Olmetec® 10 mg Film-Coated Tablets

OLMETEC belongs to a group of medicines, which are called angiotensin-ll receptor antagonists. They lower blood pressure by relaxing the blood vessels. It is 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 OLMETEC tablets. 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.

5.1 Ask yourself the following questions:

• Have you ever had an allergic reaction to olmesartan medoxomil or to other ingredients of OLMETEC tablets?
• Are you pregnant, do you think you may be pregnant, or are you planning to become pregnant?
• Are you breast-feeding?
• Do you suffer from gallstones or jaundice?
• If the answer to any of these questions is ‘yes’, do not take the tablets and tell your doctor or pharmacist.

5.2 What else should you know before taking the tablets?

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

• Kidney trouble or 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.

As with any medicine which reduces blood pressure, your doctor will monitor your blood pressure carefully.

5.3 Can you drive and use machinery?

It is unlikely that OLMETEC will affect your ability to drive or operate machinery. However, dizziness or fatigue can occasionally occur during the treatment of high blood pressure. If you notice such effects, ask your doctor for advice before driving or using machinery.

5.4 Can you take OLMETEC with other medicines?

Tell your doctor or pharmacist if you are taking any other medicines or have done so recently, even those you have bought yourself, particularly -

• if you are taking potassium supplements, a salt substitute which contains potassium, water tablets (diuretics) or heparin
• if you are taking lithium
• if you are taking Non-Steroidal Anti-Inflammatory (NSAIDs) medicines
• if you are already taking other blood pressure lowering medicines
• if you are taking certain indigestion remedies (antacids).

Always take OLMETEC tablets exactly as instructed by your doctor. Please ask your doctor or pharmacist if you are unsure about anything.

How to take the tablets

OLMETEC tablets can be taken with or without food. Swallow the tablets with a little water. If possible, take your daily dose at the same time each day, for example at breakfast time. It is important to continue to take OLMETEC tablets unless your doctor tells you to stop. Tell your doctor if you have any worries about your treatment. OLMETEC tablets are not recommended to be taken by children.

How many tablets to take - OLMETEC 10:

The usual dose is one tablet of OLMETEC 10 once a day. However, if your blood pressure is not controlled, your doctor may decide to change your dose to up to two tablets (20 mg olmesartan medoxomil) once a day or prescribe additional medicines.

How many tablets to take - OLMETEC 20:

The usual dose is one tablet of OLMETEC 20 once a day. However, if your blood pressure is not controlled, your doctor may decide to prescribe additional medicines.

What if you take too many tablets or miss a dose?

If you have taken more tablets than you should or if a child has swallowed the tablets, contact your doctor or nearest hospital 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 any extra tablets to make up for the missed dose.

OLMETEC is suitable for most people. However, like all medicines, the tablets can have side effects. If they do occur, they are often mild and do not require treatment to be stopped. Common side effects include the following: Dizziness, feeling sick, indigestion, diarrhoea, stomach ache, gastroenteritis, tiredness, sore throat, runny or stuffy nose, bronchitis, flu-like symptoms, cough, pain in the chest, back, bones or joints, infection of the urinary tract, swollen ankles, blood in the urine. Some changes in blood test results have also been seen and include the following: Increased fat levels (hypertriglyceridaemia), increased uric acid levels (hyperuricaemia), increases in tests of liver and muscle function. Less common side effects include the following: Vertigo, skin rash, angina. Rare side effects: Feeling light-headed, faint or dizzy. If this happens stop taking OLMETEC and contact your doctor immediately. Rarely, blood test results have shown increased potassium levels (hyperkalaemia). Very rarely: Swelling of the tissue of the face, mouth and/or larynx (voice box) may occur during treatment with this medicine. If this happens stop taking OLMETEC and contact your doctor immediately. Tell your doctor or pharmacist as soon as possible if you notice any side effects, even if they are not listed in this leaflet.

Keep this medicine out of the reach and sight of children. Store at temperatures below 30 °C.