Abacavir Mylan: detailed information

Patient Information Leaflet

Abacavir Mylan 300 mg film-coated tablets

Abacavir
Generic Medicine
Please read all of this leaflet carefully before you start 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, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

IMPORTANT – Hypersensitivity reactions
Abacavir Mylan contains abacavir. Some people taking abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which can be life-threatening if treatment with abacavir-containing medicines is continued.
Please read carefully all the information under 'Hypersensitivity reactions' in the box in section 4.
The Abacavir Mylan package includes a Warning Card to remind you and healthcare professionals about abacavir hypersensitivity. Remove this card and carry it with you at all times.

Contents of this leaflet:

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

1. What Abacavir Mylan is and what it is used for

Abacavir Mylan is used to treat HIV (Human Immunodeficiency Virus) infection.
Abacavir Mylan contains the active substance abacavir. Abacavir belongs to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Abacavir 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 cell important in helping the body fight infection.
Not everyone responds to treatment with abacavir in the same way. Your doctor will monitor how well the treatment is working.

2. What you need to know before taking Abacavir Mylan

Do not take Abacavir Mylan:

if you are allergic ( hypersensitive ) to abacavir (or to any other medicine containing abacavir –
such as abacavir/lamivudine, abacavir/lamivudina/zidovudine, abacavir/dolutegravir/lamivudine), or
to any of the other ingredients of this medicine (listed in section 6).
Please read carefully all the information about hypersensitivity reactions in section 4.
Contact your doctor if you think this applies to you.
Be especially careful with Abacavir Mylan
Some people taking abacavir for the treatment of HIV are at higher risk of serious side effects. You should be aware of these additional risks:
Inform your doctor or pharmacist before taking Abacavir Mylan:
if you have moderate or severe liver disease
if you have had liver disease, including hepatitis B or C
if you are severely overweight (especially if you are a woman)
if you have severe kidney disease.

Inform your doctor if any of these situations apply to you. You may need additional monitoring, including blood tests, while taking this medicine. See section 4 for further information.
Hypersensitivity reactions to abacavir
Even patients who do not have the HLA-B*5701 gene can still develop a hypersensitivity reaction (a severe allergic reaction).
Please read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.
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 have diseases that increase the risk of heart disease, such as high blood pressure or diabetes. Do not stop taking Abacavir Mylan unless your doctor advises you to do so.
Pay attention to important symptoms
Some people taking medicines for HIV infection develop other conditions that may be serious. You should be aware of important signs and symptoms so that you can remain vigilant while taking Abacavir Mylan.
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 transmission of infected blood (e.g. by sharing injecting needles).
You may 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 Mylan
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription. Some medicines interact with Abacavir Mylan
These include:

rifampicin, used to treat bacterial infections
phenobarbital or phenytoin, used to treat epilepsy. Inform your doctor if you are taking rifampicin, phenobarbital or phenytoin. Your doctor may need to monitor you while you are taking Abacavir Mylan.
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 signs of withdrawal. It may be necessary to adjust your methadone dose. Inform your doctor if you are taking methadone.

Pregnancy
The use of abacavir during pregnancy is not recommended. Abacavir and similar medicines may cause side effects in unborn children. If you have taken abacavir during pregnancy, your doctor may regularly perform 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.
Breast-feeding
Women who are HIV-positive must not breast-feed because HIV infection can be transmitted to the child through breast milk. A small amount of the components of Abacavir Mylan may also pass into breast milk. If you are breast-feeding or are considering doing so:
talk to your doctor immediately.
Driving and using machines
Do not drive or operate machinery unless you feel well.

3. How to take Abacavir Mylan

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Swallow the tablets with water. Abacavir Mylan may be taken with or without food.
Stay in regular contact with your doctor.
Abacavir helps control your condition. You must take it every day to prevent the 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 Mylan without your doctor's advice.

Dosage
Adults, adolescents and children weighing at least 25 kg
The recommended dose is 600 mg daily. This may be taken either as one 300 mg tablet twice daily or as two 300 mg tablets once daily.

