Olmita

Package leaflet: Information for the patient

Olmita, 20 mg+5 mg, film-coated tablets
Olmita, 40 mg+5 mg, film-coated tablets
Olmita, 40 mg+10 mg, film-coated tablets
Olmesartanum medoxomilum + Amlodipinum
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet for future reference.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, 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 Olmita is and what it is 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 Olmita is and what it is used for

Olmita contains two active substances: olmesartan medoxomil and amlodipine (as amlodipine besylate). Both of these 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 in blood vessels.
• Amlodipine belongs to a group of medicines called calcium channel blockers. It inhibits the influx of calcium into the walls of blood vessels, preventing their constriction, which also results in lowering blood pressure.

Both substances prevent the narrowing of blood vessels by causing them to widen, thereby lowering blood pressure.
Olmita is used to treat high blood pressure in patients whose blood pressure is not sufficiently controlled with olmesartan medoxomil alone or amlodipine alone.

2. Important information before using Olmita

When not to use Olmita

• if the patient is allergic to olmesartan medoxomil, amlodipine, calcium antagonists of the dihydropyridine class, or to any of the other components of this medicine (listed in section 6). If allergy is suspected, consult a doctor before using Olmita.
• after the third month of pregnancy (Olmita should also be avoided during early pregnancy - see section "Pregnancy and breastfeeding").
• if the patient has diabetes or kidney dysfunction and is being treated with a blood pressure-lowering medicine containing aliskiren.
• if there are severe liver diseases, biliary secretion disorders, or impaired bile outflow from the gallbladder (e.g. due to gallstones), or if jaundice occurs (yellowing of the skin and eyes).
• if the patient has very low blood pressure.
• in cases of insufficient blood flow to tissues, with symptoms such as low blood pressure, weak pulse, rapid heartbeat (shock, including cardiogenic shock caused by severe heart disorders).
• in cases of impaired blood outflow from the heart (e.g. due to aortic valve stenosis).
• in cases of weakened heart function (causing breathlessness or peripheral edema) following a heart attack.

Warnings and precautions
Before starting Olmita, discuss this with your doctor or pharmacist.
Tell your doctor if the patient is taking any of the following medicines used to treat high blood pressure:

• angiotensin-converting enzyme (ACE) inhibitors (e.g. enalapril, lisinopril, ramipril), especially if the patient has kidney disorders 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 Olmita".
Tell your doctor if the patient has any of the following conditions:

• kidney disease or history of kidney transplant;
• liver disease;
• heart failure, heart valve disorders, or myocardial disorders;
• severe vomiting, diarrhea, treatment with high-dose diuretics, or a low-sodium diet;
• elevated blood potassium levels;
• adrenal gland disorders (hormone-producing glands located above the kidneys).

Contact your doctor if the patient develops severe, persistent diarrhea leading to significant weight loss. The doctor will assess symptoms and decide how to continue antihypertensive treatment.
If the patient experiences abdominal pain, nausea, vomiting, or diarrhea after taking Olmita, discuss this with the doctor. The doctor will decide on further treatment. Do not discontinue Olmita on your own.
As with other blood pressure-lowering medicines, excessive reduction of blood pressure in patients with circulatory disorders of the heart or brain may lead to myocardial infarction or stroke. Your doctor will recommend careful blood pressure monitoring in such patients.
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning pregnancy. Olmita is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child (see section "Pregnacy and breastfeeding").

Children and adolescents (under 18 years of age)
Olmita is not recommended for use in children and adolescents under 18 years of age.

Olmita and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use. This especially includes the following:

• Other blood pressure-lowering medicines – may enhance the effect of Olmita.
• ACE inhibitors or aliskiren – your doctor may recommend dose adjustment and/or additional precautions (see also sections "When not to use Olmita" and "Warnings and precautions").
• Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (a blood-thinning medicine preventing blood clots) – concomitant use with Olmita may increase blood potassium levels.
• Lithium (a medicine used to treat mood disorders and certain types of depression) – concomitant use with Olmita may increase lithium toxicity. If lithium treatment is necessary, your doctor will recommend monitoring lithium blood levels.
• Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling, and other inflammatory symptoms, including joint inflammation) – when taken together with Olmita, may increase the risk of kidney failure. NSAIDs may reduce the effectiveness of Olmita.
• Colesevelam hydrochloride (a medicine that lowers blood cholesterol levels) – may reduce the effectiveness of Olmita. Your doctor may recommend taking Olmita at least 4 hours before colesevelam hydrochloride.
• Certain antacids (medicines used for indigestion or heartburn) – may slightly reduce the effectiveness of Olmita.
• Medicines used to treat HIV/AIDS infections (e.g. ritonavir, indinavir, nelfinavir) or fungal infections (e.g. ketoconazole, itraconazole).
• Diltiazem, verapamil (medicines used for heart rhythm disorders and hypertension treatment).
• Rifampicin, erythromycin, clarithromycin (antibiotics), medicines used for tuberculosis or other infections.
• St John's wort (Hypericum perforatum), a herbal preparation.
• Dantrolene (administered intravenously in severe body temperature disorders).
• Simvastatin, used to reduce blood cholesterol and fat (triglyceride) levels.
• Tacrolimus, sirolimus, temsirolimus, everolimus, and cyclosporine, used to control immune system responses, allowing the body to accept a transplanted organ.

