Introduction About LAMIVIR HBV TABLET

LAMIVIR HBV TABLET contains Lamivudine which belongs to a group of medicines called Anti-viral drugs. It is used to manage chronic (long-term) hepatitis B infection in adults. Hepatitis B is a virus that infects the liver, causes long-term infection and can result in liver damage.

LAMIVIR HBV TABLET should be used with caution if you have any liver disease including hepatitis C, or kidney problems. Consult your doctor before taking it.

LAMIVIR HBV TABLET should be used during pregnancy only if clearly necessary. It is also not recommended for use in breastfeeding women unless it is considered clearly necessary. Consult your doctor before taking it.

The safety and efficacy of LAMIVIR HBV TABLET in infants, children and adolescents aged below 18 years have not been established. LAMIVIR HBV TABLET should be used with caution in elderly patients. Consult your doctor before taking it.

The most common side effects of taking LAMIVIR HBV TABLET are muscle cramps, skin rash or hives, tiredness, respiratory tract infections, throat discomfort, headache, nausea, vomiting, diarrhoea, stomach pain. Contact your doctor if any of the symptoms worsen.

Uses Of LAMIVIR HBV TABLET

• To manage chronic Hepatitis B infection

How LAMIVIR HBV TABLET Works

LAMIVIR HBV TABLET inhibits the activity of enzyme (HBV polymerase) which is responsible for virus replication. Thus, LAMIVIR HBV TABLET helps to reduce the amount of hepatitis B virus in the body and also reduce the liver damage, leading to improvement in your liver function.

How to use LAMIVIR HBV TABLET

Take LAMIVIR HBV TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. It can be taken with or without food.

Your doctor will decide the correct dose and duration for you depending on your age, body weight and disease condition. Do not stop taking LAMIVIR HBV TABLET unless your doctor advises you to stop. Otherwise, your hepatitis will get worse.

Side Effects Of LAMIVIR HBV TABLET

How To Manage Side Effects

Headache:

Rest and relax. Drink plenty of fluids such as water or ORS (Oral Rehydrating Solution) and apply a pain-relieving balm on the head if necessary. Contact your doctor if the headache did not improve.

Skin rash:

Avoid hot baths because hot water can irritate your skin further. Do not scratch the affected area. Use sunscreen and wear protective clothing while going outside. Use unscented moisturizers to soothe and hydrate the affected area. Contact your doctor if your rashes worsen.

Nausea and vomiting:

Take the medicine, with or just after a meal. Stick to simple meals. Avoid eating oily or spicy food. Contact your doctor if your nausea and vomiting did not improve.

Stomach pain:

Try to rest and relax. Eat small meals but take frequently. Keep a heating pad on your stomach. Contact your doctor if the stomach pain worsens.

Diarrhoea:

Drink lots of fluids, such as water or fruit juices to keep yourself hydrated. Do not take any medicine on your own to manage diarrhoea. Contact your doctor if your diarrhoea did not improve.

Warning & Precautions

Pregnancy

LAMIVIR HBV TABLET should be used during pregnancy only if clearly necessary. Consult your doctor before taking it.

Breastfeeding

LAMIVIR HBV TABLET is not recommended for use in breastfeeding women unless it is considered necessary. Consult your doctor before taking it.

Driving and Using Machines

Do not drive or use machines if you feel tired after taking LAMIVIR HBV TABLET. Consult your doctor before taking it.

Kidney

LAMIVIR HBV TABLET should be used with caution in patients with kidney problems and may require dose adjustment. Consult your doctor before taking it.

Liver

LAMIVIR HBV TABLET should be used with caution if you have any liver disease including hepatitis C. Consult your doctor before taking it.

Allergy

Do not take LAMIVIR HBV TABLET if you are allergic to lamivudine or any of the other ingredients of this medicine.

