Package leaflet: Information for the user

Abacavir and Lamivudine Aurobindo 600 mg/300 mg film-coated tablets

Generic medicine
Please 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 their symptoms are the same as yours, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

IMPORTANT — Hypersensitivity reactions
Abacavir and Lamivudine Aurobindo contains abacavir (which is also the active substance in
medicines such as Trizivir, Triumeq, and Ziagen). 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.
Read carefully all the information under 'Hypersensitivity reactions' in the box in
section 4.
The Abacavir and Lamivudine Aurobindo pack includes an Alert Card to remind you and
healthcare professionals about abacavir hypersensitivity. Remove this card and always carry it
with you.

Contents of this leaflet:

What Abacavir and Lamivudine Aurobindo is and what it is used for
What you need to know before taking Abacavir and Lamivudine Aurobindo
How to take Abacavir and Lamivudine Aurobindo
Possible side effects
How to store Abacavir and Lamivudine Aurobindo
Contents of the pack and other information

1. What Abacavir and lamivudine Aurobindo is and what it is used for

Abacavir and lamivudine Aurobindo is used to treat HIV (Human Immunodeficiency Virus) infection in adults, adolescents, and children weighing at least 25 kg.
Abacavir and lamivudine Aurobindo contains two active substances used in the treatment of HIV infection: abacavir and lamivudine. These medicines belong to a group of antiretroviral drugs known as nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Abacavir and lamivudine Aurobindo does not completely cure HIV infection; it reduces the amount of virus in the body and maintains it at low levels. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell important in helping the body fight infection.
Not all people respond to treatment with Abacavir and lamivudine Aurobindo in the same way. Your doctor will monitor how well the treatment is working.

2. What you need to know before taking Abacavir and lamivudine Aurobindo

Do not take Abacavir and lamivudine Aurobindo:

if you are allergic (hypersensitive) to abacavir (or to any other medicine containing abacavir – for example Trizivir, Triumeq or Ziagen), to lamivudine, or to any of the other ingredients of this medicine (listed in section 6). Read carefully all the information about hypersensitivity reactions in section 4. Consult your doctor if you think this applies to you. Do not take Abacavir and lamivudine Aurobindo.

Warnings and precautions
Talk to your doctor or pharmacist before taking Abacavir and lamivudine Aurobindo.
Some people who take Abacavir and lamivudine Aurobindo or other combination therapies for the treatment of HIV are at higher risk of serious side effects. You should be aware of these additional risks:

if you have moderate or severe liver disease
if you have had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop taking Abacavir and lamivudine Aurobindo without consulting your doctor, as hepatitis may worsen)
if you are severely overweight (especially if you are a woman)
if you have a kidney problem Inform your doctor if any of these situations apply to you before using Abacavir and lamivudine Aurobindo. 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 may still develop a hypersensitivity reaction (a severe allergic reaction).
Read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.
Risk of heart attack
It cannot be ruled out that abacavir may be associated with an increased risk of heart attack.
Inform your doctor if you have heart problems, if you are a smoker, or if you suffer from conditions that increase the risk of heart disease, such as high blood pressure or diabetes. Do not stop taking Abacavir and lamivudine Aurobindo unless your doctor advises you to do so.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other conditions that may be serious. You should be informed about important signs and symptoms so that you can remain vigilant while taking Abacavir and lamivudine Aurobindo.
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 (e.g. by sharing injecting needles). You may still transmit HIV while taking this medicine, although the risk is reduced due to the effect of antiretroviral therapy. Discuss with your doctor the necessary precautions to avoid transmitting the infection to others.
Other medicines and Abacavir and lamivudine Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Remember to inform your doctor or pharmacist if you start taking a new medicine during treatment with Abacavir and lamivudine Aurobindo.
The following medicines must not be taken with Abacavir and lamivudine Aurobindo:

emtricitabine for the treatment of HIV infection
other medicines containing lamivudine, used to treat HIV infection or hepatitis B virus infection
high-dose trimethoprim/sulfamethoxazole, an antibiotic
cladribine, used to treat hairy cell leukemia
Inform your doctor if you are being treated with any of these medicines.

