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Inositol Nicotinate 500mg Tablets

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Hexopal® 500mg Tablets (inositol nicotinate)

Read all of this leaflet carefully before you start taking this medicine.

•    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 on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1)    What Hexopal 500mg Tablets are and what they are used for

2)    Before you use Hexopal 500mg Tablets

3)    How to use Hexopal 500mg Tablets

4)    Possible side-effects

5)    How to store Hexopal 500mg Tablets

6)    Further information

1)    WHAT HEXOPAL 500MG TABLETS ARE AND WHAT THEY ARE USED FOR

Hexopal 500mg Tablets contain inositol nicotinate, which works by relaxing the blood vessels.

Hexopal 500mg Tablets are used to treat intermittent claudication (pain in the legs whilst walking) and Raynaud's phenomenon (fingers and toes which go white and bloodless in the cold).

2)    BEFORE YOU USE HEXOPAL 500MG TABLETS Do not use Hexopal 500mg Tablets if you:

•    are allergic (hypersensitive) to inositol nicotinate or any of the other ingredients of Hexopal 500mg Tablets (see section 6 - Further information for details)

•    have recently had a heart attack or stroke

Take special care with Hexopal 500mg Tablets if you have:

•    poor circulation to the brain (cardiovascular insufficiency)

•    chest pains (unstable angina).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Hexopal should not usually be used during pregnancy. If you are pregnant or planning to become pregnant you should discuss your treatment with your doctor.

3)    HOW TO USE HEXOPAL 500MG TABLETS

Always take Hexopal 500mg Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Adults and the elderly

The usual dose is two tablets three times a day (3g inositol nicotinate daily). The maximum dose is 4g of inositol nicotinate daily. Swallow the tablets with a drink of water.

Children

Hexopal 500mg Tablets should not be used in children.

If you take more Hexopal 500mg Tablets than you should

An overdose of this medicine may be dangerous. If you have taken an overdose, tell your doctor or go to the nearest hospital casualty department immediately.

If you forget to take Hexopal 500mg Tablets

If you forget to take a dose at the right time, take it as soon as you remember then go on as before.

Do not take a double dose to make up for a forgotten tablet.

4)    POSSIBLE SIDE EFFECTS

Like all medicines, Hexopal 500mg Tablets can cause side-effects, although not everybody gets them.

Uncommon side-effects include:

•    headache

•    redness of the face

•    feeling sick (nausea)

•    vomiting

•    swelling (oedema)

•    dizziness and fainting caused by low blood pressure

•    pins and needles

•    rash.

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.

If any of the side-effects get serious or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

5)    HOW TO STORE HEXOPAL 500MG TABLETS

•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Do not use Hexopal 500mg Tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

•    If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.

•    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)    FURTHER INFORMATION

What Hexopal 500mg Tablets contain

The active ingredient in Hexopal 500mg Tablets is inositol nicotinate. Each tablet contains 500mg inositol nicotinate.

The other ingredients are:

pregelatinised starch, maize starch, talc, magnesium stearate, stearic acid and sodium laurilsulphate.

What Hexopal 500mg Tablets look like and contents of the pack

Hexopal 500mg Tablets are white or almost white round tablets with a break-line on one side and a logo on the reverse.

Hexopal 500mg Tablets are supplied in blister packs of 100 tablets.

Manufacturer

Clonmel Healthcare Ltd.,

Waterford Road,

Clonmel,

County Tipperary,

Ireland.

Procured from within the EU by the Product Licence holder MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER, UK

Repackaged by MPT Pharma Ltd.

PL: 33532/0476    Hexopal® 500mg Tablets

Leaflet date: 4th March 2014 Leaflet code: XXXXXXXXXX

Hexopal® is a registered trademark of

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.

Hexopal® 500mg Tablets (inositol nicotinate)

Read all of this leaflet carefully before you start taking this medicine.

