Package Leaflet: Information for the User

Olmetec® 40 mg 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. 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).

•    The name of your medicine is Olmetec® 40 mg Tablets but it will be referred as Olmetec throughout this leaflet. This product is available in other strengths also.

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).

•    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 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).

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:

•    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.

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 breast-feeding. 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.

3. HOW TO TAKE OLMETEC

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 light-headedness 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.

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), swelling of the face, 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).

Rare side effects (may affect up to 1 in 1000 people):

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.

Additional side effects in children and adolescents:

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5. HOW TO STORE OLMETEC

Keep out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use Olmetec after the expiry date (“EXP”) which is stated on the box and on the blister strip. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Olmetec contains

The active substance is olmesartan medoxomil Each film-coated tablet contains 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”).

What Olmetec looks like and contents of the pack

Olmetec 40 mg tablets are white, oval, film-coated tablets with “C15” embossed on one side and plain on the reverse.

Olmetec film-coated tablets are available in blister packs of 28.

Manufacturer

Daiichi Sankyo Europe GmbH,

Luitpoldstrasse 1,85276 Pfaffenhofen, Germany.

Or

Berlin Chemie AG,

Glienicker Weg, 125,

12489 Berlin, Germany.

Or

Laboratorios Menarini, S.A.,

Alfons XII, 587 - E 08918,

Barcelona, Spain.

Procured from within the EU and repackaged by Product Licence holder:

Kosei Pharma UK Limited,

956 Buckingham Avenue,

Slough Trading Estate,

Slough, SL1 4NL.

Olmetec® 40 mg Tablets PL: 39352/0262

Olmetec® is a registered trademark of Daiichi Sankyo Company Limited.

Leaflet date: 03.06.2016

Package Leaflet: Information for the User

Olmesartan Medoxomil 40 mg film-coated tablets

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 p harmacist. This includes any possible side effects not listed in this leaflet (see section 4).

•    The name of your medicine is Olmesartan Medoxomil 40 mg Tablets but it will be referred as Olmesartan Medoxomil throughout this leaflet. This product is available in other strengths also.

What is in this leaflet:

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

2.    What you need to know before you use 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 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 Medoxomil 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 MEDOXOMIL:

Do not take Olmesartan Medoxomil

•    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 Medoxomil 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.

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:

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

•    Other blood pressure lowering medicines, as the effect of Olmesartan Medoxomil 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 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 Medoxomil may be decreased. Your doctor may advise you to take Olmesartan Medoxomil 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 Medoxomil 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 Medoxomil before you become pregnant or as soon as you know you are pregnant and will advise you to take another medicine instead of Olmesartan Medoxomil. Olmesartan Medoxomil 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 Medoxomil 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 Medoxomil 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.

3. HOW TO TAKE OLMESARTAN MEDOXOMIL

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 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.

If you forget to take Olmesartan Medoxomil

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 Medoxomil

It is important to continue to take Olmesartan Medoxomil 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 Medoxomil. If this happens stop taking Olmesartan Medoxomil and contact your doctor immediately.

Rarely (but slightly more often in older people) Olmesartan Medoxomil 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 Medoxomil, contact your doctor immediately and lie down flat.

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

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.

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), swelling of the face, 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).

Rare side effects (may affect up to 1 in 1000 people):

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.

Additional side effects in children and adolescents:

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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5. HOW TO STORE OLMESARTAN MEDOXOMIL

Keep out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use Olmesartan Medoxomil after the expiry date (“EXP”) which is stated on the box and on the blister strip. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Olmesartan Medoxomil contains

The active substance is olmesartan medoxomil Each film-coated tablet contains 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 “Olmesartan Medoxomil contains lactose”).

What Olmesartan Medoxomil looks like and contents of the pack

Olmesartan Medoxomil 40 mg tablets are white, oval, film-coated tablets with “C15” embossed on one side and plain on the reverse.

Olmesartan Medoxomil film-coated tablets are available in blister packs of 28.

Manufacturer

Daiichi Sankyo Europe GmbH,

Luitpoldstrasse 1,85276 Pfaffenhofen, Germany.

Or

Berlin Chemie AG,

Glienicker Weg, 125,

12489 Berlin, Germany.

Or

Laboratorios Menarini, S.A.,

Alfons XII, 587 - E 08918,

Barcelona, Spain.

Procured from within the EU and repackaged by Product Licence holder:

Kosei Pharma UK Limited,

956 Buckingham Avenue,

Slough Trading Estate,

Slough, SL1 4NL.

Olmesartan Medoxomil 40 mg film-coated tablets

PL: 39352/0262    r—-i

POM

Leaflet date: 03.06.2016