Acetazolamide Crescent 250 mg Tablets

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

ACETAZOLAMIDE

Beschikbaar vanaf:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC-code:

S01EC01

INN (Algemene Internationale Benaming):

ACETAZOLAMIDE 250 mg

farmaceutische vorm:

TABLET

Samenstelling:

ACETAZOLAMIDE 250 mg

Prescription-type:

POM

Therapeutisch gebied:

OPHTHALMOLOGICALS

Product samenvatting:

Licence number in the source country: NOT APPLICAPABLE

Autorisatie-status:

Authorised

Autorisatie datum:

2020-11-24

Bijsluiter

PACKAGE INFORMATION LEAFLET
ACETAZOLAMIDE CRESCENT TABLETS 250MG
Please read all of this leaflet carefully before you start taking this
medicine. Keep the leaflet, you may
need to read it again.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
symptoms are the same as yours. If any of the side effects gets
serious, or if you notice any side effects
not listed in this leaflet tell your doctor or pharmacist
In this leaflet
1.
What Acetazolamide Crescent Tablets 250mg are and what it is used for
2.
Before you take Acetazolamide Crescent Tablets 250mg
3.
How to take Acetazolamide Crescent Tablets 250mg
4.
Possible side effects
5.
How to store Acetazolamide Crescent Tablets 250mg
6.
Further information
1.
WHAT ACETAZOLAMIDE CRESCENT TABLETS 250MG ARE AND WHAT IT IS USED
FOR
These tablets contain the active ingredient Acetazolamide, which is
one of the group of medicines
called carbonic anhydrase inhibitors.
These are used in the treatment of abnormal retention of fluids and
epilepsy. They are also used to
treat chronic simple glaucoma, secondary glaucoma and before an
operation in acute angle closure
glaucoma.
2.
BEFORE YOU TAKE ACETAZOLAMIDE CRESCENT TABLETS 250MG
DO NOT TAKE THESE TABLETS IF
:
•
you are allergic to Acetazolamide, sulphonamides or any of the
ingredients in the tablets
•
you have low blood levels of sodium or potassium
•
you have kidney disease or kidney problems
•
you have liver disease including cirrhosis, or liver problems
•
you have an underactive adrenal gland
•
you have hyperchloremic acidosis (high levels of chloride in the
blood).
DO NOT TAKE THESE TABLETS FOR A LONG TERM IF:
•
you suffer from chronic congestive angle-closure glaucoma.
CHECK WITH YOUR DOCTOR BEFORE TAKING THESE TABLETS IF:
•
you have lung problems such as bronchitis, asthma, wheezing or
emphysema
•
you have a history of kidney stones as this medicine may cause further

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SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Acetazolamide Crescent Tablets 250 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of Acetazolamide.
For excipients, see 6.1
3
PHARMACEUTICAL FORM
Acetazolamide Crescent Tablets are presented as white flat bevelled
edge tablets engraved
with R and crescent moon logo on one side and A / 303 either side of a
break-line on the
other.
The tablet can be divided into equal doses.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acetazolamide Crescent Tablets 250 mg are indicated in the treatment
of
1. Glaucoma
Chronic simple (open angle) glaucoma, secondary glaucoma and
perioperatively in acute
angle closure glaucoma where delay of surgery is desired in order to
lower intraocular
pressure. Acetazolamide acts on inflow, decreasing the amount of
aqueous secretion.
2. Abnormal retention of fluids
Acetazolamide acts on the reversible hydration of carbon dioxide and
hydration of the
carbonic acid reaction in the kidney resulting in renal loss of
bicarbonate ion which carries out
sodium, water and potassium.
It can be used in conjunction with other diuretics when effects on
several segments of the
nephron are desirable in the treatment of fluid retaining states.
3. Epilepsy
When used in conjunction with other anticonvulsants best results have
been seen in petit mal
in children. Good results have been seen in both children and adults
with grand mal, mixed
seizure patterns and myoclonic jerk patterns.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Dosage
1. Glaucoma (simple acute congestive and secondary)
Adults: 1 – 4 tablets daily, in divided doses for amounts over 250
mg daily.
2. Abnormal retention of fluid (congestive heart failure, drug-induced
oedema)
Adults: Initially 1 – 1½ tablets once daily in the morning.
If after an initial response, patient fails to continue to lose oedema
fluid, do not increase the
dose but allow for kidney recovery by omitting a day.
Best results