Mareb

Package leaflet: Information for the patient

MAREB 20 mg/5 mg film-coated tablets, 40 mg/5 mg film-coated tablets, 40 mg/10 mg film-coated tablets

olmesartan medoxomil/amlodipine
equivalent medicine
Read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What MAREB is and what it is used for
2. What you need to know before taking MAREB
3. How to take MAREB
4. Possible side effects
5. How to store MAREB
6. Contents of the pack and other information

1. What MAREB is and what it is used for

MAREB contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate).
Both help control high blood pressure (also known as arterial hypertension).

• Olmesartan medoxomil belongs to a group of medicines called "angiotensin II receptor antagonists". These reduce blood pressure by relaxing blood vessels.
• Amlodipine belongs to a group of substances called "calcium antagonists". Amlodipine prevents calcium from entering the vessel wall, thereby reducing vessel constriction and lowering blood pressure.

The combined action of both substances helps counteract vascular tension, allowing blood vessels to relax and reducing arterial pressure.
MAREB is used to treat high blood pressure in patients whose blood pressure is not sufficiently controlled by olmesartan medoxomil or amlodipine alone.

2. What you should know before taking MAREB

Do not take MAREB
If you are allergic to olmesartan medoxomil or amlodipine, or to a specific group of calcium antagonists, the dihydropyridines, or to any of the other ingredients of this medicine (listed in section 6).
If you think you may be allergic, speak with your doctor before taking MAREB.
If you are more than three months pregnant. It is best to avoid taking MAREB even in the early stages of pregnancy – see section “Pregnancy and breastfeeding”.
If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
If you have severe liver problems, if bile secretion is impaired or its outflow from the gallbladder is blocked (e.g. due to gallstones), or if you develop jaundice (yellowing of the skin and eyes).
If your blood pressure is very low.
If you have inadequate blood supply to tissues, with symptoms such as low blood pressure, weak pulse, or rapid heartbeat. These are signs of shock, including shock due to serious heart problems (cardiogenic shock).
If blood flow from your heart is obstructed, for example due to aortic narrowing (aortic stenosis).
If you have reduced cardiac output (causing shortness of breath or peripheral swelling) following a heart attack (acute myocardial infarction).

Warnings and precautions
Talk to your doctor or pharmacist before taking MAREB.
Contact your doctor if, after taking MAREB, you experience abdominal pain, nausea, vomiting, or diarrhoea. Your doctor will decide whether treatment should continue. Do not stop taking MAREB on your own.
Consult your doctor if you are taking any of the following medicines used to treat high blood pressure:

• An ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
• Aliskiren.

Your doctor may check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
See also the section “Do not take MAREB”.
Also consult your doctor if you have any of the following health conditions:
Kidney problems or kidney transplant.
Liver disease.
Heart failure or problems with heart valves or heart muscle.
Severe vomiting, diarrhoea, treatment with high doses of diuretics, or if you are on a low-salt diet.
Elevated potassium levels in the blood.
Problems with the adrenal glands (hormone-producing glands located above the kidneys).
Inform your doctor if you develop severe and prolonged diarrhoea with significant weight loss. Your doctor will evaluate your symptoms and decide whether to continue this antihypertensive treatment.
As with any medicine that lowers blood pressure, excessive reduction in blood pressure in patients with circulatory disorders of the heart or brain may lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
Inform your doctor if you suspect you are pregnant or are planning a pregnancy. MAREB is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken during this period (see section “Pregnancy and breastfeeding”).

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

Other medicines and MAREB
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including any of the following:
Other medicines that lower blood pressure, as they may enhance the effect of MAREB. Your doctor may consider it necessary to adjust the dose and/or take other precautions. If you are taking an ACE inhibitor or aliskiren (see also sections “Do not take MAREB” and “Warnings and precautions”).
Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (used to thin the blood and prevent blood clots). Taking these medicines together with MAREB may increase potassium levels in the blood.
Lithium (a medicine used to treat mood swings and certain types of depression).
When used concomitantly, MAREB may increase lithium toxicity. If you need to take lithium, your doctor will monitor your blood lithium levels.
Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis), as their use together with MAREB may increase the risk of kidney failure. The effect of MAREB may also be reduced by NSAIDs.
Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may reduce the effect of MAREB. Your doctor may advise you to take MAREB at least 4 hours before colesevelam hydrochloride.
Some antacids (used for indigestion or stomach acidity) that may slightly reduce the effect of MAREB.
Medicines for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir) or for fungal infections (e.g. ketoconazole, itraconazole).
Diltiazem, verapamil, medicines used for heart rhythm problems and high blood pressure.
Rifampicin, erythromycin, clarithromycin (antibiotics), medicines used for tuberculosis or other infections.
St. John’s Wort (Hypericum perforatum), a herbal remedy.
Dantrolene (used intravenously for severe disturbances in body temperature).
Simvastatin, a substance used to reduce cholesterol and fat (triglyceride) levels in the blood.
Tacrolimus, sirolimus, temsirolimus, everolimus, and ciclosporin, used to control your body’s immune response and thus allow your body to accept transplanted organs.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

