S1321 Brufen LEAFLET 20141009

PACKAGE LEAFLET: INFORMATION FOR USER BRUFEN SYRUP 100mg/5ml (ibuprofen)

Your medicine is known as Brufen Syrup 100mg/5ml but will be referred to as Brufen Syrup throughout the following leaflet.

Leaflet contents:

1.    What is Brufen Syrup & what is it used for?

2.    What should you know before taking Brufen Syrup?

3.    How should you take Brufen Syrup?

4.    Possible side effects of Brufen Syrup.

5.    How should you store Brufen Syrup?

6.    Further information about Brufen Syrup.

1. WHAT IS BRUFEN SYRUP & WHAT IS IT USED FOR?

Brufen Syrup belongs to a group of medicines called antiinflammatory pain killers. It can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), arthritis of the spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower back pain, sprains and strains.

Brufen Syrup can also be used to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine.

It can also be used for the short term treatment of fever in children over the age of 1 year.

The active ingredient in Brufen Syrup is ibuprofen. Each 5ml spoonful of Brufen Syrup contains 100mg ibuprofen.

2. WHAT SHOULD YOU KNOW BEFORE TAKING BRUFEN SYRUP?

If the answer to any of the following questions is 'YES' please tell your doctor or pharmacist BEFORE taking any Brufen Syrup:

•    Are you pregnant or planning to become pregnant, or are you breast-feeding? Brufen Syrup may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

•    Are you sensitive (allergic) to any of the ingredients in the syrup? These are listed in Section 6. Some people may be sensitive to the E11 0 or sodium benzoate and if you develop an unexpected rash, sore eyes, sore mouth or difficulty breathing whilst taking the medicine, stop taking it and contact your doctor for advice.

•    Do you have, or have you previously had, a stomach ulcer or other gastric complaint?

Do not take Brufen Syrup if you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past.

•    Do you have a condition which increases your tendency to bleeding?

•    Do you suffer from asthma or have you ever had an allergic reaction or suffered from wheezing after taking ibuprofen, aspirin or other anti-inflammatory pain killers?

•    Do you suffer from liver or kidney disease?

•    Do you suffer from heart disease?

Medicines such as Brufen Syrup may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

•    Do you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue)?

•    Have you been told by your doctor that you have an intolerance to some sugars? Due to the content of sorbitol (70 mg per ml or 2.8 g per dose) and sucrose (660 mg per ml or 26.4 g per dose) it is not recommended for those with hereditary fructose intolerance, glucose malabsorption syndrome or sucraseisomaltase deficiency.

•    There is a risk of kidney damage in dehydrated children and adolescents.

Can you take Brufen with other medicines?

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-11 receptor antagonists such as losartan) and other medicines may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use ibuprofen with other medicines. In particular you should tell your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above:

•    diuretics (wate r tablets)

•    cardiac glycosides, such as digoxin, used to treat heart conditions

•    lithium

•    zidovudine (an anti-viral drug)

•    steroids (used in the treatment of inflammatory conditions)

•    methotrexate (used to treat certain cancers)

•    medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen down your immune response) medicines known as selective serotonin reuptake inhibitors (SSRis), used for the treatment of depression

•    antibiotics called quinolones such as ciprofloxacin

•    aminoglycosides {a type of antibiotic)

•    mifepristone

•    any other ibuprofen preparations, such as those you can buy without a prescription

•    any other anti-inflammatory pain killer, including aspirin

•    cholestyramine (a drug used to lower cholesterol)

•    medicines known as sulphonylureas such as glibenclamide used to treat diabetes)

•    voriconazole or fluconazole (types of anti-fungal drugs)

•    Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).

Other information about Brufen Syrup:

The syrup contains small amounts of glycerin (glycerol). In high doses, glycerine may sometimes cause headache, stomach upset and diarrhoea. As such, you should not take more than the stated dose unless yo ur docto r advises you to.

