Phenoxymethylpenicillin 125mg/5ml Oral Solution
Front of leaflet -148.5mm
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PHENOXYMETHYLPENICILLIN 125mg/5ml ORAL SOLUTION BP
(Phenoxymethylpenicillin potassium)
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 or pharmacist
• 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 of the 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 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. Howto store Phenoxymethylpenicillin Oral solution
6. Contents of the pack and other information
1. WHAT PHENOXYMETHYLPENICILLIN ORAL SOLUTION IS AND WHAT IT IS USED FOR
Phenoxymethyl penicillin, is an antibiotic, which belongs to a group of medicines called penicillins, which are used to kill bacteria that cause infections in your body.
5m I of reconstituted solution contains 125mg of Phenoxymethylpenicillin as the active ingredient.
The strength you are given will be decided by your doctor.
Phenoxymethylpenicillin potassium is used to treat infections caused by bacteria that are sensitive to penicillins. These infections include:
• Infections of the lungs (such as pneumonia and bronchitis)
• Ear and throat infections (such as otitis media and pharyngitis)
• Other infections (such as infections of the skin and soft tissue, scarlet fever and erysipelas)
Phenoxymethylpenicillin is also used to prevent infections such as:
• Prevention of recurrent attacks of rheumatic fever or chorea
• Prevention of lung infections in patients with no spleen or sickle cell disease
• Prevention of bacterial endocarditis in susceptible patients before surgery
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PHENOXYMETHYLPENICILLIN ORAL SOLUTION
Do not take Phenoxymethylpenicillin Oral Solution:
• If you have ever had a bad reaction or allergic to any penicillin or cephalosporin antibiotics, or any of the other ingredients listed in section 6
• If you have ever had a skin rash or swelling of the face or neck or shortness of breath when taking any antibiotic
• If you are allergic to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking
Phenoxymethylpenicillin Oral Solution
• Have a history of allergies and/or asthma
• Have kidney disease
• Have suffered severe diarrhoea following previous
treatment with antibiotics and from any stomach problems, e.g. vomiting
• Are feeling or being sick or are suffering from any gut disorder which may affect the way your body absorbs the medicine
• Have a severe illness
• Have history of antibiotic-associated colitis
Other medicines and Phenoxymethylpenicillin Oral Solution:
Tell your doctor or pharmacist if you are taking, have recently taken any other medicines even those not prescribed, including herbal and homeopathic remedies or might take any other medicines including:
• Other antibiotics (such as tetracyclines, erythromycin, chloramphenicol, neomycin, sulphonamides, have been reported to reduce the effect of penicillin)
• Sulfinpyrazone or probenecid (used for the treatment of gout)
• Methotrexate (used in the treatment of severe rheumatoid arthritis, severe psoriasis and cancer) and guar gum (used in the treatment of diabetes)
• Anti-coagulants (e.g. warfarin to prevent blood clots)
• Oral typhoid vaccine (penicillin can stop this from working)
• Phenoxymethylpenicillin may interfere with the way the contraceptive pill works. If you are taking the Pill you should use additional precautions (such as a condom or diaphragm) for the cycle during which you took the antibiotic
Phenoxymethylpenicillin Oral Solution 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 phenoxymethyl penicillin.
Pregnancy and breast-feeding:
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.
Phenoxymethylpenicillin Oral Solution contains sucrose
Patients with rare hereditary problems of fructose intolerance, gluclose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine. 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. HOWTO TAKE PHENOXYMETHYLPENICILLIN ORAL SOLUTION
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. The dosage prescribed will depend upon the type and severity of the infection.
In general the treatment must be continued 2-3 days after improvement of the symptoms. It is important that you complete the entire course of medicine your doctor has prescribed for you.
Treatment of Infection
Adults: 2-4 teaspoonfuls (10-20ml) every 6 hours Child under lyear of age: Vi teaspoonful (2.5ml) every 6 hours Child aged 1-5 years: 1 teaspoonful (5ml) every 6 hours Child aged 6-12 years: 1-2 teaspoonfuls (5-10ml) every 6 hours
Prevention of infection
Rheumatic fever: 2 teaspoonfuls (10ml) twice daily
Lung infection in patients with no spleen or sickle cell disease
Adults: 4 teaspoonfuls (20ml) every 12 hours
Child aged 6-12 years: 2 teaspoonfuls (10ml) every 12 hours
Child under 5 years: 1 teaspoonful (5ml) every 12 hours
Continued, please turn over
If you have kidney damage your doctor may give you a different dose.
