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S0729 LEAFLET Olmetec 20140623

PACKAGE LEAFLET: INFORMATION FOR THE USER

OLMETEC 10mg TABLETS (olmesartan medoxomil)

Your medicine is known as Olmetec 10mg Tablets but will be referred to as Olmetec throughout the following leaflet.

Information regarding other strengths of Olmetec also may be present throughout the leaflet.

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. Do not pass it 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).

What is in this leaflet:

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

1. WHAT OLMETEC IS AND WHAT IT IS USED FOR

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

Olmetec 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLMETEC

Do not take Olmetec

•    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).

Warnings and precautions

Talk to your doctor before taking 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.

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).

Children and adolescents

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

Other medicines and Olmetec:

Tell your doctor or pharmacist if you are taking have recently taken or might take any of the following medicines:

•    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.

•    Other blood pressure lowering medicines, as the effect of Olmetec can be increased.

•    Certain antacids (indigestion remedies), as the effect of Olmetec 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 Olmetec is somewhat less in black patients.

Olmetec with food and drink

Olmetec 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 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 breastfeeding. Olmetec is not recommended for mothers who are breastfeeding, 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.

Olmetec contains lactose

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.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 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 Olmetec 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.

If you forget to take Olmetec

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.

If you stop taking Olmetec

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.

Although not many people may get them, the following two side effects can be serious:

On rare occasions (may affect up to 1 in 1,000 people) the following allergic reactions that may affect the whole body have been reported:

Swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during treatment with Olmetec. If this happens stop taking Olmetec and contact your doctor immediately.

Rarely (but slightly more often in older people) Olmetec can cause the blood pressure to fall too low in susceptible individuals or as the result of an allergic reaction. This could cause severe lightheadedness or fainting. If this occurs stop taking Olmetec, contact your doctor immediately and lie down flat.

These are the other side effects known about so far with Olmetec

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

Dizziness, headache, nausea, indigestion, diarrhoea, stomach ache, gastroenteritis, tiredness, sore throat, runny or stuffy nose, bronchitis, flu-like symptoms, cough, pain, pain in the chest, back, bones or joints, infection of the urinary tract, swelling of ankles, feet, legs, hands or arms, blood in the urine.

Lack of energy, muscle cramps, impaired kidney function, kidney failure.

Some changes in blood test results have also been seen. These include increased potassium levels (hyperkalaemia) and increased levels of compounds related to kidney function.

Reporting of side effects

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE OLMETEC

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not use after the expiry date printed on the carton label or blister strip.

• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Olmetec contains

•    Each film-coated tablet contains 10mg of the active ingredient, olmesartan medoxomil.

•    Olmetec Tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate, titanium dioxide, hypromellose and talc.

What Olmetec looks like and contents of the pack

Olmetec tablet is a white, round tablet with ‘C13' embossed on one

side and plain on the other

Olmetec Tablets are available as blister packs of 28 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: S&M Medical Ltd, Chemilines House,

Alperton Lane, Wembley, Middlesex, HA0 1DX.

Manufacturer

This product is manufactured by Daiichi Sankyo Europe GmbH,

Luitpoldstrasse 1,85276 Pfaffenhofen, Germany.

| POM | PL No: 19488/0729 Olmetec 10mg tablets

Leaflet revision date: 23 June 2014

Olmetec is a registered trade mark of Sankyo Company Ltd, Japan.

PACKAGE LEAFLET: INFORMATION FOR THE USER

OLMESARTAN 10mg TABLETS (olmesartan medoxomil)

Your medicine is known as Olmesartan 10mg Tablets but will be referred to as Olmesartan throughout the following leaflet. Information regarding other strengths of Olmesartan also may be present throughout the leaflet.

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. Do not pass it 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).

What is in this leaflet:

1.    What Olmesartan is and what it is used for

2.    What you need to know before you take Olmesartan

3.    How to take Olmesartan

4.    Possible side effects

5.    How to store Olmesartan

6.    Contents of the pack and other information

1. WHAT OLMESARTAN IS AND WHAT IT IS USED FOR

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

Olmesartan 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 Olmesartan 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.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLMESARTAN

Do not take Olmesartan

•    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 Olmesartan 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).

