Dexliq 4 mg/ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dexamethasone sodium phosphate

Available from:

Laboratoires CTRS

ATC code:

H02AB; H02AB02

INN (International Name):

Dexamethasone sodium phosphate

Dosage:

4 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Prescription type:

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

Therapeutic area:

Glucocorticoids; dexamethasone

Authorization status:

Not marketed

Authorization date:

2017-06-30

Patient Information leaflet

23
PACKAGE LEAFLET: INFORMATION FOR THE USER
DEXLIQ 4 MG/ML ORAL SOLUTION
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 Dexliq is and what it is used for
2.
What you need to know before you take Dexliq
3.
How to take Dexliq
4.
Possible side effects
5.
How to store Dexliq
6.
Contents of the pack and other information
1.
WHAT DEXLIQ IS AND WHAT IT IS USED FOR
Dexliq contains the active substance dexamethasone. Dexamethasone
belongs to a group of medicines
called steroids (the full name is corticosteroids). Corticosteroids
occur naturally in the body, and help
to maintain health and well-being.
Boosting your body with extra corticosteroid (such as dexamethasone)
is an effective way to treat
various illnesses involving inflammation in the body.
Dexliq reduces this inflammation, which could otherwise go on making
your condition worse. You
must take this medicine regularly to get maximum benefit from it.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEXLIQ
DO NOT TAKE DEXLIQ
-
if you are allergic (hypersensitive) to dexamethasone or any of the
other ingredients of Dexliq
(listed in section 6) or you have ever had an unusual reaction to
these substances
-
if you have an infection that affects the whole body (unless you are
receiving treatment)
-
if you have a fungal infection that affects the whole body
-
if you have a stomach or duodenal ulcer
-
if you have an infection with worms after travelling to a tropical
area
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking

Summary of Product characteristics

Health Products Regulatory Authority
17 November 2023
CRN00CR3G
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dexliq 4 mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 4 mg of dexamethasone (as dexamethasone
sodium phosphate).
Excipients with known effect: Each ml of solution also contains 275 mg
liquid maltitol (E965), 98 mg sorbitol (E420), 0.2 mg
ethanol and 90 mg of propylene glycol (E1520).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution.
A colourless to yellowish solution with a mint odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Dexliq is indicated for use in:
Infections and infestations: Tuberculous meningitis, only in
conjunction with anti-infective therapy.
Neoplasms benign, malignant and unspecified (including cysts and
polyps):

Palliative treatment of neoplastic diseases.

Prophylaxis and treatment of emesis induced by cytostatics, emetogenic
chemotherapy within antiemetic
treatment.

Treatment of symptomatic multiple myeloma, acute
lymphocytic/lymphoblastic leukaemia, Hodgkin's disease and
non-Hodgkin's lymphoma in combination with other medicinal products.
Blood and lymphatic system disorders: Idiopathic thrombocytopenic
purpura in adults.
Immune system disorders: Initial treatment of autoimmune disorders
like systemic lupus erythematodes.
Endocrine disorders: diagnostic testing of adrenocortical
hyperfunction (dexamethasone suppression test).
Nervous system disorders:
Cerebral oedema (only with symptoms of intracranial pressure evidenced
by computerised tomography) caused by a brain
tumour, neuro-surgical intervention or cerebral abscess.
Vascular disorders: Active phases of systemic vasculitides like
panarteritis nodosa (treatment duration should be limited to two
weeks in cases of concomitant positive hepatitis B serology).
Respiratory, thoracic and mediastinal disorders:

Acute asthma exacerbations when use of an oral corticosteroid is
appropriate -Croup.
Hea