Consumer Information for: AURO-ENTECAVIR
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
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 AUROENTECAVIR 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 non-medicinal 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 form it comes in
AURO-ENTECAVIR is available as 0.5 mg tablets.
Warnings
Serious Warnings and Precautions
Severe worsening of hepatitis (liver inflammation) has occurred in patients who have stopped taking antihepatitis 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).
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 AUROENTECAVIR.
If you have or get HIV (human immunodeficiency 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 AUROENTECAVIR.
- 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. AUROENTECAVIR 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
AURO-ENTECAVIR may interact with other medicines that leave the body through the kidneys.
Proper Use
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 AUROENTECAVIR 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 AUROENTECAVIR.
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.
Side Effects
The most common side effects of AUROENTECAVIR 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 talk with your doctor or pharmacist |
|---|---|---|---|
| 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 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 | ✔ | ||
Storage
Store at room temperature (15°C to 30°C). Keep out of the reach of children.
well
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 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 Info
This leaflet is Part III of a three-part “Product Monogaph” published when AURO-ENTECAVIR was approved for sale in Canada and is designed specifically for Consumers. This leaflet is a summary and will not tell you everything about AURO-ENTECAVIR. Contact your doctor or pharmacist if you have any questions about the drug.
If you want more information about AUROENTECAVIR:
- 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 ; the manufacturer’s website www.auropharma.ca, or by calling 1-855-648-6681.
This leaflet was prepared by
Auro Pharma Inc.
3700 Steels Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision: February 5, 2019
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| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ARIDOL | 02489562 | PHARMAXIS EUROPE LIMITED | MANNITOL 5 MG / CAP MANNITOL 10 MG / CAP MANNITOL 20 MG / CAP MANNITOL 40 MG / CAP |