ABACAVIR 300 mg/150 mg /300 Mg Film-Coated Tablets

Зміст інструкції

1. Abacavir/Lamivudina/Zidovudina Mylan 300 mg/150 mg/300 mg
2. abacavir/lamivudina/zidovudina
   1. What is Abacavir/Lamivudine/Zidovudine Mylan and what is it used for
   2. What you need to know before taking Abacavir/Lamivudina/Zidovudina Mylan
   3. How to take Abacavir/Lamivudine/Zidovudine Mylan
   4. Possible side effects
   5. How to store Abacavir/Lamivudina/Zidovudina Mylan
   6. Package contents and other information

Abacavir/Lamivudina/Zidovudina Mylan 300 mg/150 mg/300 mg

film-coated tablets

abacavir/lamivudina/zidovudina

Generic Medicine
Read this leaflet carefully before taking this medicine as 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, as it may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist .See section 4.

IMPORTANT — Hypersensitivity Reaction
This medicine contains abacavir(which is also the active ingredient contained in medicines
such as:

• Associations abacavir/lamivudina/zidovudina
• Associations abacavir/lamivudina
• AbacavirSome people taking abacavir may develop a hypersensitivity reaction(a severe allergic reaction) which can be life-threatening if they continue to take medicines containing abacavir.

You must carefully read all the information provided in ‘Hypersensitivity Reactions’
in the box in section 4.
The packaging of this medicine includes an Alert Cardto remind you and
medical personnel of your abacavir hypersensitivity. Remove this card and carry it with you at all times.
Contents of this leaflet

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

1. What is Abacavir/Lamivudine/Zidovudine Mylan and what is it used for

Abacavir/Lamivudine/Zidovudine Mylan is used to treat HIV
(Human Immunodeficiency Virus) infection in adults.
This medicine contains three active ingredients used in the treatment
of HIV infection: abacavir, lamivudine and zidovudine. All of these medicines belong
to a group of antiretroviral drugs called nucleoside reverse transcriptase inhibitors (NRTIs)

.
This medicine helps to control your condition. This medicine does not cure HIV
infection; it reduces the viral load in the body and keeps it at low levels. This helps the body to increase
the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that
are important in helping the body fight infection.
Not all people respond to treatment with this medicine in the same way. The doctor
will check the effectiveness of the treatment.

2. What you need to know before taking Abacavir/Lamivudina/Zidovudina Mylan

Do not take Abacavir/Lamivudina/Zidovudina Mylan:
if you are allergic (hypersensitive) to:

• abacavir or any other medicine containing abacavir, for example abacavir/lamivudina/zidovudina or abacavir/lamivudina
• lamivudina
• zidovudina
• any of the other ingredients of this medicine (listed in section 6). Read carefully all the information on the hypersensitivity reaction in section 4.if you have severe kidney problemsif you have a very low red blood cell count(anemia) or a very low white blood cell count(neutropenia).

Talk to your doctorif you think any of these situations apply to you.

Warnings and precautions
Some people taking this medicine are at greater risk of serious side effects.
You need to be aware of these additional risks:
if you have moderate or severe liver disease
if you have had liver diseaseincluding hepatomegaly or steatosis, or hepatitis B or C (if you have
hepatitis B infection do not stop taking this medicine without consulting your
doctor as hepatitis may return)
if you are taking medicines that your doctor has told you can have effects on the liver or if
you drink more alcohol than you should
if you are severely overweight(especially if you are a woman)
if you have diabetes(your doctor may need to adjust the amount of insulin or tablets you are
taking) or you have been told, or are at risk of, increased blood sugar levels.
if you have problems with your bone marrow (the tissue inside your bones that helps produce blood cells).

Tell your doctorif any of these situations apply to you before using this
medicine. You may need further checks, including blood tests, while you are
taking the medicine. See section 4 for more information.
Hypersensitivity reactions to abacavir
Even patients who do not have the HLA-B*5701 gene can still develop a hypersensitivity reaction(a serious allergic reaction). Read carefully all the information on
hypersensitivity reactions in Section 4 of this leaflet.
Your doctor should check if you have this gene before you start treatment with
Abacavir/Lamivudina/Zidovudina Mylan. If you know you have this gene, tell your doctor before
taking this medicine.
Risk of heart attack
It cannot be ruled out that abacavir may be associated with an increased risk of heart attack.

