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AMPICLOX INJECTION 500MG

Active substance(s): AMPICILLIN SODIUM / CLOXACILLIN SODIUM

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Reason for update: GDS 14 & QRD Updates – Response to questions for variation update section 4.1 of SPC
MHRA Submission Date: 6 November 2014
MHRA Approval Date:
Text Date: October 2014
Text Issue and Draft No.: Issue 2 Draft 4
SPC Issue and Draft No.: Issue 2 Draft 5
CO Number: N/A

[GlaxoSmithKline Logo]
Package Leaflet: Information for the User

Ampiclox Injection
250mg ampicillin & 250mg cloxacillin
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, pharmacist or nurse.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.

What is in this leaflet
1
2
3
4
5
6

What Ampiclox is and what it is used for
What you need to know before you have Ampiclox
How Ampiclox is given
Possible side effects
How to store Ampiclox
Contents of the pack and other information

1 What Ampiclox is and what it is used for
What Ampiclox is
Ampiclox Injection (called Ampiclox in this leaflet) is an antibiotic and works by
killing bacteria that cause infections. It contains two different medicines called
ampicillin and cloxacillin. They both belong to a group of antibiotics called
‘penicillins’.

What Ampiclox is used for
Ampiclox is used in adults and children to treat the following infections:





infected wounds or lung infections following surgery
respiratory tract infections
fever associated with childbirth
bacteraemia

2 What you need to know before you have Ampiclox
Do not have Ampiclox if you:


are allergic (hypersensitive) to amoxicillin, cloxacillin or penicillin



have ever had an allergic (hypersensitive) reaction to any antibiotic. This can
include a skin rash or swelling of the face or neck.
Do not have Ampiclox if any of the above apply. If you are not sure, talk to your
doctor, pharmacist or nurse before having Ampiclox.

Look out for important symptoms
Ampiclox can make some existing conditions worse, or cause serious side effects
such as allergic reactions, bleeding and severe diarrhoea (pseudomembranous
colitis). You must look out for certain symptoms while you are taking Ampiclox, to
help reduce the risk of any problems. See section 4.

Take special care with Ampiclox
Check with your doctor, pharmacist or nurse before having this medicine if you:
 have ever had any reactions to antibiotics, including a skin rash or swelling of
the face or neck when taking any antibiotic
 are being treated for kidney or liver problems
 have glandular fever and/or leukaemia as you may develop a rash if you have
these conditions and take ampicillin
 are on a diet that restricts the amount of sodium you can eat.
If this medicine is being given to your baby, tell your doctor:
 if you (mother) are allergic to penicillin
 if your baby has jaundice (yellowing of the skin and/or eyes).
If you are not sure if any of the above apply to you, talk to your doctor,
pharmacist or nurse before you have Ampiclox.

Other medicines and Ampiclox
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.


If you are taking allopurinol (used for gout) with Ampiclox, it may be more
likely that you’ll have an allergic skin reaction.



If you are taking probenecid (used for gout), your doctor may decide to adjust
your dose of Ampiclox.



If you are taking methotrexate for conditions such as rheumatoid arthritis,
psoriasis or cancer, your doctor may decide to adjust your dose of Ampiclox

Ampiclox may stop the contraceptive pill working. You will need to use extra
contraceptive precautions, such as using a condom. If you need any advice, talk
to your doctor, pharmacist or nurse.

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.

Important information about one of the ingredients of Ampiclox
Each vial of Ampiclox contains 30 mg of sodium.
To be taken into consideration by patients on a controlled sodium diet.

3 How Ampiclox is given
You will never give yourself this medicine. A qualified person, like a doctor or a
nurse, will give you this medicine.
 Ampiclox will be given as an injection or an infusion into a vein (intravenously)
or muscle (intramuscularly).
 Your doctor will decide how much you need each day and how often the
injections should be given.
 Make sure you drink plenty of fluids while having Ampiclox.
The usual doses are as follows.
Adults, elderly patients and children over 10 years of age
One to two vials every four to six hours
Children 2 – 10 years
Half adult dose. Dosage may be further increased where necessary.
Children up to 2 years
Quarter adult dose.

Kidney and liver problems
If you have kidney or liver problems the dose might be lower than the usual dose.

If more Ampiclox is given to you than recommended
It is unlikely you will be given too much, but if you think you have been given too
much Ampiclox, tell your doctor, pharmacist or nurse immediately. Signs might
be an upset stomach (feeling sick, being sick or diarrhoea) or neurotoxic
symptoms (limb weakness or numbness, loss of memory, loss of vision,
headache) in very high doses. You may also experience these signs if you have
kidney problems.

If you think you have missed an injection of Ampiclox
Speak to your doctor, pharmacist or nurse.

How long will you need to take Ampiclox for?
Your doctor will tell you how long you will need to be given your medication.
If you have any further questions on the use of this medication, ask your doctor,
pharmacist or nurse.

4 Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody
gets them. The following side effects may happen with this medicine.
Tell your doctor or nurse straight away if you notice any of the following
serious side effects – you may need urgent medical treatment:
The following are very rare (affects less than 1 in 10,000 people)
 allergic reactions, the signs may include: skin itching or rash, swelling of the
face, lips, tongue, body or breathing difficulties.
 rash or pinpoint flat red round spots under the skin surface or bruising of the
skin. This is due to inflammation of blood vessel walls due to an allergic
reaction. It can be associated with joint pain (arthritis) and kidney problems
 a delayed allergic reaction can occur usually 7 to 12 days after having
Ampiclox, some signs include: rashes, fever, joint pains and enlargement of
the lymph nodes especially under the arms
 a skin reaction known as ‘erythema multiforme’ where you may develop: itchy
reddish purple patches on the skin especially on the palms of the hands or
soles of the feet, ‘hive-like’ raised swollen areas on the skin, tender areas on
the surfaces of the mouth, eyes and private parts. You may have a fever and
be very tired
 other severe skin reactions can include: changes in skin colour, bumps under
the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These
may be associated with fever, headaches and body aches
 high temperature (fever), chills, a sore throat or other signs of an infection, or
if you bruise easily. These may be signs of a problem with your blood cells
 inflammation of the large bowel (colon) with diarrhoea sometimes containing
blood, pain and fever
 serious liver side effects may occur which are often reversible. You must tell
your doctor or nurse urgently if you get:
severe diarrhoea with bleeding
blisters, redness or bruising of the skin
darker urine or paler stools
yellowing of the skin or the whites of the eyes (jaundice). See also
anaemia below which might result in jaundice.
These can happen when having the medicine or for up to several weeks after.
If any of the above happen to you talk to your doctor or nurse straight away
as your medicine should be stopped.
Sometimes you may get less severe skin reactions such as:



a mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on
forearms, legs, palms, hands or feet. This is uncommon (affects less than 1 in
100 people).
If you have any of these talk to your doctor or nurse as Ampiclox will need
to be stopped.
The other possible side effects are:
Common (may affect up to 1 in 10 people)
 skin rash
 feeling sick (nausea)
 diarrhoea.
Uncommon (may affect up to 1 in 100 people)
 being sick (vomiting).
Very rare (may affect up to 1 in 10,000 people)
 kidney problems
 fits (convulsions), seen in patients on high doses or with kidney problems
 sudden, involuntary jerking or a muscle or group of muscles
 hyperactivity
 an excessive breakdown of red blood cells causing a form of anaemia. Signs
include: tiredness, headaches, shortness of breath, dizziness, looking pale
and yellowing of the skin and the whites of the eyes
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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 provide more information on the safety of
this medicine.

5 How to store Ampiclox
Ampiclox is for use in hospital only and the expiry date and storage instructions
stated on the vial label and carton are for the doctor, nurse or pharmacist’s
information. The doctor, pharmacist or nurse will make up your medicine.

6 Contents of the pack and other information
What Ampiclox contains


Each 500 mg vial of Ampiclox Injection contains ampicillin 250 mg and
cloxacillin 250 mg.
There are no other ingredients. However, for information about sodium in
Ampiclox, please see section 2 Important information about one of the
ingredients of Ampiclox.



The doctor, nurse or pharmacist will make up the injection before use using
an appropriate fluid (such as Water for Injections or an injection/infusion fluid).

What Ampiclox looks like and contents of the pack
Ampiclox is supplied as a clear glass vial of sterile powder for making up as an
injection. The vials are packed in cartons of 10.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Beecham Group plc, 980 Great West Road,
Brentford, Middlesex TW8 9GS
Manufacturer: SmithKline Beecham, Worthing, West Sussex BN14 8QH

Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please
call, free of charge:

0800 198 5000 (UK Only)
Please be ready to give the following information:
Product name
Reference number

Ampiclox Injection
00038/5003R

This is a service provided by the Royal National Institute of Blind People.
Leaflet date: October 2014
Ampiclox is a registered trademark of the GlaxoSmithKline group of companies
© [year] GlaxoSmithKline group of companies
[GlaxoSmithKline Logo]

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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