Details for: APO-LAMIVUDINE HBV
Company: APOTEX INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02393239 | APO-LAMIVUDINE HBV | LAMIVUDINE | 100 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
APO-LAMIVUDINE HBV is indicated for:
- the treatment of patients with chronic hepatitis B and evidence of hepatitis B virus (HBV) replication.
What it does
Hepatitis B is a virus which causes damage to
the liver. Treatment with APO-LAMIVUDINE
HBV can reduce the amount of hepatitis B virus
in your body. This may lead to a reduction in
further liver damage and improvement of your
liver function.
APO-LAMIVUDINE HBV is a type of medicine
known as an antiviral. It belongs to a group of
medicines called nucleoside analogue reverse
transcriptase inhibitors (NRTIs). APO-LAMIVUDINE HBV interferes with virus
replication in infected cells and therefore
reduces the amount of hepatitis B virus in your
body, and may keep the liver disease under
control. If you use APO-LAMIVUDINE HBV as
instructed, it may reduce health problems
relating to your liver in the future.
When it should not be used
APO-LAMIVUDINE HBV should not be used:
- if you have a known hypersensitivity to lamivudine or to any ingredient of the preparation. (See what the important nonmedicinal ingredients are).
What the medicinal ingredient is
The active substance in APO-LAMIVUDINE HBV is lamivudine.
What the non-medicinal ingredients are
APO-LAMIVUDINE HBV contains the following nonmedicinal ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, ferric oxide orange shade, iron oxide yellow, magnesium stearate, polyvinyl alcohol, polyethylene glycol, talc and titanium dioxide.
What dosage form it comes in
APO-LAMIVUDINE HBV is available in 100 mg
tablets.
The 100 mg tablets are orange-brown colored,
capsule shaped, biconvex film-coated tablets
with “APO” engraved on one side and “LMV
100” on the other side.
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 APOLAMIVUDINE HBV). Your doctor will monitor your condition in this case and may resume therapy.
- In patients with unrecognized or untreated HIV, HIV-resistance may develop when treated with APO-LAMIVUDINE HBV. APOLAMIVUDINE HBV contains lower doses of the same active ingredient (lamivudine) as drug products (i.e. APO-LAMIVUDINE) which are used to treat HIV.
BEFORE you use APO-LAMIVUDINE HBV talk to your doctor or pharmacist if:
- you had to stop taking this or another medication for this illness because you were allergic to them or they caused problems.
- you had, or have any diseases of the kidney, or other liver problems.
- you are pregnant or are planning to become pregnant, or if you are breast feeding. Your doctor will advise whether you should continue to take APO-LAMIVUDINE HBV while you are pregnant. Do not stop treatment with APO-LAMIVUDINE HBV without your doctor’s advice. Your doctor will advise whether you should breast feed your baby while you are taking APO-LAMIVUDINE HBV. APO-LAMIVUDINE HBV can pass into breast milk. If you take APO-LAMIVUDINE HBV while you are pregnant, talk to your doctor about how you can be included in the Antiretroviral Pregnancy Registry.
- you have any additional medical problems.
Because your medicine helps to control your hepatitis B and it is not yet known whether it will cure it, you are still at risk of transmitting this virus to others through sexual contact or by blood transfer, and you should use appropriate precautions to prevent this. There is an effective vaccine available to protect those at risk from becoming infected with hepatitis B virus.
Interactions with this medication
It is important that your doctor knows about all
your medicines so that you get the best possible
treatment. Tell your doctor about all your
medicines, including vitamin supplements,
herbal remedies or homeopathic remedies,
including those you have bought yourself.
APO-LAMIVUDINE HBV should not be taken
with emtricitabine.
Some medicines may affect how APO-LAMIVUDINE HBV works, or make it more likely
that you’ll have side effects. These include:
- medicines (usually liquids) containing sorbitol, used regularly
- trimethoprim-sulphamethoxazole (also known as co-trimoxazole), an antibiotic used to treat Pneumocystis jiroveci pneumonia (often referred to as PCP) or toxoplasmosis
- zidovudine, used to treat HIV infection
- alpha interferon, used to treat viral infections
Proper use of this medication
For effective treatment you will need to take
APO-LAMIVUDINE HBV every day. Patients
respond to the treatment differently, therefore it
is not known for how long you will have to take
this medicine. Your doctor will be checking your
response to treatment by taking regular blood
samples. The results of these tests will help your
doctor to decide when your treatment with APO-LAMIVUDINE HBV can be stopped.
