Allopurinol Sandoz tablet 300 mg, tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ALLOPURINOL 300 mg/stuk

Beschikbaar vanaf:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

ATC-code:

M04AA01

INN (Algemene Internationale Benaming):

ALLOPURINOL 300 mg/stuk

farmaceutische vorm:

Tablet

Samenstelling:

LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; POVIDON K 30 (E 1201),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Allopurinol

Product samenvatting:

Hulpstoffen: LACTOSE 1-WATER; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; POVIDON K 30 (E 1201);

Autorisatie datum:

2016-11-07

Bijsluiter

Sandoz B.V.
Page 1/8
Allopurinol Sandoz tablet 100 mg / 300 mg, tabletten
RVG 117525-6
1313-v8
1.3.1.3 Bijsluiter
December 2021
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALLOPURINOL SANDOZ
® TABLET 100 MG, TABLETTEN
ALLOPURINOL SANDOZ
® TABLET 300 MG, TABLETTEN
allopurinol
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 further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What [Nationally completed name] is and what it is used for
2. What you need to know before you take [Nationally completed name]
3. How to take [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME]
IS AND WHAT IT IS USED FOR
•
[Nationally completed name] belongs to a group of medicines called
enzyme inhibitors, which act
to control the speed at which special chemical changes occur in the
body.
•
[Nationally completed name] is used for the long term, preventative
treatment of gout and may be
used in other conditions associated with an excess of uric acid in the
body, including kidney
stones and other types of kidney disease.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [NATIONALLY COMPLETED NAME]
_ _
DO NOT TAKE [NATIONALLY COMPLETED NAME]
•
if you are allergic to allopurinol or any of the other ingredients of
this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking [Nationally completed
name] if:
•
you are of Han Chinese, African or Indian origin
Sandoz B.V.
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Allopurinol Sandoz tablet 100 mg /

Productkenmerken

Sandoz B.V.
Page 1/14
Allopurinol Sandoz tablet 100 mg / 300 mg tabletten
RVG 117525-6
1311-V8
1.3.1.1 Samenvatting van de Productkenmerken
December 2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Allopurinol Sandoz tablet 100 mg, tabletten
Allopurinol Sandoz tablet 300 mg, tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
[Nationally completed name] 100 mg tablets
Each tablet contains 100 mg of allopurinol.
Excipients with known effect
Each tablet contains 35 mg of lactose (as monohydrate)
[Nationally completed name] 300 mg tablets
Each tablet contains 300 mg of allopurinol.
Excipients with known effect
Each tablet contains 106 mg of lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
[Nationally completed name] 100 mg tablets
white to off white, scored, flat cylindrical tablet debossed with
‘I’ and ‘56’ on either side of the break
line on one side and plain on other side.
Diameter: approx. 8 mm.
[Nationally completed name] 300 mg tablets
white to off white, scored, flat cylindrical tablet debossed with
‘I’ and ‘57’ on either side of the break
line on one side and plain on other side. Diameter: approx. 11 mm.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4.
CLINICAL PARTICULARS
Sandoz B.V.
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Allopurinol Sandoz tablet 100 mg / 300 mg tabletten
RVG 117525-6
1311-V8
1.3.1.1 Samenvatting van de Productkenmerken
December 2021
4.1
THERAPEUTIC INDICATIONS
Adults
•
All forms of hyperuricaemia not controllable by diet, including
secondary hyperuricaemia of
differing origin and clinical complications of hyperuricaemic states,
particularly manifest
gout, urate nephropathy and for the dissolution and prevention of uric
acid stones.
•
The management of recurrent mixed calcium oxalate stones in concurrent
hyperuricaemia,
when fluid, dietary and similar measures have failed.
Children and adolescents
•
Secondary hyperuricaemia of differing origin
•
Uric aci