General Information
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about CIPROXIN.
This leaflet does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking CIPROXIN against the benefits they expect it will have for you.
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 IS USED FOR
CIPROXIN tablets are used for the treatment of infections of the lungs, skin, bones and joints, kidneys and bladder, prostate and bowel. However, your doctor may prescribe this medicine for another use. If you want more information, ask your doctor.
CIPROXIN tablets contain the active ingredient ciprofloxacin (present as hydrochloride) which is an antibiotic belonging to a group of medicines called quinolones (pronounced kwin-o-lones). These antibiotics work by killing the bacteria that are causing your infection.
CIPROXIN tablets are not addictive.
CIPROXIN tablets are available by prescription only.
BEFORE YOU TAKE CIPROXIN
When you must not take it
Do not take CIPROXIN if you have an allergy to ciprofloxacin, other quinolone antibiotics including nalidixic acid, or any of the ingredients in CIPROXIN tablets listed at the end of this leaflet. Some symptoms of an allergic reaction may include skin rash, itching, or difficulty breathing.
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 undersirable side effects.
Do not give CIPROXIN to children and growing adolescents unless you are told by your doctor to do so.
Do not take CIPROXIN if you are breast-feeding. CIPROXIN is excreted in breast milk and there is a possibility that the breast-fed baby may be affected. Your doctor will tell you whether you should take CIPROXIN and temporarily stop breast-feeding while you are taking the tablets.
Do not take your CIPROXIN tablets after the expiry date printed on the pack. The EXPIRY date is marked on the strip of tablets as well as on the label of the carton. For example, 11 09 refers to the eleventh month of 2009.
Do not take your tablets if the packaging is torn or show signs of tampering.
Before you start to take CIPROXIN
Tell your doctor if you:
have any allergies to ciprofloxacin or any other ingredients in CIPROXIN tablets, or to any other medicines that you have used in the past, or to any other substances such as food, preservatives or dyes.
suffer from fits (seizures, convulsions), have had a stroke, or have kidney disease or other medical problems.
are pregnant, plan to become pregnant, or are breastfeeding. It is not known if it is safe for you to take CIPROXIN tablets while you are pregnant or breastfeeding. Drugs similar to CIPROXIN have caused joint disease in immature animals.
have previously taken corticosteroids. You may be at increased risk of swelling of the tendons. Symptoms include pain, tenderness and sometimes restricted movement.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking CIPROXIN.
Taking other medicines
Tell your doctor if you are taking any other medicines, including those that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by CIPROXIN. These medicines include:
theophylline, a medicine used to treat asthma
warfarin, a medicine used to stop blood clots
glibenclamide, a medicine used to treat diabetes
didanosine, a medicine used to treat viral infections
cyclosporin, a medicine used in organ transplantation
NSAIDs (non-steroidal anti-inflammatory drugs), medicines used to treat arthritis
methotrexate, a medicine used to treat certain types of cancers, severe psoriasis and severe rheumatoid arthritis
duloxetine, a medicine used to treat depression and stress urinary incontinence
clozapine, a medicine used to treat schizophrenia
ropinirole, a medicine used to treat Parkinson’s disease and restless legs syndrome
the anaesthetic lidocaine
You may need to use different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Some medicines may interfere with the absorption of CIPROXIN. These include:
multivitamins, mineral supplements and other medicines containing iron, zinc, magnesium, aluminium or calcium
antacids used for indigestion
sucralfate, a medicine used to treat duodenal or stomach ulcers
some antiretrovirals used to treat HIV infection
probenecid, a medicine used to treat gout
omeprazole, a medicine used to treat ulcers and other conditions where stomach produces too much acid
sevelamer, a medicine used to treat high blood levels of phosphorus in patients with kidney disease who are on dialysis
metoclopramide, a medicine used to relieve nausea and vomiting; heartburn, and stomach pain, may alter the absorption of CIPROXIN
You can still take these medicines while you are taking CIPROXIN. However, you must take CIPROXIN at least 2 hours before or 2 hours after taking any of these medicines to make sure there is no problem with absorption.
HOW TO TAKE CIPROXIN
How much to take
Your doctor or pharmacist will tell you how much and how often you should take CIPROXIN. This will depend on the type of infection.
The usual adult dosage for most infections is one tablet twice daily for 7 to 14 days. You may need to take your tablets for a longer period for some types of infection. The dose will be determined by your doctor as it depends upon the type of infection you have.
When to take it
CIPROXIN tablets are usually taken twice a day. Take your tablets at the same time each day preferably on an empty stomach. However, they can be taken with or without food.
How long to take it
The length of treatment may vary from one to 28 days or longer depending on the type of infection.
Continue taking CIPROXIN until you have finished the blister pack or for as long as your doctor tells you. Do not stop taking your tablets because you are feeling better. If you do not complete the full course prescribed by your doctor, the infection may not clear completely or your symptoms may return.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking it as you would normally.
Do not take a double dose to make up for the dose that you missed.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much (overdose)
Immediately telephone your doctor, or the Poisons Information Centre (telephone in Australia 13 11 26, in New Zealand 0800 POISON or 0800 764 766), or go to the accident and emergency department at your nearest hospital, if you think you or anyone else may have taken too much CIPROXIN. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
WHILE YOU ARE TAKING CIPROXIN
Things you must do
Tell all the doctors, dentists and pharmacists who are treating you that you are taking CIPROXIN.
