Solpadol 30mg/500mg effervescent tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate; Paracetamol

Available from:

Phoenix Labs Ltd

ATC code:

N02AJ06

INN (International Name):

Codeine phosphate; Paracetamol

Dosage:

30mg ; 500mg

Pharmaceutical form:

Effervescent tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 5000283605119 5000283652892

Patient Information leaflet

420543 (alt 420419 ) GMID 772999 (alt 762057) PB Solpadol 500/30mg GB
Operator S.Goette 148 x 210 DC
Code 344 Pantone Reflex Blue min. 9pt
Ocean San pro san - Version 4
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PACKAGE INFORMATION LEAFLET
SOLPADOL 30MG/500MG
EFFERVESCENT TABLETS
Codeine Phosphate and
Paracetamol
THIS MEDICINE CONTAINS CODEINE WHICH IS AN
OPIOID, WHICH CAN CAUSE ADDICTION. YOU CAN
GET WITHDRAWAL SYMPTOMS IF YOU STOP TAKING
IT SUDDENLY.
Is this leafl et hard to
see or read?
Phone [phone]
for help
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE
• Keep this leafl et. You may need to read it
again.
• If you have further questions, please 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 of the side effects gets serious, or
if you notice any side effect not listed
in this leafl et, 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. Further information
1. WHAT SOLPADOL IS AND WHAT IT
IS USED FOR
The name of your medicine is Solpadol
30mg/500mg Effervescent Tablets (called
Solpadol throughout this leafl et). This
medicine has been prescribed for you for
the relief of 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. Solpadol
contains codeine which belongs to a class
of medicines called opioids, which are ‘pain
relievers’. It also contains paracetamol,
another analgesic to relieve pain. This
medicine has been prescribed to you and
should not be given to anyone else. Opioids
can cause addiction and you may get
withdrawal symptoms if you stop taking
it suddenly. Your prescriber should have
explained how long you will be taking it for
and when it is ap

Summary of Product characteristics

OBJECT 1
SOLPADOL 30MG/500MG EFFERVESCENT
TABLETS
Summary of Product Characteristics Updated 26-Mar-2020 | SANOFI
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Solpadol 30mg/500mg Effervescent Tablets
2. Qualitative and quantitative composition
ACTIVE CONSTITUENTS
Paracetamol
500.0mg
Codeine Phosphate Hemihydrate
30.0mg
For excipients see 6.1.
3. Pharmaceutical form
Effervescent Tablets.
Solpadol Effervescent Tablets are white bevelled-edge tablets scored
on one face.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of severe pain.
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
Prior to starting treatment with opioids, a discussion should be held
with patients to put in place a strategy for
ending treatment with codeine in order to minimise the risk of
addiction and dr