Olmita with food and drink
Olmita can be taken with or without food. Swallow the tablet with liquid (e.g. a glass of water). If possible, take the prescribed dose at the same time every day, for example during breakfast.
Patients taking Olmita should not drink grapefruit juice or eat grapefruits, as they may increase blood levels of the active substance amlodipine, potentially leading to unpredictable intensification of Olmita's blood pressure-lowering effect.

Elderly patients
In patients over 65 years of age, the doctor will monitor blood pressure with each dose increase to ensure blood pressure does not drop too much.

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

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 you are pregnant, suspect you may be pregnant, or are planning pregnancy. Your doctor will usually recommend discontinuing Olmita before a planned pregnancy or immediately after pregnancy is confirmed, and will recommend an alternative medicine. Olmita is not recommended during early pregnancy and must not be used after the third month of pregnancy, as it may seriously harm the unborn child.
If pregnancy occurs while taking Olmita, inform your doctor immediately and consult with them.

Breastfeeding
Inform your doctor if you are breastfeeding or intend to breastfeed. Small amounts of amlodipine have been shown to pass into human milk. Olmita is not recommended during breastfeeding, especially when nursing a newborn or preterm infant. Your doctor may recommend an alternative medicine.

Driving and operating machinery
Antihypertensive medicines may cause drowsiness, nausea, dizziness, or headache. In such cases, do not drive or operate machinery until symptoms resolve. Consult your doctor for advice.

Olmita contains lactose monohydrate and sodium
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, meaning the medicine is considered "sodium-free".

3. How to use Olmita

This medicine should always be taken exactly as directed by your doctor or pharmacist. If you have any doubts,
consult your doctor or pharmacist.

• The recommended dose of Olmita is one tablet per day.
• Tablets may be taken during meals or independently of meals. Swallow the tablet with liquid (e.g. a glass of water). Do not chew the tablets. Do not take Olmita with grapefruit juice.
• If possible, take the recommended dose at the same time each day, for example during breakfast.

