these medicines with Olmesartan LEK-AM may increase potassium levels in the blood;

• lithium (a medicine used to treat mood changes and some types of depression) - taking lithium with Olmesartan LEK-AM may increase the toxic effects 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, including arthritis) - taking NSAIDs with Olmesartan LEK-AM may increase the risk of kidney failure, and the effect of Olmesartan LEK-AM may be reduced by NSAIDs;
• colesevelam hydrochloride (a medicine that lowers cholesterol levels in the blood), as it may reduce the effect of Olmesartan LEK-AM - the doctor may recommend taking Olmesartan LEK-AM at least 4 hours before taking colesevelam hydrochloride;
• certain antacids (medicines used to neutralize stomach acid), as they may slightly reduce the effect of Olmesartan LEK-AM.

Olmesartan LEK-AM with food and drink

Olmesartan LEK-AM 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 should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Olmesartan LEK-AM before becoming pregnant or as soon as pregnancy is confirmed, and recommend taking another medicine. It is not recommended to take Olmesartan LEK-AM in early pregnancy. The patient should not take Olmesartan LEK-AM after the third month of pregnancy, as it may harm the baby.
Breastfeeding
The patient should inform their doctor about breastfeeding or intending to breastfeed. It is not recommended to take Olmesartan LEK-AM during breastfeeding. The doctor may recommend taking 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 occur. In such cases, the patient should not drive or operate machines until these symptoms have resolved. The patient should consult their doctor.

Olmesartan LEK-AM contains lactose

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Olmesartan LEK-AM

This medicine should always be taken as directed by the doctor. If the patient has any doubts, they should consult their doctor or pharmacist.
The recommended initial dose is 10 mg once daily. This dose cannot be obtained using Olmesartan LEK-AM - other medicines with the appropriate strength should be used. However, if adequate blood pressure control is not achieved, the doctor may increase the dose to 20 mg or 40 mg once daily, or recommend taking additional medicines.
In patients with mild to moderate kidney disease, the dose of the medicine should not exceed 20 mg once daily.
The 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). The patient should try to take the medicine at the same time every day, e.g., during breakfast.

Taking a higher dose of Olmesartan LEK-AM than recommended

If the patient has taken a higher dose of the medicine than recommended or if a child has accidentally swallowed the medicine, they should immediately go to their doctor or the emergency department of the nearest hospital and take the packaging of the medicine with them.

Missing a dose of Olmesartan LEK-AM

If the patient misses a dose of the medicine, 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 treatment with Olmesartan LEK-AM

If the patient stops taking Olmesartan LEK-AM, their blood pressure may rise again. The patient should not stop treatment without consulting their doctor first.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Olmesartan LEK-AM can cause side effects, although not everybody gets them.
Side effects are usually mild and do not require treatment to be stopped.

Some symptoms may be severe and may require immediate medical attention.

In rare cases (less than 1 in 1000), the following systemic allergic reactions have been reported:

• swelling of the face, mouth, and/or throat with accompanying itching and rash - if the patient experiences such symptoms, they should stop taking Olmesartan LEK-AM and contact their doctor immediately,
• excessive blood pressure reduction in susceptible individuals or as a result of an allergic reaction (more common in elderly patients), with severe dizziness or fainting - if the patient experiences such symptoms, they should stop taking Olmesartan LEK-AM, contact their doctor immediately, and lie down.

Frequency not known: if the patient experiences yellowing of the whites of the eyes, dark urine, itching of the skin, even if Olmesartan LEK-AM was started much earlier, they should contact their doctor immediately, who will assess the symptoms and decide how to continue blood pressure treatment.
The following side effects have been reported in patients taking Olmesartan LEK-AM:

Common side effects (may affect up to 1 in 10 patients):

Dizziness of central origin, headache, nausea, indigestion, diarrhea, stomach pain, gastritis, fatigue, sore throat, runny nose or nasal congestion, bronchitis, flu-like symptoms, cough, pain, chest pain, back pain, bone or joint pain, urinary tract infection, swelling of the ankles, feet, legs, hands, or arms, blood in the urine.
Some abnormalities in blood test results have also been observed:
Increased levels of fats (hypertriglyceridemia), increased levels of uric acid (hyperuricemia), increased levels of urea in the blood, increased activity of liver and muscle enzymes.

Uncommon side effects (may affect up to 1 in 100 patients):

Anaphylactic reactions, which can affect the whole body and cause breathing difficulties, as well as a sudden drop in blood pressure, which can lead to fainting, swelling of the face, dizziness of labyrinthine origin, vomiting, weakness, malaise, muscle pain, skin rash, allergic skin rash, itching, skin eruptions, hives (blisters), angina pectoris (pain or discomfort in the chest).
In blood test results, a decrease in the number of blood cells called platelets (thrombocytopenia) has been observed.

Rare side effects (may affect up to 1 in 1000 patients):

Lack of energy, muscle cramps, kidney problems, kidney failure.
Some abnormalities in blood test results have also been observed, including increased levels of potassium (hyperkalemia) and increased levels of substances related to kidney function.

Very rare side effects (may affect up to 1 in 10,000 patients):

Enteropathy-type celiac disease.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Olmesartan LEK-AM

The medicine should be stored out of sight and reach of children.
The medicine should not be taken after the expiry date stated on the carton and blister after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storing the medicine.
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 packaging and other information

What Olmesartan LEK-AM contains

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

What Olmesartan LEK-AM looks like and contents of the pack

Olmesartan LEK-AM, 20 mg: white or almost white, oval, film-coated tablets with a smooth surface, without discoloration or damage.
Olmesartan LEK-AM, 40 mg: white or almost white, oval, film-coated tablets with a smooth surface, without discoloration or damage, with the inscription "LEKAM" embossed.
OPA/Aluminum/PVC/Aluminum blisters containing 10 or 14 film-coated tablets are placed in a cardboard box.
The pack contains 28, 30, 56, 60, or 90 film-coated tablets.

Marketing authorization holder and manufacturer

LEK-AM Pharmaceutical Company Ltd.
Ostrzykowizna 14A
05-170 Zakroczym
Poland
Phone: +48 22 785 27 60
Fax: +48 22 785 27 60 ext. 106

Date of last revision of the leaflet:

• 28.02.2022