Lamivudine Mylan

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Lamivudine Mylan 150 mg film-coated tablets, 300 mg film-coated tablets

Generic medicine
Read this entire leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Lamivudine Mylan is and what it is used for
2. What you need to know before taking Lamivudine Mylan
3. How to take Lamivudine Mylan
4. Possible side effects
5. How to store Lamivudine Mylan
6. Contents of the pack and other information

1. What Lamivudine Mylan is and what it is used for

Lamivudine Mylan is used to treat HIV (Human Immunodeficiency Virus) infection in adults and children.
Lamivudine Mylan belongs to a group of antiviral medicines known as antiretrovirals, called nucleoside reverse transcriptase inhibitors (NRTIs).
Lamivudine Mylan does not completely cure HIV infection; it reduces the amount of virus in the body and keeps it at low levels. In addition, it increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cells that are important in maintaining a healthy immune system to help the body fight infection.
Not all people respond to lamivudine treatment in the same way. Your doctor will monitor how well the treatment is working.

2. Before taking Lamivudine Mylan

Do not take Lamivudine Mylan:

• if you are allergic to lamivudine or to any of the excipients of this medicine (listed in section 6). Consult your doctor if you think this applies to you.

Warnings and precautions
Talk to your doctor or pharmacist before taking Lamivudine Mylan:

• if you are currently being treated for HIV with tenofovir and abacavir or tenofovir and didanosine (other NRTIs)
• if you have had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop taking Lamivudine Mylan without consulting your doctor, as hepatitis may worsen again)
• if you are severely overweight (especially if you are a woman)
• if you or your child have kidney problems, the dose may need to be adjusted.

Inform your doctor if any of these situations apply to you. You may need additional monitoring, including blood tests, while taking this medicine. See section 4 for further information.
Be aware of important symptoms
Some people taking medicines for HIV infection develop other conditions that can be serious. You should be aware of the key signs and symptoms so that you can remain vigilant while taking Lamivudine Mylan.
Read the information under “Other possible side effects of combination therapy for HIV”
in section 4 of this leaflet.
Protecting other people
HIV infection spreads through sexual contact with infected individuals or through transfer of infected blood (for example, by sharing injecting needles). You may still transmit HIV while taking this medicine, although antiretroviral therapy reduces the risk.
Talk to your doctor about the precautions needed to avoid infecting others.
Other medicines and Lamivudine Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines or other medicines obtained without prescription.
Remember to inform your doctor or pharmacist if you start taking a new medicine while being treated with Lamivudine Mylan.
These medicines must not be used with Lamivudine Mylan
medicines (usually liquids) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol or maltitol), if taken regularly

• other medicines containing lamivudine (used to treat HIV infection or hepatitis B virus infection)
• a group of medicines called cytidine analogues used to treat HIV, such as emtricitabine
• cotrimoxazole (an antibiotic used to treat infections)
• cladribine (used to treat blood cancer (leukemia)).

Inform your doctor if you are taking any of these medicines.
Pregnancy and breastfeeding
Pregnancy
If you are pregnant, think you might be pregnant, or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Lamivudine Mylan and similar medicines may cause side effects in unborn children.
If you have taken Lamivudine Mylan during pregnancy, your doctor may recommend regular blood tests or other diagnostic tests to monitor your baby's development.
In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV outweighs the risk of side effects.
Breastfeeding
HIV-positive women must not breastfeed, because HIV infection can be passed to the child through breast milk.
A small amount of the components of this medicine may also pass into breast milk.
If you are breastfeeding or considering doing so, talk to your doctor immediately.
Driving and using machines
It is unlikely that Lamivudine Mylan will affect your ability to drive or operate machinery.
Lamivudine Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially “sodium-free”.

3. How to take Lamivudine Mylan

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Swallow the tablets with water. Lamivudine Mylan may be taken with or without food.
If you are unable to swallow the tablets whole, you may break them and mix them with a small amount of food or liquid, and take the entire dose immediately. Alternatively, other formulations of this medicine may be available; please ask your doctor or pharmacist.
The 150 mg tablet may be divided into two equal doses.

