Glensoludex 8mg soluble tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Dexamethasone sodium phosphate

Διαθέσιμο από:

Glenmark Pharmaceuticals Europe Ltd

Φαρμακολογική κατηγορία (ATC):

H02AB02

INN (Διεθνής Όνομα):

Dexamethasone sodium phosphate

Δοσολογία:

8mg

Φαρμακοτεχνική μορφή:

Soluble tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 06030200; GTIN: 05060204163456

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLENSOLUDEX 2 MG, 4 MG AND 8 MG SOLUBLE TABLETS
DEXAMETHASONE
IMPORTANT INFORMATION ABOUT THIS MEDICINE

GLENSOLUDEX 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

GLENSOLUDEX 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)

IF YOU TAKE IT FOR MORE THAN 3 WEEKS YOU WILL GET A ‘STEROID CARD’
: always keep it with you and show it to
any doctor or nurse treating you

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 chicken
pox or shingles,
SEE YOUR DOCTOR STRAIGHT
AWAY
NOW READ THE REST OF THIS LEAFLET. 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 side effects not listed in this
leaflet.
What is in this leaflet:
1.
What Glensoludex soluble tablets is and what it is used for
2.
What you need to know before you take Glensoludex soluble tablets
3.
How to take Glensoludex soluble tablets
4.
Possible side-

Αρχείο Π.Χ.Π.

OBJECT 1
GLENSOLUDEX 8 MG SOLUBLE TABLETS
Summary of Product Characteristics Updated 07-Jan-2021 | Glenmark
Pharmaceuticals Europe Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Glensoludex 8 mg soluble tablets
2. Qualitative and quantitative composition
Each tablet contains 8 mg dexamethasone as dexamethasone sodium
phosphate.
The sodium content of Glensoludex 8 mg soluble tablets is 60.5 mg per
tablet.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Soluble tablet
Glensoludex Soluble tablets 8 mg are salmon, biconvex, engraved '8',
round tablets
4. Clinical particulars
4.1 Therapeutic indications
Glensoludex is indicated 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:
Glensoludex may be used in the treatment of non-endocrine
corticosteroid responsive conditions
includin