1. NAME OF THE MEDICINAL PRODUCT

Colchicine Tablets 500mcg Taj Pharma
Colchicine Tablets 1mg Taj Pharma

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Colchicine Ph Eur 535 micrograms (equivalent to Colchicine 500 micrograms on a dry weight basis).
Excipients   q.s.

Colchicine Ph Eur 1035 micrograms (equivalent to Colchicine 1000 micrograms on a dry weight basis).
Excipients   q.s.

For the full list of excipients, see 6.1.

  1. PHARMACEUTICAL FORM

Tablet – oral use.

4. CLINICAL PARTICULARS

4.1 Therapeutic indications
Adults

  • Treatment of acute gout
  • Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs

4.2  Posology and method of administration

Posology

Adults

Treatment of acute gout attack:

1 mg (2 tablets) to start followed by 500 micrograms (1 tablet) after 1 hour.

No further tablets should be taken for 12 hours.

After 12 hours, treatment can resume if necessary with a maximum dose of 500 micrograms (1 tablet) every 8 hours until symptoms are relieved.

The course of treatment should end when symptoms are relieved or when a total of 6 mg (12 tablets) has been taken.

No more than 6 mg (12 tablets) should be taken as a course of treatment.

After completion of a course, another course should not be started for at least 3 days (72 hours).

Prophylaxis of gout attack during initiation of therapy with allopurinol and uricosuric drugs:

500 micrograms twice daily.

The treatment duration should be decided after factors such as flare frequency, gout duration and the presence and size of tophi have been assessed.

Patients with renal impairment:

Use with caution in patients with mild renal impairment. For patients with moderate renal impairment, reduce dose or increase interval between doses. Such patients should be carefully monitored for adverse effects of colchicine (see also section 5.2).

For patients with severe renal impairment, see section 4.3.

Patients with hepatic impairment

Use with caution in patients with mild/moderate hepatic impairment. Such patients should be carefully monitored for adverse effects of colchicine.

For patients with severe hepatic impairment, see section 4.3.

Elderly:

Use with caution.

Method of Administration

For oral administration

Tablets should be swallowed whole with a glass of water
4.3 Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Patients with blood dyscrasias
  • Pregnancy
  • Breastfeeding
  • Women of childbearing potential unless using effective contraceptive measures
  • Patients with severe renal impairment
  • Patients with severe hepatic impairment
  • Colchicine should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion.
  • Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a P-glycoprotein (P-gp) inhibitor or a strong CYP3A4 inhibitor (see section 4.5)

4.4 Special Warnings and precautions for use

Colchicine is potentially toxic so it is important not to exceed the dose prescribed by a physician with the necessary knowledge and experience.

Colchicine has a narrow therapeutic window. The administration should be discontinued if toxic symptoms such as nausea, vomiting, abdominal pain, diarrhoea occur.

Colchicine may cause severe bone marrow depression (agranulocytosis, aplastic anaemia, thrombocytopenia). The change in blood counts may be gradual or very sudden. Aplastic anaemia in particular has a high mortality rate. Periodic checks of the blood picture are essential.

If patients develop signs or symptoms that could indicate a blood cell dyscrasia, such as fever, stomatitis, sore throat, prolonged bleeding, bruising or skin disorders, treatment with colchicine should be immediately discontinued and a full haematological investigation should be conducted straight away.

Caution is advised in case of:

  • liver or renal impairment
  • cardiovascular disease
  • gastrointestinal disorders
  • elderly and debilitated patients
  • patients with abnormalities in blood counts

Patients with liver or renal impairment should be carefully monitored for adverse effects of colchicine (see section 5.2).

Co-administration with P-gp inhibitors and/or moderate or strong CYP3A4 inhibitors will increase the exposure to colchicine, which may lead to colchicine induced toxicity including fatalities. If treatment with a P-gp inhibitor or a moderate or strong CYP3A4 inhibitor is required in patients with normal renal and hepatic function, a reduction in colchicine dosage or interruption of colchicine treatment is recommended (see section 4.5).

