ABACAVIR 600 mg/300 mg Фильм-Coated Таблетки

Содержание инструкции

1. Abacavir and Lamivudine SUN 600 mg/300 mg film-coated tablets
   1. What is Abacavir and Lamivudina SUN and what it is used for
   2. What you need to know before taking Abacavir and Lamivudine SUN
   3. How to take Abacavir and Lamivudina SUN
   4. Possible side effects
2. abacavir (for example Kivexa, Trizivir, Triumeq or Ziagen). It is important that you follow this
   1. How to store Abacavir and Lamivudina SUN
   2. Package Contents and Other Information

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

abacavir/lamivudine

Generic medicine
Read this leaflet carefully before you start 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 could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist immediately. See section 4.

IMPORTANT — Hypersensitivity reactions
Abacavir and Lamivudine SUN contains abacavir(which is also the active substance contained in
medicines such as Kivexa, Trizivir, Triumeqand 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 reported in ‘Hypersensitivity reactions’ in the box of
section 4.
The pack of Abacavir and Lamivudine SUN includes an Alert Cardto remind you and
healthcare professionals about abacavir hypersensitivity. Remove this card and carry it with you at all times.
Contents of this leaflet:

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

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

Abacavir and Lamivudina SUN is used to treat HIV (Human Immunodeficiency Virus) infection in adults, adolescents and children weighing at least 25 kg.
Abacavir and Lamivudina SUN contains two active ingredients used in the treatment of HIV infection: abacavir and lamivudine. These medicines belong to a group of antiretroviral drugs called nucleoside reverse transcriptase inhibitors (NRTIs).
Abacavir and Lamivudina SUN does not completely cure HIV infection; it reduces the viral load in the body and keeps it at low levels. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell important in helping the body fight infection.
Not all people respond to treatment with Abacavir and Lamivudina SUN in the same way. The doctor will monitor the effectiveness of the treatment.

2. What you need to know before taking Abacavir and Lamivudine SUN

Do not take Abacavir and Lamivudine SUN:

• if you are allergicto abacavir (or to any other medicine containing abacavir - for example Kivexa, Trizivir, Triumeqor Ziagen), to lamivudine or to any of the other ingredients of this medicine (listed in section 6). Read carefully all the information on hypersensitivity reactions in section 4.Talk to your doctorif 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 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 ever had a liver diseaseincluding 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 return)
• if you are severely overweight(especially if you are a woman)
• if you have a kidney problemTell your doctor if any of these situations apply to you before using Abacavir andLamivudine SUN. You may need further checks, including blood tests, while taking the 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(a severe allergic reaction).

Read carefully all the information on hypersensitivity reactions in Section 4 of this
leaflet.
Risk of cardiovascular events
It cannot be excluded that abacavir may be associated with an increased risk of cardiovascular
events.

Tell your doctorif you have cardiovascular problems,are a smokeror suffer from diseases that can
increase the risk of cardiovascular disease such as high blood pressureand/or diabetes. Do not
stop taking Abacavir and Lamivudine SUN unless this is recommended by your doctor.

Pay attention to important symptoms
Some people taking medicines for HIV infection 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 Abacavir and Lamivudine SUN.

Read the information in ‘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 you bought without
prescription.
Remember to tell your doctor or pharmacist if you start taking any new medicine during
treatment with Abacavir and Lamivudine SUN.

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

• emtricitabine, to treat HIV infection
• other medicines containing lamivudine used to treat HIV infectionor hepatitis B virus infection

of hepatitis B

• high doses of trimethoprim/sulfamethoxazole,an antibiotic
• cladribine, used to treat hairy cell leukemia.Tell your doctorif you are being treated with any of these medicines.

Some medicines interact with Abacavir and Lamivudine SUN
These include:

• phenytointo treat epilepsy.Tell your doctorif 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 symptoms of withdrawal. It may be necessary to change the dose of methadone. Tell your doctorif you are taking methadone.
• medicines (usually liquid) containing sorbitol and other sweeteners(such as xylitol, mannitol, lactitol or maltitol), if taken regularly. Tell your doctor or pharmacistif you are taking any of these.
• Riociguat, for the treatment of high blood pressure in the blood vessels(pulmonary arteries) that carry blood from the heart to the lungs. Your doctor may need to reduce the dose of riociguat, as abacavir can increase the levels of riociguat in the blood.

Pregnancy
The use of Abacavir and Lamivudine SUN during pregnancy is not recommended.Abacavir and
Lamivudine SUN and similar medicines can cause unwanted effects in unborn babies. If you have
already taken Abacavir and Lamivudine SUN during pregnancy, your doctor may require regular
blood tests and other diagnostic tests to monitor the development of the baby. In children whose mothers
have taken NRTIs during pregnancy, the benefit of protection against HIV has outweighed the risk of
side effects.