•    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 on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1)    What Hexopal 500mg Tablets are and what they are used for

2)    Before you use Hexopal 500mg Tablets

3)    How to use Hexopal 500mg Tablets

4)    Possible side-effects

5)    How to store Hexopal 500mg Tablets

6)    Further information

1)    WHAT HEXOPAL 500MG TABLETS ARE AND WHAT THEY ARE USED FOR

Hexopal 500mg Tablets contain inositol nicotinate, which works by relaxing the blood vessels.

Hexopal 500mg Tablets are used to treat intermittent claudication (pain in the legs whilst walking) and Raynaud's phenomenon (fingers and toes which go white and bloodless in the cold).

2)    BEFORE YOU USE HEXOPAL 500MG TABLETS

4)    POSSIBLE SIDE EFFECTS

Like all medicines, Hexopal 500mg Tablets can cause side-effects, although not everybody gets them.

Uncommon side-effects include:

•    headache

•    redness of the face

•    feeling sick (nausea)

•    vomiting

•    swelling (oedema)

•    dizziness and fainting caused by low blood pressure

•    pins and needles

•    rash.

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.

If any of the side-effects get serious or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

5)    HOW TO STORE HEXOPAL 500MG TABLETS

Do not use Hexopal 500mg Tablets if you:

•    are allergic (hypersensitive) to inositol nicotinate or any of the other ingredients of Hexopal 500mg Tablets (see section 6 - Further information for details)

•    have recently had a heart attack or stroke

Take special care with Hexopal 500mg Tablets if you have:

•    poor circulation to the brain (cardiovascular insufficiency)

•    chest pains (unstable angina).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Hexopal should not usually be used during pregnancy. If you are pregnant or planning to become pregnant you should discuss your treatment with your doctor.

3) HOW TO USE HEXOPAL 500MG TABLETS

Always take Hexopal 500mg Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Adults and the elderly

The usual dose is two tablets three times a day (3g inositol nicotinate daily). The maximum dose is 4g of inositol nicotinate daily. Swallow the tablets with a drink of water.

Children

Hexopal 500mg Tablets should not be used in children.

If you take more Hexopal 500mg Tablets than you should

An overdose of this medicine may be dangerous. If you have taken an overdose, tell your doctor or go to the nearest hospital casualty department immediately.

If you forget to take Hexopal 500mg Tablets

If you forget to take a dose at the right time, take it as soon as you remember then go on as before.

Do not take a double dose to make up for a forgotten tablet.

•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Do not use Hexopal 500mg Tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

•    If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.

•    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) FURTHER INFORMATION

What Hexopal 500mg Tablets contain

The active ingredient in Hexopal 500mg Tablets is inositol nicotinate. Each tablet contains 500mg inositol nicotinate.

The other ingredients are:

pregelatinised starch, maize starch, talc, magnesium stearate, stearic acid and sodium laurilsulphate.

What Hexopal 500mg Tablets look like and contents of the pack

Hexopal 500mg Tablets are white or almost white round tablets with a break-line on one side and a logo on the reverse.

Hexopal 500mg Tablets are supplied in blister packs of 100 tablets.

Manufacturer

Clonmel Healthcare Ltd.,

Waterford Road,

Clonmel,

County Tipperary,

Ireland.

Procured from within the EU by the Product Licence holder MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER, UK

Repackaged by MPT Pharma Ltd.

PL: 33532/0476 Hexopal® 500mg Tablets

Leaflet date: 4th March 2014 Leaflet code: XXXXXXXXXX

Inositol Nicotinate 500mg Tablets

Read all of this leaflet carefully before you start taking this medicine.

•    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 on to others. It may harm them, even if their symptoms are the same as yours.

•    If any of the side-effects get serious, or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1)    What Inositol Nicotinate 500mg Tablets are and what they are used for

2)    Before you use Inositol Nicotinate 500mg Tablets

3)    How to use Inositol Nicotinate 500mg Tablets

4)    Possible side-effects

5)    How to store Inositol Nicotinate 500mg Tablets

6)    Further information

1)    WHAT INOSITOL NICOTINATE 500MG TABLETS ARE AND WHAT THEY ARE USED FOR

Inositol Nicotinate 500mg Tablets contain inositol nicotinate, which works by relaxing the blood vessels.

