CIPROXIN^™ Tablet

Ciprofloxacin tablet, 250mg, 500mg and 750mg.

What Ciproxin is used for

Ciproxin tablets are used for the treatment of infections of the lungs, skin, bones and joints, kidney 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 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 of symptoms of an allergic reaction may include skin rash, itching, or difficulty breathing.

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 02 refers to the eleventh month of 2002.

Do not take your tablets if the packaging is torn or shows sign 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's safe for you to take Ciproxin tablets while you are pregnant or breastfeeding. Drugs similar to Ciproxin have caused joint disease in immature animals.
• are elderly or have previously taken corticosteroids. You may be at increased risk of swelling of the tendons. Symptoms include pain, tenderness and sometimes restricted movement.

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
• probenecid, a medicine used to treat gout
• 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

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

You can still take these medicines while you're 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's 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.

How to take it

Swallow the tablets whole with a glass of water or other fluid.

Do not take Ciproxin with milk, yoghurt or other products very high in calcium, otherwise Ciproxin will not be absorbed completely from the stomach. However, if the milk, yoghurt or other high calcium products are ingredients of a meal, they will NOT interfere with Ciproxin absorption.

When to take it

Ciproxin tablets are usually taken twice a day.

Take your tablets at the same time each day. 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're 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.

While you are using 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're 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. Do it 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:

• headache
• fever
• dizziness or lightheadedness
• mild stomach upsets such as feeling sick (nausea) or stomach pains
• dyspepsia (heartburn)
• vomiting
• discharge and itching in the vagina

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)
• irregular heart beats

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 (77°F). 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:

• Ciproxin 250 - Ciprofloxacin 250mg per tablet
• Ciproxin 500 - Ciprofloxacin 500mg per tablet
• Ciproxin 750 - Ciprofloxacin 750mg per tablet

Inactive ingredients:

• colloidal silicon dioxide
• crospovidone
• macrogol 4000
• maize starch
• magnesium stearate
• microcrystalline cellulose
• hypromellose
• titanium dioxide (CI 778991)

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