Acetazolamide 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acetazolamide

Available from:

A A H Pharmaceuticals Ltd

ATC code:

S01EC01

INN (International Name):

Acetazolamide

Dosage:

250mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 11060000; GTIN: 5025903017714

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ACETAZOLAMIDE DAWA 250MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. 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 become serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
•
What Acetazolamide 250mg Tablets are and what they are used for
•
Before you take Acetazolamide 250mg Tablets
•
How to take Acetazolamide 250mg Tablets
•
Possible side effects
•
How to store Acetazolamide 250mg Tablets
•
Further information
1.
WHAT ACETAZOLAMIDE 250MG TABLET ARE AND WHAT THEY ARE USED FOR
Acetazolamide DAWA 250mg Tablets (referred to as Acetazolamide 250mg
Tablets throughout this
leaflet) contain the active substance Acetazolamide. This belongs to a
group of medicines known as
carbonic anhydrase inhibitors.
Acetazolamide 250mg Tablets are used to treat:
•
Glaucoma (a condition of the eye), by reducing the pressure within the
eye.
•
Abnormal retention of fluids (Acetazolamide 250mg Tablets acts as a
diuretic)
•
Epilepsy (fits or convulsions).
2.
BEFORE YOU TAKE ACETAZOLAMIDE 250 MG TABLET
DO NOT TAKE ACETAZOLAMIDE 250MG TABLETS IF:
•
You know you are allergic to sulphonamides, sulphonamide derivatives
including acetazolamide or
to any of the ingredients in the medicine (listed in Section 6 at the
end of this leaflet)
•
You have severe liver problems
•
You have or have ever had severe kidney problems
•
You have a particular type of glaucoma known as chronic non congestive
angle closure glaucoma
(your doctor will be able to advise you)
•
You have reduced function of the adrenal glands – glands above the
kidneys – (also known as
Addison’s disease)
•
You have low blood levels of sodium and/or p

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Acetazolamide DAWA 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
Acetazolamide Ph.Eur 250mg
Excipients QS
For excipients see 6.1.
3
PHARMACEUTICAL FORM
Tablet
White color, round shaped tablet with break line on one side & plain
on other
side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Acetazolamide Tablets are for oral administration.
Acetazolamide is an enzyme inhibitor which acts specifically on
carbonic
anhydrase. It is indicated in the treatment of:
•
Glaucoma: Acetazolamide Tablets is useful in 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) because it acts on inflow, decreasing the
amount
of aqueous secretion.
•
Abnormal retention of fluids: Acetazolamide Tablets is a diuretic
whose effect is due to the effect on the reversible hydration of
carbon dioxide
and dehydration of carbonic acid reaction in the kidney. The result is
renal
loss of HC03- ion which carries out sodium, water and potassium.
Acetazolamide Tablets 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.
•
Epilepsy: In conjunction with other anticonvulsants best results with
Acetazolamide Tablets have been seen in petit mal in children. Good
results,
however, have been seen in patients, both children and adults, with
other
types of seizures such as grand mal, mixed seizure patterns, myoclonic
jerk
patterns etc.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
•
Glaucoma (simple acute congestive and secondary):
Adults: 250 - 1,000mg (1-4 tablets) every 24 hours, usually in divided
doses for
amounts over 250mg daily.
•
Abnormal retention of fluid: Congestive heart failure, drug-induced
oedema.
Adults: For diuresis, the starting dose is usually 250 - 375mg (“one
tablet” and “one
and a half