This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Colchicine is a substrate for both CYP3A4 and the transport protein P-gp. In the presence of CYP3A4 or P-gp inhibitors, the concentrations of colchicine in the blood increase. Toxicity, including fatal cases, have been reported during concurrent use of CYP3A4 or P-gp inhibitors such as macrolides (clarithromycin and erythromycin), ciclosporin, ketoconazole, itraconazole, voriconazole, HIV protease inhibitors, calcium channel blockers (verapamil and diltiazem) and disulfiram (see section 4.4).

Colchicine is contraindicated in patients with renal or hepatic impairment who are taking a P-gp inhibitor (e.g. ciclosporin, verapamil or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, atazanavir, indinavir, clarithromycin, telithromycin, itraconazole or ketaconazole) (see section 4.3).

A reduction in colchicine dosage or an interruption of colchicine treatment is recommended in patients with normal renal or hepatic function if treatment with a P-gp inhibitor or strong CYP3A4 inhibitor is required (see section 4.4).

A 4-fold reduction in colchicine dosage is recommended when co-administered with a P-gp inhibitor and/or a strong CYP3A4 inhibitor. A 2-fold reduction in colchicine dosage is recommended when co-administered with a moderate CYP3A4 inhibitor.

The magnitude of interactions with strong and moderate CYP3A4 inhibitors as well as with P-gp inhibitors from performed in vivostudies is summarised in the table below:

Single dose of 0.6 mg colchicine without or with: Number of subjects % change in colchicine pharmacokinetic parameters Guidance for dose reduction:
Cmax AUCo-t
Strong CYP3A4 inhibitors

Clarithromycin 250 mg twice daily for 7 days

Ketoconazole 200 mg twice daily for 5 days

Ritonavir 100 mg twice daily for 5 days

 

N=23

 

N=24

 

N=18

 

297

 

190

 

267

 

339

 

287

 

345

4-fold

Acute gout regimen to be repeated no earlier than 3 days.

Moderate CYP3A4 inhibitors

Verapamil ER 240 mg once daily for 5 days

Diltiazem ER 240 mg once daily for 7 days

Grapefruit juice 240 ml twice daily for 4 days

 

N=24

 

N=20

 

N=21

 

130

 

129

 

93

 

188

 

177

 

95

2-fold

Acute gout regimen to be repeated no earlier than 3 days.

Potent P-gp inhibitors

Cyclosporin 100 mg single dose

 

N=23

 

324

 

317

4-fold

Acute gout regimen to be repeated no earlier than 3 days.

Given the nature of the side effects, caution is advised with concomitant administration of drugs that can affect the blood count or have a negative effect on hepatic and/or renal function.

In addition, substances such as cimetidine and tolbutamide reduce metabolism of colchicine and thus plasma levels of colchicine increase.

Grapefruit juice may increase plasma levels of colchicine. Grapefruit juice should therefore not be taken together with colchicine.

Reversible malabsorption of cyanocobalamin (vitamin B12) may be induced by an altered function of the intestinal mucosa.

The risk of myopathy and rhabdomyolysis is increased by a combination of colchicine with statins, fibrates, ciclosporin or digoxin.

4.6 Fertility, pregnancy and lactation

Fertility

Colchicine administration in animals induces significant reductions in fertility.

Pregnancy

Colchicine is genotoxic in vitro and in vivo, and is teratogenic in animal studies (see section 5.3). Colchicine is therefore contraindicated in pregnancy (see section 4.3).

Women of childbearing potential have to use effective contraception during treatment.

Breastfeeding

Colchicine is excreted in breast milk. Therefore, use of colchicine is contraindicated in women who are breastfeeding (see section 4.3).

4.7 Effects on ability to drive and use machines

No details are available regarding the influence of colchicine on the ability to drive and use machines. However, the possibility of drowsiness and dizziness should be taken into account.

4.8 Undesirable Effects

The following adverse reactions have been observed.

The frequencies are listed under one of the following classifications:

Very common > 1/10

Common > 1/100 and < 1/10

Uncommon > 1/1000 and < 1/100

Rare > 1/10 000 and < 1/1000

Very rare < 1/10 000

Not known (cannot be estimated from the available data)

Blood and lymphatic system disorders

Not known: bone marrow depression with agranulocytosis, aplastic anaemia and thrombocytopenia.

