Olmita

Leaflet attached to the packaging: patient information

Olmita, 20 mg+5 mg, film-coated tablets

Olmita, 40 mg+5 mg, film-coated tablets

Olmita, 40 mg+10 mg, film-coated tablets

Olmesartan medoxomil + Amlodipine

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 Olmita and what is it used for
• 2. Important information before taking Olmita
• 3. How to take Olmita
• 4. Possible side effects
• 5. How to store Olmita
• 6. Contents of the pack and other information

1. What is Olmita and what is it used for

Olmita contains two active substances: olmesartan medoxomil and amlodipine (in the form of amlodipine besylate). Both substances help lower high blood pressure.

• Olmesartan medoxomil belongs to a group of medicines called angiotensin II receptor antagonists, which lower blood pressure by reducing the tension of blood vessels.
• Amlodipine belongs to a group of medicines called calcium antagonists. It inhibits the penetration of calcium into the walls of blood vessels, preventing their constriction, which also results in lowering blood pressure.

Both substances prevent the constriction of blood vessels, causing their dilation, resulting in lowering blood pressure. Olmita is used to treat high blood pressure in patients whose blood pressure is not sufficiently controlled by taking only olmesartan medoxomil or only amlodipine.

2. Important information before taking Olmita

When not to take Olmita

• after the third month of pregnancy (it is also recommended to avoid taking Olmita in early pregnancy - see "Pregnancy and breastfeeding").

if the patient has diabetes or kidney problems and is being treated with a blood pressure-lowering medicine containing aliskiren.

• if the patient has severe liver disease, bile secretion disorders, or obstruction of bile flow from the gallbladder (e.g., due to gallstones) or if jaundice (yellowing of the skin and eyes) occurs.
• if the patient has very low blood pressure.
• in case of insufficient blood supply to tissues, with symptoms such as low blood pressure, weak pulse, rapid heart rate (shock, including cardiogenic shock, i.e., caused by severe heart problems).
• in case of blood flow disorders from the heart (e.g., due to aortic valve narrowing).
• in case of weakened heart function (causing shortness of breath or peripheral edema) after a heart attack.

Warnings and precautions

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

• an ACE inhibitor (e.g., 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) in the blood. See also "When not to take Olmita". The patient should tell their doctor if they have any of the following diseases/disorders:

• kidney disease or post-kidney transplant status;
• liver disease;
• heart failure, heart valve disorders, or heart muscle disorders;
• severe vomiting, diarrhea, treatment with high doses of diuretics, or a low-sodium diet;
• increased potassium levels in the blood;
• adrenal disorders (glands that produce hormones, located in the upper part of the kidneys).

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 the blood pressure-lowering treatment. As with other blood pressure-lowering medicines, excessive lowering of blood pressure in patients with circulatory disorders in the heart or brain may lead to a heart attack or stroke. The doctor will recommend careful monitoring of blood pressure in such patients. The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. It is not recommended to take Olmita in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus (see "Pregnancy and breastfeeding").

Children and adolescents (under 18 years of age)

Olmita is not recommended for children and adolescents under 18 years of age.

Olmita 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. This is especially important for the following medicines:

• other blood pressure-lowering medicines - may enhance the effect of Olmita.
• ACE inhibitors or aliskiren - the doctor may recommend a dose change and/or take other precautions (see also "When not to take Olmita" and "Warnings and precautions").
• potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (a blood thinner) - concomitant use of these medicines with Olmita may increase potassium levels in the blood.
• Lithium (a medicine used to treat mood swings and some types of depression) - concomitant use with Olmita may increase lithium toxicity. 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) - taken concomitantly with Olmita, may increase the risk of kidney failure. NSAIDs may weaken the effect of Olmita.
• Cholestyramine hydrochloride (a medicine that lowers cholesterol levels in the blood) - possible weakening of the effect of Olmita. The doctor may recommend taking Olmita at least 4 hours before taking cholestyramine hydrochloride.
• Certain antacids (medicines used for indigestion or heartburn) - may slightly weaken the effect of Olmita.
• Medicines used to treat HIV/AIDS (e.g., ritonavir, indinavir, nelfinavir) or fungal infections (e.g., ketoconazole, itraconazole).
• Diltiazem, verapamil (medicines used for heart rhythm disorders and to treat high blood pressure).
• Rifampicin, erythromycin, clarithromycin (medicines used to treat bacterial infections).
• St. John's Wort (Hypericum perforatum), a herbal preparation.
• Dantrolene (administered by infusion in case of severe body temperature disorders).
• Simvastatin used to lower cholesterol and triglyceride levels in the blood.
• Tacrolimus, sirolimus, temsirolimus, and everolimus (medicines that affect the patient's immune system).
• Cyclosporine (a medicine that reduces the activity of the immune system).

