Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
APPROVED PROFESSIONAL INFORMATION FOR BEXACOS  
SCHEDULING STATUS  
S3  
1 NAME OF THE MEDICINE  
BEXACOS 100 mg (tablets)  
BEXACOS 300 mg (tablets)  
2 QUALITATIVE AND QUANTITATIVE COMPOSITION  
BEXACOS 100 mg: Each tablet contains 100 mg allopurinol.  
BEXACOS 300 mg: Each tablet contains 300 mg allopurinol.  
Contains sugar (lactose monohydrate).  
BEXACOS 100 mg: Contains 53,100 mg lactose monohydrate.  
BEXACOS 300 mg: Contains 159,300 mg lactose monohydrate.  
For a full list of excipients, see section 6.1.  
3 PHARMACEUTICAL FORM  
BEXACOS 100 mg: White to off-white coloured, round tablets debossed with “U” and “5” on one  
side and score line with “H” on the other side.  
BEXACOS 300 mg: White to off-white coloured, round tablets debossed with “U” and “6” on one  
side and score line with “H” on the other side.  
4 CLINICAL PARTICULARS  
4.1 Therapeutic indications  
BEXACOS is used to reduce urate concentrations in body fluids and/or urine to prevent or reverse  
28 November 2025  
Initial…MU…….  
Page 1 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
the deposition of urate/uric acid.  
BEXACOS is indicated in:  
•
the management of the main clinical manifestations of urate deposition which are: gouty  
arthritis, skin tophi, idiopathic gout, uric acid lithiasis and acute uric acid nephropathy.  
the management of patients with neoplastic and myeloproliferative disease with high cell  
turnover rates which cause elevations of serum and urinary levels. These include  
leukaemia, lymphomas, or other malignancies, especially when cytotoxic therapy has been  
initiated.  
•
•
the management of patients with recurrent mixed calcium oxalate renal stones in the  
presence of hyperuricosuria when fluid, dietary and similar measures have failed.  
4.2 Posology and method of administration  
Posology  
The dose should be titrated against the patient by monitoring serum urate/uric acid and/or urinary  
uric acid levels at appropriate intervals. Up to and including 300 mg BEXACOS may be taken once  
a day. Larger doses should be administered as divided doses of not more than 300 mg. It is  
recommended that BEXACOS be taken after meals for better tolerance.  
Adults  
Daily oral dose 100 to 900 mg depending on severity of the condition or 2 to 10 mg/kg  
bodymass/day.  
Special populations  
Dose precautions in renal disorder: Since allopurinol and its metabolites are excreted by the  
kidney, renal failure may lead to the retention of the medicine and its metabolites with consequent  
prolongation of plasma half-lives. To reduce attendant risks, the amount and frequency of the  
dosage may require reduction.  
28 November 2025  
Initial…MU…….  
Page 2 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
The following schedule is provided for guidance in adults: If creatinine clearance exceeds 20  
ml/minute - give standard dose. If creatinine clearance is between 10 and 20 ml/minute - give 100  
to 200 mg/day. If creatinine clearance is less than 10 ml/minute - give 100 mg/day or at longer  
intervals. If plasma monitoring facilities are available, plasma oxypurinol levels should be  
maintained below 100 micromol/litre (15,2 micrograms/ml).  
Dose precautions in renal dialysis: Allopurinol and its metabolites are removed by renal dialysis  
and dosages should be adjusted accordingly. Consideration should be given to an alternative  
dosage schedule of 300 to 400 mg BEXACOS immediately after each dialysis.  
Paediatric population  
Children under 15 years:  
Daily oral dose 100 to 400 mg or 10 to 20 mg/kg bodymass/day.  
4.3 Contraindications  
•
Known hypersensitivity to allopurinol or to any of the excipients of BEXACOS (see section  
6.1).  
•
•
Severe hepatic or renal disorder.  
An acute gout attack.  
