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Ciprofloxacin Alphapharm

contains the active ingredient ciprofloxacin
CONSUMER MEDICINE INFORMATION
 

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia. This page contains answers to some common questions about Ciprofloxacin Alphapharm. It does not contain all the information that is known about Ciprofloxacin Alphapharm. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risk of you using this medicine against the benefits he/she expects it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Bookmark or print this page, you may need to read it again.

What CIPROFLOXACIN Alphapharm is used for

CIPROFLOXACIN Alphapharm is a sterile intravenous antibiotic. It contains the drug ciprofloxacin, which can kill many kinds of bacteria which cause infections in the body.
CIPROFLOXACIN Alphapharm is used in a hospital environment only.
CIPROFLOXACIN Alphapharm is used to treat serious infections in the lungs, skin, blood, bone and joints, kidneys and bladder.
CIPROFLOXACIN Alphapharm will not work against infections caused by viruses such as colds or the flu.

Before you take CIPROFLOXACIN Alphapharm

When you must not take it

Do not take CIPROFLOXACIN Alphapharm 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:
Shortness of breath
Wheezing or difficulty breathing
Swelling of the face, lips, tongue or other parts of the body,
skin rash, itching or hives.
Do not take CIPROFLOXACIN Alphapharm if you are also taking a medicine called tizanidine, a muscle relaxant used to treat spasticity associated with multiple sclerosis or injury or diseases of the spinal cord).
CIPROFLOXACIN Alphapharm can interfere with tizanidine and can lead to undesirable side effects.
Do not take CIPROFLOXACIN Alphapharm 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 infusion bag are not to be used if it is cloudy or has little specks in it.

Before you start to take it

Tell your doctor if you:
Have any allergies to ciprofloxacin or any other ingredients in CIPROFLOXACIN Alphapharm, or to any other medicines that you have used in the past, or to any other substances such as food, preservatives or dyes
CIPROFLOXACIN Alphapharm is not recommended if you are pregnant but your doctor will assess the benefit if required. Medicines similar to ciprofloxacin have caused joint disease in immature animals.
Tell your doctor if you are breastfeeding. Ciprofloxacin is excreted into the breast milk. Your doctor will tell you whether you should take it and temporarily stop breastfeeding while you are receiving ciprofloxacin Alphapharm.
CIPROFLOXACIN Alphapharm should not be used in children under 18 years of age except for use in inhalational anthrax.
CIPROFLOXACIN Alphapharm should be used with caution in elderly patients as they are more prone to side effects.
Tell your doctor if you:
Suffer from epilepsy (seizures, convulsions), have had a stroke, or have kidney or liver disease
Have arrhythmias (fast or irregular heartbeats). Ciprofloxacin may increase the risk of arrhythmias, especially in the elderly or patients with low potassium levels.
Have previously taken corticosteroids. You may be at increased risk of swelling of the tendons. Symptoms include pain, tenderness and sometimes restricted movement.
Have congestive heart failure, renal failure, nephritic syndrome. Sodium intake may be of medical concern and the additional sodium load from using CIPROFLOXACIN Alphapharm should be taken into account
Have myasthenia gravis, a condition where the muscles become weak. CIPROFLOXACIN Alphapharm can worsen the symptom of this condition.
Have a history of tendon disorders with the use of quinolones.
If you have not told your doctor or pharmacist about any of the above, tell them before you start taking CIPROFLOXACIN Alphapharm.

