OLMESARTAN 20 mg/5 mg Film-Coated Tablets

Зміст інструкції

1. Olmesartan medoxomil and Amlodipine Macleods 20 mg/5 mg film-coated tablets with
2. Olmesartan medoxomil and Amlodipine Macleods 40 mg/5 mg film-coated tablets with
   1. What is Olmesartan medoxomil and Amlodipina Macleods and what is it used for
   2. What you need to know before taking Olmesartan medoxomil and Amlodipina Macleods
   3. How to take Olmesartan medoxomil and Amlodipina Macleods
   4. Possible side effects
   5. How to store Olmesartan medoxomil and Amlodipina Macleods
   6. Package contents and other information

Olmesartan medoxomil and Amlodipine Macleods 20 mg/5 mg film-coated tablets with

film

Olmesartan medoxomil and Amlodipine Macleods 40 mg/5 mg film-coated tablets with

film
Olmesartan medoxomil and Amlodipine Macleods 40 mg/10 mg film-coated tablets
with film
Olmesartan Medoxomil/amlodipine
Generic medicine

Read this leaflet carefully before you start to take 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 their symptoms are the same as yours because it may 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 Olmesartan medoxomil and Amlodipine Macleods is and what it is used for
• 2. What you need to know before you take Olmesartan medoxomil and Amlodipine Macleods
• 3. How to take Olmesartan medoxomil and Amlodipine Macleods
• 4. Possible side effects
• 5. How to store Olmesartan medoxomil and Amlodipine Macleods
• 6. Contents of the pack and other information

1. What is Olmesartan medoxomil and Amlodipina Macleods and what is it used for

Olmesartan medoxomil and Amlodipina Macleods contains two substances called olmesartan
medoxomil and amlodipine (as amlodipine besylate). Both are used to control
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 blood vessels relax and blood pressure is reduced.

Olmesartan medoxomil and Amlodipina Macleods 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 Olmesartan medoxomil and Amlodipina Macleods

Do not take Olmesartan medoxomil and Amlodipina Macleods:

• 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 ingredients of this medicine (listed in section 6). If you think you may be allergic, talk to your doctor before taking Olmesartan medoxomil and Amlodipina Macleods.
• if you are pregnant for more than three months (it is best to avoid taking Olmesartan medoxomil and Amlodipina Macleods even in the early stages of pregnancy - see the section “Pregnancy and breastfeeding”).
• if you suffer from diabetes or your kidney function is impaired and you are being treated with a medicine that lowers blood pressure, containing aliskiren.
• if you have severe liver problems, if the secretion of bile 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 (shock, including cardiogenic shock). Cardiogenic shock means shock due to serious heart problems.
• 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
Consult your doctor or pharmacist before taking Olmesartan medoxomil and Amlodipina
Macleods.

Consult your doctorif 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 the blood at regular intervals.
See also what is stated under “Do not take Olmesartan medoxomil and Amlodipina
Macleods”.

Consult your doctorif you also 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 could lead to a
heart attack or stroke. Your doctor will therefore carefully monitor your blood
pressure.
You should tell your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Olmesartan medoxomil and Amlodipina Macleods is not recommended
at the beginning of pregnancy and should not be taken if you are pregnant for more than three
months as it can cause serious harm to the baby if taken during this period (see the section
“Pregnancy and breastfeeding”).

Elderly
If you are over 65 years of age, your doctor will regularly check your blood pressure at
each dose increase, to avoid it dropping too low.

Patients of Black ethnicity
As with other similar medicines, the blood pressure-lowering effect of Olmesartan
medoxomil and Amlodipina Macleods may be somewhat reduced in patients of Black ethnicity.

Children and adolescents (under 18 years of age)
Olmesartan medoxomil and Amlodipina Macleods is not recommended in children and adolescents
under 18 years of age.

Other medicines and Olmesartan medoxomil and Amlodipina Macleods
Tell 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 pressurecan increase the effect of Olmesartan medoxomil and Amlodipina Macleods. The doctor may need to adjust the dose and/or take other precautions: If you are taking an ACE inhibitor or aliskiren (see also what is stated under: “Do not take Olmesartan medoxomil and Amlodipina Macleods” and “Warnings and precautions”).
• Potassium supplements, salt substitutes containing potassium, diureticsor heparin(to thin the blood and prevent blood clots). Taking these medicines together with Olmesartan medoxomil and Amlodipina Macleods can increase potassium levels in the blood.
• Lithium(a medicine used to treat mood swings and some types of depression) used together with Olmesartan medoxomil and Amlodipina Macleods can increase lithium toxicity. 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, swelling and other symptoms of inflammation, including arthritis) used together with Olmesartan

medoxomil and Amlodipina Macleods can increase the risk of kidney failure.
The effect of Olmesartan medoxomil and Amlodipina Macleods may be reduced by NSAIDs.

• Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, which may decrease the effect of Olmesartan medoxomil and Amlodipina Macleods. Your doctor may advise you to take Olmesartan medoxomil and Amlodipina Macleods at least 4 hours before colesevelam hydrochloride.
• Some antacids(used for indigestion or heartburn) may slightly reduce the effect of Olmesartan medoxomil and Amlodipina Macleods.
• Medicines for HIV/AIDS(e.g. ritonavir, indinavir, nelfinavir ) or for the treatmentof fungal infections(e.g. ketoconazole, itraconazole).
• Diltiazem, verapamil(medicines used for heart rhythm problems and high blood pressure).
• Rifampicin, erythromycin, clarithromycin(antibiotics), substances used for tuberculosis or other infections.
• St John's Wort(Hypericum perforatum), a herbal remedy.
• Dantrolene(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 the immune response of your body and thus allow your body to accept transplanted organs.

Olmesartan medoxomil and Amlodipina Macleods with food and drink
Olmesartan medoxomil and Amlodipina Macleods can be taken with or without food. The
tablet should be swallowed 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 Olmesartan medoxomil and Amlodipina Macleods 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 hypotensive effect of this medicine.

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
You must tell your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). As a rule, your doctor will advise you to stop taking
Olmesartan medoxomil and Amlodipina Macleods before starting a pregnancy or as soon as you
find out you are pregnant and will advise you to take another medicine
instead of Olmesartan medoxomil and Amlodipina Macleods. This medicine is not
recommended at the beginning of pregnancy and should not be taken if you are pregnant
for more than three months, 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 this medicine, inform and see your
doctor immediately.

Breastfeeding
If you are breastfeeding or planning to start breastfeeding, you must tell your doctor before taking
this medicine. Amlodipine has been shown to pass into breast milk in small amounts.
This medicine is not recommended for mothers who are breastfeeding and your doctor may
choose another treatment for you if you wish to breastfeed, especially if the baby is newborn or
was born prematurely.

Driving and operating machinery
You may feel drowsy, unwell or dizzy or have a headache during treatment for
high blood pressure. If this happens, do not drive or operate machinery until the symptoms have
disappeared. Ask your doctor for advice.

Olmesartan medoxomil and Amlodipina Macleods contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say
essentially ‘sodium-free’.

3. How to take Olmesartan medoxomil and Amlodipina Macleods

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have doubts, consult your doctor or pharmacist.

• The recommended dose of Olmesartan medoxomil and Amlodipina Macleods is one tablet a day.
• The tablets can be taken with a full or empty stomach. 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 Olmesartan medoxomil and Amlodipina Macleods than you should
If you take more tablets than you should, you may have a reduction in blood pressure with
symptoms such as dizziness, acceleration or slowing of the heartbeat.
If you take more tablets than you should or if a child accidentally swallows any,
go immediately to your doctor or to the nearest emergency room bringing with you the

If you forget to take Olmesartan medoxomil and Amlodipina Macleods
If you forget to take a dose, take your normal dose the next day. Do not take
a double dose to make up for the missed dose.

If you stop taking Olmesartan medoxomil and Amlodipina Macleods
It is important to continue taking this medicine unless your doctor tells you to
stop.
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 everyone will experience 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 may be serious:
During treatment with Olmesartan medoxomil and Amlodipina Macleods, allergic reactions may occur, which can affect the whole body, with swelling of the face, mouth and/or larynx (the site of the vocal cords), associated with itching and rash. If this happens, stop taking Olmesartan medoxomil and Amlodipina Macleods and contact your doctor immediately.
Olmesartan medoxomil and Amlodipina Macleods may cause excessive reductions in blood pressure in sensitive individuals or as a result of an allergic reaction. This could cause severe dizziness or fainting. If this happens, stop taking Olmesartan medoxomil and Amlodipina Macleods, contact your doctor immediately and remain lying down.
Frequency not known: If you experience yellowing of the whites of the eyes, dark urine, skin itching, even if you have been taking Olmesartan medoxomil and Amlodipina Macleods for some time, contact your doctor immediatelywho will evaluate your symptoms and decide how to continue blood pressure treatment.

Other possible side effects of Olmesartan medoxomil and Amlodipina Macleods:
Common (may affect less than 1 in 10 people):
Dizziness; headache; swelling of ankles, feet, legs, hands or arms; fatigue.

Uncommon (may affect less than 1 in 100 people):
Dizziness upon 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, feeling lightheaded, difficulty breathing; cough; nausea; vomiting; indigestion; diarrhea; constipation; dry mouth; pain in the upper abdomen; rash; cramps; pain in arms and legs; back pain; feeling of urgency to urinate; sexual inactivity; inability to obtain or maintain an erection; weakness.
Some changes in blood tests have also been observed, including the following: increased or decreased potassium in the blood, increased creatinine in the blood, increased uric acid in the blood, increased liver function tests (gamma-glutamyl transferase levels).