Tell your doctorif you have heart problems, are a smoker, or suffer from illnesses that increase the
risk of heart disease such as high blood pressure, high levels of fats (triglycerides and
cholesterol) in the blood, or diabetes. Do not stop taking Abacavir/Lamivudina/Zidovudina
Mylan unless your doctor recommends it.

Pay attention to important symptoms
Some people taking this medicine develop other conditions that can be
serious. You need to be informed about important signs and symptoms so that you can pay
attention while taking this medicine.

Read the information in ‘Other possible side effects of
Abacavir/Lamivudina/Zidovudina Mylan’in section 4 of this leaflet.
Protecting others
HIV infection spreads through sexual contact with people who have the infection or
through the transfer of infected blood (for example through sharing injection needles).
You can still transmit HIV while taking this medicine, although the risk is
reduced by the effect of antiretroviral therapy. Discuss with your doctor the precautions necessary
to avoid transmitting the infection to others.

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

These medicines must not be taken with this medicine:
stavudine or emtricitabine to treat HIV infection
other medicines containing lamivudine used to treat HIV infectionor hepatitis B
ribavirin to treat viral infections
high doses of co-trimoxazole,an antibiotic
cladribine, used to treat hairy cell leukemia.
Tell your doctorif you are being treated with any of these medicines.

Some medicines can increase the likelihood that you will have side effects or that
these will worsen.
These include:
sodium valproate to treat epilepsy or a type of depression known as mania
interferon or ganciclovir, to treat viral infections
pyrimethamine, to treat malariaand other parasitic infections
dapsone, to prevent pneumoniaand to treat skin infections
fluconazole or flucytosine to treat fungal infectionssuch as candidiasis
pentamidine or atovaquone, to treat parasitic infections such as Pneumocystis jirovecii
pneumonia (often called PCP).
amphotericin or co-trimoxazole, to treat fungal and bacterial infections
probenecid to treat goutand similar conditions and given with other antibiotics to
make them more effective

methadoneused as a heroin substitute
vincristine, vinblastine or doxorubicin to treat cancer.

Tell your doctorif you are taking any of these medicines.

Some medicines interact with this medicine
These include:

clarithromycin,an antibiotic If you are taking clarithromycin, take the dose at least 2 hours
before or after taking this medicine.

phenytoin,to treat epilepsy. Tell your doctorif you are taking phenytoin. Your doctor
may need to monitor you while you are taking this medicine.
Medicines (usually liquids) containing sorbitol or other sugars(such as xylitol, mannitol
lactitol or maltitol), if taken regularly.

Tell your doctor or pharmacistif you are taking any of these medicines.

Methadone and Abacavir/Lamivudina/Zidovudina Mylan
Abacavir increases the rate at which methadone is eliminated from the body. If you are taking
methadone you will be monitored for any symptoms of withdrawal. The dose of methadone may need to be
changed.

Pregnancy
If you are pregnant, if you become pregnant, or if you are planning a pregnancy, talk to
your doctor about the risks and benefits of taking this medicine during pregnancy
for you and your baby.
This medicine and similar medicines can cause unwanted effects in unborn babies. If you have already taken abacavir/lamivudina/zidovudinaduring pregnancy, your doctor may
request regular blood tests and other diagnostic tests to monitor the development of
the baby. In children whose mothers took NRTIs during pregnancy, the benefit of
protection against HIV outweighed the risk of unwanted effects.

Breastfeeding
Women who test positive for HIV should not breastfeed,because
HIV infection can be transmitted to the baby through breast milk.
A small amount of the ingredients of this medicine can also pass into breast milk.
If you are breastfeeding, or are thinking about it: talk to your doctor immediately.

Driving and using machines
This medicine can cause dizzinessand have other side effects that cause a decrease
in alertness.

Do not drive or operate machineryunless you feel well.

Abacavir/Lamivudina/Zidovudina 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 Abacavir/Lamivudine/Zidovudine Mylan

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

Stay in contact with your doctor, and do not stop taking this medicinewithout your
doctor’s advice.

Amount to take
The usual dose in adults is one tablet twice a day.
Take the tablets at regular intervals of approximately 12 hours between taking one tablet and the next.
Swallow the tablets whole with water. This medicine can be taken with or without food.

Use in children and adolescents
Children and adolescents under 18 years of age should not take Abacavir/Lamivudine/Zidovudine
Mylan.

