Olmesartan medoxomil EG

Package leaflet: Information for the user

OLMESARTAN MEDOXOMIL EG 10 mg film-coated tablets, 20 mg film-coated tablets, 40 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. It may be harmful to people for whom it was not prescribed, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What OLMESARTAN MEDOXOMIL EG is and what it is used for

OLMESARTAN MEDOXOMIL EG contains the active substance olmesartan, which belongs to a group of
medicines called angiotensin II receptor antagonists. These medicines lower blood pressure by relaxing
blood vessels.
OLMESARTAN MEDOXOMIL EG 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 help prevent damage.
High blood pressure can be controlled with medicines such as OLMESARTAN MEDOXOMIL EG tablets. Your
doctor has likely also advised you to 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 encouraged you to exercise regularly, such as walking or swimming. It is important that you follow
these recommendations from your doctor.

2. What you need to know before taking OLMESARTAN MEDOXOMIL EG

DO NOT take OLMESARTAN MEDOXOMIL EG

• if you are allergic to olmesartan medoxomil or to any of the other ingredients of this medicine (listed in section 6);
• if you are more than three months pregnant. It is advisable to avoid OLMESARTAN MEDOXOMIL EG even in the early stages of pregnancy – see section “Pregnancy”;
• if you have yellowing of the skin and eyes (jaundice) or disorders affecting bile outflow 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 EG.
Consult your doctor or pharmacist before taking OLMESARTAN MEDOXOMIL EG

• 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 the heading "DO NOT take OLMESARTAN MEDOXOMIL EG".
Inform your doctor if you:

• have kidney problems;
• have liver disease;
• have heart failure or have problems with heart valves or heart muscle;
• experience severe vomiting;
• have diarrhoea;
• are being treated with high doses of diuretic tablets (diuretics);
• are on a low-salt diet;
• have increased potassium levels in your blood;
• have adrenal gland problems.

Inform your doctor if you develop severe and prolonged diarrhoea accompanied by significant weight loss. Your doctor will assess your symptoms and decide how to proceed with this antihypertensive 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 suspect (or are planning) a pregnancy. OLMESARTAN MEDOXOMIL EG 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 when taken during this period (see section “Pregnancy”).
Children and adolescents
The use of OLMESARTAN MEDOXOMIL EG in children and adolescents under 18 years of age is not recommended.
Other medicines and OLMESARTAN MEDOXOMIL EG
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines:

• other medicines that lower blood pressure, as the effect of OLMESARTAN MEDOXOMIL EG may be increased. 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 EG" and "Warnings and precautions");

• potassium supplements, salt substitutes containing potassium, diuretic tablets (diuretics), or heparin (used to thin the blood). Taking these medicines together with OLMESARTAN MEDOXOMIL EG may increase potassium levels in the blood;

• lithium (a medicine used to treat mood swings and certain types of depression). When used together with OLMESARTAN MEDOXOMIL EG, lithium toxicity may increase. If you need to take lithium, your doctor will monitor your lithium blood levels;

• non-steroidal anti-inflammatory drugs (NSAIDs), medicines used to reduce pain, swelling, and other symptoms of inflammation, including arthritis. When used together with OLMESARTAN MEDOXOMIL EG, they may increase the risk of kidney failure, and the effect of OLMESARTAN MEDOXOMIL EG may be reduced by NSAIDs;

• colesevelam hydrochloride, a medicine that reduces cholesterol levels in the blood, as the effect of OLMESARTAN MEDOXOMIL EG may be reduced. Your doctor may advise you to take OLMESARTAN MEDOXOMIL EG at least 4 hours before colesevelam hydrochloride;

• certain antacids (used for indigestion), as the effect of OLMESARTAN MEDOXOMIL EG may be slightly reduced.

Elderly patients
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 it from dropping too much.
Black patients
As with other similar medicines, the blood pressure-lowering effect of OLMESARTAN MEDOXOMIL EG is somewhat reduced in black patients.
OLMESARTAN MEDOXOMIL EG and food
OLMESARTAN MEDOXOMIL EG can be taken with or without food.
Pregnancy and breastfeeding
Pregnancy
You must inform your doctor if you suspect (or are planning) a pregnancy. Your doctor will usually advise you to stop taking OLMESARTAN MEDOXOMIL EG before starting pregnancy or as soon as you find out you are pregnant, and will recommend another medicine instead of OLMESARTAN MEDOXOMIL EG. OLMESARTAN MEDOXOMIL EG 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 are about to start breastfeeding. OLMESARTAN MEDOXOMIL EG is not recommended for women who are breastfeeding, and your doctor may choose another treatment if you wish to breastfeed, especially if your baby is newborn or was born prematurely.
If you are pregnant, think you may be pregnant, plan to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
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 EG contains lactose
This medicine contains lactose (a type of sugar). If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take OLMESARTAN MEDOXOMIL EG

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
The recommended starting dose is 10 mg once daily. However, if your blood pressure is not controlled, your doctor may decide to increase the dose to 20 mg or 40 mg once daily, or may prescribe additional medicines.
In patients with mild to moderate renal impairment, the dose must not exceed 20 mg once daily.
Method of administration
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 EG than you should
If you take more tablets than prescribed, or if a child accidentally swallows any, go immediately to a doctor or the nearest emergency department, taking the medicine pack with you.
If you forget to take OLMESARTAN MEDOXOMIL EG
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 EG
It is important to continue taking OLMESARTAN MEDOXOMIL EG 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 gets them. If they do occur, they are mostly mild and do not require discontinuation of treatment.

