MAREB 20 mg/5 mg Film-Coated Tablets

Зміст інструкції

1. MAREB 20 mg/5 mg film-coated tablets, 40 mg/5 mg film-coated tablets, 40 mg/10 mg film-coated tablets
   1. What is MAREB and what is it 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

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
generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is MAREB and what is it used for

MAREB contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besylate).
Both contribute to controlling high blood pressure (also called arterial hypertension).

• Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists”. They lower blood pressure by relaxing the blood vessels.
• Amlodipine belongs to a group of substances called “calcium antagonists”. Amlodipine prevents calcium from entering the vessel wall, counteracting its tension and reducing blood pressure.

The action of both substances helps to counteract vascular tension, so that the vessels relax and
blood pressure is reduced.
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 need to know before taking MAREB

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

Warnings and precautions
Talk to your doctor or pharmacist before taking MAREB.
Talk to your doctor if after taking MAREB you experience abdominal pain, nausea, vomiting or diarrhea. The
doctor will decide on the continuation of treatment. 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 (for example enalapril, lisinopril, ramipril), especially if you suffer from kidney problems related to diabetes.
• Aliskiren.

The doctor may check your kidney function, blood pressure, and the amount of electrolytes
(e.g. potassium) in your blood at regular intervals.
See also what is stated in the paragraph “Do not take MAREB”.
Consult your doctor also if you have any of the following health problems:
Kidney problems or kidney transplant.
Liver disease.
Heart failure or problems with the heart valves or heart muscle.
Severe vomiting, diarrhea, treatment with high doses of diuretics or if you are on a low-salt
diet.
Increased levels of potassium in the blood.
Problems with the adrenal glands (glands that produce hormones, located above the kidneys).
Tell your doctor if you experience severe and prolonged diarrhea with significant weight loss. Your doctor
will assess the symptoms and decide whether to continue this antihypertensive treatment.
As with any medicine that lowers blood pressure, an excessive reduction in pressure
in patients with circulatory disorders of the heart or brain may lead to a heart attack or a
stroke. Your doctor will therefore carefully monitor your blood pressure.
Tell your doctor if you suspect or are planning a pregnancy. MAREB is not recommended in early
pregnancy and should not be taken if you are more than three months pregnant, as it can cause
serious harm to the baby if taken during this period (see the paragraph “Pregnancy and breastfeeding”).

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

Other medicines and MAREB
Tell your doctor or pharmacist if you are taking, have recently taken or may
take any other medicines, including any of the following:

Other medicines that lower blood pressure,as they may increase the effect of
MAREB. Your doctor may need to adjust the dose and/or take other precautions. If
you are taking an ACE inhibitor or aliskiren (see also the paragraphs “Do not take
MAREB” and “Warnings and precautions”).

Potassium supplements, salt substitutes containing potassium, diuretics or heparin(for
thinning the blood and preventing thrombosis). The use of these medicines taken
simultaneously with MAREB may increase the levels of potassium in the blood.

Lithium(a medicine used to treat mood swings and some types of depression).
If used in combination, MAREB may increase the toxicity of lithium. If you need to take lithium, your
doctor will measure your lithium levels in the blood.

Non-steroidal anti-inflammatory drugs(NSAIDs, medicines used to reduce pain, the
swelling and other symptoms of inflammation, including arthritis), as if used together with
MAREB they may increase the risk of kidney failure. The effect of MAREB may be reduced
by NSAIDs.

Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may
decrease 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 heartburn) that may slightly reduce
the effect of MAREB.

Medicines for HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir) or for the treatment of
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 for infusion for severe alterations of body temperature).

Simvastatin, a substance used to reduce cholesterol and fat (triglyceride) levels in the blood.

Tacrolimus, sirolimus, temsirolimus, everolimus and cyclosporine, used to control
your body's immune response, and thus allow your body to accept transplanted organs.
Tell your doctor or pharmacist if you are taking, have recently taken or may 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 every day at the same time, for example with
breakfast.
People taking MAREB should not consume grapefruit and grapefruit juice as grapefruit and its juice can induce an increase in the levels of the active substance amlodipine in the
blood, and this may lead 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 check your blood pressure with each
dose increase, to avoid it dropping too much.

Black race patients
As with other similar medicines, the blood pressure lowering effect of MAREB may be, to some
extent, reduced in patients of black race.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
Tell your doctor if you are pregnant, suspect you are or are planning to become pregnant.
As a rule, your doctor will advise you to stop taking MAREB before you become pregnant or
as soon as you find out you are pregnant and will advise you to take another medicine
instead of MAREB.
MAREB is not recommended in early pregnancy and should not be taken if you are more than three months pregnant as it can cause serious harm to the baby if taken after the third month of
pregnancy.
If you should become pregnant during therapy with MAREB, inform and see your doctor
immediately.
Breastfeeding
Tell your doctor if you are breastfeeding or are planning to start breastfeeding.
Amlodipine has been shown to pass into breast milk in small amounts. MAREB is not recommended
for women who are breastfeeding and your doctor may choose another treatment for you if you wish
to breastfeed, especially if the baby is newborn or premature.

Driving and using machines
During treatment with MAREB you may experience drowsiness, dizziness or headache. If
this happens, do not drive or use machines until the
symptoms disappear. Ask your doctor for advice.
MAREB contains lactose monohydrate
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this
medicine.

