Dexamethasone 2mg Tablets

Quốc gia: Ai-len

Ngôn ngữ: Tiếng Anh

Nguồn: HPRA (Health Products Regulatory Authority)

Thành phần hoạt chất:

Dexamethasone

Sẵn có từ:

Aspen Pharma Trading Limited

Mã ATC:

H02AB; H02AB02

INN (Tên quốc tế):

Dexamethasone

Liều dùng:

2 milligram(s)

Dạng dược phẩm:

Tablet

Loại thuốc theo toa:

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

Khu trị liệu:

Glucocorticoids; dexamethasone

Tình trạng ủy quyền:

Marketed

Ngày ủy quyền:

1978-04-01

Tờ rơi thông tin

B. PACKAGE LEAFLET
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
DEXAMETHASONE 2MG TABLETS
Dexamethasone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 is and what it is used for
2.
What you need to know before you take Dexamethasone
3.
How to take Dexamethasone
4.
Possible side effects
5.
How to store Dexamethasone
6.
Contents of the pack and other information
1.
WHAT DEXAMETHASONE IS AND WHAT IT IS USED FOR
The name of your medicine is Dexamethasone. Dexamethasone is a
synthetic glucocorticoid
(adrenocortical hormone).
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

Hypersensitivity reactions (allergic reactions) to other drugs or
insect stings

Đặc tính sản phẩm

Health Products Regulatory Authority
24 June 2022
CRN00CT85
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone 2mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2mg of Dexamethasone.
Excipient with known effect:
Each tablet contains approximately 116mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Round, 6 mm, flat, white tablet with the code ‘XC/8’ engraved on
one surface 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.
Dexamethasone is indicated in the treatment of coronavirus disease
2019 (COVID-19) in adult and adolescent patients (aged
12 years and older with body weight at least 40 kg) who require
supplemental oxygen therapy.
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 min