URAMOX

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

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Navodilo za uporabo Navodilo za uporabo (PIL)
07-10-2020
Lastnosti izdelka Lastnosti izdelka (SPC)
04-08-2020
Javno poročilo o oceni Javno poročilo o oceni (PAR)
04-08-2020

Aktivna sestavina:

ACETAZOLAMIDE

Dostopno od:

TARO PHARMACEUTICAL INDUSTRIES LTD

Koda artikla:

S01EC01

Farmacevtska oblika:

TABLETS

Sestava:

ACETAZOLAMIDE 250 MG

Pot uporabe:

PER OS

Tip zastaranja:

Required

Izdeluje:

TARO PHARMACEUTICAL INDUSTRIES LTD

Terapevtska skupina:

ACETAZOLAMIDE

Terapevtsko območje:

ACETAZOLAMIDE

Terapevtske indikacije:

For adjunctive treatment of drug induced edema and edema due to congestive heart failure. Chronic simple (open angle) glaucoma, secondary glaucoma and pre operatively in acute angle closure glaucoma where delay of surgery is desired in order to lower intraocular pressure. Acute mountain sickness.

Datum dovoljenje:

2021-10-31

Navodilo za uporabo

                                1
PIL- clean 09.2020
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
URAMOX
®
, TABLETS
Name and quantity of active ingredient: Each tablet contains:
250 mg acetazolamide
For a list of inactive ingredients and allergens please see section 2
under ‘Important information
about some of this medicine’s ingredients’ and section 6
‘Additional information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains
concise information about this medicine. If you have any further
questions, consult your doctor
or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It may harm
them, even if it seems to you that their illness is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?

As a supplementary treatment of edema that is due to heart failure or
is caused by
medication.

As a supplementary treatment of different types of glaucoma.

To relieve and prevent acute mountain sickness.
THERAPEUTIC GROUP: carbonic anhydrase inhibitor.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:

you are sensitive (allergic) to sulphonamides, sulphonamide
derivatives including
acetazolamide or to any of the other ingredients in this medicine
(please see 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/or potassium or high blood
levels of chlorine (your
doctor will advise you).

you are pregnant.
SPECIAL WARNINGS ABOUT USING THIS MEDICINE

BEFORE STARTING TREATMENT WITH URAMOX, TELL YOUR DOCTOR IF:
-
you have lung problems, such as chronic bronchitis or emphysema, which
ca
                                
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Lastnosti izdelka

                                1
Uramox SPC – final 05.20
_ _
URAMOX
®
1. NAME OF THE MEDICINAL PRODUCT
URAMOX
®
Acetazolamide 250mg Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 250mg acetazolamide.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet.
White, round tablet one side engraved with "T53". Other side cross
scored.
4. CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Uramox tablets are for oral administration.
Uramox is an enzyme inhibitor which acts specifically on carbonic
anhydrase.
It is indicated for:
1. Adjunctive treatment of drug induced edema and edema due to
congestive
heart failure.
2. Chronic simple (open angle) glaucoma, secondary glaucoma and pre
operatively in acute angle closure glaucoma where delay of surgery is
desired in order to lower intraocular pressure.
3. Acute mountain sickness.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
CONGESTIVE HEART FAILURE
: For diuresis in congestive heart failure, the
starting dose is usually 250 to 375 mg once daily in the morning. If,
after an
initial response, the patient fails to continue to lose edema fluid,
do not
increase the dose but allow for kidney recovery by skipping medication
for a
day. Acetazolamide tablets yield best diuretic results when given on
alternate days, or for two days alternating with a day of rest.
Failures in therapy may be due to overdosage or too frequent dosage.
The
use of acetazolamide does not eliminate the need for other therapy
such as
digitalis, bed rest and salt restriction.
DRUG INDUCED EDEMA:
Recommended dosage is 250 to 375 mg of
acetazolamide once a day for one or two days, alternating with a day
of rest.
GLAUCOMA:
Acetazolamide should be used as an adjunct to the usual
therapy. The dosage employed in the treatment of chronic simple (open-
angle) glaucoma ranges from 250 mg to 1 g of acetazolamide per 24
hours,
usually in divided doses for amounts over 250 mg. It has usually been
found
2
Uramox SPC – final 05.20
that a dosage in excess of 1 g per 24 hours does not produce an
increas
                                
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