Patient Medication Information: uses, side effects, how to take - Auro-Entecavir
ABOUT THIS MEDICATION
What the medication is used for
AURO-ENTECAVIR is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults who also have active liver damage.
What it does
AURO-ENTECAVIR may lower the amount of
HBV in the body
AURO-ENTECAVIR may lower the ability of
HBV to multiply and infect new liver cells
AURO-ENTECAVIR may reduce the damage to
the liver by HBV
AURO-ENTECAVIR will not cure HBV infection.
It is important to stay under your healthcare provider’s care while taking AURO-ENTECAVIR. 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 AURO-ENTECAVIR if you are allergic to any of its ingredients. The active ingredient in AURO-ENTECAVIR is entecavir. See “What the nonmedicinal ingredients are” for a complete list of ingredients in AURO-ENTECAVIR.
Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.
Entecavir 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 nonmedicinal ingredients are: Lactose monohydrate, cellulose microcrystalline, crospovidone & magnesium stearate.
Coating Ingredients:
Aquarius BP 18257 cool vanilla: It contains hypromellose, titanium dioxide & polyethylene glycol.
What dosage forms it comes in:
AURO-ENTECAVIR is available as 0.5 mg tablets.
Does AURO-ENTECAVIR lower the risk of passing HBV to others?
AURO-ENTECAVIR 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
Your hepatitis B infection may get worse or become very serious if you stop AURO-ENTECAVIR.
- take AURO-ENTECAVIR exactly as prescribed
- do not run out of AURO-ENTECAVIR
- do not stop AURO-ENTECAVIR 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 AURO-ENTECAVIR. Tell your healthcare provider right away about any new or unusual symptoms that you notice after you stop taking AURO-ENTECAVIR.
If you have or get HIV (human immunodeficiency Serious Warnings and Precautions
Severe worsening of hepatitis (liver inflammation) has occurred in patients who have stopped taking anti-hepatitis B therapy (including entecavir).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, either alone or in combination. Reports of lactic acidosis with entecavir often involved patients who were seriously ill due to their liver disease or other medical condition. Lactic acidosis is a medical emergency and must 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).
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virus) infection be sure to discuss your treatment with your doctor. If you are taking AURO-ENTECAVIR 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 AURO-ENTECAVIR and anytime after that when there is a chance you were exposed to HIV. AURO-ENTECAVIR will not help your HIV infection.
BEFORE you use AURO-ENTECAVIR 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 AURO-ENTECAVIR dose or dose schedule.
are pregnant or planning to become pregnant. It is
not known if entecavir is safe to use during pregnancy. It is not known whether entecavir helps prevent a pregnant mother from passing HBV to her baby. You and your healthcare provider will need to decide if AURO-ENTECAVIR is right for you. If you use AURO-ENTECAVIR while you are pregnant, talk to your healthcare provider about the AURO-ENTECAVIR Pregnancy Registry.
are breast-feeding. It is not known if entecavir can
pass into your breast milk or if it can harm your baby. Do not breast-feed if you are taking AURO-ENTECAVIR.
are lactose intolerant. AURO-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. AURO-ENTECAVIR 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
AURO-ENTECAVIR may interact with other medicines that leave the body through the kidneys.
PROPER USE OF THIS MEDICATION
Take AURO-ENTECAVIR exactly as prescribed. Your healthcare provider will tell you how much AURO-
ENTECAVIR 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 AURO-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 AURO-ENTECAVIR less often than once a day, if you have kidney problems.
Take AURO-ENTECAVIR 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 AURO-ENTECAVIR, try to take it at the same time each day.
Do not change your dose or stop taking AURO-
ENTECAVIR without talking to your healthcare provider. Your hepatitis B symptoms may get worse or become serious if you stop taking AURO-ENTECAVIR. After you stop taking AURO-ENTECAVIR, 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 AURO-ENTECAVIR starts to run low, get more from your healthcare provider or pharmacy. Do not run out of AURO-ENTECAVIR.
Overdose
If you think you have taken too much
AUROENTECAVIR, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.
Missed Dose
If you forget to take AURO-ENTECAVIR, 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 AURO-
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
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pancreas is working may worsen.
| SERIOUS SIDE EFFECTS AND WHAT TO DO | |||||||
| ABOUT THEM | |||||||
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and get immediate medical help | |||||
Only if severe | In all cases | ||||||
| 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 AURO-ENTECAVIR, contact your doctor or pharmacist.
HOW TO STORE IT
Store at room temperature (15°C to 30°C). Keep out of the reach of children.
General Information
Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use AURO-ENTECAVIR for a condition for which it was not prescribed. Do not give AURO-ENTECAVIR to other people, even if they have the same symptoms you have. It may harm them. The leaflet summarizes the most important information about AURO-ENTECAVIR. If you would like more information, talk with your healthcare provider.
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/health-canada/services/drugs-health-
products/medeffect-canada/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
If you want more information about AURO-ENTECAVIR:
- Talk to your healthcare professional
Find the full product monograph that is prepared for healthcare professionals and includes this Consumer Information by visiting the Health Canada website (https://health-
products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
Auro Pharma Inc.
3700 Steels Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: February 5, 2019