Document: leaflet MAH GENERIC_PL 31745-0020 change

• leaflet MAH GENERIC_PL 29831-0093
• leaflet MAH GENERIC_PL 31745-0020

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Flucloxacillin 250mg, 500mg or 1g, Powder for Solution for Injection or Infusion

Fludoxacillin as Flucloxacillin Sodium

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 or nurse.

•    This medicine has been prescribed for you. Do NOT pass it on to others. It may harm them even if their symptoms are the same as yours.

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

The name of your medicine is "Flucloxacillin 250mg, 500mg, 1g Powder for Solution for Injection or Infusion" (referred to as Flucloxacillin Injection throughout this leaflet).

1. WHAT FLUCLOXACILLIN IS AND WHAT IT IS USED FOR_

Your medicine contains the active substance flucloxacillin (as flucloxacillin sodium), which is one of a group of medicines called "penicillins". These medicines are also known as "antibiotics" and they work by killing the bacteria that cause infections.

Flucloxacillin injection is used to treat a wide range of bacterial infections which may include those affecting:

■    The chest (pneumonia, emphysema and lung abscess)

■    Tonsils (tonsillitis, quinsy)

■    Pharynx (pharyngitis)

■    Sinuses (sinusitis)

■    Ears (otitis media and otitis externa)

■    Skin and soft tissue (boils, abscesses, carbuncles, impetigo. Cellulites, furunculosis, ulcers and acne)

Flucloxacillin injection can also be used to prevent infections following skin grafts or during major surgical procedures, particularly in heart or orthopaedic surgery.

2. BEFORE YOU ARE GIVEN FLUCLOXACILLIN INJECTION_

Do not have Flucloxacillin Injection

You should not be given this medicine if:

•    You are allergic to flucloxacillin

•    You are allergic to penicillin, cephalosporins or other antibiotics

•    You have had jaundice (your skin and the whites of your eyes turn yellow) or you have had other liver problems when you have been given flucloxacillin previously.

You must tell your doctor or nurse if any of these apply to you.

Before you are given Flucloxacillin Injection

If any of the following apply to you, you must tell the doctor or nurse:

•    You have ever had a skin rash or swelling of the face or neck when taking an antibiotic

•    You are being treated for kidney problems or gout

•    You are being treated for liver problems

•    You are on a low sodium diet (See "Important information about some of the ingredients of Flucloxacillin injection")

•    You are aged 50 or above.

Taking other medicines:

If you are taking another medicine when Flucloxacillin injection is given, it can affect how Flucloxacillin or the other medicine works.

Examples of other medicines that can affect Flucloxacillin injection are:

•    Probenecid (used for the treatment of gout)

•    Oral contraceptives that contain oestrogen (the "pill").

If you are using the pill, you should take extra precautions (such as using a condom) while you are being treated with this medicine, and for at least 7 days afterwards.

Please tell your doctor or nurse if you are taking or have recently taken any other medicines including medicines obtained without a prescription.

Pregnancy and breast-feeding:

Tell the doctor or nurse if you are pregnant, think you might be pregnant or if you are breast feeding before you are given this medicine.

Driving and using machines

This medicine has no known effects on the ability to drive or use machines.

Important information about some of the ingredients of Flucloxacillin injection

The sodium content of each vial is 0.57mmol (250mg vial), 1.13mmol (500mg vial) and 2.26mmol (1g vial). This must be taken into consideration for patients on a controlled sodium diet.

Tell your doctor or nurse if this applies to you.

Flucloxacillin should not be given into the eye.

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INFORMATION FOR THE HEALTHCARE PROFESSIONAL

The following information is intended for medical or healthcare professionals only.

Incompatibilities

•    It is advisable not to combine flucloxacillin with other drugs in solution for parenteral administration.

•    Flucloxacillin should not be mixed with blood products or other proteinaceous fluids (e.g. protein hydrolysates) or with intravenous lipid emulsions.

•    If flucloxacillin is prescribed concurrently with an aminoglycoside, the two antibiotics should not be mixed in the syringe, intravenous fluid container or giving set as precipitation may occur.

Shelf life 36 months unopened. After opening: 24 hours.

Special precautions for storage Store below 25°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C unless reconstitution/ dilution has taken place in controlled and validated aseptic conditions.

Administration

Intramuscular: Add 1.5 ml Water for Injections to 250 mg vial contents. Add 2 ml Water for Injections to 500 mg vial contents.

Intravenous: Dissolve 250-500 mg in 5-10 ml Water for Injections. Dissolve 1 g in 15-20 ml Water for Injections. Administer by slow intravenous injection (three to four minutes). Flucloxacillin may also be added to infusion fluids or injected, suitably diluted, into the drip tube over a period of three to four minutes.

Intrapleural: Dissolve 250 mg in 5-10 ml Water for Injections.

Intra-articular: Dissolve 250-500 mg in up to 5 ml Water for Injections or 0.5% lidocaine hydrochloride solution. Nebuliser solution: Dissolve 125-250 mg of the vial contents in 3 ml sterile water.

| 3. HOW FLUCLOXACILLIN INJECTION IS GIVEN

Your doctor or nurse will prepare your injection in the form of a liquid. They will inject this into a muscle (intramuscular) or into a vein (intravenous). It can also be given to you by injection into a joint, or injection into the lining of the lung, or by breathing in the medicine from a mask (nebuliser).

