Patient Medication Information: uses, side effects, how to take - Mint-Entecavir
ABOUT THIS MEDICATION
What the medication is used for:
MINT-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:
- MINT-ENTECAVIR may lower the amount of HBV in the body
- MINT-ENTECAVIR may lower the ability of HBV to multiply and infect new liver cells
- MINT-ENTECAVIR may reduce the damage to the liver by HBV
MINT-ENTECAVIR will not cure HBV infection.
It is important to stay under your healthcare provider’s care while taking MINT-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 MINT-ENTECAVIR if you are allergic to any of its ingredients. The active ingredient in
MINT-ENTECAVIR is entecavir. See “What the nonmedicinal ingredients are” for a complete list of ingredients in MINT-ENTECAVIR.
Tell your healthcare provider if you think you have had an allergic reaction to any of these ingredients.
MINT-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:
Crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide.
What dosage forms it comes in:
- Film-coated tablets
Does MINT-ENTECAVIR lower the risk of passing HBV to others?
MINT-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 MINT-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 MINT-ENTECAVIR, either alone or in combination. Reports of lactic acidosis with MINT-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 MINT-ENTECAVIR.
- take MINT-ENTECAVIR exactly as prescribed
- do not run out of MINT-ENTECAVIR
- do not stop MINT-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 MINT-ENTECAVIR. Tell your healthcare provider right away about any new or unusual symptoms that you notice after you stop taking MINT-ENTECAVIR.
If you have or get HIV (human immunodeficiency virus) infection be sure to discuss your treatment with your doctor. If you are taking MINT-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 MINT-ENTECAVIR and anytime after that when there is a chance you were exposed to HIV. MINT-ENTECAVIR will not help your HIV infection.
BEFORE you use MINT-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 MINT-ENTECAVIR dose or dose schedule.
are pregnant or planning to become pregnant. It is not known if MINT-ENTECAVIR is safe to use during pregnancy. It is not known whether MINT-ENTECAVIR helps prevent a pregnant mother from passing HBV to her baby. You and your healthcare provider will need to decide if MINT-ENTECAVIR is right for you. If you use MINT-ENTECAVIR while you are pregnant, talk to your healthcare provider about the MINT-ENTECAVIR Pregnancy Registry.
- are breast-feeding. It is not known if MINT-ENTECAVIR can pass into your breast milk or if it can harm your baby. Do not breast-feed if you are taking MINT-ENTECAVIR.
- are lactose intolerant. MINT-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. MINT-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
MINT-ENTECAVIR may interact with other medicines that leave the body through the kidneys.
PROPER USE OF THIS MEDICATION
Take MINT-ENTECAVIR exactly as prescribed. Your healthcare provider will tell you how much MINT-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 MINT-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 MINT-ENTECAVIR less often than once a day, if you have kidney problems.
Take MINT-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 MINT-ENTECAVIR, try to take it at the same time each day.
- Do not change your dose or stop taking MINT-ENTECAVIR without talking to your healthcare provider. Your hepatitis B symptoms may get worse or become serious if you stop taking MINT-ENTECAVIR. After you stop taking MINT-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 MINT-ENTECAVIR starts to run low, get more from your healthcare provider or pharmacy. Do not run out of MINT-ENTECAVIR.
Overdose:
| If you think you, or a person you are caring for, have taken too much MINT-ENTECAVIR, contact a healthcare professional, hospital emergency department, or regional Poison Control Centre immediately, even if there are no symptoms. |
Missed Dose:
If you forget to take MINT-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 MINT-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.
SERIOUS SIDE EFFECTS AND WHAT TO DO ABOUT THEM
| Symptom / effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |||
| 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 MINT-ENTECAVIR, contact your doctor or pharmacist.
HOW TO STORE IT
MINT-ENTECAVIR Tablets should be stored in a tightly closed container at room temperature between 15°C-30°C. Protect from light.
Do not store MINT-ENTECAVIR Tablets in a damp place such as a bathroom medicine cabinet or near the kitchen sink.
Keep container tightly closed. Discard MINT-ENTECAVIR when it is outdated or no longer needed by returning the unused portion to your pharmacist for proper disposal.
Keep MINT-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 MINT-ENTECAVIR for a condition for which it was not prescribed. Do not give MINT-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 MINT-ENTECAVIR. If you would like more information, talk with your healthcare provider. You can also call Mint Pharmaceuticals Inc.at telephone number 1.877.398.9696.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
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. |
If you want more information about MINT-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.mintpharmaceuticals.com, or by calling 1-877-398-9696.