Phenoxymethylpenicillin 125mg/5ml Oral Solution
Package leaflet: Information for the user Apsin VK
Phenoxymethylpenicillin 125 mg/5 ml and 250 mg/5 ml Oral Solution Phenoxymethylpenicillin
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
• Keep this leaflet. Y ou may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Apsin VK is and what it is used for
2. What you need to know before you take Apsin VK
3. How to take Apsin VK
4. Possible side effects
5. How to store Apsin VK
6. Contents of the pack and other information
1. What Apsin VK is and what it is used for
Apsin VK Oral Solution is available in two strengths as granules for reconstitution. It comes in 137 mg or 275 mg of phenoxymethylpenicillin potassium, providing in turn 125 mg or 250 mg of phenoxymethylpenicillin in every 5 ml.
The granules for reconstitution is prepared by the pharmacist before dispensing by adding water to the granules to give 100ml of oral solution
Phenoxymethylpenicillin, the active ingredient, is an antibiotic, which belongs to a group of medicines called penicillins.
Apsin VK is used to treat infections such as respiratory tract infections, skin and soft tissue infection and Vincent's angina (a gum disease). It may also be used to prevent rheumatic fever and infections before and after surgery or dental treatment.
2. What you need to know before you take Apsin VK Do not take Apsin VK:
• if you are allergic to Phenoxymethylpenicillin or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a bad reaction or allergic reaction to any penicillin-type antibiotic including cephalosporin drugs
Warnings and precautions
Talk to your doctor or pharmacist before taking Apsin VK Oral Solution
• if you suffer from any stomach problems, e.g. vomiting
• if you suffer from any kidney problems
if you suffer from allergies and/or asthma
Other medicines and Apsin VK
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
• 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)
• Anti-coagulants (e.g. warfarin - to prevent blood clots)
• Oral typhoid vaccine (penicillin can stop this from working)
Apsin VK 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, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
This medicine should not affect your ability to drive or to use machinery.
Apsin VK contains Ponceau 4R (E124) and sunset yellow (E110)
These ingredients can cause allergic type reactions including asthma. Such allergies are common in those people who are allergic to aspirin.
Apsin VK contains Sucrose
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Sucrose may be harmful to your teeth.
Apsin VK contains Potassium
This should be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
3. How to take Apsin VK
Always take Apsin VK exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is
Adults including the elderly and children over 12 years
250mg to 500mg every six hours (one to two 5ml spoonfuls of 250mg/5ml), up to 1000mg every six hours in severe infections
Use in 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)
For preventing the recurrence of rheumatic fever or chorea:
The usual dose in adults is 250mg twice daily on a continuing basis.
For the prevention of infection in patients without a spleen or patients with sickle cell disease:
For adults and children over 12 years, the dosage is 250mg to 500mg every 12 hours.
For children aged between 6 and 12 years, the dosage is 250mg every 12 hours and for children below 5 years, the dosage is 125mg every 12 hours.
For children over 12 years the dose should not exceed the maximum adult doses.
For elderly, the dosage is as for the adult. The dosage should be lowered in poor renal function.
Patients with kidney problems
• If you have kidney problems the dose might be changed by your doctor.
When to take your medicine
Apsin VK is usually prescribed to be taken four times a day. It is best to take it as evenly spaced as possible.
Take Apsin VK when your stomach is empty. This means at least 30mins before food and preferably not less than two hours after food.
If you take more Apsin VK than you should, contact your doctor or pharmacist who will recommend what action you should take.
If you forget to take Apsin VK
If you forget to take your dose, take it as soon as you remember. If it is almost time for the next dose (up to 6 hours before), do not take the missed dose but take your next dose at your normal time Do not take a double dose to make up for a forgotten dose you have missed.
If you stop taking your Apsin VK
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.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects although not everybody gets them.
Stop taking the medicine and tell your doctor 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)
• severe peeling/blistering of the skin
• serum sickness-like reactions (characterised by fever, chills, joint pains and oedema)
• seizures
• profuse watery diarrhoea usually with blood and mucus, stomach pain and fever
Tell your doctor immediately if you experience any of the following side effects:
• stomach pain or cramps, nausea (feeling sick), vomiting (being sick) and diarrhoea
• sore mouth
• hepatitis
• 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
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 Apsin VK
Keep this medicine out of the sight and reach of children.
Expiry date
Do not use your medicine after the expiry date which is stated on the label. The expiry date, listed as “EXP” on the label, refers to the last day of that month.
Storage conditions
Apsin VK granules should be stored in a dry place below 20°C, and reconstituted solution 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.
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 Apsin VK contains
The Active substance is phenoxymethylpenicillin potassium: Each 5ml spoonful of oral solution contains 125mg or 250mg of phenoxymethylpenicillin.
The other excipients are sucrose, orange flavouring, saccharin sodium and orange dye. The orange dye contains sunset yellow (E110) and ponceau 4R (E124).
Apsin VK is available in 150 ml bottles containing 100 ml of solution.
Marketing Authorisation Holder and Manufacturer
TEVA UK Limited, Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
PL 00289/5278R PL 00289/5279R