OLMESARTAN 20 mg/5 mg Film-Coated Tablets

Зміст інструкції

1. Olmesartan medoxomil and Amlodipine Mylan Italia 20 mg/5 mg film-coated tablets, 40 mg/5 mg film-coated tablets, 40 mg/10 mg film-coated tablets
   1. What is Olmesartan medoxomil and Amlodipina Mylan Italia and what it is used for
   2. What you need to know before taking Olmesartan medoxomil and Amlodipine Mylan Italia
   3. How to take Olmesartan medoxomil and Amlodipina Mylan Italia
   4. Possible side effects
   5. How to store Olmesartan medoxomil and Amlodipina Mylan Italia
   6. Package contents and other information

Olmesartan medoxomil and Amlodipine Mylan Italia 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 their symptoms are the same as yours, 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 Olmesartan medoxomil and Amlodipine Mylan Italia is and what it is used for
• 2. What you need to know before you take Olmesartan medoxomil and Amlodipine Mylan Italia
• 3. How to take Olmesartan medoxomil and Amlodipine Mylan Italia
• 4. Possible side effects
• 5. How to store Olmesartan medoxomil and Amlodipine Mylan Italia
• 6. Contents of the pack and other information

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

Olmesartan medoxomil and Amlodipina Mylan Italia contains two substances called olmesartan
medoxomil and amlodipine (as amlodipine besylate). Both are used to control high blood pressure.

• 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 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.
Olmesartan medoxomil and Amlodipina Mylan Italia 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 Amlodipine Mylan Italia

Do not take Olmesartan medoxomil and Amlodipine Mylan Italia:

• 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 Amlodipine Mylan Italia
• if you are pregnant for more than 3 months (it is best to avoid taking Olmesartan medoxomil and Amlodipine Mylan Italia 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 severe 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 (which causes shortness of breath or peripheral swelling) after a heart attack (acute myocardial infarction).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olmesartan medoxomil and Amlodipine Mylan Italia.

Consult your doctorif you are taking any of the following medicines used to treat high blood
pressure:

• an angiotensin-converting enzyme (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 (such
as potassium) in the blood at regular intervals.
See also what is stated in the section “Do not take Olmesartan medoxomil and Amlodipine Mylan
Italia”.

Consult your doctorif 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 following 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 may assess the symptoms and decide whether to continue this antihypertensive treatment.
Like all medicines that lower blood pressure, an excessive reduction in pressure in
patients with disorders of blood flow to the heart or brain could lead to a heart attack
or stroke. Your doctor will therefore carefully monitor your blood pressure.
You should inform your doctor if you think you are pregnant (or if there is a possibility of becoming
pregnant). Olmesartan medoxomil and Amlodipine Mylan Italia is not recommended in early
pregnancy and should not be taken if you are pregnant for more than three months, as it may cause
serious harm to the baby if taken during this period (see the section “Pregnancy and breastfeeding”).

Children and adolescents
Olmesartan medoxomil and Amlodipine Mylan Italia is not recommended in children and adolescents under
18 years of age.

Other medicines and Olmesartan medoxomil and Amlodipine Mylan Italia
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any of the following medicines:

• Other medicines that lower blood pressuremay increase the effect of Olmesartan medoxomil and Amlodipine Mylan Italia. The doctor may need to adjust the dose and/or take other precautions: if you are taking an ACE inhibitor or aliskiren (see also the section “Do not take Olmesartan medoxomil and Amlodipine Mylan Italia” 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 Amlodipine Mylan Italia may 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 Amlodipine Mylan Italia may 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 Amlodipine Mylan Italia may increase the risk of kidney failure. The effect of Olmesartan medoxomil and Amlodipine Mylan Italia may be reduced by NSAIDs.
• Colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, which may decrease the effect of Olmesartan medoxomil and Amlodipine Mylan Italia. Your doctor may advise you to take Olmesartan medoxomil and Amlodipine Mylan Italia at least 4 hours before colesevelam hydrochloride.
• Some antacids(used for indigestion or heartburn) may slightly reduce the effect of Olmesartan medoxomil and Amlodipine Mylan Italia.
• Drugs for HIV/AIDS(for example ritonavir, indinavir, nelfinavir) or for the treatment offungal infections(for example ketoconazole, itraconazole).
• Diltiazem, verapamil(drugs used for heart rhythm problems and high blood pressure).
• Rifampicin(a drug used for tuberculosis or other infections).
• Erythromycin, clarithromycin(for infections caused by bacteria).
• St. John's Wort(Hypericum perforatum), a herbal remedy.
• Dantrolene(infusion for severe temperature abnormalities).
• 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).

Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.

Olmesartan medoxomil and Amlodipine Mylan Italia with food and drink
Olmesartan medoxomil and Amlodipine Mylan Italia 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 Amlodipine Mylan Italia should not
consume grapefruit juice and grapefruit as grapefruit and its juice can induce an
increase in the levels of the active substance amlodipine in the blood, which may lead to an unpredictable
increase in the hypotensive effect of this medicine
Elderly
If you are over 65 years of age, your doctor will regularly check your blood pressure with each
increase in dose, to avoid it dropping too low.
Black patients
As with other similar medicines, the blood pressure lowering effect of this medicine may
be, to some extent, reduced in black patients.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Pregnancy
You should 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 Amlodipine Mylan Italia before starting pregnancy or as soon as you find out you are
pregnant and will advise you to take another medicine instead of
Olmesartan medoxomil and Amlodipine Mylan Italia. This medicine is not recommended in early
pregnancy and should not be taken if you are pregnant for more than three months as it may
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 consult
your doctor immediately.
Breastfeeding
Amlodipine has been shown to pass into breast milk in small amounts. Before taking
Olmesartan medoxomil and Amlodipine Mylan Italia, tell your doctor if you are breastfeeding or are about to
start breastfeeding.
This medicine 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
You may feel drowsy, unwell or dizzy or have a headache during treatment
for high blood pressure. If this happens, do not drive or use machines until the symptoms
have disappeared.
Ask your doctor for advice.

Olmesartan medoxomil and Amlodipine Mylan Italia contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Olmesartan medoxomil and Amlodipina Mylan Italia

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 Olmesartan medoxomil and Amlodipina Mylan Italia is one tablet per 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 Olmesartan medoxomil and Amlodipina Mylan Italia 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 which
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 with you the package of the

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

If you stop taking Olmesartan medoxomil and Amlodipina Mylan Italia
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 everybody gets them.
If they do occur, they are mostly mild and do not require stopping the
treatment.

Although they do not occur in all people, the following side effects can be serious:
During treatment with Olmesartan medoxomil and Amlodipina Mylan Italia, 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 Mylan Italia and contact your
doctor immediately.
Olmesartan medoxomil and Amlodipina Mylan Italia can cause excessive reductions in blood
pressure in sensitive individuals or as a result of an allergic reaction. This may cause
severe dizziness or fainting. If this happens, stop taking Olmesartan medoxomil
and Amlodipina Mylan Italia, contact your doctor immediately and remain lying down.
Frequency not known: if you experience yellowing of the whites of your eyes, dark urine, itching of the skin,
even if you have been taking Olmesartan medoxomil and Amlodipina Mylan Italia for a long time,

contact your doctor immediatelywho will evaluate the symptoms and decide how to proceed with
blood pressure treatment.

Other possible side effects of Olmesartan medoxomil and Amlodipina Mylan Italia:
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):

• orthostatic dizziness 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
• diarrhoea
• constipation
• dry mouth
• upper abdominal pain
• rash
• cramps
• arm and leg pain
• back pain
• a feeling of increased urgency to urinate
• sexual inactivity
• inability to get 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 (levels of gamma glutamyl transferase).

Rare (may affect up to 1 in 1,000 people):

• hypersensitivity to the drug
• fainting
• redness and a feeling of warmth to the face
• itchy red and raised patches 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 Mylan Italia or with a higher frequency:
Olmesartan medoxomil
Common (may affect up to 1 in 10 people):

• bronchitis
• sore throat
• runny or blocked nose
• cough
• abdominal pain
• gastrointestinal infection
• diarrhoea
• indigestion
• nausea
• joint or bone pain
• back pain
• blood in urine
• urinary tract infection
• chest pain
• flu-like symptoms
• pain.

Changes in blood test results such as increased levels of fats (hypertriglyceridaemia),
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 fainting (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 up to 1 in 1,000 people):

• swelling of the face, mouth and/or larynx (the site of the vocal cords)
• acute kidney failure and renal insufficiency
• lethargy.

