INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo ASPEN ABACAVIR 20 mg/mL (oral solution)

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

ASPEN ABACAVIR 20 mg/mL (oral solution)

WARNING
Hypersensitivity: In clinical studies, approximately 4% of subjects receiving ASPEN ABACAVIR developed a hypersensitivity reaction which in rare cases proved fatal.
Description: This is characterised by the appearance of symptoms indicating multiorgan/body-system involvement. The majority of patients have fever and/or rash as part of the syndrome. The symptoms of this hypersensitivity reaction can occur at any time during treatment with ASPEN ABACAVIR, but usually appear within the first 6 weeks of initiation of treatment with ASPEN ABACAVIR (median time to onset 11 days), and most often include fever, gastrointestinal symptoms (nausea, vomiting, diarrhoea and abdominal pain), rash and fatigue or malaise. Other symptoms may include myalgia, arthralgia, oedema, paraesthesia and respiratory symptoms such as dyspnoea, sore throat or cough.
The symptoms worsen with continued therapy and can be life-threatening. These symptoms usually resolve upon discontinuation of ASPEN ABACAVIR.
Management: To avoid a delay in diagnosis and minimize the risk of a life threatening hypersensitivity reaction, ASPEN ABACAVIR should be permanently discontinued if hypersensitivity cannot be ruled out, even when other diagnoses are possible (respiratory diseases, flu-like illness, gastroenteritis or reactions to other medications).
ASPEN ABACAVIR should not be re-started even if a recurrence of symptoms occurs following re-challenge with alternative medication(s).
An Alert Card with information for the patient about the hypersensitivity reaction is included in the ASPEN ABACAVIR pack.
Special considerations following an interruption of ASPEN ABACAVIR therapy:
If therapy with ASPEN ABACAVIR has been discontinued and restarting therapy is under consideration, the reason for discontinuation should be evaluated to ensure that the patient did not have symptoms of a hypersensitivity reaction. Patients who have stopped ASPEN ABACAVIR due to possible adverse reactions or illness should be advised to contact their doctor before restarting. If hypersensitivity cannot be ruled out ASPEN ABACAVIR should not be restarted.
There have been infrequent reports of hypersensitivity reaction following reintroduction of ASPEN ABACAVIR, where the interruption was preceded by a single key symptom (e.g. rash, fever or gastrointestinal symptoms). When patients who have discontinued ASPEN ABACAVIR present with an indeterminate diagnosis of hypersensitivity (single symptom), the doctor should:
•        Assess the probability that hypersensitivity preceded the interruption
•        Assess the risk: benefit of reinitiating ASPEN ABACAVIR
•        Select the appropriate medical setting in which to re-introduce ASPEN ABACAVIR, if such a decision is made.
On very rare occasions hypersensitivity reactions have been reported in patients who have re-started therapy, and who had no apparent preceding symptoms of a hypersensitivity reaction. Some of these cases were poorly documented. The clinical significance of these reports is unclear. If a decision is made to re-start ASPEN ABACAVIR, this must be done only if medical care can be accessed readily by the patient or others.
Essential patient information:
Prescribers must ensure that patients are fully informed regarding the following hypersensitivity reaction:
•        Patients must be made aware of the possibility of a hypersensitivity reaction to
abacavir that may result in a life-threatening reaction or death.
•        Patients developing signs or symptoms possibly linked with a hypersensitivity reaction MUST CONTACT their doctor IMMEDIATELY.
•        In order to avoid restarting ASPEN ABACAVIR, patients who have experienced a hypersensitivity reaction should be asked to return the remaining ASPEN ABACAVIR Oral Solution to the pharmacy.
•        Patients who have stopped ASPEN ABACAVIR for any reason, and particularly due to adverse reactions or illness, must be advised to contact their doctor before restarting.
•        Each patient should be reminded to read the package insert and the PIL included in the ASPEN ABACAVIR pack. They should be reminded of the importance of removing the Alert Card included in the pack and keeping it with them at all times.

COMPOSITION
Each milliliter contains the equivalent of 20 mg
abacavir as abacavir sulphate.
Preservatives: methylparaben 0,15% m/v
  propylparaben 0,018% m/v.

