Dexamethasone 10mg/5ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dexamethasone sodium phosphate

Available from:

Taw Pharma (Ireland) Ltd

ATC code:

H02AB; H02AB02

INN (International Name):

Dexamethasone sodium phosphate

Dosage:

10 mg/5ml

Pharmaceutical form:

Oral solution

Therapeutic area:

Glucocorticoids; dexamethasone

Authorization status:

Not marketed

Authorization date:

2013-12-20

Patient Information leaflet

PAGE 1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMPORTANT INFORMATION ABOUT THIS MEDICINE
•
DEXAMETHASONE IS A STEROID MEDICINE,
prescribed for many different
conditions, including serious illnesses
•
YOU NEED TO TAKE IT REGULARLY
to get the maximum benefit
•
DON’T STOP TAKING THIS MEDICINE
without talking to your doctor – you may
need to reduce the dose gradually
•
DEXAMETHASONE CAN CAUSE SIDE EFFECTS IN SOME PEOPLE
(read section 4:
Possible side effects). Some problems such as mood changes (feeling
depressed or ‘high’) or stomach problems can happen straight away.
If you
feel unwell, in any way, keep taking your medicine,
BUT SEE YOUR DOCTOR
STRAIGHT AWAY
•
SOME SIDE EFFECTS ONLY HAPPEN AFTER WEEKS OR MONTHS.
These include
weakness of arms and legs or developing a rounder face (read section 4
for
more information)
•
KEEP AWAY FROM PEOPLE WHO HAVE CHICKEN-POX, SHINGLES OR MEASLES,
if
you have never had them. They could affect you severely. If you do
come
into contact with anyone,
SEE YOUR DOCTOR STRAIGHT AWAY.
NOW READ THE REST OF THIS LEAFLET.
It includes other important information on the
safe and effective use of this medicine that might be especially
important for
you.
THIS LEAFLET WAS LAST UPDATED ON 12/2022.
•
Read all of this leaflet carefully before you start taking this
medicine.
•
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.
WHAT IS IN THIS LEAFLET
1. What Dexamethasone Oral Solution is and what it is used for
2. What you need to know before you take Dexamethasone Oral Solution
3. How to take Dexamethasone Oral Solution
4. Possible side effects
5. How to store Dexamethasone Oral Solution
6. Contents of the pack and ot

Summary of Product characteristics

Health Products Regulatory Authority
26 January 2023
CRN00D9JL
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexamethasone 10mg/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml contains 10mg Dexamethasone (as dexamethasone sodium
phosphate)
1ml contains 2mg Dexamethasone (as dexamethasone sodium phosphate)
Excipients with known effect:
Liquid maltitol (E965) - 1375mg/5ml (275mg/ml)
Sorbitol (E420) liquid (non crystallising) -700mg/5ml (140mg/ml)
Propylene Glycol (E1520) – 450mg/5ml
Benzoic acid (E210) – 5mg/5ml
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Solution
A colourless to faint yellow solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexamethasone is a corticosteroid. It is designed for use in certain
endocrine and non-endocrine disorders, in certain cases of
cerebral oedema and for diagnostic testing of adrenocortical
hyperfunction.
Endocrine disorders:
Endocrine exophthalmos.
Non-endocrine disorders:
Dexamethasone may be used in the treatment of non-endocrine
corticosteroid responsive conditions including:
Allergy and anaphylaxis: Anaphylaxis.
Arteritis collagenosis: Polymyalgia rheumatica, polyarteritis nodosa.
Haematological disorders: Haemolytic anaemia (also auto immune),
leukaemia, myeloma, idiopathic thrombocytopenic
purpura in adults, reticulolymphoproliferative disorders (see also
under oncological disorders).
Gastroenterological disorders: For treatment during the critical stage
in: ulcerative colitis (rectal only); regional enteritis
(Crohn's disease), certain forms of hepatitis.
Muscular disorders: Polymyositis.
Neurological disorders: Raised intra-cranial pressure secondary to
cerebral tumours, acute exacerbations of multiple sclerosis.
Ocular disorders: Anterior and posterior uveitis, optic neuritis,
chorioretinitis, iridocyclitis, temporal arteritis, orbital
pseudotumour.
Renal disorders: Nephrotic syndrome
Health Products Regulatory Authority
26 January 2023
CRN00D9JL
Page 2 of 15
Pulmonary