Patient leaflet - Co-fluampicil oral suspension 125 mg / 125 mg in 5 ml
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 wide range of infections caused by bacteria such as chest, ear, nose, throat, skin and soft tissue infections
In hospitals, Co-Fluampicil may be used to prevent and treat infections:
o which occur after surgery
o in patients receiving treatment which affects
the immune system
o of the blood (septicaemia)
o following difficulties in childbirth, abortion
(complicated by fever, often leading to sepsis) and puerperal fever (an infection of the membrane of the uterus following childbirth or abortion)
2. What you need to know before you take Co-Fluampicil
Do not take Co-Fluampicil if:
- You are allergic to penicillin, cephalosporins, any other antibiotic or any of the other ingredients of this medicine (listed in section 6)
- You have ever had a skin rash or swelling of the face or neck when taking an antibiotic
- You have a history of liver problems associated with taking an antibiotic
Warnings and precautions
Talk to your doctor before taking
Co-Fluampicil if:
- You have glandular fever
- You are having blood tests because this medicine may cause short term changes in blood cell counts
- You are being treated for kidney or liver problems
- You have syphilis or leptospirosis
- You need to take this medicine for a long time e.g. osteomyelitis (bone infection) or endocarditis (infection of the muscle around the heart) as additional monitoring of liver and kidney function is recommended
If you are taking or will be taking paracetamol. There is a risk of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used
concomitantly with paracetamol, particularly in certain groups of patients at risk, e.g. patients with severe renal impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used. High anion gap metabolic acidosis is a serious disease that must have urgent treatment
- The use of flucloxacillin, especially in high doses, may reduce the potassium levels in the blood (hypokalaemia). Your doctor may measure your potassium levels regularly during the therapy with higher doses of flucloxacillin
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.
Tell your doctor if you are taking any of the following:
- Other antibiotics (e.g. penicillins, or bacteriostatic medicines like tetracyclines, chloramphenicols or erythromycins)
- Contraceptive pill as you will need to take extra precautions such as use of a condom
- Probenecid and allopurinol, used to treat gout
- Methotrexate, used to treat cancer, autoimmune diseases
Urine tests
If you are required to have a urine test, please inform your doctor you are taking Co-Fluampicil. False positive results can occur with certain tests for sugar in the urine (e.g. the Fehling’s test), tests that look for antibodies, (e.g. Coomb’s test) or test for protein in the urine (e.g. Copper Sulphate test) whilst taking Co-Fluampicil.
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. Your doctor will decide if this medicine is suitable for you.
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
Take your oral suspension at least 1 hour before or 2 hours after meals
- To reduce the risk of pain in your oesophagus (the tube that connects your mouth with your stomach) take a full glass of water (250 ml) after oral suspension intake and do not lie down immediately after oral suspension intake
- If this medicine is taken with food it may not work as well
- Suspension should be used within 7 days (after reconstitution)
Adults (including the elderly and children over 10 years of age)
- The recommended dose is 10 mls four times a day
- 20 mls four times a day may be given for severe infections
Use in children (under 10 years of age)
- The recommended dose is 5 mls four times a day
- 10 mls 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 immediately 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. Always try to keep the doses evenly spaced and do not take two doses within one hour or so of each other.
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. Do not stop taking it just because you feel better. If you stop too soon, the infection may start again. PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Co-Fluampicil 125 mg/125 mg/5 ml
Oral Suspension
(Flucloxacillin and Ampicillin) Phama-
code
area
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)
- A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis)
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
- Seeing or hearing things that are not real (hallucinations)
Very Rare side effects (may affect up to 1 in 10,000 people)
Very rare cases of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used
concomitantly with paracetamol, generally in the presence of risk factors (see section 2)
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)
- Serious skin reactions
- Coma (if you are on very high doses)
Low potassium levels in the blood
(hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythm
- Pain in oesophagus (the tube that connects mouth with stomach) and other related symptoms, such as difficulties in swallowing, heartburn, throat irritation or chest pain
Patients who have syphilis have occasionally suffered from a type of reaction
(Jarisch-Herxheimer reaction) shortly after treatment, with fever, chills, headache and reactions at the site of lesions.
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 or search for MHRA Yellow Card in the Google Play or Apple App Store. 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 5 ml of reconstituted suspension contains Flucloxacillin Sodium equivalent to 125 mg of Flucloxacillin and Ampicillin Trihydrate equivalent to 125 mg 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 100 ml of suspension when reconstituted.
Product Licence Number:
PL 11311/0524
Marketing Authorisation Holder:
Tillomed Laboratories Limited
220 Butterfield, Great Marlings
Luton, LU2 8DL, United Kingdom
Manufacturer:
Tillomed Laboratories Ltd
3 Howard Road, Eaton Socon, St. Neots Cambridgeshire, PE19 8ET, United Kingdom
This leaflet was last revised in May 2023
Code 0325002LFT/Till-Ver.6
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