PACKAGE LEAFLET: INFORMATION FOR THE USER

Olmesartan Medoxomil 10 mg film coated tablets

Olmesartan Medoxomil 20 mg film coated tablets

Olmesartan Medoxomil 40 mg film coated tablets

Olmesartan Medoxomil

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 further questions, ask your doctor or pharmacist.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their sign of illness are the same as yours.

-    If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet (see section 4).

What is in this leaflet:

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

2.    What you need to know before you take Olmesartan Medoxomil

3.    How to take Olmesartan Medoxomil

4.    Possible side effects

5.    How to store Olmesartan Medoxomil

6.    Contents of the pack and other information

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

Olmesartan Medoxomil belongs to a group of medicines called angiotensin-II receptor antagonists. They lower blood pressure by relaxing the blood vessels.

Olmesartan Medoxomil are used for the treatment of 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 a heart attack, heart or kidney failure, stroke or blindness. Usually high blood pressure has no symptoms. It is important to have your blood pressure checked to prevent damage occurring.

High blood pressure can be controlled with medicines such as Olmesartan Medoxomil. Your doctor has probably also recommended that you make some changes in your lifestyle to help lower your blood pressure (for example losing weight, giving up smoking, reducing the amount of alcohol you drink and reducing the amount of salt in your diet). Your doctor may also have urged you to take regular exercise, such as walking or swimming. It is important to follow this advice from your doctor.

2. What you need to know before you take Olmesartan Medoxomil Do not take Olmesartan Medoxomil

-    if you are allergic (hypersensitive) to Olmesartan Medoxomil or to any other of the ingredients of this medicine (listed in section 6).

-    if you are more than 3 months pregnant. (It is also better to avoid Olmesartan Medoxomil in early pregnancy - see pregnancy section.)

-    if you suffer from yellowing of the skin and eyes (jaundice) or problems with drainage of the bile from the gallbladder (biliary obstruction e.g. gallstones).

-    if you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren.

Warnings and precautions

Talk to your doctor before taking Olmesartan Medoxomil.

Tell 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), in particular if you have diabetes related kidney problems.

-    Aliskiren

Your doctor may check your kidney function, blood pressure, and the amount of electrolytes (e.g. potassium) in your blood at regular intervals.

See also information under the heading "Do not take Olmesartan Medoxomil ".

Tell your doctor if you have any of the following health problems:

-    Kidney problems

-    Liver disease

-    Heart failure or problems with your heart valves or heart muscle

-    Severe vomiting, diarrhoea, treatment with high doses of water tablets (diuretics) or if you are on a low salt diet

-    Increased levels of potassium in your blood

-    Problems with your adrenal glands.

Contact your doctor if you experience diarrhoea that is severe, persistent and causes substantial weight loss. Your doctor may evaluate your symptoms and decide on how to continue your blood pressure medication.

As with any medicine which reduces blood pressure, an excessive drop in blood pressure in patients with blood flow disturbances of the heart or brain could lead to a heart attack or stroke. Your doctor will therefore check your blood pressure carefully.

You must tell your doctor if you think you are (or might become) pregnant. Olmesartan Medoxomil is not recommended in early pregnancy, and must not be taken if you are more than 3 months pregnant, as it may cause serious harm to your baby if used at that stage (see pregnancy section).

Children and adolescents

Olmesartan Medoxomil is not recommended for children and adolescents under the age of 18.

Other medicines and Olmesartan Medoxomil

Please tell your doctor or pharmacist if you are

taking or have recently taken or might take any of

the following medicines:

-    Other blood pressure lowering medicines, as the effect of Olmesartan Medomoxil Tablets can be increased and as the frequency of adverse events can be higher.

Your doctor may need to change your dose and/or to take other precautions:

If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not take Olmesartan Medoxomil” and “Warnings and precautions”).

-    Potassium supplements, a salt substitute which contains potassium, water tablets (diuretics) or heparin (for thinning the blood). Using these medicines at the same time as Olmesartan Medoxomil may raise the levels of potassium in your blood.

-    Lithium (a medicine used to treat mood swings and some types of depression) used at the same time as Olmesartan Medoxomil may increase the toxicity of lithium. If you have to take lithium, your doctor will measure your lithium blood levels.

-    Non-Steroidal Anti-Inflammatory (NSAIDs) medicines (medicines used to relieve pain, swelling and other symptoms of inflammation, including arthritis) used at the same time as Olmesartan Medoxomil may increase the risk of kidney failure and the effect of Olmesartan Medoxomil can be decreased by NSAIDs.

-    Colesevelam hydrochloride, a drug that lowers the level of cholesterol in your blood, as the effect of Olmesartan Medomoxil Tablets may be decreased. Your doctor may advise you to take Olmesartan Medomoxil Tablets at least 4 hours before colesevelam hydrochloride.

-    Certain antacids (indigestion remedies), as the effect of Olmesartan Medoxomil can be slightly decreased.

Older people

If you are over 65 years of age and your doctor decides to increase your dose of Olmesartan medoxomil to 40 mg daily, then you need to have your blood pressure regularly checked by your doctor to make sure that your blood pressure does not become too low.

Black patients

As with other similar drugs the blood pressure lowering effect of Olmesartan Medomoxil Tablets is somewhat less in black patients.

Olmesartan Medoxomil with food and drink

Olmesartan Medoxomil can be taken with or without food.

Pregnancy and breast-feeding Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Olmesartan Medomoxil Tablets before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Olmesartan Medomoxil Tablets. Olmesartan Medomoxil Tablets is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.

Breast-feeding

Tell your doctor if you are breast-feeding or about to start breast-feeding. Olmesartan Medomoxil Tablets is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

You may feel sleepy or dizzy while being treated for your high blood pressure. If this happens, do not drive or use machines until the symptoms wear off. Ask your doctor for advice.

Important information about some of the ingredients in Olmesartan Medoxomil

This medicine contains lactose (a type of sugar).

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Olmesartan Medoxomil

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist or nurse has told you. Check with your doctor or pharmacist or nurse if you are not sure.

The recommended starting dose is one 10 mg tablet once a day. However, if your blood pressure is not controlled, your doctor may decide to change your dose up to 20 or 40 mg once a day, or prescribe additional medicines.

In patients with mild to moderate kidney disease, your dose will not be higher than 20 mg once a day.

The tablets can be taken with or without food. Swallow the tablets with a sufficient amount of water (e.g. one glass). If possible, take your daily dose at the same time each day, for example at breakfast time.

If you take more Olmesartan Medoxomil than you should

If you take more tablets than you should or if a child accidentally swallows some, go to your doctor or nearest emergency department immediately and take your medicine pack with you.