PHENOXYMETHYLPENICILLIN 250MG/5ML ORAL SOLUTION

Active substance: PHENOXYMETHYLPENICILLIN POTASSIUM

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PATIENT INFORMATION LEAFLET – SPOON
PHENOXYMETHYLPENICILLIN 125MG/5ML AND 250MG/5ML ORAL SOLUTION SUGAR
FREE

Read all of this leaflet carefully before you start taking your medicine.
Keep this leaflet. You may need it again.
If you have further questions, please ask your doctor or pharmacist (chemist).
This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
IN THIS LEAFLET
1.
2.
3.
4.
5.
6.

What your medicine is and what it is used for
Before you take your medicine
How to take your medicine
Possible side effects
How to store your medicine
Further information

1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
Phenoxymethylpenicillin Oral Solution Sugar Free is available in two strengths as a powder for
reconstitution. The powder for reconstitution is prepared by the pharmacist before dispensing by adding
water to the powder to give 100ml of oral solution. The strength you are given will be decided by your
doctor.
Phenoxymethylpenicillin, the active ingredient, is an antibiotic, which belongs to a group of medicines
called penicillins, which are used to kill bacteria that cause infections in your body.
Your medicine is used to:





treat bacterial infections of the ear, throat, respiratory tract, skin and soft tissues
prevent infections such as rheumatic fever or chorea recurring
prevent bacterial endocarditis in susceptible patients before surgery
prevent infection in patients with sickle cell disease

2. BEFORE YOU TAKE YOUR MEDICINE
Do not take this medicine if:




You have ever had a bad reaction or allergic reaction to any penicillin-type antibiotic including
cephalosporin drugs
You have ever had a skin rash or swelling of the face or neck or shortness of breath when taking any
antibiotic
You are allergic to any of the ingredients contained in this medicine

Take special care with your medicine if:




You suffer from any stomach problems, e.g. vomiting
You suffer from any kidney problems
You suffer from allergies and/or asthma

Taking other medicines:
Your medicine may interfere with other medicines that you may be taking. Please inform your doctor or
pharmacist if you are taking, or have recently taken, any other medicines even those not prescribed,
including herbal and homeopathic remedies.

Inform your doctor if you are taking:
 Methotrexate (a drug used to treat cancers and psoriasis)
 Some other antibiotics (tetracyclines, erythromycin, neomycin and chloramphenicol have been
reported to reduce the effect of penicillin)
 Sulfinpyrazone or probenecid (medicines used to treat gout)
 The oral contraceptive pill (your medicine may reduce the effectiveness of oral contraceptive pills, in
which case you will need to take extra contraceptive measures such as using a condom)
 Anti-coagulants (e.g. warfarin - to prevent blood clots)
In addition:
 Oral typhoid vaccine (penicillin can stop this from working)
Taking with food and drink
Guar gum (used as a thickening agent and normally found in puddings and ice-cream and benefiber) can
reduce the absorption of phenoxymethylpenicillin.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients in your medicine
Ponceau 4R (E124) and sunset yellow (E110)
Can cause allergic type reactions including asthma. Such allergies are common in those people who are
allergic to aspirin.

Sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. HOW TO TAKE YOUR MEDICINE
Follow all directions given to you by your doctor or pharmacist. Their directions may differ from the
information contained in this leaflet. The pharmacist’s label should tell you how much to take and how
often. If it does not, or you are not sure, check with your doctor or pharmacist.

How much of your medicine to take
The dose will depend on the patient and will be decided by your doctor.
The usual doses for each age group are as follows:
Adults including the elderly and children over 12 years
250mg to 500mg every six hours (one to two 5ml spoonfuls of 250mg/5ml)
Prophylactic use: 250mg twice daily is recommended for long term prophylaxis of rheumatic fever (one
5ml spoonful of 250mg/5ml)

Children
Infants (up to 1 year): 62.5mg every 6 hours
1- 5 years: 125mg every six hours (one 5ml spoonful of 125mg/5ml)
6 – 12 years: 250mg every six hours (one 5ml spoonful of 250mg/5ml or two 5ml spoonfuls of 125
mg/5ml)
When to take your medicine
Phenoxymethylpenicillin Oral Solution Sugar Free is usually prescribed to be taken four times a day. It is
best to take it as evenly spaced as possible.
Take this medicine when your stomach is empty. This means an hour before food or 2 hours after food.
If you take more of your medicine than you should
If you accidentally take too much medicine, contact your doctor or pharmacist who will recommend what
action you should take.

If you forget to take your medicine
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose.
DO NOT take a double dose to make up for the dose you have missed.

If you stop taking your medicine
Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel
better. If you stop taking the medicine, your condition may re-occur or get worse.

