Olmesartan medoxomil and amlodipine Zentiva: detailed information

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olmesartan Medoxomil and Amlodipine Zentiva

20 mg/5 mg film-coated tablets
Olmesartan Medoxomil and Amlodipine Zentiva
40 mg/5 mg film-coated tablets
Olmesartan Medoxomil and Amlodipine Zentiva
40 mg/10 mg film-coated tablets
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine, because 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 appear to be the same as yours, as it could be harmful.
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What Olmesartan Medoxomil and Amlodipine Zentiva is and what it is used for

Olmesartan Medoxomil and Amlodipine Zentiva 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” that reduce blood pressure by relaxing blood vessels.
Amlodipine belongs to a group of substances called “calcium antagonists”. Amlodipine prevents calcium from entering the walls of blood vessels, thereby reducing their constriction and lowering blood pressure as well. The combined action of these two substances helps counteract vascular tension, allowing blood vessels to relax and blood pressure to decrease. Olmesartan Medoxomil and Amlodipine Zentiva 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 Zentiva

Do not take Olmesartan Medoxomil and Amlodipine Zentiva if

you are allergic to olmesartan medoxomil or amlodipine, or to a specific group of calcium antagonists called 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 Zentiva.
you are more than 3 months pregnant (it is also advisable to avoid taking Olmesartan Medoxomil and Amlodipine Zentiva during early pregnancy – see section “Pregnancy and breastfeeding”).
you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.
you have severe liver problems, impaired bile secretion, or blocked bile outflow from the gallbladder (e.g. due to gallstones), or if you develop jaundice (yellowing of the skin and eyes).
your blood pressure is very low.
you have 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 severe heart problems.
blood flow from your heart is obstructed (e.g. due to aortic narrowing (aortic stenosis)).
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 Zentiva.
Consult your doctor if you are taking any of the following medicines used to treat high blood pressure:
an ACE inhibitor (e.g. enalapril, lisinopril, ramipril), particularly if you have kidney problems related to diabetes.
aliskiren.
Your doctor may monitor your kidney function, blood pressure, and blood electrolyte levels (e.g. potassium) at regular intervals. See also the section “Do not take Olmesartan Medoxomil and Amlodipine Zentiva”.
Consult your doctor if you have any of the following health conditions:

Kidney problems or kidney transplant.
Liver disease.
Heart failure or heart valve or heart muscle disorders.
Severe vomiting, diarrhoea, treatment with high doses of "water pills" (diuretics), or if you are on a low-salt diet.
Elevated potassium levels in the blood.
Adrenal gland problems (hormone-producing glands located above the kidneys). Inform your doctor if you develop severe and prolonged diarrhoea with 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 Zentiva is not recommended during early pregnancy and must not be taken if you are more than 3 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 Zentiva is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan Medoxomil and Amlodipine Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines:

Other medicines that lower blood pressure may increase the effect of Olmesartan Medoxomil and Amlodipine Zentiva. Your doctor may need to adjust the dose and/or take other precautions: if you are taking an ACE inhibitor or aliskiren (see also sections “Do not take Olmesartan Medoxomil and Amlodipine Zentiva” and “Warnings and precautions”).
Potassium supplements, potassium-containing salt substitutes, "water pills" (diuretics), or heparin (used to thin the blood and prevent blood clots). Taking these medicines together with Olmesartan Medoxomil and Amlodipine Zentiva 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 Zentiva may increase lithium toxicity. If you are to take lithium, your doctor will monitor your blood lithium levels.
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 Zentiva may increase the risk of kidney failure. The effect of Olmesartan Medoxomil and Amlodipine Zentiva may be reduced by NSAIDs.
Colesevelam hydrochloride, a medicine that lowers cholesterol levels in the blood, may reduce the effect of Olmesartan Medoxomil and Amlodipine Zentiva. Your doctor may advise you to take Olmesartan Medoxomil and Amlodipine Zentiva 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 Zentiva.
Medicines for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir) or antifungal medicines (e.g. ketoconazole, itraconazole).
Diltiazem, verapamil (medicines used for heart rhythm problems and high blood pressure).
Rifampicin, erythromycin, clarithromycin (medicines used for tuberculosis or other bacterial 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, cyclosporine (used to control your body’s immune response, allowing your body to accept a transplanted organ).
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Olmesartan Medoxomil and Amlodipine Zentiva with food and drink
Olmesartan Medoxomil and Amlodipine Zentiva 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 Zentiva must not consume grapefruit or grapefruit juice, as grapefruit and grapefruit juice may increase blood levels of the active ingredient amlodipine, which could lead to an unpredictable increase in the blood pressure-lowering effect of Olmesartan Medoxomil and Amlodipine Zentiva.

