APO-Ciprofloxacin

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Contains the active ingredient, ciprofloxacin hydrochloride
Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about this medicine. It 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 this medicine 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 is this medicine used for

Ciprofloxacin is used to treat:
urinary tract infections
kidney and bladder infections
bowel infections
lung infections
skin infections
bone and joint infections
prostate infections
Ciprofloxacin belongs to a group of antibiotic medicines called quinolones.
It works by killing the bacteria which cause these infections.
It will not work against viral infections such as colds or flu.
Ask your doctor if you have any questions about why this medicine has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.
This medicine is available only with a doctor's prescription.
There is no evidence that this medicine is addictive.
This medicine is not recommended for use in children or pre-pubertal teenagers.

Before you take this medicine

When you must not take it

Do not take this medicine if you have an allergy to:
any medicine containing ciprofloxacin
other quinolone antibiotics or nalidixic acid
any of the ingredients listed at the end of this leaflet
Some of the 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 on the skin
Do not take this medicine if you are taking a medicine called tizanidine (used for multiple sclerosis or spinal injuries).
Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.
Tell your doctor if you have or have had any of the following medical conditions:
kidney disease
liver disease
brain disease or stroke
epilepsy (seizures or fits)
arrhythmias (fast or irregular heartbeats)
Ciprofloxacin may increase the risk of arrhythmias, especially in the elderly or patients with low potassium levels.
myasthenia gravis (disease of the muscles causing drooping eyelids, double vision, difficulty in speaking and swallowing and sometimes muscle weakness in the arms or legs)
tendon disorders with the use of quinolones (e.g. moxifloxacin, norfloxacin, nalidixic acid).
Tell your doctor if you are elderly or have previously taken corticosteroids such as prednisolone or cortisone, or have had problems with your tendons before when taking quinolone medicines.
You may be at increased risk of swelling of or damage to the tendons. Symptoms include pain, tenderness and sometimes restricted movement.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
Do not take this medicine until you and your doctor have discussed the risks and benefits involved.
Ciprofloxacin passes into human breast milk and may affect your baby, so your doctor will discuss with you what to do.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines must not be taken with ciprofloxacin.
Do not take ciprofloxacin if you are taking tizanidine, used for multiple sclerosis or spinal injuries.
Some medicines and ciprofloxacin may interfere with each other. These include:
multivitamins, mineral supplements, antacids (used for indigestion) and other medicines containing iron, magnesium, aluminium or calcium
certain anti-arrhythmics, antidepressants, antibiotics and antipsychotics
theophylline, and other methylxanthines, used to help breathing. Caffeine is also a methylxanthine.
duloxetine, used for depression, incontinence or diabetic neuropathy
cyclosporin, used in organ transplants, or for severe arthritis or psoriasis
methotrexate, used to treat certain cancers, or for severe arthritis or psoriasis
warfarin or other medicines called anticoagulants, used to prevent blood clots
phenytoin, used to treat epilepsy
certain non-steroidal anti-inflammatory medicines (NSAIDs), used to treat muscular problems and arthritis. The combination of these medicines with ciprofloxacin may cause convulsions
clozapine, used to treat schizophrenia
ropinirole, used to treat restless legs syndrome
lidocaine, used in certain heart conditions and for local or spinal anaesthesia
sildenafil, used to treat erectile dysfunction
probenecid, used for gout or arthritis
omeprazole, used to treat stomach ulcers.
sucralfate, used to treat stomach ulcers
metoclopramide, used to treat nausea and vomiting
oral anti-diabetic agents such as glibenclamide and glimepiride
antiretroviral medicines such as didanosine, used to treat HIV infections
sevelamer, used to treat high blood levels of phosphate
oxpentifylline, used to treat circulation disorders
agomelatine, used to treat depression
zolpidem, used to treat sleep disorders
These medicines may be affected by ciprofloxacin or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

Follow carefully all directions given to you by your doctor.
They may differ from the information contained in this leaflet.
If you do not understand the directions, ask your doctor or pharmacist for help.

How much to take

Your doctor will tell you how many tablets you will need to take. This will depend on your condition and whether or not you are taking any other medicines.
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 infections.

How to take it

Swallow the tablets whole with a full glass of water.

When to take it

Take your medicine at about the same time each day.
Taking it at the same time each day will have the best effect. It will also help you remember when to take it.
It does not matter if you take this medicine before or after food.
If you need to take an antacid, take it at least 2 hours before or 2 hours after your dose of ciprofloxacin.

How long to take it for

The length of treatment may vary from 1 to 28 days or longer depending on the type of infection.
Continue taking your medicine until you finish the 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 to take your next dose, skip the missed dose and take your next dose at the usual time.
Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.
Do not take a double dose to make up for the missed doses.
This may increase the chance of you experiencing side effects.
If you are not sure what to do, ask your doctor or pharmacist.
If you have trouble remembering 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 13 11 26) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much of this medicine. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

While you are taking this medicine

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.
If you become pregnant or start to breastfeed while taking this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.
Keep all your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.
Drink plenty of water or fluids while taking this medicine.
This will help to prevent crystals forming in the urine which can cause kidney problems. However, this is not a common problem.
Protect your skin when you are in the sun, especially between 10 am and 3 pm, or in the presence of artificial ultraviolet (UV) light. Wear protective clothing and use a 15+ sunscreen. If your skin does appear to be burning, stop taking this medicine and tell your doctor.
Ciprofloxacin may cause your skin to be much more sensitive to sunlight and UV light than it is normally. This may cause a skin rash, itching, redness, or a severe sunburn.