PHARMACOLOGICAL CLASSIFICATION
A 20.2.8 Antivirals

PHARMACOLOGICAL ACTION
Abacavir is a nucleoside analogue reverse transcriptase inhibitor. It is an antiviral agent against HIV-1 and HIV-2, including HIV-1 isolates that are resistant to zidovudine, lamivudine, zalcitabine, didanosine or nevirapine. In vitro studies have demonstrated that its mechanism of action in relation to HIV is inhibition of the HIV reverse transcriptase enzyme, an event that results in chain termination and interruption of the viral replication cycle. Abacavir shows synergy in vitro in combination with nevirapine and zidovudine. It has been shown to be additive in combination with didanosine, zalcitabine, lamivudine and stavudine.
Abacavir-resistant isolates of HIV-1 have been selected in vitro and are associated with specific genotypic changes in the reverse transcriptase (RT) codon region (codons M184V, K65R, L74V and Y115F). Viral resistance to abacavir develops relatively slowly in vitro and in vivo, requiring multiple mutations to reach an eight-fold increase in IC50 over wild-type virus, which may be a clinically relevant level. Isolates resistant to abacavir may also show reduced sensitivity to lamivudine, zalcitabine and/or didanosine, but remain sensitive to zidovudine and stavudine. Cross-resistance between abacavir and protease inhibitors or non-nucleoside reverse transcriptase inhibitors is unlikely.
Treatment failure following initial therapy with abacavir, lamivudine and zidovudine is mainly associated with the M184V alone, thus maintaining many therapeutic options for a second line regimen.
In therapy experienced patients, limited data show that the addition of ASPEN ABACAVIR to nucleoside reverse transcriptase inhibitors provides additional benefit in reducing viral load, and increasing CD4 cell count. The degree of benefit will depend on the nature and duration of prior therapy, which may have been selected for cross-resistance to abacavir.
Pharmacokinetics:
Absorption:
Abacavir is well absorbed following oral administration. The absolute bioavailability of oral abacavir in adults is about 83%. Following oral administration, the mean time (t
max) to maximal serum concentrations of abacavir is about 1,0 hour for the solution formulation.
Food delayed absorption and decreased C
max but did not affect overall plasma concentrations (AUC). Therefore abacavir can be taken with or without food.
Distribution:
Studies in HIV infected patients have shown good penetration of abacavir into the cerebrospinal fluid (CSF), with a CSF to plasma AUC ratio of between 30 to 44%.
In a phase I pharmacokinetic study, the penetration of abacavir into the CSF was investigated following administration of abacavir 300 mg twice a day. The mean concentration of abacavir achieved in the CSF 1,5 hours post dose was 0,14 micrograms/mL.
In a further pharmacokinetic study of 600 mg twice a day, the CSF concentration of abacavir increased over time, from approximately 0,13 micrograms/mL at 0,5 to 1 hour after dosing, to approximately 0,74 micrograms/mL after 3 to 4 hours. While peak concentrations may not have been attained by 4 hours, the observed values are 9-fold greater than the IC50 of abacavir 0,08 micrograms/mL or 0,26 microM.
Plasma protein binding studies in vitro indicate that abacavir binds only moderately (~49%) to human plasma proteins at therapeutic concentrations. This indicates a low likelihood for drug interactions through plasma protein binding displacement.
Metabolism:
Abacavir is primarily metabolised by the liver with less than 2% of the administered dose being renally excreted, as unchanged compound. The primary pathways of metabolism in man are by alcohol dehydrogenase and by glucuronidation to produce the 5'-carboxylic acid and 5'-glucuronide which account for about 66% of the dose in the urine.
Elimination:
The mean half-life of abacavir is about 1,5 hours. Following multiple oral doses of abacavir 300 mg twice a day there is no significant drug accumulation. Elimination of abacavir is via hepatic metabolism with subsequent excretion of metabolites primarily in the urine. The metabolites and unchanged abacavir account for about 83% of the administered abacavir dose in the urine, the remainder is eliminated in the faeces.
Special populations:
Hepatic impairment:
Abacavir is metabolised primarily by the liver. The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6).
The results showed that there was a mean increase of 1,89-fold in the abacavir AUC, and 1,58-fold in the half-life of abacavir. The AUCs of the metabolites were not modified by the liver disease. However, the rates of formation and elimination of these were decreased. The pharmacokinetics have not been studied in patients with moderate or severe hepatic impairment, therefore abacavir is contra-indicated in these patient groups.
Renal impairment:
Abacavir is primarily metabolised by the liver with approximately 2% of abacavir excreted unchanged in the urine. The pharmacokinetics of abacavir in patients with end-stage renal disease is similar to patients with normal renal function. Therefore no dosage reduction is required in patients with renal impairment.
Children:
Abacavir is well absorbed from an oral solution administered to children. The overall pharmacokinetic parameters in children are comparable to adults, with slightly greater variability in plasma concentrations. The recommended dose for children from 3 months to 12 years is 8 mg/kg twice daily. This will provide slightly higher mean plasma concentrations in children, ensuring that the majority will achieve therapeutic concentrations equivalent to 300 mg twice a day in adults.
There are insufficient safety data to recommend the use of abacavir in infants less than 3 months old.
Elderly:
The pharmacokinetics of abacavir has not been studied in patients over 65 years of age.
When treating elderly patients consideration needs to be given to the greater frequency of decreased hepatic, renal and cardiac function, and concomitant disease or other drug therapy.