Elderly
If you are over 65 years old, your doctor will regularly monitor your blood pressure with each dose increase to prevent it from dropping too low.

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

Pregnancy and breastfeeding
Pregnancy
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 Zentiva before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine. Olmesartan Medoxomil and Amlodipine Zentiva is not recommended during early pregnancy and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your unborn child if taken after the third month of pregnancy.
If you become pregnant while taking Olmesartan Medoxomil and Amlodipine Zentiva, inform and see your doctor immediately.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to breastfeed. Olmesartan Medoxomil and Amlodipine Zentiva 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, ask your doctor or pharmacist for advice 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 Zentiva contains lactose
If you have been diagnosed by your doctor with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Olmesartan Medoxomil and Amlodipine Zentiva

Take this medicine exactly as your doctor or pharmacist has told you.
If you are unsure, consult your doctor or pharmacist.

The recommended dose of Olmesartan Medoxomil and Amlodipine Zentiva 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 Zentiva than you should
If you take more tablets than you should, your blood pressure may drop, causing symptoms such as dizziness, or a faster or slower heartbeat.
If you take too many tablets or if a child accidentally swallows any, go immediately to a doctor or the nearest emergency department, taking the medicine pack or this leaflet with you.

If you forget to take Olmesartan Medoxomil and Amlodipine Zentiva
If you forget to take a dose, take your usual dose the next day at the usual time. Do not take a double dose to make up for the forgotten dose.

If you stop taking Olmesartan Medoxomil and Amlodipine Zentiva
It is important to keep taking Olmesartan Medoxomil and Amlodipine Zentiva 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.
Although they do not occur in all people, the following two side effects can be serious:
during treatment with Olmesartan Medoxomil and Amlodipine Zentiva, allergic reactions may occur, which can affect the whole 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 Zentiva and contact your doctor immediately.
Olmesartan Medoxomil and Amlodipine Zentiva 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 Amlodipine Zentiva, contact your doctor immediately and lie down.
Other possible side effects of Olmesartan Medoxomil and Amlodipine Zentiva:
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):
Loss of sexual interest; lack of energy; tingling or numbness in hands or feet; dizziness upon standing; vertigo; awareness of heartbeat; faster heartbeat; cough; low blood pressure with symptoms such as dizziness, feeling of emptiness in the head, shortness of breath; constipation; diarrhoea; dry mouth; indigestion; nausea; pain in the upper abdomen; vomiting; rash; back pain; muscle cramps; pain in arms and legs; urgency to urinate; inability to achieve or maintain erection; weakness.
Some blood test abnormalities have also been observed, including the following:
increase or decrease in blood potassium, increase in blood creatinine, increase in blood uric acid, increase in liver function tests (levels of gamma-glutamyl transferase).
Rare (may affect up to 1 in 1,000 people):
Fainting; drug hypersensitivity; redness and feeling of warmth in the face; itchy red raised rash (urticaria); facial swelling.
Side effects reported with use of olmesartan medoxomil or amlodipine alone, but not with Olmesartan Medoxomil and Amlodipine Zentiva or with higher frequency:
Olmesartan medoxomil
Common (may affect up to 1 in 10 people):
Bronchitis; cough; sore throat; blocked or runny nose; abdominal pain; diarrhoea; indigestion; gastroenteritis; 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 (hypertriglyceridaemia); increased plasma urea or uric acid; 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 whole body and may cause breathing difficulties as well as rapid drop in blood pressure which may also lead to fainting (anaphylactic reactions); angina (pain or discomfort in the chest known as angina pectoris); allergic skin rash; skin rash; itching; skin rash with raised areas, muscle pain; facial swelling; feeling of malaise.
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):
Drowsiness; redness and feeling of warmth in the face; abdominal pain; nausea; swollen ankles; 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):
Depression; irritability; restless sleep; sleep disturbances; mood disorders including anxiety; taste disturbances; fainting; ringing in the ears (tinnitus); worsening of angina pectoris (pain or discomfort in the chest); irregular heartbeat; blocked or runny nose; hair loss; skin rash; excessive sweating; itching; red spots or patches on the skin due to small haemorrhages (purpura); skin discolouration; itchy red raised rash (urticaria); muscle or joint pain; increased need to urinate; difficulty urinating; need to urinate at night; breast enlargement in men; chest pain; feeling of malaise; pain; 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 stomach wall; gum enlargement; inflammation of the liver or pancreas; elevated liver enzyme levels; yellowing of the skin and eyes; increased skin sensitivity to light; allergic reactions (itching, rash, swelling of the face, mouth and/or larynx (site of the vocal cords)) together with itching and skin rash, severe skin reactions including intense skin rash, urticaria, redness of the skin over the entire body surface, severe itching, blisters, peeling and swelling of the skin, mucosal inflammation, sometimes life-threatening.
Frequency not known (frequency cannot be estimated from the available data):
Tremor, rigid posture, mask-like facial expression, slow shuffling gait, unsteady walking.
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 the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazioneavversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olmesartan Medoxomil and Amlodipine Zentiva

