BETADEXAMINE TABLETS

Land: Sydafrika

Språk: engelska

Källa: South African Health Products Regulatory Authority (SAHPRA)

Tillgänglig från:

Pharmacare Limited û Woodmead

Dos:

250,0 mcg/2,0 mg

Läkemedelsform:

TABLET

Sammansättning:

EACH TABLET CONTAINS BETAMETHASONE 250,0 mcg and DEXCHLORPHENIRAMINE 2,0 mg

Bemyndigande status:

Registered

Bipacksedel

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1.3.2 PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S4
BETADEXAMINE TABLETS 0,25 MG/2 MG
BETAMETHASONE, DEXCHLORPHENIRAMINE MALEATE
CONTAINS SUGAR: ANHYDROUS LACTOSE 174,75 MG
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
BETADEXAMINE TABLETS
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other
healthcare provider.
•
BETADEXAMINE TABLETS has been prescribed for you personally and you
should
not share your medicine with other people. It may harm them, even if
their symptoms
are the same as yours.
WHAT IS IN THIS LEAFLET
1.
What BETADEXAMINE TABLETS is and what it is used for
2.
What you need to know before you take BETADEXAMINE TABLETS
3.
How to take BETADEXAMINE TABLETS
4.
Possible side effects
5.
How to store BETADEXAMINE TABLETS
6.
Contents of the pack and other information
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1.
WHAT BETADEXAMINE TABLETS IS AND WHAT IT IS USED FOR
BETADEXAMINE TABLETS belongs to a group of medicines known as
corticosteroids in
combination with anti-histamines. BETADEXAMINE TABLETS is used for the
treatment of
allergic rhinitis (hay fever) and certain allergic skin conditions
.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETADEXAMINE TABLETS
DO NOT TAKE BETADEXAMINE TABLETS
•
if you are hypersensitive (allergic) to betamethasone,
dexchlorpheniramine or any of
the other ingredients of BETADEXAMINE TABLETS (listed in section 6).
•
if you have an infection.
•
if you take medicines referred to as Monoamine Oxidase Inhibitors
(MAOIs), used to
treat depression.
BETADEXAMINE TABLETS should not be administered to new-borns,
premature infants or
children (see section titled Children below).
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH BETADEXAMINE TABLETS
•
BETADEXAMINE TABLETS may lead to disturbed concentration and excessive
sleepiness (drowsiness).
•
If you recently had a heart attack.
•
If you need to go for a vaccination or have bee

Produktens egenskaper

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1.3.1.1 PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS
S4
1.
NAME OF THE MEDICINE
BETADEXAMINE TABLETS 0,25 mg/2 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0,25 mg betamethasone and 2 mg
dexchlorpheniramine maleate.
Contains sugar: Anhydrous lactose 174,75 mg
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
BETADEXAMINE TABLETS are white to off-white round tablets debossed
with A24 on one side
and a score line on the other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
BETADEXAMINE TABLETS are recommended in the treatment of:
•
Acute allergic rhinitis, not responsive to conventional therapy.
•
Steroid-responsive dermatological allergies and steroid-responsive
dermatoses.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
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POSOLOGY
DOSAGE SHOULD BE INDIVIDUALISED AND ADJUSTED ACCORDING TO THE
CONDITION UNDER TREATMENT AND THE RESPONSE OBTAINED.
BETADEXAMINE TABLETS are only to be used for short-term treatment
(less than 5 days).
BETADEXAMINE TABLETS should only be used for well-defined indications.
BETADEXAMINE TABLETS should not be mixed with other mixtures.
_ _
_Adults _
The recommended initial dosage for adults and children over 12 years
is 1 (one) to 2 (two)
tablets four times daily after meals and at bedtime. The dose is not
to exceed 8 (eight) tablets
per day.
As improvement occurs, the dosage should be reduced gradually to the
minimum maintenance
level and discontinued if at all possible. Treatment should not exceed
5 days.
A course of treatment should not be repeated within 28 days unless
specifically indicated and
prescribed by the medical practitioner.
PAEDIATRIC POPULATION_ _
The safety and efficacy of BETADEXAMINE TABLETS in children younger
than 12 years of
age have not been established.
MET