Diamox 250mg Tablets/Acetazolamide 250mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

ACETAZOLAMIDE

Available from:

Mercury Pharmaceuticals Limited Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

ATC code:

S01EC01

INN (International Name):

ACETAZOLAMIDE 250 mg

Pharmaceutical form:

TABLET

Composition:

ACETAZOLAMIDE 250 mg

Prescription type:

POM

Therapeutic area:

OPHTHALMOLOGICALS

Authorization status:

Withdrawn

Authorization date:

2006-11-17

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAMOX® 250MG TABLETS
Acetazolamide
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
symptoms 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 Diamox 250mg Tablets are and what they are used for
2. What you need to know before you take Diamox 250mg Tablets
3. How to take Diamox 250mg Tablets
4. Possible side effects
5. How to store Diamox 250mg Tablets
6. Contents of the pack and other information
1. WHAT DIAMOX 250MG TABLETS ARE AND WHAT THEY ARE USED FOR
Diamox® 250mg Tablets (referred to as Diamox 250mg Tablets throughout
this leaflet) contain the active
substance Acetazolamide.
This belongs to a group of medicines known as carbonic anhydrase
inhibitors.
Diamox 250mg Tablets are used to treat:
• glaucoma (a condition of the eye), by reducing the pressure within
the eye
• abnormal retention of fluids (Diamox 250mg Tablets acts as a
diuretic)
• epilepsy (fits or convulsions).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAMOX 250MG TABLETS
DO NOT TAKE DIAMOX 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)
• 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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
DIAMOX* 250mg Tablets
Acetazolamide Mercury
_ _
Pharma 250mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg acetazolamide BP.
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White, circular shallow biconvex tablets with quarter breakline on one
side and
engraved “FW” and “147” on other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DIAMOX Tablets are for oral administration.
Acteazolamide is an enzyme inhibitor which acts specifically on
carbonic anhydrase.
It is indicated in the treatment of:
i)
_Glaucoma:_
DIAMOX 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.
ii)
_Abnormal retention of fluids:_
DIAMOX 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 HC0
3-
ion which carries out sodium,
water and potassium. DIAMOX Tablets can be used in conjunction with
other diuretics
when effects on several segments of the nepbron are desirable in the
treatment of fluid
retaining states.
iii)
_Epilepsy:_
In conjunction with other anticonvulsants best results with DIAMOX
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
Posology
i)
Glaucoma (simple acute congestive and secondary):
Adults: 250 - 1,000mg (1-4 tablets) per 24 hours, usually in divided
doses for amounts
over 250mg daily.
ii)
Abnormal retention of fluid: Congestive heart failure, drug-induced
oedema.
Adul