MAREB with food and drink
MAREB can be taken with or without food. Swallow the tablet with some liquid (such as a glass of water). If possible, take your daily dose at the same time each day, for example with breakfast.
People taking MAREB must not consume grapefruit or grapefruit juice, as grapefruit and its juice may increase blood levels of the active ingredient amlodipine, potentially leading to an unpredictable increase in the blood pressure-lowering effect of MAREB.

Elderly
If you are over 65 years of age, your doctor will regularly monitor your blood pressure with each dose increase to prevent it from dropping too much.

Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of MAREB may be somewhat reduced in patients of Black ethnicity.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Inform your doctor if you are pregnant, suspect you may be pregnant, or are planning a pregnancy.
Your doctor will usually advise you to stop taking MAREB before you become pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of MAREB.
MAREB is not recommended during early pregnancy and must not be taken if you are more than three months pregnant, as it may cause serious harm to the unborn child if taken after the third month of pregnancy.
If you become pregnant while taking MAREB, inform your doctor immediately and seek medical advice.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed.
It has been shown that amlodipine passes into breast milk in small amounts. MAREB is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.

Driving and using machines
During treatment with MAREB, you may experience drowsiness, malaise, dizziness, or headache. If this occurs, do not drive or operate machinery until these symptoms have resolved. Consult your doctor.

MAREB contains lactose monohydrate
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take MAREB

Take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, consult your doctor or pharmacist.
The recommended dose of MAREB is one tablet daily.
The tablets can be taken with or without food. Swallow the tablets with some liquid (such as a glass of water). Do not chew the tablets. Do not take them with grapefruit juice.
If possible, take your daily dose at the same time each day, for example with breakfast.

If you take more MAREB than you should
If you take more tablets than prescribed, you may experience a drop in blood pressure with symptoms such as dizziness, a faster or slower heartbeat.
Excess fluid may accumulate in the lungs (pulmonary edema), causing shortness of breath, which may develop up to 24–48 hours after ingestion.
If you take more tablets than prescribed or if a child accidentally swallows any, go immediately to your doctor or the nearest emergency department, taking the medicine pack or this leaflet with you.

If you forget to take MAREB
If you forget to take a dose, take your usual dose the next day. Do not take a double dose to make up for the missed dose.

If you stop taking MAREB
It is important to continue taking MAREB unless your doctor tells you to stop.
If you have any doubts about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they occur, they are mostly mild and do not require discontinuation of treatment.

Although not occurring in all individuals, the following side effects can be serious:

During treatment with MAREB, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash. If this happens, stop taking MAREB and contact your doctor immediately.

MAREB may cause rapid allergic reactions affecting the entire body, which may lead to breathing difficulties or excessive drop in blood pressure, possibly causing severe dizziness or fainting (anaphylactic reactions).

If this happens, stop taking MAREB, contact your doctor immediately and remain lying down.

Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, or skin itching, even if you have been taking MAREB for a long time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your treatment for high blood pressure.

Other possible side effects of MAREB:

Common (may affect up to 1 in 10 people):
Dizziness; headache; swelling of ankles, feet, legs, hands or arms; fatigue.

Uncommon (may affect up to 1 in 100 people):
Dizziness upon standing; lack of energy; tingling or numbness in hands or feet; vertigo; awareness of heartbeat; faster heartbeat; low blood pressure with symptoms such as dizziness, feeling of emptiness in the head, shortness of breath; cough; nausea; vomiting; indigestion; diarrhoea; constipation; dry mouth; upper abdominal pain; skin rash; cramps; pain in arms and legs; back pain; feeling of urgency to urinate; loss of sexual interest; inability to achieve or maintain an erection; weakness.

Blood test abnormalities have also been observed, including: increased or decreased blood potassium levels, increased creatinine in blood, increased uric acid in blood, increased liver function tests (levels of gamma-glutamyl transferase).