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 a feeling of warmth to the face
• visual disturbance (including double vision and blurred vision)
• awareness of heartbeat
• diarrhoea
• constipation
• indigestion
• cramps
• weakness
• difficulty in breathing

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

• difficulty sleeping
• sleep disturbances
• changes in mood including feeling anxious
• depression
• irritability
• tremor
• changes in taste
• fainting
• ringing in the ears (tinnitus)
• worsening of angina pectoris (chest pain or discomfort)
• irregular heartbeats
• runny or blocked nose
• hair loss
• small red or purple spots on the skin due to small haemorrhages (purpura)
• skin discoloration
• excessive sweating
• rash
• itching
• itchy red and raised patches on the skin (urticaria)
• muscle or joint pain
• problems with urination
• increased need to urinate at night
• increased frequency of urination
• increase in the volume of the breasts in men
• chest pain
• pain, malaise
• weight gain or loss.

Rare (may affect up to 1 in 1,000 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 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 constriction or increased resistance to passive movement (hypertonia)
• tingling or numbness in the hands or feet
• heart attack
• inflammation of the blood vessels
• inflammation of the liver or pancreas
• inflammation of the stomach lining
• thickening of the gums
• elevated 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 a feeling of 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, stiff posture, mask-like face, slow movements and a shuffling, dragging gait
• severe skin reactions including intense rash (toxic epidermal necrolysis).

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 Olmesartan medoxomil and Amlodipina Mylan Italia

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 package or blister. The expiry date
refers to the last day of that month.
Do not store at a temperature above 30ºC.
Do not dispose of any medicine in wastewater 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 Olmesartan medoxomil and Amlodipina Mylan Italia contains
The active ingredients are olmesartan medoxomil and amlodipine (as amlodipine besylate).
Each film-coated tablet of Olmesartan medoxomil and Amlodipina Mylan Italia 20 mg/5 mg
contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besylate).
Each film-coated tablet of Olmesartan medoxomil and Amlodipina Mylan Italia 40 mg/5 mg
contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besylate).
Each film-coated tablet of Olmesartan medoxomil and Amlodipina Mylan Italia 40 mg/10 mg
contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besylate).
The other components of the tablet core are microcrystalline cellulose, sodium lauryl sulfate, citric
acid monohydrate, hydroxypropylcellulose, sodium croscarmellose, maltose, mannitol,
low-substituted hydroxypropylcellulose and magnesium stearate.
The tablet coating for 20 mg/5 mg contains polyvinyl alcohol, titanium dioxide (E 171),
macrogol and talc.
The tablet coating for 40 mg/5 mg contains polyvinyl alcohol, titanium dioxide (E 171),
macrogol, talc, yellow iron oxide (E 172) and red iron oxide (E 172).
The tablet coating for 40 mg/10 mg contains polyvinyl alcohol, titanium dioxide (E 171),
macrogol, talc, yellow iron oxide (E 172) and red iron oxide (E 172).

Description of the appearance of Olmesartan medoxomil and Amlodipina Mylan Italia and package contents
Olmesartan medoxomil and Amlodipina Mylan Italia 20 mg/5 mg: film-coated tablets, round,
biconvex, white in color, with the letter M imprinted on one side and the abbreviation OA1 on the other.
Olmesartan medoxomil and Amlodipina Mylan Italia 40 mg/5 mg: film-coated tablets, round,
biconvex, yellow in color, with the letter M imprinted on one side and the abbreviation OA2 on the other.
Olmesartan medoxomil and Amlodipina Mylan Italia 40 mg/10 mg: film-coated tablets, round,
biconvex, brown in color, with the letter M imprinted on one side and the abbreviation OA3 on the other.
Blisters coated with aluminum foil containing 28 film-coated tablets.

Marketing authorization holder and manufacturer
Marketing authorization holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milan, Italy

Manufacturer
Mylan Hungary Kft., Mylan utca 1, Komarom, 2900, Hungary

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
Austria Olmesartanmedoxomil/Amlodipin Arcana 20 mg/ 5 mg Filmtabletten
Olmesartanmedoxomil/Amlodipin Arcana 40 mg/ 5 mg Filmtabletten
Olmesartanmedoxomil/Amlodipin Arcana 40 mg/ 10 mg Filmtabletten
Italy Olmesartan and Amlodipina Mylan Italia 20 mg/ 5 mg, 40 mg/ 5 mg, 40 mg/ 10 mg