NTS033I 150X210 05/03/13 09:12 Pagel

PACKAGE LEAFLET: INFORMATION FOR THE USER METRONIDAZOLE MACOPHARMA 0.5%w/v SOLUTION FOR INFUSION (metronidazole)

Read all of this leaflet carefully before being given 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 or nurse

-    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet

1.    What Metronidazole MacoPharma 0.5%w/v Solution for Infusion is and what it is used for

2.    What you need to know before you are given Metronidazole MacoPharma 0.5%w/v Solution for Infusion

3.    How Metronidazole MacoPharma 0.5%w/v Solution for Infusion is given

4.    Possible side effects

5.    How to store Metronidazole MacoPharma 0.5%w/v Solution for Infusion

6.    Contents of the pack and other information

1. WHAT METRONIDAZOLE MACOPHARMA 0.5%w/v SOLUTION FOR INFUSION IS AND WHAT IT IS USED FOR

Metronidazole is an antibiotic used in adults and children to treat severe infection caused by certain anaerobic bacteria, ie bacteria which do not live or grow in the presence of oxygen.

It may also be used to prevent infection in patients who cannot be treated by mouth.

The solution is mainly used in abdominal and gynaecological surgery and will be given to you by slow injection into a vein by a doctor or nurse.

2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN METRONIDAZOLE MACOPHARMA 0.5%w/v SOLUTION FOR INFUSION

You must NOT be given this solution if you have ever had:

•    an allergy (hypersensitivity) to metronidazole or any of the other ingredients in the solution (see Section 6)

•    acute pancreatitis, or pancreatitis as a serious side effect to metronidazole.

Warnings and precautions

Talk to your doctor or nurse if you:

•    have liver disease (the amount of medicine you are given may be reduced or given less often)

•    have any disease or condition affecting the brain or nervous system

•    are receiving the solution intensively, or for more than 10 days - you will be closely monitored

•    are pregnant, think you may be pregnant, or are breastfeeding

Treatment will be stopped if signs of nervous system problems develop.

Other medicines and Metronidazole MacoPharma 0.5%w/v Solution for Infusion

Tell your doctor if you are taking or have recently taken any other medicines.

In particular, the following medicines may affect, or be affected by, metronidazole:

•    anti-coagulants (blood thinning agents), such as warfarin or coumarins. The dose of warfarin may need to be reduced if you are taking this drug.

•    lithium (used to treat depression). If taken at the same time as metronidazole, your kidneys may be affected. Lithium treatment should be withdrawn or gradually reduced before receiving metronidazole. Additional blood tests will be done during treatment.

•    phenobarbitone or phenytoin (to treat epilepsy)

•    5-fluorouracil (to treat tumours)

•    vecuronium (used in anaesthesia)

•    cimetidine (to treat stomach ulcers)

•    disulfiram and metronidazole together may cause psychotic effects.

Some laboratory tests may also be affected during treatment with metronidazole.

The solution may also be given at the same time (but separately) as other appropriate antimicrobial medicines in injection form.

Metronidazole MacoPharma 0.5%w/v Solution for Infusion with food, drink and alcohol

You must NOT drink alcohol during treatment or for 48 hours after treatment with metronidazole.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor for advice before being given this

Driving and using machines

If you feel dizzy or drowsy after receiving this medicine then you must not drive or operate machinery.

Metronidazole MacoPharma 0.5%w/v Solution for Infusion contains sodium.

This product contains 15 mmol or 340 mg sodium per bag which needs to be taken into consideration by patients on a sodium-controlled diet.

3. HOW METRONIDAZOLE MACOPHARMA 0.5%w/v SOLUTION FOR INFUSION IS GIVEN

This solution will be given to you by slow injection into a vein (usually in your arm) by a doctor or nurse. It should take 10 -20 minutes to receive the contents of a 100ml bag.

Adults and children over 12 years: one 100ml bag is usually given every 8 hours. This dose may differ if you are having surgery.

Children over 8 weeks up to 12 years: The usual daily dose is 4-6ml/kg/day as a single dose or 1.5ml/kg every 8 hours. In severe infections the dose may be increased to 8ml/kg/day.

Babies under 8 weeks: 3ml/kg as a single dose daily or 1.5ml/kg every 12 hours.