Inositol Nicotinate 500mg Tablets are used to treat intermittent claudication (pain in the legs whilst walking) and Raynaud's phenomenon (fingers and toes which go white and bloodless in the cold).

2)    BEFORE YOU USE INOSITOL NICOTINATE 500MG TABLETS

4)    POSSIBLE SIDE EFFECTS

Like all medicines, Inositol Nicotinate 500mg Tablets can cause side-effects, although not everybody gets them.

Uncommon side-effects include:

•    headache

•    redness of the face

•    feeling sick (nausea)

•    vomiting

•    swelling (oedema)

•    dizziness and fainting caused by low blood pressure

•    pins and needles

•    rash.

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.

If any of the side-effects get serious or if you notice any side-effects not listed in this leaflet, please tell your doctor or pharmacist.

5)    HOW TO STORE INOSITOL NICOTINATE 500MG TABLETS

Do not use Inositol Nicotinate 500mg Tablets if you:

•    are allergic (hypersensitive) to inositol nicotinate or any of the other ingredients of Inositol Nicotinate 500mg Tablets (see section 6 -Further information for details)

•    have recently had a heart attack or stroke

Take special care with Inositol Nicotinate 500mg Tablets if you have:

•    poor circulation to the brain (cardiovascular insufficiency)

•    chest pains (unstable angina).

Using other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Inositol Nicotinate 500mg Tablets should not usually be used during pregnancy. If you are pregnant or planning to become pregnant you should discuss your treatment with your doctor.

3) HOW TO USE INOSITOL NICOTINATE 500MG TABLETS

Always take Inositol Nicotinate 500mg Tablets exactly as your doctor has told you to. You should check with your doctor or pharmacist if you are not sure.

Adults and the elderly

The usual dose is two tablets three times a day (3g inositol nicotinate daily). The maximum dose is 4g of inositol nicotinate daily. Swallow the tablets with a drink of water.

Children

Inositol Nicotinate 500mg Tablets should not be used in children.

If you take more Inositol Nicotinate 500mg Tablets than you should

An overdose of this medicine may be dangerous. If you have taken an overdose, tell your doctor or go to the nearest hospital casualty department immediately.

If you forget to take Inositol Nicotinate 500mg Tablets

If you forget to take a dose at the right time, take it as soon as you remember then go on as before.

Do not take a double dose to make up for a forgotten tablet.

•    Keep out of the sight and reach of children.

•    Do not store above 25°C.

•    Do not use Inositol Nicotinate 500mg Tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month.

•    If your medicine becomes discoloured or shows any sign of deterioration, return it to your pharmacist.

•    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) FURTHER INFORMATION

What Inositol Nicotinate 500mg Tablets contain

The active ingredient in Inositol Nicotinate 500mg Tablets is inositol nicotinate.

Each tablet contains 500mg inositol nicotinate.

The other ingredients are:

pregelatinised starch, maize starch, talc, magnesium stearate, stearic acid and sodium laurilsulphate.

What Inositol Nicotinate 500mg Tablets look like and contents of the pack

Inositol Nicotinate 500mg Tablets are white or almost white round tablets with a break-line on one side and a logo on the reverse.

Inositol Nicotinate 500mg Tablets are supplied in blister packs of 100 tablets.

Manufacturer

Clonmel Healthcare Ltd.,

Waterford Road,

Clonmel,

County Tipperary,

Ireland.

Procured from within the EU by the Product Licence holder MPT Pharma Ltd, Westgate Business Park, Unit 5-7 Tintagel Way, Aldridge, Walsall, WS9 8ER, UK

Repackaged by MPT Pharma Ltd.

PL: 33532/0476 Inositol Nicotinate 500mg Tablets

P


Leaflet date: 4th March 2014 Leaflet code: XXXXXXXXXX

If you have any further questions on the use of this product, ask your

doctor or pharmacist.