Diamox Powder for Solution for Injection 500 mg/vial

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Indlægsseddel Indlægsseddel (PIL)
24-01-2019
Produktets egenskaber Produktets egenskaber (SPC)
09-02-2018

Aktiv bestanddel:

ACETAZOLAMIDE SODIUM

Tilgængelig fra:

Mercury Pharmaceuticals Ltd

ATC-kode:

S01EC; S01EC01

INN (International Name):

ACETAZOLAMIDE SODIUM

Dosering:

500 milligram(s)

Lægemiddelform:

Powder for solution for injection

Recept type:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Carbonic anhydrase inhibitors; acetazolamide

Autorisation status:

Not marketed

Autorisation dato:

1978-04-01

Indlægsseddel

                                PATIENT INFORMATION LEAFLET
DIAMOX® POWDER FOR SOLUTION FOR INJECTION
500MG/VIAL
(Acetazolamide)
Please read all of this leaflet carefully before you start using this
medicine. It provides important
information about this medicine.
Keep this leaflet. You may need to read it again.
If you have any questions or are not sure about anything, ask your
doctor or pharmacist.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet:
1. What DIAMOX® is and what it is used for
2. Before you use DIAMOX®
3. How to use DIAMOX®
4. Possible side effects
5. How to store DIAMOX®
6. Further information
1. WHAT DIAMOX® IS AND WHAT IT IS USED FOR
DIAMOX® Powder for Solution for Injection 500mg/viaI belongs to a
group of drugs called
carbonic anhydrase inhibitors. DIAMOX® is used to treat the eye
condition glaucoma, and also
fluid retention and epilepsy.
2. BEFORE YOU USE DIAMOX®
If the answer to any of the following questions is “YES” you
should talk to your doctor before
administration of DIAMOX® Powder for Solution for Injection
500mg/vial as it may not be
suitable for you:
• are you pregnant, breast feeding or trying for a baby?
• are you allergic to sulpha-containing medicines?
•
have you
ever had an allergic reaction to acetazolamide, sulphonamides,
sulphonamide
derivatives or to any of the ingredients in the formulation?
• do you have liver problems?
• do you have or have you ever had kidney problems such as kidney
stones?
• do you have trouble passing urine?
• do you have lung problems such as chronic bronchitis or emphysema?
• are you taking medicines for your heart such as cardiac glycosides
(e.g. digoxin), blood
pressure, to thin your blood (e.g. warfarin), to lower the sugar in
your blood, or for epilepsy (in
particular, phenytoin, primidone or carbamazepine)?
• are you taking any of the following:
methotrexate, pyrimethamine or trimethoprim; or steroids such as
prednisolone?
• are you tak
                                
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Produktets egenskaber

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Diamox Powder for Solution for Injection 500 mg/vial
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains Acetazolamide Sodium equivalent to Acetazolamide
500mg.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
Sterile, white, lyophilised powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DIAMOX is an enzyme inhibitor which acts specifically on carbonic
anhydrase. It is indicated in the treatment of:
i)
GLAUCOMA:
DIAMOX 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 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
HCO
3-
ion which carries out sodium, water and potassium.
DIAMOX 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.
iii)
EPILEPSY:
In conjunction with other anticonvulsants best results with DIAMOX
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.
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