Amoxicillin Sodium for Injection

INFORMATION FOR PATIENTS

Please read this leaflet carefully before this medicine is administered. It gives an outline of the more important things you should know. If you want to know more about this medicine or you are not sure about anything, ask your doctor, dentist, nurse or pharmacist. You should keep this leaflet throughout your course of treatment.

THE NAME OF YOUR MEDICINE IS AMOXICILLIN SODIUM FOR INJECTION BP

Amoxicillin Sodium for Injection BP contains the active ingredient amoxicillin as Amoxicillin Sodium BP. Each vial contains 250mg, 500mg or 1g of Amoxicillin.

Amoxicillin Sodium for Injection BP is a white powder for solution for injection.

Amoxicillin Sodium for Injection BP 250mg and 500mg are available in packs containing 10 vials. Amoxicillin Sodium for Injection BP 1g is available in single packs.

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for the Product Licence holder

HOW DOES YOUR MEDICINE WORK?

Amoxicillin belongs to a group of medicines called penicillins which are antibiotics. These medicines work by killing bacteria that cause infections.

WHAT IS AMOXICILLIN SODIUM FOR INJECTION BP FOR?

Amoxicillin Sodium for Injection BP is used for the treatment of a range of bacterial infections including gall bladder infection, bone and joint infections, chest infections, gastroenteritis (gut infections), gonorrhoea (a sexually transmitted infection), mouth infections, sinusitis, ear infections, typhoid, urinary infections, meningitis and Lyme disease (an infection due to tick bites). It is also used to protect against infection of the heart valves after dental procedures and other operations, due to bacteria in the bloodstream.

BEFORE ADMINISTRATION OF THIS MEDICINE

Amoxicillin Sodium for Injection BP should not be administered if:-

• You are allergic to amoxicillin or any other penicillin. You should also let your doctor know if you are allergic to any other drugs (besides penicillin) before the injection is administered.
• You have glandular fever or a tumour of the lymph glands (lymphoma).
• The infection is caused by penicillin-resistant bacteria.

Before administration of this medicine, you should let your doctor or dentist know if you are pregnant or breast-feeding or planning to become pregnant or start breast-feeding.

Taking another medicine when Amoxicillin Sodium for Injection BP is administered can affect how it or the other medicine works. Make sure that your doctor or dentist knows what other medicines you are taking. Do not take any other medicines while you are being treated with Amoxicillin Sodium for Injection BP unless you have told your doctor, dentist, nurse or pharmacist and asked for advice. This includes medicines you may have bought yourself.

Examples of medicines that can affect Amoxicillin Sodium for Injection BP are:-

• Oral contraceptives that contain oestrogen e.g. the combined pill.
• Probenecid, a drug used for the treatment of gout.
• Methotrexate, a drug used in the treatment of inflammation.
• Some other antibiotics, such as chloramphenicol.
• Allopurinol, a drug used to prevent gout

If you have any doubts about whether you should be given this medicine then talk to your doctor.

ADVICE WHEN AMOXICILLIN SODIUM FOR INJECTION BP IS ADMINISTERED

• Care is required if you are prone to urinary infections.
• If you are using an oral contraceptive ("the pill") you should take other precautions as well while you are having amoxicillin and for at least seven days afterwards. If these seven days run beyond the end of a packet you should start the next packet immediately, without a break.
• Care is required if you are given a high dose of amoxicillin, especially if you have kidney or heart problems. You will be carefully monitored during high dose or long-term treatment.
• Care is required if you have syphilis (a sexually transmitted disease), leukaemia or AIDS. You should let your doctor, dentist or nurse know.
• Patients with a sore throat for no apparent reason should ideally not be given amoxicillin, in case they have glandular fever.

ADMINISTERING THIS MEDICINE

Your doctor, dentist or nurse will prepare your injection by mixing your medicine with a diluent, either in the vial or in another container. The mixture is usually injected intramuscularly (into a muscle) or slowly intravenously (into a vein) over three to four minutes using a syringe or over 30 to 60 minutes with a drip (infusion).

The usual adult dose for treatment of infection by intramuscular injection is 500mg every eight hours. The usual adult dose by intravenous injection is 500mg every eight hours or 1g every six hours for severe infection.

The usual dose for children up to ten years old for treatment of infection is 50 to 100mg per kg bodyweight daily in divided doses.

The usual adult dose for prevention of infection following dental procedures and other operations is 1g before the anaesthetic given by intravenous or intramuscular injection.

The usual dose for prevention of infection following dental procedures and other operations in children under five years old is a quarter of the adult dose and in children aged five to ten years, half of the adult dose.

Dosage will be reduced if you have kidney problems.

Your doctor or dentist will decide the dose which is best for you. If you do not understand, or are in any doubt, ask your doctor, dentist or nurse.

ARE THERE ANY SIDE-EFFECTS?

Like many medicines amoxicillin may cause side-effects in some patients, particularly when it is first given. Amoxicillin Sodium for Injection BP may cause allergic reactions such as rash, fever, aching joints, swelling, jaundice and blood in the urine. You should tell your doctor or dentist immediately if you develop any of these, even if they occur some weeks after you have stopped having the injections.

The side effects that some other patients have had with amoxicillin include feeling tired with mouth and throat ulcers, thirst, a tendency to bleed easily, fits (convulsions) and other problems affecting the nervous system. These occur most commonly with patients who have kidney problems or who have been given high doses of amoxicillin.

Antibiotic treatment can affect the normal bacteria in the gut, causing new infection (colitis). You should tell your doctor if you develop diarrhoea.

Patients who have syphilis have occasionally suffered from a reaction after the injection, with fever, chills, headache and heart problems.

If you experience any other side-effects or feel that the medicine is affecting you badly, tell your doctor or pharmacist.

SAFE KEEPING FOR THIS MEDICINE

• This medicine should not be administered if the expiry date on the label has passed or if the powder shows signs of "going off" such as discoloration.
• The vials should be kept below 25°C.
• Amoxicillin Sodium for Injection BP should be kept in a secure place where children cannot get at it.