ABACAVIR 600 mg/300 mg Фильм-Coated Таблетки

Содержание инструкции

1. Abacavir and Lamivudine Aurobindo 600 mg/300 mg film-coated tablets
   1. What is Abacavir and lamivudina Aurobindo and what it is used for
   2. What you need to know before taking Abacavir and lamivudine Aurobindo
   3. How to take Abacavir and lamivudine Aurobindo
   4. Possible side effects
   5. How to store Abacavir and lamivudine Aurobindo
   6. Package Contents and Other Information

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

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. See section 4.

IMPORTANT— Hypersensitivity reactions
Abacavir and Lamivudine Aurobindo contains abacavir(which is also the active substance contained in
medicines such as Trizivir, Triumeqand Ziagen). Some people taking abacavir may
develop a hypersensitivity reaction(a serious allergic reaction) which can be life-threatening
if they continue to take medicines containing abacavir.

Read carefully all the information provided in ‘Hypersensitivity reactions’ in the
box in section 4.
The pack of Abacavir and Lamivudine Aurobindoincludes a Warning Cardto remind
you and your 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 Aurobindo is and what it is used for
• 2. What you need to know before you take Abacavir and Lamivudine Aurobindo
• 3. How to take Abacavir and Lamivudine Aurobindo
• 4. Possible side effects
• 5. How to store Abacavir and Lamivudine Aurobindo
• 6. Contents of the pack and other information

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

Abacavir and lamivudina Aurobindo is used to treat HIV (Human Immunodeficiency Virus) infection in adults, adolescents and children weighing at least 25 kg.
Abacavir and lamivudina Aurobindo contains two active ingredients used in the treatment of HIV infection: abacavir and lamivudina. These medicines belong to a group of antiretroviral drugs called nucleoside reverse transcriptase inhibitors (NRTIs).
Abacavir and lamivudina Aurobindo 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 Aurobindo in the same way. The doctor will monitor the effectiveness of the treatment.

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, Triumeqor Ziagen), to lamivudine or to any of the other ingredients of this medicine (listed in section 6). Read all the information about hypersensitivity reactions carefully in section 4.Talk to your doctorif you think this applies to you. Do not takeAbacavir and lamivudine Aurobindo.

Warnings and precautions
Talk to your doctor or pharmacist before taking Abacavir and lamivudine Aurobindo.
Some people taking Abacavir and lamivudine Aurobindo 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 had liver diseaseincluding hepatitis B or C (if you have hepatitis B infection do not stop taking Abacavir and lamivudine Aurobindo without consulting your doctor as the 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 usingAbacavir and lamivudine Aurobindo. You may need further checks, including blood tests, while taking the medicine. See section 4 for furtherinformation.

Hypersensitivity reactionsto abacavir
Even patients who do not have the HLA-B*5701 gene can still develop a hypersensitivityreaction(a severe allergic reaction).

Read all the information about hypersensitivity reactions carefully 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.

Tell your doctorif you have heart problems, are a smoker or suffer from illnesses that increase the risk
of heart disease such as high blood pressure or diabetes. Do not stop taking
Abacavir and lamivudine Aurobindo 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 Aurobindo.

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

Other medicines and Abacavir and lamivudine Aurobindo
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Remember to tell your doctor or pharmacist if you are taking a new medicine during
treatment with Abacavir and lamivudine Aurobindo.

These medicines must not be taken withAbacavir and lamivudine Aurobindo:

• emtricitabine 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 withAbacavir and lamivudine Aurobindo
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 Aurobindo.
• methadone, used as a substitute for heroin. 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.
• ribavirin, for the treatment of hepatitis C. Abacavir can make the combination of ribavirin and peginterferon less effective at reducing levels of hepatitis C virus in the body. Tell your doctorif you are taking ribavirin.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are
breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The use of Abacavir and lamivudine Aurobindo is not recommended during pregnancy.
Abacavir and lamivudine Aurobindo and similar medicines can cause unwanted effects in babies
who have not yet been born.
If you have already taken Abacavir and lamivudine Aurobindo during pregnancy, your doctor may
request regular blood tests and other diagnostic tests to monitor the development of the baby. In
children whose mothers took NRTIs during pregnancy, the benefit of protection against
HIV outweighed the risk of side effects.

Breastfeeding
Women who test positive for HIV should not breastfeedwith breast milkbecause
HIV infection can be transmitted to the baby through breast milk. A small amount of the
components of Abacavir and lamivudine Aurobindo can also pass into breast milk.
If you are breastfeeding, or are thinking about it:

talk to your doctor immediately.
Driving and using machines
Abacavir and lamivudine Aurobindo 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 Aurobindo.

Important information about some of the excipients of Abacavir and lamivudine Aurobindotablets
Abacavir and lamivudine Aurobindo contains the colouring agent called sunset yellow (E110) which may
cause allergic reactions in some individuals.

3. How to take Abacavir and lamivudine Aurobindo

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask 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 a day.
Swallow the tablets whole with water. Abacavir and lamivudine Aurobindo can be taken with or
without food.

Remain in constant contact with your doctor
Abacavir and lamivudine Aurobindo 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 lamivudine Aurobindo
without your doctor's advice.

If you take more Abacavir and lamivudine Aurobindothan you should
If you accidentally take more Abacavir and lamivudine Aurobindo, inform your doctor or pharmacist or
contact the Emergency Room of the 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 the
treatment as before.
Do not take a double dose to make up for a missed dose.
It is important to take Abacavir and lamivudine Aurobindo regularly as irregular taking
can increase the risk of having a hypersensitivity reaction.