Taking other medicines

Tell your doctor or pharmacist if you are taking or given any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may be affected by CIPROFLOXACIN Alphapharm. These medicines include:
medicines used to treat arrhythmias (fast or irregular heartbeats)
theophylline, a medicine used to treat asthma
oral anticoagulants, warfarin and its derivatives, medicines used to stop blood clots
cyclosporin, an medicine used to suppress the immune system
phenytoin, a medicine used to treat epilepsy
oral antibiotic agents
non-steroidal anti-inflammatory drugs (NSAIDs), used to treat arthritis and other painful conditions secondary to inflammation
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 local anaesthetic lignocaine, a medicine used to numb pain or cause loss of sensation
warfarin, a medicine used to stop blood clots
glibenclamide, a medicine used to treat diabetes
These medicines may be affected by CIPROFLOXACIN Alphapharm, 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 CIPROFLOXACIN Alphapharm. These include:
probenecid, a medicine used to treat gout
omeprazole, a medicine used to treat ulcers and other conditions where stomach produces too much acid
You can still take these medicines while you are taking CIPROFLOXACIN Alphapharm. However, you must take CIPROFLOXACIN Alphapharm at least 2 hours before or 2 hours after taking any of these medicines.
Your doctor or pharmacist have more information on medicines to be careful with or avoid while receiving this medicine.

How CIPROFLOXACIN Alphapharm is given

CIPROFLOXACIN Alphapharm is given as a slow injection into a vein, usually as a drip, by a doctor or a nurse.
CIPROFLOXACIN Alphapharm 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 take are given too much (overdose)

Immediately tell your doctor or nurse on duty or 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 received too much CIPROFLOXACIN Alphapharm. Do this even if there are no signs of discomfort or poisoning.
You may need urgent medical attention.

While you are using CIPROFLOXACIN Alphapharm

Things you must do

Tell all doctors, dentists, nurse and pharmacists who are treating you that you are receiving CIPROFLOXACIN Alphapharm.
Tell your doctor if you need to have a surgical or dental procedure that you are receiving CIPROFLOXACIN Alphapharm.
The use of CIPROFLOXACIN Alphapharm may affect the results of certain laboratory tests.
If you are about to have any tests, tell your doctor that you are receiving this medicine.
If you are about to be started on any new medicine, remind your doctor and pharmacist that you are receiving CIPROFLOXACIN Alphapharm.
Drink plenty of water while you are receiving CIPROFLOXACIN Alphapharm.
This helps to stop crystals forming in your urine.
If you become pregnant while you are taking CIPROFLOXACIN Alphapharm, 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 finished your course of CIPROFLOXACIN Alphapharm. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any anti-diarrhoea medicine without first checking with your doctor or pharmacist.
Tell your doctor immediately if you experience symptoms of depression or self-endangering behaviour.
CIPROFLOXACIN Alphapharm should be discontinued immediately.

