INTRODUCTION

GETON TABLET contains Colchicine which belongs to a group of medicines called Antigout agents. GETON TABLET is used in adults, in the short-term treatment of gout attacks and to prevent gout recurrence. It is also indicated in familial mediterranean fever (FMF) to prevent fever attacks and amyloidosis (a rare protein disorder that interferes with normal functioning of organs). Gout is a common and complex form of arthritis (joint pain) which is characterized by sudden, severe attacks of pain, swelling, redness and tenderness in one or more joints which most often occurs in the big toe. Familial mediterranean fever is a genetic disorder that causes recurrent fevers and painful inflammation of the abdomen, chest and joints.

Colchicine is an antigout agent which works by lessening the buildup of hard uric acid crystals in the joints by reducing the uric acid level in the blood which are needed for the formation of hard uric acid crystals that cause pain in joints resulting in the decreased swelling and relief from pain in the joints. It also works by preventing the occurrence of pain in the abdomen, chest or joints in patients suffering from familial mediterranean fever by decreasing the production of amyloid protein which is an abnormal protein that forms due to a rare protein disease called amyloidosis which causes interference in the normal functioning of an organ. Along with this treatment, your doctor might advise regular blood tests to check for any occurence of blood disorders.

Before taking GETON TABLET, inform your doctor if you are allergic to Colchicine, and or have blood disorders, heart, kidney, or liver disease which is not recommended for use in patients with severe liver or kidney disease. GETON TABLET is not recommended for use in pregnant women when indicated for gout treatment and used with caution in familial mediterranean fever (FMF) only if it’s clearly necessary in pregnant and childbearing potential women who should use effective contraception during and for at least 3 months following the termination of treatment with GETON TABLET when indicated for gout treatment. GETON TABLET is not recommended for use to treat gout in children and adolescents (below 18 years of age) which is indicated for use in children less than 5 years of age and adolescents (from 10 to 18 years of age) in the treatment of familial mediterranean fever (FMF) after consulting the doctor for an advice. The most common side effects of taking GETON TABLET are nausea, vomiting, abdominal cramps and diarrhea. Contact your doctor if any of the symptoms worsen.

USES OF GETON TABLET

• To treat gout attacks for short-term and to prevent recurrence of gout
• Treats familial mediterranean fever to prevent fever attacks and amyloidosis

HOW GETON TABLET WORKS

GETON TABLET is an antigout agent which works by lessening the buildup of hard uric acid crystals in the joints by reducing the uric acid level in the blood. In familial mediterranean fever it works by decreasing the production of amyloid protein which is an abnormal protein that forms due to a rare protein disease called amyloidosis which causes interference in the normal functioning of an organ.

DIRECTIONS FOR USE

Take GETON TABLET as advised by your physician. Swallow GETON TABLET with a glass of water and do not chew or crush the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

SIDE EFFECTS OF GETON TABLET

HOW TO MANAGE SIDE EFFECTS

Diarrhea

Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to treat diarrhea and consult your doctor if the symptom gets worse.

Nausea And Vomiting

Try to take GETON TABLET with or just after a meal or a snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom gets worse.

WARNING & PRECAUTIONS

PREGNANCY

Monitoring required

GETON TABLET is not recommended for use in pregnant women when indicated for gout treatment and is used with caution in familial mediterranean fever (FMF) only if it’s clearly necessary in pregnant and childbearing potential women. Women with childbearing potential should use effective contraception during and for at least 3 months following the termination of treatment with GETON TABLET when indicated for gout treatment who should consult doctor before taking GETON TABLET.

BREASTFEEDING

Monitoring required

GETON TABLET is not recommended for use in breastfeeding women when indicated for the treatment of gout which is advised to be used with caution for familial mediterranean fever (FMF) only if it is clearly necessary. Consult your doctor before taking GETON TABLET.

DRIVING AND USING MACHINES

Use with Caution

GETON TABLET may cause drowsiness and dizziness which could affect your ability to drive or operate machines. Consult your doctor before taking GETON TABLET.

ALCOHOL

Consult your doctor

Avoid consumption of alcohol while taking GETON TABLET. Consult your doctor before taking GETON TABLET.

KIDNEY

Consult your doctor

GETON TABLET should be used with caution in patients with kidney problems which would be carefully monitored by your doctor.  It is not recommended for use in patients with severe renal impairment. Consult your doctor for advice before taking GETON TABLET.

LIVER

Consult your doctor

GETON TABLET should be used with caution in patients with liver problems which would be carefully monitored by your doctor. It is not recommended for use in patients with severely impaired liver disease or severe liver impairment. Consult your doctor for advice before taking GETON TABLET.

ALLERGY

Contraindicated

GETON TABLET is not recommended for use if you are allergic to colchicine or any of the other ingredients of this medicine.

HEART DISEASE

Use with Caution

GETON TABLET should be used with caution in patients with heart or vascular disease. Consult your doctor before taking GETON TABLET.

USE IN PEDIATRICS

Consult your doctor

GETON TABLET is not recommended for use to treat gout in children and adolescents (below 18 years of age). GETON TABLET is used when indicated for familial mediterranean fever (FMF) in children less than 5 years of age and adolescents (from 10 to 18 years of age) after consulting the doctor for an advice.

USE IN GERIATRICS

Use with Caution

GETON TABLET should be used with caution in elderly patients (aged 70 years or above) especially when you are weak after careful assessment of potential benefits and consequences of therapy. Consult your doctor before taking GETON TABLET.

