Solpadol Caplets 500 mg/30 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate hemihydrate

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

N02AJ; N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate hemihydrate

Dosage:

500/30 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

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

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

1991-06-26

Patient Information leaflet

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

Summary of Product characteristics

Health Products Regulatory Authority
28 April 2020
CRN0098P3
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
28 April 2020
CRN0098P3
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 variabl