Children from one year of age weighing less than 25 kg
The dose depends on the child's body weight. The recommended doses are:

Children weighing at least 20 kg and less than 25 kg: The recommended dose is 450 mg daily. This may be taken either as 150 mg (half a tablet) in the morning and 300 mg (one whole tablet) in the evening, or as 450 mg (one and a half tablets) once daily, as advised by the doctor.
Children weighing at least 14 kg and less than 20 kg: The recommended dose is 300 mg daily. This may be taken either as 150 mg (half a tablet) twice daily or as 300 mg (one whole tablet) once daily, as advised by the doctor. The tablet may be divided into equal doses. Other formulations of this medicine may be more suitable for treating children older than three months and weighing less than 14 kg, or for patients requiring a lower than usual dose, or for patients unable to swallow tablets.

If you take more Abacavir Mylan than you should
If you accidentally take more Abacavir Mylan than prescribed, inform your doctor or pharmacist or contact the nearest hospital emergency department for further advice.

If you forget to take Abacavir Mylan
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. Do not take a double dose to make up for the forgotten dose.
It is important to take Abacavir Mylan regularly, as taking it at irregular intervals may increase the risk of developing a hypersensitivity reaction.

If you have stopped taking Abacavir Mylan
If you have stopped taking Abacavir Mylan for any reason—particularly because you thought you were experiencing side effects or other illnesses—
talk to your doctor before starting to take it again. Your doctor will 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 Mylan or any other medicine containing abacavir again (e.g., abacavir/lamivudine, abacavir/lamivudine/zidovudine, abacavir/dolutegravir/lamivudina). It is important that you follow this advice.
If your doctor advises restarting Abacavir Mylan, 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 body 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 medicines themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
During HIV treatment, it may be difficult to determine whether a symptom is an unwanted side effect of abacavir 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 health.
Even patients who do not carry the HLA-B*5701 gene can still develop a hypersensitivity reaction (a serious 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.
When taking combination therapy for HIV, the side effects listed below for abacavir may occur, as well as other conditions.
It is important to read the information contained elsewhere in this leaflet under ‘Other possible side effects of combination therapy for HIV’.

Contact a doctor immediately if you experience any of the following side effects:

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

Hypersensitivity (allergic) reactions. For further information about these symptoms, see the box below “Hypersensitivity reactions”.

Hypersensitivity reactions
Abacavir Mylan contains abacavir.
Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction.
Such hypersensitivity reactions have been observed more frequently in people taking medicines containing abacavir.
Who is at risk of these reactions?
Any person taking Abacavir Mylan could develop a hypersensitivity reaction to abacavir, which could be life-threatening if Abacavir Mylan 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 must be tested for the presence of this gene before Abacavir Mylan is prescribed. If you know you carry this gene, inform your doctor before taking Abacavir Mylan. In a clinical study, among 100 patients treated with abacavir who did not have the HLA-B*5701 gene, approximately 3 to 4 patients experienced a hypersensitivity reaction.
What are the symptoms?
The most common symptoms are:

fever (high temperature) and skin rash.

Other common symptoms are:

nausea (feeling unwell), vomiting (being sick), diarrhoea, abdominal pain (stomach pain), severe tiredness.

Other symptoms include:
Joint or muscle pain, swelling of the face, mouth, tongue or throat with difficulty breathing or swallowing, swelling of glands in the arm or neck, general swelling, shortness of breath, signs of respiratory problems such as rapid and shallow breathing, fatigue or confusion, sore throat, cough, occasional headaches, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness in the hands or feet, signs of liver problems such as elevated liver function tests, yellowing of the skin or whites of the eyes, dark urine or pale stools, signs of kidney problems such as little or no urine production or back pain, and increased creatinine or creatine phosphokinase, which may be detected by a blood test.
When do these reactions occur?
The hypersensitivity reaction can start at any time during treatment with Abacavir Mylan, but is most likely during the first 6 weeks of treatment.
If you are caring for a child being treated with Abacavir Mylan, it is important that you understand the information about this hypersensitivity reaction. If the child shows any of the symptoms described below, it is essential that you follow the instructions provided.
Contact your doctor immediately:

if you develop a skin rash OR
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 a general feeling of being unwell. Your doctor may advise you to stop taking Abacavir Mylan.