4.4 Special warnings and precautions for use  
Treatment of neoplasia  
Before instituting cytotoxic therapy it is advisable to assess existing serum urate and urinary acid  
levels. When hyperuricaemia and/or hyperuricosuria are present, they should be corrected prior to  
starting treatment. Adequate hydration to maintain maximum diuresis throughout is important (see  
section 4.2).  
28 November 2025  
Initial…MU…….  
Page 3 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
Hepatic disorder  
Reduced doses should be used in patients with hepatic or renal impairment (see section 4.2).  
Patients under treatment for hypertension or cardiac insufficiency, for example with diuretics or  
ACE inhibitors, may have some concomitant impairment of renal function and BEXACOS should  
be used with caution.  
Acute gouty attacks  
Mobilisation of urate deposition may result in exacerbation of attacks of acute gouty arthritis.  
Hence, when starting treatment with BEXACOS, it is advisable to give colchicine at prophylactic  
doses or an anti-inflammatory agent for at least one month. This effect can be avoided by using a  
small initial dose (100 mg per day) of BEXACOS, gradually increasing the dose at intervals.  
Hypersensitivity syndrome, Stevens-Johnson syndrome (SJS) and toxic epidermal  
necrolysis (TEN)  
Allopurinol hypersensitivity reactions can manifest in many different ways, including maculopapular  
exanthema, hypersensitivity syndrome (also known as DRESS) and SJS/TEN. These reactions are  
clinical diagnoses, and their clinical presentations remain the basis for decision making. If such  
reactions occur at any time during treatment, allopurinol should be withdrawn immediately.  
Rechallenge should not be undertaken in patients with hypersensitivity syndrome and SJS/TEN.  
Corticosteroids may be beneficial in overcoming hypersensitivity skin reactions.  
HLA-B*5801 allele  
The HLA-B*5801 allele has been shown to be associated with the risk of developing allopurinol  
related hypersensitivity syndrome and SJS/TEN.  
Extra vigilance for signs of hypersensitivity syndrome or SJS/TEN is required and the patient  
should be informed of the need to stop treatment immediately at the first appearance of symptoms.  
28 November 2025  
Initial…MU…….  
Page 4 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
SJS/TEN can still occur in patients who are found to be negative for HLA-B*5801 irrespective of  
their ethnic origin.  
Chronic renal impairment  
Patients with chronic renal impairment and concomitant diuretic use, in particular thiazides, may be  
at increased risk of developing hypersensitivity reactions including SJS/TEN associated with  
allopurinol. Extra vigilance for the signs of hypersensitivity syndrome or SJS/TEN is required and  
the patient should be informed of the need to stop treatment immediately and permanently at the  
first appearance of symptoms (see section 4.8).  
Asymptomatic hyperuricaemia  
Asymptomatic hyperuricaemia per se is generally not considered an indication for use of  
Allopurinol. Fluid and dietary modification with management of the underlying cause may correct  
the condition.  
Xanthine deposition  
In conditions where the rate of urate formation is greatly increased (e.g. malignant disease and its  
treatment, Lesch-Nyhan syndrome) the absolute concentration of xanthine in urine could, in rare  
cases, rise sufficiently to allow deposition in the urinary tract. This risk may be minimised by  
adequate hydration to achieve optimal urine dilution.  
Impaction of uric acid renal stones  
Adequate therapy with Allopurinol will lead to dissolution of large uric acid renal pelvic stones, with  
the remote possibility of impaction in the ureter.  
Thyroid disorders  
Increased TSH values (> 5,5 μIU/ml) were observed in patients on long-term treatment with  
28 November 2025  
Initial…MU…….  
Page 5 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
allopurinol (5,8 %) in a long-term open label extension study. Caution is required when allopurinol  
is used in patients with alteration of thyroid function.  
Lactose warning  
BEXACOS contains lactose. Patients with rare hereditary problems of galactose intolerance, total  
lactase deficiency or glucose-galactose malabsorption should not take this medicine.  
4.5 Interaction with other medicine and other forms of interaction  
6-Mercaptopurine and azathioprine are inactivated by the action of xanthine oxidase. Hence  
inhibition of xanthine oxidase may prolong the action of these medicines. Therefore, when either of  
these substances is given by mouth concomitantly with BEXACOS, only one-quarter of the usual  
dosage of these substances should be given.  
