Details for: ENTECAVIR TABLETS
Company: STRIDES PHARMA CANADA INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02453797 | ENTECAVIR TABLETS | ENTECAVIR (ENTECAVIR MONOHYDRATE) | 0.5 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
ENTECAVIR TABLETS is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults who also have active liver damage.
What it does
- ENTECAVIR TABLETS may lower the amount of HBV in the body
- ENTECAVIR TABLETS may lower the ability of HBV to multiply and infect new liver cells
- ENTECAVIR TABLETS may reduce the damage to the liver by HBV
ENTECAVIR TABLETS will not cure HBV infection.
It is important to stay under your healthcare provider’s care while taking ENTECAVIR TABLETS. Your healthcare provider will test the level of the hepatitis B virus in your blood regularly.
When it should not be used
Do not take ENTECAVIR TABLETS if you are allergic to any of its ingredients. The active ingredient in ENTECAVIR TABLETS is entecavir. See “What the nonmedicinal ingredients are” for a complete list of ingredients in ENTECAVIR TABELTS.
Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.
ENTECAVIR TABLETS has not been studied in children and is not recommended for anyone less than 16 years old.
What the medicinal ingredient is
Entecavir
What the non-medicinal ingredients are
ENTECAVIR TABLETS: crospovidone, hypromellose, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, polysorbate 80 and titanium dioxide.
What dosage form it comes in
- ENTECAVIR TABLETS film-coated tablets
Does ENTECAVIR TABLETS lower the risk of passing HBV to others?
ENTECAVIR TABLETS does not stop you from spreading HBV to others by sex, sharing needles, or being exposed to your blood. Talk to your healthcare provider about safe sexual practices that protect your partner. Never share needles. Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades. A shot (vaccine) is available to protect people at risk from becoming infected with HBV.
Warnings and precautions
Serious Warnings and Precautions
Severe worsening of hepatitis (liver inflammation) has occurred in patients who have stopped taking anti- hepatitis B therapy (including ENTECAVIR TABLETS). Your doctor will monitor your condition in this case and may resume therapy.
Lactic acidosis (increase in acid level of blood) and severe hepatomegaly with steatosis (enlarged fatty liver), including fatal cases have been reported in patients using nucleoside analogue medicines, including ENTECAVIR TABLETS, either alone or in combination. Reports of lactic acidosis with ENTECAVIR TABLETS often involved patients who were seriously ill due to their liver disease or other medical condition. Lactic acidosis is a medical emergency andmust be treated in the hospital. Call your healthcare provider right away if you get any of the signs of lactic acidosis (see table Serious Side Effects and What to do About them).
Your hepatitis B infection may get worse or become very serious if you stop ENTECAVIR TABLETS.
- take ENTECAVIR TABLETS exactly as prescribed
- do not run out of ENTECAVIR TABLETS
- do not stop ENTECAVIR TABLETS without talking to your healthcare provider
Your healthcare provider will need to monitor your health and do regular blood tests to check your liver if you stop ENTECAVIR TABLETS. Tell your healthcare provider right away about any new or unusual symptoms that you notice after you stop taking ENTECAVIR TABLETS.
If you have or get HIV (human immunodeficiency virus) infection be sure to discuss your treatment with your doctor. If you are taking ENTECAVIR TABLETS to treat chronic hepatitis B and are not taking medicines for your HIV at the same time, some HIV treatments that you take in the future may be less likely to work. You are advised to get an HIV test before you start taking ENTECAVIR TABLETS and anytime after that when there is a chance you were exposed to HIV. ENTECAVIR TABLETS will not help your HIV infection.
BEFORE you use ENTECAVIR TABLETS talk to your healthcare provider about all of your medical conditions, including if you:
- have had a liver transplant.
- have kidney problems. Your doctor may need to adjust your ENTECAVIR TABLETS dose or dose schedule.
- are pregnant or planning to become pregnant. It is not known if ENTECAVIR TABLETS is safe to use during pregnancy. It is not known whether ENTECAVIR TABLETS helps prevent a pregnant mother from passing HBV to her baby. You and your healthcare provider will need to decide if ENTECAVIR TABLETS is right for you. If you use ENTECAVIR TABLETS while you are pregnant, talk to your healthcare provider about the ENTECAVIR TABLETS Pregnancy Registry.