Nervous system disorders

Not known: peripheral neuritis, neuropathy.

Gastrointestinal system disorders

Common: abdominal pain, nausea, vomiting and diarrhoea.

Not known: gastrointestinal haemorrhage.

Hepatobiliary disorders

Not known: hepatic damage.

Skin and subcutaneous tissue disorders

Not known: alopecia, rash.

Musculoskeletal and connective tissue disorders

Not known: myopathy and rhabdomyolysis.

Renal and urinary disorders

Not known: renal damage.

Reproductive system and breast disorders

Not known: amenorrhoea, dysmenorrhoea, oligospermia, azoospermia.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard.

4.9Overdose
Colchicine has a narrow therapeutic window and is extremely toxic in overdose. Patients at particular risk of toxicity are those with renal or hepatic impairment, gastrointestinal or cardiac disease, and patients at extremes of age.

Following colchicine overdose, all patients, even in the absence of early symptoms, should be referred for immediate medical assessment.

Clinical:

Symptoms of acute overdosage may be delayed (3 hours on average): nausea, vomiting, abdominal pain, hemorrhagic gastroenteritis, volume depletion, electrolyte abnormalities, leukocytosis, hypotension in severe cases. The second phase with life threatening complications develops 24 to 72 hours after drug administration: multisystem organ dysfunction, acute renal failure, confusion, coma, ascending peripheral motor and sensory neuropathy, myocardial depression, pancytopenia, dysrhythmias, respiratory failure, consumption coagulopathy. Death is usually a result of respiratory depression and cardiovascular collapse. If the patient survives, recovery may be accompanied by rebound leukocytosis and reversible alopecia starting about one week after the initial ingestion.

Treatment:

No antidote is available.

Elimination of toxins by gastric lavage within one hour of acute poisoning.

Consider oral activated charcoal in adults who have ingested more than 0.1mg/kg bodyweight within 1 hour of presentation and in children who have ingested any amount within 1 hour of presentation.

Haemodialysis has no efficacy (high apparent distribution volume).

Close clinical and biological monitoring in hospital environment.

Symptomatic and supportive treatment: control of respiration, maintenance of blood pressure and circulation, correction of fluid and electrolytes imbalance.

The lethal dose varies widely (7-65 mg single dose) for adults but is generally about 20 mg.

  1. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamics properties

Pharmacotherapeutic group: drugs for gout, with no effect on uric acid metabolism.

In the AGREE (Acute Gout Flare Receiving Colchicine Evaluation) study low- and high-dose colchicine were compared using a randomized, placebo controlled design. The high-dose prolonged colchicine regimen (4.8 mg total over 6 hours) was compared with a placebo and a low-dose abbreviated regimen (1.8 mg total over 1 hour, i.e. 1.2 mg followed by 0.6 mg in 1 hour). Both colchicine regimens were significantly more effective than placebo, with 32.7% responders in the high dose group, 37.8% responders in the low-dose group, and 15.5% responders in the placebo group (P = 0.034 and P = 0.005, respectively, versus placebo). The results at the primary 24hour end point demonstrate superior safety of low dose colchicine, without loss of efficacy, relative to high dose colchicine for early acute gout flare (self-administered within 12 hours of flare onset). The pharmacokinetic analysis performed in this study showed that the colchicine plasma concentration was decreased substantially from about 12 hours after administration in healthy volunteers.

Colchicine prophylaxis (0.6 mg twice daily) during initiation of allopurinol for chronic gouty arthritis reduced the frequency and severity of acute flares, and reduced the likelihood of recurrent flares. Treatment may be continued for up to 6 months, based on clinical data. Prospective randomized controlled trials are needed to further evaluate flare prophylaxis for up to 6 months, after 6 months, and over time.

The mechanism of action of colchicine in the treatment of gout is not clearly understood. Colchicine is considered to act against the inflammatory response to urate crystals, by possibly inhibiting the migration of granulocytes into the inflamed area. Other properties of colchicine, such as interaction with the microtubules, could also contribute to the operation. Onset of action is approximately 12 hours after oral administration and is maximal after 1 to 2 days.