Taking more Olmita than recommended
Taking more tablets than recommended may cause low blood pressure, with symptoms such as dizziness, and may also lead to an increased or decreased heart rate.
Breathlessness due to fluid accumulation in the lungs (pulmonary oedema) may occur within 24–48 hours after taking the medicine.
If you take more than the recommended dose or if a child accidentally swallows the medicine, seek immediate medical advice from your doctor or the nearest hospital emergency department, taking the medicine pack or leaflet with you.
If you forget to take Olmita
If you miss a dose, take the next dose at the usual time the following day. Do not take a double dose to make up for a missed dose.
Stopping Olmita
It is important to continue taking Olmita until your doctor advises you to stop.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
Adverse effects are often mild and do not require discontinuation of the medicine.
The following adverse effects may be severe, although they do not occur frequently:
During treatment with Olmita, allergic reactions may occur, which may affect the whole body,
with facial swelling, swelling of the oral cavity and (or) larynx, accompanied by itching and rash. If
such symptoms occur, Olmita must be discontinued and medical advice must be sought
immediately.
In susceptible individuals, taking Olmita may lead to excessive lowering of arterial blood pressure,
including as a result of an allergic reaction. Severe dizziness or fainting may occur. If such
symptoms occur, Olmita must be discontinued, a doctor must be notified immediately, and the
patient must remain in a lying position.
Frequency unknown: if yellowing of the whites of the eyes, dark urine colour, or skin itching occur,
even if Olmita treatment was initiated significantly earlier, medical advice must be sought
immediately. The physician will assess the symptoms and decide how to continue treatment
for arterial hypertension.
Other possible adverse effects of Olmita:
Common (may occur in fewer than 1 in 10 people):
Dizziness, headache, swelling around the ankles, feet, legs, hands or arms, fatigue.
Uncommon (may occur in fewer than 1 in 100 people):
Dizziness upon standing, lack of energy, tingling or numbness in hands or feet, vertigo, awareness
of heartbeat, increased heart rate, low blood pressure with symptoms such as dizziness, feeling of
"emptiness" in the head; difficulty breathing, cough, nausea, vomiting, indigestion, diarrhoea,
constipation, dryness of the oral mucosa, abdominal pain, skin rash, pain in hands and legs, back
pain, increased urge to urinate, reduced sexual performance, inability to achieve or maintain an
erection, weakness.
The following changes in blood test results have also been observed:
increased or decreased blood potassium concentration, increased creatinine concentration,
increased uric acid concentration, increased activity of liver enzymes (gamma-glutamyl transferase).
Rare (may occur in fewer than 1 in 1,000 people):
Hypersensitivity to the medicine, fainting, redness and feeling of warmth in the face, red itchy
bumps (urticaria), facial swelling.
Adverse effects observed during treatment with olmesartan medoxomil or amlodipine alone, but
not observed during treatment with Olmita or observed more frequently during monotherapy:
Olmesartan medoxomil
Common (may occur in fewer than 1 in 10 people):
Bronchitis; sore throat; nasal congestion or runny nose; cough; abdominal pain; gastroenteritis;
diarrhoea; indigestion; nausea; joint or bone pain; back pain; presence of blood in urine; urinary tract
infection; chest pain; influenza-like symptoms; pain. Changes in blood test results – increased blood
lipid (triglyceride) concentration, increased blood urea or uric acid concentration, and increased
activity of liver and muscle enzymes.
Uncommon (may occur in fewer than 1 in 100 people):
Decreased platelet count, which may lead to easy bruising or prolonged bleeding time; sudden
allergic reaction affecting the whole body and causing difficulty breathing, as well as sudden drop in
arterial blood pressure, which may even lead to fainting (anaphylactic reaction); angina pectoris
(chest pain or discomfort known as angina attack); itching; skin eruptions; allergic skin rash;
urticarial rash; facial swelling; muscle pain; malaise.
Rare (may occur in fewer than 1 in 1,000 people):
Swelling of the face, oral cavity and (or) larynx; acute kidney failure and kidney function disorders;
lethargy. Intestinal angioedema: intestinal swelling with symptoms such as abdominal pain,
nausea, vomiting and diarrhoea.
Amlodipine
Very common (may occur in at least 1 in 10 people):
Swelling (fluid retention).
Common (may occur in fewer than 1 in 10 people):
Abdominal pain; nausea; swelling around the ankles; drowsiness; flushing and feeling of warmth in
the face, visual disturbances (including double vision and blurred vision); awareness of heartbeat;
diarrhoea; constipation; indigestion; cramps; weakness; difficulty breathing.
Uncommon (may occur in fewer than 1 in 100 people):
Difficulty falling asleep, sleep disturbances; mood changes, including anxiety; depression;
irritability; chills; altered taste; fainting; ringing in the ears (tinnitus); worsening of angina pectoris
(chest pain or discomfort); heart rhythm disorders; nasal congestion or runny nose; hair loss; blue
spots or patches on the skin due to small bleedings (purpura); skin discoloration; excessive
sweating; skin eruptions; itching; red itchy bumps (urticaria); joint or muscle pain; urinary disorders;
need to urinate at night; increased urge to urinate; breast enlargement in men; chest pain; pain,
malaise; increased or decreased body weight.
Rare (may occur in fewer than 1 in 1,000 people):
Disorientation.
Very rare (may occur in fewer than 1 in 10,000 people):
Decreased number of white blood cells in blood, which may increase the risk of infections;
decreased platelet count, which may lead to easy bruising or prolonged bleeding time; increased
blood glucose concentration; increased muscle tone or resistance to passive movement (hypertonia);
tingling or numbness in hands or feet; myocardial infarction; vasculitis; hepatitis or pancreatitis;
gastritis; gingival hyperplasia; increased liver enzyme activity; jaundice of skin and eyes; increased
skin sensitivity to light; allergic reactions: itching, rash, swelling of the face, oral cavity and (or)
larynx, accompanied by itching and rash; severe skin reactions, including intense skin rash,
urticaria, redness of the entire skin surface, severe itching, blistering, skin peeling and swelling,
mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-
threatening.
Frequency unknown (cannot be determined from available data):
Tremor, rigidity, facial masking, slowed movements and dragging of legs while walking, unsteady
gait.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or
nurse. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug
Reactions 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
Adverse effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Olmita

Keep the medicine out of 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 specified month.
Store in the original packaging to protect from light and moisture.
No special temperature storage requirements for this medicine.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Olmita contains

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

Other components are:
Tablet core: microcrystalline cellulose, cross-linked carboxymethylcellulose sodium, maize starch, lactose monohydrate, magnesium stearate.
Tablet coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, iron oxide yellow (E172) (only in Olmita 40 mg + 5 mg film-coated tablets), iron oxide red (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 bevelled edges. Tablet dimensions: diameter 7 mm, thickness 2.5 – 4.2 mm.
Olmita 40 mg + 5 mg film-coated tablets: pale brownish-yellow, round, biconvex film-coated tablets with bevelled edges, marked with the number "5" on one side. Tablet dimensions: diameter 9 mm, thickness 3.6 – 5.3 mm.
Olmita 40 mg + 10 mg film-coated tablets: brownish-red, round, biconvex film-coated tablets with bevelled edges and a groove on one side. 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 or 98 film-coated tablets in calendar packs.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

Manufacturers:
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia
TAD Pharma GmbH
Heinz-Lohmann-Straße 5
27472 Cuxhaven
Germany

For further information, please contact the local representative of the Marketing Authorisation Holder:
KRKA-POLSKA Sp. z o.o.,
ul. Równoległa 5,
02-235 Warsaw,
Tel.: 22 57 37 500