Lamivudine Hetero 100 Mg Film-Coated Tablets
PACKAGE LEAFLET
Package leaflet: Information for the user
Lamivudine 100 mg Film-coated tablets
lamivudine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Lamivudine 100 mg is and what it is used for
2. What you need to know before you take Lamivudine 100 mg
3. How to take Lamivudine 100 mg
4. Possible side effects
5. How to store Lamivudine 100 mg
6. Contents of the pack and other information
1. What Lamivudine 100 mg is and what it is used for
Lamivudine 100 mg is used to treat long term (chronic) hepatitis B infection in adults.
The active ingredient in Lamivudine 100 mg is lamivudine. Lamivudine 100 mg is an antiviral drug that suppresses the hepatitis B virus infection and belongs to a group 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 100 mg can be used in people whose liver is damaged, but still functions normally (compensated liver disease) and in people whose liver is damaged and does not function normally (decompensated liver disease).
Treatment with Lamivudine 100 mg 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 100 mg in the same way. Your doctor will monitor the effectiveness of your treatment.
2. What you need to know before you take Lamivudine 100 mg Do not take Lamivudine 100 mg:
• if you are allergic (hypersensitive) to lamivudine or to any of the other ingredients of this medicine (listed in section 6).
Check with your doctor if you think this applies to you.
Warnings and precautions
Talk to your doctor or pharmacist before taking Lamivudine 100 mg.
Some people taking Lamivudine 100 mg 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).
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.
Don’t stop taking Lamivudine 100 mg without your doctor’s advice, as there is a risk of your hepatitis getting worse. When you stop taking Lamivudine 100 mg your doctor will monitor you for at least the following four months to check for any problems. This will mean taking blood samples to check for any abnormal liver enzymes, indicating liver damage.
Look out for important symptoms
Some people taking medicines for hepatitis B infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you’re taking Lamivudine 100 mg.
Read the information “Other possible side effects of therapy for Hepatitis B” in section 4 of this leaflet.
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 100 mg 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.
There is an effective vaccine available to protect those at risk from becoming infected with hepatitis B virus.
Other medicines and Lamivudine 100 mg
Tell your doctor or pharmacist if you’re taking any other medicines, or if you’ve taken any recently, 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 100 mg.
These medicines should not be used with Lamivudine 100 mg:
• zalcitabine or 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
Tell your doctor if you’re being treated with any of these.
Pregnancy and breast-feeding
Pregnancy
If you are pregnant, if you become pregnant, or if you’re planning to become pregnant:
* Talk to your doctor immediately about the risks and benefits of taking Lamivudine 100 mg during your pregnancy.
Do not stop treatment with Lamivudine 100 mg without your doctor’s advice.
Breast-feeding
The ingredients in Lamivudine 100 mg can pass into breast-milk. If you are breast-feeding, or thinking about breast-feeding:
* Talk to your doctor before you take Lamivudine 100 mg.
Driving and using machines
Lamivudine 100 mg is unlikely to affect your ability to drive or use machines.
3. How to take Lamivudine 100 mg
Always take this medicine exactly as your doctor has told you to. Check with your doctor or pharmacist if you are not sure.
Swallow the tablet whole, with some water. Lamivudine 100 mg can be taken with or without food.
Stay in regular contact with your doctor
Lamivudine 100 mg 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.
* Keep in touch with your doctor, and don’t stop taking Lamivudine 100 mg without your doctor’s advice.
How much to take
The usual dose of Lamivudine 100 mg 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 dose, or who can’t take tablets.
* Talk to your doctor if this applies to you.
If you are already taking another medicine that contains lamivudine for HIV infection, your doctor will continue to treat you with the higher dose, (usually 150 mg twice a day), because the dose of lamivudine in Lamivudine 100 mg (100 mg) is not enough to treat HIV infection. If you are planning to change your HIV treatment, discuss this change with your doctor first.
If you take more Lamivudine 100 mg than you should
Accidentally taking too much Lamivudine 100 mg is unlikely to cause any serious problems. If you accidentally take too much, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
If you forget to take Lamivudine 100 mg
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 forgotten dose.
If you stop taking Lamivudine 100 mg
You must not stop taking Lamivudine 100 mg without consulting your doctor. There is a risk of your hepatitis getting worse (see “Warnings and precautions” in section 2).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
As well as the side effects listed below for Lamivudine 100 mg, other conditions can develop during therapy for hepatitis B.
Side effects that were commonly reported in Lamivudine 100 mg 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 very rare in people taking Lamivudine 100 mg. Signs include:
• sudden wheeziness and chest pain or tightening.
• swelling of eyelids, face or lips.
• Skin rash or ‘hives’ anywhere on the body.
Contact a doctor immediately if you get these symptoms. Stop taking Lamivudine 100 mg.
Side effects thought to be caused by Lamivudine 100 mg
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
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.
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 100 mg is stopped or during treatment if the hepatitis B virus becomes resistant to Lamivudine 100 mg. This can be fatal in some people.
• lactic acidosis (see the next section, “Other possible side effects of therapy for Hepatitis B”)
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, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme
(www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
If you get any side effects
Talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Other possible side effects of therapy for Hepatitis B
Lamivudine 100 mg and related medicines (NRTIs) may cause other conditions to develop during hepatitis B treatment.
Lactic acidosis is a rare but serious side effect
Some people taking Lamivudine 100 mg, or other medicines like it (NRTIs), develop a condition called lactic acidosis, together with an enlarged liver.
Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if it happens, it usually develops after a few months of treatment. It can be life-threatening, causing failure of internal organs.
Lactic acidosis is more likely to develop in people who have liver disease, or in obese (very overweigth) people, especially women.
Signs of lactic acidosis include:
• deep, rapid, difficult breathing
• drowsiness
• numbness or weakness in the limbs
• feeling sick (nausea), being sick (vomiting)
• stomach pain
During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed above, or any other symptoms that worry you:
See your doctor as soon as possible.
5. How to store Lamivudine 100 mg
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 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 100 mg 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 100 mg 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 Hetero Europe S.L.
Viladecans Business Park - Edificio Brasil
Catalunya 83-85
08840 Viladecans (Barcelona)
Spain
Manufacturer
Pharmadox Healthcare Ltd.
KW 20A - Kordin Industrial Park
PLA 3000 Paola
Malta
Este medicamento esta autorizado en los estados miembros del Espacio Economico Europeo con los siguientes nombres:
Germany:
Italy:
Netherland:
Spain:
Great Britain:
Lamivudin Hetero 100 mg Filmtabletten Lamivudina Hetero
Lamivudine Hetero 100 mg, filmomhulde tabletten
Lamivudina Hetero 100 mg, comprimidos recubiertos con pelicula EFG
Lamivudine 100 mg Film-coated tablets
This leaflet was last revised in 05/2013.
Detailed information on this medicine is available on the web site of Medicines and Healthcare Products Regulatory Agency (www.mhra.gov.uk).