OLMETEC film-coated tablets

• 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 signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to olmesartan medoxomil or any of the other ingredients of this medicine (listed in section 6).
• if you are more than 3 months pregnant. (It is also better to avoid Olmetec tablets 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.

Talk to your doctor before using Olmetec.

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 Olmetec".

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. Olmetec 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).

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

If you are 65 years or over 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.

Olmetec has been studied in children and adolescents. For more information, talk to your doctor. Olmetec is not recommended for children from 1 year to less than 6 years and should not be used in children under the age of 1 year as no experience is available.

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, tell your doctor or pharmacist about any of the following:

• Other blood pressure lowering medicines, as the effect of Olmetec can be increased.
  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 Olmetec” 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 Olmetec 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 Olmetec 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 Olmetec may increase the risk of kidney failure and the effect of Olmetec can be decreased by NSAIDs.
• Colesevelam hydrochloride, a drug that lowers the level of cholesterol in your blood, as the effect of Olmetec may be decreased. Your doctor may advise you to take Olmetec at least 4 hours before colesevelam hydrochloride.
• Certain antacids (indigestion remedies), as the effect of Olmetec can be slightly decreased.

Olmetec can be taken with or without food.

Pregnancy

You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Olmetec before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Olmetec. Olmetec 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. Olmetec 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.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

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.

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.

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.

If you forget a dose, take your normal dose on the following day as usual. Do not take a double dose to make up for a forgotten tablet.

It is important to continue to take Olmetec unless your doctor tells you to stop.

In children, side effects are similar to those reported in adults. However, dizziness and headache are seen more often in children, and nose bleeding is a common side effect seen in children only.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

The active substance is olmesartan medoxomil

Each film-coated tablet contains 10 mg, 20 mg or 40 mg olmesartan medoxomil.

The other ingredients are microcrystalline cellulose, lactose monohydrate, hydroxypropylcellulose, low substituted hydroxypropylcellulose, magnesium stearate, titanium dioxide (E171), talc and hypromellose. (See section 2 “Olmetec contains lactose”)

Olmetec 10 mg film-coated tablets are white, circular with C 13 on one side.

Olmetec 20 mg film-coated tablets are white, circular with C 14 on one side.

Olmetec 40 mg film-coated tablets are white, oval with C 15 on one side.

Olmetec film-coated tablets are available in packs of 14, 28, 30, 56, 84, 90, 98 and 10 x 28 film-coated tablets and in packs with perforated unit dose blisters of 10, 50 and 500 film-coated tablets.

Not all pack sizes may be marketed.

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