Daclatasvir Dihydrochloride Tablets 60mg
What is in this leaflet
Read this leaflet carefully before taking Daclatasvir Dihydrochloride.
This leaflet answers some common questions about Daclatasvir Dihydrochloride.
It does not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risks of you taking Daclatasvir Dihydrochloride against the benefits they expect it will have for you.
If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may need to read it again.
What Daclatasvir Dihydrochloride is used for
Daclatasvir Dihydrochloride is a trading name (manufacturer’s name) for the medicine, daclatasvir. Daclatasvir Dihydrochloride is a direct-acting antiviral agent (DAA) against the hepatitis C virus (HCV). Daclatasvir Dihydrochloride is an inhibitor of NS5A, which is a protein that is required to form new HCV particles.
You should not take Daclatasvir Dihydrochloride alone to treat chronic (lasting a long time) hepatitis C infection in adults. Daclatasvir Dihydrochloride should only be used together with other antiviral medicines such as sofosbuvir, or asunaprevir, or together with, peginterferon alfa, and ribavirin.
How Daclatasvir Dihydrochloride Works
Daclatasvir Dihydrochloride (in combination with other medicines) works by stopping the HCV from multiplying and infecting liver cells. After you stop taking Daclatasvir Dihydrochloride, your doctor will monitor your blood for HCV. If HCV is still not detected in your blood at least 12 weeks after stopping treatment, you have what is called a sustained virologic response (SVR), also referred to as virologic cure.
It is not known if Daclatasvir Dihydrochloride is safe and effective in children under 18 years of age.
Ask your doctor if you have any questions about why Daclatasvir Dihydrochloride has been prescribed for you.
Daclatasvir Dihydrochloride is not addictive. This medicine is available only with a doctor’s prescription.
Before you take Daclatasvir Dihydrochloride
It is important that you check the information below before you take Daclatasvir Dihydrochloride.
When you must not take Daclatasvir Dihydrochloride
Daclatasvir Dihydrochloride is sometimes used with peginterferon alfa and ribavirin.
Peginterferon alfa and ribavirin may cause birth defects or death of your unborn baby. If you are pregnant or planning to become pregnant, or your sexual partner is pregnant or plans to become pregnant, do not take these medicines. You or your sexual partner should not become pregnant while taking peginterferon alfa and ribavirin, and for 6 months after treatment ends.
????Two effective forms of birth control must be used, one by each partner, male and female, during treatment and for the 6 months after treatment with peginterferon alfa and ribavirin.
Talk with your doctor about forms of birth control that may be used during this time.
- Females must have a negative pregnancy test before starting treatment with peginterferon alfa and ribavirin, every month while being treated, and every month for 6 months after your treatment ends.
If you or your female sexual partner becomes pregnant while taking, or within 6 months after you stop taking, peginterferon alfa and ribavirin, tell your doctor right away.
Do not take Daclatasvir Dihydrochloride if you have an allergy to it or to any other ingredients in the formulation listed at the end of this leaflet.
Do not take Daclatasvir Dihydrochloride if you are currently taking any of these medicines:
- dexamethasone (when administered by injection or taken by mouth)
- St. John’s wort (Hypericum perforatum) or a product that contains St. John’s wort
If you are not sure if any of these medicines are in the products you are taking, talk to your doctor or pharmacist.
Do not use Daclatasvir Dihydrochloride after the expiry date printed on the back of the pack. If this medicine is taken after the expiry date has passed, it may not work as well.
Do not take Daclatasvir Dihydrochloride if the packaging is torn or shows signs of tampering.
Before you start to take Daclatasvir Dihydrochloride
Tell your doctor if you:
- have a current or previous infection with the hepatitis B virus
- have liver problems other than hepatitis C infection
- have had, or are intending to have a liver transplant
- have diabetes
- have any other medical condition
Daclatasvir Dihydrochloride should not be used during pregnancy.
