Olmesartan medoxomil and amlodipine Mylan Italia: detailed information

Patient Information Leaflet

Olmesartan medoxomil and Amlodipine Mylan Italia 20 mg/5 mg film-coated tablets

Olmesartan medoxomil and Amlodipine Mylan Italia 40 mg/5 mg film-coated tablets
Olmesartan medoxomil and Amlodipine Mylan Italia 40 mg/10 mg film-coated tablets
olmesartan medoxomil/amlodipine
Generic Medicine
Please read this leaflet carefully before 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 give it to others, even if they have the same symptoms as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Olmesartan medoxomil and Amlodipine Mylan Italia is and what it is used for
What you need to know before taking Olmesartan medoxomil and Amlodipine Mylan Italia
How to take Olmesartan medoxomil and Amlodipine Mylan Italia
Possible side effects
How to store Olmesartan medoxomil and Amlodipine Mylan Italia
Contents of the pack and other information

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

Olmesartan medoxomil and Amlodipine Mylan Italia contains two substances called olmesartan medoxomil and amlodipine (as amlodipine besilate). Both are used to control hypertension.

Olmesartan medoxomil belongs to a group of medicines known as “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 tension and lowering blood pressure.

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

2. What you should 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 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 Olmesartan medoxomil and Amlodipine Mylan Italia
if you are more than 3 months pregnant (it is better to avoid taking Olmesartan medoxomil and Amlodipine Mylan Italia 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 (for example, by gallstones), or if you develop jaundice (yellowing of the skin and eyes)
if your blood pressure is very low
if you suffer from inadequate blood supply to 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 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 Olmesartan medoxomil and Amlodipine Mylan Italia.
Consult your doctor if 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), particularly if you have kidney problems related to diabetes
aliskiren.

Your doctor may monitor your kidney function, blood pressure, and blood levels of electrolytes (such as potassium) at regular intervals.
See also the section “Do not take Olmesartan medoxomil and Amlodipine Mylan Italia”.
Consult your doctor if you also 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 accompanied by significant weight loss. Your doctor may assess your symptoms and decide whether to continue this antihypertensive treatment.
Like all medicines that lower blood pressure, excessive reduction of blood pressure in patients with impaired blood flow to the heart or brain may lead to a heart attack or stroke. Your doctor will therefore carefully monitor your blood pressure.
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Olmesartan medoxomil and Amlodipine Mylan Italia 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 baby if taken during this period (see section “Pregnancy and breastfeeding”).
Children and adolescents
Olmesartan medoxomil and Amlodipine Mylan Italia is not recommended for children and adolescents under 18 years of age.
Other medicines and Olmesartan medoxomil and Amlodipine Mylan Italia
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any of the following medicines:

Other medicines that lower blood pressure may enhance the effect of Olmesartan medoxomil and Amlodipine Mylan Italia. 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 the sections “Do not take Olmesartan medoxomil and Amlodipine Mylan Italia” 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 Olmesartan medoxomil and Amlodipine Mylan Italia may increase potassium levels in the blood.
Lithium (a medicine used to treat mood swings and certain types of depression) taken together with Olmesartan medoxomil and Amlodipine Mylan Italia 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) taken 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 lowers cholesterol levels in the blood, which may reduce 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.
Medicines for HIV/AIDS (for example ritonavir, indinavir, nelfinavir) or for fungal infections (for example ketoconazole, itraconazole).
Diltiazem, verapamil (medicines used for heart rhythm problems and high blood pressure).
Rifampicin (a medicine used for tuberculosis or other infections).
Erythromycin, clarithromycin (for bacterial infections).
St. John’s wort (Hypericum perforatum), a herbal remedy.
Dantrolene (intravenous infusion for severe abnormalities 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, allowing your body to accept transplanted organs).

Inform 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 drinks
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 at the same time each day, for example with breakfast.
People taking Olmesartan medoxomil and Amlodipine Mylan Italia must not consume grapefruit or grapefruit juice, as grapefruit and its juice may increase blood levels of the active ingredient amlodipine, potentially causing an unpredictable increase in the blood pressure-lowering effect of this medicine.
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 low.
Patients of black origin
As with other similar medicines, the blood pressure-lowering effect of this medicine may be somewhat reduced in patients of black origin.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
You must inform your doctor if you think you may be pregnant (or if there is a possibility of becoming pregnant). Your doctor will usually advise you to stop taking Olmesartan medoxomil and Amlodipine Mylan Italia before becoming pregnant or as soon as you know you are pregnant, and will recommend another medicine instead. This medicine 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 baby if taken after the third month of pregnancy.
If you become pregnant while taking this medicine, inform and consult your doctor immediately.
Breastfeeding
It has been shown that amlodipine passes into breast milk in small amounts. Before taking Olmesartan medoxomil and Amlodipine Mylan Italia, inform your doctor if you are breastfeeding or planning to breastfeed.
This medicine is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment for you if you wish to breastfeed, especially if the baby is a newborn or was born prematurely.
Driving and using machines
You may experience drowsiness, discomfort, dizziness, or headache during antihypertensive treatment. If this occurs, do not drive or operate machinery until symptoms have resolved. Consult your doctor.
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 Amlodipine Mylan Italia

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

The recommended dose of Olmesartan medoxomil and Amlodipine Mylan Italia 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 Olmesartan medoxomil and Amlodipine Mylan Italia than you should
If you take more tablets than prescribed, you may experience a drop in blood pressure with symptoms
such as dizziness, increased or slowed 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 Olmesartan medoxomil and Amlodipine 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 the missed dose.
If you stop taking Olmesartan medoxomil and Amlodipine Mylan Italia
It is important to continue taking this medicine unless your doctor tells you to stop.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them. If they do 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 Olmesartan medoxomil and Amlodipina Mylan Italia, allergic reactions may occur, which can affect the entire body, with swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash. If this occurs, stop taking Olmesartan medoxomil and Amlodipina Mylan Italia and contact your doctor immediately.