Rare (may affect up to 1 in 1000 people):
Hypersensitivity to the medicine; fainting; facial flushing and sensation of warmth; red, itchy welts (urticaria); facial swelling.

Side effects reported with olmesartan medoxomil or amlodipine used alone, but not with MAREB or at higher frequency:

Olmesartan medoxomil

Common (may affect up to 1 in 10 people):
Bronchitis; sore throat; stuffy or runny nose; cough; abdominal pain; gastroenteritis; diarrhoea; indigestion; nausea; bone or joint pain; back pain; blood in urine; urinary tract infection; chest pain; flu-like symptoms; pain; laboratory test abnormalities such as increased fats (hypertriglyceridemia); increased blood urea or uric acid, and increased liver and muscle function test values.

Uncommon (may affect up to 1 in 100 people):
Reduction in the number of a type of blood cells called platelets, which may lead to easier bruising or prolonged bleeding time; immediate allergic reactions affecting the whole body, possibly causing breathing difficulties or rapid drop in blood pressure, which may also cause weakness (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; skin rash; allergic skin rash; skin rash with urticaria, facial swelling; muscle pain; feeling of malaise.

Rare (may affect up to 1 in 1000 people):
Swelling of the face, mouth and/or larynx (site of the vocal cords); acute renal failure and kidney failure; lethargy. Intestinal angioedema: intestinal swelling presenting with symptoms such as abdominal pain, nausea, vomiting and diarrhoea.

Frequency not known (frequency cannot be estimated from available data):
Autoimmune hepatitis.

Amlodipine

Very common (may affect more than 1 in 10 people):
Oedema (fluid retention).

Common (may affect up to 1 in 10 people):
Abdominal pain; nausea; swollen ankles; drowsiness; facial flushing and sensation of warmth; visual disturbances (including double vision and blurred vision); awareness of heartbeat; diarrhoea; constipation; indigestion; cramps; weakness; shortness of breath.

Uncommon (may affect up to 1 in 100 people):
Restless sleep; sleep disturbances; mood changes including anxiety; depression; irritability; tremors; altered taste; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (chest pain or discomfort); irregular heartbeat; stuffy or runny nose; hair loss; red spots or patches on the skin due to minor bleeding (purpura); skin discolouration; excessive sweating; skin rash; itching; red, itchy welts (urticaria); muscle or joint pain; urinary problems; need to urinate at night; increased need to urinate; breast enlargement in men; chest pain; pain, discomfort; weight gain or weight loss.

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

Very rare (may affect up to 1 in 10,000 people):
Reduction in the number of white blood cells in the blood, which may increase the risk of infections; reduction in the number of a type of blood cells called platelets, which may lead to easier bruising or prolonged bleeding time; increased blood glucose; increased muscle rigidity or increased resistance to passive movements (hypertonia); tingling or numbness in hands or feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas; inflammation of the stomach wall; gum overgrowth; elevated liver enzyme levels; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions (itching, skin rash, swelling of the face, mouth and/or larynx (site of the vocal cords) together with itching and skin rash), severe skin reactions including intense skin rash, urticaria, redness of the skin over the entire body, severe itching, blistering, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening.

Frequency not known (frequency cannot be estimated from available data):
Tremor, rigid posture, expressionless face, slow movements and an unbalanced, shuffling gait.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, please consult your doctor or pharmacist. You may also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MAREB

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What MAREB contains
The active substances are olmesartan medoxomil and amlodipine (as besilate).
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate).
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate).
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besilate).
The other components are:
Tablet core: povidone K30, pregelatinized starch, silicified microcrystalline cellulose, monohydrate lactose, magnesium stearate.
Coating: polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), yellow iron oxide (E172) (only in MAREB 40 mg/5 mg film-coated tablets) and red iron oxide (E172) (only in MAREB 40 mg/10 mg film-coated tablets).

Description of the appearance of MAREB and contents of the pack
MAREB 20 mg/5 mg, film-coated tablets, white, round, with bevelled edges, marked with "OA1" on one side;
MAREB 40 mg/5 mg, film-coated tablets, cream-coloured, round, with bevelled edges, marked with "OA3" on one side;
MAREB 40 mg/10 mg, film-coated tablets, reddish-brown, round, with bevelled edges, marked with "OA4" on one side.
MAREB is available in packs of 28 film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
ERREKAPPA EUROTERAPICI S.P.A
Via Ciro Menotti, 1/A
20129 Milano, Italy

Manufacturer responsible for batch release
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
Barcelona, 08040 - Spain