Metronidazole 5 Mg/Ml Solution For Infusion
Day210
Metronidazole 5mg/ml Solution for Infusion
PL 00289/1466
UK/H/4504/01/DC
PACKAGE LEAFLET: INFORMATION FOR THE USER Metronidazole 5 mg/ml Solution for Infusion
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 pharmacist.
- 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 gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Metronidazole is and what it is used for
2. Before you are given Metronidazole
3. How you will be given Metronidazole
4. Possible side effects
5. How to store Metronidazole
6. Further information
1. WHAT METRONIDAZOLE IS AND WHAT IT IS USED FOR
Metronidazole 5 mg/ml Solution for Infusion (called Metronidazole in this leaflet) contains an ingredient called metronidazole. This belongs to a group of medicines called antibiotics.
It works by killing the bacteria that cause infections in your body.
It can be used to:
• Treat infections of the blood, brain, lung, bones, genital tract, pelvic area and stomach
• Prevent infections after surgery
If you need any further information on your illness, speak to your doctor.
2. BEFORE YOU ARE GIVEN METRONIDAZOLE You must NOT be given Metronidazole if you are:
- allergic (hypersensitive) to metronidazole or any of the other ingredients of Metronidazole (see section 6).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue.
Do not have Metronidazole if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before receiving your medicine.
Take special care with Metronidazole and check with your doctor before being given your medicine if:
- you have or have ever had a liver problem
- you are having kidney dialysis (see section 3: ‘People having dialysis’).
If you are not sure if any of the above apply to you, talk to your doctor before receiving your medicine. Do this even if thay have applied in the past.
Before you are given Metronidazole
Tell your doctor or pharmacist if you are:
- suffering from disease of the nervous system
- pregnant or breast-feeding, or think you might be pregnant
- undergoing kidney dialysis
- taking any other medicines. Some medicines may change the way metronidazole works, e.g. warfarin, lithium, phenobarbital, colestyramine, phenytoin cimetidine and cyclosporine. Always tell your doctor about any other medicine you are taking whether on prescription or bought by yourself.
If you have to go to a doctor, dentist or hospital for any reason, tell them that you are receiving metronidazole.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines. This is because Metronidazole can affect the way some other medicines work. Also, some other medicines can affect the way Metronidazole works.
In particular tell your doctor if you are taking any of the following medicines:
• Medicines used to thin the blood such as warfarin
• Lithium for mental illness
• Phenobarbital for epilepsy
• 5 fluorouracil for cancer
• Busulfan for leukaemia (cancer of the blood cells)
• Cimetidine for heartburn or stomach ulcers
• Ciclosporin used to prevent the rejection of organs after transplant.
• Carbamazepine for epilepsy and bipolar
• Tacrolimus, an immunosuppressant
• Amiodarone for irregular heart beat
• Mycophenolat mophetil, an immunosuppressant used following transplant surgery
• Contraceptive drugs
If you are not sure, talk to your doctor before receiving your medicine.
Using Metronidazole with food and drink
Do NOT drink any alcohol while receiving Metronidazole , and for 48 hours after finishing your course. Drinking alcohol whilst you are being treated might cause unpleasant side effects, such as feeling sick (nausea), being sick (vomiting), stomach pain, hot flushes, very fast or uneven heart rate (tachycardia), and headache.
Pregnancy and breast-feeding
Tell your doctor before receiving Metronidazole if:
• you are pregnant, might become pregnant or think you may be pregnant. Metronidazole should not be given during pregnancy unless considered absolutely necessary
• you are breast-feeding. It is better not to use Metronidazole if you are breast-feeding. This is because small amounts may pass into the mother’s milk.
Driving and using machines
While taking Metronidazole you may feel sleepy, dizzy, confused, see or hear things that are not there (hallucinations), have fits (convulsions) or temporary eyesight problems (such as blurred or double vision). If this happens, do not drive or use any machinery or tools.
Tests
Your doctor may wish to carry out some tests if you have been having this medicine for more than 10 days.
Important information about some of the ingredients of Metronidazole
• Sodium: This medicinal product contains 318 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
3. HOW YOU WILL BE GIVEN METRONIDAZOLE How your medicine will be given
Your medicine will be administered to you by a doctor or nurse. The length of your course of treatment will depend on your needs and the illness being treated.
• Metronidazole is administered into a vein using a drip at a rate of 5ml/minute
• The dose of Metronidazole will depend on your needs and the illness being treated
• The length of your treatment will depend on the type of infection you have and how bad it is
• As soon as possible after starting your treatment with Metronidazole , your doctor will suggest
changing to a medicine taken by mouth.
The usual dose for adults and children is given below:
To treat bacterial infection Adults
• You will be given a dose of 500 mg (100 ml) Metronidazole every 8 hours Children > 2 months old
• Your doctor will work out how much your child should be given depending on their weight, usually 20-30 mg/kg
• The dose will be repeated every 8 hours To prevent infections from happening after surgery
Adults
• You will be given 500 mg (100 ml) Metronidazole shortly before your operation
• The dose may be repeated twice at 8 hourly intervals Children
• Your doctor will work out how much your child should be given depending on their weight, usually 20-30 mg/kg
• Your child will receive the first dose shortly before their operation
• The dose may be repeated twice at 8 hourly intervals
People having dialysis
Kidney dialysis removes Metronidazole from your blood. If you are having kidney dialysis you must have this medicine after your dialysis.