If you take more Abacavir/Lamivudine/Zidovudine Mylanthan you should
If you accidentally take too much of this medicine, tell your doctor or pharmacist or contact
the Emergency Room of the nearest hospital for further advice.

If you forget to take Abacavir/Lamivudine/Zidovudine Mylan
If you forget to take a dose, take it as soon as possible when you remember. Then continue
your treatment as before. Do not take a double dose to make up for a missed dose.
It is important to take this medicine regularly as taking it at irregular intervals
may mean that it stops working against the HIV infection and you are more likely to
have a hypersensitivity reaction.

If you stop taking Abacavir/Lamivudine/Zidovudine Mylan
If you have stopped taking this medicine for any reason - in particular because you
thought you had side effects or other illnesses:

talk to your doctor before starting to take it again.Your doctor will check if your
symptoms were related to a hypersensitivity reaction. If your doctor thinks that these
symptoms may have been related to a hypersensitivity reaction, you will be told not to
take this medicine or any other medicine containing abacaviragain (examples
of these include abacavir/lamivudine/zidovudineor abacavir/lamivudine). It is important that
you follow this advice.
If your doctor advises you to start taking this medicine again, you will be asked to
take the first doses in a place where you will be able to receive, if necessary, prompt
medical attention.
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 everyone gets them.
During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. The doctor will check these changes.
Treatment with abacavir/lamivudine/zidovudine often causes a loss of fat from the legs, arms and face (lipoatrophy). This loss of body fat has been shown to be not completely reversible after stopping zidovudine. The doctor should monitor for signs of lipoatrophy. Tell your doctor if you notice any loss of fat from your legs, arms and face.
If these signs are found, this medicine should be stopped and the HIV treatment changed.
During HIV treatment, it can be difficult to tell if a symptom is a side effect of this medicine or of other medicines you are taking, or an effect of the HIV infection itself.

For this reason, it is very important to inform your doctor about any changes in your health condition.
Even patients who do not have the HLA-B*5701 gene can still develop a hypersensitivity reaction(a severe allergic reaction), described in this leaflet in a section entitled ‘Hypersensitivity reactions’. It is very important to read and understand the information on this serious reaction.
During treatment, both the side effects listed below for this medicineand other illnesses may occur. It is important to read the information in another part of this leaflet under ‘Other possible side effects of this medicine’.

If you notice any of the following symptoms, contact a doctor urgently:

• Hypersensitivity (allergic) reactions. See below the box “Hypersensitivity reactions” for important information about these symptoms.

Rare side effects
These may affect up to 1in 1,000patients:
inflammation of the pancreas (pancreatitis)
heart muscle disease causing fatigue, chest pain and fast or irregular heartbeat (cardiomyopathy)
liver disorders such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
convulsions
muscle tissue breakdown (rhabdomyolysis)
lactic acidosis (see the next section ‘Other possible side effects of Abacavir/Lamivudine/Zidovudine Mylan’)
A rare side effect that can be detected by blood tests is:
bone marrow failure to produce new red blood cells (pure red cell aplasia).

Very rare side effects
These may affect up to 1in 10,000patients:
skin rash with blistering formations resembling small targets (a dark spot in the centre surrounded by a clear area with a black ring around the edge) (erythema multiforme)
widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form that causes peeling of the skin in more than 30% of the body surface (toxic epidermal necrolysis).
A very rare side effect that can be detected by blood tests is:
bone marrow failure to produce new red blood cells or white blood cells (aplastic anemia).

Side effects with unknown frequency (cannot be estimated from available data)

• kidney, liver or respiratory failure.

Hypersensitivity reactions
This medicine contains abacavir,which is the active ingredient contained in medicines such as:

• Combinations abacavir/lamivudine/zidovudine
• Combinations abacavir/lamivudine
• Abacavir

Abacavir can cause a severe allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in people taking medicines that contain abacavir.

Who gets these reactions?
Anyone taking this medicine could develop a hypersensitivity reaction to abacavir which could be life-threatening if they continue to take it.
You are more likely to develop this reaction if you have a gene called HLA-B*5701(but you can still develop the reaction even if you do not have this gene). You will be tested to check for the presence of this gene before this medicine is prescribed to you. If you know you have this gene, tell your doctor before taking this medicine.
In a clinical study, out of 100 patients treated with abacavir who did not have the gene called HLA-B*5701, about 3 to 4 patients developed a hypersensitivity reaction.