Pregnancy and breast-feeding: The use of Brufen Syrup whilst pregnant or breast feeding should be avoided. Brufen Syrup should not be used in late (the last three months) of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

Driving and Using Machines: Brufen Syrup may make you feel dizzy or drowsy. If it affects you in this way do not drive, operate machinery or do anything that requires you to be alert.

3. HOW SHOULD YOU TAKE BRUFEN SYRUP?

ALWAYS take Brufen Syrup exactly as your doctor has told you. If you are not sure refer to the label on the carton or check with your doctor or pharmacist.

Ensure the bottle is thoroughly shaken before use. Take with or after food.

DOSAGE:

Adults - The usual dosage is 4 to 6 spoonfuls (5 ml) taken three times a day.

Your doctor may choose to increase or decrease this depending on what you are being treated for, but no more than 24 spoonfuls (120 ml/2400 mg) should be taken in one day.

Children - Brufen Syrup should NOT be taken by children weighing less than 7 kg. When used to treat fever, the syrup should not be used long term or given to children under the age of 1 year.

The usual dose in children is 20 mg per kg of bodyweight each day, in divided doses. This can be given as follows:

1-2 years: One 2.5 ml (50 mg) dose three/four times a day 3-7 years: One 5 ml {1 00 mg) dose three/four times a day 8-12 years: Two 5 ml (200 mg) doses three/four times a day The doctor may choose to increase this dose in children with juvenile rheumatoid arthritis.

This dose should not exceed 40mg/kg bodyweight daily in divided doses.

IF YOU TAKE MORE BRUFEN SYRUP THAN PRESCRIBED (AN OVERDOSE) you should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your syrup with you.

IF YOU FORGET TO TAKE YOUR BRUFEN SYRUP take it as soon as you remember, unless it is almost time for your next dose. If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.

4. POSSIBLE SIDE EFFECTS OF BRUFEN SYRUP

As with all medicines, Brufen Syrup may cause side effects, although they are usually mild and not everyone will suffer from them. If any side effects become serious or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist. You can minimise the risk of side effects by taking the least amount of syrup for the shortest amount of time necessary to control yo ur symptoms.

If you suffer from any of the following at any Ume during your treatment STOP TAKING Brufen Syrup and seek immediate medical help:

•    Severe headache, high temperature, stiffness of the neck or intolerance to bright light.

•    Pass blood in your faeces (stools/motions)

•    Pass black tarry stools

•    Vomit any blood or dark particles that look like coffee grounds.

TELL YOUR DOCTOR AND STOP TAKING THE SYRUP IF YOU EXPERIENCE:

•    Unexplained stomach pain or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting.

•    Unexplained wheezing, shortness of breath, skin rash, itching or bruising.

•    Yellowing of the eyes and/or skin.

•    Severe sore throat with high fever.

•    Blurred or disturbed vision or seeing/hearing strange things.

•    Fluid retention (e.g. swollen ankles).

Medicines such as Brufen Syrup have been associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Very rarely Brufen Syrup may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain). Other side effects may include headache, hallucinations, dizziness, tingling of hands and feet, ringing in the ears, depression, confusion, difficulty sleeping, anxiety, impaired hearing, a temporary sensation of burning in the mouth or throat, diarrhoea, constipation, flatulence (wind), unexpected sensitivity of the skin to the sun, tiredness, malaise, mood swings and swelling and irritation inside the nose.

Brufen has also been shown to sometimes worsen the symptoms of Crohn's disease or colitis.

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 SHOULD YOU STORE BRUFEN SYRUP?

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    Store in the original package to protect from light.

•    Use within twelve months after first opening.

•    If your doctor stops your treatment, take any leftover suspension back to the pharmacy for safe disposal.

•    Do not take your suspension after the expiry date on the container. Take any suspension which is out of date back to the pharmacy.

•    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. FURTHER INFORMATION ABOUT BRUFEN SYRUP

What Brufen Syrup contains

•    Each 5ml of oral suspension contains 100mg ibuprofen.

•    Brufen Syrup also contains the following: methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), sunset yellow (E110), sodium benzoate, glycerin, sorbitol solution 70% (non-crystallising) (E420), sucrose, citric acid monohydrate granular, agar powder, light kaolin, polysorbate 80, orange flavour (D717) and purified water.