5.2 Pharmacokinetic properties

Colchicine is rapidly and almost completely absorbed after oral administration. Maximum plasma concentrations are met usually after 30 to 120 minutes. The terminal half-life is 3 to 10 hours. Plasma protein binding is approximately 30%. Colchicine is partially metabolised in the liver and then in part via the bile. It accumulates in leucocytes. Colchicine is largely excreted (80%) in unchanged form and as metabolites in the faeces. 10-20% is excreted in the urine.

Renal impairment

Colchicine is significantly excreted in urine in healthy subjects. Clearance of colchicine is decreased in patients with impaired renal function. Total body clearance of colchicine was reduced by 75% in patients with end-stage renal disease undergoing dialysis.

The influence of renal impairment on the pharmacokinetics of colchicine was assessed in a study in patients with familial Mediterranean fever (FMF), 5 women and 4 men, with (n=4) and without (n=5) renal impairment. The mean age was 30 years (range 19-42 years). All 5 patients with renal impairment had biopsy-proven amyloidosis; 4 were on routine haemodialysis and 1 had a serum creatinine CL of 15 ml/min. They could therefore be classified as having severe renal impairment. Subjects received 1 mg colchicine except for 1 subject with cirrhosis who received 500 micrograms. A 4-fold decrease in colchicine CL was observed in subjects with renal impairment compared to those with normal renal function (0.168 ± 0.063 l/h/kg vs. 0.727 ± 0.110 l/h/kg). The terminal half-life was 18.8 ± 1.2 h for subjects with severe renal impairment and 4.4 ± 1.0 h for those with normal renal function. The volume of distribution was similar between groups. The patient with cirrhosis had a 10-fold lower CL compared to the subjects with normal renal function.

Paediatric population

No pharmacokinetics data are available in children.

5.3 Preclinical safety data

Genotoxicity

In one study, a bacterial test indicated that colchicine has a slight mutagenic effect.

However, two other bacterial tests and a test in Drosophila melanogaster found that colchicine was not mutagenic.

Tests have shown that colchicine induces chromosomal aberrations and micronuclei, and causes some DNA damage.

Teratogenicity

Tests in animals have shown that colchicine is teratogenic.

  1. PHARMACEUTICAL PARTICULARS

    6.1 List of excipients

    Lactose

Pregelatinised Maize Starch Stearic Acid, Purified Talc, Purified Water, Ethanol 96%

 6.2 Incompatibilities
none known.

6.3 Shelf life

Three years in polypropylene or polyethylene tablet containers.

Two years in strip packs of opaque white or clear PVC film and 20µ aluminium foil of 10 or 14 tablets.

6.4 Special precautions for storage
Do not store above 25°C

Store in the original container.

6.5 Nature and contents of container

Polypropylene or polyethylene containers containing 100 or 500 tablets. Strip packs of opaque white or clear PVC film and 20µ aluminium foil of 10 or 14 tablets.

The tablets will be packed in multiple strips of 10 tablets ie 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 tablets.

The tablets will be packed in multiple strips of 14 tablets ie 14, 28, 56, 84 or 112 tablets.

6.6 Special precautions for disposal and other handling

None

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

COLCHICINE TABLETS 500 µG, 1mg TAJ PHARMA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

 (COLCHICINE)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

–  Keep this leaflet. You may need to read it again.
 – If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4).
-The full name of the product is Colchicine 500 micrograms Film-coated Tablets but within the leaflet it will be referred to as Colchicine tablets.

WHAT IS IN THIS LEAFLET

  1. What Colchicine tablets are and what they are used for
  2. What you need to know before you take Colchicine tablet
  3. How to take Colchicine tablets
  4. Possible side effects
  5. How to store Colchicine tablets
  6. Contents of the pack and other information1. WHAT COLCHICINE TABLETS ARE AND WHAT THEY ARE USED FOR

The name of your medicine is Colchicine Tablets. The active ingredient, colchicine, in Colchicine Tablets is an anti-gout agent. Colchicine Tablets are used to treat gout attacks. They are also used to prevent flare-ups of gout when treatment is started with other drugs such as allopurinol, probenecid and sulfinpyrazone.