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage temperature. Store in the
original packaging to protect the medicine from light.
Do not use this medicine after the expiry date stated on the pack after “Exp”. The
expiry date refers to the last day of that month.
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 Zentiva contains
The active substances are olmesartan medoxomil and amlodipine (as besylate).
Olmesartan Medoxomil and Amlodipine Zentiva 20 mg/5 mg
Each film-coated tablet contains 20 mg of olmesartan medoxomil and 5 mg of
amlodipine (as amlodipine besylate).
Olmesartan Medoxomil and Amlodipine Zentiva 40 mg/5 mg
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 5 mg of
amlodipine (as amlodipine besylate).
Olmesartan Medoxomil and Amlodipine Zentiva 40 mg/10 mg
Each film-coated tablet contains 40 mg of olmesartan medoxomil and 10 mg of
amlodipine (as amlodipine besylate).
The other components are: Tablet core: pregelatinized starch (maize), silicified microcrystalline cellulose, sodium croscarmellose, lactose monohydrate, anhydrous colloidal silica, magnesium stearate.
Tablet coating: polyvinyl alcohol, polyethylene glycol (macrogol 4000), titanium dioxide (E171), talc, yellow iron oxide (E172, Olmesartan Medoxomil and Amlodipine Zentiva 40 mg/5 mg film-coated tablets only), red iron oxide (E172, Olmesartan Medoxomil and Amlodipine Zentiva 40 mg/5 mg film-coated tablets and 40 mg/10 mg film-coated tablets only), black iron oxide (E172, Olmesartan Medoxomil and Amlodipine Zentiva 40 mg/5 mg film-coated tablets only).

Description of the appearance of Olmesartan Medoxomil and Amlodipine Zentiva and contents of the pack
Olmesartan Medoxomil and Amlodipine Zentiva 20 mg/5 mg film-coated tablets are white, round, film-coated, smooth tablets, 6.61 mm in diameter.
Olmesartan Medoxomil and Amlodipine Zentiva 40 mg/5 mg film-coated tablets are orange, round, film-coated, smooth tablets, 9.1 mm in diameter.
Olmesartan Medoxomil and Amlodipine Zentiva 40 mg/10 mg film-coated tablets are red, round, film-coated, smooth tablets, 9.1 mm in diameter.
Olmesartan Medoxomil and Amlodipine Zentiva is available in packs containing 14, 28, 30, 56, 90, or 98 film-coated tablets. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Zentiva Italia S.r.l.
Viale L. Bodio, 37/b
20158 Milan
Italy

Manufacturer
S.C. ZENTIVA S.A.
B-dul Theodor Pallady nr. 50, sector 3
032266 Bucharest
Romania

This medicinal product is authorized in the European Economic Area Member States under the following names:
Czech Republic: Olmesartan/Amlodipin Zentiva
Estonia: Olmesartan medoxomil/Amlodipine Zentiva
Germany: Olmesartan Amlodipin Zentiva
Italy: Olmesartan Medoxomil e Amlodipina Zentiva
Latvia: Olmesartan medoxomil/Amlodipine Zentiva
Portugal: Olmesartan +Amlodipina Zentiva
Romania: Olmesartan medoxomil/Amlodină Zentiva
United Kingdom: Olmesartan/Amlodipine