ALLORIL 100

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ALLOPURINOL

Available from:

DEXCEL LTD, ISRAEL

ATC code:

M04AA01

Pharmaceutical form:

TABLETS

Composition:

ALLOPURINOL 100 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

DEXCEL LTD, ISRAEL

Therapeutic group:

ALLOPURINOL

Therapeutic area:

ALLOPURINOL

Therapeutic indications:

Management of patients with signs and symptoms of primary or secondary gout (acute attacks, tophi, joint destruction, uric acid lithiasis and/or nephropathy). Management of patients with leukemia, lymphoma, and malignancies who are receiving cancer therapy which causes elevations of serum and urinary uric acid levels. Management of patients with recurrent calcium oxalate calculi whose daily uric acid excretion exceeds 800 mg/day in male patients and 750 mg/day in female patients. Therapy in such patients should be carefully assessed initially and reassessed periodically to determine in each case that treatment is beneficial and that the benefits outweigh the risks.

Authorization date:

2014-02-28

Patient Information leaflet

Pallent peckage וי-t ecconllng tס Phamוacl8ts' Regשlloחa
)Pnוןנeratlona(-1986
This medicine can be sold w�h a physician
י
s prescription only
Alloril
@
Tablets
100mg, 300mg
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out attack
.
ALLORIL 100:
E
a
ch t
a
blet c
o
nt
a
ins 100 mg
All
o
p
u
rin
o
l.
ALLORIL 300:
E
a
ch t
a
blet c
o
nt
a
ins 300 mg
All
o
p
u
rin
o
l.
ln
a
ctive ingredien
t
s
a
nd
a
llergens in
t
he
medicine - see sec
t
i
o
n 6 "Addi
t
i
o
n
a
l lnl
o
rm
a
ti
o
n"
a
nd sec
t
i
o
n 2 "lmp
o
rt
a
n
t
inl
o
rm
at
i
o
n
a
b
out
s
o
me
o
f
t
he ingredients
o
f this medicine".
READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE.
This le
a
fle
t
contains
concise inl
o
rm
a
ti
o
n
a
b
out
t
he
medicine.
11 y
ou
h
a
ve
a
ny further q
u
es
t
i
o
ns,
a
s
k
y
ou
r doct
o
r
o
r
ph
a
rm
a
cis
t
.
This medicine h
a
s been pres
c
ribed f
o
r y
ou
. D
o
n
ot
p
a
ss it סח t
o ot
hers. 11 m
a
y h
a
rm
t
hem, even il y
ou
t
hin
k
t
h
at
t
heir medical condi
t
i
o
n is
t
he s
a
me
a
s
y
ou
rs.
1. WHAT IS THE MEDICINE LNTENDED FOR?
F
o
r
t
he
t
re
at
men
t
o
l
g
out
atta
c
k
s
a
nd
ot
her
conditi
o
ns rel
at
ed t
o a
n excess
o
f
u
ric
a
cid in the
b
o
dy, by red
u
cing
t
he concen
t
ra
t
i
o
n
o
f
u
ric
a
cid in
the bl
oo
d
a
nd
u
rine.
THERAPEUTIC
GROUP:
An
inhibit
o
r
o
l
x
a
nthine
o
xid
a
se,
the
enzyme
resp
o
nsible
l
o
r
u
ric
a
cid
prod
u
c
t
i
o
n.
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
Y
ou a
re hypersensitive (
a
llergic)
to
the
a
ctive
ingredien
t
(
a
ll
o
p
u
rin
o
l) or
to a
ny
o
f
t
he
a
ddili
o
n
a
l
ingredients this medicine contains (see secti
o
n
6).
11 y
ou a
re n
ot
s
u
re, cons
u
l
t
y
ou
r doct
o
r
o
r
ph
a
rm
a
cis
t
bel
o
re ta
k
ing
ALLORIL.
SPECIAL WARNINGS REGARDING THE USE OF THIS
MEDICINE:
BEFORE TREATMENT WITH ALLORIL, TEL1 YOUR DOCTOR
IF:
• y
ou a
re
o
f H
a
n Chinese, Th
a
i
o
r K
o
re
a
n
o
rigin.
• y
ou
h
a
ve liver
o
r
k
idney problems. Y
ou
r doct
o
r
m
a
y prescribe
a
l
o
wer d
o
s
a
ge l
o
r y
ou o
r
a
s
k
y
ou
t
o
ta
k
e
t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
ALLORIL 100
ALLORIL 300
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
ALLORIL 100
Each tablet contains Allopurinol 100 mg
Excipient with known effect:
Each tablet contains approximately 59 mg Lactose
ALLORIL 300
Each tablet contains Allopurinol 300 mg
Excipient with known effect:
Each tablet contains approximately 177 mg Lactose
For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
ALLORIL 100:
White, round, biconvex, film coated tablets
ALLORIL 300:
White, round, biconvex, film coated tablets, scored on one side
The tablet can be divided into equal doses
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ALLORIL is indicated for:
-
Management of patients with signs and symptoms of primary or secondary
gout (acute
attacks, tophi, joint destruction, uric acid lithiasis and/or
nephropathy).
-
Management of patients with leukemia, lymphoma, and malignancies who
are receiving
cancer therapy which causes elevations of serum and urinary uric acid
levels.
-
Management of patients with recurrent calcium oxalate calculi whose
daily uric acid
excretion exceeds 800 mg/day in male patients and 750 mg/day in female
patients.
Therapy in such patients should be carefully assessed initially and
reassessed periodically to
determine in each case that treatment is beneficial and that the
benefits outweigh the risks.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_ADULTS_
Allopurinol should be introduced at low dosage e.g. 100 mg/day to
reduce the risk of adverse
reactions and increased only if the serum urate response is
unsatisfactory. Extra caution should
be exercised if renal function is poor (_see section 4.2 Renal
impairment_). The following dosage
schedules are suggested:
100 to 200 mg daily in mild conditions,
300 to 600 mg daily in moderately severe conditions,
700 to 800 mg daily in severe conditions.
If dosage on a mg/kg bodyweight basis is required, 2 to 10 mg/kg
bodyweight/day should be
used.
_PAEDIATRIC POPULATION_
Children under 1