Children doses given before surgery:

Children over 40 weeks up to 12 years: 4-6ml/kg as a single dose Babies under 40 weeks: A single dose of 2ml/kg is given before surgery.

Elderly: your doctor will decide the amount you will receive.

Treatment usually lasts for 7 days, but may be longer depending on your condition and response to treatment. Your doctor will decide how long treatment is needed for.

As soon as possible, your doctor will change your treatment from an injection to tablets (taken by mouth).

If you are receiving treatment for more than 10 days, your doctor will do blood tests and monitor you regularly.

If you are given more Metronidazole MacoPharma 0.5%w/v Solution for Infusion than you should

It is unlikely you will be given too much solution as your doctor or nurse will monitor the amount you receive. If you are concerned about the volume of solution given, or are worried about any effects you notice, talk to the doctor or nurse. If the side effects are severe the treatment may have to be stopped.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Important side effects or symptoms to look out for. If you think you may have any of the following side effects or symptoms, tell the doctor or nurse immediately.

•    If you have an allergic reaction to the medicine, tell the doctor or nurse immediately as treatment must be stopped. Symptoms of an allergic reaction are rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue. This is rare (affecting fewer than 1 in 1000 patients) and unlikely to happen.

The following are very rare side affects (affecting fewer than 1 in 10,000 patients):

•    confusion, fever, headache, hallucinations, paralysis, light sensitivity, disturbances in sight and movement, or a stiff neck.

•    severe pain in the abdomen and back.

•    yellowing of the skin or whites of the eyes caused by liver or blood problems.

Other possible side effects

You may feel some irritation and discomfort at the site of injection. This will disappear.

Very rare side effects (affecting fewer than 1 in 10,000 patients). Some of these symptoms disappear on reducing or stopping treatment

•    tingling, numbness in fingers and toes, or epilepsy seen in patients having high dose treatment for a long time

•    skin rash redness or sores, itchy skin

•    visual problems

•    severe bleeding or bruising (due to blood disorders)

•    severe infections (due to low blood cell count)

•    fits (convulsions)

•    drowsiness, dizziness

•    darkening of the urine

•    muscle or joint pain.

•    weakness and lack of coordination of movement.

Side effects where the frequency is not known:

•    nausea, upset stomach, diarrhoea, anorexia, unpleasant taste in the mouth, furred tongue, sore mouth

•    change in mood, depression, sleeplessness.

Results of some liver function laboratory tests may be abnormal.

Side effects are the same in adults and children.

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

5. HOW TO STORE METRONIDAZOLE MACOPHARMA 0.5%w/v SOLUTION FOR INFUSION

Keep this medicine out of the sight and reach of children.

Do not store above 25°C. Store in the original outer container in order to protect from light.

Do not freeze. Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.

The solution should only be used if it is clear without visible particles and the container is not damaged. It should be used immediately on removal from the overwrap. For single use only. Any unused solution in the bag must oe discarded.

Do not throw away any medicines via wastewater or household waste. The doctor or nurse will dispose of this medicine. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Metronidazole MacoPharma 0.5%w/v Solution for Infusion contains

The active substance is metronidazole (500mg of metronidazole per 100ml)

The other ingredients are sodium chloride, anhydrous disodium phosphate, citric acid monohydrate and water for injections.

What Metronidazole MacoPharma 0.5%w/v Solution for Infusion looks like and contents of the pack

Metronidazole MacoPharma 0.5%w/v Solution for Infusion is a clear yellow solution without visible particles.

The solution for infusion is packaged in a plastic bag or flexible container with an integral infusion set for direct connection to a catheter. It is available in a pack size of 100ml.

Marketing Authorisation Holder

Maco Pharma (UK) Ltd - 8th Floor - Regal House 70 London Road - Twickenham Middlesex TW1 3QS - United Kingdom

Manufacturer

Maco Productions SAS

Rue Lorthiois - 59420 Mouvaux - France

Distributor in Ireland

Technopharm Limited - Pharmapark - Chapelizod Dublin 20

This leaflet was last revised in MM/YYYY.

PL 12580/0010    PA 931/3/1

For information on CD, please contact the Royal National Institute of Blind People. Central phone number:

(+44) 0800 198 5000.

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