- are breast-feeding. It is not known if ENTECAVIR TABLETS can pass into your breast milk or if it can harm your baby. Do not breast-feed if you are taking ENTECAVIR TABLETS
- are lactose intolerant. ENTECAVIR TABLETS contain lactose. If you have been told that you have intolerance to some sugars, contact your doctor before taking this medicine.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. ENTECAVIR TABLETS may interact with other medicines that leave the body through the kidneys.
Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist.
Interactions with this medication
ENTECAVIR TABLETS may interact with other medicines that leave the body through the kidneys.
Proper use of this medication
Take ENTECAVIR TABLETS exactly as prescribed. Your healthcare provider will tell you how much ENTECAVIR TABLETS to take. Your dose will depend on whether you have been treated for HBV infection before and what medicine you took.
Usual Dose
The usual dose of ENTECAVIR TABLETS in adults and children over 16 years of age is either one or two 0.5 mg tablets once daily by mouth. Your dose may be lower or you may take ENTECAVIR TABLETS less often than once a day, if you have kidney problems.
- Take ENTECAVIR TABLETS once a day on an empty stomach to help it work better. Empty stomach means at least 2 hours after a meal and at least 2 hours before the next meal. To help you remember to take your ENTECAVIR TABLETS, try to take it at the same time each day.
- Do not change your dose or stop taking ENTECAVIR TABLETS without talking to your healthcare provider. Your hepatitis B symptoms may get worse or become serious if you stop taking ENTECAVIR TABLETS. After you stop taking ENTECAVIR TABLETS, it is important to stay under your healthcare provider’s care. Your healthcare provider will need to do regular blood tests to check your liver.
- When your supply of ENTECAVIR TABELTS starts to run low, get more from your healthcare provider or pharmacy. Do not run out of ENTECAVIR TABLETS.
Overdose
If you think you have taken too much ENTECAVIR TABLETS, contact your healthcare professional(e.g. doctor), hospital emergency department or regional poison control centre, even if there are no symptoms.
Missed Dose
If you forget to take ENTECAVIR TABLETS, take it as soon as you remember and then take your next dose at its regular time. If it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time. Call your healthcare provider or pharmacist if you are not sure what to do.
Side effects and what to do about them
The most common side effects of entecavir are headache, tiredness, dizziness, and nausea. Rash has also been reported. Less common side effects include diarrhea, indigestion, vomiting, sleepiness, and trouble sleeping. In some patients, the results of blood tests that measure how the liver or pancreas is working may worsen.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| Lactic acidosis(high level of lactic acid in the blood) Symptoms: | |||
| Feeling very weak or tired | ✔ | ||
| Unusual (not normal) muscle pain | ✔ | ||
| Trouble breathing | ✔ | ||
| Stomach pain with nausea and vomiting | ✔ | ||
| Feeling cold especially in arms and legs | ✔ | ||
| Feeling dizzy or lightheaded | ✔ | ||
| Fast or irregular heartbeat | ✔ | ||
| Worsening hepatitis (inflamed liver), liver enlargement (hepatomegaly) or fatty liver Symptoms: | |||
| Skin or the white part of eyes turn yellow (jaundice) | ✔ | ||
| Dark urine | ✔ | ||
| Bowel movements(stools) turn light in colour | ✔ | ||
| Nausea | ✔ | ||
| Lower stomach pain | ✔ | ||
| Loss of appetite for several days or longer | ✔ | ||
This is not a complete list of side effects. For any unexpected effects while taking ENTECAVIR TABLETS, contact your doctor or pharmacist.
How to store
Store ENTECAVIR TABLETS at room temperature, 15˚ to 30˚ C (59˚ F to 86˚ F). They do not require refrigeration.
Do not store ENTECAVIR TABLETS in a damp place such as a bathroom medicine cabinet or near the kitchen sink.
Keep the container tightly closed.
Discard ENTECAVIR TABLETS when it is outdated or no longer needed by returning the unused portion to your pharmacist for proper disposal.
Keep out of reach and sight of children.
General Information
Medicines are sometimes prescribed for conditions
other than those described in patient information
leaflets. Do not use ENTECAVIR TABLETS for a
condition for which it was not prescribed. Do not give
ENTECAVIR TABLETS to other people, even if they
have the same symptoms you have. It may harm them.
The leaflet summarizes the most important information
about ENTECAVIR TABLETS. If you would like
more information, talk with your healthcare provider.
You can also call Strides Pharma Canada Inc. at
telephone number 1.888.318.0234.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffectcanada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Strides Pharma Canada Inc., at 1-888-318-0234.
This leaflet was prepared by
Strides Pharma Canada Inc.
Date of Revision: January 22, 2020