Things you must not do

Do not take this medicine to treat any other complaints unless your doctor tells you to.
Do not give your medicine to anyone else, even if they have the same condition as you.
Do not stop taking your medicine or lower the dosage without checking with your doctor.
If you do not complete the full course prescribed by your doctor, all the bacteria causing your infection may not be killed. These bacteria may continue to grow and multiply so that your infection may not clear completely or it may return and be more difficult to treat.

Things to be careful of

Be careful while driving or operating machinery until you know how ciprofloxacin affects you.
This medicine may cause dizziness, light-headedness or drowsiness in some people, or may change your reaction time. If you have any of these symptoms, do not drive or operate machinery or do anything else that could be dangerous.
Be careful when drinking alcohol while you are taking this medicine.
If you drink alcohol, dizziness, light-headedness or drowsiness may be worse.
Be careful when drinking beverages containing caffeine (e.g. coffee, cola drinks) while you are taking this medicine.
Ciprofloxacin 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 this medicine.
All medicines can have side effects. Sometimes they are serious but most of the time they are not.
Do not be alarmed by the following lists of side effects. You may not experience any of them.
Tell your doctor if you notice any of the following:
nausea, vomiting, mild diarrhoea
loss of appetite
mild stomach pain or wind
agitation, anxiety or restlessness
sleeping disorders
headache
dizziness or light-headedness
tremor, twitching or weakness
purple or red spots on the skin
strange taste, smell or touch sensations.
Tell your doctor as soon as possible if you notice any of the following:
vaginal itching or discharge
a sore white mouth or tongue
altered vision (specialist consult needed)
migraine
difficulty walking, uncoordinated, shaking
getting sunburnt very easily
joint or muscle pain, muscle cramps, or inflamed, painful or ruptured tendons such as the Achilles tendon
tinnitus (ringing in the ears), problems with hearing
symptoms of hypoglycaemia (low blood sugar) e.g. sweating, weakness, dizziness, trembling, headache, and having a fast, pounding heartbeat
symptoms of hyperglycaemia (high blood sugar) e.g. feeling hungry, thirsty and/or frequent or excessive urination
a worsening of the symptoms of myasthenia gravis, e.g. weaker muscles which tire more easily, drooping eyelids, double vision, difficulty in speaking and swallowing
confusion, hallucinations, depression
The above list includes serious side effects and you may need medical attention.
If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:
severe watery or bloody diarrhoea, even if it occurs several weeks after you have stopped taking this medicine
severe stomach pains
severe skin rashes or blistering
numbness, pain, burning, tingling or pins and needles in outer limbs
palpitations, or fast or irregular heart beats
chest pain
fainting
dark, bloody or cloudy urine
yellowing of the skin or eyes (jaundice)
fits (convulsions or seizures)
confusion, nightmares, hallucinations, depression and psychotic reaction (even progressing to self-endangering behaviour)
ringing in the ear, loss of hearing
visual disturbances
symptoms of an allergic reaction including cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin
The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.
Other side effects not listed above may occur in some patients.

After finishing it

Tell your doctor immediately if you notice any of the following side effects, particularly if they occur several weeks after stopping treatment with ciprofloxacin:
severe abdominal cramps or stomach cramps
watery and severe diarrhoea, which may also be bloody
fever, in combination with one or both of the above
Do not take any anti-diarrhoea medicine without first checking with your doctor.
You may have a serious condition affecting your bowel, and may therefore need urgent medical attention. However, this side effect is rare.

Storage and disposal

Storage

Keep your medicine in its original packaging until it is time to take it.
If you take your medicine out of its original packaging they may not keep well.
Keep your medicine in a cool dry place where the temperature will stay below 25°C.
Do not store your medicine, or any other medicine, in the bathroom or near a sink. Do not leave it on a window sill or in the car on hot days.
Heat and dampness can destroy some medicines.
Keep it where children cannot reach it.
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 this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What APO-Ciprofloxacin looks like

250 mg:
White to off-white, round, film-coated tablets marked with "250" on one side and plain on the other. AUST R 135650.
500 mg:
White to off-white, caplet (oval) shaped, film-coated tablets marked with "500" on one side and plain on the other. AUST R 135651.
750 mg:
White to off-white, caplet (oval) shaped, film-coated tablets marked with "750" on one side and plain on the other. AUST R 135652.
Available in blister packs of 14 tablets
* Not all strengths, pack types and/or pack sizes may be available.

Ingredients

Each tablet contains 250 mg, 500 mg or 750 mg of ciprofloxacin.
It also contains the following inactive ingredients:
microcrystalline cellulose
maize starch
magnesium stearate
purified talc
colloidal anhydrous silica
sodium starch glycollate type A
purified water
This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

Sponsor

Apotex Pty Ltd
16 Giffnock Avenue
Macquarie Park NSW 2113
APO and APOTEX are registered trademarks of Apotex Inc.
This leaflet was updated in September 2019.