Olmesartan medoxomil and Amlodipina Mylan Italia may cause excessive lowering of blood pressure in sensitive individuals or as a consequence of an allergic reaction. This could lead to severe dizziness or fainting. If this occurs, 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 the eyes, dark urine, or skin itching, even if you have been on Olmesartan medoxomil and Amlodipina Mylan Italia for a long time, contact your doctor immediately. Your doctor will evaluate your symptoms and decide how to proceed with your 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 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
skin rash
cramps
pain in arms and legs
back pain
increased urgency to urinate
sexual inactivity
inability to achieve or maintain erection
weakness.

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

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

hypersensitivity to the medicine
fainting
flushing and sensation of warmth in the face
red, itchy welts (urticaria)
facial swelling.

Side effects reported with olmesartan medoxomil or amlodipine used alone, but not with Olmesartan medoxomil and Amlodipina Mylan Italia or at a higher frequency:

Olmesartan medoxomil

Common (may affect up to 1 in 10 people):

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

Blood test abnormalities such as increased levels of fats (hypertriglyceridaemia), increased plasma 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, which may cause breathing difficulties or a rapid drop in blood pressure, possibly leading to fainting (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 unwell.

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

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

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
flushing and sensation of warmth in the face
visual disturbance (including double vision and blurred vision)
awareness of heartbeat
diarrhoea
constipation
indigestion
cramps
weakness
difficulty breathing

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

difficulty sleeping
sleep disorders
mood changes including anxiety
depression
irritability
tremor
taste disturbances
fainting
ringing in the ears (tinnitus)
worsening of angina pectoris (chest pain or discomfort)
irregular heartbeats
runny or blocked nose
hair loss
red spots or dots on the skin due to small bleedings (purpura)
skin discoloration
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 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 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 contraction or increased resistance to passive movement (hypertonia)
tingling or numbness in hands or feet
heart attack
inflammation of blood vessels
inflammation of the liver or pancreas
inflammation of the gastric mucosa
gum enlargement
elevated liver enzymes
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 severe rash, urticaria, redness of the skin over the entire body surface, severe itching, blisters, peeling and swelling of the skin, mucosal inflammation (Stevens-Johnson syndrome, toxic epidermal necrolysis), sometimes life-threatening.

Not known (frequency cannot be estimated from the available data):

tremor, rigid posture, mask-like face, slow movements and unbalanced, shuffling gait
severe skin reactions including severe rash (toxic epidermal necrolysis).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can 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 Olmesartan medoxomil and Amlodipine Mylan Italia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton or blister. The expiry date refers to the last day of that month.
Do not store above 30°C.
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. Package contents and other information

What Olmesartan medoxomil and Amlodipine Mylan Italia contains
The active substances are olmesartan medoxomil and amlodipine (as amlodipine besilate).
Each film-coated tablet of Olmesartan medoxomil and Amlodipine Mylan Italia 20 mg/5 mg contains 20 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).
Each film-coated tablet of Olmesartan medoxomil and Amlodipine Mylan Italia 40 mg/5 mg contains 40 mg of olmesartan medoxomil and 5 mg of amlodipine (as amlodipine besilate).
Each film-coated tablet of Olmesartan medoxomil and Amlodipine Mylan Italia 40 mg/10 mg contains 40 mg of olmesartan medoxomil and 10 mg of amlodipine (as amlodipine besilate).
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 film coating of the 20 mg/5 mg tablet contains polyvinyl alcohol, titanium dioxide (E 171), macrogol and talc.
The film coating of the 40 mg/5 mg tablet contains polyvinyl alcohol, titanium dioxide (E 171), macrogol, talc, yellow iron oxide (E 172) and red iron oxide (E 172).
The film coating of the 40 mg/10 mg tablet 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 Amlodipine Mylan Italia and contents of the pack
Olmesartan medoxomil and Amlodipine Mylan Italia 20 mg/5 mg: film-coated tablets, round, biconvex, white in colour, marked with the letter M on one side and the code OA1 on the other.
Olmesartan medoxomil and Amlodipine Mylan Italia 40 mg/5 mg: film-coated tablets, round, biconvex, yellow in colour, marked with the letter M on one side and the code OA2 on the other.
Olmesartan medoxomil and Amlodipine Mylan Italia 40 mg/10 mg: film-coated tablets, round, biconvex, brown in colour, marked with the letter M on one side and the code OA3 on the other.
Aluminium foil blister packs containing 28 film-coated tablets.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano, Italy

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

This medicinal product is authorised in the European Economic Area countries under the following names:
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 Amlodipine Mylan Italia 20 mg/ 5 mg, 40 mg/ 5 mg, 40 mg/ 10 mg