Goutnil 0.5mg Tablet 10'S

Introduction About GOUTNIL 0.5MG TABLET

GOUTNIL 0.5MG TABLET contains Colchicine which belongs to a group of medicines called Antigout agents. GOUTNIL 0.5MG TABLET is used in adults, in the short-term management of gout attacks and to manage gout recurrence. It is also indicated in familial mediterranean fever (FMF) to manage 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 managing 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 management, your doctor might advise regular blood tests to check for any occurence of blood disorders.

Before taking GOUTNIL 0.5MG 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. GOUTNIL 0.5MG TABLET is not recommended for use in pregnant women when indicated for gout management 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 management with GOUTNIL 0.5MG TABLET when indicated for gout management. GOUTNIL 0.5MG TABLET is not recommended for use to manage 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 management of familial mediterranean fever (FMF) after consulting the doctor for an advice. The most common side effects of taking GOUTNIL 0.5MG TABLET are nausea, vomiting, abdominal cramps and diarrhea. Contact your doctor if any of the symptoms worsen.

Uses Of GOUTNIL 0.5MG TABLET

• To manage gout attacks for short-term and to manage recurrence of gout
• Manage familial mediterranean fever to manage fever attacks and amyloidosis

How GOUTNIL 0.5MG TABLET Works

GOUTNIL 0.5MG 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.

How to use GOUTNIL 0.5MG TABLET

Take GOUTNIL 0.5MG TABLET as advised by your physician. Swallow GOUTNIL 0.5MG 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 GOUTNIL 0.5MG 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 manage diarrhea and consult your doctor if the symptom gets worse.

Nausea And Vomiting

Try to take GOUTNIL 0.5MG 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

GOUTNIL 0.5MG TABLET is not recommended for use in pregnant women when indicated for gout management 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 management with GOUTNIL 0.5MG TABLET when indicated for gout management who should consult doctor before taking GOUTNIL 0.5MG TABLET.

Breastfeeding

Monitoring required

GOUTNIL 0.5MG TABLET is not recommended for use in breastfeeding women when indicated for the management 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 GOUTNIL 0.5MG TABLET.

Driving and Using Machines

Use with Caution

GOUTNIL 0.5MG TABLET may cause drowsiness and dizziness which could affect your ability to drive or operate machines. Consult your doctor before taking GOUTNIL 0.5MG TABLET.

Alcohol

Consult your doctor

Avoid consumption of alcohol while taking GOUTNIL 0.5MG TABLET. Consult your doctor before taking GOUTNIL 0.5MG TABLET.

Kidney

Consult your doctor

GOUTNIL 0.5MG 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 GOUTNIL 0.5MG TABLET.

Liver

Consult your doctor

GOUTNIL 0.5MG 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 GOUTNIL 0.5MG TABLET.

Allergy

Contraindicated

GOUTNIL 0.5MG 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

GOUTNIL 0.5MG TABLET should be used with caution in patients with heart or vascular disease. Consult your doctor before taking GOUTNIL 0.5MG TABLET.

Use In Pediatrics

Consult your doctor

GOUTNIL 0.5MG TABLET is not recommended for use to manage gout in children and adolescents (below 18 years of age). GOUTNIL 0.5MG 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

GOUTNIL 0.5MG 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 GOUTNIL 0.5MG TABLET.

Interactions

A. Drug-Drug Interactions:

Before taking GOUTNIL 0.5MG TABLET, inform your doctor, if you are taking any of the following medicine:

• erythromycin, telithromycin, clarithromycin and azithromycin (antibiotics used to manage bacterial infections)
• ketoconazole, itraconazole, voriconazole (medicines used to manage fungal infections)
• ritonavir, atazanavir, amprenavir, saquinavir, nelfinavir, fosamprenavir and indinavir (medicines used to manage HIV infection)
• verapamil, quinidine, and diltiazem (medicines used to manage 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 manage 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 management of anemia)

B. Drug-Food Interactions:

GOUTNIL 0.5MG TABLET should not be taken with grapefruit juice.

Overdosage:

If you or anyone else accidentally takes too much of GOUTNIL 0.5MG 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 GOUTNIL 0.5MG TABLET out of reach in children
• Store GOUTNIL 0.5MG TABLET at room temperature

FAQs About GOUTNIL 0.5MG TABLET

Q: What GOUTNIL 0.5MG TABLET is used for?

A: GOUTNIL 0.5MG TABLET is used in adults, in the short-term management of gout attacks and to manage gout recurrence. It is also indicated in familial mediterranean fever (FMF) to manage 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 GOUTNIL 0.5MG TABLET?

A: If you forget to take GOUTNIL 0.5MG 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 GOUTNIL 0.5MG TABLET than your required dose?

A: If you or anyone else accidentally takes too much of GOUTNIL 0.5MG 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 GOUTNIL 0.5MG TABLET be taken with grapefruit juice?

A: No, GOUTNIL 0.5MG 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 GOUTNIL 0.5MG TABLET.

Q: Is GOUTNIL 0.5MG TABLET safe to use in children?

A: GOUTNIL 0.5MG TABLET is not recommended for use to manage 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

Author Details

Written By Dr. R. Dinesh John Rajkumar - Pharm.D

Reviewed For Accuracy By Dr. Srikar Modepu - MBBS, MD (Diabetology)

Last updated on 20 Mar 2023 | 08:57 AM(IST)