Phenoxymethylpenicillin 125mg/5ml Oral Solution
100 ml
Each 5ml of reconstituted solution contains 125mg of Phenoxymethylpenidllin as Phenoxymettiyfpenicillin Potassium as the active ingredient Also contains sucrose, saccharin sodium, strawberry flavour and colour E124 (see leaflet for further information).
To the Pharmacist:
To dispense, add 65ml of water and shake well until all the powder is dissolved.
Date of Dispensing:
To the Patient:
Shake well before Bach use. For oral administration only.
Take as directed by the physician.
For further information please see the enclosed Patient Information Leaflet before use. KEEP OUTOFTHE SIGHT AND REACH OF CHILDREN. |jg%
Unconstituted powder Do not store above 25°C. Store in a dry place. ILJ
Reconstituted oral solution. Store for 7 days in a refrigerator Bristol
BN:
EXP:
PL 17907/0034 [POM]
Code: BL 501 PL Holder:
Bristol Laboratories Ltd.,
Berkhamsted, Herts, HP4 1EG, UK,
>
s th' active :~gred ient. m i, strawberry flavour and coburE12
as Pherp xymethylpenicilli Also contains sucrose, saccharin sodium,
(see leaflet for further infbnnation).
(fe the F irmad : # # # •
To dispose, add 65"! of water and shake wHI r-'till Date of bispersing: w *
Tq the Patient:
Shake well before each use. For oral administration only.
Take as traded |y the physician.
For further information please see theNer
i<EcP OUT OF TnE SIGITr AND REnCH OF Cl_________
1 jnconstituted pd..der Do not store t-ove 2^. Store ..] a dry^# Reconstituted oral solution. Store for 7 days In a refrigerator
100 0b • •• _
EaG 5ml o. 3cc itituted solutionOntains(_25mg c. ?henox, nethylpeni. Jin
<■
• •
qf tie powder is dissolved.
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Information Leaflet before use ' ' ..
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 suffer from 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, ta ke them back to you r pha rmacist for safe disposal.
Read th is enti re leaflet caref u lly before youstarttakingthismedicine.
• 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.
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.
|2. What you need to know before you take this medicinal Do not take this medicine if you:
■ Ever had a bad reaction or allergic reaction to Phenoxymethylpenidllin, 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 taking this medicine if you have any medical conditions, and espedallyifyou:
• 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 take any other
medidnes.
• tetracycline, neomydn, erythromydn, chloramphenicol (othertypes of antibiotics)
• probenedd(used to treat gout- painful inflammation of the joints)
Phenoxy methyl-penicillin 125mg/5ml Oral Solution
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16. Contents of the pack and other information |
What Phenoxymethylpenidllin 125mg/5ml Oral Solution Contains
• Each 5ml of reconstituted oral solution contains 125mg 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 125mg/5ml Oral Solution; PL17907/0034 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.
• the oral contraceptive pill
• methotrexate (a drug used to treat cancerand psoriasis- a chronic skin disease)
• anti- coagulants (medication used to prevent blood clots 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 fake this medidne if you are pregnant, think you have become pregnant or intend to become pregnant whilst taking this medidne or are breast-feeding.
• This medidne 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 medidnal product
13. How to take this medicine |
• 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 orat 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 125mg/5ml Oral Solution than you should If you accidently take 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 identity your medication easily.
If you forget to take Phenoxymethylpenicillin 125mg/5ml Oral Solution than you should
If you forget to take a dose, take it as soon as you remember, however, if it is almost time for
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