INDICATIONS
ASPEN ABACAVIR is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected adults and children.

CONTRA-INDICATIONS
ASPEN ABACAVIR is contra-indicated:
- in patients with known hypersensitivity to abacavir or any ingredient of the formulations (see WARNINGS)
- in patients with a hereditary fructose intolerance
- in patients with liver function impairment
- in pregnancy and lactation (see PREGNANCY AND LACTATION)
- in infants under 3 months of age.

WARNINGS
Hypersensitivity: Approximately 4% of subjects receiving ASPEN ABACAVIR develop a hypersensitivity reaction which in rare cases has proved fatal. This is characterised by the appearance of symptoms indicating multi-organ/body-system involvement.
Patients who develop a hypersensitivity reaction must discontinue ASPEN ABACAVIR and MUST not be re-challenged with ASPEN ABACAVIR (see SIDE-EFFECTS AND SPECIAL PRECAUTIONS).
Lactic acidosis/severe hepatomegaly with steatosis:
Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues alone or in combination, including abacavir, in the treatment of HIV infection (see SIDE-EFFECTS AND SPECIAL PRECAUTIONS).
Patients receiving ASPEN ABACAVIR may still develop opportunistic infections and other complications of HIV infection. Therefore patients should remain under close clinical observation by physicians experienced in the treatment of these associated HIV diseases. Patients should be advised that antiretroviral therapy with ASPEN ABACAVIR has not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination. Appropriate precautions should continue to be taken. ASPEN ABACAVIR contains sorbitol which may cause abdominal pains and diarrhoea.

INTERACTIONS
Based on the results of in vitro experiments and the known major metabolic pathways of abacavir, the potential for drug interactions involving abacavir is low. Abacavir shows no potential to inhibit metabolism mediated by the cytochrome P450 3A4 enzyme.
It has also been shown in vitro not to interact with medicines that are metabolised by CYP3A4, CYP2C9 or CYP2D6 enzymes. Induction of hepatic metabolism has not been observed in clinical studies. Therefore, there is little potential for medicine interactions with antiretroviral protease inhibitors and other medicines metabolised by major P450 enzymes. Clinical studies have shown that there are no clinically significant interactions between abacavir, zidovudine, and lamivudine.
Ethanol:
The metabolism of abacavir is altered by concomitant ethanol resulting in an increase in AUC of abacavir of about 41%. No dose reduction of abacavir is necessary. Abacavir has no effect on the metabolism of ethanol.
Methadone:
In a pharmacokinetic study, co-administration of 600 mg abacavir twice daily with methadone showed a 35% reduction in abacavir C
max and a one hour delay in tmax, but the AUC was unchanged. The changes in abacavir pharmacokinetics are not considered clinically relevant. In this study abacavir increased the mean methadone systemic clearance by 22%. This change is not considered clinically relevant for the majority of patients, however occasionally methadone re-titration may be required.
Retinoids:
Retinoid compounds such as isotretinoin, are eliminated via alcohol dehydrogenase. Interaction with abacavir is possible but has not been studied.

