Package Leaflet: Information for the User

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

abacavir/lamivudine
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 others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist immediately. See section 4.

IMPORTANT — Hypersensitivity Reactions
Abacavir and Lamivudine SUN contains abacavir (which is also the active substance in
medicines such as Kivexa, 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 taking medicines containing abacavir.
Read carefully all information under 'Hypersensitivity Reactions' in the box in section 4.
The Abacavir and Lamivudine SUN package 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:

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

1. What Abacavir and Lamivudine SUN is and what it is used for

Abacavir and Lamivudine SUN is used to treat HIV (Human Immunodeficiency Virus) infection in adults, adolescents, and children weighing at least 25 kg.
Abacavir and Lamivudine SUN 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 reverse transcriptase inhibitors (NRTIs).
Abacavir and Lamivudine SUN 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 cells important in helping the body fight infection.
Not all people respond to treatment with Abacavir and Lamivudine SUN 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 SUN

Do not take Abacavir and Lamivudine SUN:

if you are allergic to abacavir (or to any other medicine containing abacavir – for example Kivexa, 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. Contact your doctor if you think this applies to you. Do not take Abacavir and Lamivudine SUN.

Warnings and precautions
Some people taking Abacavir and Lamivudine SUN 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 ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop taking Abacavir and Lamivudine SUN without consulting your doctor, as hepatitis may reappear)
if you are severely overweight (especially if you are a woman)
if you have kidney problems Tell your doctor if any of these situations apply to you before using Abacavir and Lamivudine SUN. 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).
Read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.

Risk of cardiovascular events
It cannot be ruled out that abacavir may be associated with an increased risk of cardiovascular events.
Tell your doctor if you have cardiovascular problems, are a smoker, or have conditions that may increase the risk of cardiovascular disease such as high blood pressure or diabetes. Do not stop taking Abacavir and Lamivudine SUN unless your doctor advises you to do so.

Be aware of 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 SUN.
Read the information under 'Other possible side effects of combination therapy for HIV' in section 4 of this leaflet.

Other medicines and Abacavir and Lamivudine SUN
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including herbal medicines or other medicines purchased without a prescription.
Remember to inform your doctor or pharmacist if you start taking a new medicine during treatment with Abacavir and Lamivudine SUN.

These medicines must not be taken with Abacavir and Lamivudine SUN:

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

Some medicines interact with Abacavir and Lamivudine SUN
These include:

phenytoin, used to treat epilepsy. Tell your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking Abacavir and Lamivudine SUN.
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. Tell your doctor if you are taking methadone.
medicines (usually liquids) containing sorbitol and other sweeteners (such as xylitol, mannitol, lactitol or maltitol), if taken regularly. Tell your doctor or pharmacist if you are taking any of these.
riociguat, used to treat high blood pressure in the blood vessels (pulmonary arteries) carrying blood from the heart to the lungs. Your doctor may need to reduce the dose of riociguat, as abacavir may increase blood levels of riociguat.

Pregnancy
The use of Abacavir and Lamivudine SUN during pregnancy is not recommended. Abacavir and Lamivudine SUN and similar medicines may cause side effects in unborn children. If you have already taken Abacavir and Lamivudine SUN 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
Breast-feeding is not recommended for women with HIV, because HIV infection can be transmitted to the baby through breast milk. A small amount of the components of Abacavir and Lamivudine SUN may also pass into breast milk.
If you are breast-feeding or are considering doing so:
discuss this with your doctor as soon as possible.

Driving and using machines
Abacavir and Lamivudine SUN may cause side effects that could affect your ability to drive and use machines.
Talk to your doctor about your ability to drive and use machines while taking Abacavir and Lamivudine SUN.

Abacavir and Lamivudine SUN contains a colouring agent called sunset yellow (E110)
Abacavir and Lamivudine SUN contains a colouring agent called sunset yellow (E110) which may cause allergic reactions in some individuals.
This medicine contains less than 1 mmol of sodium (23 mg) per film-coated tablet, i.e. essentially 'sodium-free'.

