Colchicine Tablet USP 0.6mg Taj Pharma

Colchicine Tablet USP 0.6mg Taj Pharma

1. Name of the medicinal product

Colchicine Tablet USP 0.6mg Taj Pharma

2. Qualitative and quantitative composition

Colchicine Tablet USP 0.6mg Taj Pharma
Each film coated tablet contains:
Colchicine USP 0.6mg
Excipients: Q.S.

Excipient with known effect:

One tablet contains 59mg lactose monohydrate (see section 4.4).

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film coated Tablet.

A white to off white in color film coated tablets.

4. Clinical particulars

Therapeutic indications

Adults

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

Posology and method of administration

Posology

Adults

Treatment of acute gout attack:

1mg (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 6mg (12 tablets) has been taken. No more than 6mg (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 Taj Pharma (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 Taj Pharma.

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

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 Taj Pharma should not be used in patients undergoing haemodialysis since it cannot be removed by dialysis or exchange transfusion.
• Colchicine Taj Pharma 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)

Special warnings and precautions for use

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

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

Colchicine Taj Pharma 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 Taj Pharma 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 Taj Pharma (see section 5.2).

Co-administration with P-gp inhibitors and/or moderate or strong CYP3A4 inhibitors will increase the exposure to Colchicine Taj Pharma, which may lead to Colchicine Taj Pharma-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 Taj Pharma dosage or interruption of Colchicine Taj Pharma treatment is recommended (see section 4.5).

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

Interaction with other medicinal products and other forms of interaction

Colchicine Taj Pharma 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 Taj Pharma 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).

Concomitant administration of azithromycin and P-gp substrates such as Colchicine Taj Pharma has been reported to result in increased serum levels of P-gp substrate. Therefore, if Colchicine Taj Pharma and azithromycin are administered concomitantly, the possibility of elevated serum Colchicine Taj Pharma concentrations should be considered.

Colchicine Taj Pharma 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 Taj Pharma dosage or an interruption of Colchicine Taj Pharma treatment is recommended in patients with normal renal or hepatic function if treatment with a P-gp inhibitor or moderate or strong CYP3A4 inhibitor is required (see section 4.4). A 4-fold reduction in Colchicine Taj Pharma dosage is recommended when co-administered with a P-gp inhibitor and/or a strong CYP3A4 inhibitor. A 2-fold reduction in Colchicine Taj Pharma 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 vivo studies is summarised in the table below:

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 Taj Pharma and thus plasma levels of Colchicine Taj Pharma increase.

Grapefruit juice may increase plasma levels of Colchicine Taj Pharma. Grapefruit juice should therefore not be taken together with Colchicine Taj Pharma.

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 Taj Pharma with statins, fibrates, ciclosporin or digoxin.

Fertility, pregnancy and lactation

Fertility

Colchicine Taj Pharma administration in animals induces significant reductions in fertility.

Pregnancy

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

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

Breastfeeding

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

Effects on ability to drive and use machines

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

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 anemia 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: hepatotoxicity.

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.

Overdose

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

Following Colchicine Taj Pharma 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 – 65mg single dose) for adults but is generally about 20mg.

5. Pharmacological properties

Pharmacodynamic properties

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

In the AGREE (Acute Gout Flare Receiving Colchicine Taj Pharma Evaluation) study low- and high-dose Colchicine Taj Pharma were compared using a randomized, placebo-controlled design. The high-dose prolonged Colchicine Taj Pharma regimen (4.8mg total over 6 hours) was compared with a placebo and a low-dose abbreviated regimen (1.8mg total over 1 hour, i.e. 1.2mg followed by 0.6mg in 1 hour). Both Colchicine Taj Pharma 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 24-hour end point demonstrate superior safety of low-dose Colchicine Taj Pharma, without loss of efficacy, relative to high-dose Colchicine Taj Pharma for early acute gout flare (self-administered within 12 hours of flare onset). The pharmacokinetic analysis performed in this study showed that the Colchicine Taj Pharma plasma concentration was decreased substantially from about 12 hours after administration in healthy volunteers.

Colchicine Taj Pharma prophylaxis (0.6mg 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 Taj Pharma in the treatment of gout is not clearly understood. Colchicine Taj Pharma 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 Taj Pharma, 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.

Pharmacokinetic properties

Colchicine Taj Pharma 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 Taj Pharma is partially metabolised in the liver and then in part via the bile. It accumulates in leucocytes. Colchicine Taj Pharma is largely excreted (80%) in unchanged form and as metabolites in the faeces. 10-20% is excreted in the urine.

Renal impairment

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

The influence of renal impairment on the pharmacokinetics of Colchicine Taj Pharma 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 hemodialysis and 1 had a serum creatinine CL of 15 ml/min. They could therefore be classified as having severe renal impairment. Subjects received 1mg Colchicine Taj Pharma except for 1 subject with cirrhosis who received 500 micrograms. A 4-fold decrease in Colchicine Taj Pharma 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.

Preclinical safety data

Genotoxicity

In one study, a bacterial test indicated that Colchicine Taj Pharma has a slight mutagenic effect.

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

Tests have shown that Colchicine Taj Pharma induces chromosomal aberrations and micronuclei, and causes some DNA damage.

Teratogenicity

Tests in animals have shown that Colchicine Taj Pharma is teratogenic.

6. Pharmaceutical particulars

List of excipients

Lactose monohydrate

Microcrystalline cellulose

Pregelatinised starch

Sodium starch glycolate

Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

2 years

Special precautions for storage

Store in the original package in order to protect from light.