What Brufen Syrup looks like and contents of the pack

•    Brufen Syrup is an orange-coloured, orange-flavoured, suspension.

•    Brufen Syrup is available in bottles of 200ml.

Product Licence holder

Procured from within the EU and repackaged by the Product

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

Lane, Wembley, HA0 1 DX.

Manufacturer

This product is manufactured by AbbVie S.r.L., S.R. 148 Pontina

km 52 snc, 04011 Campoverde di Aprilia (LT), Italy.

| POM | PL No: 19488/1321 Leaflet revision date: 09 October 2014.

Brufen is a registered trade mark of Abbott GmbH & Co. KG, Germany.

S1321 Brufen LEAFLET 20141009

S1321 Ibuprofen LEAFLET 20141009

PACKAGE LEAFLET: INFORMATION FOR USER IBUPROFEN SYRUP 100mg/5ml (ibuprofen)

Your medicine is known as Ibuprofen Syrup 100mg/5ml but will be referred to as Ibuprofen Syrup throughout the following leaflet.

IMPORTANT INFORMATION

Read all of this leaflet carefully before you start taking this

medicine

•    Keep this leaflet as you may need to read it again

•    This leaflet provides a summary of the information currently available about Ibuprofen Syrup

•    For further information or advice ask your doctor or pharmacist

•    This medicine is for you only and should never be given to anyone else, even if they appear to have the same symptoms as you

•    Tell your doctor or pharmacist if you experience any side effects

Leaflet contents:

1.    What is Ibuprofen Syrup & what is it used for?

2.    What should you know before taking Ibuprofen Syrup?

3.    How should you take Ibuprofen Syrup?

4.    Possible side effects of Ibuprofen Syrup.

5.    How should you store Ibuprofen Syrup?

6.    Further information about Ibuprofen Syrup.

1. WHAT IS IBUPROFEN SYRUP & WHAT IS IT USED FOR?

Ibuprofen Syrup belongs to a group of medicines called antiinflammatory pain killers. It can be used to relieve pain and inflammation in conditions such as osteoarthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease), arthritis of the spine (ankylosing spondylitis), swollen joints, frozen shoulder, bursitis, tendinitis, tenosynovitis, lower back pain, sprains and strains.

Ibuprofen Syrup can also be used to treat other painful conditions such as toothache, pain after operations, period pain and headache, including migraine.

It can also be used for the short term treatment of fever in children over the age of 1 year.

The active ingredient in Ibuprofen Syrup is ibuprofen. Each 5ml spoonful of Ibuprofen Syrup contains 100mg ibuprofen.

2. WHAT SHOULD YOU KNOW BEFORE TAKING IBUPROFEN SYRUP?

If the answer to any of the following questions is 'YES' please tell your doctor or pharmacist BEFORE taking any Ibuprofen Syrup:

•    Are you pregnant or planning to become pregnant, or are you breast-feeding? Ibuprofen Syrup may make it more difficult to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

•    Are you sensitive (allergic) to any of the ingredients in the syrup? These are listed in Section 6. Some people may be sensitive to the E11 0 or sodium benzoate and if you develop an unexpected rash, sore eyes, sore mouth or difficulty breathing whilst taking the medicine, stop taking it and contact your doctor for advice.

•    Do you have, or have you previously had, a stomach ulcer or other gastric complaint?

Do not take Ibuprofen Syrup if you currently have a peptic ulcer (ulcer in your stomach or duodenum) or bleeding in your stomach, or have had two or more episodes of peptic ulcers, stomach bleeding or perforation in the past.

•    Do you have a condition which increases your tendency to bleeding?

•    Do you suffer from asthma or have you ever had an allergic reaction or suffered from wheezing after taking ibuprofen, aspirin or other anti-inflammatory pain killers?

•    Do you suffer from liver or kidney disease?

•    Do you suffer from heart disease?