Stay in regular contact with your doctor
Lamivudine Mylan helps control your condition. It is important to take it every day to prevent your illness from worsening. You may still develop other infections and diseases related to HIV infection.
Stay in contact with your doctor and do not stop taking Lamivudine Mylan without consulting your doctor.

Dosage
For 150 mg tablets only:

Use in adults, adolescents and children weighing at least 25 kg:
The recommended dose of Lamivudine Mylan is 300 mg daily, taken as:

• one 150 mg tablet twice daily, with approximately 12 hours between doses, or
• two 150 mg tablets once daily, as prescribed by your doctor.

Use in children weighing at least 20 kg and less than 25 kg:
The recommended dose is 225 mg daily. This may be taken as:

• 75 mg (half a 150 mg Lamivudine Mylan tablet) in the morning and
• one full Lamivudine Mylan tablet (150 mg) in the evening, or
• 225 mg (one and a half 150 mg tablets) once daily, as prescribed by your doctor.

Use in children weighing at least 14 kg and less than 20 kg:
The recommended dose is 150 mg daily. This may be taken as:

• 75 mg (half a 150 mg Lamivudine Mylan tablet) twice daily, with approximately 12 hours between doses, or
• 150 mg (one 150 mg tablet) once daily, as prescribed by your doctor.

For 300 mg tablets only:
The usual dose of Lamivudine Mylan for adults, adolescents and children weighing at least 25 kg is:

• one 300 mg tablet once daily.

Other pharmaceutical forms of this medicine may be more suitable for children, for people who require a lower than usual dose, or for those unable to swallow tablets; please ask your doctor or pharmacist.
If you or your child have kidney problems, the dose may need to be adjusted. Speak with your doctor if this applies to you or your child.

If you take more Lamivudine Mylan than you should
Accidentally taking too much Lamivudine Mylan is unlikely to cause serious problems. However, you should inform your doctor or pharmacist, or contact the nearest hospital emergency department for further advice.

If you forget to take Lamivudine Mylan
If you forget to take a dose, take it as soon as you remember, then continue your treatment as before. Do not take a double dose to make up for the missed dose.

If you have any questions about how to use this medicine, ask your doctor or pharmacist.

4. Possible side effects

During HIV therapy, an increase in weight as well as in blood lipid and glucose levels may occur.
This is particularly associated with improved health and lifestyle, and in the case of lipids, sometimes linked to the HIV medications themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During treatment for HIV, it may be difficult to determine whether a symptom is a side effect of lamivudine or of other medicines you are taking, or an effect of the HIV disease itself. For this reason, it is very important to inform your doctor about any changes in your health status.
During combination therapy for HIV, both the side effects listed below for Lamivudina Mylan and other conditions may occur.
It is important to read the information in another section of this leaflet, under "Other possible side effects of combination therapy for HIV".

If you notice any of the following side effects, contact your doctor immediately:
Uncommon (may affect up to 1 in 100 people):

• an increase in the number of infections occurring, causing fever, severe chills, sore throat or mouth ulcers. This may be a sign that you have a low number of white blood cells in the blood (neutropenia)
• unexplained bruising or bleeding lasting longer than usual. These may be signs of a reduced number of cells involved in blood clotting (thrombocytopenia)

Rare (may affect up to 1 in 1,000 people):

• swelling of the face, mouth, lips, tongue or throat causing difficulty in breathing or swallowing (angioedema)
• severe stomach pain that may spread to the back. This may be a sign of problems with the pancreas (pancreatitis)
• yellowing of the skin or whites of the eyes, dark urine, pale stools, tiredness, fever, feeling unwell (nausea), weakness, drowsiness and abdominal pain. These may be signs of serious liver problems (hepatitis)
• dark-coloured urine with muscle weakness or tiredness. These may be signs of muscle breakdown (rhabdomyolysis)

Very rare (may affect up to 1 in 10,000 people):

• tiredness, weakness, pale skin colour, shortness of breath. These may be signs of a disorder in which red blood cells are not produced (pure red cell aplasia)
• numbness and tingling, burning, severe or shooting pain in the feet or hands leading to loss of balance and coordination. These may be signs of nerve damage (peripheral neuropathy)
• difficulty breathing, deep, rapid breathing, drowsiness, numbness or weakness in limbs, feeling unwell (nausea), discomfort (vomiting) and stomach ache. These may be signs of excess lactic acid in the blood (lactic acidosis)