Although they do not occur in everyone, the following two side effects can be serious:

Rarely (affecting up to 1 in 1,000 people), the following allergic reactions affecting the whole body have been reported:

During treatment with OLMESARTAN MEDOXOMIL EG, swelling of the face, mouth and/or larynx (site of the vocal cords), associated with itching and skin rash, may occur. If this happens, stop taking OLMESARTAN MEDOXOMIL EG and contact your doctor immediately.

Rarely (but slightly more frequently in elderly people), OLMESARTAN MEDOXOMIL EG 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 this happens, stop taking OLMESARTAN MEDOXOMIL EG, contact your doctor immediately and remain lying down.

The following are the other side effects known to date with olmesartan:

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

• dizziness, fatigue;
• headache;
• nausea, indigestion, diarrhoea, stomach ache, gastroenteritis;
• sore throat, nasal congestion or runny nose, bronchitis, flu-like symptoms, cough;
• pain, chest, back, bone or joint pain;
• urinary tract infection, blood in the urine;
• swelling of ankles, feet, legs, hands or arms.

Some laboratory test abnormalities have also been observed, including the following: 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):

• rapid allergic reactions affecting the whole body, which may cause breathing difficulties as well as a rapid drop in blood pressure that may lead to fainting (anaphylactic reactions);
• vertigo;
• vomiting, feeling unwell;
• weakness;
• muscle pain;
• skin rash, allergic skin rash, itching, rash (skin eruption), skin blisters (wheals);
• angina (pain or discomfort in the chest).

A reduction in the number of a type of particle normally present in the blood, called platelets (thrombocytopenia), has been observed in blood tests.

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

• lack of energy;
• muscle cramps;
• reduced kidney function, kidney failure.

Some laboratory test abnormalities have also been observed. These include increased levels of potassium (hyperkalaemia) and increased levels of substances related to kidney function.

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 only in children.

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 EG

Keep this medicine out of the sight and reach of children.
10 mg and 20 mg
This medicine does not require any special storage conditions.
40 mg
Store below 30°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 EG contains
The active substance is olmesartan medoxomil.
Each film-coated tablet contains 10 mg, 20 mg or 40 mg of olmesartan medoxomil.
The other components are: monohydrate lactose, microcrystalline cellulose, crospovidone, silica, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide.

Description of the appearance of OLMESARTAN MEDOXOMIL EG and package contents
OLMESARTAN MEDOXOMIL EG 10 mg Film-coated tablets are round, white, biconvex film-coated tablets with a diameter of 6 mm.
The film-coated tablets are available in blister packs containing 10, 10 (sample), 14, 28, 30, 56, 60, 90, 98, 100 film-coated tablets.

OLMESARTAN MEDOXOMIL EG 20 mg Film-coated tablets are round, white, biconvex film-coated tablets with a diameter of 8 mm.
The film-coated tablets are available in blister packs containing 10, 14, 14 (sample), 28, 28 (sample), 30, 56, 60, 90, 98, 100 film-coated tablets.

OLMESARTAN MEDOXOMIL EG 40 mg Film-coated tablets are white, oval, biconvex film-coated tablets with a length of 15 mm and a thickness of 6 mm.
The film-coated tablets are available in blister packs containing 10, 14, 28, 30, 56, 60, 90, 98, 100 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
EG S.p.A., Via Pavia 6, 20136 Milano, Italy

Manufacturer
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
Centrafarm Services B.V., Nieuwe Donk 9, NL - 4879 AC Etten-Leur (The Netherlands)
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary (Ireland)
STADA Arzneimittel GmbH, Muthgasse 36/2, 1190 Wien (Austria)
STADA Nordic ApS, Marielundvej 46A, DK - 2730 Herlev (Denmark)

This medicinal product is authorized in the EEA Member States under the following names:
AT Olmesartan STADA 10, 20, 40 mg Filmtabletten
BE Olmesartan EG 10, 20, 40 mg filmomhulde tabletten
DE Olmesartan AL 10, 20, 40 mg Filmtabletten
ES Olmesartan STADA 10, 20, 40 mg comprimidos recubiertos con película EFG
FI Olmesartan medoxomil STADA 10, 20, 40 mg kalvopäällysteiset tabletit
FR OLMESARTAN MEDOXOMIL EG 10, 20, 40 mg, comprimé pelliculé
IE Olmesartan Medoxomil Clonmel 10, 20, 40 mg film-coated tablets
IT Olmesartan Medoxomil EG
LU Olmesartan EG 10, 20, 40 mg comprimés pelliculés
NL Olmesartanmedoxomil CF 10, 20, 40 mg, filmomhulde tabletten
PT Olmesartan medoxomilo Ciclum