PREGNANCY AND LACTATION
ASPEN ABACAVIR is contra-indicated in pregnancy and lactation

DOSAGE AND DIRECTIONS FOR USE
Adults and adolescents over 12 years: The recommended dose of ASPEN ABACAVIR 20 mg/mL is 300 mg (15 mL) twice daily.
Children from 3 months to 12 years: The recommended dosage is 8 mg/kg twice daily up to a maximum of 600 mg daily.
Children less than 3 months: There are no data available on the use of ASPEN ABACAVIR in this age group.
ASPEN ABACAVIR can be taken with or without food.
An oral dosing syringe is provided for accurate measurement of the prescribed dose of oral solution.
Therapy should be initiated by a medical practitioner experienced in the management of HIV-infection.
Renal impairment:
No dosage adjustment of ASPEN ABACAVIR is necessary in patients with renal dysfunction (see Pharmacokinetics).
Hepatic impairment: Abacavir is metabolised primarily by the liver.
There are insufficient data to recommend the use of ASPEN ABACAVIR in patients with impaired hepatic function.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Side-effects:
Hypersensitivity: In clinical studies, approximately 4% of subjects receiving ASPEN ABACAVIR developed a hypersensitivity reaction which in rare cases proved fatal. This is characterised by the appearance of symptoms indicating multi-organ/ body-system involvement.
Almost all patients developing hypersensitivity reactions will have fever and/or rash (usually maculopapular or urticarial) as part of the syndrome, however reactions have occurred without rash or fever.
Symptoms can occur at any time while being treated with ASPEN ABACAVIR, but usually appear within the first 6 weeks of initiation of treatment with ASPEN ABACAVIR (median time to onset 11 days).(see WARNINGS)

