Consumer Information for: JAMP 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
JAMP 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
- JAMP ENTECAVIR may lower the amount of HBV in the body
- JAMP ENTECAVIR may lower the ability of HBV to multiply and infect new liver cells
- JAMP ENTECAVIR may reduce the damage to the liver by HBV
JAMP ENTECAVIR will not cure HBV infection.
It is important to stay under your healthcare provider’s care while taking JAMP 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 JAMP ENTECAVIR if you are allergic to any of its ingredients. The active ingredient in JAMP ENTECAVIR is entecavir. See “What the nonmedicinal ingredients are” for a complete list of ingredients in JAMP ENTECAVIR.
Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.
JAMP 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
JAMP ENTECAVIR tablets: crospovidone, hypromellose, lactose monohydrate, macrogol, magnesium stearate, microcrystalline cellulose, polysorbate 80 and titanium dioxide
What dosage form it comes in
- JAMP ENTECAVIR film-coated tablets
Does JAMP ENTECAVIR lower the risk of
passing HBV to others?
JAMP 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
Serious Warnings and Precautions
Severe worsening of hepatitis (liver inflammation) has occurred in patients who have stopped taking anti- hepatitis B therapy (including JAMP 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 JAMP ENTECAVIR, either alone or in combination. Reports of lactic acidosis with JAMP 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 JAMP ENTECAVIR.
- take JAMP ENTECAVIR exactly as prescribed
- do not run out of JAMP ENTECAVIR
- do not stop JAMP 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 JAMP ENTECAVIR. Tell your healthcare provider right away about any new or unusual symptoms that you notice after you stop taking JAMP ENTECAVIR.
If you have or get HIV (human immunodeficiency virus) infection be sure to discuss your treatment with your doctor. If you are taking JAMP 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 JAMP ENTECAVIR and anytime after that when there is a chance you were exposed to HIV. JAMP ENTECAVIR will not help your HIV infection.
BEFORE you use JAMP 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 JAMP ENTECAVIR dose or dose schedule.
- are pregnant or planning to become pregnant. It is not known if JAMP ENTECAVIR is safe to use during pregnancy. It is not known whether JAMP ENTECAVIR helps prevent a pregnant mother from passing HBV to her baby. You and your healthcare provider will need to decide if JAMP ENTECAVIR is right for you. If you use JAMP ENTECAVIR while you are pregnant, talk to your healthcare provider about the JAMP ENTECAVIR Pregnancy Registry.
- are breast-feeding. It is not known if JAMP ENTECAVIR can pass into your breast milk or if it can harm your baby. Do not breast-feed if you are taking JAMP ENTECAVIR.
- are lactose intolerant. JAMP 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.
JAMP 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
JAMP ENTECAVIR may interact with other medicines that leave the body through the kidneys.
Proper use of this medication
Take JAMP ENTECAVIR exactly as prescribed. Your healthcare provider will tell you how much JAMP 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 JAMP 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 JAMP ENTECAVIR less often than once a day, if you have kidney problems.
- Take JAMP 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 JAMP ENTECAVIR, try to take it at the same time each day.
- Do not change your dose or stop taking JAMP ENTECAVIR without talking to your healthcare provider. Your hepatitis B symptoms may get worse or become serious if you stop taking JAMP ENTECAVIR. After you stop taking JAMP 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 JAMP ENTECAVIR starts to run low, get more from your healthcare provider or pharmacy. Do not run out of JAMP ENTECAVIR.
Overdose
Missed Dose
If you forget to take JAMP 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 JAMP 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 call 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 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 | ✔ | ||
How to store
Store JAMP ENTECAVIR Tablets at room temperature, 15˚ to 30˚ C.
Do not store JAMP ENTECAVIR Tablets in a damp place such as a bathroom medicine cabinet or near the kitchen sink.
Keep the container tightly closed.
Discard JAMP ENTECAVIR when it is outdated or no longer needed by returning the unused portion to your pharmacist for proper disposal.
Keep JAMP ENTECAVIR and all medicines out of the reach of children and pets.
General Information
Medicines are sometimes prescribed for conditions
other than those described in patient information
leaflets. Do not use JAMP ENTECAVIR for a
condition for which it was not prescribed. Do not give
JAMP 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 JAMP 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 (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
This document plus the full product monograph, prepared for health professionals, can be obtained by contacting the sponsor, Jamp Pharma Corporation at 1 866-399-9091.
This leaflet was prepared by Jamp Pharma
Corporation
1310 rue Nobel, Boucherville, Québec J4B 5H3
Last revised: February 20, 2019
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| THYMOGLOBULIN | 02246805 | SANOFI-AVENTIS CANADA INC | ANTI-THYMOCYTE GLOBULIN (RABBIT) 25 MG / VIAL |