Tell your doctor if you are pregnant or intend to become pregnant.
It is not known if Daclatasvir Dihydrochloride will harm your unborn baby.
If you can become pregnant, continue the use of effective contraception for 5 weeks after the end of your treatment with Daclatasvir Dihydrochloride.
If you are also taking ribavirin, you must follow the contraception instructions under “When you must not take Daclatasvir Dihydrochloride” above.
Tell your doctor or pharmacist if you are breast-feeding or plan to breast-feed.
It is recommended that you do not breast-feed while taking Daclatasvir Dihydrochloride. It is not known if Daclatasvir Dihydrochloride passes into breast milk.
If you have not told your doctor about any of the above, tell them before you use Daclatasvir Dihydrochloride.
As Daclatasvir Dihydrochloride should only be used together with other antiviral medicines such as sofosbuvir, or, or together with, peginterferon alfa, and ribavirin, please read the Consumer Medicine Information for the other products prescribed by your doctor before starting Daclatasvir Dihydrochloride.
Taking other medicines
Be sure to inform your doctor of all medications you are taking including prescribed drugs, over the counter products, natural therapies, vitamin supplements and recreational drugs.
Daclatasvir Dihydrochloride and other medicines may affect each other. This can cause you to have too much or not enough Daclatasvir Dihydrochloride or other medicines in your body, which may affect the way Daclatasvir Dihydrochloride or your other medicines work or may cause side effects.
Medicines for other conditions:
Tell your doctor if you are taking or starting to take medicines that contain:
- atazanavir. You may need a lower dose of Daclatasvir Dihydrochloride (30 mg).
- boceprevir or telaprevir. You may need a lower dose of Daclatasvir Dihydrochloride (30 mg).
- clarithromycin, erythromycin. You may need a lower dose of Daclatasvir Dihydrochloride (30 mg).
- diltiazem, verapamil
- efavirenz, etravirine, or nevirapine. You may need a higher dose of Daclatasvir Dihydrochloride (90 mg).
- elvitegravir, cobicistat, emtricitabine, or tenofovir disoproxil fumarate. You may need a lower dose of Daclatasvir Dihydrochloride (30 mg).
- fluconazole, ketoconazole, itraconazole, posaconazole, or voriconazole. You may need a lower dose of Daclatasvir Dihydrochloride (30 mg).
- rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin, or pravastatin
- warfarin and other similar medicines called vitamin K antagonists used to thin the blood
Your doctor will be able to advise you about the most appropriate medications to treat your condition. It is important that you tell your doctor or pharmacist about the medicines you are taking, even if they are not listed in this leaflet.
They will be able to provide you with more information than is contained within this leaflet on the medicines you need to be careful with, or should avoid while taking Daclatasvir Dihydrochloride.
How to take Daclatasvir Dihydrochloride
Daclatasvir Dihydrochloride should be given only when prescribed by your doctor. Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.
How much to take
Take Daclatasvir Dihydrochloride exactly as your doctor tells you to take it. Do not change your dose unless your doctor tells you to.
Do not stop taking Daclatasvir Dihydrochloride without first talking with your doctor. If you think there is a reason to stop taking Daclatasvir Dihydrochloride, talk with your doctor before doing so.
How to take it
Swallow the tablet whole with a drink such as a glass of water.
When to take Daclatasvir Dihydrochloride
Take Daclatasvir Dihydrochloride once each day with or without food.
How long to take it
Continue taking Daclatasvir Dihydrochloride for as long as your doctor tells you to.
Do not stop taking Daclatasvir Dihydrochloride unless your doctor tells you to – even if you feel better.
If you forget to take it
If you miss a dose of Daclatasvir Dihydrochloride and less than 20 hours have passed since you were to take the missed dose, take the missed dose as soon as possible. Take the next dose at your regular time.
If you miss a dose of Daclatasvir Dihydrochloride and more than 20 hours have passed since you were to take the missed dose, skip the missed dose. Take the next dose at your regular time.