  1. WHAT YOU NEED TO KNOW BEFORE YOU TAKE COLCHICINE TABLETS

Do not take Colchicine Tablets:
• if you are allergic to colchicine or any of the other ingredients of this medicine (listed in section 6)
• if you have a severe blood disorder
• if you are pregnant
• if you are breastfeeding
• if you are a woman of childbearing age, unless you are using effective contraception
• if you have severe kidney or liver problems
• if you are undergoing haemodialysis
• if you have kidney or liver problems and you are taking certain medicines (see ‘Other medicines and Colchicine Tablets’)
If you are not sure whether any of the above apply to you, talk to your doctor or pharmacist before

Warnings and precautions
Talk to your doctor or pharmacist before taking Colchicine Tablets if you:
• have problems with your heart, kidneys, liver or digestive system
• are elderly and weak
• have a blood disorder

Colchicine Tablets can be toxic so it is important that you do not exceed the dose prescribed by your doctor. There is only a slight difference between an effective dose of  Colchicine Tablets and an overdose. Therefore, if you get symptoms such as nausea (feeling sick), vomiting (being sick), stomach pain and diarrhoea, stop taking Colchicine Tablets and immediately contact your doctor (see also section 4 ‘Possible side effects’).

Colchicine Tablets can cause a serious decrease in bone marrow function leading to a decrease in certain white blood cells (agranulocytosis), a decrease in red blood cells and pigment (aplastic anaemia) and/or a low blood platelet count (thrombocytopenia). You should have regular blood tests to monitor any changes. If you develop symptoms such as fever, inflammation of the mouth, sore throat, prolonged bleeding, bruising or skin problems, stop taking this medicine and contact your doctor immediately. These could be signs that you have a serious blood problem and your doctor may want you to have blood tests straight away (see also section 4 ‘Possible side effects’).

Other medicines and Colchicine Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Taking another medicine whilst you are taking Colchicine Tablets can affect how they or the other medicine works.

When Colchicine Tablets are taken together with any of the following medicines, side effects due to colchicine toxicity are more likely and these can be serious and life-threatening:

  • Certain antibiotics such as clarithromycin, erythromycin and telithromycin (used to treat infections)
    • Anti-viral drugs such as ritonavir, atazanavir and indinavir (used to treat HIV infection)
    • Ciclosporin (used to prevent organ rejection after a transplant, psoriasis and rheumatoid arthritis)
    • Anti-fungal medicines such as ketoconazole, itraconazole and voriconazole
    • Certain heart medicines such as verapamil and diltiazem
    • Disulfram (used to help treat alcoholism)

If you are taking any of the above medicines, your doctor may want to adjust your dose of Colchicine Tablets or temporarily stop your treatment with Colchicine Tablets. If you have liver or kidney problems and you are taking any of the above medicines, you should not take Colchicine Tablets.

It is also important to tell your doctor or pharmacist if you are taking any of the following medicines:

  • Cimetidine (used to reduce stomach acid), as it may increase the amount of colchicine in your blood
    • Tolbutamide (used to control blood sugar), as it may increase the amount of colchicine in your blood
    • Digoxin (used to treat certain heart conditions) and ‘fibrates’ (medicines used to lower cholesterol), as they may increase your risk of a muscle disease known as ‘rhabdomyolysis’. Taking Colchicine Tablets together with ciclosporin or ‘statins’ also increases your risk of developing this disease.

Talk to your doctor before taking Colchicine Tablets if you are taking any medicines that may possibly damage your kidneys, liver or blood. Check with your doctor if you are not sure. Colchicine Tablets may reduce the amount of vitamin B12 that your body can absorb through your gut.

Colchicine Tablets with food and drink Grapefruit juice may increase the amount of colchicine in your blood. Therefore, you should not drink grapefruit juice whilst you are taking Colchicine Tablets.

Pregnancy and breast-feeding

If you are pregnant, think you may be pregnant or are planning to have a baby, do not take this medicine.
If you are a woman of childbearing potential, do not take this medicine unless you are using effective contraception.
Colchicine passes into breast milk. If you are breast-feeding, do not take this medicine.

Driving and using machines

The possibility of drowsiness and dizziness should be taken into account. If affected, do not drive or operate machinery.

Colchicine Tablets contain lactose

Colchicine Tablets contain lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Colchicine Tablets.

