METRONIDAZOLE NORIDEM

METRONIDAZOLE NORIDEM

Active ingredient(s): Metronidazole

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Consumer Medicine Information (CMI)

This leaflet provides important information about using METRONIDAZOLE NORIDEM You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using METRONIDAZOLE NORIDEM

Where to find information in this leaflet:

1. Why am I being given METRONIDAZOLE NORIDEM?
2. What should I know before I am given METRONIDAZOLE NORIDEM?
3. What if I am taking other medicines?
4. How is METRONIDAZOLE NORIDEM given?
5. What should I know while being given METRONIDAZOLE NORIDEM?
6. Are there any side effects?
7. Product details

1. Why am I being given METRONIDAZOLE NORIDEM?

METRONIDAZOLE NORIDEM contains the active ingredient Metronidazole.

METRONIDAZOLE NORIDEM is used to treat serious infections caused by bacteria and other organisms when metronidazole cannot be given orally. It is also used to prevent certain infections that may occur during surgery.

METRONIDAZOLE NORIDEM is an antibiotic which works by killing or stopping the growth of bacteria and other organisms causing these infections.

2. .What should I know before I am given METRONIDAZOLE NORIDEM?

Warnings

Do not use METRONIDAZOLE NORIDEM if:

• You are allergic to metronidazole, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives.
• you have or have had a blood disorder
• you have a disease or disorder involving the brain, spinal cord or nerves
• you have taken disulfiram (a medicine used to treat chronic alcohol dependence) within the last two weeks
• you have drunk any alcohol or products containing propylene glycol
• you have Cockayne syndrome

If you are not sure whether you should be given this medicine, talk to your doctor.

Check with your doctor if you

• have had any of the following medical conditions:-
  – blood disease or history of blood disease
  – disease or disorder involving the brain, spinal cord or nerves
  – liver disease or any liver problems
  – heart disease or any heart problems
  – any kidney problems
  – Crohn’s disease, an inflammatory disease of the intestines
• drink alcohol. Do not drink alcohol during (and for 3 days after stopping) treatment with metronidazole
• if you are on a low sodium diet

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Metronidazole may affect your developing baby if you use it during pregnancy.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Metronidazole passes into breast milk and may affect your baby.

If you have not told your doctor about any of the above, tell your doctor before you are given METRONIDAZOLE NORIDEM

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with metronidazole and affect how it works. These include:

• disulfiram, a medicine used to treat chronic alcohol dependence
• some anticancer drugs such as carmustine, cyclophosphamide fluorouracil, 5-fluorouracil and busulfan
• warfarin or other medicines used to prevent blood clots
• phenytoin, a medicine used to treat convulsions
• phenobarbital(phenobarbitone), a medicine to treat convulsions or for sedation
• cimetidine, a medicine used to treat ulcers
• corticosteroids such as prednisone or cortisone
• lithium, a medicine used to treat some types of depression
• azathioprine, a medicine used to suppress the immune system
• ciclosporin, a medicine used to prevent organ transplant rejection or to treat immune responses
• alcohol, medications containing alcohol (ethanol) e.g., some cough syrups, or products containing propylene glycol taken with metronidazole can cause abdominal cramps, nausea, vomiting, headaches and flushing.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect METRONIDAZOLE NORIDEM.

4. How is METRONIDAZOLE NORIDEM given?

• Metronidazole Intravenous Infusion is given by injection into a vein.
• Metronidazole Intravenous Infusion must only be given by a doctor or nurse.
• Your doctor will decide what dose and how long you will receive METRONIDAZOLE NORIDEM. This will depend on your age, weight, type of infection and how well your kidneys and liver are working.
• The usual adult dose of METRONIDAZOLE NORIDEM is 500mg is given by injection into a vein every eight hours for the course of treatment, as decided by your doctor.
• METRONIDAZOLE NORIDEM must only be given by a doctor or nurse.

If you use too much Metronidazole Intravenous Infusion

As METRONIDAZOLE NORIDEM is most likely to be given to you in hospital under the supervision of your doctor, it is very unlikely that you will be given too much.

If you think that you have been given too much metronidazole, you may need urgent medical attention.

You should immediately: phone the Poisons Information Centre (by calling 13 11 26), contact your doctor, or go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while being given METRONIDAZOLE NORIDEM?