Some medicines interact with Abacavir and lamivudine Aurobindo
These include:

phenytoin, used to treat epilepsy. Inform your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking Abacavir and lamivudine Aurobindo.
methadone, used as a heroin substitute. 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. Your methadone dose may need to be adjusted. Inform your doctor if you are taking methadone.
ribavirin, for the treatment of hepatitis C. Abacavir may reduce the effectiveness of the combination of ribavirin and pegylated interferon in lowering hepatitis C virus levels in the body. Inform your doctor if you are taking ribavirin.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Use of Abacavir and lamivudine Aurobindo during pregnancy is not recommended.
Abacavir and lamivudine Aurobindo and similar medicines may cause side effects in unborn children.
If you have already taken Abacavir and lamivudine Aurobindo during pregnancy, your doctor may request regular blood tests and other diagnostic examinations to monitor the child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of side effects.
Breastfeeding
Women who are HIV-positive must not breastfeed because HIV infection can be transmitted to the child through breast milk. A small amount of the components of Abacavir and lamivudine Aurobindo may also pass into breast milk.
If you are breastfeeding or are considering doing so:
talk to your doctor immediately.
Driving and using machines
Abacavir and lamivudine Aurobindo may cause side effects that could affect your ability to drive and use machinery. Talk to your doctor about your ability to drive and use machinery while taking Abacavir and lamivudine Aurobindo.
Important information about some excipients of Abacavir and lamivudine Aurobindo tablets
Abacavir and lamivudine Aurobindo contains the colouring agent sunset yellow (E110), which may cause allergic reactions in some individuals.

3. How to take Abacavir and Lamivudine Aurobindo

Take this medicine exactly as instructed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose of Abacavir and Lamivudine Aurobindo in adults, adolescents, and
children weighing 25 kg or more is one tablet once daily.
Swallow the tablets whole with water. Abacavir and Lamivudine Aurobindo can be taken with or
without food.
Stay in regular contact with your doctor
Abacavir and Lamivudine Aurobindo helps control your condition. You must take it every
day to prevent your condition from worsening. You may still develop other infections and illnesses related
to HIV infection.
Stay in contact with your doctor, and do not stop taking Abacavir and Lamivudine Aurobindo
without medical advice.
If you take more Abacavir and Lamivudine Aurobindo than you should
If you accidentally take more Abacavir and Lamivudine Aurobindo, inform your doctor or pharmacist or
contact the Emergency Department of your nearest hospital for further advice.
If you forget to take Abacavir and Lamivudine Aurobindo
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 Abacavir and Lamivudine Aurobindo regularly, as taking it at irregular
intervals may increase the risk of developing a hypersensitivity reaction.
If you have stopped taking Abacavir and Lamivudine Aurobindo
If you have stopped taking Abacavir and Lamivudine Aurobindo for any reason – particularly
because you thought you were experiencing side effects or because you had other illnesses:
talk to your doctor before starting to take it again. Your doctor will assess whether your symptoms
were related to a hypersensitivity reaction. If your doctor suspects that your symptoms may have been
due to a hypersensitivity reaction, you will be told never to take Abacavir and Lamivudine Aurobindo
or any other medicine containing abacavir again (for example, Trizivir, Triumeq, or Ziagen).
It is important that you follow this advice.
If your doctor advises restarting Abacavir and Lamivudine Aurobindo, you will be asked to take the first
doses in a setting where you can receive immediate medical assistance if needed.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

During HIV treatment, weight gain and increased levels of lipids and glucose in the blood 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.

During HIV treatment, it may be difficult to determine whether a symptom is an unwanted effect of Abacavir and lamivudine Aurobindo, 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.