Medicines such as Ibuprofen Syrup may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment. If you have heart problems, previous stroke or think that you might be at risk of these conditions (e.g. if you have high blood pressure, diabetes, high cholesterol or are a smoker) you should discuss your treatment with your doctor or pharmacist.

•    Do you have systemic lupus erythematosus (SLE, sometimes known as lupus) or a connective tissue disease (autoimmune diseases affecting connective tissue)?

•    Have you been told by your doctor that you have an intolerance to some sugars? Due to the content of sorbitol (70 mg per ml or 2.8 g per dose) and sucrose (660 mg per ml or 26.4 g per dose) it is not recommended for those with hereditary fructose intolerance, glucose malabsorption syndrome or sucraseisomaltase deficiency.

•    There is a risk of kidney damage in dehydrated children and adolescents.

Can you take Ibuprofen with other medicines?

Some medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicyclic acid, warfarin, ticlodipine), some medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers such as atenolol, or angiotensin-11 receptor antagonists such as losartan) and other medicines may affect or be affected by treatment with ibuprofen. You should therefore always seek the advice of your doctor or pharmacist before you use ibuprofen with other medicines. In particular you should tell your doctor or pharmacist if you are taking any of the following medicines in addition to those mentioned above:

•    diuretics (wate r tablets)

•    cardiac glycosides, such as digoxin, used to treat heart conditions

•    lithium

•    zidovudine (an anti-viral drug)

•    steroids (used in the treatment of inflammatory conditions)

•    methotrexate (used to treat certain cancers)

•    medicines known as immunosuppressants such as ciclosporin and tacrolimus (used to dampen down your immune response) medicines known as selective serotonin reuptake inhibitors (SSRis), used for the treatment of depression

•    antibiotics called quinolones such as ciprofloxacin

•    aminoglycosides {a type of antibiotic)

•    mifepristone

•    any other ibuprofen preparations, such as those you can buy without a prescription

•    any other anti-inflammatory pain killer, including aspirin

•    cholestyramine (a drug used to lower cholesterol)

•    medicines known as sulphonylureas such as glibenclamide used to treat diabetes)

•    voriconazole or fluconazole (types of anti-fungal drugs)

•    Gingko biloba herbal medicine (there is a chance you may bleed more easily if you are taking this with ibuprofen).

Other information about Ibuprofen Syrup:

The syrup contains small amounts of glycerin (glycerol). In high doses, glycerine may sometimes cause headache, stomach upset and diarrhoea. As such, you should not take more than the stated dose unless your doctor advises you to.

Pregnancy and breast-feeding: The use of Ibuprofen Syrup whilst pregnant or breast feeding should be avoided. Ibuprofen Syrup should not be used in late (the last three months) of pregnancy and should only be taken in the first six months of pregnancy on the advice of your doctor.

Driving and Using Machines: Ibuprofen Syrup may make you feel dizzy or drowsy. If it affects you in this way do not drive, operate machinery or do anything that requires you to be alert.

3. HOW SHOULD YOU TAKE IBUPROFEN SYRUP?

ALWAYS take Ibuprofen Syrup exactly as your doctor has told you. If you are not sure refer to the label on the carton or check with your doctor or pharmacist.

Ensure the bottle is thoroughly shaken before use. Take with or after food.

DOSAGE:

Adults - The usual dosage is 4 to 6 spoonfuls (5 ml) taken three times a day.

Your doctor may choose to increase or decrease this depending on what you are being treated for, but no more than 24 spoonfuls (120 ml/2400 mg) should be taken in one day.

Children - Ibuprofen Syrup should NOT be taken by children weighing less than 7 kg. When used to treat fever, the syrup should not be used long term or given to children under the age of 1 year.

The usual dose in children is 20 mg per kg of bodyweight each day, in divided doses. This can be given as follows:

1-2 years: One 2.5 ml (50 mg) dose three/four times a day 3-7 years: One 5 ml {1 00 mg) dose three/four times a day 8-12 years: Two 5 ml (200 mg) doses three/four times a day The doctor may choose to increase this dose in children with juvenile rheumatoid arthritis.

