LAMIVUDINA 150 mg Фильм-Coated Таблетки

Содержание инструкции

1. Lamivudina Mylan 150 mg film-coated tablets, 300 mg film-coated tablets
   1. What is Lamivudina Mylan and what is it used for
   2. Before taking Lamivudina Mylan
   3. How to take Lamivudina Mylan
   4. Possible side effects
   5. How to store Lamivudina Mylan
   6. Contents of the pack and other information

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

Generic medicine
Read this leaflet carefully before taking this medicineas 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 pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

2. Before taking Lamivudina Mylan

Do not take Lamivudina Mylan:

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

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

• if you are currently being treated for HIV with tenofovir and abacavir or tenofovir and didanosine (other NRTIs)
• if you have had a liver disease including hepatitis B or C (if you have hepatitis B infection do not stop taking Lamivudina Mylan without consulting your doctor because the hepatitis may return)
• 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 changed.

Tell your doctor if any of these situations apply to you. You may need
further checks, including blood tests, while you are taking the medicine. See section 4
for more information.

Pay attention to important symptoms
Some people taking medicines for HIV infection develop other conditions that can
be serious. You need to be aware of the important signs and symptoms so that
you can pay attention while taking Lamivudina Mylan.

Read the information in “Possible other side effects of combination therapy for HIV”
in section 4 of this leaflet.
Protecting other people
HIV infection is spread through sexual contact with people who have the infection or through
the transfer of infected blood (for example through sharing needles). You can
still pass on HIV while taking this medicine, although the risk is lower because of
antiretroviral therapy.
Talk to your doctor about the precautions you need to take to avoid infecting others.

Other medicines and Lamivudina Mylan
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including herbal remedies or other medicines you bought
without a prescription.
Remember to tell your doctor or pharmacist if you start taking a new medicine while you are
being treated with Lamivudina Mylan.

These medicines must not be used with Lamivudina 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
• co-trimoxazole (an antibiotic used to treat infections
• cladribine (used to treat blood cancer (leukaemia)).

Tell your doctorif you are being treated with any of these medicines.

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, or suspect you may be pregnant or are planning to become pregnant, ask your doctor or
pharmacist for advice before taking this medicine.
Lamivudina Mylan and similar medicines can cause unwanted effects in unborn babies.
If you have taken Lamivudina Mylan during pregnancy, your doctor may ask you for 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 is greater than the risk of unwanted effects.
Breastfeeding

HIV-positive women must not breastfeedbecause HIV infection can be passed on to the
baby through breast milk.
A small amount of the ingredients in this medicine may also pass into breast milk.
If you are breastfeeding, or thinking about starting breastfeeding talk to your doctor immediately.
Driving and using machines
It is unlikely that Lamivudina Mylan will affect your ability to drive or use machines.

Lamivudina Mylan contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, that is to say essentially “sodium-free”.

3. How to take Lamivudina Mylan

Take this medicine following the instructions of your doctor exactly. If you have any doubts, ask your doctor or pharmacist.
Swallow the tablets with water. Lamivudina Mylan can be taken with or without food.
If you are unable to swallow the tablets whole, you can break them and add them to a small amount of food or drink and take the entire dose immediately. Alternatively, other formulations of this medicine may be available, ask your doctor or pharmacist.
The 150 mg tablet can be divided into two equal doses.

Stay in constant contact with your doctor
Lamivudina Mylan helps to control your condition. It is necessary to take it every day to prevent the disease 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 Lamivudina Mylanwithout your doctor's advice.

Quantity to take
Only for the 150 mg:

Use in adults, adolescents and children weighing at least 25 kg:
The recommended dose of Lamivudina Mylan is 300 mg per day to be taken as:

• one 150 mg tablet twice a day, leaving approximately 12 hours between each dose, or
• two 150 mg tablets once a day, as prescribed by your doctor.

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

• 75 mg (half a 150 mg Lamivudina Mylan tablet) in the morning and
• one whole Lamivudina Mylan tablet (150 mg) in the evening, or
• 225 mg (one and a half 150 mg tablet) once a day, as prescribed by your doctor.

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

• 75 mg (half a 150 mg Lamivudina Mylan tablet) twice a day, leaving approximately 12 hours between each dose, or
• 150 mg (one 150 mg tablet) once a day, as prescribed by your doctor.

Only for the 300 mg:
The usual dose of Lamivudina Mylan for adults, adolescents and children weighing at least 25 kg:

• one 300 mg tablet once a day.

