INTRODUCTION

DACLAWIN 60MG TABLET contains Daclatasvir which belongs to the group of medicines called Antiviral agents. It is used with sofosbuvir (with/without) ribavirin to treat chronic hepatitis C virus (genotype 1 or 3) infection in affected individuals.

Hepatitis C is a liver infection which occurs due to contact with hepatitis C virus which spreads in a healthy person due to contact with blood of an infected person. It is generally characterized by symptoms such as bloating, fluid in the abdomen, nausea, fatigue, fever, and/or loss of appetite.

DACLAWIN 60MG TABLET is not recommended for use if you are allergic to Daclatasvir. Before taking DACLAWIN 60MG TABLET, inform your doctor if you have heart problems, liver problems (such as history of hepatitis B infection, liver transplant, mild, moderate, severe hepatic impairment) and end-stage renal disease.

DACLAWIN 60MG TABLET is not recommended for use during pregnancy and in breastfeeding women as it may pass through milk. It is not known whether this medicine is safe and effective in children and adolescents below 18 years of age. Consult your doctor before taking the medicine.

The most common side effects associated with the use of DACLAWIN 60MG TABLET are headache, anaemia, tiredness, nausea, diarrhoea, rash, and sleeplessness. Consult your doctor before taking the medicine.

USES OF DACLAWIN 60MG TABLET

• Used with sofosbuvir (with/without) ribavirin to treat chronic hepatitis C virus (genotype 1 or 3) infection in affected individuals

HOW DACLAWIN 60MG TABLET WORKS

DACLAWIN 60MG TABLET works by preventing the hepatitis C virus from multiplying and infecting new cells and also lowering its load in the body thus treating the infection and also providing relief from the associated symptoms of the chronic hepatitis C infection in affected individuals.

DIRECTIONS FOR USE

Take DACLAWIN 60MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew 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 DACLAWIN 60MG TABLET

HOW TO MANAGE SIDE EFFECTS

Headache:

Take rest and plenty of water. Avoid taking alcohol and skipping meals. Do not strain your eyes by watching screen for long time. Consult your doctor if the condition persists for long or gets worsened.

Tiredness:

Make sure you take rest and drink plenty of fluids. Avoid or limit the consumption of alcohol. Try to take DACLAWIN 60MG TABLET at a time when you can sit down (or lie down) when the symptoms are at their worst. Avoid driving or using tools or machinery until you feel well.

Nausea:

Try to take DACLAWIN 60MG 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.

Diarrhoea:

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

Dizziness:

Try to rest and get enough sleep. Try to avoid driving or operating any tools or machines while you feel dizzy. Limit consumption of alcohol, as it can aggravate dizziness. Consult and inform your doctor if the symptom worsens.

WARNING & PRECAUTIONS

PREGNANCY

DACLAWIN 60MG TABLET is not recommended for use in pregnant women. Consult your doctor before taking the medicine.

BREASTFEEDING

It is not known whether DACLAWIN 60MG TABLET passes into human breast milk, hence it is not recommended for use in breastfeeding women. Consult your doctor taking the medicine.

DRIVING AND USING MACHINES

Do not drive or operate any machines while taking DACLAWIN 60MG TABLET since this medicine may cause dizziness, difficulty while concentrating or vision problems. Consult your doctor before taking the medicine.

KIDNEY

DACLAWIN 60MG TABLET should be used with caution in patients with kidney diseases such as end-stage renal disease. Consult your doctor before taking the medicine.

LIVER

DACLAWIN 60MG TABLET should be used with caution in patients with a history of hepatitis B infection, liver transplant, mild, moderate, severe hepatic impairment or liver damage (such as decompensated liver disease). Consult your doctor before taking the medicine.

ALLERGY

DACLAWIN 60MG TABLET is not recommended for use if you are allergic to Daclatasvir or any other ingredients of this medicine. Consult your doctor before taking the medicine.

HEART DISEASE

DACLAWIN 60MG TABLET should be used with caution in patients with heart problems. Consult your doctor before taking.

INTERACTIONS

A. Drug-Drug Interactions:

Before taking DACLAWIN 60MG TABLET inform your doctor if you are taking any of the following medicine:

