Olmesartan medoxomil and amlodipine Accord: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olmesartan medoxomil and Amlodipine Accord 20 mg/5 mg film-coated tablets, 40 mg/5 mg film-coated tablets, 40 mg/10 mg film-coated tablets

Generic medicine
Please read all of 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Olmesartan medoxomil and Amlodipine Accord contains two substances called olmesartan medoxomil and
amlodipine (as amlodipine besilate). Both of these substances help control high blood pressure.

Olmesartan medoxomil belongs to a group of medicines called “angiotensin II receptor antagonists”. These medicines lower blood pressure by relaxing blood vessels.
Amlodipine belongs to a group of substances called “calcium antagonists”. Amlodipine prevents calcium from entering the vessel walls, thereby preventing blood vessels from narrowing and reducing blood pressure.

The action of both substances helps counteract blood vessel constriction, allowing the vessels to relax and blood pressure to decrease.
Olmesartan medoxomil and Amlodipine Accord 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 must do before taking Olmesartan medoxomil and Amlodipine Accord

Do not take Olmesartan medoxomil and Amlodipine Accord

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 Accord.
if you are more than three months pregnant (it is also advisable to avoid taking Olmesartan medoxomil and Amlodipine Accord 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, due to 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, or 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 Accord.
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), particularly if you have kidney problems related to diabetes.
aliskiren.

Your doctor may monitor your kidney function, blood pressure, and levels of electrolytes (such as potassium) in your blood at regular intervals.
See also the information under “Do not take Olmesartan medoxomil and Amlodipine Accord”.
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 your 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 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.
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 Accord 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 (under 18 years)
Olmesartan medoxomil and Amlodipine Accord is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan medoxomil and Amlodipine Accord
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Other medicines that lower blood pressure, because the effect of Olmesartan medoxomil and Amlodipine Accord may be increased. Your doctor may need to adjust the dose and/or take additional precautions: If you are taking an ACE inhibitor or aliskiren (see also “Do not take Olmesartan medoxomil and Amlodipine Accord” and “Warnings and precautions”).
Potassium supplements, potassium-containing salt substitutes, diuretics, or heparin (used to thin the blood and prevent thrombosis). Taking these medicines together with Olmesartan medoxomil and Amlodipine Accord may increase potassium levels in the blood.
Lithium (a medicine used to treat mood swings and certain types of depression) used together with Olmesartan medoxomil and Amlodipine Accord may increase lithium toxicity. If you need to take lithium, your doctor will monitor lithium levels in your blood.
Non-steroidal anti-inflammatory drugs (NSAIDs) (medicines used to relieve pain, swelling, and other symptoms of inflammation, including arthritis) used together with Olmesartan medoxomil and Amlodipine Accord may increase the risk of kidney failure. The effect of Olmesartan medoxomil and Amlodipine Accord 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 Accord. Your doctor may advise you to take Olmesartan medoxomil and Amlodipine Accord at least 4 hours before colesevelam hydrochloride.
Some antacids (used for indigestion or stomach acidity) may slightly reduce the effect of Olmesartan medoxomil and Amlodipine Accord.
Medicines for HIV/AIDS (for example ritonavir, indinavir, nelfinavir) or for treating fungal infections (for example ketoconazole, itraconazole).
Diltiazem, verapamil, medicines used for heart rhythm problems and high blood pressure.
Rifampicin, erythromycin, medicines used for tuberculosis or other infections.
St. John’s wort (Hypericum perforatum), a herbal remedy.
Dantrolene (infusion for severe disturbances in body temperature).
Simvastatin, a substance used to reduce cholesterol and fat (triglyceride) levels in the blood.
Tacrolimus, ciclosporin, used to control your body’s immune response, thereby allowing your body to accept transplanted organs.
Clarithromycin, for bacterial infections.

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

Olmesartan medoxomil and Amlodipine Accord with food and drinks
Olmesartan medoxomil and Amlodipine Accord 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 Olmesartan medoxomil and Amlodipine Accord must not consume grapefruit or grapefruit juice, as grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, potentially causing an unpredictable increase in the blood pressure-lowering effect of Olmesartan medoxomil and Amlodipine Accord.

Elderly
If you are over 65 years old, your doctor will regularly monitor your blood pressure with each dose increase to avoid excessive lowering.

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

Pregnancy and breastfeeding
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 Accord before becoming pregnant or as soon as you find out you are pregnant, and will recommend an alternative medicine. Olmesartan medoxomil and Amlodipine Accord 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 Olmesartan medoxomil and Amlodipine Accord, inform your doctor and seek medical advice immediately.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Olmesartan medoxomil and Amlodipine Accord 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.

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

Driving and using machines
You may experience drowsiness, discomfort, dizziness, or headache during treatment for high blood pressure. If this occurs, do not drive or operate machinery until symptoms resolve. Consult your doctor.

Olmesartan medoxomil and Amlodipine Accord contains lactose monohydrate
This medicine contains lactose (a type of sugar). If your doctor has informed you of an intolerance to certain sugars, inform your doctor before taking this medicine.