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

Side effects reported with the use of olmesartan medoxomil or amlodipine alone, but not with Olmesartan medoxomil and Amlodipina Macleods or with a higher frequency:
Olmesartan medoxomil
Common (may affect less than 1 in 10 people):
Bronchitis; sore throat; stuffy or runny nose; cough; abdominal pain; flu-like symptoms; 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 the plasma and increased values of liver and muscle function tests.

Uncommon (may affect less than 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 rapid drop in blood pressure which can also cause weakness (anaphylactic reactions); angina (chest pain or discomfort, known as angina pectoris); itching; rash; allergic skin rash; skin rash with urticaria; swelling of the face; muscle pain; feeling unwell.

Rare (may affect less than 1 in 1000 people):
Swelling of the face, mouth and/or larynx (the site of the vocal cords); acute renal failure and kidney failure; lethargy.

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

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

Uncommon (may affect less than 1 in 100 people):
Restless sleep; sleep disturbances; mood disturbances including anxiety; depression; irritability; tremors; changes in 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 small hemorrhages (purpura); skin discoloration; excessive sweating; rash; itching; itchy, raised bumps on the skin (urticaria); muscle or joint pain; problems with urination; need 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 less than 1 in 1000 people):
Confusion.

Very rare (may affect less than 1 in 10,000 people):
Reduction in the number of white blood cells in the blood, 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 lining; 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, rash, swelling of the face, mouth and/or larynx (the site of the vocal cords) together with itching and rash, severe skin reactions including intense rash, urticaria, 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 necrolysis) sometimes life-threatening.

Not known (frequency cannot be estimated from available data):
Tremor, rigid posture, face that looks like a mask, slow movements and an unbalanced, shuffling gait.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at http://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 Olmesartan medoxomil and Amlodipina Macleods

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 EXP. The
expiry date refers to the last day of that month.
Do not store at a temperature above 30 °C.
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. Package contents and other information

What the medicine containsOlmesartan medoxomil and Amlodipine Macleods
The active ingredients areolmesartan medoxomil and amlodipine (as besilate).
Each film-coated tablet of Olmesartan medoxomil and Amlodipine Macleods 20 mg/5 mg
contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate).
Each film-coated tablet of Olmesartan medoxomil and Amlodipine Macleods 40 mg/5 mg
contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besilate).
Each film-coated tablet of Olmesartan medoxomil and Amlodipine Macleods 40 mg/10
mg contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besilate).

• Other ingredients are:silicified microcrystalline cellulose (E460), colloidal silicon dioxide (E551), pregelatinized starch, sodium croscarmellose (E468) and magnesium stearate (E572) which constitute the core of the tablet.

titanium dioxide (E171), polyethylene glycol (E1521) and talc (E553b) which constitute the
tablet coating.
Coating: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide (E171) (film-coated
tablets 20 mg/5 mg, 40 mg/5 mg and 40 mg/10 mg), yellow iron oxide (E172) (only
for the 40 mg/5 mg film-coated tablets)
Red iron oxide, Yellow iron oxide (E172) (only for the 40
mg/10 mg film-coated tablets).

Description of the appearance of Olmesartan medoxomil and Amlodipine Macleods and package contents
Olmesartan medoxomil and Amlodipine Macleods 20 mg/5 mg film-coated tablets:
Film-coated tablets of white color, round, biconvex with imprinted “L75” on one side
and plain on the other side.

Olmesartan medoxomil and Amlodipine Macleods 40 mg/5 mg film-coated tablets:
Film-coated tablets of light yellow color, round, biconvex with imprinted “L77” on
one side and plain on the other side.

Olmesartan medoxomil and Amlodipine Macleods 40 mg/10 mg film-coated tablets:
Film-coated tablets of red (reddish-brown) color, round, biconvex, with
imprinted “L78” on one side and plain on the other side.
OPA/aluminum/PVC blisters and aluminum foil.
The packages contain 28, 56, 98 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Macleods Pharma España, S.L.U.
Avenida. Diagonal, 468, 6°A, puerta A
Barcelona – 08006
Spain

Manufacturer
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland

This medicinal product is authorised in the Member States of the European Economic Area under the
following designations:
DE Olmesartan medoxomil/ Amlodipine Macleods 20mg/5mg, 40mg/5mg, 40 mg/10 mg
filmtabletten
ES OLMESARTAN / AMLODIPINO MACLEODS 20MG/5MG, 40 MG/5 MG, 40 MG/10
MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG
IT Olmesartan medoxomil e Amlodipina Macleods
PT Amlodipina + Olmesartan medoxomilo Macleods