Solpadol Caplets 500 mg/30 mg Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Paracetamol; Codeine phosphate hemihydrate

Verfügbar ab:

Opella Healthcare France SAS T/A Sanofi

ATC-Code:

N02AJ; N02AJ06

INN (Internationale Bezeichnung):

Paracetamol; Codeine phosphate hemihydrate

Dosierung:

500/30 milligram(s)

Darreichungsform:

Tablet

Therapiebereich:

Opioids in combination with non-opioid analgesics; codeine and paracetamol

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

1991-06-26

Gebrauchsinformation

SOLPADOL® CAPLETS 500MG/30MG TABLETS
_Paracetamol _
_Codeine Phosphate Hemihydrate _
_ _
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP.
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. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
-
If any side effects gets serious, or if you notice any side effect not
listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Solpadol is and what it is used for
2.
What you need to know before you take Solpadol
3.
How to take Solpadol
4.
Possible side effects
5.
How to store Solpadol
6.
Contents of the pack and other information
1.
WHAT SOLPADOL IS AND WHAT IT IS USED FOR
The name of this medicine is Solpadol Caplets 500mg/30mg Tablets.
Solpadol belongs to a group of medicines called analgesics
(painkillers) and is used to treat
severe pain. Solpadol can be used in children over 12 years of age for
the short-term relief
of moderate pain that is not relieved by other painkillers such as
paracetamol or ibuprofen
alone.
This product contains codeine. Codeine belongs to a group of medicines
called opioid
analgesics which act to relieve pain. It can be used on its own or in
combination with other
pain killers such as paracetamol.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLPADOL
DO NOT TAKE SOLPADOL:
•
For pain relief in children and adolescents (0-18 years of age) after
removal of their tonsils
or adenoids due to obstructive sleep apnoea syndrome
•
If you know that you metabolise very rapidly codeine into morphine
•
If you are pregnant or are breastfeeding
•
If you are allergic to codeine, paracetamol or any of the other
ingredients
•
If you have asthma or severe breathing problems
•
If you have recently had a head injury
•
If you have recently had gall bladder surgery or a similar operatio

Fachinformation

Health Products Regulatory Authority
26 September 2022
CRN00CN3D
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpadol Caplets 500 mg/30 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Paracetamol 500.0 mg
Codeine Phosphate Hemihydrate 30.0 mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White to off‐white capsule‐shaped tablet with flat sides marked
‘SOLPADOL’ on one side and blank on the reverse.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of severe pain.
Solpadol is indicated in patients older than 12 years of age for the
treatment of acute moderate pain which is not considered
to be relieved by other analgesics such as paracetamol or ibuprofen
(alone).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Solpadol should be used at the lowest effective dose for the shortest
period of time. This dose may be taken, up to 4 times a
day at intervals of not less than 6 hours. Maximum daily dose of
codeine should not exceed 240mg.
The duration of treatment should be limited to 3 days and if no
effective pain relief is achieved the patients/carers should be
advised to seek the views of a physician.
Adults (18 years and over):
Two tablets every 4‐6 hours to a maximum of four doses in any 24
hours.
Do not exceed eight tablets in 24 hours.
Elderly:
The initial dosage should be reduced to half the recommended dosage
and should be titrated to the individuals need and
overall medical condition.
Paediatric Population
Children aged 16 to 18 years:
One to two tablets every 6 hours to a maximum of four doses in any 24
hours.
Do not exceed 8 tablets in 24 hours.
Children (12-15 years):
One tablet every 6 hours to a maximum of four doses in any 24 hours.
Do not exceed 4 tablets in 24 hours.
Health Products Regulatory Authority
26 September 2022
CRN00CN3D
Page 2 of 10
Children aged less than 12 years:
Solpadol should not be used in children below the age of 12 years
because of the risk of opioid toxicity due to the