When to take your medicine
Phenoxymethylpenicillin Oral Solution 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. You should swallow this medicine about half an hour before meals.
If you take more Phenoxymethylpenicillin Oral Solution 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 Phenoxymethylpenicillin Oral Solution
If you forget to take your medicine take it as soon as you remember.
Do not take a double dose to make up for a forgotten dose.
If you or a child ever takes too much medicine contact your doctor or local casualty department immediately. Take any remaining solution and this leaflet to show to your doctor.
If you stop taking Phenoxymethylpenicillin Oral Solution
Keep taking this medicine until your doctor tells you to stop.
Do not stop taking the solution if you feel better, as your infection may come back 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.
Phenoxymethylpenicillin potassium is generally well tolerated. Occasionally soft stools occur but this does not require interruption of treatment. However, if you develop severe diarrhoea, which may contain blood, you should contact your doctor immediately.
STOP taking the medicine and tell your doctor IMMEDIATELY if
you experience any of the following:
• Feeling or being sick is a rare reaction
• Allergic reactions can occur, which may rarely be severe. Stop taking the mixture and contact a doctor immediately if you notice skin rash or itching, hives, severe peeling/ blistering of the skin, which may be itchy raised or red, fever, chills, joint pains, swelling of the face, lips, throat or tongue, breathing difficulties or dizziness. Allergic reactions may also include affects on the blood and kidney
• Seizures
• Effects on the nervous system occur rarely and are more likely if you have an injection of an antibiotic or have severe kidney damage. If you experience numbness or tingling of the hands or feet, or fits, you should see your doctor
• Profuse watery diarrhoea usually with blood and mucus, stomach pain and fever
• Kidney problems, which might cause blood in the urine or reduced amounts of urine
• Jaundice -yellowing of skin or whites of the eyes
• Convulsions
Tell your doctor or pharmacist if you notice any of the following and they worry you.
• 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)
Phenoxymethylpenicillin may alter the number and type of blood cells. If you notice you have more nose bleeds, bruise easily or have frequent infections talk to your doctor who may want to test your blood.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 PHENOXYMETHYLPENICILLIN ORAL SOLUTION
Keep this medicine out of the sight and reach of children.
Expiry date
Do not use this medicine after the expiry date which is stated on the carton.
The expiry date refers to the last day of that month.
Storage conditions:
Phenoxymethylpenicillin potassium powder for solution.
Do not store above 25°C. Keep the container tightly closed.
Store the reconstituted solution preferably in the refrigerator (2°C - 8°C) and use within 7 days after the reconstitution.
If your doctor decides to stop the treatment, return any medicine which you no longer need to the pharmacist. Only keep them if your doctor tells you to. Do not use this medicine if you notice visible signs of deterioration. 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.
Important reminder: Do not give your medicine to anyone else, even if they suffer from the same condition as you. This medicine could be harmful to them or interfere with other treatments. Your medicine has been prescribed by your doctor specifically for you.
6. CONTENTS OF THE PACK AND OTHER
What Phenoxymethylpenicillin Oral Solution contains:
Active ingredient: Each 5mI spoonful of oral solution contains 125mg of Phenoxymethylpenicillin as Phenoxymethylpenicillin potassium.
The Other ingredients are: sodium saccharin (E954), citric acid (E330), sodium citrate (E331), sucrose, banana flavour, preservative: E 211 sodium benzoate, colouring agent:E 127 erythrosine.
What Phenoxymethylpenicillin Oral Solution looks like and contents of the pack
Phenoxymethylpenicillin Potassium powder for solution come in bottles of 60ml and 100ml.
Marketing Authorisation Holder:
Special Concept Development (UK) Limited, Units 1-7 Colonial Way, Watford, Hertfordshire, WD24 4YR.
Manufacturer:
Karib Kemi Pharm Limited, Karib House, 63-65 Imperial Way, Croydon, Surrey CRO 4RR, U.K.
This leaflet was last revised in February 2016.
PL 36722/0063
If you would like this leaflet in a different format, please contact the licence holder at the above address.