4. POSSIBLE SIDE EFFECTS
Like all medicines phenoxymethylpenicillin may cause you some problems.

STOP taking the medicine and tell your doctor IMMEDIATELY if you experience any of the
following:





an allergic reaction - symptoms may include: shortness of breath, skin rash or itching, hives, swelling
of the skin (especially of the lips, face or tongue), chills or fever, painful joints
severe peeling/blistering of the skin
seizures
profuse watery diarrhoea usually with blood and mucus, stomach pain and fever

The following are the more common effects. Tell your doctor or pharmacist if they worry you.


stomach pain or cramps, nausea (feeling sick), vomiting (being sick) and diarrhoea

The following are other possible side effects:









sore mouth
black hairy tongue
pins and needles or numbness
sore throats, infections, or fever (may be caused by low white blood cells)
problems with blood clotting (unusual bleeding or bruising)
anaemia (may cause lack of energy or tiredness)
kidney problems, which might cause blood in the urine or reduced amounts of urine
jaundice – yellowing of skin or whites of the eyes

If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, you should
contact your doctor or pharmacist.
5. HOW TO STORE YOUR MEDICINE

Do not use your medicine after the expiry date shown on the label.
KEEP THIS MEDICINE IN A SAFE PLACE WHERE CHILDREN CANNOT SEE OR REACH
IT.
Phenoxymethylpenicillin Oral Solution Sugar Free should be stored for up to 7 days in a refrigerator.
Keep it in the pack in which it was given to you. Do not transfer your medicine to another container.
If your doctor tells you to stop your treatment return any left over to the pharmacist. Only keep it if your
doctor tells you to.

6. FURTHER INFORMATION
What Phenoxymethylpenicillin Oral Solution Sugar Free contains:
Active ingredient: Each 5ml spoonful of oral solution contains 125mg or 250mg of
phenoxymethylpenicillin as phenoxymethylpenicillin potassium.
Other ingredients: sodium benzoate (E211), saccharin sodium, trusil orange flavour, orange colour
(containing sunset yellow (E110) and ponceau 4R (E124)), sorbitol 60W (E420) and mono ammonium
glycyrrhizate.

The product licence holder and manufacturer is:
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

Your medicine is distributed by:

PL 30464/0052 and PL 30464/0053

This leaflet was last revised September 2012

PATIENT INFORMATION LEAFLET – SYRINGE
PHENOXYMETHYLPENICILLIN 125MG/5ML AND 250MG/5ML ORAL SOLUTION SUGAR
FREE

Read all of this leaflet carefully before you start taking your medicine.
Keep this leaflet. You may need it again.
If you have further questions, please ask your doctor or pharmacist (chemist).
This medicine has been prescribed for you personally and you should not pass it on to
others. It may harm them, even if their symptoms are the same as yours.
In this leaflet
1.
2.
3.
4.
5.
6.

What your medicine is and what it is used for
Before you take your medicine
How to take your medicine
Possible side effects
How to store your medicine
Further information

1. WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
Phenoxymethylpenicillin Oral Solution Sugar Free is available in two strengths as a powder for
reconstitution. The powder for reconstitution is prepared by the pharmacist before dispensing by adding
water to the powder to give 100ml of oral solution. The strength you are given will be decided by your
doctor.
Phenoxymethylpenicillin, the active ingredient, is an antibiotic, which belongs to a group of medicines
called penicillins, which are used to kill bacteria that cause infections in your body.
Your medicine is used to:





treat bacterial infections of the ear, throat, respiratory tract, skin and soft tissues
prevent infections such as rheumatic fever or chorea recurring
prevent bacterial endocarditis in susceptible patients before surgery
prevent infection in patients with sickle cell disease

2. BEFORE YOU TAKE YOUR MEDICINE
Do not take this medicine if:


You have ever had a bad reaction or allergic reaction to any penicillin-type antibiotic including
cephalosporin drugs




You have ever had a skin rash or swelling of the face or neck or shortness of breath when taking any
antibiotic
You are allergic to any of the ingredients contained in this medicine

Take special care with your medicine if:




You suffer from any stomach problems, e.g. vomiting
You suffer from any kidney problems
You suffer from allergies and/or asthma

Taking other medicines:
Your medicine may interfere with other medicines that you may be taking. Please inform your doctor or
pharmacist if you are taking, or have recently taken, any other medicines even those not prescribed,
including herbal and homeopathic remedies.

Inform your doctor if you are taking:
 Methotrexate (a drug used to treat cancers and psoriasis)
 Some other antibiotics (tetracyclines, erythromycin, neomycin and chloramphenicol have been
reported to reduce the effect of penicillin)
 Sulfinpyrazone or probenecid (medicines used to treat gout)
 The oral contraceptive pill (your medicine may reduce the effectiveness of oral contraceptive pills, in
which case you will need to take extra contraceptive measures such as using a condom)
 Anti-coagulants (e.g. warfarin - to prevent blood clots)
In addition:
 Oral typhoid vaccine (penicillin can stop this from working)
Taking with food and drink
Guar gum (used as a thickening agent and normally found in puddings and ice-cream and benefiber) can
reduce the absorption of phenoxymethylpenicillin.

Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients in your medicine
Ponceau 4R (E124) and sunset yellow (E110)
Can cause allergic type reactions including asthma. Such allergies are common in those people who are
allergic to aspirin.

Sorbitol
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicinal product.
3. HOW TO TAKE YOUR MEDICINE
Follow all directions given to you by your doctor or pharmacist. Their directions may differ from the
information contained in this leaflet. The pharmacist’s label should tell you how much to take and how
often. If it does not, or you are not sure, check with your doctor or pharmacist.

