Solpadol 30mg/500mg capsules

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:

Oral capsule

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 5000283642350

Patient Information leaflet

THIS MEDICINE CONTAINS CODEINE WHICH IS AN OPIOID,
WHICH CAN CAUSE ADDICTION. YOU CAN GET WITHDRAWAL
SYMPTOMS IF YOU STOP TAKING IT SUDDENLY.
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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 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 effects 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. Further information
1. WHAT SOLPADOL IS AND WHAT IT IS USED FOR
The name of your medicine is Solpadol 30mg/500mg
Capsules (called Solpadol throughout this leaflet).
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 appropriate to stop, how to do this safely.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLPADOL
IMPORTANT THINGS YOU SHOULD KNOW ABOUT SOLPADOL
Do not take for longer than your doctor tells you to.
Taking this medicine regularly, particularly for a long
time can lead to addiction. Your prescriber should
have

Summary of Product characteristics

OBJECT 1
SOLPADOL 30MG/500MG CAPSULES
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
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5.1 Pharmacodynamic properties
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5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
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6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
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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
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8. Marketing authorisation number(s)
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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 Capsules
Co-codamol 30mg/500mg Capsules
2. Qualitative and quantitative composition
Active Constituents
Paracetamol
500.0mg
Codeine Phosphate Hemihydrate
30.0mg
For excipients see 6.1.
3. Pharmaceutical form
Capsules.
Solpadol Capsules are grey and purple with SOLPADOL printed on them in
black ink.
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 drug wi