3. How to take Abacavir and Lamivudine SUN

Always take this medicine exactly as instructed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
The recommended dose of Abacavir and Lamivudine SUN in adults, adolescents, and children
weighing 25 kg or more is one tablet once daily.
Swallow the tablets whole with water. Abacavir and Lamivudine SUN may be taken with or without food.
Stay in regular contact with your doctor.
Abacavir and Lamivudine SUN 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 SUN without medical advice.
If you take more Abacavir and Lamivudine SUN than you should
If you accidentally take more Abacavir and Lamivudine SUN, 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 SUN
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 SUN regularly, as taking it at irregular intervals may increase the risk of developing a hypersensitivity reaction.
If you have stopped taking Abacavir and Lamivudine SUN
If you have stopped taking Abacavir and Lamivudine SUN for any reason – particularly because you thought you were experiencing side effects or because you had other illnesses:
talk to your doctor before restarting treatment. 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 instructed never to take
Abacavir and Lamivudine SUN or any other medicine containing abacavir (e.g.
Kivexa, Trizivir, Triumeq or Ziagen) again. It is important that you follow this advice.
If your doctor advises restarting Abacavir and Lamivudine SUN, you will be asked to take the first doses in a setting where you can receive immediate medical assistance if needed.

4. Possible side effects

During HIV therapy, an increase in weight and in blood levels of lipids and glucose may occur.
This is partly related to the recovery of health status and lifestyle, and in the case of blood lipids, sometimes also to the HIV medications themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause side effects, although not everyone experiences them.
During HIV treatment, it may be difficult to determine whether a symptom is an unwanted effect of Abacavir and Lamivudina SUN, of other medicines you are taking, or a consequence of 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 Lamivudina SUN and other diseases may occur.
It is important to read the information provided below in the section 'Other possible side effects of combination HIV therapy'.

Hypersensitivity reactions
Abacavir and Lamivudina SUN contains abacavir (which is also the active substance in medicines such as Kivexa, Trizivir, Triumeq, and Ziagen). Abacavir can 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 may experience these reactions?
Any person taking Abacavir and Lamivudina SUN could develop a hypersensitivity reaction to abacavir, which could be life-threatening if Abacavir and Lamivudina SUN is continued.
You are more likely to develop this reaction if you carry a gene called HLA-B*5701 (but you may still have this reaction even if you do not have this gene). You will be tested for the presence of this gene before Abacavir and Lamivudina SUN is prescribed. If you know you carry this gene, inform your doctor before taking Abacavir and Lamivudina SUN.
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 and rash.

Other common symptoms include:

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

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 hands or feet.

When do these reactions occur?
Hypersensitivity reactions can start at any time during treatment with Abacavir and Lamivudina SUN, 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 body aches, or a general feeling of being unwell.

Your doctor may advise you to stop taking Abacavir and Lamivudina SUN.

If you have stopped taking Abacavir and Lamivudina SUN
If you have stopped taking Abacavir and Lamivudina SUN due to a hypersensitivity reaction, YOU MUST NEVER TAKE Abacavir and Lamivudina SUN AGAIN, OR ANY OTHER MEDICINE CONTAINING ABACAVIR (e.g. Kivexa, 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 Lamivudina SUN 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 believes your symptoms may have been due to a hypersensitivity reaction, you will be advised never to take Abacavir and Lamivudina SUN or any other medicine containing abacavir again (e.g. Kivexa, Trizivir, Triumeq, or Ziagen). It is important that you follow this advice.
Sometimes, hypersensitivity reactions have occurred in patients who restarted medicines containing abacavir, even if they had 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 Lamivudina SUN, 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 Lamivudina SUN, you must return all unused tablets of Abacavir and Lamivudina SUN for safe disposal. Ask your doctor or pharmacist for advice.
The Abacavir and Lamivudina SUN packaging 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
These may affect up to 1 in 10 people:

hypersensitivity reaction
headache
vomiting
nausea
diarrhoea
stomach pain
loss of appetite
fatigue, lack of energy
fever (elevated 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