Breast-feeding
Breast-feeding is not recommended in women infected 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 can also pass into breast milk.
If you are breast-feeding, or planning to:

talk to your doctor as soon as possible.
Driving and using machines
Abacavir and Lamivudine SUN can cause side effects that may affect your ability to
drive and use machines.

Talk to your doctorabout your ability to drive and use machines while taking Abacavir and
Lamivudine SUN.

Abacavir and Lamivudine SUN contains a dye called sunset yellow (E110)
Abacavir and Lamivudine SUN contains a dye 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, that is to say
essentially ‘sodium-free’.

3. How to take Abacavir and Lamivudina SUN

Always take this medicine exactly as your doctor has told you. If you have any doubts
ask your doctor or pharmacist.

The recommended dose of Abacavir and Lamivudina SUN in adults, adolescents and children
weighing 25 kg or more is one tablet once a day.
Swallow the tablets whole with water. Abacavir and Lamivudina SUN can be taken with or without food.

Stay in constant contact with your doctor
Abacavir and Lamivudina SUN helps to control the disease. It is necessary to take it every day to
prevent the disease from worsening. You may still develop other infections and diseases related to HIV infection.

Stay in contact with your doctor, and do not stop taking Abacavir and Lamivudina SUNwithout your
doctor's advice.

If you take more Abacavir and Lamivudina SUN than you should
If you accidentally take more Abacavir and Lamivudina SUN, inform your doctor or pharmacist or contact
the Emergency Room of the nearest hospital for further advice.

If you forget to take Abacavir and Lamivudina SUN
If you forget to take a dose, take it as soon as possible when you remember. Then continue the
treatment as before. Do not take a double dose to make up for a missed dose.
It is important to take Abacavir and Lamivudina SUN regularly, as taking it at irregular intervals may increase the risk of having a hypersensitivity reaction.

If you have stopped taking Abacavir and Lamivudina SUN
If you have stopped taking Abacavir and Lamivudina SUN for any reason - in particular
because you thought you had unwanted effects or because you had other diseases:

talk to your doctor before starting to take it again.The doctor will check if the symptoms
were related to a hypersensitivity reaction. If the doctor believes that these symptoms may
have been related to a hypersensitivity reaction, you will be told to never take
Abacavir and Lamivudina SUN or any other medicine containing abacavir (e.g.
Kivexa, Trizivir, Triumeq or Ziagen)again. It is important that you follow this advice.
If the doctor advises you to start taking Abacavir and Lamivudina SUN again, you will be asked
to take the first doses in a place where you will be able to receive, if necessary, medical assistance.

4. Possible side effects

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 medications themselves. The doctor will check these changes.
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
During HIV treatment, it may be difficult to tell whether a symptom is a side effect of Abacavir and Lamivudina SUN or other medicines you are taking, or an effect of the HIV disease itself. For this reason, it is very important to inform your doctor about any changes in your health.
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 about this serious reaction.
During combination therapy for HIV, both the side effects listed below for Abacavir and Lamivudina SUN,and other illnesses may occur.
It is important to read the information below in the section ‘Other possible side effects of combination therapy for HIV’.

Hypersensitivity reactions
Abacavir and Lamivudina SUNcontains abacavir(which is also the active ingredient contained in medicines such as Kivexa, Trizivir, Triumeqand Ziagen). 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 can experience these reactions?
Anyone taking Abacavir and Lamivudina SUN could develop a hypersensitivity reaction to abacavir that could be life-threatening if Abacavir and Lamivudina SUN continues to be taken.
You are more likely to develop this reaction if you have a gene called HLA-B*5701(but you can experience this reaction even if you do not have this gene). You will be tested for the presence of this gene before you are prescribed Abacavir and Lamivudina SUN. If you know you have this gene, tell your doctor before taking Abacavir and Lamivudina SUN.
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 experienced a hypersensitivity reaction.

What are the symptoms?
The most common symptoms are:

• feverand skin rash.

Other common symptoms are:

• nausea, vomiting, diarrhea, abdominal pain (stomach pain), severe fatigue.

Other symptoms include:
muscle or joint pain, swelling of the 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?
Hypersensitivity reactions can start at any time during treatment with Abacavir and Lamivudina SUN but are more likely during the first 6 weeks of treatment.

Contact your doctor immediately:
1if you develop a skin rash, OR
2if you experience symptoms from at least 2 of the following groups:

• fever
• shortness of breath, sore throat or cough
• nausea or vomiting, diarrhea or abdominal pain
• severe fatigue or feeling unwell, or general malaise.