People with liver problems
Your doctor may lower your dose or use the medicine less often.
If you are given more Metronidazole than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor or nurse will monitor your progress and check how much medicine you are given. If you think you have been given too much medicine, tell your doctor or nurse, who will know what to do. Always ask if you are not sure why you are being given a medicine.
If you are not given Metronidazole at the right time
Your doctor or nurse will have instructions about when to give you your medicine. It is unlikely that you will not be given the medicine as it has been prescribed. If you think that you may have missed a dose, then talk to your doctor or nurse.
If you stop having Metronidazole
Keep having Metronidazole until your doctor tells you to stop. Do not stop having Metronidazole just because you feel better. It is important for you to keep having Metronidazole infusions until your doctor decides to stop them. If you stop, your infection may get worse again.
If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Metronidazole can cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor, pharmacist or nurse straight away.
Tell your doctor straight away if:
• you have an allergic reaction. The signs may include: swelling of the hands, feet, ankles, a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. You could also notice an itchy, lumpy rash (hives) or nettle rash (urticaria)
• you get a high fever, headache, see or hear things that are not there, feel clumsy or have difficulty in controlling your movements, are confused, more sensitive to light than usual, notice a stiff neck, unusual behaviour or eye movements or have problems with speaking. This could be a serious but very rare condition called encephalopathy.
Talk to your doctor straight away if you notice any of the following side effects:
Very Rare (affects less than 1 in 1,000 people)
• Yellowing of the skin and eyes. This could be due to a liver problem (jaundice)
• Unexpected infections, mouth ulcers, bruising, bleeding gums, or severe tiredness. This could be caused by a blood problem
• Severe stomach pain which may reach through to your back (pancreatitis).
Tell your doctor if any of the following side effects gets serious or lasts longer than a few days:
Very Rare (affects less than 1 in 10,000 people)
• Low white blood cell count
• You may feel weak, bruise more easily and get more infections than usual. This could be because of a blood problem called ‘pancytopenia’
• Headache
• Confusion, hallucinations
• Feeling of weakness.
• Feeling sleepy or dizzy
• Fits (convulsions)
• Clumsiness or poor coordination
• Difficulties speaking
• Problems with your eyesight such as blurred or double vision
• Darkening of the urine
• Itching, inflammation or swelling of the skin, or skin rashes, all of which may sometimes be severe
• Pain in the muscles or joints
• Abnormal liver function tests, hepatitis (inflammation of the liver)
Not known:
• Fever
• Angioedema (swelling of face and/or neck which may affect breathing and swallowing)
• Feeling sick (nausea), being sick (vomiting), upset stomach or diarrhoea
• Depressed mood
• Numbness, tingling, pain, or a feeling of weakness in the arms or legs
• Unpleasant taste in the mouth
• Mouth sores; inflammation of the mouth and tongue, dry mouth
• Skin rash (erythema multiforme)
• You may get more infections than usual. This could be because of a blood problem called ‘leucopenia’
• Mental problems such as feeling confused and seeing or hearing things that are not there (hallucinations)
• Meningitis (inflammation of the tissues surrounding the brain)
• Inflammation of the optic nerve which may affect your eyesight
• Loss of appetite
Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice any side effects not listed in this leaflet.
5. HOW TO STORE METRONIDAZOLE
Keep this medicine out of the sight and reach of children.
This medicine will be kept by your doctor or pharmacist in a safe place where children cannot see or reach it.
Store in original packaging to protect from light. Do not store above 25°C.
Do not freeze.
Do not use Metronidazole after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Do not use Metronidazole if you notice particulates in solution, or leakage from the bag.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION What Metronidazole contains:
- Each ml of solution for infusion contains 5 mg metronidazole as the active substance
- Each 100 ml of solution for infusion contains 500 mg metronidazole as the active substance
- The other ingredients are: sodium chloride, sodium dihydrogen phosphate dihydrate, citric acid monohydrate, sodium hydroxide and water for injections.
What Metronidazole looks like and contents of the pack
Metronidazole is a clear, slightly greenish-yellow solution for infusion.
Metronidazole is available in infusion bags containing 100 ml of solution.
Marketing Authorisation Holder
Teva UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
TEVA Pharmaceutical Works Private Limited Company, H-2100 Godollo, Tancsics Mihaly ut 82, Hungary
This leaflet was last revised in April 2012.
PL 00289/1466
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The following information is intended for medical or healthcare professionals only:
This section contains practical information about the administration. Read the SmPC to be completely informed about the posology and method of administration (including dose adjustment for patients with renal function damage), contra-indications and warnings.
Metronidazole should be administered by intravenous infusion.
For single use only
In patients maintained on intravenous fluids, Metronidazole 5 mg/ml Solution for Infusion may be diluted with appropriate volumes of 0.9% sodium chloride solution, dextrose 5% - 0.9% sodium chloride solution, dextrose 5% w/v or potassium chloride infusions (20 and 40 mmol/litre).