Olmesartan medoxomil Zentiva

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Olmesartan Medoxomil Zentiva 10 mg, 20 mg, 40 mg

Film-coated tablets
Generic medicine
Please read all of this leaflet carefully before 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 give it to other people, even if their symptoms are the same as yours, because 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:

1. What Olmesartan Medoxomil Zentiva is and what it is used for
2. What you need to know before taking Olmesartan Medoxomil Zentiva
3. How to take Olmesartan Medoxomil Zentiva
4. Possible side effects
5. How to store Olmesartan Medoxomil Zentiva
6. Contents of the pack and other information

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

Olmesartan Medoxomil Zentiva belongs to a group of medicines called angiotensin II receptor antagonists. These medicines reduce blood pressure by relaxing blood vessels.
Olmesartan Medoxomil Zentiva is used to treat high blood pressure (also known as “hypertension”). High blood pressure can damage blood vessels in organs such as the heart, kidneys, brain, and eyes. In some cases, this may lead to heart attacks, heart or kidney failure, stroke, or blindness. High blood pressure usually does not cause symptoms. It is important to monitor your blood pressure regularly to prevent such complications.
High blood pressure can be controlled with medicines such as Olmesartan Medoxomil Zentiva tablets. Your doctor has likely also recommended that you make certain lifestyle changes to help lower your blood pressure (for example, losing weight, quitting smoking, reducing alcohol intake, and reducing dietary salt). Your doctor may also have advised you to exercise regularly, such as walking or swimming. It is important that you follow your doctor’s advice.

2. What you need to know before taking Olmesartan Medoxomil Zentiva

Do not take Olmesartan Medoxomil Zentiva

• If you are allergic to olmesartan medoxomil or to any of the excipients of this medicine (listed in section 6).
• If you are more than three months pregnant (Olmesartan Medoxomil Zentiva should also be avoided during early pregnancy – see section “Pregnancy”).
• If you have yellowing of the skin and eyes (jaundice) or disorders affecting bile flow from the gallbladder (biliary obstruction, for example gallstones). If you have diabetes or impaired kidney function and are being treated with a blood pressure-lowering medicine containing aliskiren.

Warnings and precautions
Talk to your doctor before taking Olmesartan Medoxomil Zentiva.
Before taking the tablets, inform your doctor if any of the following medical conditions apply to you:
Kidney problems,
Liver disease,
Heart failure or problems with heart valves or heart muscle,
Severe vomiting or diarrhoea,
If you are being treated with high doses of diuretic tablets (water tablets) or if you are on a low-salt diet,
Elevated potassium levels in the blood,
Problems with the adrenal glands (e.g. primary aldosteronism),
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 check your kidney function, blood pressure, and levels of electrolytes (e.g. potassium) in your blood at regular intervals.
Also read the information in the section “Do not take Olmesartan Medoxomil Zentiva”.
Talk to your doctor if you have severe, persistent diarrhoea causing significant weight loss. Your doctor may assess your symptoms and decide how to continue your blood pressure treatment.
As with any medicine that lowers blood pressure, excessive reduction of 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 Zentiva 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”).

Children and adolescents
Olmesartan Medoxomil Zentiva is not recommended for children and adolescents under 18 years of age.

Other medicines and Olmesartan Medoxomil Zentiva
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any of the following medicines, particularly:
Other medicines to lower blood pressure, as the effect of Olmesartan Medoxomil Zentiva may be increased. Your doctor may need to adjust your dose and/or take other precautions. If you are taking an ACE inhibitor or aliskiren (also see information in the sections “Do not take Olmesartan Medoxomil Zentiva” and “Warnings and precautions”).
Potassium supplements, potassium-containing salt substitutes, diuretic tablets (water tablets), or heparin (used to thin the blood). Taking these medicines together with Olmesartan Medoxomil Zentiva may increase potassium levels in the blood.
Lithium (a medicine used to treat mood disorders and certain types of depression) taken together with Olmesartan Medoxomil Zentiva may increase lithium toxicity. If you need to take lithium, your doctor will monitor your lithium blood levels.
Non-steroidal anti-inflammatory drugs (NSAIDs, medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) taken together with Olmesartan Medoxomil Zentiva may increase the risk of kidney failure, and the effectiveness of Olmesartan Medoxomil Zentiva may be reduced by NSAIDs.
Colesevelam hydrochloride, an active substance that lowers cholesterol levels in the blood. Your doctor may advise you to take Olmesartan Medoxomil Zentiva at least 4 hours before colesevelam hydrochloride.
Some antacids (used for indigestion) may slightly reduce the effectiveness of Olmesartan Medoxomil Zentiva.

Elderly
If you are over 65 years of age and your doctor decides to increase your dose of olmesartan medoxomil to 40 mg daily, your blood pressure must be regularly monitored by your doctor to prevent excessive lowering.

Black patients
As with other similar medicines, the blood pressure-lowering effect of Olmesartan Medoxomil Zentiva is somewhat reduced in black patients.

Olmesartan Medoxomil Zentiva with food and drink
Olmesartan Medoxomil Zentiva can be taken with or without food.

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 Zentiva before becoming pregnant or as soon as you know you are pregnant, and will recommend an alternative medicine instead of Olmesartan Medoxomil Zentiva. Olmesartan Medoxomil Zentiva 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.

Breastfeeding
Inform your doctor if you are breastfeeding or planning to start breastfeeding. Olmesartan Medoxomil Zentiva is not recommended for women who are breastfeeding, and your doctor may choose an alternative treatment if you wish to breastfeed, especially if your baby is newborn or premature.

