C-Flox

ciprofloxacin (as hydrochloride)

Consumer Medicine Information

This leaflet answers some common questions about C-FLOX. It does not contain all of 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 C-FLOX against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

C-FLOX tablets are used to treat certain infections of the:

lungs

skin

bones and joints

kidney and bladder

prostate

bowel

C-FLOX is also used to treat inhalational anthrax (an infection caused by breathing in the spores of bacteria.)

C-FLOX tablets contain the active ingredient ciprofloxacin (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.

C-FLOX does not work against infections caused by viruses, such as colds or the flu.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Your doctor may have prescribed it for another reason.

Do not take C-FLOX if you have an allergy to:

ciprofloxacin

other quinolone antibiotics including nalidixic acid, moxifloxacin, norfloxacin

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 C-FLOX if you are also taking a medicine called tizanidine, a muscle relaxant used to treat spasticity associated with multiple sclerosis, injury or diseases of the spinal cord.

C-FLOX can interfere with tizanidine and can lead to undesirable side effects.

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.

Tell your doctor if you have allergies to any other medicines, foods, dyes or preservatives.

Tell your doctor if you are pregnant or plan to become pregnant.

C-FLOX is not recommended if you are pregnant. Medicines similar to C-FLOX have caused joint disease in immature animals.

Your doctor will discuss the risks and benefits of taking C-FLOX during pregnancy.

Do not take C-FLOX if you are breastfeeding.

C-FLOX passes into breast milk and may affect your baby. Your doctor will tell you whether you should take C-FLOX or temporarily stop breastfeeding while you are taking the tablets.

C-FLOX is not recommended for children under 18 years of age except for use in inhalational anthrax.

C-FLOX should be used with caution in elderly patients as they are more prone to side effects.

Tell your doctor if you have or have had any of the following medical conditions:

epilepsy, fits, seizures or convulsions

stroke

kidney disease

liver disease

arrhythmias (fast or irregular heartbeats). C-FLOX may increase the risk of arrhythmias, especially in the elderly or patients with low potassium levels

conditions where you have taken corticosteroids. You may be at increased risk of swelling of the tendons. Symptoms include pain, tenderness and sometimes restricted movement

myasthenia gravis, a condition where the muscles become weak. C-FLOX can worsen symptoms of this condition

a history of tendon disorders with the use of quinolones (e.g. moxifloxacin, norfloxacin, nalidixic acid)

have or have had a mental illness

have diabetes

If you have not told your doctor about any of the above, tell them before you start taking C-FLOX.

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

Some medicines may be affected by C-FLOX, or may affect how well it works. These include:

medicines used to treat arrhythmias (fast or irregular heartbeats)

theophylline, a medicine used to treat asthma

oral anticoagulants, medicines used to prevent blood clots such as warfarin and its derivatives

phenytoin, a medicine used to treat epilepsy

medicines used to control diabetes

didanosine, a medicine used to treat viral infections

ciclosporin, a medicine used to suppress the immune system following organ transplantation

NSAIDs (non-steroidal anti-inflammatory drugs), medicines used to treat pain, arthritis and other inflammatory conditions

methotrexate, a medicine used to treat severe rheumatoid arthritis, severe psoriasis or some types of cancer

duloxetine, a medicine used to treat depression, anxiety and nerve pain in people with diabetes

clozapine, a medicine used to treat schizophrenia

ropinirole, a medicine used to treat Parkinson’s disease or restless legs syndrome

lidocaine (lignocaine), a local anaesthetic medicine used to numb pain or cause loss of sensation

pentoxifylline (oxpentifylline), a medicine used to treat circulation disorders

sildenafil, a medicine used to treat erectile dysfunction

agomelatine, a medicine used to treat depression

zolpidem, a medicine used to treat sleep disorders

These medicines may be affected by C-FLOX, 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 the absorption of C-FLOX.

These include:

multivitamins, mineral supplements, antacids (used for indigestion) and other medicines containing iron, zinc, magnesium, aluminium or calcium

sucralfate, a medicine used to treat duodenal or stomach ulcers

medicines used to treat HIV infection

probenecid, a medicine used to treat gout

omeprazole, a medicine used to treat stomach ulcers and other conditions where the 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 treat nausea and vomiting, heartburn and stomach pain

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

If you are not sure whether you are taking any of these medicines, check with your doctor or pharmacist.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist for help.

Your doctor will tell you how much and how often you should take C-FLOX. This will depend on the type of infection and any medical conditions you have.

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 of time for some types of infection.

Elderly people and people with kidney problems may need smaller doses.

Swallow the tablets whole with a glass of water.

C-FLOX tablets are usually taken twice a day.

Take your tablets at the same time each day, preferably on an empty stomach. However, C-FLOX can be taken with or without food.

Continue taking your medicine for as long as your doctor tells you.

The length of treatment may vary from 1 to 28 days or longer depending on the type of infection.

Do not stop taking C-FLOX even if you are feeling better, unless advised by your doctor.

If you stop taking your medicine too soon, the infection may not clear completely or your symptoms may return.

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 your medicine as you would normally.

Do not take a double dose to make up for the dose you missed.

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.

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26), or go to Accident and Emergency at the nearest hospital, if you think you or anyone else may have taken too much C-FLOX.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking C-FLOX.

Tell all other doctors, dentists and pharmacists who are treating 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.

