Diamox 250 mg Tablets

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:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Carbonic anhydrase inhibitors; acetazolamide

Authorization status:

Marketed

Authorization date:

1978-04-01

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, 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® 250 mg Tablets it will be called
Diamox for ease
here after.
WHAT IS IN THIS LEAFLET
1. What Diamox are and what they are used for
2. What you need to know before you take Diamox
3. How to take Diamox
4.
Possible side effects
5.
How to store Diamox
6.
Contents of the pack and other information
1.
WHAT DIAMOX ARE AND WHAT THEY ARE USED FOR
Diamox contain the active substance acetazolamide. This belongs to a
group of medicines known as
carbonic anhydrase inhibitors.
Diamox 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
DO NOT TAKE DIAMOX:
-
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 and its derivatives
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before taking Diamox:
-
if you have or ever had suicidal thoughts.
-
if you have sensation of tingling, tickling, pricking and burning in
the extremities
-

Summary of Product characteristics

Health Products Regulatory Authority
04 December 2018
CRN008N4H
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diamox 250 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Acetazolamide 250 mg.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White circular, biconvex tablet engraved with ‘FW’ and ‘147’
on one side and scored
in quarters on the other.
The tablet can be divided in equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
It is indicated in the treatment of glaucoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults_
250mg – 1,000 mg daily; One to four 250mg tablets a day in divided
doses.
_Paediatric population_
This product is not intended for administration to children.
_Elderly _
Diamox 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
not exceed
250mg per day or the dosage interval should be increased to every 12
hours.
Health Products Regulatory Authority
04 December 2018
CRN008N4H
Page 2 of 10
Method of administration
For oral use only.
Tablets 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.

Acetazolamide therapy is contra-indicated in cases of marked kidney
disease or dysfunction, adrenal gland failure, and hyper-chloraemic
acidosis. Diamox should not be used in patients with liver disease or
impairment of liver function including cirrhosis as this may increase
the risk
of hepatic encephalopathy. Diamox is contra-indicated in patients with
hypokalemia and hyponatraemia.

Long-term administration of Diamox is contra-indicated in patients
with
chronic non-congestive angle-closure glaucoma since it may permit
organic clos