Solpadol Caplets 500mg/30mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Paracetamol; Codeine phosphate hemihydrate

Available from:

Imbat Limited

ATC code:

N02AJ; N02AJ06

INN (International Name):

Paracetamol; Codeine phosphate hemihydrate

Dosage:

500 mg/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:

Authorised

Authorization date:

2014-02-28

Patient Information leaflet

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLPADOL
® CAPLETS 500MG/30MG TABLETS (paracetamol / codeine phosphate hemihydrate)
THIS PRODUCT IS AVAILABLE AS ‘CO-CODAMOL 30/500
TABLETS’ IN OTHER JURISDICTIONS.
Solpadol is available as Solpadol Caplets 500mg/30mg
Tablets and Solpadol 500mg/30mg Effervescent Tablets.
This leaflet applies to Solpadol Caplets 500mg/30mg Tablets
which will be referred to as Solpadol throughout this leaflet.
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 codein

Summary of Product characteristics

Health Products Regulatory Authority
11 October 2019
CRN008Z15
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpadol Caplets 500mg/30mg 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.
_Product imported from: UK_
White to off-white, capsule-shaped tablets with flat sides, marked
‘SOLPADOL’ on one side and blank on the reverse.
4 CLINICAL PARTICULARS
As per PA0540/159/001
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/159/001
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Pregelatinised starch
Maize starch
Povidone
Potassium sorbate
Microcrystalline cellulose
Stearic acid
Talc
Magnesium sterate
Croscarmellose sodium (Type A)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the blisters and outer carton of the product as marketed in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Store in the original package in order to protect from moisture.
6.5 NATURE AND CONTENTS OF CONTAINER
Health Products Regulatory Authority
11 October 2019
CRN008Z15
Page 2 of 2
Blisters in a cardboard outer carton.
Pack size: 100
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Imbat Limited
Unit L2
North Ring Business Park
Santry
Dublin 9
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1151/191/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 28
th
February 2014
10 DATE OF REVISION OF THE TEXT
October 2019