Prednisolone 5mg/5ml oral solution unit dose

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Prednisolone

Tilgjengelig fra:

Logixx Pharma Solutions Ltd

ATC-kode:

H02AB06

INN (International Name):

Prednisolone

Dosering :

1mg/1ml

Legemiddelform:

Oral solution

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 06030200; GTIN: 5060347610015

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PREDNISOLONE 1MG/ML ORAL SOLUTION
Prednisolone sodium phosphate
_ _
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.
-
PREDNISOLONE IS A STEROID MEDICINE, prescribed for many different
conditions, including serious
illnesses.
-
YOU NEED TO TAKE IT REGULARLY to get the maximum benefit.
-
DO NOT STOP TAKING THIS MEDICINE without talking to your doctor. You
may need to reduce the dose
gradually.
-
Prednisolone Dompé can cause side effects in some people (read
section 4 below). SOME SIDE EFFECTS
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 oral solution, 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 OR SHINGLES, 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. It includes other important
information on the safe and effective use of this
medicine that may be especially important for you.
WHAT IS IN THIS LEAFLET
1.
What Prednisolone Dompé Oral Solution is and what it is used for
2.
What you need to know before you take Prednisolone Dompé Oral
Solution
3.
How to take Prednisolone Dompé Oral Solution
4.
Possible side effects
5.
How to store Prednisolone Dompé Oral Solutio

Preparatomtale

OBJECT 1
PREDNISOLONE DOMPE 1.0 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 18-May-2018 | Logixx Pharma
Solutions Ltd
1. Name of the medicinal product
Prednisolone Dompé 1.0 mg/ml oral solution
2. Qualitative and quantitative composition
The active ingredient of Prednisolone Dompé is prednisolone as the
sodium phosphate ester.
Each 1 ml oral solution contains 1 mg prednisolone (as sodium
phosphate).
Each 5 ml single-dose container contains 5 mg of prednisolone (as
sodium phosphate).
Each 5 ml single-dose container contains 0.5 mmole sodium per dose.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral Solution
4. Clinical particulars
4.1 Therapeutic indications
Rheumatological disorders and connective tissue diseases such as:
• rheumatoid arthritis (for primary chronic disease and maintenance
therapy)
• systemic lupus erythematosus (non-organ threatening disease)
• mild-moderate juvenile dermatomyositis
Severe or debilitating allergic conditions, not treatable in a
conventional manner such as:
• bronchial asthma in children
• bronchial asthma in adults (for maintenance therapy)
Sarcoidosis in children and for maintenance therapy in adults
Acquired haemolytic anaemia (autoimmune, for maintenance therapy)
4.2 Posology and method of administration
Posology
The lowest dosage that will produce an acceptable result should be
used (See section 4.4); when it is
possible to reduce the dosage, this must be accomplished by stages.
During prolonged therapy any
intercurrent illness, trauma or surgical procedure will require a
temporary increase in dosage; if
corticosteroids have been stopped following prolonged therapy they may
need to be temporarily re-
introduced.
The medicinal product should preferably be taken as a single dose in
the morning. However, divided daily
dosages may be employed if required.
_NOTE TO THE PRESCRIBER:_
This 5 ml single-dose unit presentation should not be prescribed for
doses exceeding 30 mg daily, because
opening more than 6 containers in a da