Lamivudine Milan

Package Leaflet: Information for the Patient

Lamivudine Mylan, 100 mg, Film-Coated Tablets

Lamivudine

Read the package leaflet carefully before taking the medicine, as it contains important information for you.

• You should 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Lamivudine Mylan and what is it used for
• 2. Important information 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 is Lamivudine Mylan and what is it used for

Lamivudine Mylan is used to treat long-term (chronic) hepatitis B virus infection in adults.
The active substance of Lamivudine Mylan is lamivudine. Lamivudine Mylan is an antiviral medicine that inhibits the replication of the hepatitis B virus and belongs to a group of medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Hepatitis B virus is a virus that causes long-term (chronic) infection and can lead to liver damage. Lamivudine Mylan can be used in patients with liver damage with preserved liver function (compensated liver disease) and in combination with other medicines in patients with liver damage that does not function properly (decompensated liver disease).
Treatment with Lamivudine Mylan may reduce the amount of hepatitis B virus in the body. This can lead to a reduction in liver damage and improvement in liver function. Not everyone responds to treatment with Lamivudine Mylan in the same way. Your doctor will monitor the effectiveness of treatment and regularly order blood tests.

2. Important information before taking Lamivudine Mylan

When not to take Lamivudine Mylan:

• if you are allergic to lamivudine or any of the other ingredients of this medicine (listed in section 6).

You should consult your doctorif you think any of the above applies to you.

Warnings and precautions

Before taking Lamivudine Mylan, you should discuss it with your doctor or pharmacist.
Some patients taking Lamivudine Mylan or similar medicines are more likely to experience severe side effects.
You should be aware of this additional risk:

• if you have ever had other liver diseases, such as hepatitis C
• if you are overweight (especially in women) You should inform your doctor if any of the above applies to you. Your doctor may order additional monitoring tests, including blood tests, during treatment. More informationabout this risk, see section 4.

Do not stoptaking Lamivudine Mylan without your doctor's advice, as there is a risk of worsening hepatitis. After stopping Lamivudine Mylan, your doctor will monitor you for at least 4 months to detect any complications. This means that blood samples will be taken to detect increased liver enzyme activity, which may indicate liver damage. More information about taking Lamivudine Mylan, see section 3.

Protecting others

Hepatitis B virus infection can be transmitted through sexual contact with infected people or through infected blood (e.g., by sharing needles for injections). Taking Lamivudine Mylan does not prevent the transmission of hepatitis B virus to others.
To protect others from hepatitis B virus infection:

• use a condomduring oral sex and penetration;
• do not risk transmitting the infection through blood- e.g., do not share needles.

Lamivudine Mylan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including herbal products and medicines bought without a prescription.
If you start taking a new medicine while taking Lamivudine Mylan, remember to inform your doctor or pharmacist.

The following medicines must not be taken with Lamivudine Mylan:

• medicines (usually in liquid form) containing sorbitol or other sugar alcohols (such as xylitol, mannitol, lactitol, or maltitol) if taken for a long time
• other medicines containing lamivudine used to treat HIV infection (sometimes called AIDS)
• emtricitabine used to treat HIV infection or hepatitis B virus infection
• cladribine used to treat hairy cell leukemia Tell your doctorif you are being treated with any of these medicines.

Pregnancy and breastfeeding

Pregnancy

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctorto discuss the benefits and risks of taking Lamivudine Mylan during pregnancy.
Do not stop treatment with Lamivudine Mylan without consulting your doctor.

Breastfeeding

Lamivudine Mylan may pass into breast milk. If you are breastfeeding or planning to breastfeed:
consult your doctorbefore taking Lamivudine Mylan.

Driving and using machines

Lamivudine Mylan may cause fatigue, which can affect your ability to drive and use machines.
Do notdrive or operate machinery unless you are sure that the medicine does not affect you in this way.

Lamivudine Mylan contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially sodium-free.

3. How to take Lamivudine Mylan

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Stay in regular contact with your doctor

Lamivudine Mylan helps control hepatitis B virus infection. You should take it every day to control the infection and prevent the disease from getting worse.
Stay in regular contact with your doctor and do not stop takingLamivudine Mylan without your doctor's advice.

