Co-Fluampicil Oral Suspension 125 Mg/125 Mg In 5 Ml
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT Co-Fluampicil 125/mg/125mg/5ml Oral Suspension
(Flucloxacillin and Ampicillin)
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 onto 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Co-Fluampicil is and what it is used for
2. What you need to know before you take Co-Fluampicil
3. How to take Co-Fluampicil
4. Possible side effects
5. How to store Co-Fluampicil
6. Contents of the pack and other information
1. What Co-Fluampicil is and what it is used for
This medicine contains two active ingredients, flucloxacillin and ampicillin which together are known as Co-Fluampicil. Co-Fluampicil belongs to a group of medicines called penicillin antibiotics and works by killing bacteria that cause infections.
Co-Fluampicil is used to treat the following:
• A range of severe infections such as chest, ear, nose, throat and soft tissue infections
• In hospitals, Co-Fluampicil may be used to treat respiratory tract infections, post-operative chest and wound infections, and septicaemia (blood poisoning). It may also be given before major surgery or to patients who are receiving treatment which affects the immune system
• Co-Fluampicil may also be given following difficulties in childbirth or abortion (as you may have a condition known as puerperal fever, an infection of the membrane of the uterus),
2. What you need to know before you take Co-Fluampicil Do not take Co-Fluampicil if:
• You are allergic (hypersensitive) to antibiotics e.g. penicillins, cephalosporins or to any of the other ingredients of this medicine ( listed in section 6)
• You have a history of yellowing of the skin or whites of the eyes (jaundice) or liver problems associated with taking flucloxacillin
• This medicine is not to be used on the eyes
Warnings and precautions
Talk to your doctor before taking Co-Fluampicil if:
• You have infectious mononucleosis (glandular fever) and/or acute (short-lived) or chronic (long term) leukaemia (cancer of the blood) of lymphoid origin
• You have liver problems
• This medicine is to be given to a newborn baby
• You need to take this medicine for a long time as your liver and kidney function should be monitored
Other medicines and Co-Fluampicil
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription. This includes herbal medicines.
In particular, tell your doctor if you are taking any of the following:
• Medicines that inhibit the growth of bacteria (bacteriostatic medicines) e.g. co-trimoxazole (sulfomamides), doxycycline (tetracyclines), chloramphenicols
• Oral contraceptives (‘the pill’) as they may not be as effective. Other contraceptive precautions should be used e.g. condoms
• Probenecid and allopurinol, used to treat gout
Glucose urine test
If you need to be tested for the presence of glucose in your urine, tell your doctor or nurse that you are taking Co-Fluampicil. A certain method of testing may need to be used to avoid false positive readings.
Taking Co-Fluampicil with food and drink
Co-Fluampicil should be taken half an hour to one hour before meals.
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 for advice before taking this medicine.
Pregnancy
Co-Fluampicil should only be used if the benefits outweigh the risks..
Breast-feeding
Co-Fluampicil is passed into breast milk, therefore it should only be used if the benefits outweigh the risks.
Driving and using machines
Co-Fluampicil should not affect your ability to drive or operate machinery.
Co-Fluampicil contains:
• Azo colouring agent sunset yellow (E110). It may cause allergic reactions.
• Sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
• Sodium. If you are on a low salt diet, contact your doctor before taking this medicine.
• Sodium benzoate. It may increase the risk of jaundice in newborn babies.
3. How to take Co-Fluampicil
Always take Co-Fluampicil exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
• This medicine is for oral use only..
• Co-Fluampicil should be taken half an hour to one hour before meals.
• Suspension should be used within 7 days (after reconstitution).
Adults (including the elderly)
• The recommended dose is 10mls four times a day
• 20mls four times a day may be given for severe infections
Use in children
• The recommended dose is 5mls four times a day
• 10mls four times a day may be given for severe infections
If you take more Co-Fluampicil than you should
If you accidentally take too much suspension, contact your doctor or nearest hospital emergency department for advice. Remember to take this leaflet and any remaining suspension with you. Symptoms of overdose include: feeling (nausea) or being sick (vomiting) and diarrhoea.
