Diamox SR 250mg Modified Release Hard Capsules

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Acetazolamide

Available from:

Mercury Pharmaceuticals Ltd

ATC code:

S01EC; S01EC01

INN (International Name):

Acetazolamide

Dosage:

250 milligram(s)

Pharmaceutical form:

Capsules Modified Release

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Carbonic anhydrase inhibitors; acetazolamide

Authorization status:

Not marketed

Authorization date:

1992-03-20

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DIAMOX
® SR 250MG MODIFIED RELEASE HARD CAPSULES
(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, pharmacist or
nurse.
- 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, pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Diamox
®
SR 250mg Modified Release Hard Capsules. It will be referred to
as Diamox SR 250mg capsules for ease hereafter.
WHAT IS IN THIS LEAFLET
1. What Diamox SR 250mg capsules are and what they are used for
2. What you need to know before you take Diamox SR 250mg capsules
3. How to take Diamox SR 250mg capsules
4. Possible side effects
5. How to store Diamox SR 250mg capsules
6. Contents of the pack and other information
1.
WHAT DIAMOX SR 250MG CAPSULES ARE AND WHAT THEY ARE USED FOR
Diamox SR 250mg capsules contain the active substance acetazolamide.
This belongs to a group of
medicines known as carbonic anhydrase inhibitors.
Diamox SR 250mg capsules are used to treat glaucoma (a condition of
the eye), by reducing the pressure
within the eye.
It is indicated in adults and older people.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIAMOX SR 250MG CAPSULES
DO NOT TAKE DIAMOX SR 250MG CAPSULES:
- If you are allergic to acetazolamide or any of the other ingredients
of this medicine (listed in section 6)
- if you have severe kidney or liver problems
- if you are suffering from adrenal glands disorders
- if you have high blood levels of chlorine
- if you have low blood levels of sodium and/or potassium
- if you have a particular type of glaucoma known as chronic non
congestive angle closure glaucoma
- if you are allergic to sulphonamides

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diamox SR 250mg Modified Release Hard Capsules.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Acetazolamide 250 mg
Excipient(s) with known effect: Contains FD + C yellow no. 6 (E110)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Modified-release capsule.
Hard shell capsule with clear body and orange cap, containing orange
spherical pellets.
Capsules are printed GS 250 in black.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
It is indicated in the treatment of glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
One or two 250mg capsules a day.
_Paediatric population:_
This product is not intended for administration to children.
Older people:
Diamox SR should be used with particular caution in older people or
those with potential
obstruction in the urinary
tract or with disorders rendering their electrolyte balance precarious
or with liver dysfunction.
Renal impairment:
In patients with moderate to severe renal impairment, the dose should
be reduced by half or the dosage interval should
be increased to every 12 hours.
Method of administration
For oral use only.
Capsules should be swallowed whole. Do not chew or crush.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
Diamox SR therapy is contra-indicated in cases of marked kidney
disease or dysfunction suprarenal gland failure, and
hyperchloraemic acidosis.
Diamox should not
be used in patients with liver disease or impairment
of liver function
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