The signs and symptoms of this hypersensitivity reaction are listed below.
Blood and the lymphatic system disorders
Less frequent (incidence approximately 5%): lymphadenopathy, lymphopenia
Nervous system disorders
Less frequent (incidence approximately 5%): paraesthesia
Eye disorders
Less frequent (incidence approximately 5%): conjunctivitis
Cardiac disorders
Less frequent (incidence approximately 5%): hypotension
Vascular disorders
Less frequent (incidence approximately 5%): headache
Respiratory, thoracic and mediastinal disorders
Less frequent (incidence approximately 5%): dyspnoea, sore throat, cough
Gastrointestinal disorders
Less frequent (incidence approximately 5%): nausea, vomiting, diarrhoea, abdominal pain, mouth ulceration
Hepato-biliary disorders
Less frequent (incidence approximately 5%): elevated liver function tests, hepatic failure
Skin and subcutaneous tissue disorders
Less frequent (incidence approximately 5%): rash (usually maculopapular or urticarial)
Musculoskeletal, connective tissue and bone disorders
Less frequent (incidence approximately 5%): myalgia, myolysis, arthralgia, elevated creatine phosphokinase
Renal and urinary disorders
Less frequent (incidence approximately 5%): elevated creatinine, renal failure
General disorders and administrative site conditions
Less frequent (incidence approximately 5%): fever, fatigue, malaise, oedema, anaphylaxis
Some patients with hypersensitivity reactions were initially thought to have respiratory disease (pneumonia, bronchitis, pharyngitis), a flu-like illness, gastroenteritis or reactions to other medications. This delay in diagnosis of hypersensitivity has resulted in ASPEN ABACAVIR being continued or re-introduced, leading to more severe hypersensitivity reactions or death. Therefore, the diagnosis of hypersensitivity reactions should be carefully considered for patients presenting with symptoms of these diseases.
Symptoms worsen with continued therapy, and usually resolve upon discontinuation of ASPEN ABACAVIR. Restarting ASPEN ABACAVIR following a hypersensitivity reaction results in a prompt return of symptoms within hours. This recurrence of the hypersensitivity reaction may be more severe than on initial presentation, and may include life-threatening hypotension and death. Patients who develop this hypersensitivity reaction MUST discontinue ASPEN ABACAVIR and MUST NOT be re-challenged.
An Alert Card with information for the patient about the hypersensitivity reaction is included in the ASPEN ABACAVIR pack (see boxed WARNING above).
The adverse events reported during therapy for HIV disease with ASPEN ABACAVIR were similar in adults and children.
Endocrine disorders
Rare: pancreatitis
Metabolism and nutrition disorders
Frequency unknown: elevated blood glucose and triglyceride concentrations, anorexia
Vascular disorders
Frequency unknown: headache
Gastrointestinal disorders
Frequent: nausea, vomiting, diarrhoea
Skin and subcutaneous tissue disorders
Frequency unknown: skin rash (without systemic symptoms), erythema multiforma, Stevens-Johnson syndrome, toxic epidermal necrolysis
General disorders and administrative site conditions
Frequent: fatigue and lethargy
Frequency unknown: fever
Hepato-biliary disorders
Rare: lactic acidosis, severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of antiretroviral nucleoside analogues alone or in combination, including abacavir, in the treatment of HIV infection. A majority of these cases have been in women. Caution should be exercised when administering ASPEN ABACAVIR to any patient, and particularly to those with known risk factors for liver disease. Treatment with ASPEN ABACAVIR should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or hepatotoxicity.
Special Precautions:
ASPEN ABACAVIR contains sorbitol which is metabolised to fructose and is therefore unsuitable for patients who have hereditary fructose intolerance (see CONTRAINDICATIONS).
No currently available data suggests that ASPEN ABACAVIR affects the ability to drive or operate machinery.
Abacavir was not mutagenic in bacterial tests, but showed activity in vitro in the human lymphocyte chromosome aberration assay, the mouse lymphoma assay, and the in vivo micronucleus test. This is consistent with the known activity of other nucleoside analogues. These results indicate that abacavir is a weak clastogen both in vitro and in vivo at high test concentrations.
Carcinogenicity studies with orally administered abacavir in mice and rats showed an increase in the incidence of malignant and non-malignant tumours. Malignant tumours occurred in the preputial gland of males and the clitoral gland of females of both species, and in rats in the thyroid gland of males and the liver, urinary bladder, lymph nodes and the sub cutis of female rats. The majority of these tumours occurred at the highest dose levels equivalent to 24 to 32 times the expected systemic exposure in humans.
The exception was the preputial gland tumour which occurred at a dose equivalent to 6 times the expected human systemic exposure. There is no structural counterpart of this gland in humans. While the carcinogenic potential in humans is unknown, these data suggest that a carcinogenic risk to humans is outweighed by the potential clinical benefit. Mild myocardial degeneration in the heart of mice and rats was observed following administration of abacavir for 2 years. The systemic exposures were equivalent to 7 to 24 times the expected systemic exposure in humans. The clinical relevance of this finding has not been determined.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Single doses up to 1200 mg and daily doses up to 1800 mg of abacavir have been administered to patients in clinical studies. No unexpected adverse reactions were reported. The effects of higher doses are not known. If overdosage occurs the patient should be monitored for evidence of toxicity (see SIDE-EFFECTS AND SPECIAL PRECAUTIONS), and standard supportive treatment applied as necessary. It is not known whether abacavir can be removed by peritoneal dialysis or haemodialysis

IDENTIFICATION
ASPEN ABACAVIR 20 mg/mL oral solution is a colourless to straw-coloured solution with a strawberry banana taste and smell, free from extraneous matter.

PRESENTATION
ASPEN ABACAVIR 20 mg/mL oral solution is supplied in high density polyethylene bottles with child-resistant closures, containing 240 mL of oral solution. A 10 mL polypropylene oral dosing syringe and a polyethylene adaptor are also included in the pack.

STORAGE INSTRUCTIONS
Store below 25ºC.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
41/20.2.8/0988

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191
DATE OF PUBLICATION OF PACKAGE INSERT
12 March 2009
575402

Updated on this site: December 2009
Source: Pharmaceutical Industry

PATIENT INFORMATION LEAFLET
Read all of this leaflet carefully before you start taking ASPEN ABACAVIR.
•        Keep this leaflet. You may need to read it again.
•        If you have further questions, please ask your doctor or pharmacist.
•        ASPEN ABACAVIR has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours.

SCHEDULING STATUS: S4
ASPEN ABACAVIR 20 mg/mL (oral solution)

1. WHAT ASPEN ABACAVIR CONTAINS
Each 1 mL of liquid contains 20 mg of the active substance, abacavir. The other ingredients are banana flavour, citric acid monohydrate, non-crystallising sorbitol solution, saccharin sodium, sodium citrate dihydrate strawberry flavour and water.
ASPEN ABACAVIR 20 mg/mL is preserved with methylparaben 0,15% m/v and propylparaben 0,018% m/v. Contains no sugar and no alcohol.