Warnings and precautions

Talk to your doctor before taking Olmesartan. 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.

You must tell your doctor if you think you are (or might become) pregnant. Olmesartan 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 is not recommended for children and adolescents under the age of 18.

Other medicines and Olmesartan:

Tell your doctor or pharmacist if you are taking have recently taken or might take any of the following medicines:

•    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 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 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 may increase the risk of kidney failure and the effect of Olmesartan can be decreased by NSAIDs.

•    Other blood pressure lowering medicines, as the effect of Olmesartan can be increased.

•    Certain antacids (indigestion remedies), as the effect of Olmesartan 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 is somewhat less in black patients.

Olmesartan with food and drink

Olmesartan 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 before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Olmesartan. Olmesartan 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 breastfeeding. Olmesartan 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.

Olmesartan contains lactose

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.

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist 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 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.

If you forget to take Olmesartan

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.

If you stop taking Olmesartan

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them. If they do occur, they are often mild and do not require treatment to be stopped.

Although not many people may get them, the following two side effects can be serious:

On rare occasions (may affect up to 1 in 1,000 people) the following allergic reactions that may affect the whole body have been reported:

Swelling of the face, mouth and/or larynx (voice box) together with itching and rash may occur during treatment with Olmesartan. If this happens stop taking Olmesartan and contact your doctor immediately.

Rarely (but slightly more often in older people) Olmesartan can cause the blood pressure to fall too low in susceptible individuals or as the result of an allergic reaction. This could cause severe lightheadedness or fainting. If this occurs stop taking Olmesartan, contact your doctor immediately and lie down flat.

These are the other side effects known about so far with Olmesartan

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

Dizziness, headache, nausea, indigestion, diarrhoea, stomach ache, gastroenteritis, tiredness, sore throat, runny or stuffy nose, bronchitis, flu-like symptoms, cough, pain, pain in the chest, back, bones or joints, infection of the urinary tract, swelling of ankles, feet, legs, hands or arms, blood in the urine.

Lack of energy, muscle cramps, impaired kidney function, kidney failure.

Some changes in blood test results have also been seen. These include increased potassium levels (hyperkalaemia) and increased levels of compounds related to kidney function.

Reporting of side effects

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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE OLMESARTAN

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not use after the expiry date printed on the carton label or blister strip.

• If your doctor tells you to stop using the medicine, please take it back to the pharmacist for safe disposal. Only keep the medicine if your doctor tells you to.

•    If the medicine becomes discoloured or shows any other signs of deterioration, you should seek the advice of your pharmacist who will tell you what to do.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Olmesartan contains

•    Each film-coated tablet contains 10mg of the active ingredient, olmesartan medoxomil.

•    Olmesartan Tablets also contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium stearate, titanium dioxide, hypromellose and talc.

What Olmesartan looks like and contents of the pack

Olmesartan tablet is a white, round tablet with ‘C13' embossed on

one side and plain on the other

Olmesartan Tablets are available as blister packs of 28 tablets.

Product Licence holder

Procured from within the EU and repackaged by the Product

Licence holder: S&M Medical Ltd, Chemilines House, Alperton

Lane, Wembley, Middlesex, HA0 1DX.

Manufacturer

This product is manufactured by Daiichi Sankyo Europe GmbH,

Luitpoldstrasse 1,85276 Pfaffenhofen, Germany.

| POM | PL No: 19488/0729 Olmesartan 10mg tablets

Leaflet revision date: 23 June 2014

S0729 LEAFLET Olmesartan 20140623

Some changes in blood test results have also been seen and include the following:

Increased fat levels (hypertriglyceridaemia), increased uric acid levels (hyperuricaemia), rise in blood urea, increases in tests of liver and muscle function.

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

Quick allergic reactions that may affect the whole body and may cause breathing problems as well as a rapid fall of blood pressure that may even lead to fainting (anaphylactic reactions), vertigo, vomiting, weakness, feeling unwell, muscular pain, skin rash, allergic skin rash, itching, exanthema (skin eruption), skin lumps (wheals), angina (pain or uncomfortable feeling in the chest).

In blood tests a reduction of the numbers of a type of blood cell,

known as platelets has been seen (thrombocytopenia).