3. How to take MAREB

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose of MAREB is one tablet a day.
The tablets can be taken with or without food. Swallow the tablets with some liquid (such as a glass of water). The tablets must not be chewed. Do not take them with grapefruit juice.
If possible, take your daily dose every day at the same time, for example with breakfast.

If you take more MAREB than you should
If you take more tablets than you should, you may experience a reduction in blood pressure with symptoms such as dizziness, acceleration or slowing of the heartbeat.
Excess fluid may accumulate in the lungs (pulmonary edema) causing shortness of breath that may develop up to 24-48 hours after taking the medicine.
If you take more tablets than you should or if a child accidentally swallows any, go immediately to your doctor or the nearest emergency room, bringing the package with you.

If you forget to take MAREB
If you forget to take a dose, take your normal dose the next day. Do nottake a double dose to make up for a missed dose.

If you stop taking MAREB
It is important to continue taking MAREB unless your doctor tells you to stop treatment.
If you have any doubts about the use of 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 do occur, they are mostly mild and do not require discontinuation of
treatment.

Although they do not occur in all people, 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 (the seat of the vocal cords), associated with
itching and skin rash. If this happens, stop taking MAREB and contact
your doctor immediately.
MAREB can cause rapid allergic reactions that can affect the whole body and can cause
breathing problems or excessive reduction of blood pressure, which can also cause severe
dizziness or fainting (anaphylactic reactions).

If this happens, stop taking MAREB, contact your doctor immediately and lie
down.
Frequency not known: if you experience yellowing of the whites of your eyes, dark urine, skin itching, even
if you have started therapy with MAREB a long time ago, contact your doctor
immediatelywho will evaluate the
symptoms and decide how to proceed with therapy for the treatment of 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 on standing up; lack of energy; tingling or numbness in the hands or feet; vertigo;
awareness of heartbeat; faster heartbeat; low blood pressure with symptoms such as
dizziness, lightheadedness, difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation;
dry mouth; pain in the upper abdomen; skin rash; cramps; pain in arms and
legs; back pain; feeling of needing to urinate urgently; sexual inactivity; inability to obtain or
maintain an erection; weakness.
Some changes in blood tests have also been observed, including: increased or decreased
potassium in the blood, increased creatinine in the blood, increased uric acid in the blood, increased
liver function tests (levels of gamma glutamyl transferase).

Rare (may affect up to 1 in 1000 people):
Hypersensitivity to the drug; fainting; redness and warmth on the face; itchy, raised welts
(urticaria); swelling of the face.

Side effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with
MAREB or with a higher frequency:
Olmesartan medoxomil
Common (may affect up to 1 in 10 people):
Bronchitis; sore throat; stuffy or runny nose; cough; abdominal pain; gastrointestinal infection; diarrhea;
indigestion; nausea; bone or joint pain; back pain; blood in urine; urinary tract infection; chest pain; flu-like
symptoms; pain; changes in laboratory tests such as
increased fats (hypertriglyceridemia); increased urea or uric acid in plasma and increased values
of liver and muscle function tests.

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

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

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

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

Common (may affect up to 1 in 10 people):
Abdominal pain; nausea; swollen ankles; drowsiness; redness and warmth on the face, changes
in vision (including double vision and blurred vision), awareness of heartbeat, diarrhea,
constipation, indigestion, cramps, weakness, difficulty breathing.

Uncommon (may affect up to 1 in 100 people):
Restless sleep; sleep disturbances; mood disturbances 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;
small, red or purple spots on the skin due to minor bleeding (purpura); skin discoloration;
excessive sweating; skin rash; itching; itchy, raised welts (urticaria); muscle or
joint pain; problems with urination; needing to urinate at night; increased need
to urinate; enlargement of the breasts in men; chest pain; pain, malaise; weight gain or
loss.

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

Very rare (may affect up to 1 in 10000 people):
Reduction in the number of white blood cells, which can increase the risk of infections; reduction in the
number of a type of blood cells called platelets, which can lead to easier bruising or prolonged bleeding time; increased glucose in the blood; increased muscle stiffness or increased resistance to passive movements (hypertonia); tingling or numbness in the hands or
feet; heart attack; inflammation of blood vessels; inflammation of the liver or pancreas;
inflammation of the stomach wall; thickening of the gums; high levels of liver enzymes;
yellowing of the skin and eyes; increased sensitivity of the skin to light; allergic reactions
(itching, skin rash, swelling of the face, mouth and/or larynx (the seat of the vocal cords) together with
itching and skin rash, severe skin reactions including intense skin rash, hives,
redness of the skin over the entire body surface, severe itching, blisters, peeling and
swelling of the skin, inflammation of the mucous membranes (Stevens Johnson syndrome, toxic epidermal
necrosis), sometimes life-threatening.

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

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly through 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 which is stated on the pack after “Scad”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water 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 ingredients 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 ingredients are:

Tablet core:povidone K30, pregelatinized starch, microcrystalline cellulose silicified,
lactose monohydrate, magnesium stearate.

Coating:polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E171), yellow iron oxide (E 172)
(only MAREB film-coated tablets 40 mg/5 mg and 40 mg/10 mg) and red iron oxide (E 172) (only
MAREB film-coated tablets 40 mg/10 mg)

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ERREKAPPA EUROTERAPICI S.P.A
Via Ciro Menotti, 1/A
20129 Milano

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