3. How to take Olmesartan medoxomil and Amlodipine Accord

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

The recommended dose of Olmesartan medoxomil and Amlodipine Accord 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). The tablets must not be chewed. 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 Accord than you should
If you take more tablets than you should, you may experience a drop in blood pressure with symptoms
such as dizziness, increased or slowed heart rate.
If you take more tablets than you should, 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 Accord
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 forgotten dose.
If you stop taking Olmesartan medoxomil and Amlodipine Accord
It is important to keep taking Olmesartan medoxomil and Amlodipine Accord 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 everybody gets them.
If they do occur, they are mostly mild and do not require discontinuation of treatment.
However, the following two side effects, although not occurring in all people, can be serious:
during treatment with Olmesartan medoxomil and Amlodipina Accord, 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 happens, stop taking Olmesartan medoxomil and Amlodipina Accord
and contact your doctor immediately.
Olmesartan medoxomil and Amlodipina Accord 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 happens, stop taking Olmesartan medoxomil and Amlodipina Accord, contact your doctor
immediately and remain lying down.
Other possible side effects of Olmesartan medoxomil and Amlodipina Accord:
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; urgency to urinate; lack of sexual
interest; inability to achieve or maintain erection; weakness.
Some blood test abnormalities have also been observed, including the following: increase or decrease in
potassium in the blood, increase in creatinine in the blood, increase in uric acid in the blood, increase in liver
function tests (levels of gamma-glutamyl transferase).
Rare (may affect up to 1 in 1,000 people):
Hypersensitivity to the medicine; fainting; facial flushing and sensation of warmth; red, itchy skin welts
(urticaria); swelling of the face.
Side effects reported with olmesartan medoxomil or amlodipine used alone, but not with Olmesartan
medoxomil and Amlodipina Accord or with 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;
influenza-like symptoms; pain. Laboratory test abnormalities such as increased fats (hypertriglyceridemia);
increased blood urea or uric acid levels; 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 which may affect the entire body and may cause
breathing difficulties or rapid drop in blood pressure, possibly leading to weakness (anaphylactic reactions);
angina (pain or discomfort in the chest, known as angina pectoris); itching; skin rash; allergic skin rash;
skin rash with hives, 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 kidney failure and kidney failure;
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; 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 disorders; mood disturbances including anxiety; depression; irritability; tremors;
taste disturbances; 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 dots on the skin due to small
bleeding (purpura); skin discoloration; excessive sweating; skin rash; itching; red, itchy skin welts
(urticaria); muscle or joint pain; difficulty urinating; need to urinate at night; increased need to urinate;
breast enlargement in men; chest pain; pain, discomfort; 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 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 stiffness 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 lining; 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 severe rash, urticaria, redness of the skin over the
entire body surface, severe itching, blisters, peeling and swelling of the skin, inflammation of mucous
membranes, sometimes life-threatening.
Frequency not known:
Tremors, rigid posture, mask-like facial expression, slowed movements, and shuffling, unbalanced gait.
Reporting of side effects
If you experience any side effects, 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:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting
side effects, you can help provide more information on the safety of this medicine.

5. How to store Olmesartan medoxomil and Amlodipine Accord

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, blister, and label following "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
HDPE bottle: use within 90 days after first opening.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Olmesartan medoxomil and Amlodipine Accord contains
The active substances are olmesartan medoxomil and amlodipine.
Olmesartan medoxomil and Amlodipine Accord 20 mg/5 mg: each film-coated tablet contains
20 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
Olmesartan medoxomil and Amlodipine Accord 40 mg/5 mg: each film-coated tablet contains
40 mg of olmesartan medoxomil and 5 mg of amlodipine (as besylate).
Olmesartan medoxomil and Amlodipine Accord 40 mg/10 mg: each film-coated tablet contains
40 mg of olmesartan medoxomil and 10 mg of amlodipine (as besylate).

The other components are:
Tablet core:
pregelatinized corn starch, silicified microcrystalline cellulose (microcrystalline cellulose with anhydrous colloidal silica), lactose monohydrate, magnesium stearate, povidone K-30.

Tablet coating:
The white coating Opadry II 85F18422 of Olmesartan medoxomil and Amlodipine Accord 20 mg/5 mg contains:
polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc.

The yellow coating Opadry II 85F520132 of Olmesartan medoxomil and Amlodipine Accord 40 mg/5 mg contains:
polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172).

The brown coating Opadry II 85F565114 of Olmesartan medoxomil and Amlodipine Accord 40 mg/10 mg contains:
polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc, yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Olmesartan medoxomil and Amlodipine Accord and contents of the
pack
Olmesartan medoxomil and Amlodipine Accord 20 mg/5 mg are film-coated tablets, round, white in colour, with "OA1" engraved on one side and smooth on the other. Size:
diameter 6.10 mm ± 0.20 mm.

Olmesartan medoxomil and Amlodipine Accord 40 mg/5 mg are film-coated tablets, round, white to off-white in colour, with "OA3" engraved on one side and smooth on the other. Size:
diameter 8.10 mm ± 0.20 mm.

Olmesartan medoxomil and Amlodipine Accord 40 mg/10 mg are film-coated tablets, round, red-brown in colour, with "OA4" engraved on one side and smooth on the other. Size:
diameter 8.10 mm ± 0.20 mm.

OPA/Al/PVC-Al blisters:
OPA/Al/PVC-Al blisters containing 28, 30, 56, 90 and 98 tablets or perforated OPA/Al/PVC-Al unit dose blisters containing 28 or 30 tablets.

HDPE bottles:
Opaque white HDPE bottle with a white child-resistant screw cap made of polypropylene, containing 30 and 90 tablets.
Opaque white HDPE bottle with a continuous white polypropylene screw cap, containing 500 and 1,000 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center,
Moll de Barcelona,
s/n, Edifici Est 6ª planta,
08039 Barcelona,
Spain

Manufacturer
Accord Healthcare Limited
Sage House, 319, Pinner Road, North Harrow
Middlesex, HA1 4HF
United Kingdom

LABORATORI FUNDACIÓ DAU,
C/ C, 12-14 Pol. Ind. Zona Franca
Barcelona, 08040
Spain

Wessling Hungary Kft.
Fòti ùt 56,
Budapest, 1047
Hungary