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

If you take more Lamivudina Mylan than you should
It is unlikely that accidentally taking too much Lamivudina Mylan will cause serious problems.
However, you should inform your doctor or pharmacist or contact the nearest hospital emergency room for further advice.

If you forget to take Lamivudina Mylan
If you forget to take a dose, take it as soon as you remember, and then continue treatment as before. Do not take a double dose to make up for a missed dose.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

During therapy for HIV, an increase in weight and lipid and glucose levels in the
blood may occur. This is particularly related to improvement in health and lifestyle, and in the case of lipids
is sometimes linked to the medications themselves for the treatment of HIV. Your doctor will monitor these
changes.
Like all medicines, this medicine can cause side effects, although not everyone will
experience them.
During the treatment of HIV, it may be difficult to tell whether a symptom is a side effect of
lamivudine or 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 state of
health.
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 paragraph 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 that occur and that cause 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 for longer than usual. These may be signs of a decrease in the number of cells involved in blood clotting (thrombocytopenia) Rare(may affect up to 1 in 1000 people):
• swelling of the face, mouth, lips, tongue or throat causing difficulty breathing or swallowing (angioedema)
• severe stomach pain, which may radiate 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, fatigue, fever, feeling unwell (nausea), weakness, drowsiness and abdominal pain. These may be signs of serious liver problems (hepatitis)
• dark urine with muscle weakness or fatigue. These may be signs of muscle breakdown (rhabdomyolysis)

Very rare(may affect up to 1 in 10000 people):

• fatigue, weakness, pale skin, 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 stabbing 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, drowsiness, numbness or weakness of the limbs, feeling unwell (nausea), discomfort (vomiting) and stomach pain. 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
• diarrhea
• headache
• joint pain
• discomfort and muscle pain
• cough
• nasal irritation or runny nose
• fever (high temperature)
• fatigue, lack of energy
• general feeling of unwellness
• skin rash
• hair loss (alopecia)
• sleep disturbances (insomnia)

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

• low number of red blood cells (anemia)
• increased liver enzymes.

Rare(may affect up to 1 in 1000 people):

• an increase in an enzyme called amylase that can be seen from blood tests.

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

Old infections can flare up
People with advanced HIV infection (AIDS) have a weakened immune system and are
more likely to develop serious infections (opportunistic infections). When these people
start treatment, old infections, hidden, may flare up causing
signs and symptoms of inflammation. These symptoms are likely due to the reconstitution of the immune system,
so that the body begins to fight these infections.
In addition to opportunistic infections, autoimmune diseases (a condition that occurs when the immune system attacks healthy body tissues) may also occur after starting
taking drugs to treat HIV infection. Autoimmune disorders can occur many months
after starting treatment. If you notice any symptoms of infection or other symptoms such as muscle weakness, weakness starting from hands and feet and up to the trunk of the body, palpitations, tremors or
hyperactivity, inform your doctor immediately for the necessary care.
If you notice any symptoms of infection while taking Lamivudina Mylan:

inform your doctor immediately. Do not take other medicines for the infection without advice
from your doctor.

You may have bone problems
Some people in 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 flow to the bone. People may be more likely to develop this condition:

• if they have been taking combination therapy for a long period
• if they are also taking anti-inflammatory drugs called corticosteroids
• if they drink alcohol
• if their immune system is very weak
• if they are overweight.

Signs of osteonecrosis include:

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through 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 Lamivudina Mylan

Keep out of sight and reach of children .
Do not use this medicine after the expiry date stated on the bottle or blister or packaging
after the wording “Exp.”. The expiry date refers to the last day of the month.
This medicine does not require special storage conditions.
Medicines should 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. Contents of the pack and other information

What Lamivudina Mylan contains
The active ingredient is lamivudine.
Each 150 mg film-coated tablet contains 150 mg of lamivudine. Each film-coated
tablet of 300 mg 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: film-coated tablets, white to off-white in colour, capsule-shaped,
with sides curving downwards, with “M105” imprinted on one side and a score line on the other.
Lamivudina Mylan 300 mg: film-coated tablets, white to off-white in colour, oval-shaped, with
sides curving downwards, with “M300” imprinted on one side and smooth on the other.
Lamivudina Mylan is available in blisters of 30, 60, 90, 120 tablets and in bottles of 60 tablets.
Not all pack sizes may be marketed.

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

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 authorised in the Member States of the European Economic Area under the
following denominations:
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