Solpadol 500mg/30mg Effervescent Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Codeine phosphate hemihydrate; Paracetamol

Available from:

Imbat Limited

ATC code:

N02AJ; N02AJ06

INN (International Name):

Codeine phosphate hemihydrate; Paracetamol

Dosage:

500/30 milligram(s)

Pharmaceutical form:

Effervescent 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
® 500MG/30MG EFFERVESCENT TABLETS
(paracetamol / codeine phosphate hemihydrate)
THIS PRODUCT IS AVAILABLE AS ‘CO-CODAMOL 30/500
EFFERVESCENT TABLETS’ IN OTHER JURISDICTIONS.
Solpadol is available as Solpadol Caplets 500mg/30mg Tablets
and Solpadol 500mg/30mg Effervescent Tablets.
This leaflet applies to Solpadol 500mg/30mg Effervescent 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.
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
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.
BEFORE YOU USE 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 breast-feeding

If you are allergic to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solpadol 500mg/30mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Paracetamol
500.0 mg
Codeine Phosphate Hemihydrate
30.0 mg
Excipients of known effect: sorbitol (E420) and sodium
For a full list of excipeints see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent Tablet.
_Product imported from: UK_
A white bevelled-edge tablet scored on one face and plain on the
reverse.
4 CLINICAL PARTICULARS
As per PA0540/159/003
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/159/003
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Citric Acid Anhydrous
Saccharin Sodium
Povidone
Sodium Bicarbonate
Sodium Carbonate Anhydrous
Sorbitol Powder (E420)
Sodium Laurilsulfate
Dimeticone
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the laminate strips 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.
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6.5 NATURE AND CONTENTS OF CONTAINER
Strips of 10 tablets in a cardboard outer carton.
Pack size: 100
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM
SUC