2. WHAT ASPEN ABACAVIR IS USED FOR
ASPEN ABACAVIR belongs to a group of medicines called antivirals and is used to treat Human Immunodeficiency Virus (HIV) infection. It is used in combination with other antivirals to treat HIV infections.

3. BEFORE YOU TAKE ASPEN ABACAVIR
Do not take ASPEN ABACAVIR:
If you are hypersensitive (allergic) to abacavir or any of the other ingredients of ASPEN ABACAVIR.
If you have stopped taking ASPEN ABACAVIR due to an allergic reaction you MUST NOT start taking it again as you may have a life-threatening drop in blood pressure or death.
If you have a hereditary fructose intolerance as ASPEN ABACAVIR contains sorbitol which is converted into fructose.
If you have problems with your liver.
If you are pregnant or breastfeeding your baby.
Taking ASPEN ABACAVIR with food and drink:
ASPEN ABACAVIR may be taken with or without food.
Pregnancy and breastfeeding:
ASPEN ABACAVIR is contra-indicated in pregnancy and breastfeeding.
If you are pregnant or breastfeeding your baby while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.
Driving and using machinery:
ASPEN ABACAVIR should not have an effect on driving and using machinery.
Important information about some of the ingredients of ASPEN ABACAVIR:
ASPEN ABACAVIR contains sorbitol as a sweetener. Sorbitol may occasionally cause stomach pain and diarrhoea.
Taking other medicines with ASPEN ABACAVIR:
If you are taking other medicines on a regular basis, including complementary or traditional medicines, the use of ASPEN ABACAVIR with these medicines may cause undesirable interactions. Please consult your doctor, pharmacist or other healthcare professional for advice.

4. HOW TO TAKE ASPEN ABACAVIR
Always take ASPEN ABACAVIR exactly as your doctor has instructed you.
You should check with your doctor or pharmacist if you are unsure.
If you have the impression that the effect of ASPEN ABACAVIR is too strong or too weak, talk to your doctor or pharmacist.
The usual dose in adults and adolescents over 12 years is 300 mg (15 mL or 3 medicine measures) twice daily.
The usual dose in children from 3 months to 12 years is 8 mg/kg twice daily up to a maximum of 600 mg daily (30 mL or 6 medicine measures).
Each dose should be taken approximately 12 hours apart. ASPEN ABACAVIR does not have to be taken with food.
To accurately measure your dose of oral solution use the oral dosing syringe supplied with the pack as follows:
1. Remove the bottle cap.
2. Push the plastic adapter into the neck of the bottle, while holding the bottle firmly.
3. Insert the syringe firmly into the adapter.
4. Turn the bottle upside down.
5. Pull out syringe plunger until the correct amount is withdrawn.
6. Turn the bottle the correct way up and remove the syringe from the adapter.
7. Replace and tighten the bottle cap.
8. Administer the dose into the mouth by placing the tip of the syringe against the inside of the cheek. Slowly depress the plunger, allowing time to swallow. Forceful squirting to the back of the throat may cause choking.
After use the syringe must not be left in the bottle and should be washed thoroughly in clean water.
If you take more ASPEN ABACAVIR than you should:
In the event of overdosage, consult your doctor or pharmacist. If neither is available, seek help at the nearest hospital or poison control center.
If you forget to take ASPEN ABACAVIR:
If you miss a dose of ASPEN ABACAVIR, take it as soon as you remember and then continue as before. Do not take a double dose to make up for forgotten individual doses.
Effects when treatment with ASPEN ABACAVIR is stopped:
If you have stopped taking ASPEN ABACAVIR due to a hypersensitivity reaction, YOU MUST NEVER TAKE IT AGAIN, as within hours you may experience a life-threatening lowering of your blood pressure or death. On very rare occasions hypersensitivity has been reported when ASPEN ABACAVIR was restarted in patients who had no symptoms of hypersensitivity before stopping. If you have stopped taking ASPEN ABACAVIR for any reason, particularly because you think you are having side-effects or for other illness, it is important that you contact your doctor before restarting. Your doctor will check whether any symptoms you had before stopping may be related to this hypersensitivity reaction. If your doctor thinks there is a possibility that they were related, you may be told never to take ASPEN ABACAVIR again. It is important that you follow this advice. If you are hypersensitive to ASPEN ABACAVIR you should return all of your unused ASPEN ABACAVIR to your doctor or pharmacist for proper disposal.