Your doctor may recommend that you 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 should NEVER take Abacavir and Lamivudina SUN again, or any other medicine containing abacavir (e.g. Kivexa, Trizivir, Triumeq or Ziagen).If this happens, your blood pressure could drop dangerously within hours, which could be fatal.
If you have stopped taking Abacavir and Lamivudina SUN for any reason - especially 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 the symptoms were related to a hypersensitivity reaction. If the doctor believes that these symptoms may have been related to a hypersensitivity reaction, you will be told not to ever take Abacavir and Lamivudina SUN or any other medicine containing

abacavir (for example Kivexa, Trizivir, Triumeq or Ziagen). It is important that you follow this

advice.
Hypersensitivity reactions have sometimes occurred in patients who started taking
medicines containing abacavir again, but who had also reported even one of the symptoms
described in the Warning Card before stopping the medicine.
Very rarely, patients who had previously taken medicines containing abacavir without
any symptoms of hypersensitivity, then developed a hypersensitivity reaction when
they started taking these medicines again.
If the doctor recommends starting Abacavir and Lamivudine SUN again, you will be
asked to take the first doses in a place where you will be able to receive, if necessary, medical
assistance.

If you are hypersensitive to Abacavir and Lamivudine SUN, you must return all unused tablets of
Abacavir and Lamivudine SUN for safe disposal.Ask your
doctor or pharmacist for advice.
The package of Abacavir and Lamivudine SUN includes a Warning Cardto remind you
and medical personnel of hypersensitivity reactions. Detach this card and keep it with you at all
times.
Common side effects
These may affect up to 1in 10people:

• hypersensitivity reaction
• headache
• vomiting
• nausea
• diarrhoea
• stomach pain
• loss of appetite
• fatigue, lack of energy
• fever (high temperature)
• general feeling of being unwell
• sleep disorders ( insomnia)
• muscle discomfort and pain
• joint pain
• cough
• irritation in the nasal mucous membranes or runny nose
• skin rash
• hair loss

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

• low number of red blood cells ( anaemia) or low number of white blood cells ( neutropenia)
• increased liver enzymes
• reduction in the number of cells involved in blood clotting ( thrombocytopenia)

Rare side effects
These may affect up to 1in 1000:

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

Rare side effects that can be detected by blood tests are:

• an increase in an enzyme called amylase

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

• feeling of numbness or tingling in the skin (pins and needles)
• feeling of weakness in the arms and legs
• skin rash with blister-like formations resembling small targets (a dark spot in the centre surrounded by a clear area with a black ring around the edge) ( erythemamultiforme)
• widespread skin 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).
• 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 can be detected by blood tests is:

• bone marrow failure to produce new red blood cells ( pure red cell aplasia).

If you get side effects
Tell your doctor or pharmacistif any of the side effects becomes
serious or worrying, 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 SUN can cause the development of other
diseases 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). These infections can
be “silent” and not detected by the weakened immune system before treatment begins.
After treatment begins, the immune system becomes stronger and can react against infections
causing symptoms of infection or inflammation. Symptoms generally include fever,plus some
of the following symptoms:

• headache
• stomach pain
• difficulty breathing

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

• palpitations (rapid or irregular heartbeat) or tremor
• hyperactivity (agitation and excessive movement)
• weakness that starts in the hands and feet and spreads to the trunk of the body. If you experience any symptoms of infectionand inflammation or if you notice any of the symptoms listed above: tell your doctor immediately. Do not take other medicines for the infection without

medical advice.

You may have problems with your bones
Some people taking 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 flow to the bone. People may be more likely to develop this
disease:

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

Signs of osteonecrosis include:

• joint stiffness
• pain (especially in the hip, knee or shoulder)
• difficulty moving

If you notice any of these symptoms:

tell your doctor.

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly
through 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 box, bottle and blister,
after the wording “Exp.”. The expiry date refers to the last day of that month.
Bottle: after the first opening of the bottle, use within 100 days.
Do not store at a temperature above 30°C.
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 and Lamivudina SUN contains
The active ingredients contained in each film-coated tablet of Abacavir and Lamivudina 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
silicon dioxide and magnesium stearate in the tablet core. The tablet coating contains Opadry
Orange YS-1-1306 which in turn contains hypromellose, titanium dioxide (E171), macrogol 400,
polysorbate 80 and the sunset yellow FCF dye (E110).

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

Packs:
Triple blister pack: PVC/PE/PVDC/Al blister containing 30 tablets.
Blister pack: PVC/PA/Al blister containing 30 tablets.
HDPE bottle pack: HDPE bottle with a polypropylene screw cap or child-resistant closure,
containing 30 or 90 tablets.
Not all pack sizes may be 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 Italia

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87, 2132 JH Hoofddorp
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 Member States of the European Economic Area and in the
United Kingdom (Northern Ireland) with the following denominations:
United Kingdom (Northern
Ireland)
Abacavir/Lamivudine 600 mg/300 mg film-coated tablets
Spain Abacavir/Lamivudina SUN 600 mg/300 mg film-coated tablets 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