iMedi.co.uk

Brufen 100mg/5ml Syrup

Informations for option: Brufen 100mg/5ml Syrup, show other option
Document: leaflet MAH BRAND_PLPI 16369-0624 change

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?


PACKAGE LEAFLET: INFORMATION FOR THE USER BRUFEN® 100 mg / 5 ml SYRUP

(Ibuprofen)

The name of your medicine is Brufen 100mg/5ml Syrup but will be referred to as Brufen Syrup throughout the remainder of this leaflet.

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 Brufen 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 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.

Brufen Syrup belongs to a group of medicines called anti-inflammatory 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.

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 E110, methyl hydroxybenzoate, propyl hydroxybenzoate 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 swelling and irritation inside the nose?

•    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. You should discuss your treatment with your doctor or pharmacist before taking Brufen Syrup if you:

-    have heart problems including heart failure, angina (chest pain) or you have had a heart attack, bypass surgery or peripheral artery disease (poor circulation in the legs or feet due to narrow or blocked arteries).

-    have any kind of stroke or think that you might be at risk of these conditions (e.g. if you have a family history of heart disease or stroke, high blood pressure, diabetes, high cholesterol or are a smoker).

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

•    Do you have chicken pox or shingles?

•    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 26.4g per dose) it is not recommended for those with hereditary fructose intolerance, glucose malabsorption syndrome or sucraseisomaltase deficiency.

•    Is your child dehydrated? As 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- II 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 (water 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 and rheumatoid arthritis)

•    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, 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 (type 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, glycerin 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. The syrup contains sucrose and therefore may be harmful to your teeth.

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.

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 and children over 12 years -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 (100 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.

I

I


I


I

I