If you have stopped taking Abacavir and lamivudine Aurobindo
If you have stopped taking Abacavir and lamivudine Aurobindo for any reason - in particular
because you thought you had undesirable 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 lamivudine Aurobindo or any other medicine containing abacavir (such
as Trizivir, Triumeq or Ziagen)again. It is important that you follow this advice.
If the doctor advises you to start taking Abacavir and lamivudine Aurobindo 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 have any 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 gets them.
During HIV therapy, an increase in weight and levels of lipids and glucose in the blood may occur.
This is partly related to the restoration of health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. The doctor will check for these changes.
During HIV treatment, it may be difficult to tell whether a symptom is a side effect of Abacavir and lamivudina Aurobindo or 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 state of health.
Even patients who do not have the HLA-B*5701 gene can still develop a hypersensitivity reaction(a serious 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 Aurobindoand other illnesses may occur.
It is important to read the information in another part of this leaflet under “Other possible side effects of combination therapy for HIV”.

Hypersensitivity reactions
Abacavir and lamivudina Aurobindo contains abacavir (which is also the active ingredient contained in medicines such as 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 that contain abacavir.

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

What are the symptoms?
The most common symptoms are:

• fever(high temperature) and skin rash.

Other common symptoms are:

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

Other symptoms include:

• muscle or joint pain, swelling of the 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 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 experience symptoms from at least 2 of the following groups:

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

Your doctor may recommend that you stop taking Abacavir and lamivudina Aurobindo.
If you have stopped taking Abacavir and lamivudina Aurobindo
If you have stopped taking Abacavir and lamivudina Aurobindo due to a hypersensitivity reaction, you MUST NEVER take Abacavir and lamivudina Aurobindo again, or any other medicine containing abacavir (e.g. 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 Aurobindo 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 thinks that these symptoms may have been related to a hypersensitivity reaction, you will be told not to take Abacavir and lamivudina Aurobindo or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen) ever again. 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 previously reported only one of the symptoms described in the Alert Card before stopping the medicine.
Very rarely, patients who had previously taken medicines containing abacavir without any symptoms of hypersensitivity have then developed a hypersensitivity reaction when they started taking these medicines again.
If your doctor recommends starting to take Abacavir and lamivudina Aurobindo again, you will be asked to take the first doses in a place where you will be able to receive medical assistance if necessary.

If you are hypersensitive to Abacavir and lamivudina Aurobindo, you must return all unused tablets of Abacavir and lamivudina Aurobindo for safe disposal. Ask your doctor or pharmacist for advice.
The pack of Abacavir and lamivudina Aurobindo includes an Alert Cardto remind you and your 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 10people):

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

Uncommon side effects(these may affect up to 1 in 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
• reduced number of cells involved in blood clotting (thrombocytopenia)

Rare side effects(these may affect up to 1 in 1000people):

• 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 can be detected by blood tests are:

• increased level of an enzyme called amylase

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

• feeling of numbness or tingling in the skin
• 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 pale area with a black ring around the edge) (erythema multiforme)
• widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome) and a more severe form causing 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 side effect becomes serious or bothersome, 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 lamivudina Aurobindo can cause the development of other illnesses during HIV treatment.

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 may be “silent” and not detected by the weakened immune system before treatment starts. After treatment starts, the immune system becomes stronger and may 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 may also attack healthy tissues in the body (autoimmune disorders). Symptoms of autoimmune disorders can develop many months after starting to take the medicine for HIV infection. Symptoms may include:

• palpitations (fast or irregular heartbeat) or tremor
• hyperactivity (agitation and excessive movement)
• weakness starting in the hands and feet and spreading to the trunk of the body.

If you experience any symptoms of infectionand inflammation or notice any of the symptoms listed above: tell your doctor immediately. Do not take any other medicines for the infection without your doctor’s advice.

You may have bone problems
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 time
• if they are also taking anti-inflammatory drugs called corticosteroids
• if they drink alcohol
• if their immune system is very weak
• if they are overweight.

Signs of osteonecrosis include:

• stiffness of the joints
• 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 or nurse. You can also report side effects directly through 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 which is stated on the label, on the pack and on the
blister after EXP. The expiry date refers to the last day of that month.

Blister pack: Store at a temperature below 30  C

HDPE bottle: This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water 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 Aurobindo contains
The active ingredients are abacavir and lamivudine.
Each film-coated tablet contains 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
The other ingredients 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, yellow FD&C No. 6 aluminum lake (E110)

Description of the appearance of Abacavir and lamivudina Aurobindo and package contents
Film-coated tablets.
Film-coated tablets in a modified capsule shape, orange in color, with “H” imprinted on
one side and “27” on the other side. The size is 20.7 mm x 9.2 mm.
Abacavir and lamivudina Aurobindo film-coated tablets are available in blister packs and in
opaque white HDP containers with an opaque white polypropylene closure.
Packs:
Blister packs: 30, 50, 60, 90 film-coated tablets
HDPE packs: 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)

Manufacturers responsible 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 Member States of the European Economic Area under the
following denominations:
Belgium Abacavir/Lamivudine AB 600 mg/300 mg film-coated tablets
France Abacavir/Lamivudine Arrow 600 mg/300 mg coated tablets
Germany Abacavir/Lamivudin Aurobindo 600 mg/300 mg film tablets
Italy Abacavir e Lamivudina Aurobindo
Portugal Abacavir + Lamivudina Aurovitas
Romania Abacavir/Lamivudină Aurobindo 600 mg/300 mg film-coated tablets
Spain Abacavir/Lamivudina Aurovitas 600 mg/300 mg film-coated tablets EFG
Netherlands Abacavir/Lamivudine Aurobindo 600 /300 mg, film-coated tablets
United Kingdom Abacavir/Lamivudine Milpharm 600 mg/300 mg film-coated tablets