What are the symptoms?
The most common symptoms are:

fever(high temperature) and skin rash.
Other common symptoms are:
nausea, vomiting, diarrhoea, abdominal (stomach) pain, severe fatigue.
Other symptoms include:
muscle or joint pain, swelling of the glands (such as those in the armpits or neck), shortness of breath, sore throat, cough, occasional headache
eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness in the hands or feet.

When do these reactions occur?
The hypersensitivity reaction can start at any time during treatment with this medicine but is more likely during the first 6 weeks of treatment.

Contact your doctor immediately:

• 1)if you develop a rash OR
• 2)if you develop symptoms from at least 2 of the following groups:
• fever
• shortness of breath, sore throat or cough
• nausea or vomiting, diarrhoea or abdominal pain
• severe fatigue or feeling unwell. Your doctor may recommend that you stop taking this medicine

If you have stopped taking this medicine
If you have stopped taking this medicine because of a hypersensitivity reaction, you MUST NEVER take this medicine again, or any other medicine containing abacavir.
If this happens, your blood pressure could drop dangerously within hours, which could be fatal.
If you have stopped taking this medicine for any reason – particularly because you thought you had side effects or other illnesses:

talk to your doctor before starting to take it again.
The doctor will check if your symptoms were related to a hypersensitivity reaction. If the doctor thinks these symptoms may have been related to a hypersensitivity reaction, you will be told not to take this medicine or any other medicine containing abacavir again.
It is important that you follow this advice.
Sometimes, hypersensitivity reactions have occurred in patients who started taking medicines containing abacavir again, but had also reported only one of the symptoms described in the Alert Card before stopping the medicine.
Very rarely, patients who had previously taken medicines containing abacavir without any symptoms of hypersensitivity have then developed a hypersensitivity reaction when they started taking these medicines again.
If your doctor recommends starting to take this medicine again, they will ask you to take the first doses in a place where you will be able to receive prompt medical attention if needed.

If you are hypersensitive to this medicine, you must return all unused tablets for safe disposal.
Ask your doctor or pharmacist for advice.
The packaging of this medicine includes an Alert Cardto remind you and healthcare professionals about hypersensitivity reactions. Detach this card and keep it with you at all times.
Other side effects are:

Very common side effects
These may affect more than 1in 10patients:
headache
nausea

Common side effects
These may affect up to 1in 10patients:
vomiting
diarrhoea
stomach pain
loss of appetite
dizziness
fatigue, lack of energy
fever (high temperature)
general feeling of being unwell
sleep disorders (insomnia)
muscle and pain
joint pain
cough
irritation in the nasal mucous membranes or runny nose
skin rash
hair loss.
Common side effects that can be detected by blood tests are:
low number of red blood cells (anemia) or low number of white blood cells (neutropenia, lymphopenia or leucopenia)
increased levels of enzymes produced by the liver
increased amount of bilirubinin the blood (a substance produced by the liver) which can make the skin appear yellow.

Uncommon side effects
These may affect up to 1in 100patients:
shortness of breath
flatulence
itching
muscle weakness
feeling of weakness in the limbs.
An uncommon side effect that can be detected by blood tests is:
reduction in the number of cells involved in blood clotting (thrombocytopenia) or of all types of blood cells (pancytopenia). This may be associated with bone marrow suppression.

Rare side effects
These may affect up to 1in 1,000patients:

• chest pain;
• anxiety or depression, inability to concentrate, drowsiness
• indigestion, taste disorders
• change in the colour of the nails and skin, or of the mucous membrane inside the mouth
• swelling of the skin that is pink and itchy (known as hives)
• feeling similar to the flu - chills and sweating
• tingling sensation on the skin (pins and needles)
• more frequent urination
• enlargement of the male breast glands.

A rare side effect that can be detected by blood tests is:

• increase in an enzyme called amylase

Very rare side effects
These may affect up to 1in 10,000patients:

• numbness of the arms and legs (peripheral neuropathy).

Side effects with unknown frequency (cannot be estimated from available data)

• swelling or fluid retention.

If you get side effects
Tell your doctor or pharmacistif any side effect becomes severe or bothersome, or if you notice any side effect not listed in this leaflet.