Even patients who do not carry 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 combination therapy for HIV, both the side effects listed below for Abacavir and lamivudine Aurobindo and other diseases may occur.
It is important to read the information in another section of this leaflet titled “Other possible side effects of combination therapy for HIV”.

Hypersensitivity reactions
Abacavir and lamivudine Aurobindo contains abacavir (which is also the active substance contained in medicines such as Trizivir, Triumeq and Ziagen).
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 Abacavir and lamivudine Aurobindo could develop a hypersensitivity reaction to abacavir, which could be life-threatening if Abacavir and lamivudine Aurobindo is continued.
You are more likely to develop this reaction if you carry a gene called HLA-B*5701 (but you may still experience this reaction even if you do not have this gene). You must be tested for the presence of this gene before Abacavir and lamivudine Aurobindo is prescribed. If you know you carry this gene, inform your doctor before taking Abacavir and lamivudine Aurobindo.
In a clinical study, among 100 patients treated with abacavir who did not have the gene called HLA-B*5701, 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 include:

nausea, vomiting, diarrhoea, abdominal pain (stomach pain), severe tiredness.

Other symptoms include:

muscle or joint pain, neck swelling, 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?
Hypersensitivity reactions can start at any time during treatment with Abacavir and lamivudine Aurobindo, but are 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 tiredness or discomfort, or general feeling of being unwell.

Your doctor may advise you to stop taking Abacavir and lamivudine Aurobindo.

If you have stopped taking Abacavir and lamivudine Aurobindo
If you have stopped taking Abacavir and lamivudine Aurobindo due to a hypersensitivity reaction, NEVER take Abacavir and lamivudine Aurobindo again, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen). If you do, your blood pressure could drop dangerously within a few hours, which could lead to death.

If you have stopped taking Abacavir and lamivudine Aurobindo for any reason – particularly because you thought you were experiencing side effects or other illnesses:
talk to your doctor before restarting the medicine. Your doctor will assess whether your symptoms were related to a hypersensitivity reaction. If your doctor suspects that your symptoms may have been due to a hypersensitivity reaction, you will be advised never to take Abacavir and lamivudine Aurobindo or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen) again. It is important that you follow this advice.

Sometimes, hypersensitivity reactions have occurred in patients who restarted abacavir-containing medicines, even if they had previously experienced only one of the symptoms listed on the Warning Card before stopping the medicine.

Very rarely, patients who previously took abacavir-containing medicines without any signs of hypersensitivity have later developed a hypersensitivity reaction when restarting these medicines.

If your doctor advises restarting Abacavir and lamivudine Aurobindo, you will be asked to take the first doses in a setting where you can receive immediate medical assistance if needed.

If you are hypersensitive to Abacavir and lamivudine Aurobindo, you must return all unused tablets of Abacavir and lamivudine Aurobindo for safe disposal. Ask your doctor or pharmacist for advice.

The packaging of Abacavir and lamivudine Aurobindo includes a Warning Card to remind you and healthcare professionals about hypersensitivity reactions. Detach this card and keep it with you at all times.

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

hypersensitivity reaction
headache
vomiting
nausea
diarrhoea
stomach pain
loss of appetite
tiredness, lack of energy
fever (high temperature)
general feeling of being unwell
difficulty sleeping (insomnia)
muscle disorders and muscle pain
joint pain
cough
nasal mucosal irritation or runny nose
rash
hair loss

Uncommon side effects (may affect up to 1 in 100 people, and may be detected by blood tests):

low number of red blood cells (anaemia) or low number of white blood cells (neutropenia)
increased liver enzymes
reduced number of platelets (thrombocytopenia)

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

liver disorders such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
inflammation of the pancreas (pancreatitis)
muscle tissue breakdown

Rare side effects that may be detected by blood tests include:

increase in an enzyme called amylase

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

sensation of numbness or tingling in the skin
feeling of weakness in arms and legs
rash with blister-like lesions resembling small targets (a dark spot in the centre surrounded by a pale area with a dark 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 causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
lactic acidosis (excess lactic acid in the blood)

If you notice any of these symptoms, contact your doctor urgently.

