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Details for: APO-LAMIVUDINE HBV

Company: APOTEX INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02393239APO-LAMIVUDINE HBVLAMIVUDINE100 MGTABLETORAL
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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

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

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.

Serious side effects and what to do about them
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:

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

Date modified: