Abacavir/lamivudine/zidovudine Mylan

Package Leaflet: Information for the User

Abacavir/Lamivudine/Zidovudine Mylan 300 mg/150 mg/300 mg

film-coated tablets
abacavir/lamivudine/zidovudine
Generic Medicine
Read this 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 they have the same symptoms as you, because it could be harmful.
• If you experience any side effect, 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 substance in medicines such as:

• abacavir/lamivudine/zidovudine combinations
• abacavir/lamivudine combinations
• Abacavir

Some 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 read carefully all the information under 'Hypersensitivity Reactions'
in the box in section 4.
This medicine’s packaging includes a Warning Card to remind you and healthcare professionals about abacavir hypersensitivity. Remove this card and always carry it with you.

Contents of this leaflet

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

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

Abacavir/Lamivudine/Zidovudine Mylan is used to treat HIV infection in adults
(Human Immunodeficiency Virus).
This medicine contains three active substances used in the treatment of HIV infection: abacavir, lamivudine and zidovudine. All of these medicines belong to a group of antiretroviral drugs known as nucleoside reverse transcriptase inhibitors (NRTIs).
This medicine helps control your condition. It does not cure HIV infection, but reduces the viral load in the body and keeps it at low levels. This helps the body increase the CD4 cell count in the blood. CD4 cells are a type of white blood cells that play an important role in helping the body fight infection.
Not all people respond to treatment with this medicine in the same way. Your doctor will monitor the effectiveness of the treatment.

2. What you should know before taking Abacavir/Lamivudine/Zidovudine Mylan

Do not take Abacavir/Lamivudine/Zididovudine Mylan:
if you are allergic ( hypersensitive ) to:

• abacavir or to any other medicine containing abacavir, for example abacavir/lamivudine/zidovudine or abacavir/lamivudine
• lamivudine
• zidovudine
• any of the other ingredients of this medicine (listed in section 6). Please read carefully all the information about hypersensitivity reaction in section 4. if you have severe kidney problems if you have a very low red blood cell count ( anaemia ) or a very low white blood cell count ( neutropenia ).

Talk to your doctor if you think any of these situations apply to you.
Warnings and precautions
Some people taking this medicine are at higher 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 disease, including 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 reappear)
if you are taking medicines that your doctor has told you may affect 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 your insulin or tablet dosage) or if you have been told, or are at risk, of increased blood sugar levels.
if you have bone marrow problems (the tissue inside the bones that helps produce blood cells).
Tell your doctor if any of these situations apply to you before using this
medicine. You may need additional monitoring, including blood tests, while taking this medicine. See section 4 for further information.
Hypersensitivity reactions to abacavir
Even patients who do not have the HLA-B*5701 gene can still develop a hypersensitivity reaction (a severe allergic reaction). Please read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.
Your doctor must check whether you have this gene before you start treatment with
Abacavir/Lamivudine/Zidovudine 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 doctor if you have heart problems, if you are a smoker, or if you have conditions 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/Lamivudine/Zidovudine Mylan unless your doctor advises you to do so.
Be alert to important symptoms
Some people taking this medicine develop other conditions that may be serious. You need to be aware of important signs and symptoms so that you can pay attention while taking this medicine.
Read the information in 'Other possible side effects of Abacavir/Lamivudine/Zidovudine Mylan'
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 can still transmit HIV while taking this medicine, although the risk is reduced by the effect of antiretroviral therapy. Discuss with your doctor the necessary precautions to avoid transmitting the infection to others.
Other medicines and Abacavir/Lamivudine/Zidovudine Mylan
Tell your doctor or pharmacist if you are taking any other medicine, or have recently taken any, including herbal remedies or other medicines purchased without a prescription.
Remember to inform your doctor or pharmacist if you start taking a new medicine while being treated with Abacavir/Lamivudine/Zidovudine 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 infection or hepatitis B
ribavirin to treat viral infections
high doses of co-trimoxazole, an antibiotic
cladribine, used to treat hairy cell leukaemia.
Tell your doctor if you are being treated with any of these medicines.
Some medicines may increase the likelihood of side effects or worsen existing ones.
These include:
sodium valproate, used to treat epilepsy or a type of depression known as mania
interferon or ganciclovir, to treat viral infections
pyrimethamine, to treat malaria and other parasitic infections
dapsone, to prevent pneumonia and to treat skin infections
fluconazole or flucytosine, to treat fungal infections such as candida
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, used to treat gout and similar conditions, and given with other antibiotics to make them more effective
methadone, used as a heroin substitute
vincristine, vinblastine or doxorubicin, to treat cancer.
Tell your doctor if 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 doctor if 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 pharmacist if you are taking any of these medicines.
Methadone and Abacavir/Lamivudine/Zidovudine Mylan
Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will be monitored for any withdrawal symptoms. The dose of methadone may need to be adjusted.
Pregnancy
If you are pregnant, think you may be pregnant, or 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 side effects in unborn children. If you have already taken abacavir/lamivudine/zidovudine during pregnancy, your doctor may request regular blood tests and other diagnostic examinations to monitor the baby's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
Breast-feeding
Women who are HIV-positive must not breast-feed, because HIV infection can be transmitted to the baby through breast milk.
A small amount of the components of this medicine may also pass into breast milk.
If you are breast-feeding or thinking about breast-feeding: talk to your doctor immediately.
Driving and using machines
This medicine may cause dizziness and other side effects that may reduce alertness.
Do not drive or operate machinery unless you feel well.
Abacavir/Lamivudine/Zidovudine 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 instructed by your doctor. Check with your
doctor or pharmacist if you are unsure.
Stay in contact with your doctor, and do not stop taking this medicine without your
doctor's advice.

Dosage
The usual dose for adults is one tablet twice daily.
Take the tablets at regular intervals of approximately 12 hours between doses.
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 must not take Abacavir/Lamivudine/Zidovudine Mylan.

If you take more Abacavir/Lamivudine/Zidovudine Mylan than you should
If you accidentally take too much of this medicine, inform your doctor or pharmacist or contact
the Emergency Department 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 you remember. Then continue your treatment as before.
Do not take a double dose to make up for the forgotten dose.
It is important to take this medicine regularly, because taking it at irregular intervals may mean that it
no longer works effectively against HIV infection, and you are more likely to have a hypersensitivity reaction.

If you have stopped taking Abacavir/Lamivudine/Zidovudine Mylan
If you have stopped taking this medicine for any reason – particularly because you thought you were
experiencing side effects or other illnesses:
talk to your doctor before starting to take it again. Your doctor will check whether your
symptoms were related to a hypersensitivity reaction. If your doctor thinks that your symptoms
might have been related to a hypersensitivity reaction, you will be told never to take this
medicine or any other medicine containing abacavir again (examples of these include
abacavir/lamivudine/zidovudine or abacavir/lamivudine). It is important that you follow this advice.
If your doctor advises restarting this medicine, you will be asked to take the first doses in a place
where you can receive prompt medical attention if necessary.

If you have any further questions about 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 will experience them.
During HIV treatment, an increase in weight and in blood lipid and glucose levels may occur. This is partly related to the recovery of health status and lifestyle, and, in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.
Treatment with abacavir/lamivudine/zidovudine often causes loss of fat from the legs, arms and face (lipoatrophy). This loss of body fat has been shown not to be completely reversible after discontinuation of zidovudine. Your doctor should monitor for signs of lipoatrophy. Inform your doctor if you notice any fat loss from your legs, arms or face.
If such signs occur, this medicine must be discontinued and HIV treatment changed.
During HIV treatment, it may be difficult to determine whether 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 status.
Even patients who do not have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a severe allergic reaction), described in this leaflet in a section titled 'Hypersensitivity reactions'. It is very important to read and understand the information about this serious reaction.
During treatment, both the side effects listed below for this medicine and other conditions may occur. It is important to read the information elsewhere in 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 the box below “Hypersensitivity reactions” for important information about these symptoms.