If you forget to take your Co-Fluampicil
Take it as soon as you remember, unless it is nearly time for your next dose. If you miss a dose, do not take a double dose to make up for a forgotten dose.
If you stop taking Co-Fluampicil
It is important that you keep taking Co-Fluampicil for as long as your doctor has told you to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Co-Fluampicil can cause side effects although not everybody gets them.
Seek medical advice immediately if you develop the following symptoms:
• Allergic reactions: swelling of the face, throat or tongue, difficulty breathing or dizziness (anaphylaxis)
• Frequent wheezing, breathlessness, abdominal pain, diarrhoea, fever, cough and rashes due to an increase in certain white blood cells (eosinophilia)
• Swelling of the deeper layers of the skin caused by a build-up of fluid (angioneurotic oedema)
• Fever, general ill feeling, itching, joint aches, multiple skin lesions (erythema multiforme)
• Severe blistering of the skin (toxic epidermal necrolysis), mouth, eyes and genitals (Stevens-Johnson syndrome)
Rare side effects (may affect up to 1 in 1000 people)
• Kidney inflammation [interstitial nephritis] (reversible when treatment is discontinued)
• Reduction in blood platelets, which increases the risk of bleeding or bruising (reversible thrombocytopenia)
• Reduction in white blood cells, which may make infections more likely (reversible leucopenia)
• Reduction in red blood cells which can make the skin pale yellow and cause weakness or breathlessness (haemolytic anaemia)
• Inflammation of the large intestine from an infection caused by an overgrowth of bacteria (pseudomembranous colitis)
• Inflammation of the liver (hepatitis) or yellowing of the skin or whites of the eyes (jaundice). These side effects may develop two months after finishing treatment
Other side effects (frequency not known)
• Skin rash
• Severe itching (pruritus)
• Skin rashes with the formation of wheals (urticaria)
• Skin rash caused by small blood vessels bleeding into the skin (purpura)
• Fever (may develop more than 48 hours after the start of the treatment)
• Pain or swelling in the joints [arthralgia] (may develop more than 48 hours after the start of the treatment)
• Muscle pain [myalgia] (may develop more than 48 hours after the start of the treatment)
• Feeling (nausea) or being sick (vomiting)
• Diarrhoea
• Increase in liver enzymes (detected through blood test)
Reporting 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 the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help to provide more information on the safety of this medicine.
5. How to store Co-Fluampicil
• Keep this medicine out of the sight and reach of children.
• Do not use Co-Fluampicil after the expiry date, which is stated on the label/carton after EXP. The expiry date refers to the last day of that month.
• Store in a cool dry place, below 25°C.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information What Co-Fluampicil contains:
Each 5ml of reconstituted suspension contains Flucloxacillin Sodium equivalent to 125mg of Flucloxacillin and Ampicillin Trihydrate equivalent to 125mg of Ampicillin.
The other ingredients are: sodium benzoate, disodium edetate, saccharin sodium, mono-ammonium glycyrrhizinate, sodium citrate (dried), apricot flavour, menthol flavour, Yellow FD & C No.6 (E110) and sucrose (caster).
What Co-Fluampicil looks like and contents of the pack:
Co-Fluampicil is a free-flowing powder in two layers, the top being white, the bottom layer being off white. The suspension is orange in colour.
Co-Fluampicil is available in:
Each bottle contains 100ml of suspension when reconstituted.
Product Licence Number:
PL 11311/0524
Marketing Authorisation Holder and Manufacturer:
Tillomed Laboratories Ltd 3 Howard Road Eaton Socon St. Neots Cambridgeshire PE198ET UK
This leaflet was last revised in June 2016 Till-Ver.2.1 s