Salicylates and uricosuric medicines  
Oxypurinol, the major metabolite of allopurinol and itself therapeutically active, is excreted by the  
kidney in a very similar way to urate. Hence medicines causing uricosuria (e.g. probenecid, large  
doses of salicylate) may also accelerate the excretion of oxypurinol. This may lead to partial loss of  
therapeutic activity of BEXACOS, but the significance of this needs to be assessed in each case.  
Chlorpropamide  
In the presence of allopurinol, there may be competition in the renal tubule for excretion of  
chlorpropamide. When renal function is poor, the recognised risk of prolonged hypoglycaemic  
activity of chlorpropamide may be increased if BEXACOS is given concomitantly.  
Coumarin anticoagulants  
There is no evidence that interaction between allopurinol and the coumarins seen under  
experimental conditions has any clinical significance. However, all patients receiving anticoagulants  
28 November 2025  
Initial…MU…….  
Page 6 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
must be carefully monitored.  
Allopurinol may inhibit hepatic oxidation of phenytoin but the clinical significance has not been  
demonstrated.  
Adenine arabinoside  
Evidence suggests that the plasma half-life of adenine arabinoside is increased in the presence of  
allopurinol. When the two products are used concomitantly, extra vigilance is necessary, to  
recognise enhanced toxic effects.  
Cytostatics  
With administration of allopurinol and cytostatics (e.g. cyclophosphamide, doxorubicin, bleomycin,  
procarbazine, alkylhalogenides), blood dyscrasias occur more frequently than when these active  
substances are administered alone.  
Blood count monitoring should therefore be performed at regular intervals.  
Aluminium hydroxide  
If aluminium hydroxide is taken concomitantly, allopurinol may have an attenuated effect. There  
should be an interval of at least 3 hours between taking both medicines.  
Theophylline  
Inhibition of the metabolism of theophylline has been reported. The mechanism of the interaction  
may be explained by xanthine oxidase being involved in the biotransformation of theophylline in  
man. Theophylline levels should be monitored in patients starting or increasing allopurinol therapy.  
Ampicillin / amoxicillin  
An increase in the frequency of skin rash has been reported among patients receiving ampicillin or  
amoxicillin concurrently with allopurinol compared with patients who are not receiving both  
28 November 2025  
Initial…MU…….  
Page 7 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
medicines. The cause of the reported association has not been established. However, it is  
recommended that in patients receiving allopurinol an alternative to ampicillin or amoxicillin is used  
where available.  
Ciclosporin  
Reports suggest that the plasma concentration of ciclosporin may be increased during concomitant  
treatment with allopurinol. The possibility of enhanced ciclosporin toxicity should be considered if  
the medicines are co-administered.  
Cyclophosphamide, doxorubicin, bleomycin, procarbazine, mechloroethamine  
Enhanced bone marrow suppression by cyclophosphamide and other cytotoxic medicines has  
been reported among patients with neoplastic disease (other than leukaemia), in the presence of  
allopurinol. However, in a well-controlled study of patients treated with cyclophosphamide,  
doxorubicin, bleomycin, procarbazine and/or mechloroethamine (chlormethine hydrochloride)  
allopurinol did not appear to increase the toxic reaction of these cytotoxic medicines.  
Didanosine  
In healthy volunteers and HIV patients receiving didanosine, plasma didanosine Cmax and AUC  
values were approximately doubled with concomitant allopurinol treatment (300 mg daily) without  
affecting terminal half-life. Co-administration of these 2 medicines is generally not recommended. If  
concomitant use is unavoidable, a dose reduction of didanosine may be required, and patients  
should be closely monitored.  
Diuretics  
An interaction between allopurinol and furosemide that results in increased serum urate and  
plasma oxypurinol concentrations has been reported.  
An increased risk of hypersensitivity has been reported when allopurinol is given with diuretics, in  
28 November 2025  
Initial…MU…….  