What dose to take

The recommended dose ofLamivudine Mylan is one tablet(100 mg lamivudine) once a day.
Your doctor may prescribe a lower dose of Lamivudine Mylan if you have kidney problems. Lamivudine is available as an oral solution for patients who require a dose lower than the usual dose or who cannot take tablets.
Tell your doctorif any of the above applies to you.
If you are already taking another medicine containing lamivudine to treat HIV infection, your doctor will advise you to continue treatment with a higher dose (usually 150 mg twice a day), as the dose of lamivudine in Lamivudine Mylan (100 mg) is not sufficient to treat HIV infection. If you plan to change your HIV treatment, you should discuss this change with your doctor first.
Swallow the tablet whole with water. Lamivudine Mylan can be taken with or without food.

Taking a higher dose of Lamivudine Mylan than recommended

It is unlikely that accidentally taking too much Lamivudine Mylan will cause serious problems. If you accidentally take too much, tell your doctor or pharmacist or contact the nearest hospital emergency department for further advice.

Missing a dose of Lamivudine Mylan

If you miss a dose, take it as soon as possible, and then continue treatment as recommended. Do not take a double dose to make up for the missed dose.

Stopping treatment with Lamivudine Mylan

Do not stop takingLamivudine Mylan without consulting your doctor. There is a risk of worsening hepatitis (see section 2 "Warnings and precautions").
If you stop taking this medicine, your doctor will monitor you for at least 4 months to detect any complications. This includes taking blood samples to detect increased liver enzyme activity, which may indicate liver damage.
If you have any further questions about taking 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.
Side effects that were commonly reported in clinical trials of lamivudine were: fatigue, respiratory tract infections, throat discomfort, headaches, discomfort, and abdominal pain, nausea, vomiting, and diarrhea, increased liver enzyme activity and muscle enzyme activity (see below).

If you experience any of the following side effects, stop taking lamivudine and contact your doctor immediately:

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

• swelling of the eyelids, face, lips, tongue, or throat, which may cause difficulty breathing or swallowing (angioedema) and possible sudden wheezing with chest pain or tightness (allergic reaction)

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

• deep, rapid, difficult breathing, sleepiness, numbness, or weakness of the limbs, nausea (vomiting), vomiting, and abdominal pain. These may be symptoms of excessive lactic acid in the blood (lactic acidosis)

Frequency not known (cannot be estimated from the available data):

• muscle tissue breakdown with symptoms that may include muscle pain, vomiting, and confusion (rhabdomyolysis)
• worsening of liver disease after stopping lamivudine or during treatment if the hepatitis B virus becomes resistant to lamivudine. In some patients, this can be fatal;
• reduced platelet count, which can lead to bleeding or bruising, which may be visible in blood test results.

Other side effects

Very common side effects (may affect more than 1 in 10 people):

• increased activity of liver enzymes called aminotransferases, which may be visible in blood test results and may indicate liver inflammation or damage.

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

• muscle cramps and muscle pain
• skin rash or hives anywhere on the body
• increased activity of the enzyme produced in the muscles (creatine kinase), which may be visible in blood test results and may indicate muscle tissue damage.

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49 21 301, fax: 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lamivudine Mylan

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/bottle after: EXP.
The expiry date refers to the last day of that month.
There are no special storage instructions for this medicine.
Bottles: Use within 100 days after first opening.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Lamivudine Mylan contains

The active substance is lamivudine. Each film-coated tablet contains 100 mg of lamivudine.
The other ingredients are: microcrystalline cellulose (PH 102), sodium carboxymethylcellulose (type A), magnesium stearate, hypromellose 6mPas, titanium dioxide (E 171), propylene glycol, yellow iron oxide (E 172), and red iron oxide (E 172)

What Lamivudine Mylan looks like and contents of the pack

Lamivudine Mylan is a peach-colored, film-coated, biconvex, beveled-edge capsule-shaped tablet with "LN1" engraved on one side and "M" on the other.
Lamivudine Mylan is available in blister packs of 28 or 84 tablets or in bottles containing 84 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
DUBLIN
Ireland

Manufacturer

McDermott Laboratories Limited trading as Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13
Ireland
Mylan Hungary Kft
H-2900 Komárom
Mylan utca 1
Hungary
To obtain more detailed information on this medicine and its authorized names in the European Economic Area countries, please contact the local representative of the marketing authorization holder:

Mylan Healthcare Sp. z o.o.

Tel: +48 22 546 64 00
Date of last revision of the leaflet:September 2022