Other possible side effects of abacavir/lamivudine/zidovudine
This medicine can cause the development of other illnesses during treatment for HIV.

Symptoms of infection and inflammation
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 that were hidden may flare up, causing signs and symptoms of inflammation. These symptoms are probably due to the immune system being restored, so that the body starts to fight these infections.
Symptoms generally include feverplus some of the following symptoms:

• headache
• stomach pain
• difficulty breathing

In rare cases, as the immune system strengthens, it can also attack healthy tissues in the body (autoimmune disorders). Symptoms of autoimmune disorders can develop many months after starting to take the medicine for HIV infection. Symptoms may include:

• palpitations (fast or irregular heartbeat) or tremor
• hyperactivity (agitation and excessive movement)
• weakness starting in the hands and feet and spreading to the trunk of the body. If you notice any symptoms of infection while taking this medicine: tell your doctor immediately. Do not take other medicines for the infection without your doctor’s advice.

Lactic acidosis is a rare but serious side effect
Some people taking this medicine develop a condition called lactic acidosis, along with an enlargement of the liver.
Lactic acidosis is caused by an increase in lactic acid in the body. It is a rare effect and, if it occurs, generally develops after several months of treatment. It can be life-threatening, causing impairment of internal organs.
Lactic acidosis is more likely to develop in people who have liver disease, are taking medicines that can affect the liver, or drink more alcohol than they should, or in obese (very overweight) people, especially if they are women.

Signs of lactic acidosis include:
difficulty breathing, deep and rapid
drowsiness, confusion
general feeling of unwellness, loss of appetite, weight loss
weakness or numbness in the limbs
nausea, vomiting
stomach pain.
During treatment, the doctor will check for signs of lactic acidosis. If you experience any of the symptoms listed above or any other symptom that concerns you: contact your doctor as soon as
possible.
You may have problems with your bones
Some people undergoing combination antiretroviral therapy for HIV infection develop a condition defined as 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 alcoholic beverages
if their immune system is very weak
if they are overweight.

Signs of osteonecrosis include:
joint stiffness
aches and pains (especially in the hip, knee or shoulder)
difficulty moving.
If you notice any of these symptoms: tell your doctor.
Other effects may be detected by blood tests
This medicine can also cause:
increased levels of lactic acid in the blood, which in rare cases can lead to lactic acidosis
increased levels of sugar and fats (triglycerides and cholesterol) in the blood
insulin resistance (if you are diabetic you may need to adjust your dose of insulin or tablets to control your blood sugar).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system at 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 Abacavir/Lamivudina/Zidovudina 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 packaging after the wording
“Exp.”. The expiry date refers to the last day of that month.
Blisters: do not store at a temperature above 30° C.
Bottles: this medicine does not require special storage conditions. Do not use this
medicine after 60 days from the first opening of the bottle.
Do not dispose of any medicine in 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 Abacavir/Lamivudina/Zidovudina Mylan contains

• The active ingredients are abacavir (as sulfate), lamivudine and zidovudine.
• The excipients are: microcrystalline cellulose, anhydrous colloidal silica, sodium starch glycolate and magnesium stearate contained in the core of the tablet. The tablet coating contains hypromellose, titanium dioxide (E171), macrogol 400, indigo carmine aluminum lake (E132), yellow iron oxide (E172), red iron oxide (E172).

Description of the appearance of Abacavir/Lamivudina/Zidovudina Mylan and package contents
The film-coated tablets of Abacavir/Lamivudina/Zidovudina Mylan are light green in color,
oval in shape, biconvex and have ‘ALZ1’ imprinted on one side and “M” on the other.
Abacavir/Lamivudina/Zidovudina Mylan film-coated tablets are supplied in blisters
containing 30, 50x1, 60, 60x1, 90 or 120 tablets or in bottles containing 60 tablets.

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

Manufacturer
Mylan Hungary Kft, H-2900, Komárom, Mylan utca 1; Hungary
McDermott Laboratories Limited; 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 with the
following denominations:
FranceAbacavir/Lamivudine/Zidovudine Mylan 300 mg/150 mg/300 mg film-coated
tablets

ItalyAbacavir/Lamivudina/Zidovudina Mylan 300 mg/150 mg/300 mg film-coated
tablets

NetherlandsAbacavir/Lamivudine/Zidovudine Mylan 300 mg/150 mg/300 mg film-coated
tablets