Olmita with food and drink

Olmita can be taken with or without food. The patient should swallow the tablet with a liquid (e.g., a glass of water). If possible, the prescribed dose should be taken daily at the same time, for example, during breakfast. Patients taking Olmita should not drink grapefruit juice or eat grapefruits, as they may cause an increase in the level of the active substance amlodipine in the blood, which may result in unpredictable intensification of the blood pressure-lowering effect of Olmita.

Elderly patients

In patients over 65 years of age, during each dose increase, the doctor will monitor blood pressure to check if it has not decreased too much.

Black patients

As with other similar medicines, the blood pressure-lowering effect of Olmita may be slightly weaker in black patients.

Pregnancy and breastfeeding

Pregnancy The patient should inform their doctor about pregnancy, suspected pregnancy, or planned pregnancy. The doctor will usually recommend stopping Olmita before planned pregnancy or immediately after confirming pregnancy and recommend taking another medicine instead of Olmita. It is not recommended to take Olmita in early pregnancy, and it should not be taken after the third month of pregnancy, as it may seriously harm the fetus. It has been shown that small amounts of amlodipine pass into human milk. If the patient becomes pregnant while taking Olmita, they should contact their doctor immediately. Breastfeeding The patient should inform their doctor about breastfeeding or intending to breastfeed. It is not recommended to take Olmita during breastfeeding, especially in the case of breastfeeding a newborn or premature baby. The doctor may recommend taking another medicine. 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.

Driving and using machines

During treatment with blood pressure-lowering medicines, drowsiness, nausea, dizziness, or headache may occur. In such cases, the patient should not drive vehicles or operate machines until the symptoms have resolved. The patient should consult their doctor for advice.

Olmita contains lactose and sodium

If the patient has been diagnosed with intolerance to some sugars, they should contact their doctor before taking this medicine. This medicine contains less than 1 mmol of sodium (23 mg) per tablet, so it can be considered "sodium-free".

3. How to take Olmita

This medicine should always be taken exactly as prescribed by the doctor or pharmacist. If the patient has any doubts, they should consult their doctor or pharmacist.

• The recommended dose of Olmita is one tablet per day.
• The tablets can be taken with or without food. The tablet should be swallowed with a liquid (e.g., a glass of water). The tablets should not be chewed. Olmita should not be taken with grapefruit juice.
• If possible, the prescribed dose should be taken daily at the same time, for example, during breakfast.

Taking a higher dose of Olmita than recommended

Taking more tablets than recommended may cause a decrease in blood pressure, with symptoms such as dizziness and rapid or slow heart rate. If the patient has taken more tablets 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, taking the packaging or leaflet with them. Even 24-48 hours after taking the medicine, shortness of breath caused by excessive fluid accumulation in the lungs (pulmonary edema) may occur.

Missing a dose of Olmita

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

Stopping treatment with Olmita

It is important to continue taking Olmita until the doctor recommends stopping it. 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, Olmita can cause side effects, although not everybody gets them.

The following side effects may be serious, but they are rare:

During treatment with Olmita, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth, and/or throat, accompanied by itching and rash (Stevens-Johnson syndrome, toxic epidermal necrolysis). If such symptoms occur, the patient should stop taking Olmita and immediately consult their doctor. In susceptible individuals, taking Olmita may cause excessive lowering of blood pressure, also as a result of an allergic reaction. Severe dizziness or fainting may occur. If such symptoms occur, the patient should stop taking Olmita, immediately inform their doctor, and remain in a lying position. Unknown frequency: If the patient experiences yellowing of the whites of the eyes, dark urine, itching of the skin, even if treatment with Olmita was started a long time ago, they should immediately contact their doctor, who will assess the symptoms and decide how to continue taking the blood pressure medicine. Other possible side effects of Olmita:

Common (may affect up to 1 in 10 people):

Dizziness, headache, swelling of the ankles, feet, legs, hands, or arms, fatigue.

Uncommon (may affect up to 1 in 100 people):

Dizziness when standing up, lack of energy, tingling or numbness of the hands or feet, vertigo, palpitations, rapid heart rate, low blood pressure with symptoms such as dizziness, feeling of "emptiness" in the head; breathing difficulties, cough, nausea, vomiting, indigestion, diarrhea, constipation, dryness of the mouth, abdominal pain, skin rash, muscle cramps, pain in the arms and legs, back pain, increased urination, decreased sexual performance, inability to achieve or maintain an erection, weakness. The following changes in blood test results have also been observed: increased or decreased potassium levels in the blood, increased creatinine levels, increased uric acid levels, increased liver enzyme activity (gamma-glutamyltransferase).

Rare (may affect up to 1 in 1000 people):

Hypersensitivity to the medicine, fainting, flushing and feeling of heat on the face, red, itchy bumps (hives), swelling of the face. Side effects observed during treatment with only olmesartan medoxomil or only amlodipine, but not observed during treatment with Olmita or observed more frequently in monotherapy: Olmesartan medoxomil

Common (may affect up to 1 in 10 people):

Bronchitis; sore throat; runny or stuffy nose; cough; abdominal pain; flu-like symptoms; diarrhea; indigestion; nausea; back pain; urinary tract infection; chest pain; flu-like symptoms; pain. Changes in blood test results - increased triglyceride levels in the blood, increased urea or uric acid levels in the blood, and increased liver and muscle enzyme activity.