Rare side effects
These may affect up to 1 in 1,000 patients:
inflammation of the pancreas ( pancreatitis )
heart muscle disease causing fatigue, chest pain and rapid or irregular heartbeat ( cardiomyopathy )
liver disorders such as jaundice, enlarged liver or fatty liver, inflammation ( hepatitis )
seizures
breakdown of muscle tissue ( rhabdomyolysis )
lactic acidosis ( see the next section ‘Other possible side effects of Abacavir/Lamivudina/Zidovudina Mylan’ )
A rare side effect that may be detected by blood tests is:
failure of the bone marrow to produce new red blood cells ( pure red cell aplasia ).
Very rare side effects
These may affect up to 1 in 10,000 patients:
skin rash with blister-like spots resembling small targets (a dark spot in the center surrounded by a light area with a black ring around the edge) ( erythema multiforme )
widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes and genitals ( Stevens-Johnson syndrome ) and a more severe form causing skin peeling over more than 30% of the body surface ( toxic epidermal necrolysis ).
A very rare side effect that may be detected by blood tests is:
failure of the bone marrow to produce new red blood cells or white blood cells ( aplastic anaemia ).
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 substance found in medicines such as:

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

Abacavir may cause a serious allergic reaction known as a hypersensitivity reaction. These
hypersensitivity reactions have been observed more frequently in people taking
medicines containing abacavir.
Who is at risk of these reactions?
Any person taking this medicine could develop a hypersensitivity reaction to abacavir, which could be life-threatening if treatment continues.
You are more likely to develop such a reaction if you have a gene called HLA-B*5701 (but you may still experience this reaction even if you do not have this gene). A test for this gene should be performed before this medicine is prescribed. If you know you have this gene, inform your doctor before taking this medicine.
In a clinical study, among 100 patients treated with abacavir who did not have the HLA-B*5701 gene, approximately 3 to 4 patients experienced a hypersensitivity reaction.
What are the symptoms?
The most common symptoms are:
fever (high temperature) and rash.
Other common symptoms are:
nausea, vomiting, diarrhoea, abdominal pain (stomach pain), severe fatigue.
Other symptoms include:
muscle or joint pain, swollen glands (such as in the armpits or neck), shortness of breath, sore throat, cough, occasional headache,
inflammation of the eye ( conjunctivitis ), mouth ulcers, low blood pressure, tingling or numbness in hands or feet.
When do these reactions occur?
Hypersensitivity reactions can start at any time during treatment with this medicine, but are most 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 discomfort, or general feeling of being unwell.
  Your doctor may advise you to stop taking this medicine.

If you have stopped taking this medicine
If you have stopped taking this medicine due to a hypersensitivity reaction, you must NEVER take this medicine again, or any other medicine containing abacavir. If you do, within a few hours your blood pressure could drop dangerously, which could lead to death.
If you have stopped taking this medicine for any reason – particularly because you thought you were experiencing side effects or other illnesses:
talk to your doctor before restarting. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor believes your symptoms may have been due to a hypersensitivity reaction, you will be told never 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 restarted taking medicines containing abacavir, even if they had experienced only one of the symptoms described in the Warning Card before stopping the medicine.
Very rarely, patients who previously took abacavir-containing medicines without any symptoms of hypersensitivity have later developed a hypersensitivity reaction when restarting these medicines.
If your doctor advises restarting this medicine, you will be asked to take the first doses in a setting where you can receive immediate 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 a Warning Card to remind you and healthcare professionals about hypersensitivity reactions. Detach this card and keep it with you at all times.
Other side effects include:
Very common side effects
These may affect more than 1 in 10 patients:
headache
nausea
Common side effects
These may affect up to 1 in 10 patients:
vomiting
diarrhoea
stomach pain
loss of appetite
dizziness
tiredness, lack of energy
fever (high temperature)
general feeling of being unwell
sleep disturbances ( insomnia )
muscle discomfort and pain
joint pain
cough
irritation of nasal mucosa or runny nose
rash
hair loss.
Common side effects that may be detected by blood tests are:
low number of red blood cells ( anaemia ) or low number of white blood cells ( neutropenia, lymphopenia or leucopenia )
increased liver enzymes
increased levels of bilirubin in the blood (a substance produced by the liver) which may cause yellowing of the skin.
Uncommon side effects
These may affect up to 1 in 100 patients:
shortness of breath
flatulence
itching
muscle weakness
feeling of weakness in limbs.
An uncommon side effect that may 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 1 in 1,000 patients:

• chest pain;
• anxiety or depression, difficulty concentrating, drowsiness
• indigestion, taste disturbances
• change in the colour of nails, skin or the mucosa inside the mouth
• pink, itchy skin swelling (known as urticaria)
• flu-like feeling – chills and sweating
• tingling sensation on the skin (pins and needles)
• more frequent urination
• increase in breast size in male patients.