Page 8 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
particular thiazides, especially in renal impairment.  
Angiotensin-converting-enzyme (ACE) inhibitors  
An increased risk of hypersensitivity has been reported when allopurinol is given with ACE  
inhibitors especially in renal impairment.  
4.6 Fertility, pregnancy and lactation  
Pregnancy  
There is inadequate evidence of the safety of BEXACOS in human pregnancy. Use in pregnancy  
only when there is no safer alternative and when the disease itself carries risk for the mother or  
unborn child.  
Breastfeeding  
BEXACOS should not be given to nursing mothers since it is excreted in breast milk.  
4.7 Effects on ability to drive and use machines  
Since adverse reactions such as somnolence, vertigo and ataxia have been reported in patients  
receiving allopurinol, patients should exercise caution before driving, using machinery or  
participating in dangerous activities until they are reasonably certain that BEXACOS does not  
adversely affect performance.  
4.8 Undesirable effects  
a) Tabulated summary of adverse reactions  
Infections and infestations  
Less frequent: Furunculosis  
Blood and lymphatic system disorders  
28 November 2025  
Initial…MU…….  
Page 9 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
Less frequent: Agranulocytosis, aplastic anaemia, thrombocytopenia  
Immune system disorders  
Less frequent: Hypersensitivity, angioimmunoblastic T-cell lymphoma, anaphylactic reaction  
Metabolism and nutrition disorders  
Less frequent: Diabetes mellitus, hyperlipidaemia  
Psychiatric disorders  
Less frequent: Depression  
Nervous system disorders  
Less frequent: Coma, paralysis, ataxia, neuropathy, paraesthesia, somnolence, headache,  
dysgeusia  
Eye disorders  
Less frequent: Cataract, visual impairment, maculopathy  
Ear and labyrinth disorders  
Less frequent: Vertigo  
Cardiac disorders  
Less frequent: Angina pectoris, bradycardia  
Vascular disorders  
Less frequent: Hypertension  
28 November 2025  
Initial…MU…….  
Page 10 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
Gastrointestinal disorders  
Less frequent: Vomiting, nausea, haematemesis, steatorrhoea, stomatitis, change of bowel habit  
Hepato-biliary disorders  
Less frequent: Liver function test abnormal, hepatitis (including hepatic necrosis and  
granulomatous hepatitis)  
Skin and subcutaneous tissue disorders  
Frequent: Rash  
Less frequent: Stevens-Johnson syndrome/toxic epidermal necrolysis, angioedema, drug eruption,  
alopecia, hair colour changes  
Renal and urinary disorders  
Less frequent: Haematuria, azotaemia, nocturnal emission  
Reproductive system and breast disorders  
Less frequent: Infertility male, erectile dysfunction, gynecomastia, impotence  
General disorders and administration site conditions  
Less frequent: Fever, oedema, malaise, asthenia  
Investigations  
Frequent: Blood thyroid stimulating hormone increased  
b) Description of selected adverse reactions  
The incidence of adverse effects is higher in the presence of renal and/or hepatic disorder and a  
28 November 2025  
Initial…MU…….  
Page 11 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
dosage reduction should be considered in these cases. Skin reactions are the most common and  
may occur anytime during treatment. They may be pruritic, maculopapular, sometimes scaly,  
sometimes purpuric and rarely exfoliative. As severe skin reactions may occur, BEXACOS should  
be withdrawn IMMEDIATELY should such reactions occur. After recovery from mild reactions  
BEXACOS may, if desired, be reintroduced at a small dose (e.g. 50 mg per day) and gradually  
increased. If the rash recurs, BEXACOS should be PERMANENTLY withdrawn. Skin reactions  
associated with exfoliation, fever, lymphadenopathy, arthralgia and/or eosinophilia resembling  
Stevens-Johnson and/or Lyell Syndrome occur rarely.  
Associated vasculitis and tissue response may be manifested in various ways including hepatitis,  
interstitial nephritis and very rarely, epilepsy. If such reactions do occur, BEXACOS should be  
withdrawn IMMEDIATELY AND PERMANENTLY.  