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

low red blood cell count (anaemia) or low white blood cell count (neutropenia)
increased liver enzymes
reduced number of cells involved in blood clotting (thrombocytopenia)

Rare side effects
These 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)
breakdown of muscle tissue

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

increase in an enzyme called amylase

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

sensation of numbness or tingling in the skin (pins and needles)
feeling of weakness in arms and legs
rash with blister-like spots resembling small targets (a dark spot in the center 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 HIV therapy
Combination therapy such as Abacavir and Lamivudina SUN may lead to the development of other conditions during HIV treatment.

Symptoms of infection and inflammation
Old infections may flare up again
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). These infections may have been "silent" and undetected 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 usually include fever, plus some of the following:

headache
stomach pain
difficulty breathing

In rare cases, as the immune system strengthens, it may also attack healthy body tissues (autoimmune disorders). Symptoms of autoimmune disorders may develop many months after starting HIV treatment. Symptoms may include:

palpitations (rapid or irregular heartbeat) or tremor
hyperactivity (agitation and excessive movement)
weakness starting in the hands and feet and spreading toward the trunk of the body.
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 medicines called corticosteroids
if they consume alcohol
if their immune system is very weak
if they are overweight.

Signs of osteonecrosis include:

stiffness in the joints
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 or pharmacist. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Abacavir and Lamivudina SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton, bottle, and blister pack,
following the term “Exp.”. The expiry date refers to the last day of that month.
Bottle: after first opening the bottle, use within 100 days.
Do not store above 30°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Abacavir and Lamivudine SUN contains
The active substances in each film-coated tablet of Abacavir and Lamivudine SUN are 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
The excipients are microcrystalline cellulose, sodium starch glycolate (type A), anhydrous colloidal silica, and magnesium stearate in the tablet core. The tablet coating contains Opadry Orange YS-1-1306, which in turn consists of hypromellose, titanium dioxide (E171), polyethylene glycol 400, polysorbate 80, and the colourant sunset yellow FCF (E110).

Description of the appearance of Abacavir and Lamivudine SUN and package contents
The film-coated tablets of Abacavir and Lamivudine SUN are orange in colour, capsule-shaped tablets measuring 21.4 mm in length and 8.3 mm in width, with "RF-90" engraved on one side and smooth on the other side.

Packaging:
Triple blister pack: PVC/PE/PVDC/Al blister containing 30 tablets.
Blister pack: PVC/PA/Al blister containing 30 tablets.
HDPE bottle: HDPE bottle with polypropylene screw cap or child-resistant closure, containing 30 or 90 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Sun Pharma France
31, Rue Des Poissonniers
92200 Neuilly sur Seine
France

Local representative:
Sun Pharma Italia Srl
Viale Giulio Richard, 3 – 20143 Milano
Italy

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132 JH Hoofddorp
The Netherlands

S.C. Terapia S.A.
Str. Fabricii nr. 124, Cluj, Napoca
Romania

Alkaloida Chemical Company Zrt
Kabay János u.29, Tiszavasvári, H-4440
Hungary

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

United Kingdom (Northern Ireland): Abacavir/Lamivudine 600 mg/300 mg film-coated tablets
Spain: Abacavir/Lamivudina SUN 600 mg/300 mg comprimidos recubiertos con pelicula EFG
Italy: Abacavir e Lamivudina SUN
Germany: Abacavir/Lamivudin Basics 600 mg/300 mg Filmtabletten
France: Abacavir/Lamivudine SUN 600 mg/300 mg comprimé pelliculé
Romania: Abacavir/ Lamivudină Terapia 600 mg/300 mg comprimate filmate

Abacavir and lamivudine Sun

Package Leaflet: Information for the User