Patient Medication Information: uses, side effects, how to take - Jamp Lamivudine Hbv
ABOUT THIS MEDICATION
The name of your medicine is JAMP Lamivudine HBV. JAMP Lamivudine HBV can only be obtained with a prescription from your doctor.
What the medication is used for:
JAMP 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 JAMP 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.
JAMP 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). JAMP 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 JAMP Lamivudine HBV as instructed, it may reduce health problems relating to your liver in the future.
When it should not be used:
JAMP 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 JAMP Lamivudine HBV is lamivudine.
What the nonmedicinal ingredients are: JAMP Lamivudine HBV tablets contain the following nonmedicinal ingredients: microcrystalline cellulose, sodium starch glycolate, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, polysorbate 80, iron oxide yellow and iron oxide red.
What dosage forms it comes in:
JAMP Lamivudine HBV is available in 100 mg tablets.
The 100 mg tablets are beige colored, capsule shaped, biconvex, film-coated engraved “LMV’’ on one side and ‘’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 lamivudine tablets). 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 JAMP Lamivudine HBV. JAMP Lamivudine HBV contains lower doses of the same active ingredient (lamivudine) as drug products (i.e. lamivudine tablets 150 mg and 300 mg) which are used to treat HIV.
BEFORE you use JAMP 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 JAMP Lamivudine HBV while you are pregnant. Do not stop treatment with JAMP Lamivudine HBV without your doctor’s advice. Your doctor will advise whether you should breast feed your baby while you are taking JAMP Lamivudine HBV. JAMP Lamivudine HBV can pass into breast milk. If you take JAMP Lamivudine HBV while you are pregnant, talk to your doctor about how you can be included in the JAMP Lamivudine HBV Pregnancy Registry. You can call JAMP Medical Information Services at 1-866-399-9091.
- 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.
JAMP Lamivudine HBV should not be taken with emtricitabine.
Some medicines may affect how JAMP 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 JAMP 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 JAMP 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. Lamivudine is available as an oral solution so that your doctor can prescribe a lower dose for you if required.
The active substance in JAMP Lamivudine HBV is lamivudine. If you are already taking this medicine for HIV infection (lamivudine tablets 150 mg and 300 mg), 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 JAMP Lamivudine HBV for adults and adolescents 16 years and older is one tablet once a day. The tablet should be swallowed whole with water. JAMP 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 JAMP Lamivudine HBV if you have kidney problems. Lamivudine oral solution is available so that the dose of your medicine can be accurately reduced.
Overdose:
If you think you have taken too much JAMP Lamivudine HBV, contact your doctor, nurse, pharmacist, 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 JAMP Lamivudine HBV without instruction from your doctor, as there is a small risk of your hepatitis getting worse. When you stop taking JAMP 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 lamivudine tablets 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, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Frequency | Side Effect/ Symptom | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | |||
| 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. | √ | |||
| Rare | 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 JAMP Lamivudine HBV, contact your doctor or pharmacist.
HOW TO STORE IT
Store JAMP Lamivudine HBV tablets between 15 and 30°C.
As with all medicines, keep JAMP Lamivudine HBV out of the reach and sight of children.
Do not take your medicine after the expiry date shown on the bottle.
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/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
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.
If you want more information about JAMP Lamivudine HBV:
- 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); or by contacting the sponsor, JAMP Pharma Corporation, at: 1-866-399-9091.
1310 rue Nobel, Boucherville,
Québec, Canada, J4B 5H3
Date of preparation: February 11, 2021