Diamox SR 250mg Modified Release Hard Capsules

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Acetazolamide

Mevcut itibaren:

Amdipharm Limited

ATC kodu:

S01EC; S01EC01

INN (International Adı):

Acetazolamide

Doz:

250 milligram(s)

Farmasötik formu:

Modified-release capsule, hard

Terapötik alanı:

Carbonic anhydrase inhibitors; acetazolamide

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

1992-03-20

Bilgilendirme broşürü

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 an

Ürün özellikleri

Health Products Regulatory Authority
17 January 2024
CRN00DZ9Q
Page 1 of 7
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.
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 including
cirrhosis as this may increase the risk of hepatic encephalopathy.
Diamox is contraindicated in patients with hypokalaemia and
hyponatraemia.
Long term administration of Diamox SR is contra-indicated in patients
with chronic non-congestive angle-closure glaucoma
since it may permit organic closure of the angle to occur while the
worsening glaucoma is masked by lowered intraocular
pressure.
Diamox SR should not be used in patients hypersensit