5. POSSIBLE SIDE-EFFECTS
ASPEN ABACAVIR can have side-effects.
Not all side-effects reported for ASPEN ABACAVIR are included in this leaflet. Should your general health worsen while taking ASPEN ABACAVIR, please consult your doctor, pharmacist or other health care professional for advice.
A serious allergic reaction has been reported in about 4 in every 100 patients who have been treated with ASPEN ABACAVIR. The most common symptoms of this reaction are high temperature and a skin rash. Other frequently observed signs or symptoms include nausea, vomiting, diarrhoea, stomach pain, shortness of breath, cough, headache and tiredness. Other symptoms may include joint or muscle pain, swelling of the neck and sore throat. Occasionally inflammation of the eye, ulcers in the mouth or low blood pressure may occur. The symptoms of this allergic reaction can occur at any time during treatment with ASPEN ABACAVIR. However they usually occur in the first 6 weeks of treatment and get worse with continued treatment. The hypersensitivity reaction can be life-threatening or fatal if treatment with ASPEN ABACAVIR is continued. You should contact your doctor immediately for advice on whether you should stop taking ASPEN ABACAVIR if:
•        You get a skin rash or
•        You get one or more symptoms from at least TWO of the following groups
-        fever
-        shortness of breath, sore throat or cough
-        nausea or vomiting or diarrhoea or stomach pain
-        severe tiredness or achiness or generally feeling ill
The following side-effects are very common: nausea, vomiting, lack of energy and tiredness. Other commonly reported side-effects are: fever, headache, diarrhoea, lack of appetite and skin rash.
Severe skin disorders such as erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis are rare. Inflammation of the pancreas (pancreatitis), liver disorders and an increase in blood glucose and triglycerides have also been reported.
If you notice any side-effects not mentioned in this leaflet, please inform your doctor or pharmacist.

6. STORING AND DISPOSING OF ASPEN ABACAVIR
Store below 25ºC.
KEEP ALL MEDICINES OUT OF THE REACH AND SIGHT OF CHILDREN.
Return all unused medicine to your pharmacist.

7. PRESENTATION OF ASPEN ABACAVIR
ASPEN ABACAVIR is supplied in white plastic bottles containing 240 mL oral solution with a white child-resistant plastic cap. A 10 mL oral dosing syringe and a plastic adaptor are also included.

8. IDENTIFICATION OF ASPEN ABACAVIR
This medicine is a colourless to straw-coloured solution with a strawberry banana smell and taste.

9. REGISTRATION NUMBER
41/20.2.8/0988

10. NAME AND ADDRESS OF REGISTRATION HOLDER
PHARMACARE LIMITED
Building 12
Healthcare Park
Woodlands Drive
Woodmead
2191

11. DATE OF PUBLICATION
12 March 2009        575402

IMPORTANT ALERT CARD

ASPEN ABACAVIR 20 mg/mlORAL SOLUTION

Carry this card with you at all times

Patients taking ASPEN ABACAVIR may develop a hypersensitivity reaction (serious
allergic reaction) that can be life-threatening if treatment with ASPEN ABACAVIR is
continued. CONTACT YOUR DOCTOR IMMEDIATELY for advice on whether you
should stop taking ASPEN ABACAVIR if:
1) you get a skin rash OR
2) you get one or more symptoms from at least TWO of the following groups:
•        fever
•        shortness of breath, cough or sore throat
•        nausea, vomiting, diarrhoea or stomach ache
•        severe tiredness or aches or general ill feeling
If you have discontinued ASPEN ABACAVIR due to this reaction, YOU MUST NEVER take ASPEN ABACAVIR again as within hours you may experience a life-threatening lowering of your blood pressure or death.
You should immediately contact your Doctor if you think you are having a hypersensitivity reaction to ASPEN ABACAVIR. Write your Doctor’s details below:
Doctor:                                                                                                                       
Tel:                                                                                                                               
If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).

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