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

Olmesartan Medoxomil Zentiva contains lactose
This medicine contains lactose (a type of sugar). If your doctor has informed you that you have an intolerance to certain sugars, contact him before taking this medicine.

3. How to take Olmesartan Medoxomil Zentiva

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended starting dose is one 10 mg tablet once daily. However, if your
blood pressure is not controlled, your doctor may decide to increase the dose to 20 or 40
mg once daily, or may prescribe other medicines.
In patients with mild or moderate kidney disease, the dose must not exceed 20 mg once daily.
The tablets can be taken with or without food. Swallow the tablets with a sufficient amount of water (for example, a glass of water). If possible, take your daily dose at the same time each day, for example with breakfast.
If you take more Olmesartan Medoxomil Zentiva than you should
If you take more tablets than you should, or if a child accidentally swallows any, go immediately to your doctor or nearest emergency department, taking the medicine pack with you.
If you forget to take Olmesartan Medoxomil Zentiva
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 tablet.
If you stop taking Olmesartan Medoxomil Zentiva
It is important to continue taking Olmesartan Medoxomil Zentiva unless your doctor tells you to stop.
If you have any questions about how to use Olmesartan Medoxomil Zentiva, ask 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 everyone, the following side effects can be serious:
 Uncommonly (may affect up to 1 in 100 people), an immediate allergic reaction may occur, which can affect the whole body and may cause breathing difficulties as well as a rapid drop in blood pressure that could even lead to fainting (anaphylactic reactions).
 Rarely (may affect up to 1 in 1,000 people), during treatment with Olmesartan Medoxomil Zentiva, swelling of the face, mouth and/or larynx (site of the vocal cords) may occur, associated with itching and skin rash. Rarely (but slightly more frequently in elderly people), Olmesartan Medoxomil Zentiva may cause excessive lowering of blood pressure in sensitive individuals or as a result of an allergic reaction. This could cause severe dizziness or fainting.
 If any of the above conditions occur, stop taking Olmesartan Medoxomil Zentiva, contact your doctor immediately and lie down.

The following are other side effects known so far with olmesartan medoxomil:

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

• Dizziness; headache.
• Bronchitis; sore throat; runny or stuffy nose.
• Gastroenteritis (inflammation of the stomach or intestine); diarrhoea; stomach pain; nausea; indigestion.
• Joint pain; back pain; bone pain.
• Blood in urine; urinary tract infection.
• Pain; chest pain; swelling of ankles, feet, legs, hands or arms; flu-like symptoms; fatigue.

Laboratory test abnormalities that have also been observed:

• Increase in blood fats (hypertriglyceridaemia),
• Increase in uric acid in the blood (hyperuricaemia),
• Increase in blood urea,
• Increase in liver and muscle function tests.

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

• A sensation of dizziness or spinning (vertigo).
• Angina (pain or discomfort in the chest).
• Vomiting.
• Skin rash, allergic skin rash, urticaria, itching, exanthema (skin rash), skin blisters (wheals).
• Muscle pain.
• Facial swelling; feeling of weakness or unwellness.
• Decrease in the number of a type of blood cells called platelets (thrombocytopenia) has been observed in blood tests.

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

• Acute kidney failure: kidney damage.
• Muscle cramps.
• Lack of energy.
• Laboratory test abnormalities that have also been observed:
• increase in potassium levels (hyperkalaemia),
• increase in substances related to kidney function.

Additional side effects in children and adolescents
In children, side effects are similar to those reported in adults. However, dizziness and headache have been observed more frequently in children, and nosebleeds are a common side effect seen only in children.

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
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 Zentiva

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date which is stated on the carton and blister 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 Zentiva contains
The active substance is olmesartan medoxomil.
Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomil.
The other excipients are:
Microcrystalline cellulose, monohydrate lactose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose,
magnesium stearate, anhydrous colloidal silica, hypromellose, talc, titanium dioxide (E171).

Description of the appearance of Olmesartan Medoxomil Zentiva and package contents
Olmesartan Medoxomil Zentiva 10 mg and 20 mg are white, circular, film-coated tablets.
Olmesartan Medoxomil Zentiva 40 mg are white, oval, film-coated tablets.
Olmesartan Medoxomil Zentiva film-coated tablets are packed in Al/Al blisters (OPA/Al/PVC and Al foil).
Olmesartan Medoxomil Zentiva film-coated tablets are available in blister packs containing 14,
28, 30, 50, 56, 84, 90, 98, 100 and 500 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Zentiva Italia S.r.l., Viale L. Bodio 37/B – 20158 Milano, 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 EEA Member States under the following names:
Czech Republic: Zeota 10, 20, 40 mg
Latvia: Osaver 10, 20, 40 mg apvalkotās tabletes
Lithuania: Osaver 10, 20, 40 mg plėvele dengtos tabletės
Greece: Olmesartan/Zentiva
Cyprus: Olmesartan/Zentiva 10, 20, 40 mg film-coated tablets
Italy: Olmesartan Medoxomil Zentiva
Spain: Olmesartan Zentiva 10, 20, 40 mg comprimidos recubiertos con película EFG
France: Olmesartan Zentiva 10, 20, 40 mg, comprimé pelliculé
Portugal: Olmesartan Zentiva
United Kingdom: Olmesartan 10, 20, 40 mg film-coated tablets
Poland: Osaver