Your doctor will decide how much you need each day and how often the injections should be given. The usual doses are as follows.

Adults and children over 10 years old:

The usual dose for treating infections is:

•    by intramuscular injection: 250mg four times a day.

•    by intravenous injection is 250mg to 1g four times a day.

•    by injection into the lining of the lung: 250mg once daily

•    by breathing in the medicine from a mask (nebuliser): 125mg to 250mg four times a day

•    by injection into a joint: 250mg to 500mg once daily

For infections of the bones and joints (osteomyelitis) or the heart (endocarditis) - up to 8g daily can be given in divided doses, every 6 to 8 hours.

To prevent infections after an operation, the usual dose is 1 to 2g before the operation when you are given your anaesthetic. This is then followed by 500mg four times a day for up to three days after your operation.

Children aged 10 years and below:

The usual dose for children aged two to ten is half the adult dose.

The usual dose for children under two years old is a quarter of the adult dose.

These doses can be increased in more serious infections.

If you are given more of this medicine than you should

This is unlikely to happen but if it does, the doctor will treat any symptoms that follow.

Like all medicines, Flucloxacillin Injection can cause side effects, although not everybody gets them.

If you get any of the following side effects soon after receiving this medicine, tell your doctor or nurse immediately. If you get them, you may have had a serious allergic reaction or other type of reaction to this medicine. You may need urgent medical attention:

•    Stomach pain or diarrhoea (possibly with bleeding)

•    Your skin or the whites of your eyes turn yellow

•    Your urine becomes darker or your faeces become paler

•    Any unexplained bleeding or bruising or skin discolouration

•    Skin rash and itching

•    Blistering of the skin, mouth, eyes or genitals

•    Any sudden wheeziness, difficulty in breathing or dizziness

•    Any swelling of the face, neck or tongue.

Some of these reactions can be delayed for several weeks after finishing treatment.

The following side effects may also occur. Tell your doctor if any of these become troublesome.

Common side effects (probably affecting more than 1 in 100 people given this injection)

•    Stomach upset.

Very Rare side effects (probably affecting fewer than 1 in 10,000 people given this injection)

•    Reduction in blood cell counts which makes infections more likely

•    Inflammation of the kidney which can cause swollen ankles or high blood pressure

•    Joint pain, muscle pain or fever. This may develop after 2 days or more from the start of treatment

•    Convulsions ("fits”) in patients taking high doses. Reporting of side effects

If you get any side effects, talk to your doctor, nurse, 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. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE FLUCLOXACILLIN INJECTION

Keep out of the reach and sight of children.

Store vials below 25°C. Your doctor, pharmacist or nurse will know how to store Flucloxacillin Injection properly.

Do not use after the expiry date which is printed on the label and carton, or if the powder shows signs of discoloration.

6. FURTHER INFORMATION_

What Flucloxacillin injection contains

Each vial contains 250mg, 500mg or 1g of Flucloxacillin (as flucloxacillin sodium). There are no other ingredients.

What Flucloxacillin injection looks like and contents of the pack:

Flucloxacillin injection is a white powder in a glass vial. Each carton contains 1, 5, 10, 20 or 50 glass vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Ibigen Srl

Via Fossignano 2, 04011 Aprilia (LT) Italy

Manufacturer:

Istituto Biochimico Italiano

Via Fossignano 2, 04011 Aprilia (LT)

Italy

This leaflet was last revised in January 2015.

Instructions for use and handling

Flucloxacillin powder for solution may be added to most intravenous fluids (e.g. Water for Injections, sodium chloride 0.9%, glucose 5%, sodium chloride 0.18% with glucose 4%).

N.B. FLUCLOXACILLIN VIALS ARE NOT SUITABLE FOR MULTIDOSE USE.

Any residual flucloxacillin should be discarded.

Posology and method of administration

Depends on the age, weight and renal function of the patient, as well as the severity of the infection.

Usual adult dosage (including elderly patients) Intramuscular - 250 mg four times a day.

Intravenous - 250 mg to 1 g four times a day.

The above systemic dosages may be doubled where necessary.

Osteomyelitis, endocarditis - Up to 8 g daily, in divided doses six to eight hourly.

Surgical prophylaxis - 1 to 2 g IV at induction of anaesthesia followed by 500 mg six hourly IV, IM or orally for up to 72 hours.

Flucloxacillin may be administered by other routes in conjunction with systemic therapy. (Proportionately lower doses should be given in children.)

Intrapleural - 250 mg once daily.

By nebuliser - 125 to 250 mg four times a day. Intra-articular - 250 to 500 mg once daily.

Usual children's dosage 2-10 years: half adult dose Under 2 years: quarter adult dose.

Abnormal renal function:

In common with other penicillins, flucloxacillin usage in patients with renal impairment does not usually require dosage reduction. However, in the presence of severe renal failure (creatinine clearance < 10 ml/min) a reduction in dose or an extension of dose interval should be considered. Flucloxacillin is not significantly removed by dialysis and hence no supplementary dosages need to be administered either during, or at the end of the dialysis period.

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