3. HOW TO TAKE COLCHICINE TABLETS

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Your doctor will tell you how many Colchicine Tablets to take and for how long you should take them.
Colchicine Tablets should be swallowed whole with a glass of water

Use in adults

Dose to treat gout attack:

  • The recommended dose is 2 Colchicine Tablets to start followed by 1 Colchicine Tablet after 1 hour. No further tablets should then be taken for 12 hours. If necessary, treatment with Colchicine Tablets can then resume with a maximum dose of 1 tablet three times daily until symptoms are relieved. The course of treatment should end when symptoms are relieved or when a total of 12 Colchicine Tablets have been taken. You should not take more than 12 Colchicine Tablets as a course of treatment.
    After completion of a course of Colchicine Tablets, you should not start another course for at least three days.Dose to prevent flare-ups of gout when treatment is started with other drugs:
  • The recommended dose is one Colchicine Tablet twice daily. Your doctor will tell you how long your treatment with Colchicine Tablets will last.If you have kidney or liver problems
  • Your doctor may reduce your dose of Colchicine Tablets, and you should be carefully monitored for side effects. Do not take Colchicine Tablets if you have severe kidney or liver problems.

If you take more Colchicine Tablets than you should
If you take more Colchicine Tablets than you are supposed to, contact your doctor or nearest hospital accident and emergency department immediately. Take this leaflet and any Colchicine Tablets you have left with you. At too high a dose Colchicine Tablets can be seriously toxic, even fatal. Early symptoms of overdose (which appear on average after 3 hours but can take longer) may include nausea, vomiting, stomach pain, bloody diarrhoea and low blood pressure.

If you forget to take Colchicine Tablets
If you forget to take a dose take another as soon as you remember. If it is almost time for your next dose do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet. Do not take Colchicine Tablets with a shorter interval than prescribed by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

 4. POSSIBLE SIDE EFFECTS

Like all medicines Colchicine Tablets can cause side effects, although not everybody gets them. If you notice any of the following side effects, stop taking Colchicine Tablets and immediately contact a doctor or the nearest hospital accident and emergency department:
• Nausea (feeling sick), vomiting (being sick), stomach pain and diarrhoea (see also section 2 ‘Warnings and Precautions’). These side effects are common (may affect up to 1 in 10 people).

  • Symptoms such as fever, inflammation of the mouth, sore throat, prolonged bleeding, bruising or skin problems. These could be signs that you have a serious blood problem as a result of bone marrow depression (see also section 2 ‘Warnings and Precautions’). The frequency of these side effects is not known (cannot be estimated from the available data).

Other side effects that have been seen (with unknown frequency) are:
• Inflammation of the nerves which can cause pain, weakness, tingling or numbness
• Nerve damage
• Gastrointestinal bleeding
• Liver damage
• Hair loss

  • Rash
    • Pain or weakness in muscles
    • Abnormal muscle breakdown which can lead to kidney problems (rhabdomyolysis)
    • Kidney damage
    • Absence of menstrual periods
    • Painful periods
    • Reduced ability to produce sperm (low or zero sperm count)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below.


5. HOW TO STORE COLCHICINE TABLETS

Keep this medicine out of the sight and reach of children.

  • Do not take Colchicine Tablets after the expiry date which is stated on the label. The expiry date refers to the last day of that month.

Do not take Colchicine Tablets if you notice that they are showing signs of deterioration such as discolouration.

  • Do not store above 25ºC
  • Store in the original package in order to protect from light.
    Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
  1. CONTENTS OF THE PACK AND FURTHER INFORMATION

What Colchicine Tablets contains
The active ingredient in Colchicine Tablets is Colchicine. Colchicine Ph Eur 535 micrograms (equivalent to Colchicine 500 micrograms on a dry weight basis).

The other ingredients are lactose, maize starch, stearic acid and purified talc.

What Colchicine Tablets look like and the contents of the pack

Colchicine Tablets are white to pale yellow in colour and are either unmarked or marked CP on one face. Colchicine Tablets are available in plastic (polypropylene or polyethylene) containers of 100 tablets.

  1. MANUFACTURED IN INDIA BY:

TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com