Acetazolamide 250mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Acetazolamide

Available from:

Crescent Pharma 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: 5017123303265

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 Tablets 250 mg.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250 mg of Acetazolamide.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Acetazolamide 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 is an enzyme inhibitor which acts specifically on
carbonic
anhydrase. It is indicated in the treatment of:
1. Glaucoma
Acetazolamide 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.
2. Abnormal retention of fluids
Acetazolamide 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 HC0
3-
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, however, have been seen
in 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
Posology
1.
Glaucoma (simple acute congestive and secondary)
Adults: 250 - 1,000mg (1 – 4 tablets) per 24 hours, usually in
divided doses
for amounts over 250 mg daily.
2. Abnormal retention of fluid (congestive heart failure, drug-induced
oedema)
Adults: For diuresis, the starting dose is usually 250 - 375mg (1 –
1½ ta