Dexamethasone Activase 2 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dexamethasone

Available from:

Activase Pharmaceuticals Limited

ATC code:

H02AB02

INN (International Name):

Dexamethasone

Pharmaceutical form:

Tablet

Therapeutic area:

dexamethasone

Authorization date:

2022-06-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DEXAMETHASONE ACTIVASE 0.5 MG TABLETS
DEXAMETHASONE ACTIVASE 2 MG TABLETS
(dexamethasone)
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 or pharmacist.

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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT DEXAMETHASONE TABLETS IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXAMETHASONE TABLETS
3. HOW TO TAKE DEXAMETHASONE TABLETS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DEXAMETHASONE TABLETS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT DEXAMETHASONE TABLETS IS AND WHAT IT IS USED FOR
The name of your medicine is Dexamethasone. This belongs to a group of
medicines called
corticosteroids.
Corticosteroids are hormones that are found naturally in your body
that help to keep you healthy and
well. Taking extra corticosteroids, such as Dexamethasone, is used to
treat various illnesses involving
inflammation in the body.
Dexamethasone lowers inflammation, which could otherwise go on making
your condition worse.
You must take this medicine regularly to get maximum benefit from it.
Dexamethasone can be used to:

Reduce inflammation

Treat a number of different diseases of the immune system including:
•
Rheumatism (pain, stiffness or limitation of motion in the joints,
muscles and
tendons)
•
Inflammations including inflammation of the joints and tissue around
the
joint (rheumatoid arthritis), inflammation of the skin (such as
contact
dermatitis), the eye, blood vessels and other parts of the body
•
Allergic conditions which cause joint pain, skin rashes and fever
•
Hypersen

Summary of Product characteristics

Health Products Regulatory Authority
03 June 2022
CRN00C380
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone Activase 2 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2 mg dexamethasone
Excipients with known effect
Each tablet contains 72.5 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
White, round, flat bevelled tablets of about 6.0 mm in diameter and
2.5-2.8mm, thickness, debossed 'D' on top and '2'
underneath on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexamethasone tablets are used for the treatment of various
inflammatory and autoimmune diseases e.g.:
RHEUMATISM, as pain, stiffness or limitation of motion, especially in
the joints and related structures, including muscles, bursae,
tendons, fibrous tissue;
COLLAGEN DISEASE, as lupus erythematosus, dermatomyositis,
polyarteritis nodosa, thrombotic purpura and rheumatoid arthritis;
ALLERGIES, as status asthmaticus, bronchial asthma, contact
dermatitis, inflammatory processes of the eye and its adnexa, severe
hypersensitivity reactions to drugs or insect stings, anaphylactic
shock, impending allograft rejection;
PRIMARY OR SECONDARY ADRENOCORTICAL INSUFFICIENCY, AND ADRENOGENITAL
SYNDROMES.
Besides Dexamethasone is used as an adjunct in the control of CEREBRAL
OEDEMA (not in those cases where the oedema is
caused by head injury), for treatment of LYMPHOCYTIC LEUKAEMIA, as
ANTI-EMETIC in antineoplastic regimens and for palliative
treatment in terminal stages of NEOPLASTIC DISEASE.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration
Glucocorticoids may be administered by a number of routes, depending
on the nature of the disease and the condition of the
patient. Localised therapy is generally preferred because it minimises
adverse effects. When systemic administration is required,
the oral route is preferred for ease in regulation of dose and the
variety in regimens. Dexametha