Interactions

A. Drug-Drug interactions:

Before taking LAMIVIR HBV TABLET, inform your doctor if you are taking any of the following medicine:

• medicines (generally liquids) containing sorbitol and other sugar alcohols (Ex. xylitol, mannitol, lactitol or maltitol)
• other medicines containing lamivudine (used to manage HIV infection or hepatitis B infection) Ex. dolutegravir and lamivudine, tenofovir and lamivudine
• emtricitabine (used to manage HIV infection or hepatitis B infection)
• cladribine (used to manage hairy cell leukaemia- a type of bone marrow cancer)

Overdose:

If you or anyone else accidentally take too much of LAMIVIR HBV TABLET, consult your doctor immediately or visit the nearby hospital.

Synopsis

More Information

• Keep LAMIVIR HBV TABLET out of the sight and reach of children
• Store LAMIVIR HBV TABLET below 30°C

FAQs About LAMIVIR HBV TABLET

Is LAMIVIR HBV TABLET safe in pregnancy?

LAMIVIR HBV TABLET should be used during pregnancy only if clearly necessary. If you are pregnant, think you are pregnant or are planning to get pregnant, consult your doctor about the risks and benefits of taking LAMIVIR HBV TABLET during pregnancy. Do not stop taking the medicine unless your doctor asks you to do so.

How effective is LAMIVIR HBV TABLET?

Management with LAMIVIR HBV TABLET can lower the amount of hepatitis B virus in your body. This should reduce liver damage and improve liver function. Everyone doesn’t respond to this medicine in the same way. Your doctor will assess the effectiveness of your management with regular blood tests.

What if I forget to take a dose of LAMIVIR HBV TABLET?

If you forget to take a dose of LAMIVIR HBV TABLET, take it as soon as you remember and then continue your management as usual. Do not take the medicine twice to make up for the forgotten dose.

Can I stop taking LAMIVIR HBV TABLET?

Do not stop taking LAMIVIR HBV TABLET without consulting your doctor, as it may worsen your hepatitis. When you stop taking LAMIVIR HBV TABLET, your doctor will monitor you for at least four months, by taking blood samples to check for any increased liver enzyme levels, which may indicate liver damage.

What precautions have to be taken while taking LAMIVIR HBV TABLET?

Hepatitis B infection is spread by sexual contact with someone who has the infection or by transfer of infected blood (Ex. by sharing injection needles). LAMIVIR HBV TABLET will not stop you from passing hepatitis B infection on to other people. To protect other people from becoming infected with hepatitis B: use a condom when you have oral or penetrative sex and avoid sharing needles.

References

1. Barbara G. Wells, Joseph T. Dipiro, Terry L. Shwinghammer, Cecily V. DiPiro. Human Immunodeficiency Virus Infection. Pharmacotherapy Handbook. Ninth edition. 2015. Page- 371.

2. KD. Tripathi. Antiviral Drugs. Essentials of Medical Pharmacology. Seventh edition. 2013. Page – 807, 808.

3. Taylor K, Fritz K, Parmar M. Lamivudine. NIH National Library of Medicine, National Center for Biotechnology Information. StatPearls. January 2022. [Accessed on 29th April 2022] https://www.ncbi.nlm.nih.gov/books/NBK559252/

4. Wani HU, Al Kaabi S, Sharma M, Singh R, John A, Derbala M, Al-Mohannadi MJ. High dose of Lamivudine and resistance in patients with chronic hepatitis B. NIH National Library of Medicine, National Center for Biotechnology Information. PubMed Central. September 2014. [Accessed on 29th April 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4199074/

5. Pharmadox Healthcare Ltd. Electronic Medicines Compendium (EMC). [Revised in September 2021] [Accessed on 29th April 2022] https://www.medicines.org.uk/emc/files/pil.2262.pdf

6. Teva Pharmaceutical Works Private Limited Company. European Medeical Agency (EMA). [Accessed on 29th April 2022] https://www.ema.europa.eu/en/documents/product-information/lamivudine-teva-epar-product-information_en.pdf

Useful Diagnostic Tests

• “Hepatitis B Panel” of Blood Tests
• Liver Function Test
• Complete Blood Count (CBC)