Nausea and vomiting have been reported. Recurrent haematemesis and steatorrhoea are  
extremely rare occurences. Angio-immunoblastic lymphadenopathy, following biopsy of a  
generalised lymphadenopathy, and granulomatous hepatitis rarely occur and appear to be  
reversible on withdrawal of BEXACOS. Occasional reports have been received of  
thrombocytopaenia, agranulocytosis and aplastic anaemia, particularly in individuals with impaired  
renal function.  
Reporting of suspected adverse reactions  
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows  
continued monitoring of the benefit/risk balance of the medicine. Health care providers are  
requested to report any suspected adverse reactions to SAHPRA via the Med Safety APP  
(Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website or to  
the Holder of certificate of registration through the mail: pvg.cdma@heterogroups.com.  
4.9 Overdose  
Massive absorption of BEXACOS may lead to considerable inhibition of xanthine oxidase activity,  
28 November 2025  
Initial…MU…….  
Page 12 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
which should have no untoward effects unless 6- mercaptopurine and/or azathioprine is being  
taken concomitantly. In this case, the risk of increased activity of these medicines must be  
recognised. Adequate hydration to maintain maximum diuresis facilitates excretion of allopurinol  
and its metabolites. Haemodialysis may be resorted to if considered necessary.  
5 PHARMACOLOGICAL PROPERTIES  
5.1 Pharmacodynamic properties  
Category and Class: A 3.3 Antigout preparations  
Pharmacotherapeutic group: Antigout preparations inhibiting uric acid production, ATC code:  
M04 AA01.  
Allopurinol is an anti-hyperuricaemic. Allopurinol inhibits xanthine oxidase (XO), the enzyme which  
catalyses the following reactions: hypoxanthine XO > xanthine > XO urate (uric acid).  
Allopurinol decreases body urate by reducing formation and hence the amount entering the  
miscible pool. Allopurinol inhibits the conversion of hypoxanthine and xanthine to urate, thus  
leading to a proportional redistribution of oxypurines (i.e. relative increase of hypoxanthine and  
xanthine). It also decreases the overall oxypurine formation since re-entry of hypoxanthine and  
xanthine into the purine anabolic pathway reduces de novo purine synthesis by feedback inhibition.  
In the presence of excess body urate, the reduction of the miscible pool permits mobilization and  
excretion of urate deposited throughout the body, such as in the skin, joints, bones and kidney.  
5.2 Pharmacokinetic properties  
Absorption  
Allopurinol is active when given orally and is rapidly absorbed from the upper gastrointestinal tract.  
Studies have detected allopurinol in the blood 30-60 minutes after dosing. Estimates of  
bioavailability vary from 67 % to 90 %. Peak plasma levels of allopurinol generally occur  
28 November 2025  
Initial…MU…….  
Page 13 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
approximately 1,5 hours after oral administration of allopurinol, but fall rapidly and are barely  
detectable after 6 hours. Peak levels of oxipurinol generally occur after 3-5 hours after oral  
administration of allopurinol and are much more sustained.  
Distribution  
Allopurinol is negligibly bound by plasma proteins and therefore variations in protein binding are not  
thought to significantly alter clearance. The apparent volume of distribution of allopurinol is  
approximately 1,6 litre/kg which suggests relatively extensive uptake by tissues. Tissue  
concentrations of allopurinol have not been reported in humans, but it is likely that allopurinol and  
oxipurinol will be present in the highest concentrations in the liver and intestinal mucosa where  
xanthine oxidase activity is high.  
Biotransformation  
The main metabolite of Allopurinol tablets is oxipurinol. Other metabolites of allopurinol include  
allopurinol-riboside andoxipurinol-7-riboside.  
Elimination  
Approximately 20 % of the ingested allopurinol is excreted in the faeces. Elimination of allopurinol  
is mainly by metabolic conversion to oxipurinol by xanthine oxidase and aldehyde oxidase, with  
less than 10 % of the unchanged drug excreted in the urine. Allopurinol has a plasma half-life of  
about 1 to 2 hours.  
Oxipurinol is a less potent inhibitor of xanthine oxidase than allopurinol, but the plasma half-life of  
oxipurinol is far more prolonged. Estimates range from 13 to 30 hours in man. Therefore effective  
inhibition of xanthine oxidase is maintained over a 24 hour period with a single daily dose of  
Allopurinol. Patients with normal renal function will gradually accumulate oxipurinol until a steady-  
state plasma oxipurinol concentration is reached. Such patients, taking 300 mg of allopurinol per  
28 November 2025  
Initial…MU…….  
Page 14 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
day will generally have plasma oxipurinol concentrations of 5-10 mg/litre.  
Oxipurinol is eliminated unchanged in the urine but has a long elimination half-life because it  
undergoes tubular reabsorption. Reported values for the elimination half-life range from 13,6 hours  
to 29 hours. The large discrepancies in these values may be accounted for by variations in study  
design and/or creatinine clearance in the patients.  
Characteristics in specific groups of patients  
Renal impairment  
Allopurinol and oxipurinol clearance are greatly reduced in patients with poor renal function  
resulting in higher plasma levels in chronic therapy. Patients with renal impairment, where  
creatinine clearance values were between 10 and 20 ml/min, showed plasma oxipurinol  
concentrations of approximately 30 mg/litre after prolonged treatment with 300 mg allopurinol per  
day. This is approximately the concentration which would be achieved by doses of 600 mg/day in  
those with normal renal function. A reduction in the dose of Allopurinol is therefore required in  
patients with renal impairment.  
Elderly  
The kinetics of the drug are not likely to be altered other than due to deterioration in renal function.  
6 PHARMACEUTICAL PARTICULARS  
6.1 List of excipients  
•
•
•
•
•
Crospovidone type A  
Crospovidone type B  
Lactose monohydrate  
Magnesium stearate  
Maize starch  
28 November 2025  
Initial…MU…….  
Page 15 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
•
Povidone  
6.2 Incompatibilities  
Not applicable.  
6.3 Shelf life  
24 months.  
6.4 Special precautions for storage  
•
•
•
Store at or below 25 °C.  
Keep the tablets in the original container until required for use.  
KEEP OUT OF REACH OF CHILDREN  
6.5 Nature and contents of container  
Blister strips:  
Blister strips of clear, transparent, thermoformable rigid PVC forming film and plain aluminium  
lidding foil, containing 10 tablets per blister.  
Pack sizes  
BEXACOS 100 mg: 10 tablets per blister. 10’s x 10 blisters, 10’s x 6 blisters and 10’s x 3 blisters  
packed in a box.  
BEXACOS 300 mg: 10 tablets per blister. 10’s x 7 blisters and 10’s x 3 blisters packed in a box.  
Blister strips are enclosed in an outer carton box.  
Not all pack sizes may be marketed.  
6.6 Special precautions for disposal and other handling  
No special requirements  
28 November 2025  
Initial…MU…….  
Page 16 of 17  
Applicant/PHRC: Hetero Drugs South Africa (Pty) Ltd  
Product proprietary name: BEXACOS 100 & 300  
Dosage form and strength: Tablet contains allopurinol 100 mg and 300 mg  
7 HOLDER OF CERTIFICATE OF REGISTRATION  
Hetero Drugs South Africa (Pty) Ltd  
Waterfall Corporate Campus  
Building No.2, First Floor  
74 Waterfall Drive  
Midrand, 2066  
Telephone number: 012 644 1220  
e-mail address: nokuthula.n@hetero.com  
8 REGISTRATION NUMBER(S)  
BEXACOS 100 mg: 56/3.3/1019  
BEXACOS 300 mg: 56/3.3/1020  
9 DATE OF FIRST AUTHORISATION  
25 February 2025  
10 DATE OF REVISION OF THE TEXT  
28 November 2025  
28 November 2025  
Initial…MU…….  
Page 17 of 17