Solpadol 30mg/500mg caplets

Țară: Regatul Unit

Limbă: engleză

Sursă: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredient activ:

Codeine phosphate; Paracetamol

Disponibil de la:

Phoenix Labs Ltd

Codul ATC:

N02AJ06

INN (nume internaţional):

Codeine phosphate; Paracetamol

Dozare:

30mg ; 500mg

Forma farmaceutică:

Oral tablet

Calea de administrare:

Oral

Clasă:

Schedule 5 (CD Inv)

Tip de prescriptie medicala:

Valid as a prescribable product

Rezumat produs:

BNF: 04070100; GTIN: 5000283594123 5000283606499

Caracteristicilor produsului

OBJECT 1
SOLPADOL CAPLETS
Summary of Product Characteristics Updated 21-Dec-2016 | SANOFI
1. Name of the medicinal product
Solpadol 30mg/500mg Caplets
2. Qualitative and quantitative composition
Active Constituents
Paracetamol
500.0mg
Codeine Phosphate Hemihydrate
30.0mg
For excipients see 6.1.
3. Pharmaceutical form
Tablet
Solpadol Caplets are white capsule shaped tablets, marked SOLPADOL on
one side.
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
Adults:
Two tablets not more frequently than every 4 hours, up to a maximum of
8 tablets in any 24 hour period.
Elderly:
As adults, however a reduced dose may be required. See warnings.
Children aged 16 to 18 years:
One to two tablets every 6 hours when necessary to a maximum of 8
tablets in 24 hours.
Children aged 12 to 15 years:
One tablet every 6 hours when necessary to a maximum of 4 tablets in
24 hours.
Children under 12:
Not recommended for children under 12 years of age. This is because of
codeine risk of opioid toxicity
due to the variable and unpredictable metabolism of codeine to
morphine (see sections 4.3 and 4.4).
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.
Solpadol Caplets are for oral administration.
4.3 Contraindications
Hypersensitivity to paracetamol or codeine which is rare.
Hypersensitivity to any of the other constituents.
Conditions where morphine and opioids are contraindicated e.g:
• Acute asthma
• Respiratory depression
• Acute alcoholism
• Head injuries
• Raised intra-cranial pressure
• Following biliary tract surgery
• Breast-feeding (see Section 4.6)
Monoamine oxidase inhibitor therapy, concurrent or within 14 days.
In all paediatric patient