Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about COLCINE. 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 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 COLCINE is used for

COLCINE contains colchicine as the active ingredient.

COLCINE is used for the relief of pain in acute attacks of gout. It is not an analgesic and does not provide relief from other types of pain.

COLCINE has a preventative effect that helps to reduce the incidence of acute attacks. It will not reduce the amount of uric acid in the body.

COLCINE belongs to a group of medicines called antigout drugs.

Ask your doctor if you have any questions about why COLCINE has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor's prescription.

There is no evidence that it is addictive.

How COLCINE works

• Colchicine decreases leucocyte chemo taxis and phagocytosis and thereby inhibits the formation and release of a chemotactic glycoprotein that is produced during the phagocytosis of urate crystals.
• Colchicine also inhibits urate crystal deposition, which is enhanced by a low pH in the tissues, probably by inhibiting oxidation of glucose and subsequent, lactic acid production in leucocytes.

Ask your doctor if you have any questions about why COLCINE has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is only available with a doctor's prescription.

There is no evidence that it is addictive.

Before you take COLCINE

When you must not take it

Do not take COLCINE if you have an allergy to:

• any medicine containing colchicine
• 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 or tongue; skin rash, itching or hives.

Do not give this medicine to children. This medication may be dangerous to children. It is important that it is kept out of reach of children at all times.

Do not take COLCINE if you have:

• combined kidney and liver disease
• serious kidney or liver disease
• serious heart disease
• severe stomach disorder
• a blood disorder.

Do not take this medicine after the expiry date (EXP) printed on the pack. If you take this medicine after the expiry date has passed, it may not work as well.

Do not take this medicine if the bottle shows signs of having been tampered with.

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 are allergic to any other medicines or any foods, preservatives or dyes.

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

• stomach problems
• kidney or liver disease
• heart disease
• alcoholism.

Tell your doctor if you are pregnant or plan to become pregnant. COLCINE may affect your developing baby if you take it during pregnancy.

Tell your doctor if you are breast-feeding or plan to breastfeed. Your doctor will discuss the risks and benefits of you taking COLCINE when breast-feeding.

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

Taking other medicines

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

Some medicines may interfere with COLCINE.

These include:

• cyclosporin - a medicine used to suppress the immune system
• erythromycin, clarithromycin and telithromycin - antibiotics used to treat bacterial infection
• protease inhibitors, including atazanavir, indinavir, nelfinavir, ritonavir and saquinavir, used to treat HIV and other viral infections
• ketoconazole and itraconazole, used to treat certain fungal infections
• nefazodone, used to treat depression
• acidifying and alkalinising agents, such as ammonium chloride, ascorbic acid (vitamin C), sodium bicarbonate
• medicines to help you sleep
• alcohol
• NSAIDs or aspirin - anti-inflammatory drugs used to treat pain
• medicines used to treat cancer including radiation therapy
• vitamin B12
• anticoagulants such as coumarin, heparin
• antithyroid medicines.

These medicines may be affected by COLCINE or may affect how well it works. You may need to take different amounts of your medicines or you may need to take different medicines. Your doctor or pharmacist has a more complete list of medicines to be careful with or avoid while taking COLCINE.

How to take COLCINE

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

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

How much to take

Your doctor will tell you how much COLCINE to take.

Do not take more than your doctor tells you to.

The maximum recommended dose for treatment of gout flares is 1.5 mg over a one hour period. Do not repeat the course within 3 days.

How to take COLCINE

Swallow the tablet whole with a full glass of water.

When to take COLCINE

COLCINE may be taken before or after food.

How long to take COLCINE for

Continue taking your medicine for as long as your doctor tells you. This will depend on your condition and your response to the treatment.

COLCINE helps to control your condition but does not cure it.

Immediately stop taking COLCINE at the first sign of stomach pain, nausea, vomiting or diarrhoea. Do this even if your symptoms have not been relieved.

If you forget to take COLCINE

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

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 COLCINE (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 COLCINE. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of an overdose may include:

• severe nausea, vomiting, stomach pain and diarrhoea
• burning feeling or rawness in the mouth and throat
• difficulty in breathing or swallowing
• fever
• muscle weakness
• mental confusion, delirium, convulsions.