Other possible side effects include:
Common (may affect up to 1 in 10 people):

• feeling unwell (nausea)
• discomfort (vomiting)
• stomach pain
• diarrhoea
• headache
• joint pain
• muscle disorders and pain
• cough
• nasal irritation or runny nose
• fever (high temperature)
• tiredness, lack of energy
• general feeling of being unwell
• skin rash
• hair loss (alopecia)
• sleep disorders (insomnia)

Uncommon (may affect up to 1 in 100 people):

• low number of red blood cells (anaemia)
• increased levels of liver enzymes

Rare (may affect up to 1 in 1,000 people):

• an increase in an enzyme called amylase, which may be detected in blood tests

Other possible side effects of combination therapy for HIV
Combination therapy including Lamivudina Mylan may lead to the development of other conditions during HIV treatment.

Old infections may flare up again
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious (opportunistic) infections. When these people start treatment, previously hidden infections may flare up again, causing signs and symptoms of inflammation. These symptoms are likely due to immune reconstitution, whereby the body starts fighting these infections.
In addition to opportunistic infections, autoimmune diseases (a condition in which the immune system attacks healthy body tissues) may also occur after starting medications for HIV infection. Autoimmune disorders may occur several months after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting in the hands and feet and spreading towards the trunk, palpitations, tremors or hyperactivity, inform your doctor immediately to receive appropriate treatment.

If you experience any symptoms of infection while taking Lamivudina Mylan:
contact your doctor immediately. Do not take any other medicines for the infection without medical advice.

You may have bone problems
Some people receiving combination therapy for HIV infection develop a condition called osteonecrosis. As a result of this condition, part of the bone tissue dies due to reduced blood supply to the bone. People may be more likely to develop this condition if they:

• have been on combination therapy for a long time
• are also taking anti-inflammatory medicines called corticosteroids
• consume alcoholic beverages
• have a very weak immune system
• are overweight

Signs of osteonecrosis include:

• stiffness of the joints
• pain (especially in the hip, knee or shoulder)
• difficulty in movement
  If you notice any of these symptoms: contact your doctor.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lamivudine Mylan

Keep out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle, blister pack, or outer packaging,
following the word "Exp.". The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lamivudina Mylan contains
The active substance is lamivudine.
Each 150 mg film-coated tablet contains 150 mg of lamivudine. Each 300 mg film-coated tablet contains 300 mg of lamivudine.
The excipients are:
Tablet core: microcrystalline cellulose, sodium starch glycolate, magnesium stearate.
Tablet coating: hypromellose, titanium dioxide, propylene glycol.

Description of the appearance of Lamivudina Mylan and contents of the pack
Lamivudina Mylan 150 mg: white to off-white, capsule-shaped, film-coated tablets, with bevelled edges, marked “M105” on one side and a score line on the other.
Lamivudina Mylan 300 mg: white to off-white, oval-shaped, film-coated tablets, with bevelled edges, marked “M300” on one side and smooth on the other.
Lamivudina Mylan is available in blisters containing 30, 60, 90, or 120 tablets, and in bottles containing 60 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Mylan S.p.A., Via Vittor Pisani, 20, 20124 Milano, Italy

Manufacturer:
McDermott Laboratories Limited trading as Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland
Generics [UK] Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

This medicinal product is authorized in the European Economic Area countries under the following names:
France: Lamivudine Mylan 150 mg and 300 mg, comprimé pelliculé sècable
Germany: Lamivudin Mylan 150 mg and 300 mg Filmtabletten
Malta: Lamivudine Mylan 150 mg and 300 mg Film-coated tablets
Italy: Lamivudina Mylan
Poland: Lamivudine Mylan
Portugal: Lamivudina Mylan
Romania: Lamivudină Mylan 150 mg and 300 mg comprimate filmate
United Kingdom: Lamivudine Mylan 150 mg and 300 mg Film-coated tablets