Patient leaflet - Lamivudine 100 mg film-coated tablets

1. What Lamivudine is and what it is used for

The active ingredient in Lamivudine is lamivudine.

Lamivudine is used to treat long term (chronic) hepatitis B infection in adults.

Lamivudine is an antiviral medicine that suppresses the hepatitis B virus and belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Hepatitis B is a virus which infects the liver, causes long term (chronic) infection, and can lead to liver damage. Lamivudine can be used in people whose liver is damaged, but still functions normally (compensated liver disease) and in combination with other medicines in people whose liver is damaged and does not function normally (decompensated liver disease).

Treatment with Lamivudine can reduce the amount of hepatitis B virus in your body. This should lead to a reduction in liver damage and an improvement in your liver function. Not everyone responds to treatment with Lamivudine in the same way. Your doctor will monitor the eﬀectiveness of your treatment with regular blood tests.

2. What you need to know before you take Lamivudine

Your healthcare provider should oﬀer you counselling and testing for HIV infection before you start treatment with lamivudine for hepatitis B infection and during treatment. If you have or get HIV infection, see section 3.

Do not take Lamivudine:

if you are allergic to lamivudine or to any of the other
ingredients of this medicine (listed in section 6). è Check with your doctor if you think this applies to you.

Warnings and precautions

Some people taking Lamivudine or other similar medicines are more at risk of serious side eﬀects. You need to be aware of the extra risks:

if you have ever had other types of liver disease, such as
hepatitis C
if you're seriously overweight (especially if you're a
woman).

è Talk to your doctor if any of these apply to you. You may

need extra check-ups, including blood tests, while you're taking your medication. See section 4 for more information about the risks.

Don't stop taking Lamivudine without your doctor's advice, as there is a risk of your hepatitis getting worse. When you stop taking Lamivudine your doctor will monitor you for at least four months to check for any problems. This will mean taking blood samples to check for any raised liver enzyme levels, which may, indicate liver damage. See section 3 for more information about how to take Lamivudine.

Protect other people

Hepatitis B infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). Lamivudine will not stop you 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. · Don't risk blood transfer – for example, don't share needles.

Other medicines and Lamivudine

Tell your doctor or pharmacist if you're taking, have recently taken or might take any other medicines, including herbal medicines or other medicines you bought without a prescription.

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you're taking Lamivudine.

These medicines should not be used with Lamivudine:

medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly
other medicines containing lamivudine, used to treat HIV infection (sometimes called the AIDS virus) · emtricitabine used to treat HIV or hepatitis B infection · cladribine, used to treat hairy cell leukaemia è Tell your doctor if you're being treated with any of these.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby:

è Talk to your doctor about the risks and beneﬁts of taking

Lamivudine during your pregnancy.

Do not stop treatment with Lamivudine without your doctor's advice.

Breast-feeding

Lamivudine can pass into breast-milk. If you are breast-feeding, or thinking about breast-feeding:

è Talk to your doctor before you take Lamivudine.

Driving and using machines

Lamivudine may make you feel tired which could aﬀect your ability to drive or use machines.

è Don't drive or use machines unless you are sure you're not aﬀected.

Lamivudine tablets contain Isomalt

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Lamivudine

Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.

Stay in regular contact with your doctor

Lamivudine helps to control your hepatitis B infection. You need to keep taking it every day to control your infection and stop your illness getting worse.

è Keep in touch with your doctor, and don't stop taking

Lamivudine without your doctor's advice.

Package leaﬂet: Information for the user Lamivudine 100 mg ﬁlm-coated tablets

lamivudine

Leaﬂet size: 180 x 340 mm

Font Name: TIMES NEW ROMAN

UK (Unit-V) Lamivudine 100 mg Leaﬂet

1st Page: XXXX

2nd Page: XXXX

Printing Colour: Black

The usual dose of Lamivudine is one tablet (100 mg lamivudine) once a day.

Your doctor may prescribe a lower dose if you have problems with your kidneys. An oral solution of lamivudine is available for people who need a lower than usual dose, or who can't take tablets.

è Talk to your doctor if this applies to you.