While you are taking COLCINE

Things you must do

Immediately stop taking COLCINE at the first sign of stomach pain, nausea, vomiting or diarrhoea. Do this even if your symptoms have not been relieved.

Remember to take note of the number of tablets you took before the onset of these symptoms so that you can take fewer tablets during subsequent attacks.

Tell any other doctors, dentists, and pharmacists who are treating you that you are taking this medicine, especially if you are being started on any new medicines.

Tell your doctor, surgeon or anaesthetist that you are taking COLCINE if you are about to undergo surgery or an operation.

Tell your doctor immediately if you become pregnant while taking COLCINE.

If you are about to have any blood tests remind your doctor that you are taking COLCINE. It may interfere with the results of some tests.

Keep all of 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.

Things you must not do

Do not take COLCINE 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.

Things to be careful of

Be careful driving or operating machinery until you know how COLCINE affects you.

Check with your doctor or pharmacist before drinking alcohol while you are taking COLCINE. If you drink alcohol while taking this medicine, you may develop stomach problems.

This medication may be dangerous to children. It is important that it is kept out of reach of children at all times.

Side effects

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

This medicine helps most people with gout, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

If you are elderly you may have an increased chance of getting side effects.

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

Immediately stop taking COLCINE at the first sign of stomach pain, nausea, vomiting or diarrhoea. Do this even if your symptoms have not been relieved.

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

• loss of appetite
• loss of hair.

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

Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital if you notice any of the following symptoms:

• burning feeling in the stomach or throat
• severe stomach pain, nausea, vomiting
• severe diarrhoea with bloody or black tarry stools
• itchy skin, skin rash, hives, unusual bleeding or bruising under the skin
• difficulty in passing urine or blood in urine
• confusion, convulsions
• fever
• muscle weakness
• numbness or weakness in the fingers and toes.

These are all very serious side effects. You may need urgent medical attention or hospitalisation.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Some people may get other side effects while taking COLCINE. Some of these side effects (e.g. changes in thyroid function or in the blood) can only be found when your doctor does tests from time to time to check your progress.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After taking COLCINE

Storage

Keep your tablets in the bottle until it is time to take them. If you take the tablets out of the bottle they may not keep well.

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

Do not store COLCINE or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. 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 COLCINE or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

COLCINE Round, off white coloured biconvex, uncoated tablets embossed “C5” on one upper side and plain on the bottom face.

COLCINE available in a

• Al/Al blister pack containing 30 tablets & 100 tablets
• HDPE bottle of 30 tablets.

Ingredients

Active ingredient:

COLCINE

Each uncoated tablets contain 500 microgram of colchicine as the active ingredient.

Inactive ingredients:

• pregelatinised maize starch
• microcrystalline cellulose
• lactose monohydrate
• sodium starch glycollate
• magnesium stearate

This medicine contains lactose

Sponsor

COLCINE is supplied in Australia by:

Pharmacor Pty Ltd.
CHATSWOOD, NSW 2067,
Australia
www.pharmacor.com.au

Australian Registration Numbers

COLCINE 500 MICROGRAM
bottle pack– AUSTR 335430
Blister pack-AUSTR 335431

This leaflet was prepared in Mar 2021

Published by MIMS September 2021

1 Name of Medicine

Colchicine.

2 Qualitative and Quantitative Composition

Colcine - Each uncoated tablet contains 500 microgram of colchicine.
Excipient with known effect. Contains lactose.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Uncoated Tablets.
Colcine - Round, off white coloured biconvex, uncoated tablets embossed "C5" on one upper side and plain on the bottom face.

