Patient Medication Information: uses, side effects, how to take - Apo-Lamivudine Hbv
Serious Warnings and Precautions
- Worsening of your hepatitis: Your hepatitis B infection may become worse after stopping treatment with APO-LAMIVUDINE HBV. This can be serious. Your healthcare professional will closely monitor your hepatitis if you stop treatment. See “Other warnings you should know about” for more information.
- Monitoring in patients with Human Immunodeficiency virus (HIV) and hepatitis B virus (HBV): If you are infected with both HIV and HBV, talk to your healthcare professional before you take APO-LAMIVUDINE HBV. If you stop treatment with APO-LAMIVUDINE HBV, your healthcare professional will closely monitor your health for several months after.
- HIV resistance in people with unknown HIV infection or in people with untreated HIV infection: If you have HIV that is not being treated or if you have HIV but don’t know that you do, your HIV infection may become harder to treat if you take APO-LAMIVUDINE HBV. Talk to your healthcare professional before you take APO-LAMIVUDINE HBV if you have HIV infection or think you might have HIV infection.
What is APO-LAMIVUDINE HBV used for?
APO-LAMIVUDINE HBV is used to treat patients with chronic hepatitis B infection for which there is evidence of hepatitis B virus replication.
It is not known if APO-LAMIVUDINE HBV is safe in:
- Patients with chronic hepatitis B infection who have a severely damaged liver that does not work properly. This is known as decompensated liver disease.
- Patients less than 16 years of age.
How does APO-LAMIVUDINE HBV work?
Hepatitis B is a virus which causes damage to the liver. APO-LAMIVUDINE HBV is a type of medicine known as an antiviral. APO-LAMIVUDINE HBV can reduce the spread of the virus by acting on infected cells. This 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.
What are the ingredients in APO-LAMIVUDINE HBV?
Medicinal ingredients: lamivudine (as lamivudine methanol solvate)
Non-medicinal ingredients: colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, polyethylene glycol, red ferric oxide-orange shade #34690, titanium dioxide and yellow ferric oxide.
APO-LAMIVUDINE HBV comes in the following dosage form:
As tablets containing 100 mg lamivudine
Do not use APO-LAMIVUDINE HBV if:
- you are allergic to lamivudine or to any of the ingredients in APO-LAMIVUDINE HBV.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take APO-LAMIVUDINE HBV. Talk about any health conditions or problems you may have, including if you:
- had to stop taking this or another medicine to treat your hepatitis B because you were allergic to them or they caused problems.
- have human immunodeficiency virus (HIV) infection.
- had, or have kidney problems.
- have other liver problems or are at risk of liver problems.
- are obese.
- are taking emtricitabine, used to treat HIV infection.
- have any additional medical problems.
Other warnings you should know about:
Resistant hepatitis B infection: The hepatitis B virus can change during your treatment with APO-LAMIVUDINE HBV. This might make it harder to treat (resistant). If this happens, your hepatitis might get worse.
Infecting others with hepatitis B virus: APO-LAMIVUDINE HBV does not stop you from spreading hepatitis B virus to others. You should avoid infecting others with hepatitis B virus.
Always use condoms when you have sex. Never reuse or share needles or other injection equipment.
Worsening of your hepatitis B: Do not stop taking APO-LAMIVUDINE HBV without instruction from your healthcare professional, since your hepatitis can get worse. Your healthcare professional will closely monitor your hepatitis B if you stop treatment. Your healthcare professional will monitor your liver enzymes after you stop treatment.
Pregnancy: Tell your healthcare professional if you are pregnant, think you might be pregnant or are planning to become pregnant. Your healthcare professional will decide whether you should continue to take APO-LAMIVUDINE HBV while you are pregnant.
Pregnancy Registry: There is a pregnancy registry for women who take APO-LAMIVUDINE HBV while they are pregnant. The purpose of this registry is to collect information about the health of you and your baby. If you do become pregnant while taking APO-LAMIVUDINE HBV, talk to your healthcare professional about taking part in this registry.
Breastfeeding: Tell your healthcare professional if you are breastfeeding or plan to breastfeed. Lamivudine can pass into your breastmilk and may harm your baby. Your healthcare professional will tell you if you can breastfeed your baby while taking APO-LAMIVUDINE HBV.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with APO-LAMIVUDINE HBV:
- emtricitabine, used to treat HIV infection. You should not take APO-LAMIVUDINE HBV if you are taking emtricitabine.
- medicines containing sorbitol, these are usually liquids. trimethoprim-sulphamethoxazole (also known as co-trimoxazole), an antibiotic used to treat pneumonia.
- zidovudine, used to treat HIV infection.
- alpha interferon, used to treat viral infections.
How to take APO-LAMIVUDINE HBV:
- Always take APO-LAMIVUDINE HBV exactly as your healthcare professional has told you to.
- Check with your healthcare professional or pharmacist if you are not sure.
- Stay under the care of a healthcare professional who has experience in treating hepatitis B while you are taking APO-LAMIVUDINE HBV.
You can take APO-LAMIVUDINE HBV with or without food.
- APO-LAMIVUDINE HBV tablets should be swallowed whole with water.
- Your healthcare professional will tell you how long to take APO-LAMIVUDINE HBV for.
Usual dose:
The usual dose for adults and adolescents who are 16 years of age or older is one tablet once a day.
Your healthcare professional may need to reduce your dose of APO-LAMIVUDINE HBV if you have kidney problems. The oral solution is available so that the dose of your medicine can be accurately reduced.
Overdose:
| If you think you, or a person you are caring for, have taken too much APO-LAMIVUDINE HBV, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms. |
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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 a missed dose.
What are possible side effects from using APO-LAMIVUDINE HBV?
These are not all the possible side effects you may have when taking APO-LAMIVUDINE HBV. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- 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)
- hair loss
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| UNCOMMON | |||
| Thrombocytopenia (decrease in the number of platelets in the blood): small red spots under the skin, bleeding that lasts longer than usual, bruising more easily than normal. | ✓ | ||
| Anemia (decrease in red blood cell count): fatigue, breathlessness, weakness. | ✓ | ||
| Neutropenia (low white blood cell count): fatigue, fever, infections. | ✓ | ||
| RARE | |||
| Allergic reactions: swelling of eyes, face, lips, throat, difficulty breathing or swallowing, chest pain and tightening, skin rash or hives anywhere on the body. | ✓ | ||
| Rhabdomyolosis (muscle damage): muscle tenderness or pain, weakness, reddish-brown or tea-coloured urine. | ✓ | ||
| Peripheral neuropathy (nerve damage): numbing sensation in hands and feet. | ✓ | ||
| Lactic acidosis (too much lactic acid in the blood): weight loss, fatigue, feeling dizzy or light-headed, malaise, loss of appetite, abdominal pain, shortness of breath, severe hepatomegaly and hepatic steatosis (swollen and enlarged liver) with symptoms of liver problems such as nausea, vomiting, abdominal pain, weakness and diarrhea. | ✓ | ||
| Pancreatitis (inflammation of the pancreas): severe abdominal cramps, nausea, vomiting. | ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
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. |
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Storage:
Store APO-LAMIVUDINE HBV tablets at room temperature 15°C - 30°C. Protect from moisture.
Keep out of reach and sight of children.
Do not take your medicine after the expiry date shown on the bottle.
If you want more information about APO-LAMIVUDINE HBV:
- 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 (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.apotex.ca/products, or by calling 1-800-667-4708.