Patients who also have or may get HIV infection

If you have or get HIV that is not being treated with medicines while taking lamivudine for the treatment of hepatitis B infection, the HIV virus may develop resistance to certain HIV medicines and become harder to treat. Lamivudine can also be used to treat HIV infection. Talk to your doctor if you have HIV infection. Your doctor may treat you with another medicine that contains a higher dose of lamivudine, usually 150 mg twice a day, as the lower dose of 100 mg lamivudine is not enough to treat HIV infection. If you are planning to change your HIV treatment, discuss this change with your doctor ﬁrst. è Talk to your doctor if this applies to you.

Swallow the tablet whole, with some water. Lamivudine can be taken with or without food.

If you take more Lamivudine than you should

If you accidentally take too much Lamivudine, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice. If possible, show them the Lamivudine pack.

If you forget to take Lamivudine

If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. Don't take a double dose to make up for a missed dose.

Don´t stop taking Lamivudine

You must not stop taking Lamivudine without consulting your doctor. There is a risk of your hepatitis getting worse (see section 2). When you stop taking Lamivudine your doctor will monitor you for at least four months to check for any problems. This will mean taking blood samples to check for any raised liver enzyme levels, which may indicate liver damage.

4. Possible side eﬀects

Like all medicines, this medicine can cause side eﬀects, although not everybody gets them.

Side eﬀects that were commonly reported in Lamivudine clinical trials were tiredness, respiratory tract infections, throat discomfort, headache, stomach discomfort and pain, nausea, vomiting and diarrhoea, increases in liver enzymes and enzymes produced in the muscles (see below).

Allergic reaction

These are rare (may aﬀect up to 1 in 1,000 people). Signs include:

swelling of eyelids, face or lips
diﬃculty swallowing or breathing

Contact a doctor immediately if you get these symptoms. Stop taking Lamivudine.

Side eﬀects thought to be caused by Lamivudine

A very common side eﬀect (these may aﬀect more than 1 in 10 people) which may show up in blood tests is:

an increase in the level of some liver enzymes (transaminases), which may be a sign of inﬂammation or damage in the liver.

A common side eﬀect (these may aﬀect up to 1 in 10 people) is:

cramps and muscle pains
skin rash or “hives” anywhere on the body

A common side eﬀect which may show up in blood tests is: · an increase in the level of an enzyme produced in the

muscles (creatine phosphokinase) which may be a sign that body tissue is damaged

A very rare side eﬀect (these may aﬀect up to 1 in 10,000 people) is:

lactic acidosis (excess lactic acid in the blood)
Other side eﬀects
Other side eﬀects have occurred in a very small number of people but their exact frequency is unknown
- breakdown of muscle tissue
- a worsening of liver disease after Lamivudine is stopped or during treatment if the hepatitis B virus becomes resistant to Lamivudine. This can be fatal in some people.

A side eﬀect which may show up in blood tests is: · a decrease in the number of cells involved in blood clotting (thrombocytopenia).

If you get any side eﬀects

è Talk to your doctor or pharmacist. This includes any possible side eﬀects not listed in this leaﬂet.

Reporting of side eﬀects

If you get any side eﬀects, talk to your doctor or pharmacist. This includes any possible side eﬀects not listed in this leaﬂet. You can also report side eﬀects directly via the Yellow Card Scheme website www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side eﬀects you can help provide more information on the safety of this medicine.

5. How to store Lamivudine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister pack.

This medicinal product does not require any special storage conditions

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Lamivudine contains

The active substance is lamivudine. Each ﬁlm-coated tablet contains 100 mg of lamivudine.

The other ingredients are: isomalt (E953), crospovidone A, magnesium stearate (E572), hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80 (E433), red and yellow iron oxides (E172).

What Lamivudine looks like and contents of the pack

Lamivudine 100 mg ﬁlm-coated tablets are supplied in Alu/PVC-Alu-OPA blister pack containing 28 and 84 tablets.

The tablets are pink capsule shaped, biconvex, ﬁlm coated tablets with a dimension of 12.00 x 6.00 mm, debossed with '37' on one side and 'I' on the other side.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Amarox Limited

Congress House, 14 Lyon Road

Harrow, Middlesex HA1 2EN

United Kingdom

Manufacturer

Pharmadox Healthcare Ltd.

KW 20A - Kordin Industrial Park

PLA 3000 Paola

Malta