Fortum Injection: Consumer Medicine Information

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Consumer Medicine Information

FORTUM INJECTION
Ceftazidime pentahydrate, 500 mg, 1 g and 2 g injection

What is in this leaflet


Please read this leaflet carefully.

This leaflet answers some common questions about FORTUM injection. It does not contain all of the
available information.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you being administered
Fortum Injection against the benefits this medicine is expected to have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet. You may need to read it again.

What FORTUM is used for


FORTUM Injection contains an antibiotic called ceftazidime, which treats infections caused by
bacteria, in different parts of the body.

FORTUM injection belongs to a group of antibiotics called cephalosporins. These antibiotics work by
either killing the bacteria that cause the infections or stopping their growth.

FORTUM will not work against infection cased by viruses such as colds or the flu (influenza).

Ask your doctor if you have any questions or if you aren't sure why FORTUM injection has been
prescribed for you.

FORTUM is only available with a doctor's prescription.

FORTUM is not addictive.

Before you are given FORTUM


When you must not be given it
Do not use FORTUM if you have ever had an allergic reaction to FORTUM, other cephalosporins or
any of the ingredients listed at the end of this leaflet.

Before you start using FORTUM


You must tell your doctor if:

you have had an allergic reaction to penicillin or cephalosporin antibiotics


You may have an increased chance of being allergic to FORTUM if you are allergic to penicillins.
you have had or have kidney problems
you need a low salt intake
you are pregnant, trying to become pregnant or breastfeeding

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you are taking any other medicines, including medicines you buy without a prescription from a
pharmacy, supermarket or health food shop.
Some medicines may affect the way others work. Your doctor or pharmacist will be able to tell you
what to do when using FORTUM with other medicines such as chloramphenicol and aminoglycoside
antibiotics.

How FORTUM is given


FORTUM can be given in two ways:

as a slow injection into a vein


as a deep injection into a large muscle
Fortum is generally administered by a doctor or a nurse in a hospital.

Your doctor will decide on the dose and the length of time that you will receive FORTUM. This
depends on the severity of your infection and other factors such as your weight. FORTUM is generally
given twice a day.

If too much FORTUM is given (overdose)


You may experience symptoms such as convulsions and coma. Tell your doctor if you are feeling
unwell.

While you are using FORTUM


Things you must do
Tell your doctor if your infection symptoms don't improve or they become worse.
Tell your doctor if you get a sore, white mouth or tongue while using or soon after stopping
FORTUM.
Tell your doctor if you get vaginal itching or discharge.
This may mean that you have a fungal infection called thrush. The use of FORTUM sometimes
allows fungi to grow, causing the above symptoms. FORTUM does not work against fungi.
Tell your doctor if you become pregnant or you are breastfeeding.
If you have any urine tests while taking FORTUM, tell your doctor. FORTUM may affect the
results of some urine tests.

Things you must not do


Do not give this medicine to anyone else, even if their symptoms seem similar to yours.

Things to be careful of
FORTUM can cause side effects that affect your ability to drive, such as dizziness. Don’t drive or use
machines unless you are sure you’re not affected.

Side-Effects
Tell your doctor or pharmacist as soon as possible if you have any problems while using FORTUM
even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

Like other medicines, FORTUM can cause some side effects. If they occur, they are most likely to be
minor and temporary. However, some may be serious and need medical attention.

Some reported side effects are:

White, furry, sore tongue and mouth (oral thrush)


Sore, itchy vagina and/or discharge (vaginal thrush)

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Swelling, pain or tenderness at the injection site
Diarrhoea, feeling sick (nausea), vomiting, stomach pain
Bad taste in the mouth
Headache
Dizziness
Tingling sensations
These are more common side effects. If any of these side effects persist, or are troublesome, see your
doctor or pharmacist.

If you have any of the following, contact your doctor promptly:

fits (seizures)
tremor
confusion
jaundice – yellowing of the skin possibly with nausea and vomiting and low energy.
Severe chills, sore throat or mouth ulcers
Tendency to bruise or bleed easily
These may be more serious side effects. They are rare.

If you think you are having an allergic (hypersensitivity) reaction to FORTUM, TELL YOUR
DOCTOR IMMEDIATELY or go to the emergency department at your nearest hospital.
Symptoms include:

Severe skin rash, itching or hives


Swelling of the face, lips, mouth or throat
Difficulty breathing and swallowing
Fever
Low blood pressure
This is a rare but serious side effect and needs immediate medical attention.

Tell your doctor immediately if you notice any of the following side effects, particularly if they
occur several weeks after stopping treatment with FORTUM:

severe abdominal/stomach cramps


watery and severe diarrhoea, which may also be bloody
fever, in combination with one or both of the above
You may have a serious condition affecting your bowel. Therefore, you may need urgent medical
attention. However, this side effect is rare.

Do not take any diarrhoea medicine without first checking with your doctor.

Ask your doctor or pharmacist to answer any questions you may have.

This is not a complete list of all possible side effects.

Tell your doctor if you notice anything else that is making you feel unwell, even if it is not on this list.

Ask your doctor or pharmacist if you don't understand anything in this list.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using FORTUM


Storage
FORTUM powder vials should be stored in a cool, dry place, below 25°C.

Protect the vial from direct sunlight.

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Do not put the vial in the freezer.

Do not store the medicine, in a bathroom or near a sink.

Keep your product in its pack until it is time to use it.

If you take the product out of its packaging it may not keep well.

Product description
What FORTUM looks like
FORTUM is a white to faintly yellow powder. When water is added, FORTUM dissolves with
effervescence (fizzing) and becomes a clear solution.

The powder comes in a vial packed into a box. Each vial contains either 500 mg, 1 g or 2 g ceftazidime
pentahydrate.

Ingredients
Each 1 g of FORTUM contains 52 mg of sodium (118 mg sodium carbonate per gram of ceftazidime).

Supplier
Your FORTUM Injection is supplied by:

GlaxoSmithKline NZ Limited
Private Bag 106600
Downtown
Auckland
NEW ZEALAND

Phone: (09) 367 2900


Fax: (09) 367 2910

Further Information
This is not all the information that is available on FORTUM. If you have any more questions or are not
sure about anything, ask your doctor or pharmacist.

Pharmaceutical companies are not in a position to give people an individual diagnosis or medical
advice. Your doctor or pharmacist is the best person to give you advice on the treatment of your
condition. You may also be able to find general information about your disease and its treatment from
books, for example in public libraries.

Do not throw this leaflet away. You may need to read it again.

The information provided applies only to: FORTUM

Version 4.0, 16 June 2017

Trade marks are owned by or licensed to the GSK group of companies.

© 2017 GSK group of companies or its licensor.

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