If you have kidney disease the dose of this
medicine may have to be reduced, as the kidney
is mainly responsible for getting rid of the
medicine from your body. If required, your doctor
can prescribe a lower dose of lamivudine as an
oral solution to you.
The active substance in APO-LAMIVUDINE
HBV is lamivudine. If you are already taking this
medicine for HIV infection (lamivudine 150 mg or
300 mg tablets), your doctor will continue to treat
you with the higher dose, usually 150 mg twice
per day, as the lower dose of 100 mg lamivudine
is insufficient to treat HIV infection.
Usual Dose
Take your medicine as your doctor has advised
you. The label on it will usually tell you the
amount to take, and how frequently. If it does
not, or you are not sure, ask your doctor or
pharmacist.
The recommended dose of APO-LAMIVUDINE
HBV for adults and adolescents 16 years and
older is one tablet (100 mg lamivudine) once a
day. The tablet should be swallowed whole with
water. APO-LAMIVUDINE HBV can be taken
with or without food. Your doctor will advise you
how long you have to take the medicine for.
Your doctor may need to reduce your dose of
APO-LAMIVUDINE HBV if you have kidney
problems.
Overdose
Missed Dose
If you forget to take your medicine, take it as soon as you remember. Then continue as before. Do not take a double dose to make up for forgotten individual doses. Do not stop taking APO-LAMIVUDINE HBV without instruction from your doctor, as there is a small risk of your hepatitis getting worse. When you stop taking APO-LAMIVUDINE HBV your doctor will monitor you over the following four months to check for any problems. Blood samples will be taken to check for any abnormal liver enzymes, indicating liver damage.
Side effects and what to do about them
All medicines may cause some undesirable effects. The number and type of undesirable effects reported were similar whether patients received APO-LAMIVUDINE HBV or an inactive substance (placebo). The most commonly reported were tiredness, respiratory tract infections, headache, stomach discomfort and pain, nausea, vomiting and diarrhea, cough, ear, nose, and throat infections, musculoskeletal pain, nasal signs and symptoms, dizziness, sleep disorders, temperature regulation disturbances, elevated liver enzymes, elevated enzymes produced in the muscles (creatine phosphokinase), rash, muscle disorders (including muscle pain and cramps), and alopecia (hair loss). These were generally mild in severity.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and call your doctor or pharacist |
|---|---|---|---|
| Uncommon | |||
| A decrease in the number of cells involved in blood clotting (thrombocytopenia, symptoms may include small red spots under the skin, bleeding that lasts longer than usual or bruising more easily than normal. | ✔ | ||
| Blood problems and symptoms such as anemia (lowered red blood cell count) resulting in fatigue, breathlessness. | ✔ | ||
| Low white blood cell count making you more prone to infections. | ✔ | ||
| Rare | |||
| Allergic reactions and symptoms such as swelling of eyes, face, lips, throat, sudden wheeziness, chest pain and tightening, skin rash or hives anywhere on the body. | ✔ | ||
| Rhabdomyolosis (muscle wasting) and peripheral neuropathy (nerve damage). | ✔ | ||
| Lactic acidosis (high level of lactic acid in the blood) and symptoms such as weight loss, fatigue, malaise, nausea, vomiting, abdominal pain, shortness of breath. | ✔ | ||
| Severe hepatomegaly with steatosis (swollen and enlarged liver), with symptoms of liver problems such as nausea, vomiting, abdominal pain, weakness and diarrhea. | ✔ | ||
| Pancreatitis (inflammation of the pancreas) and symptoms such as severe stomach cramps, nausea, vomiting. | ✔ | ||
If you feel unwell in any other way or have any
symptoms that you do not understand, you
should contact your doctor immediately.
This is not a complete list of side effects. For
any unexpected effects while taking APO-LAMIVUDINE HBV, contact your doctor or
pharmacist.
How to store
Store APO-LAMIVUDINE HBV at room
temperature (15°C to 30°C). Protect from
moisture.
As with all medicines, keep APO-LAMIVUDINE
HBV out of the reach and sight of children.
Do not take your medicine after the expiry date
shown on the bottle and the carton.
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
Remember: This medicine is for you. Never give it to someone else. It may harm them even if their symptoms are the same as yours
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.
This leaflet was prepared by Apotex Inc.,
Toronto, Ontario, M9L 1T9.
Last revised: April 30, 2019