4 Clinical Particulars

4.9 Overdose

Symptoms. A latent period of 2 to 12 hours occurs between overdose and the onset of gastrointestinal symptoms.
The first signs of toxicity may be a feeling of burning and rawness in the mouth and throat and difficulty in swallowing. These symptoms are followed by severe nausea, vomiting, abdominal pain, haemorrhagic gastroenteritis, with resulting electrolyte abnormalities, volume depletion and hypotension.
The second phase consists of multisystem failure and generally occurs at 24 to 72 hours post ingestion. Effects include CNS toxicity, bone marrow depression, hepatocellular damage, muscle damage, respiratory distress, myocardial injury and renal damage. Multiple organ failure caused by tissue damage including bone marrow hypoplasia is likely to be followed by agranulocytosis, leukopenia, thrombocytopenia and disseminated intravascular coagulation. In some patients, disseminated intravascular coagulation may be the first haematological sign of toxicity, with the most severe coagulopathy occurring about 25 hours following the administration of a large overdose. Leucopenia may persist for several days followed by leucocytosis with numerous metamyelocytes and myelocytes. Other haematological manifestations of colchicine poisoning include granulocytopenia, immature leukocytes, pancytopenia, anaemia with anisocytosis, polychromasia and basophilic stippling.
Cerebral oedema and CNS toxicity are also associated with acute colchicine toxicity and may be characterised by marked muscular weakness and the development of ascending CNS paralysis with the patient remaining conscious. Mental confusion, delirium, seizures and convulsions may occur as a result of CNS toxicity. There may be a loss of deep tendon and Achilles tendon reflexes, and Babinski's reflex may be elicited.
A fever may develop; sepsis is a well recognised complication and should not be ruled out.
Death may occur as a result of respiratory depression, cardiovascular collapse, or sepsis.
In surviving patients, alopecia, rebound leucocytosis and stomatitis may occur about 10 days after the acute overdose.
Severe toxicity and death have been associated with oral doses exceeding 0.5 mg/kg. The lethal dose varies. While it appears to be about 40 mg in adults with normal renal function, a fatal dose of 7 mg has been recorded.
Treatment. When treating colchicine overdosage or acute poisoning, patients should be carefully monitored for at least 12 hours to take into account the delayed onset of symptoms.
There is no specific antidote for colchicine poisoning. Activated charcoal should be administered, preferably within one hour of ingestion. Repeated oral charcoal dosing (every 2 to 6 hours), administered as a slurry, may enhance total body clearance and elimination, but has not been shown to affect outcome and is not routinely recommended. Consider administration of more than one dose of activated charcoal in patients with moderate to severe poisoning or very large ingestions, and those with clinical deterioration or rising levels despite initial decontamination.
Measures to prevent shock should be taken and diarrhoea should not be treated as this is the main route of elimination.
Other treatment is symptomatic and supportive with attention being given to the control of respiration, maintenance of blood pressure and the circulation, and correction of fluid and electrolyte imbalance.
Analgesics with or without atropine may relieve the abdominal pain, but monitor carefully for possible paralytic ileus.
A benzodiazepine such as diazepam may be given to control convulsions.
Both acute and chronic toxicity may lead to bone marrow depression. Isolate patient if there is evidence of bone marrow depression.
Due to the large apparent volume of distribution of colchicine, haemodialysis and peritoneal dialysis are not recommended.
Monitoring should include haemodynamic, cardiac, and respiratory status and blood electrolytes. In some circumstances, prolonged observation may be recommended as the most severe toxic effects may not appear until 24 hours after ingestion of an acute dose.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Mutagenicity studies of colchicine have not been evaluated. Colchicine is a known genotoxin, causing gene mutations, DNA damage and chromosomal damage in several in vitro and in vivo assays.
Carcinogenicity. Animal studies have not been performed to assess the potential carcinogenic effect of colchicine. Since colchicine is an established mutagen, its ability to act as a carcinogen must be suspected and treatment with Colcine should involve a weighing of the benefit vs risk when long term administration is being considered.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Colchicine occurs as pale yellow, amorphous scales or powder and darkens on exposure to light. Colchicine is soluble in water, freely soluble in alcohol and chloroform, and slightly soluble in ether.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSCOLCHI.gif Chemical name: (S)-N-(5,6,7,9-Tetrahydro-1,2,3,10-tetramethoxy-9-oxobenzo [α] heptalen-7-yl) acetamide.
Empirical formula: C₂₂H₂₅NO₆.
Molecular weight: 399.4.
CAS number. 64-86-8.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/COLCINST.gif