Things you should do

• If you get severe diarrhoea tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after METRONIDAZOLE NORIDEM has been stopped.
  Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.
• If the symptoms of your infection do not improve or if they become worse, tell your doctor
• If you get a sore white mouth or tongue while using or soon after stopping METRONIDAZOLE NORIDEM, tell your doctor. Also tell your doctor if you get vaginal itching or discharge.
  This may mean you have a fungal infection called thrush. Sometimes the use of METRONIDAZOLE NORIDEM allows fungi to grow and the above symptoms to occur. METRONIDAZOLE NORIDEM does not work against fungi.
• If you are using METRONIDAZOLE NORIDEM for 10 days or longer, make sure you have any tests of your blood and nervous system that your doctor may request.
• If you need to have any blood tests tell your doctor you are being given METRONIDAZOLE NORIDEM. METRONIDAZOLE NORIDEM may affect the results of some blood tests.
• If you become pregnant while you are being treated with METRONIDAZOLE NORIDEM tell your doctor immediately.

Tell any other doctors, dentists, and pharmacists who are treating you that you are being given METRONIDAZOLE NORIDEM.

Things you should not do

Drinking alcohol

Tell your doctor if you drink alcohol.

• Do not drink any alcohol or any alcoholic drinks while being treated with (and for at least 3 days after stopping) METRONIDAZOLE NORIDEM
  Alcohol with METRONIDAZOLE NORIDEM may make you feel sick, vomit or have stomach cramps, headaches or flushing.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how METRONIDAZOLE NORIDEM affects you.

METRONIDAZOLE NORIDEM may cause dizziness, confusion, hallucination (hearing or seeing strange or unusual things), convulsions (“fits”) or affect how you see things.

Looking after your medicine

• METRONIDAZOLE NORIDEM will be stored in the pharmacy or on the ward. The infusion is kept in a cool dry place, protected from light, where the temperature stays below 30°C.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Gastrointestinal/Digestive nausea and vomiting ‘gas’ or abdominal bloating loss of appetite constipation/diarrhoea abdominal pain, indigestion or discomfort Mouth metallic or unpleasant taste in the mouth swollen red or sore tongue dryness of the mouth oral thrush – white, furry, sore tongue and/or mouth sore, red mouth ulcers or cold sores Nasal nasal congestion Muscles & Joints joint pains Eye yellowing of the eyes/skin or flushing blurred/ double vision or other eye problems Genito-urinary tract pain when passing urine or passing more urine than normal blood or pus in the urine, darker urine loss of control of your bladder or bowels feeling of pressure around the pelvis sore back passage, sometimes with bleeding or discharge loss of sex drive or painful sex vaginal thrush – sore and itchy vagina and/or discharge dryness of vagina or genitals Neurological dizziness or spinning sensation problems with sleeping

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Heart fast erratic heartbeats and /or fainting General Body rash, itchiness, hives swelling of the face, lips, mouth, throat or neck which may cause difficulty swallowing or breathing tingling or numbness of the hands or feet, pins and needles or muscle weakness severe blisters and bleeding in the lips, eyes, mouth, nose and genitals signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers Gastrointestinal severe abdominal cramps or stomach cramps watery, severe diarrhoea, which may also be bloody Ears ringing/persistent noise in the ears (tinnitus) or other hearing problems Injection Site swelling or redness along the vein which is extremely tender when touched Neurological confusion, irritability, depression, disorientation clumsiness, lack of co-ordination, problems with moving or balancing difficulty in speaking headache, stiff neck and extreme sensitivity to bright light fits or seizures

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Some of these side effects (changes in the liver, levels of blood cells or changes in heart rhythm) can only be found when your doctor does tests from time to time to check your progress.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What METRONIDAZOLE NORIDEM contains

Active ingredient (main ingredient)	Metronidazole
Other ingredients (inactive ingredients)	Citric acid monohydrate Dibasic sodium phosphate dodecahydrate Sodium chloride Water for Injections

Do not take this medicine if you are allergic to any of these ingredients.

METRONIDAZOLE NORIDEM does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes

What METRONIDAZOLE NORIDEM looks like

METRONIDAZOLE NORIDEM is a clear, almost colourless to pale yellow solution. It is available in a polypropylene bottle for infusion.

METRONIDAZOLE NORIDEM 500 mg/100 mL

AUST R 384574

METRONIDAZOLE NORIDEM is available in 100 mL bottles in packs of 20 bottles per carton.

Who distributes METRONIDAZOLE NORIDEM

InterPharma Pty Ltd
Suite 103, 39 East Esplanade
MANLY NSW 2095 AUSTRALIA
Ph.: 029976 6876

This leaflet was prepared in TBC