Nature and contents of container

White opaque PVC/ plain push through aluminum foil.

Blisters: 20, 40, 50, 60, 80, 100, 200, 250, 300, 360 and 500 tablets.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements for disposal.

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 Tablet USP 0.6mg Taj Pharma

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 this medicine is Colchicine Taj Pharma 500microgram Tablets but within the leaflet it will be referred to as Colchicine Taj Pharma Tablets.

What is in this leaflet

1. What Colchicine Taj Pharma Tablets are and what they are used for
2. What you need to know before you take Colchicine Taj Pharma Tablets
3. How to take Colchicine Taj Pharma Tablets
4. Possible side effects
5. How to store Colchicine Taj Pharma Tablets
6. Contents of the pack and other information

1. What Colchicine Taj Pharma Tablets are and what they are used for

The active ingredient in Colchicine Taj Pharma Tablets is colchicine.

Colchicine Taj Pharma is an anti-gout agent.

Colchicine Taj Pharma Tablets are used to treat gout attacks in adults. They are also used to prevent flare-ups of gout in adults when treatment is started with other drugs such as allopurinol, probenecid and sulfinpyrazone.

2. What you need to know before you take Colchicine Taj Pharma Tablets

Do not take Colchicine Taj Pharma Tablets

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 breast-feeding
• 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 Taj Pharma Tablets’)

If you are not sure whether any of the above apply to you, talk to your doctor or pharmacist before taking Colchicine Taj Pharma Tablets.

Warnings and precautions

Talk to your doctor or pharmacist before taking Colchicine Taj Pharma Tablets if you

• have problems with your heart, kidneys, liver or digestive system
• are elderly and weak
• have a blood disorder

Colchicine Taj Pharma 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 Taj Pharma Tablets

Colchicine Taj Pharma 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 Taj Pharma 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 Taj Pharma Tablets.

3. How to take Colchicine Taj Pharma 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 Taj Pharma Tablets to take and for how long you should take them. Colchicine Taj Pharma Tablets should be swallowed whole with a glass of water.

Use in adults

Dose to treat gout attack:

• The recommended dose is 2 Colchicine Taj Pharma Tablets to start followed by 1 Colchicine Taj Pharma

Tablet after 1 hour. No further tablets should then be taken for 12 hours. If necessary, treatment with Colchicine Taj Pharma

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 Taj Pharma Tablets have been taken. You should not take more than 12 Colchicine Taj Pharma Tablets as a course of treatment.

After completion of a course of Colchicine Taj Pharma 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 Taj Pharma Tablet twice daily.

Your doctor will tell you how long your treatment with Colchicine Taj Pharma Tablets will last.

If you have kidney or liver problems

Your doctor may reduce your dose of

Colchicine Taj Pharma Tablets, and you should be carefully monitored for side effects.

Do not take Colchicine Taj Pharma Tablets if you have severe kidney or liver problems.

If you take more Colchicine Taj Pharma Tablets than you should

If you take more Colchicine Taj Pharma Tablets than you are supposed to, contact your doctor or nearest hospital accident and emergency department immediately. Take this leaflet and any

Colchicine Taj Pharma Tablets you have left with you.

At too high a dose Colchicine Taj Pharma 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 Taj Pharma 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 Taj Pharma 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, this medicine can cause side effects, although not everybody gets them.

If you notice any of the following side effects, stop taking Colchicine Taj Pharma Tablets and immediately contact a doctor or the nearest hospital accident and emergency department:

• Nausea (feeling sick), vomiting (being sick), stomach pain and diarrhea (see also section 2 ‘Warnings and Precautions’). These side effects are common (may affect up to 1 in 10 people). and an overdose. Therefore, if you get symptoms such as nausea (feeling sick), vomiting (being sick), stomach pain and diarrhoea, stop taking Colchicine Taj Pharma Tablets and immediately contact your doctor (see also section 4 ‘Possible side effects’).

Colchicine Taj Pharma 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 Taj Pharma 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 Taj Pharma Tablets can affect how they or the other medicine works.

When Colchicine Taj Pharma 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 antiobiotics such as clarithromycin, erythromycin, telithromycin and azithromycin (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 Taj Pharma Tablets or temporarily stop your treatment with Colchicine Taj Pharma Tablets. If you have liver or kidney problems and you are taking any of the above medicines, you should not take Colchicine Taj Pharma 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 Taj Pharma Tablets together with ciclosporin or ‘statins’ also increases your risk of developing this disease.

Talk to your doctor before taking Colchicine Taj Pharma 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 Taj Pharma Tablets may reduce the amount of vitamin B12 that your body can absorb through your gut.

Colchicine Taj Pharma 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 Taj Pharma 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.

• 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.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Colchicine Taj Pharma Tablets

Keep this medicine out of the sight and reach of children. Store in the original package in order to protect from light.

Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use.

These measures will help protect the environment.

6. Contents of the pack and other information

What Colchicine Taj Pharma Tablets contain

• The active substance is colchicine.

Each tablet contains 0.6mg of colchicine.

• The other ingredients are lactose monohydrate, microcrystalline cellulose, pregelatinised starch, sodium starch glycolate, magnesium stearate.

What Colchicine Taj Pharma Tablets looks like and contents of the pack

White opaque PVC/ plain push through aluminum foil.

Blisters: 20, 40, 50, 60, 80, 100, 200, 250, 300, 360 and 500 tablets.

Not all pack sizes may be marketed.

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