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INFORMATION FOR CONSUMERS

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Consumer Medicine Information

CIPROXIN® IV

(Ciprofloxacin)

WHAT IS IN THIS LEAFLET

This leaflet contains answers to some common questions about CIPROXIN IV.

It does not contain all the information available on CIPROXIN IV. It does NOT take the place of talking to your doctor or your pharmacist.

Please read this leaflet carefully. If you have any concerns about being given this medicine, ask your doctor or your pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Ciproxin IV against the benefits they expect it will have for you.

As Ciproxin IV is a prescription medicine, it should only be used under medical supervision.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

WHAT CIPROXIN IV IS USED FOR

CIPROXIN IV is a sterile intravenous antibiotic. It contains the drug ciprofloxacin, which can kill many kinds of bacteria which cause infections in the body.

CIPROXIN IV is used in a hospital environment only.

CIPROXIN IV is used to treat serious infections in the lungs, skin, blood, bone and joints, kidneys and bladder.

CIPROXIN IV will not work against infections caused by viruses such as colds or the flu.

BEFORE YOU TAKE CIPROXIN IV

When you must not take it

Do not take Ciproxin IV if you are allergic to ciprofloxacin, other quinolone antibiotics or any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching, and difficulty breathing.

CIPROXIN IV should not be used in children and growing adolescents except when recommended by your doctor.

Do not take CIPROXIN if you are also taking a medicine called tizanidine (Zanaflex™) a muscle relaxant used to treat spasticity associated with multiple sclerosis or injury or diseases of the spinal cord). CIPROXIN can interfere with tizanidine and can lead to undesirable side effects.

Do not take Ciproxin IV if the expiry date on the pack has passed. This date appears after the words "EXP" or "EXPIRY" printed on the pack.

The contents of the vial are not to be used if it is cloudy or has little specks in it.

Before you start to take Ciproxin IV

Tell your doctor if you:

If you have not told your doctor or pharmacist about any of the above, tell them before you start taking Ciproxin IV.

Taking other medicines

Tell your doctor if you are taking or given any of the following medicines. Some medicines may be affected by CIPROXIN. These medicines include:

These medicines may be affected by CIPROXIN IV, or may affect how well it works. You may need different amounts of your medicine, or you may need to take different medicines.

Some medicines may interfere with CIPROXIN IV. These include:

You can still take these medicines while you are taking CIPROXIN IV. However, you must take CIPROXIN IV at least 2 hours before or 2 hours after taking any of these medicines.

Tell your doctor if you are taking or given any other medicines, including any you have bought at your pharmacy, supermarket or health food shop. Some of these medicines may be affected by CIPROXIN IV.

HOW CIPROXIN IV IS GIVEN

CIPROXIN IV is given as a slow injection into a vein, usually as a drip, by a doctor or a nurse.

CIPROXIN IV is incompatible with alkaline drugs.

How much to take

This depends on your condition, and will be decided by your doctor.

The usual adult dose is 200-300 mg twice a day for one to two weeks. Normally your doctor will put you on antibiotic tablets as soon as possible; but for difficult infections longer intravenous therapy may be required.

If you have not been given the next dose tell the doctor or nurse on duty as soon as possible.

If you are given too much (overdose)

Tell the doctor or nurse on duty if you think you have been given an overdose of CIPROXIN IV, even if you do not feel worse.

WHILE YOU ARE USING CIPROXIN IV

Things you must do

Tell your doctor or nurse if you:

SIDE EFFECTS

All medicines have unwanted side effects. Sometimes they are serious, most of the time they are not. In cases of serious side effects, you may need prompt medical attention.

CIPROXIN IV is usually well tolerated. However, there may be unwanted effects which are presently unknown.

CIPROXIN IV can cause redness, pain, oedema, hypersensitivity and inflammation at the injection site.

Tell your doctor if you notice any of the following and they worry you:

These are the more common side effects of CIPROXIN IV. They are usually mild and short-lived.

It can sometimes increase the stimulating effect of coffee.

Tell your doctor immediately, or go to the accident and emergency department at your nearest hospital if you notice any of the following:

These are serious side effects. If you have them, you may need urgent medical attention.

Photosensitivity (getting sunburnt very easily) can occasionally occur with ciprofloxacin. However, it is temporary and staying out of direct sunlight while on CIPROXIN IV will prevent it from happening.

Rarely, there can be a worsening of the symptoms of myasthenia gravis. This is a condition in which the muscles become weak and tire easily, causing drooping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms or legs.

Rarely, the Achilles tendon (extending from the calf to the heel of the foot) or other tendons have been torn after CIPROXIN IV therapy. Tell your doctor straight away if you have a pain, inflammation or rupture of a tendon.

Severe allergic reactions (anaphylactic reactions) can occur with CIPROXIN IV. Symptoms of a severe allergic reaction include flushing, hives on the skin, itchy skin, nausea, a rapid or very slow pulse and difficulty breathing.

Very rarely, hypoglycaemia (low blood sugar) may also occur. Symptoms include sweating, weakness, dizziness, trembling, headache, and having a fast pounding heartbeat. Contact your doctor if you experience these symptoms.

If you experience any of these symptoms during the treatment with CIPROXIN IV, notify the nurse or the doctor immediately. CIPROXIN IV may need to be discontinued and medications are required to treat these symptoms.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

If you need to know more about the drug, please consult your doctor. Also please be sure to tell your doctor of any unusual effects or symptoms.

AFTER USING CIPROXIN IV

When treatment is to be stopped, your prescribing doctor may need to alter the dose of other medicine(s) accordingly and monitor your condition.

Each vial of CIPROXIN IV is to be used once only. Any unused portion remaining in the vial must be discarded.

Storage

CIPROXIN IV will be stored in the pharmacy or on the ward. The vial is kept in a cool, dry place away from sunlight, where the temperature stays below 30°C. The vial should not be stored in the refrigerator.

If you have any further questions on CIPROXIN IV, or are unsure of the information given above, please see your doctor or nurse, who will be able to assist you.

PRODUCT DESCRIPTION

What it looks like

CIPROXIN IV is a clear isotonic solution containing ciprofloxacin in the following strengths:

Ingredients

Active Ingredients:

CIPROXIN IV 100 - 100 mg ciprofloaxcin /50 mL vial

CIPROXIN IV 200 - 200 mg ciprofloxacin /100 mL vial

Inactive ingredients:

Manufacturer

BAYER HealthCare AG, Germany

Sponsor

BAYER AUSTRALIA LIMITED
ABN 22 000 138 714
875 Pacific Highway
PYMBLE NSW 2073
Australia

BAYER NEW ZEALAND LIMITED
3 Argus Place, Hillcrest, North Shore, AUCKLAND 0627
New Zealand

Free phone 0800 233 988

Australian Registration Numbers

CIPROXIN IV 100 - AUST R 43098

CIPROXIN IV 200 - AUST R 43099

Date of preparation

March 2008

® Trademark of Bayer AG, Germany

© Bayer Australia Ltd
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