A very 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).

If you experience side effects
Inform your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effect not listed in this leaflet.

Other possible side effects of combination therapy for HIV

Combination therapy such as Abacavir and lamivudine Aurobindo 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 infections (opportunistic infections). These infections may be “silent” and not detected by the weakened immune system before starting treatment. After starting treatment, the immune system becomes stronger and may react against these infections, causing symptoms of infection or inflammation. Symptoms generally include fever, plus some of the following:

headache
stomach pain
difficulty breathing

Rarely, as the immune system strengthens, it may also attack the body's healthy tissues (autoimmune disorders). Symptoms of autoimmune disorders may develop several months after starting treatment 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 towards the body trunk.

If you experience any symptoms of infection and inflammation or notice any of the symptoms listed above: inform your doctor immediately. Do not take any other medicines for infection without medical advice.

You may have bone problems
Some people receiving combination antiretroviral therapy for HIV infection develop a condition called osteonecrosis. As a result of this disease, 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
if they are also taking anti-inflammatory drugs called corticosteroids
if they consume 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 experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abacavir and Lamivudine Aurobindo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, the carton, and the
blister pack after EXP. The expiry date refers to the last day of that month.
Blister pack: Store below 30  C
HDPE bottle: This medicine does not require any special storage conditions.
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 and Lamivudine Aurobindo contains
The active substances are abacavir and lamivudine.
Each film-coated tablet contains 600 mg of abacavir (as sulphate) and 300 mg of lamivudine.
The other components are:
Tablet core: microcrystalline cellulose, sodium starch glycolate (type A), magnesium stearate
Tablet coating: hypromellose 2910 (3cp), hypromellose 2910 (6cp), titanium dioxide,
polysorbate 80, macrogol 400, FD&C yellow no. 6 aluminium lake (E110)
Description of the appearance of Abacavir and Lamivudine Aurobindo and package contents
Film-coated tablets.
Modified capsule-shaped, orange-coloured film-coated tablets, marked with "H" on one side and "27" on the other. Size: 20.7 mm x 9.2 mm.
Abacavir and Lamivudine Aurobindo film-coated tablets are available in blister packs and in white opaque HDP containers with white opaque polypropylene closures.
Pack sizes:
Blister packs: 30, 50, 60, 90 film-coated tablets
HDPE containers: 30, 100 film-coated tablets
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Aurobindo Pharma (Italia) s.r.l. – Via San Giuseppe, 102 – 21047 Saronno (Varese), Italy
Responsible manufacturers for batch release:
APL Swift Services (Malta) Limited - HF26, Hal Far Industrial Estate, Hal Far, Birzebbugia, BBG 3000, Malta
Milpharm Limited - Ares Block, Odyssey Business Park, West End Road, Ruislip - HA4 6QD, United Kingdom
This medicinal product is authorised in the European Economic Area Member States under the
following names:
Belgium Abacavir/Lamivudine AB 600 mg/300 mg film-coated tablets
France Abacavir/Lamivudine Arrow 600 mg/300 mg film-coated tablets
Germany Abacavir/Lamivudin Aurobindo 600 mg/300 mg Filmtabletten
Italy Abacavir and Lamivudine Aurobindo
Portugal Abacavir + Lamivudina Aurovitas
Romania Abacavir/Lamivudină Aurobindo 600 mg/300 mg comprimate filmate
Spain Abacavir/Lamivudina Aurovitas 600 mg/300 mg comprimidos recubiertos con película EFG
Netherlands Abacavir/Lamivudine Aurobindo 600 /300 mg, filmomhulde tabletten
United Kingdom Abacavir/Lamivudine Milpharm 600 mg/300 mg film-coated tablets