Uncommon (may affect up to 1 in 100 people):

Decreased platelet count, which may cause easy bruising or prolonged bleeding; sudden allergic reaction, which can affect the whole body and cause breathing difficulties, as well as sudden lowering of blood pressure, which can lead to fainting (anaphylactic reaction); angina pectoris (chest pain or discomfort, known as an angina attack); itching; skin rash; allergic skin rash; hives; swelling of the face; muscle pain; malaise.

Rare (may affect up to 1 in 1000 people):

Swelling of the face, mouth, and/or throat; acute kidney failure and kidney function disorders; lethargy. Amlodipine

Very common (may affect more than 1 in 10 people):

Swelling (fluid retention in the body).

Common (may affect up to 1 in 10 people):

Abdominal pain; nausea; swelling of the ankles; feeling of tiredness; flushing and feeling of heat on the face; visual disturbances (including double vision and blurred vision); palpitations; indigestion; weakness; breathing difficulties.

Uncommon (may affect up to 1 in 100 people):

Difficulty falling asleep, sleep disorders; mood changes, including anxiety; depression; irritability; chills; changes in taste; changes in bowel movements (including diarrhea and constipation); fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); heart rhythm disorders; runny or stuffy nose; hair loss; purple spots or patches on the skin caused by small bleeding (purpura); skin discoloration; excessive sweating; skin rash; itching; hives; pain in the joints or muscles; urinary disorders; need to urinate at night; increased urination; breast enlargement in men; chest pain; pain, malaise.

Rare (may affect up to 1 in 1000 people):

Disorientation.

Very rare (may affect up to 1 in 10,000 people):

Decreased white blood cell count, which may increase the risk of infections; decreased platelet count, which may cause easy bruising or prolonged bleeding; increased blood glucose levels; increased muscle tone or increased resistance to passive movement (hypertonia); tingling or numbness of the hands or feet; heart attack; vasculitis; liver or pancreas inflammation; stomach lining inflammation; gum hypertrophy; increased liver enzyme activity; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions: itching, rash, swelling of the face, mouth, and/or throat with accompanying itching and rash; severe skin reactions, including intense skin rash, hives, redness of the skin, severe itching, blistering, and peeling of the skin, inflammation of the mucous membranes, sometimes life-threatening.

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. 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, Al. Jerozolimskie 181C, 02-222 Warsaw, Phone: (22) 49-21-301, Fax: (22) 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Olmita

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month. Store in the original packaging to protect from light and moisture. There are no special storage temperature requirements. 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 Olmita contains

• The active substances of Olmita are olmesartan medoxomil and amlodipine (in the form of amlodipine besylate).
• Olmita, 20 mg + 5 mg, film-coated tablets: Each tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (in the form of amlodipine besylate). Olmita, 40 mg + 5 mg, film-coated tablets: Each tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (in the form of amlodipine besylate). Olmita, 40 mg + 10 mg, film-coated tablets: Each tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (in the form of amlodipine besylate).

Other ingredients are: Tablet core: microcrystalline cellulose, maize starch, lactose monohydrate, sodium croscarmellose, magnesium stearate. Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172) (only in Olmita 40 mg + 5 mg and Olmita 40 mg + 10 mg film-coated tablets), red iron oxide (E172) (only in Olmita 40 mg + 10 mg film-coated tablets). See section 2 "Olmita contains lactose and sodium".

What Olmita looks like and contents of the pack

Olmita, 20 mg + 5 mg, film-coated tablets: white or almost white, round, biconvex film-coated tablets with beveled edges. Tablet dimensions: diameter 7 mm, thickness 2.5 - 4.2 mm. Olmita, 40 mg + 5 mg, film-coated tablets: pale yellow-brown, round, biconvex film-coated tablets with beveled edges, marked with the number 5 on one side of the tablet. Tablet dimensions: diameter 9 mm, thickness 3.6 - 5.3 mm. Olmita, 40 mg + 10 mg, film-coated tablets: brown-red, round, biconvex film-coated tablets with beveled edges, with a score line on one side of the tablet. Tablet dimensions: diameter 9 mm, thickness 3.6 - 5.3 mm. The tablet can be divided into equal doses. Olmita film-coated tablets are available in packs containing: 14, 28, 30, 56, 60, 84, 90, 98, or 100 film-coated tablets, 14, 28, 56, 98 film-coated tablets, calendar packaging. Not all pack sizes may be marketed.

Marketing authorization holder:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer:

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia, TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany For more detailed information, please contact: KRKA Polska Sp. z o.o., ul. Równoległa 5, 02-235 Warsaw, Poland, phone: 22 57 37 500 Date of last revision of the leaflet:13.08.2022