Drink plenty of water while you are taking CIPROXIN. This helps to stop crystals forming in the urine.
If you become pregnant while you are taking CIPROXIN, tell your doctor immediately.
If you develop diarrhoea, tell your doctor or pharmacist immediately - even if it occurs several weeks after you have stopped taking CIPROXIN. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any medications for diarrhoea without checking with your doctor.
Things you must not do
Do not give your CIPROXIN tablets to anyone else, even if they have the same condition as you.
Do not use CIPROXIN to treat other conditions unless your doctor tells you to.
Do not stop taking your tablets because you are feeling better, unless your doctor told you to do so. If you do not complete the full course prescribed by your doctor, some of the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear up completely or it may return.
What to be careful of
Avoid excessive exposure to direct sunlight. Your skin may become more prone to sunburn. If such a reaction occurs, stop taking CIPROXIN immediately and call your doctor.
Be careful driving or operating machinery until you know how CIPROXIN affects you. CIPROXIN tablets may cause dizziness or faintness in some patients, especially after the first few doses. The ability to drive and/or operate machinery may be impaired. If you drink alcohol, dizziness or faintness may be worse.
CIPROXIN tablets may increase the stimulatory effects of caffeine.
SIDE EFFECTS
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking CIPROXIN.
CIPROXIN helps most people with bacterial infections, but it may have unwanted side effects. Sometimes they are serious, most of the time they are not. You may need to stop taking the tablets or have medical treatment if you get some of the serious side effects.
Tell your doctor if you notice any of the following and they worry you:
headache
fever
dizziness or lightheadedness
mild stomach upsets such as feeling sick (nausea) or stomach pains
dyspepsia (heartburn)
nausea, vomiting and/or diarrhoea
flatulence
discharge and itching in the vagina
loss of appetite
rash, ankle swelling
agitation, anxiety, confusion
altered taste.
These are the more common side effects of CIPROXIN. They are usually mild and short-lived.
Tell your doctor immediately, or go to the accident and emergency department at your nearest hospital if you notice any of the following:
severe skin rashes
swelling of the face, lips, mouth or throat
fainting
yellowing of the skin and eyes, also called jaundice
severe watery or bloody diarrhoea, even if it occurs several weeks after taking your tablets
fits (seizures, convulsions)
confusion, nightmares, hallucinations, and psychotic reaction (even progressing to self-endangering behaviour)
irregular heart beats
joint/muscle pain or cramping
visual disturbances
ringing in the ear, loss of hearing
wheezing or difficulty in breathing
inflammation of the bowel, abdominal cramps. Very rarely this can progress to a serious condition accompanied by fever and fatigue.
These are serious side effects. If you have them, you may need urgent medical attention or hospitalisation.
Rarely, the Achilles tendon (extending from the calf to the heel of the foot) or other tendons have been torn after CIPROXIN therapy. Call your doctor if you feel any discomfort, pain or inflammation of this or any other tendon.
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.
Photosensitivity (getting sunburnt very easily) can occasionally occur with ciprofloxacin. However, it is temporary and staying out of direct sunlight while on CIPROXIN tablets will prevent it from happening.
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.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
AFTER USING CIPROXIN
Storage
Keep your tablets in the blister pack until it is time to take them. If you take the tablets out of the box or the blister pack they may not keep well.
Keep your tablets in a cool dry place where the temperature stays below 25 ° C. Do not leave the tablets in the car on hot days. Do not store it or any other medicine in the bathroom or near a sink. Heat and damp can destroy some medicines.
Keep your tablets where children cannot reach them. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.
Disposal
If your doctor tells you to stop taking CIPROXIN tablets or the tablets have passed their expiry date, ask your pharmacist what to do with any that are left over.
PRODUCT DESCRIPTION
What it looks like
CIPROXIN 250 mg tablets are white, film-coated, round, scored and marked CIP 250 on top and the Bayer Cross on bottom (available in blister packs of 2 [Australia only] and 14 tablets).
CIPROXIN 500 mg tablets are white, film-coated, oblong, scored and marked CIP 500 on top and Bayer on the bottom (available in blister packs of 14 tablets).
CIPROXIN 750 mg tablets are white, film-coated, oblong, marked CIP 750 on top and Bayer on the bottom (available in blister packs of 14 tablets).
Ingredients
Active Ingredients per tablet:
CIPROXIN 250 - ciprofloxacin (as hydrochloride) 250 mg
CIPROXIN 500 - ciprofloxacin (as hydrochloride) 500 mg
CIPROXIN 750 - ciprofloxacin (as hydrochloride) 750 mg
Inactive ingredients:
colloidal silicon dioxide
crospovidone
macrogol 4000
maize starch
magnesium stearate
microcrystalline cellulose
hypromellose
titanium dioxide (CI 778991).
Manufacturer
BAYER HealthCare AG, Germany
Sponsor
BAYER AUSTRALIA LIMITED
ABN 22 000 138 714
875 Pacific Highway
PYMBLE NSW 2073Australia
BAYER NEW ZEALAND LIMITED
3 Argus Place,
Hillcrest, North Shore, AUCKLAND 0627
New Zealand
Free phone 0800 233 988
Australian Registration Numbers
CIPROXIN 250 -AUST R 35317
CIPROXIN 500 -AUST R 35361
CIPROXIN 750 -AUST R 35367
Date of preparation
March 2008
® Trademark of Bayer AG, Germany
© Bayer Australia Ltd
All rights reserved.