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Fortum For Injection 250mg

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Package Leaflet: Information for the User

Fortum® for Injection 250 mg ceftazidime

Read all of this leaflet carefully before you start using this medicine.

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

• If you have any further questions, ask your doctor.

• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

1 What Fortum is and what it is used for

2 Before you are given Fortum

3 How Fortum is given

4 Possible side effects

5 How to store Fortum

6 Further information

1. What Fortum is and what it is used for

Fortum is an antibiotic used in adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Fortum is used to treat severe bacterial infections of:

• the lungs or chest

• the lungs and bronchi in patients suffering from cystic fibrosis

• the brain (meningitis)

• the ear

• the urinary tract

• the skin and soft tissues

• the abdomen and abdominal wall (peritonitis)

• the bones and joints.

Fortum can also be used:

• to prevent infections during prostate surgery in men

• to treat patients with low white blood cell counts (neutropenia) who have a fever due to a bacterial infection.

2. Before you are given Fortum

You must not be given Fortum:

• If you are allergic (hypersensitive) to ceftazidime, or any of the other ingredients of this medicine (listed in section 6).

• If you have had a severe allergic reaction to any other antibiotic (penicillins, monobactams and carbapenems) as you may also be allergic to Fortum.

^ Tell your doctor before you start on Fortum if you think that this applies to you. You must not be given Fortum.

Take special care with Fortum

You must look out for certain symptoms such as allergic reactions, nervous system disorders and gastrointestinal disorders such as diarrhoea while you are being given Fortum. This will reduce the risk of possible problems. See (‘Conditions you need to look out for) in section 4. If you have had an allergic reaction to other antibiotics you may also be allergic to Fortum.

If you need a blood or urine test

Fortum can affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are having tests:

^ Tell the person taking the sample that you have been given Fortum.

Taking other medicines

Tell your doctor if you are taking any other medicines, if you’ve started taking any recently or you start taking new ones. This includes medicines you can obtain without a prescription.

You shouldn’t be given Fortum without talking to your doctor if you are also taking:

• an antibiotic called chlorampenicol

• a type of antibiotic called aminoglycosides e.g. gentamicin, tobramycin

• water tablets called furosemide

^ Tell your doctor if this applies to you.

Pregnancy and breast-feeding

Tell your doctor before you are given Fortum:

• If you are pregnant, think you might be pregnant or are planning to become pregnant

• If you are breast-feeding

Your doctor will consider the benefit of treating you with Fortum against the risk to your baby.

Driving and using machines

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.

Important information about some of the ingredients of Fortum Fortum contains sodium

You need to take this into account if you are on a controlled sodium diet.

Fortum Strength	Amount per vial
Fortum 250 mg	13 mg

3. How Fortum is used

Fortum is usually given by a doctor or a nurse. It can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle.

Fortum is made up by the doctor, pharmacist or nurse using water for injections or a suitable infusion fluid.

The usual dose

The correct dose of Fortum for you will be decided by your doctor and depends on: the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys are working.

Newborn babies (0-2 months)

For every 1 kg the baby weighs, they’ll be given 25 to 60 mg Fortum per day divided in two doses.

Babies (over 2 months) and children who weigh less than 40 kg

For every 1 kg the baby or child weighs, they’ll be given 100 to 150 mg of Fortum

per day divided in three doses. Maximum 6 g per day.

Adults and adolescents who weigh 40 kg or more 1 to 2 g of Fortum three times daily. Maximum of 9 g per day.

Patients over 65

The daily dose should not normally exceed 3 g per day, especially if you are over 80 years of age.

Patients with kidney problems

You may be given a different dose to the usual dose. The doctor or nurse will decide how much Fortum you will need, depending on the severity of the kidney disease. Your doctor will check you closely and you may have more regular kidney function tests.

If you are given more Fortum than you should

If you accidentally use more Fortum than your prescribed dose, contact your doctor or nearest hospital straight away.

If you forget to use Fortum

If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Don’t take a double dose (two injections at the same time) to make up for a missed dose.

If you stop using Fortum

Don’t stop taking Fortum unless your doctor tells you to. If you have any questions ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Fortum can cause side effects, although not everybody gets them. Conditions you need to look out for

The following serious side effects have occurred in a small number of people but their exact frequency is unknown:

• severe allergic reaction. Signs include raised and itchy rash, swelling,

sometimes of the face or mouth causing difficulty in breathing.

• Skin rash, which may blister, and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge).

• A widespread rash with blisters and peeling skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).

• Nervous system disorders: tremors, fits and, in some cases coma. These have occurred in people when the dose they are given is too high, particularly in people with kidney disease.

^ Contact a doctor or nurse immediately if you get any of these symptoms.

Common side effects

These may affect up to 1 in 10 people:

• diarrhoea

• swelling and redness along a vein

• red raised skin rash which may be itchy

• pain, burning, swelling or inflammation at the injection site.

^ Tell your doctor if any of these are troubling you.

Common side effects that may show up in blood tests:

• an increase in a type of white blood cell (eosinophilia)

• an increase in the number of cells that help the blood to clot

• an increase in liver enzymes.

Uncommon side effects

These may affect up to 1 in 100 people:

• inflammation of the gut which can cause pain, or diarrhoea which may contain blood

• thrush (fungal infections in the mouth or vagina)

• headache

• dizziness

• stomach ache

• feeling sick or being sick

• fever and chills.

^ Tell your doctor if you get any of these.

Uncommon side effects that may show up in blood tests:

• a decrease in the number of white blood cells

• a decrease in the number of blood platelets (cells that help the blood to clot)

• an increase in the level of urea, urea nitrogen or serum creatinine in the blood.

Other side effects

Other side effects have occurred in a small number of people but their exact frequency is unknown:

• inflammation or failure of the kidneys

• pins and needles

• unpleasant taste in the mouth

• yellowing of the whites of the eyes or skin.

Other side effects that may show up in blood tests:

• red blood cells destroyed too quickly

• an increase in a certain type of white blood cells

• severe decrease in the number of white blood cells.

If you get side effects

^ Tell your doctor or pharmacist if any of the effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.

5. HOW TO STORE FORTUM

Keep out of the reach and sight of children.

Fortum 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. FURTHER INFORMATION What Fortum contains

• Fortum is available in the following strengths: 3 g, 2 g, 1 g and 500 mg. The active substance is 3 g, 2 g, 1 g or 500 mg of ceftazidime (present as ceftazidime pentahydrate).

• The only other ingredient is sodium carbonate (anhydrous sterile).

• See section 2 for further important information about sodium, one of the ingredients of Fortum.

What Fortum looks like and contents of the pack

Fortum 3 g, 2 g, 1 g and 500 mg is supplied as sterile powder in glass vials. Each individual vial is packed in a carton. These are supplied to the hospital in packs of 1 or 5 for all except the 3 g strength which is only available as a single pack. Your doctor, pharmacist or nurse will make the injection or infusion up with Water for Injections or a suitable infusion fluid. When made up, Fortum varies in colour from light yellow to amber. This is perfectly normal.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex. UB11 1BT

Manufacturer: GlaxoSmithKline Manufacturing S.p.A., Verona, Italy.

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)

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Product names Fortum for Injection 250 mg

Reference numbers 00004/0304

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Leaflet date: September 2012