Do not take 2 doses of Daclatasvir Dihydrochloride at the same time to make up for the missed dose.
If you take too much (overdose)
Immediately call your doctor or the Poisons Information Centre on
Daclatasvir Dihydrochloride and the other medicine may interfere with each other.
- If you are taking Daclatasvir Dihydrochloride together with, your doctor may perform additional tests that will determine how well your liver is working. Please read the Consumer Medicine Information for.
Things you must not do
- Do not give Daclatasvir Dihydrochloride to anyone else, even if they have the same condition as you.
- Do not use Daclatasvir Dihydrochloride to treat any other complaints unless your doctor tells you to.
- Do not stop taking Daclatasvir Dihydrochloride without checking with your doctor.
Things to be careful of
Be careful driving or operating machinery until you know how Daclatasvir Dihydrochloride affects you.
Make sure that you visit your doctor regularly throughout your entire course of treatment with Daclatasvir Dihydrochloride.
The most common side effects when Daclatasvir Dihydrochloride is taken in combination with sofosbuvir (some patients in studies of this regimen also received ribavirin) include:
- joint pain
The most common side effects when Daclatasvir Dihydrochloride is taken in combination with , peginterferon alfa, and ribavirin include:
- unusual weakness
- flu-like symptoms
- dry skin
- hair loss
Accident and Emergency Centre at your nearest hospital if you or anyone else takes too much Daclatasvir Dihydrochloride.
Do this even if there are no signs of discomfort or poisoning.
While you are using Daclatasvir Dihydrochloride
Things you must do
- If you become pregnant while taking Daclatasvir Dihydrochloride, tell your doctor immediately.
- If you are about to start taking any new medicines, tell your doctor and pharmacist that you are taking Daclatasvir Dihydrochloride.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Daclatasvir Dihydrochloride. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects
Ask your doctor or pharmacist to answer any questions you may have.
The most common side effects when Daclatasvir Dihydrochloride is taken in combination with include:
- nasal congestion (blocked nose)
- muscle aches
If any of the following happen, tell your doctor immediately, or go to the Accident and Emergency Centre at your nearest hospital:
- allergic reaction – swelling of the face, lips, or throat which makes breathing difficult
If you have these side effects, you may have had a serious reaction to Daclatasvir Dihydrochloride. You may need urgent medical attention or hospitalisation.
This is not a complete list of side effects, other side effects not listed above may also occur in some patients.
Tell your doctor if you notice anything that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them or only some of them.
After using Daclatasvir Dihydrochloride
Store Daclatasvir Dihydrochloride tablets in a cool dry place where the temperature stays below 30?C.
Keep your tablets in the original container until it is time to take them.
Do not store Daclatasvir Dihydrochloride or any other medicine in the bathroom or near the kitchen sink. Do not leave it in the car. Heat and dampness can destroy some medicines.
Keep Daclatasvir Dihydrochloride tablets where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.
If your doctor tells you to stop taking Daclatasvir Dihydrochloride tablets, or the tablets have passed their expiry date, ask your pharmacist what to do with any that are leftover.
What it looks like
- Daclatasvir Dihydrochloride 60 mg tablets Available in packs of 7 and 28 tablets.
Daclatasvir Dihydrochloride 60 mg tablets – 60 mg of daclatasvir as daclatasvir dihydrochloride per tablets
anhydrous lactose, microcrystalline cellulose, croscarmellose sodium, silicon dioxide, magnesium stearate, and OPADRY Green.
Opadry Green contains hypromellose, titanium dioxide, Macrogol 400, indigo carmine aluminium lake, and iron oxide yellow.
Daclatasvir Dihydrochloride tablets do not contain gluten or sucrose.
7. Manufactured in India by:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
at: Ahmedabad- Gujarat, INDIA.
Ho.NO. +91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)