PHENOXYMETHYLPENICILLIN 250mg/

Oral Solution 5ml

Phenoxym ethyl penicillin Potassium

58 MM

100 ml

Each 5ml of reconstituted solution contains 250mg of as Phenoxymethylpenicillin Potassium as the active in.

Also contains sucrose, saccharin sodium, strawberry flavour and colour E124 (see leaflet for further information).

To dispense, add 65ml of water and shake wall untl all the powder is dissolved.

Date of Dispensing:

To the Patient

Shake well before each use. For oral administration only.

Take as directed by the physician.

For further Information please see the enclosed Patient Information Leaflet before use.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.    _

Unconstituted powder Do not store above 25°C. Store In a dry place.    ©

Reconstituted oral solution. Store for 7 days in a refrigerator    |ISJ

Bristol

BN:

EXP:

PL 17907/0035    [TOM]

Cods: BL 501 PL Holder:

Bristol Laboratories Ltd.,

Berkhamsted, Herts, HP41EG, UK.

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Base Label Size : 124 x 58 mm

124 MM

Phenoxy methyl-penicillin 250mg/5ml Oral Solution

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Read thisentire leafletcarefully beforeyoustarttakingthismedicine.

•    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 others. It may harm them, even if the i r 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.

What is in this leaflet:

1.    What this medicine is and what it is used for

2.    What you need to know before you take this medicine

3.    Howto take this medicine

4.    Possible side effects

5.    How to store this medicine

6.    Contents of the pack and other information

11. What this medicine is and what it is used for|

Phenoxymethylpenicillin belongs to a group of medicines called penicillin, which are used to treat mild to moderate severe infections associated with microorganisms whose susceptibility to penicillin is within the range of serum levels attained with the dosage form.

your next dose, skip the missed dose and then take your next dose when itisdue.

DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR THE FORGOTTEN DOSE.

If you stop taking this medicine

Take this medicine that has been prescribed for you, even if you start to feel better. If you stop taking the medicine, your condition may re-occur or get worse.

[47Possible side effects |

Like all medicines, this medicine may sometimes cause side effects, although not everybody gets them.

STOP TAKING this medicine and tell your doctor immediately if you sufferfrom any of the following:

•    allerg i c reactions-sym ptomssuchasshortnessofbreath.skinrash or itching, hives, swelling of your lips, face or tongue, chills or fever or painful joints

•    unusual bleeding or bruising Other side effects that may occur indude:

•    nausea, vomiting and stomach upset

•    diarrhoea

•    sore mouth

•    black hairy tongue

•    coagulation disorders (including prolongation of bleeding time and defective function)

•    central nervous system toxicity (especially with high doses or in severe renal impairment)

•    paraesthesia (tingling or numbness in the hands or feet)

•    reactions resembling serum sickness including interstitial nephritis, neutropenia, chills, fever, oedema, arthralgia (joint pains) and prostration

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,

please tell yourdoctor or pharmacist.

| 5. How to store this medicine |

•    Keep out of the sight and reach of children

•    Do not store above 25°C. Store in the original packaging and keep the packaging tightly dosed in orderto protect from light and moisture.

•    Do not use this medicine afterthe expiry date shown on the pack.

•    If you have any left over left ove r media ne, take them back to you r pha rmacist for safe disposal.

16. Contents of the pack and other information |

What Phenoxymethylpenicillin 250mg/5ml Oral Solution Contains

•    Each 5ml of reconstituted oral solution contains 250mg of Phenoxymethylpenicillin potassium as the active ingredient.

•    The other ingredients are strawberry flavor, red dye (Anstead) 1578 ponceau 4R, sodium saccharin, sucrose, industrial methylated spirit.

Marketing Authorisation Holder and Manufacturer Name and address: Bristol Laboratories Ltd,

Unit 3, Canalside, NorthbridgeRoad,

Berkhamsted, United Kingdom, HP41 EG Telephone:    0044(0)1442200922

Fax:    0044(0)1442 873717

Email:    info@bristol-labs.co.uk

Phenoxymethylpenicillin 250mg/5fnl Oral Solution; PL 17907/0035 This leaflet was last revised in April 2012

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (or telephone, fax, email) above.

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The name of your medicine is phenoxymethylpenicillin potassium. It is available as a powder for reconstitution. The powder for reconstitution is prepared by the pharmacist before dispensing by adding waterto the powderto give 100ml of oral solution.

12. What you need to know before you take this medicine]

Do not take this medicine if you:

■ Ever had a bad reaction or allergic reaction to Phenoxymethylpenicillin, any other penicillin or cephalosporins or any other ingredients (these listed in Section 6, Further Information)

Take special care with this medicine

Tell your doctor before faking this medicine if you have any medical conditions, and especially if you:

•    Sufferfrom kidney or stomach problems

•    have a history of allergy or asthma

Other medicines and Phenoxy methyl penicillin oral solution

Tell your doctor or pharmacist if you are taking, have recently taken or might fake any other

medicines.

•    tetracycline, neomycin, erythromycin, chloramphenicol (othertypes of antibiotics)

•    probenecid (used to treat gout - painful inflammation of the joints)

•    the oral contraceptive pill

•    methotrexate (a drug used to treat cancer and psoriasis-a chronic skin disease)

•    anti-coagulants (medication used to prevent blood dots e.g, Warfarin)

•    guar gum (used as a thickening agent and normally found in puddings and ice cream)

Pregnancy and breast-feeding and fertility

•    Do not take this medicine if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking this medicine or are breast-feeding.

•    This medicine is excreted in breast milk and may cause allergic reaction in the offspring

Penicillin solution contains Sucrose

If you have been told by your doctor that you have an intolerance to some sugars, contact

yourdoctor before taking this medicinal product

13. How to take this medicine I

•    Always take this medicine exactly as advised by your doctor. You should check with your doctor or pharmacist if you are not sure.

•    The dosage and duration of treatment will depend on the type and severity of the infection.

•    It should be given in divided doses (4 times a day) and preferably half an hour before meals or at least three hours after a meal

The following dosage schedule applies to Phenoxymethylpenicillin Oral Solution BP.

Adults, elderly and children over 12 years: 250mg-500mg every six hours Children 1 -5 years: 125mg every six hours.

Infants (up to 1 year): 62.5 mg every six hours.

6-12 years: 250mg every six hours

Renal Impairment: Reduced dosage recommended

Prophylactic use: 250 mg twice daily is recommended for long term prophylaxis of rheumatic fever. To avoid com plications treatment must beforatleast 10 days Your doctor may sometimes prescribe a different dose to that stated above and if this applies to you, discuss it with your doctor if you have not already done so. You should always follow your doctor's instructions as to how and when to take your medicine,

If you take more Phenoxymethylpenicillin 250mg/5ml Oral Solution than you should If you accidently fake too many doses, tell your doctor immediately or contact your nearest Hospital Casuality/Accident and Emergency Department even if there are no signs of discomfort. Take your medicine in its original packaging with you in orderto enable the doctor to identify your medication easily.

If you forget to take Phenoxymethylpenicillin 250mg/5ml Oral Solution than you should

If you forget to fake a dose, fake it as soon as you remember, however, if it is almost time for

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