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

• increase in an enzyme called amylase

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

• numbness in arms and legs (peripheral neuropathy).

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

• swelling or fluid retention.

If you experience side effects
Inform your doctor or pharmacist if any of the side effects become severe or concerning, or if you notice any side effect not listed in this leaflet.
Other possible side effects of abacavir/lamivudine/zidovudine
This medicine may cause the development of other conditions during HIV treatment.
Symptoms of infection and inflammation
Old infections may flare up
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious (opportunistic) infections. When these individuals start treatment, previously hidden infections may flare up, causing signs and symptoms of inflammation. These symptoms are likely due to immune reconstitution, whereby the body starts fighting these infections.
Symptoms generally include fever plus one or more of the following:

• headache
• stomach pain
• difficulty breathing

In rare cases, as the immune system strengthens, it may also attack the body's own healthy tissues ( autoimmune disorders ). Symptoms of autoimmune disorders may appear many months after starting the medicine for HIV infection. Symptoms may include:

• palpitations (rapid or irregular heartbeat) or tremor
• hyperactivity (agitation and excessive movement)
• weakness starting in the hands and feet and spreading towards the trunk of the body.
  If you notice any signs of infection while taking this medicine: contact your doctor immediately. Do not take other medicines for infection without consulting your doctor.

Lactic acidosis is a rare but serious side effect
Some people taking this medicine develop a condition called lactic acidosis, together with liver enlargement.
Lactic acidosis is caused by a build-up of lactic acid in the body. It is a rare side effect and, if it occurs, usually develops after several months of treatment. It can be life-threatening and may lead to organ failure.
Lactic acidosis is more likely to occur in people with liver disease, those taking medicines that affect the liver, those who drink excessive alcohol, or in obese individuals (particularly women).
Signs of lactic acidosis include:
difficult, deep and rapid breathing
drowsiness, confusion
general feeling of being unwell, loss of appetite, weight loss
weakness or numbness in limbs
nausea, vomiting
stomach pain.
During treatment, your doctor will monitor 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 develop bone problems
Some people receiving combination antiretroviral 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:
joint stiffness
aches and pains (especially in the hip, knee or shoulder)
difficulty moving.
If you notice any of these symptoms: inform your doctor.
Other effects may be detected by blood tests
This medicine may also cause:
increased levels of lactic acid in the blood, which in rare cases may 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 insulin dose or oral medication to control blood sugar).
Reporting of side effects
If you experience any side effect, 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 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/Lamivudine/Zidovudine Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after the word
“Exp.”. The expiry date refers to the last day of that month.
Blister packs: do not store above 30°C.
Bottles: this medicine does not require any special storage conditions. Do not use this
medicine more than 60 days after first opening the bottle.
Do not dispose of medicines 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 Abacavir/Lamivudine/Zidovudine Mylan contains

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

Description of the appearance of Abacavir/Lamivudine/Zidovudine Mylan and contents of the
pack
The film-coated tablets of Abacavir/Lamivudine/Zidovudine Mylan are light green, oval-shaped, biconvex, and marked with 'ALZ1' on one side and 'M' on the other.
Abacavir/Lamivudine/Zidovudine Mylan film-coated tablets are supplied in blisters containing 30, 50x1, 60, 60x1, 90 or 120 tablets, or in bottles containing 60 tablets.

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

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 authorized in the Member States of the European Economic Area under the
following names:
France Abacavir/Lamivudine/Zidovudine Mylan 300 mg/150 mg/300 mg film-coated tablets
Italy Abacavir/Lamivudina/Zidovudina Mylan 300 mg/150 mg/300 mg film-coated tablets
Netherlands Abacavir/Lamivudine/Zidovudine Mylan 300 mg/150 mg/300 mg film-coated tablets