TO THE PHARMACIST: INSTRUCTIONS FOR RECONSTITUTION OF THE POWDER

1. Remove the cap and add the correct volume of potable water (85mls for the 125mg/5ml strength of
product and 84mls for the 250mg/5ml strength of product)
2. Replace the cap and shake gently to avoid foaming.
3. Remove the cap once more and place the adaptor (Fig 1) into the
bottle opening. The adaptor should not be removed at any stage.
4. Replace the cap, do not shake any further.

TO THE PATIENT: INSTRUCTIONS FOR USE OF THE SYRINGE

1. Remove the cap and if necessary push the adaptor into the
neck of the bottle (Fig 1).
2. Push the plunger of the syringe to remove all the air.
3. Insert the syringe into the adaptor until it is firmly in place (Fig 2).
4. While holding the bottle and syringe shake the contents gently.
5. While holding the bottle, turn the entire assembly upside down.

Fig 1

Fig 2

Fig 3

6. While supporting the syringe draw off the required amount of
medicine into the syringe (Fig 3).
7. Turn the assembly back up the right way and remove the syringe from the bottle.
8. Replace the cap onto the bottle.

Administer the dose by introducing the tip of the syringe into the mouth of the infant/child, then apply a
light pressure on the plunger to slowly release the solution. Keep it out of the reach of children.
Note: For subsequent dosage follow steps 3 and 4 above, before shaking in order to prevent leakage.

How much of your medicine to take
The dose will depend on the patient and will be decided by your doctor.
The usual doses for each age group are as follows:
Adults including the elderly and children over 12 years
250mg to 500mg every six hours (5ml to 10ml of 250mg/5ml)
Prophylactic use: 250mg twice daily is recommended for long term prophylaxis of rheumatic fever (5ml
of 250mg/5ml)

Children
Infants (up to 1 year): 62.5mg every 6 hours
1- 5 years: 125mg every six hours (5ml of 125mg/5ml)
6 – 12 years: 250mg every six hours (5ml of 250mg/5ml or 10ml of 125 mg/5ml)
When to take your medicine
Phenoxymethylpenicillin Oral Solution Sugar Free is usually prescribed to be taken four times a day. It is
best to take it as evenly spaced as possible.
Take this medicine when your stomach is empty. This means an hour before food or 2 hours after food.

If you take more of your medicine than you should
If you accidentally take too much medicine, contact your doctor or pharmacist who will recommend what
action you should take.

If you forget to take your medicine
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose.
DO NOT take a double dose to make up for the dose you have missed.

If you stop taking your medicine
Keep taking this medicine until your doctor tells you to stop. Do not stop taking it just because you feel
better. If you stop taking the medicine, your condition may re-occur or get worse.

4. POSSIBLE SIDE EFFECTS
Like all medicines phenoxymethylpenicillin may cause you some problems.

STOP taking the medicine and tell your doctor IMMEDIATELY if you experience any of the
following:





an allergic reaction - symptoms may include: shortness of breath, skin rash or itching, hives, swelling
of the skin (especially of the lips, face or tongue), chills or fever, painful joints
severe peeling/blistering of the skin
seizures
profuse watery diarrhoea usually with blood and mucus, stomach pain and fever

The following are the more common effects. Tell your doctor or pharmacist if they worry you.


stomach pain or cramps, nausea (feeling sick), vomiting (being sick) and diarrhoea

The following are other possible side effects:









sore mouth
black hairy tongue
pins and needles or numbness
sore throats, infections, or fever (may be caused by low white blood cells)
problems with blood clotting (unusual bleeding or bruising)
anaemia (may cause lack of energy or tiredness)
kidney problems, which might cause blood in the urine or reduced amounts of urine
jaundice – yellowing of skin or whites of the eyes

If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, you should
contact your doctor or pharmacist.
5. HOW TO STORE YOUR MEDICINE
Do not use your medicine after the expiry date shown on the label.
KEEP THIS MEDICINE IN A SAFE PLACE WHERE CHILDREN CANNOT SEE OR REACH
IT.
Phenoxymethylpenicillin Oral Solution Sugar Free should be stored for up to 7 days in a refrigerator.
Keep it in the pack in which it was given to you. Do not transfer your medicine to another container.
If your doctor tells you to stop your treatment return any left over to the pharmacist. Only keep it if your
doctor tells you to.

6. FURTHER INFORMATION
What Phenoxymethylpenicillin Oral Solution Sugar Free contains:
Active ingredient: Each 5ml of oral solution contains 125mg or 250mg of phenoxymethylpenicillin as
phenoxymethylpenicillin potassium.
Other ingredients: sodium benzoate (E211), saccharin sodium, trusil orange flavour, orange colour
(containing sunset yellow (E110) and ponceau 4R (E124)), sorbitol 60W (E420) and mono ammonium
glycyrrhizate.

The product licence holder and manufacturer is:
Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland.

Your medicine is distributed by:

PL 30464/0052 and PL 30464/0053

This leaflet was last revised September 2012

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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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