This dose should not exceed 40mg/kg bodyweight daily in divided doses.

IF YOU TAKE MORE IBUPROFEN SYRUP THAN PRESCRIBED (AN OVERDOSE) you should contact a doctor or go to the nearest hospital casualty department IMMEDIATELY taking your syrup with you.

IF YOU FORGET TO TAKE YOUR IBUPROFEN SYRUP take it as soon as you remember, unless it is almost time for your next dose.

If it is, do not take the missed dose at all. Never double up on a dose to make up for the one you have missed.

4. POSSIBLE SIDE EFFECTS OF IBUPROFEN SYRUP

As with all medicines, Ibuprofen Syrup may cause side effects, although they are usually mild and not everyone will suffer from them. If any side effects become serious or if you notice any side effects that are not listed in this leaflet, please tell your doctor or pharmacist. You can minimise the risk of side effects by taking the least amount of syrup for the shortest amount of time necessary to control your symptoms.

If you suffer from any of the following at any Ume during your treatment STOP TAKING Ibuprofen Syrup and seek immediate medical help:

•    Severe headache, high temperature, stiffness of the neck or intolerance to bright light.

•    Pass blood in your faeces (stools/motions)

•    Pass black tarry stools

•    Vomit any blood or dark particles that look like coffee grounds.

TELL YOUR DOCTOR AND STOP TAKING THE SYRUP IF YOU EXPERIENCE:

•    Unexplained stomach pain or other abnormal stomach symptoms, indigestion, heartburn, feeling sick and/or vomiting.

•    Unexplained wheezing, shortness of breath, skin rash, itching or bruising.

•    Yellowing of the eyes and/or skin.

•    Severe sore throat with high fever.

•    Blurred or disturbed vision or seeing/hearing strange things.

•    Fluid retention (e.g. swollen ankles).

Medicines such as Ibuprofen Syrup have been associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Very rarely Ibuprofen Syrup may cause aseptic meningitis (inflammation of the protective membrane surrounding the brain). Other side effects may include headache, hallucinations, dizziness, tingling of hands and feet, ringing in the ears, depression, confusion, difficulty sleeping, anxiety, impaired hearing, a temporary sensation of burning in the mouth or throat, diarrhoea, constipation, flatulence (wind), unexpected sensitivity of the skin to the sun, tiredness, malaise, mood swings and swelling and irritation inside the nose.

Ibuprofen has also been shown to sometimes worsen the symptoms of Crohn's disease or colitis.

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 SHOULD YOU STORE IBUPROFEN SYRUP?

•    KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.

•    Do not store above 25°C.

•    Store in the original package to protect from light.

•    Use within twelve months after first opening.

•    If your doctor stops your treatment, take any leftover suspension back to the pharmacy for safe disposal.

•    Do not take your suspension after the expiry date on the container. Take any suspension which is out of date back to the pharmacy.

•    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. FURTHER INFORMATION ABOUT IBUPROFEN SYRUP

What Ibuprofen Syrup contains

•    Each 5ml of oral suspension contains 100mg ibuprofen.

•    Ibuprofen Syrup also contains the following: methyl hydroxybenzoate (E218), propyl hydroxybenzoate (E216), sunset yellow (E110), sodium benzoate, glycerin, sorbitol solution 70% (non-crystallising) (E420), sucrose, citric acid monohydrate granular, agar powder, light kaolin, polysorbate 80, orange flavour (D717) and purified water.

What Ibuprofen Syrup looks like and contents of the pack

•    Ibuprofen Syrup is an orange-coloured, orange-flavoured, suspension.

•    Ibuprofen Syrup is available in bottles of 200ml.

Product Licence holder

Procured from within the EU and repackaged by the Product

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

Lane, Wembley, HA0 1DX.

Manufacturer

This product is manufactured by AbbVie S.r.L., S.R. 148 Pontina

km 52 snc, 04011 Campoverde di Aprilia (LT), Italy.

| POM | PL No: 19488/1321 Leaflet revision date: 09 October 2014.

S1321 Ibuprofen LEAFLET 20141009