INTERACTIONS

A. Drug-Drug Interactions:

Before taking GETON TABLET, inform your doctor, if you are taking any of the following medicine:

• erythromycin, telithromycin, clarithromycin and azithromycin (antibiotics used to treat bacterial infections)
• ketoconazole, itraconazole, voriconazole (medicines used to treat fungal infections)
• ritonavir, atazanavir, amprenavir, saquinavir, nelfinavir, fosamprenavir and indinavir (medicines used to treat HIV infection)
• verapamil, quinidine, and diltiazem (medicines used to treat heart disease)
• ciclosporin (medicine used to reduce the body’s resistance to infection by suppressing the immune system)
• Statins such as simvastatin, fluvastatin or pravastatin (medicines used to lower cholesterol)
• fibrates (medicines used to lower cholesterol and some fats in the blood)
• digoxin (medicine used to treat heart failure and irregular heart rate)
• cimetidine (medicine used to reduce intestinal or gastric ulcers)
• tolbutamide (medicine used to lower blood sugar)
• vitamin B12 (medicine used in the treatment of anemia)

B. Drug-Food Interactions:

GETON TABLET should not be taken with grapefruit juice.

Overdosage:

If you or anyone else accidentally takes too much of GETON TABLET, contact your doctor immediately or go to a hospital straight away. Early symptoms of overdose are burning sensation in the throat, stomach and skin, nausea and vomiting, abdominal cramps, bloody diarrhea, dehydration, and lowering of blood pressure and shock. Overdosage symptoms after 24 – 72 hours can result in life-threatening complications such as consciousness disorder with possible delusions, coma, symptoms of paralysis, respiratory depression, fluid retention in the lungs, kidney damage, shortage of blood and cardiac arrest.

SYNOPSIS

MORE INFORMATION

• Keep GETON TABLET out of reach in children
• Store GETON TABLET at room temperature

FAQs ABOUT GETON TABLET

Q: What GETON TABLET is used for?

A: GETON TABLET is used in adults, in the short-term treatment of gout attacks and to prevent gout recurrence. It is also indicated in familial mediterranean fever (FMF) to prevent fever attacks and amyloidosis (a rare protein disorder that interferes with normal functioning of organs). Gout is a common and complex form of arthritis (joint pain) which is characterized by sudden, severe attacks of pain, swelling, redness and tenderness in one or more joints which most often occurs in the big toe. Familial mediterranean fever is a genetic disorder that causes recurrent fevers and painful inflammation of the abdomen, chest and joints.

Q: What happens if you forget to take GETON TABLET?

A: If you forget to take GETON TABLET, take another dose as soon as you remember. If it is almost time for your next dose, do not take the missed dose at all and continue as per your prescribed dosing regime. Consult your doctor if you are not sure about the missed dose.

Q: What happens if you take more GETON TABLET than your required dose?

A: If you or anyone else accidentally takes too much of GETON TABLET, contact your doctor immediately or go to a hospital straight away. Early symptoms of overdose are burning sensation in the throat, stomach and skin, nausea and vomiting, abdominal cramps, bloody diarrhea, dehydration, and lowering of blood pressure and shock.

Q: Can GETON TABLET be taken with grapefruit juice?

A: No, GETON TABLET should not be taken with grapefruit juice since it may increase the risks of side effects and lead to some unwanted complications. Consult your doctor before taking GETON TABLET.

Q: Is GETON TABLET safe to use in children?

A: GETON TABLET is not recommended for use to treat gout in children and adolescents (below 18 years of age). It is used when indicated for familial mediterranean fever (FMF) in children less than 5 years of age and adolescents (from 10 to 18 years of age) after consulting the doctor for an advice.

REFERENCES

1. KD. Tripathi. Antirheumatoid and Antigout Drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 214.

2. Regeneron Pharmaceuticals. Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised in May 2014]  [Accessed on 4th May 2022] https://clinicaltrials.gov/ct2/show/NCT01451645

3. Nicola Dalbeth, Thomas J Lauterio, Henry R Wolfe. Mechanism of action of colchicine in the treatment of gout. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. [Revised in August 2014] [Accessed on 4th May 2022] https://pubmed.ncbi.nlm.nih.gov/25151572/

4. C Cerquaglia, M Diaco,G Nucera,M La Regina, M Montalto, R Manna.Pharmacological and clinical basis of treatment of Familial Mediterranean Fever (FMF) with colchicine or analogues:an update.NIH National Library of Medicine,National center for biotechnology information.Pubmed.gov. [Revised in February 2005] [Accessed on 4th May 2022] https://pubmed.ncbi.nlm.nih.gov/15720245/

5. Michelle A Fravel, Michael E Ernst. Management of gout in the older adult.NIH National Library of Medicine,National center for biotechnology information.Pubmed.gov.[Revised in August 2017] [Accessed on 4th May 2022] https://pubmed.ncbi.nlm.nih.gov/21849262/

6. A Rambaldi 1, C Gluud. Colchicine for alcoholic and non-alcoholic liver fibrosis and cirrhosis. NIH National Library of Medicine, National center for biotechnology information. Pubmed.gov. [Revised in April 2014] [Accessed on 4th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3991555/

7. Tiofarma B.V. Health Products Regulatory Authority (HPRA). [Revised in July 2021] [Accessed on 4th May 2022] https://www.hpra.ie/img/uploaded/swedocuments/aefb96f2-6bfc-45d9-a8147a9782bf7708.pdf

USEFUL DIAGNOSTIC TESTS

• Kidney function test
• Liver function test
• Uric acid test