Things you must not do

Do not give CIPROFLOXACIN Alphapharm to anyone else, even if they have the same condition as you.
Do not use Ciprofloxacin Alphapharm to treat other conditions unless your doctor tells you to.
Do not stop using CIPROFLOXACIN Alphapharm 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, tell your doctor.
Be careful driving or operating machinery until you know how CIPROFLOXACIN Alphapharm affects you.
Ciprofloxacin may cause dizziness in some patients, especially after the first doses. Your ability to drive and/or operate machinery may be impaired. If you drink alcohol while using this medicine, dizziness may be worse.
CIPROFLOXACIN Alphapharm may increase the stimulating effect of caffeine.
If you have congestive heart failure, renal failure, nephritic syndrome. Sodium intake may be of medical concern and the additional sodium load from using CIPROFLOXACIN Alphapharm should be taken into account.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are receiving CIPROFLOXACIN Alphapharm.
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.
CIPROFLOXACIN Alphapharm is usually well tolerated. However, there may be unwanted effects which are presently unknown.
CIPROFLOXACIN Alphapharm can cause redness, pain, oedema, hypersensitivity and inflammation at the injection site.
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.
Vomiting and rash were common in patients switching from ciprofloxacin injection to ciprofloxacin tablets.
Tell your doctor if you notice any of the following and they worry you:
nausea
diarrhoea
These are the more common side effects of CIPROFLOXACIN Alphapharm. 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, peeling of the skin and/or mucosal reactions
signs of allergy such as rash, swelling of the face, lips, mouth or throat or other parts of the body
shortness of breath, wheezing or difficulty in breathing
fainting
yellowing of the skin and eyes, also called jaundice
severe watery or bloody diarrhoea, even if it occurs several weeks after receiving CIPROFLOXACIN Alphapharm.
fits (seizures, convulsions)
confusion, nightmares, hallucinations, and psychotic reaction (even progressing to self-endangering behaviour)
fast or irregular heart beats
visual disturbances
ringing in the ear, loss of hearing
inflammation of the bowel, abdominal pain/cramps. Very rarely this can progress to a serious condition accompanied by fever and fatigue.
joint/muscle pain or cramping
These serious side effects are rare. 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 CIPROFLOXACIN Alphapharm 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 CIPROFLOXACIN Alphapharm therapy. Tell your doctor straight away if you feel any discomfort, pain, inflammation or rupture of a tendon.
Rarely, hypoglycaemia (low blood sugar) may also occur. Symptoms include increased thirst, appetite, urination, weakness, trembling, sweating, dizziness, headache, behavioural changes, confusion, numbness/pins and needles in the lips, fingers or toes, irritability, hunger and having a fast pounding heartbeat. Contact your doctor if you experience these symptoms.
Severe allergic reactions (anaphylactic reactions) can occur with CIPROFLOXACIN Alphapharm.
Symptoms of a severe allergic reaction include flushing, hives on the skin, itchy skin, nausea, a rapid or very slow pulse and difficulty breathing.
If you experience any of these symptoms during the treatment with CIPROFLOXACIN Alphapharm, notify the doctor, nurse or pharmacist immediately.
CIPROFLOXACIN Alphapharm may need to be discontinued and medications are required to treat these symptoms.
Tell your doctor, pharmacist or nurse if you notice anything that is making you feel unwell.
Also please be sure to tell your doctor of any other effects or symptoms.

After using CIPROFLOXACIN Alphapharm

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 infusion bag of CIPROFLOXACIN Alphapharm is to be used once only. Any unused portion remaining in the bag must be discarded.

Storage

CIPROFLOXACIN Alphapharm will be stored in the pharmacy or on the ward.
The infusion bag is kept in a cool, dry place away from sunlight, where the temperature stays below 25°C. The infusion bag should not be stored in the refrigerator or freezer. The infusion bag should be stored in the outer overwrap in order to protect it from light.
If you have any further questions on CIPROFLOXACIN Alphapharm, 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

CIPROFLOXACIN Alphapharm is a clear, colourless to slightly yellow solution containing ciprofloxacin in the following strengths:
200 mg/100 mL infusion bag
400 mg/200 mL infusion bag

Ingredients

Active Ingredients:
CIPROFLOXACIN Alphapharm - 200 mg ciprofloxacin /100 mL infusion bag
CIPROFLOXACIN Alphapharm - 400 mg ciprofloxacin /200 mL infusion bag
Inactive ingredients:
lactic acid
glucose
water for injections
small amounts of hydrochloric acid to adjust the acidity of the solution.

Supplier

Alphapharm Pty Limited
(ABN 93 002 359 739)
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
Phone: (02) 9298 3999
www.alphapharm.com.au
 
Medical Information
Phone: 1800 028 365
 
Australian registration number:
CIPROFLOXACIN Alphapharm - 200 mg ciprofloxacin /100 mL infusion bag AUST R 154611
CIPROFLOXACIN Alphapharm - 400 mg ciprofloxacin /200 mL infusion bag AUST R 154612
Each carton of CIPROFLOXACIN Alphapharm ciprofloxacin injection for IV infusion 200 mg/100mL and CIPROFLOXACIN Alphapharm ciprofloxacin injection for IV infusion 400 mg/200mL contains 10 infusion bags per carton.
 
This leaflet was prepared on
2 December 2015.
Ciprofloxacin Alphapharm_cmi/Dec15