• medicine used to treat epileptic seizures (Ex. phenytoin, carbamazepine, oxcarbazepine, phenobarbital)
• medicines used to treat tuberculosis (Ex. rifampicin, rifampin, rifabutin, rifapentine)
• dexamethasone (medicine used to treat allergic and inflammatory diseases)
• medicines containing St. John’s wort (Ex. hypericum perforatum)
• medicine used to treat irregular heartbeats (Ex. amiodarone, digoxin)
• medicines used to treat HIV infection (Ex. atazanavir, ritonavir, atazanavir, cobicistat, elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate combination, etravirine, nevirapine, efavirenz, darunavir, dolutegravir, lopinavir, simeprevir)
• medicines used to treat Hepatitis C infection (Ex. boceprevir, telaprevir)
• medicines used to bacterial infections (Ex. clarithromycin, telithromycin, erythromycin)
• medicines used to prevent blood clot formation (Ex. dabigatran etexilate)
• medicines used to treat fungal infections (Ex. ketoconazole, itraconazole, posaconazole, voriconazole)
• medicines used to decrease blood pressure (Ex. verapamil, diltiazem, nifedipine, amlodipine)
• medicine used to lower blood cholesterol (Ex. rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin, pravastatin)
• oestrogen (medicines used to prevent pregnancy)
• medicine used to treat opioid addiction (Ex. buprenorphine, naloxone)
• medicine used for pain relief and treatment of drug addiction (Ex. methadone)
• medicine used to lower the immune responses (Ex. cyclosporine)
• medicine used to treat depression and anxiety (Ex. escitalopram)
• medicine used to treat heartburn (Ex. famotidine)
• medicine used to treat acidity (Ex. omeprazole)

Overdosage:

If you or anyone else accidentally takes too much of DACLAWIN 60MG TABLET, consult your doctor immediately or visit the nearby hospital.

SYNOPSIS

MORE INFORMATION

• Keep the medicine out of reach in children
• Store DACLAWIN 60MG TABLET below 30°C

FAQs ABOUT DACLAWIN 60MG TABLET

What DACLAWIN 60MG TABLET is used for?

DACLAWIN 60MG TABLET is used with sofosbuvir (with/without) ribavirin to treat chronic hepatitis C virus (genotype 1 or 3) infection which is a liver infection that occurs due to contact with hepatitis C virus that spreads in a healthy person due to contact with blood of an infected person.

What side effects are seen with DACLAWIN 60MG TABLET?

The most common side effects associated with the use of DACLAWIN 60MG TABLET are headache, anaemia, tiredness, nausea, diarrhoea, rash, and sleeplessness. Consult your doctor before taking the medicine.

Who should avoid taking DACLAWIN 60MG TABLET?

DACLAWIN 60MG TABLET is not recommended for use in patients allergic to daclatasvir, pregnant and breastfeeding women. Consult your doctor before taking the medicine.

How DACLAWIN 60MG TABLET works?

DACLAWIN 60MG TABLET works by preventing the hepatitis C virus from multiplying and infecting new cells and also lowering its load in the body thus treating the infection and also providing relief from the associated symptoms of the chronic hepatitis C infection in affected individuals.

What is method of taking DACLAWIN 60MG TABLET?

Take DACLAWIN 60MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

What if I forget to take DACLAWIN 60MG TABLET dose?

If you forgot to take DACLAWIN 60MG TABLET dose, take it as early as possible. Do not double up the dose to make up for the forgotten one. Consult your doctor if you have queries on missed dose.

Is DACLAWIN 60MG TABLET safe to be used in children?

It is not known whether DACLAWIN 60MG TABLET is safe and effective in children and adolescents below 18 years of age. Consult your doctor before taking the medicine.

Is DACLAWIN 60MG TABLET safe to be used in liver patients?

Yes, DACLAWIN 60MG TABLET should be used with caution in patients with liver problems such as hepatitis B infection, liver transplant, mild/moderate/severe hepatic impairment, and/or liver damage (due to decompensated liver disease). Consult your doctor before taking the medicine.

Is it safe to drive while taking DACLAWIN 60MG TABLET?

Do not drive or operate any machines while taking DACLAWIN 60MG TABLET as this medicine may cause dizziness, difficulty while concentrating or vision problems. Consult your doctor before taking this medicine.

REFERENCES

1. J. L. Jameson, A. S. Fauci, D. L. Kasper, S. L. Hauser, D. L. Longo, J. Loscalzo. Chronic Hepatitis. Harrison’s Principles of Internal Medicine. Twentieth edition. 2018. Page - 2393.

2. Maggie Montgomery, Natalie Ho, Elizabeth Chung, Nino Marzella. Daclatasvir (Daklinza); A Treatment Option for Chronic Hepatitis C Infection. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. December 2016. [Accessed on 7th September 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5132415/

3. Bristol-Myers Squibb Company. Food and Drugs Administration (FDA). [Revised in February 2017] [Accessed on 8th September 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206843s006lbl.pdf

4. EUROPEAN EGYPTIAN PHARM. IND. Daclavir 60mg Film Coated Tablet. [Revised in April 2018] [Accessed on 8th September 2022] https://quest3plus.bpfk.gov.my/front-end/attachment/465/pharma/509322/509322_20190401_164410_.pdf

USEFUL DIAGNOSTIC TESTS

• Liver Function Test

AUTHOR DETAILS

Written By Dr. Janet.C, Pharm.D
Last updated on 24 Sep 2022 | 12:27 PM(IST)