If you are about to have any laboratory, blood or urine tests, tell your doctor that you are taking this medicine.

It may affect the results of some tests.

Drink plenty of water while you’re taking C-FLOX.

This helps to stop crystals forming in your urine.

If you become pregnant while taking C-FLOX, tell your doctor immediately.

If you develop diarrhoea, tell your doctor or pharmacist immediately. Do this even if it occurs several weeks after you have stopped taking C-FLOX.

Diarrhoea may mean that you have a serious condition affecting your bowel.

You may need urgent medical care.

Do not take any medicines for diarrhoea without checking with your doctor or pharmacist.

Tell your doctor immediately if you experience symptoms of depression or self-endangering behaviour. C-FLOX should be discontinued immediately.

Tell your doctor immediately if you develop pain, burning, tingling, numbness or weakness is any part of the body. C-FLOX should be discontinued immediately.

Do not take C-FLOX 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 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.

Avoid excessive exposure to direct sunlight.

Your skin may become more prone to sunburn. If such a reaction occurs, stop taking C-FLOX immediately and tell your doctor.

Be careful driving or operating machinery until you know how C-FLOX affects you.

C-FLOX may cause dizziness in some people, especially after the first few doses. Your ability to drive and/or operate machinery may be impaired. If you drink alcohol while taking this medicine, dizziness may be worse.

C-FLOX tablets may increase the stimulatory effects of caffeine.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking C-FLOX.

This medicine is generally well tolerated and helps most people with bacterial infections, but it may have unwanted side effects in some people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects.

You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

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

nausea or vomiting

diarrhoea

These are the more mild and common side effects of your medicine.

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, peeling of the skin and/or mucosal reactions

signs of allergy such as rash, swelling of the face, lips, mouth, throat or other parts of the body, shortness of breath, wheezing or trouble breathing

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)

fast or irregular heartbeats

visual disturbances (eyesight problems)

ringing in the ear, loss of hearing

abdominal pain/cramps. Very rarely this can progress to a serious condition accompanied by fever and fatigue

pain, burning, tingling, numbness and/or weakness in your limbs

The above list includes serious side effects that may require medical attention.

In isolated instance, some serious side effects may be long-lasting (more than 30 days) and disabling, such as tendonitis, tendon rupture, musculoskeletal disorders and other reactions affecting the nervous system including mental health disorders and disturbance of senses.

Photosensitivity (getting sunburnt very easily) can occasionally occur with C-FLOX. However, it is temporary and staying out of direct sunlight while taking C-FLOX will prevent this 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 muscle in the leg to the heel of the foot) or other tendons have been torn after C-FLOX therapy. This may occur even within the first 48 hours of treatment and up to several months after completing treatment with C-FLOX. This risk of tendon damage may be increased in elderly patients, during strenuous physical activity, if you are currently being treated with a type pf medicine called corticosteroids, if you have reduced kidney function or have received solid organ transplants.

Tell your doctor immediately if you feel any discomfort, pain or inflammation of a tendon.

Rarely, you may experience hyperglycaemia (high blood sugar) or hypoglycaemia (low blood sugar). Symptoms of hyperglycaemia include increased thirst, appetite and urination. Symptoms of hypoglycaemia include weakness, shaking, sweating, light headedness, headache, behavioural changes, confusion, numbness/pins and needles in the lips, fingers or toes, irritability and hunger. Tell your doctor if you experience these symptoms.

If you experience any of these symptoms during treatment with C-FLOX, tell your doctor or pharmacist immediately. C-FLOX may need to be discontinued.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people. 

Keep your tablets in the pack until it is time to take them.

If you take the tablets out of the pack they may not keep well.

Keep your tablets in a cool dry place where the temperature stays below 25°C.

Do not store C-FLOX or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills.

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.

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.

C-FLOX is available in 3 tablet strengths:

C-FLOX 250: white, biconvex, round, film-coated tablets marked “CF” scoreline “250” on one side and “G” on the other side. Packs of 14 tablets

C-FLOX 500: white, biconvex, capsule shaped, film-coated tablets marked “CF” scoreline “500” on one side and “G” on the other side. Packs of 14 tablets

C-FLOX 750: white, biconvex, capsule shaped, film-coated tablets marked “CF” scoreline “750” on one side and “G” on the other side. Packs of 14 tablets

The active ingredient in C-FLOX is ciprofloxacin (as hydrochloride).

Each tablet contains:

C-FLOX 250 – ciprofloxacin (as hydrochloride) 250 mg

C-FLOX 500 – ciprofloxacin (as hydrochloride) 500 mg

C-FLOX 750 – ciprofloxacin (as hydrochloride) 750 mg

The tablets also contain the following inactive ingredients:

microcrystalline cellulose

maize starch

crospovidone

pregelatinised maize starch

colloidal anhydrous silica

magnesium stearate

hypromellose

titanium dioxide CI77891 (E171)

polydextrose

triacetin

macrogol 8000

C-FLOX contains sulfites. The tablets are gluten free.

Alphapharm Pty Ltd

Level 1, 30 The Bond

30 – 34 Hickson Road

Millers Point NSW 2000

www.mylan.com.au

 

Australian registration numbers:

C-FLOX 250 – AUST R 195202

C-FLOX 500 – AUST R 195203

C-FLOX 750 – AUST R 195204

 

This leaflet was prepared in

January 2020

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