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PHENOXYMETHYLPENICILLIN 125MG/5ML GRANULES FOR ORAL SOLUTION

Active substance(s): PENICILLIN V POTASSIUM / PHENOXYMETHYLPENICILLIN POTASSIUM / PENICILLIN V POTASSIUM / PHENOXYMETHYLPENICILLIN POTASSIUM

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13 213-9753 0 C
PL 20416/0203
M0238TB

UKL 003

To the Patient: Shake well be ore
ea h use S or n a r r ger or
Keep the b tle ig tly cl se Use
within 7 days o dispe sing Complete
the prescribed course o treatment
Dispose o any unused medicine
To the Pha macist: Do not store
above 25°C Keep the bottle tightly
closed o dispense, add 65ml o
water and shake well until all the
powder is d sso ved
or oral administration, as directed by
the doctor
or urther in ormation, see enclosed
Pa ient n o mation Lea le

POM

If you stop taking Phenoxymethylpenicillin Oral Solution
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 have any further questions on the use of this medicine,
ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you develop any of the 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)
• skin eruptions including nettle rash/hives (urticaria), itching or
severe peeling of the skin
• serum sickness (symptoms are feeling of coldness, fever, swelling
of the body, joint pains, extreme exhaustion)
• convulsions (fits)
• severe diarrhoea usually with blood or mucus, stomach pain and
fever.
Tell your doctor or pharmacist if you notice any of the side effects in
the following sections:
Common: may affect up to 1 in 10 people
• nausea, vomiting, stomach pain, diarrhoea.
Rare: may affect up to 1 in 1,000 people
• black hairy tongue, sore mouth.

Very rare: may affect up to 1 in 10,000 people
• a change in the number of white or red blood cells and platelets
(symptoms can be bleeding under the skin and easier bruising,
pale yellow skin, weakness or breathlessness, or make infections
more likely)
• yellowing of the skin or whites of the eyes, pale stools and dark
urine, loss of appetite, stomach discomfort caused by liver or
blood problems
• inflammation of the kidney which can cause swollen ankles or high
blood pressure.
Not known: frequency cannot be estimated from the available
data
• problems with blood clotting
• tingling or numbness
• kidney disease.

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 Phenoxymethylpenicillin Oral Solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the
pack. The expiry date refers to the last day of that month.
Dry granules: Do not store above 25°C. Keep the bottle tightly closed.
Oral Solution: Store in a refrigerator (2 - 8°C). Keep the bottle tightly

closed. Use within 7 days of preparation.
Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Phenoxymethylpenicillin Oral Solution contains
Each 5ml of oral solution contains 125mg of phenoxymethylpenicillin
(as potassium salt) as the active ingredient.
The other ingredients are sucrose, saccharin sodium, ponceau 4R
(E124) and strawberry flavour.
What Phenoxymethylpenicillin Oral Solution looks like and
contents of the pack
Phenoxymethylpenicillin Oral Solution is a clear pink solution with an
odour of strawberry.

This medicine is available in a pack size of 100ml.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited, Units 3 & 4, Quidhampton Business
Units, Polhampton Lane, Overton, Hants, RG25 3ED, UK.
This leaflet was last revised in July 2017
If you would like this leaflet in a different format please contact the
licence holder at the above address.

573 mm

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

PHENOXYMETHYLPENICILLIN
125mg/5ml Granules for Oral Solution
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.

- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist
or nurse.
- This medicine has been prescribed for you only. Do not pass it
on to others. It may harm them, even if their signs of illness are
the same as yours.
- If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. See section 4

What is in this leaflet:
1. What Phenoxymethylpenicillin Oral Solution is and what it is used for
2. What you need to know before you take Phenoxymethylpenicillin
Oral Solution
3. How to take Phenoxymethylpenicillin Oral Solution
4. Possible side effects
5. How to store Phenoxymethylpenicillin Oral Solution
6. Contents of the pack and other information

1. What Phenoxymethylpenicillin Oral Solution is and what it is
used for

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. What you need to know before you take
Phenoxymethylpenicillin Oral Solution

Do not take Phenoxymethylpenicillin Oral Solution if:
• you have a history of allergic reactions to any penicillins,
cephalosporins or other allergy causing agents
• you are allergic to phenoxymethylpenicillin or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking Phenoxymethylpenicillin Oral
Solution if:
• you are suffering from severe illness, nausea, vomiting, stomach

bloating/cramping or difficulty swallowing
• you suffer from allergies and/or asthma
• you have impaired kidney function.
Other medicines and Phenoxymethylpenicillin Oral Solution
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines, especially:
• antibacterial medicines e.g. tetracycline, erythromycin, neomycin,
chloramphenicol
• probenecid or sulfinpyrazone – used for treatment of gout
• guar gum – used in diabetes
• anticoagulants e.g. warfarin (to prevent blood clots)
• methotrexate (to treat cancer or psoriasis)
• oral typhoid vaccine.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or

M0238TB

573 mm

PL 20416/0203

Braille Note:
Global Pharma Artworks cannot accept responsibility for
any errors in this proof after approval by the customer.
Whilst extreme care is taken in the setting of Braille, the
customer must take the final responsibility for its
accuracy.
It is important that the local braille authority is consulted
to ensure that the correct local braille characters have
been used.
This Braille is set to the Marburg Medium format unless
you have requested otherwise.
When you sign this proof you are signifying full approval
of the Braille text and specification.

are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
This medicine may be present in breast milk and can cause an allergic
reaction in the infant.
Phenoxymethylpenicillin Oral Solution contains sucrose and
E124
Each 5ml of this medicine contains 2.61g of sucrose, this should be
taken into account in patients with diabetes mellitus. May be harmful
to the teeth. Also if you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before taking this
medicine.
This medicine contains E124 which may cause allergic reactions.

3. How to take Phenoxymethylpenicillin Oral Solution

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.
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is:
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.
If you take more Phenoxymethylpenicillin Oral Solution than you
should
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.
If you forget to take Phenoxymethylpenicillin Oral Solution
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 take a double dose to make up for a forgotten dose.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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