If you have stopped taking Abacavir Mylan
If you have stopped taking Abacavir Mylan due to a hypersensitivity reaction, you must NEVER take Abacavir Mylan again, or any other medicine containing abacavir (e.g. abacavir/lamivudine, abacavir/lamivudine/zidovudine and abacavir/dolutegravir/lamivudine). If you do, within a few hours your blood pressure could drop dangerously, which could lead to death.
If you have stopped taking Abacavir Mylan for any reason – particularly because you thought you were experiencing side effects or other illnesses:
Talk to your doctor before restarting treatment. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor thinks your symptoms may have been due to a hypersensitivity reaction, you will be told never to take Abacavir Mylan or any other medicine containing abacavir (e.g. abacavir/lamivudine, abacavir/lamivudine/zidovudine and abacavir/dolutegravir/lamivudine) 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 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 hypersensitivity symptoms have later developed a hypersensitivity reaction when restarting these medicines.
If your doctor advises restarting abacavir, you will be asked to take the first doses in a place where you can receive immediate medical help if needed.
If you are hypersensitive to abacavir, you must return all unused Abacavir Mylan tablets for safe disposal. Ask your doctor or pharmacist for advice.
The Abacavir Mylan package includes a Warning Card to remind you and medical staff about hypersensitivity reactions. Detach this card and keep it with you at all times.

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

Inflammation of the pancreas (pancreatitis). You may experience severe stomach pain spreading to your back, a swollen and tender stomach, and a general feeling of being unwell.

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

Skin rash with blistering 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 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 causing peeling of the skin over more than 30% of the body surface (toxic epidermal necrolysis).
Lactic acidosis (excess lactic acid in the blood).

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

Feeling unwell (nausea)
Headache
Feeling sick (vomiting)
Diarrhoea
Loss of appetite
Tiredness, lack of energy
Fever (high temperature)
Skin rash

If you experience side effects
Tell 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 including abacavir 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 (Acquired Immunodeficiency Syndrome - AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). When these people start treatment, previously hidden infections may flare up, causing signs and symptoms of inflammation. These symptoms are probably due to immune reconstitution, meaning the body starts fighting these infections. 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 tissues in the body (autoimmune disorders). Symptoms of autoimmune disorders may develop many months after starting the medicine for HIV infection. Symptoms may include:

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

If you notice any symptoms of infection while taking Abacavir Mylan:
contact your doctor immediately. Do not take any other medicines for the infection without consulting your doctor.
You may have bone problems
Some people receiving combination antiretroviral therapy for HIV infection develop a condition called osteonecrosis. As a result of this condition, part of the bone tissue dies due to reduced blood supply to the bone. People may be more likely to develop this condition:

if they have been on combination therapy for a long time
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 http://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 Mylan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister after "Exp.". The
expiry date refers to the last day of that month.
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. Contents of the pack and other information

What Abacavir Mylan contains
Each film-coated tablet contains 300 mg of abacavir.
The other excipients are microcrystalline cellulose, sodium starch glycolate, magnesium stearate and anhydrous colloidal silica in the tablet core. The tablet coating contains hypromellose, titanium dioxide, triacetin, yellow iron oxide (E172) and polysorbate.

Description of the appearance of Abacavir Mylan and contents of the pack
Abacavir Mylan is a yellow, capsule-shaped, film-coated tablet with rounded edges, marked with "H" on one side with a breakline, and "A" and "26" separated by a breakline on the other side.
Abacavir Mylan is available in blisters containing 60 and 60 x 1 film-coated tablets.

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

Manufacturer:
Pharmadox Healthcare Limited, KW20A Kordin Industrial Park, Paola, PLA 3000, Malta

This medicine is authorised in the European Economic Area countries under the following names:
France Abacavir Mylan 300 mg, comprimés pelliculés
Italy Abacavir Mylan
Netherlands Abacavir Mylan 300 mg filmomhulde tabletten
Portugal Abacavir Mylan
United Kingdom Abacavir Mylan 300 mg Film-coated Tablets