Phenoxymethylpenicillin 125mg/5ml Granules For Oral Solution

Document: label-leaflet MAH GENERIC_PL 20416-0203 change

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^Wh"ⁿ prepared as directed, each 5ml contains phenoxymethylpenicillin

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To the Patient: Shake well before e#KUs& Sore in a rfrigertor. OO Keenthebottl^^tly^l^e^ Use O within 7 days of dispensing. Complete the prescribed course of treatment. ^{Dispose of any unused med}«^ne.

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Crescent - UK - Phenoxymethylpenicillin O/S 125mg/5ml

82 mm

80.5 mm

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It is important to finish your prescribed course of this medicine. If you stop taking your medicine too soon, your infection may come back.

If you miss a dose of this medicine:

Take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and continue with the regular dosing schedule. DO NOT DOUBLE THE DOSES.

If you have taken too much medicine:

Contact your doctor straight away or go to the nearest hospital casualty department. Take with you any remaining oral solution and the container so that the medicine can be identified.

4. Possible side effects

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

If you develop any of the allergic reactions listed below -

IMMEDIATELY STOP taking your medicine and contact your doctor or

go to the nearest hospital.

• swelling of the throat and severe allergic reaction (symptoms are itchy, red or swollen skin, wheeziness, shortness of breath, swelling of the face, lips or tongue and in severe cases collapse). Sometimes fever and eosinophilia (condition in which there are increased number of white blood cells) are the only side-effects seen

• skin eruptions including nettle rash/hives (urticaria) and itching

• serum sickness (symptoms are feeling of coldness, fever, swelling of the body, joint pains, extreme exhaustion).

The side effects commonly seen are:

• nausea, vomiting, stomach pain, heartburn, diarrhoea and black hairy tongue.

Side effects rarely seen

• a reduction in the number of blood cells and platelets (symptoms can be bleeding under the skin and easier bruising)

• neuropathy (a disease affecting the nerves).

These usually occur with high doses of injected penicillin.

You may develop a yeast/fungal infection if you have been taking this medicine for a long period.

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 to store this medicine

Store this medicine in a refrigerator (2-8°C). Keep the bottle tightly closed. Use within 7 days of preparation. Keep this medicine out of the sight and reach of children. This medicine could harm them.

Do not take the medicine if the expiry date on the label has passed.

If you have any medicines that are out of date, return them to your pharmacist for safe disposal.

6. FURTHER INFORMATION

Ingredients:

Each 5ml of oral solution contains 125mg of phenoxymethylpenicillin (as potassium salt) as the active ingredient.

It also contains sucrose, saccharin sodium, ponceau 4R (E124) and strawberry flavour.

What the medicine looks like:

Phenoxymethylpenicillin Oral Solution is a clear pink solution with an odour of strawberry.

This medicine is available in a pack size of 100ml.

Who makes this medicine and holds the product licence:

Crescent Pharma Limited, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hants. RG25 3ED

Date leaflet revised June 2015

If you would like this leaflet in a different format please contact the licence holder at the above address.

50mm 50mm

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493 mm

80 mm

81.5 mm

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82 mm

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PATIENT INFORMATION LEAFLET

PHENOXYMETHYLPENICILLIN 125mg/5ml Granules for Oral Solution

Please read all of this leaflet carefully before you start taking this medicine.

Keep the leaflet; you may need to read it again. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This medicine is for you. Only a doctor can prescribe it. Never give the medicine to someone else. It may harm them even if their symptoms are the same as yours.

In this leaflet:

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

2. Before you take this medicine

3. How to take this medicine

4. Possible side effects

5. How to store this medicine

6. Further information

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

Each 5ml of oral solution contains 125mg of phenoxymethylpenicillin (as potassium salt) as the active ingredient.

This medicine belongs to the penicillin group of antibiotics. Phenoxymethylpenicillin is an antibacterial drug used in the treatment of mild to moderately severe infections such as chest and throat infections, skin and soft tissue infections, infections of the mouth,

gums and teeth, scarlet fever (characterised by high fever, sore throat and skin rashes), and mild erysipelas (disease marked by red skin eruptions, chills and fever). Also used in the prevention of rheumatic fever and chorea (a group of disorders characterised by brief rapid involuntary movements of limbs, face, trunk and head).

2. Before you take this medicine Do not take this medicine if:

• you are allergic to any penicillin or any of the other ingredients listed (see section 6). (This medicine contains E124 which can cause allergic reactions).

Check with your doctor before taking this medicine if:

• you have a history of allergic reactions to penicillins, cephalosporins or other allergy causing agents

• you are suffering from severe illness, nausea, vomiting, stomach bloating/cramping or heart problems

• you have impaired kidney function

• you are pregnant or breastfeeding. This medicine may be present in breast milk and can cause an allergic reaction in the infant

• you have been told by your doctor that you have an intolerance to some sugars or if you have diabetes mellitus, as each 5ml of this medicine contains 2.61g of sucrose and this needs to be taken into account.

Taking other medicines:

Check with your doctor or pharmacist before taking this medicine if you are taking other medicines, including any that you can buy without a prescription. This is important if you are taking other medicines, especially:

• probenecid - used for treatment of gout

• guar gum - used in diabetes

• birth control pills containing oestrogen. This medicine may stop the pill from working properly, therefore, you should use additional means of birth control whilst taking this medicine and for a full cycle afterwards.

3. How to take this medicine

For oral use. Shake the bottle well before use. Take the medicine half an hour before or at least 3 hours after a meal. The dose will be different for different medical conditions and patients.

Take the medicine as directed by your doctor or pharmacist. The usual doses are as follows:

Adults (including the elderly): 125 - 500mg (one to four 5ml spoonfuls), every 4 to 6 hours.

For long-term preventative treatment of rheumatic fever, the dose is 125mg (one 5ml spoonful), twice a day. The dose will be reduced if you have kidney problems.

Children, up to 1 year of age: 62.5mg (2.5ml/half a 5ml spoonful) every 6 hours.

Children 1 to 5 years of age: 125mg (one 5ml spoonful), every 6 hours. Children 6 to 12 years of age: 250mg (two 5ml spoonfuls), every 6 hours. In patients with bacterial infection (such as streptococcal infection), treatment is continued at the full dosage for 10 days to minimise complications.

The pharmacist’s label will tell you how much to take and how often.

If you are not sure about anything ask your doctor or pharmacist.

You should always follow your doctor’s advice about when and how to take your medicine and always read the label.

Removable Glue Area

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7mm

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493 mm

Booklet Placement

Width 89 MM

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To the Patient: Shake well before each use Store In a refrigerator.

Keep the bottle tightly closed. Use within 7 days ot dispensing. Complete the prescribed course ot treatment, Dispose ot any unused medicine To the Pharmacist: Do not store abcwe 25°C. Keep the bottle tightly closed. To dispense, add 65ml ot water and shake well until all the powder Is dissolved,

For oral administration, as directed by the doctor.

For further Information, see enclosed Patient Information Leaflet,

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN IpOMI PL20416/0103

^rescent Iharma™

PH ENOXYM ETHYL-PENICILLIN

I25m§/5ml Granules for Oral Solution

When prepared as directed, each 5ml contains phenoxymethylpenicillin 125mg (as potassium salt). Also contains sucrose and colour E124 (see leaflet for further information)

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O ' Code: KR/DRUGS/KTK/28/337/2003^™

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Space for B. no. & Exp dts.

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135 mm

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