Co-codamol 30mg/500mg tablets

Država: Velika Britanija

Jezik: angleščina

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivna sestavina:

Codeine phosphate; Paracetamol

Dostopno od:

Zentiva Pharma UK Ltd

Koda artikla:

N02AJ06

INN (mednarodno ime):

Codeine phosphate; Paracetamol

Odmerek:

30mg ; 500mg

Farmacevtska oblika:

Oral tablet

Pot uporabe:

Oral

Razred:

Schedule 5 (CD Inv)

Tip zastaranja:

Valid as a prescribable product

Povzetek izdelek:

BNF: 04070100; GTIN: 5000283607069

Lastnosti izdelka

OBJECT 1
CO-CODAMOL 30/500 TABLETS
Summary of Product Characteristics Updated 11-Jan-2017 | Zentiva
1. Name of the medicinal product
Co-codamol 30/500 Tablets.
2. Qualitative and quantitative composition
Each tablet contains 500mg paracetamol and 30mg codeine phosphate
hemihydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White capsule-shaped tablets, marked SOLPADOL on one side.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of severe pain.
Codeine is 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
POSOLOGY
Adults: Two tablets not more frequently than every 4 hours, up to a
maximum of 8 tablets in any 24 hour
period.
Elderly: As for 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 up 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.
Do not take for more than 3 days without consulting your doctor.
PAEDIATRIC POPULATION
Children aged less than 12 years: Codeine should not be used in
children below the age of 12 years
because of the risk of opioid toxicity due to the variable and
unpredictable metabolism of codeine to
morphine (see section 4.3 and 4.4).
METHOD OF ADMINISTRATION
For oral administration.
4.3 Contraindications
• Hypersensitivity to the active substances or any of the other
excipients listed in Section 6.1.
• Conditions where morphine and opioids are contraindicated e.g.,
acute asthma, respiratory depression,
acute alcoholism, head injuries, raised intra-cranial pressure and
following biliary tract surgery;
monoamine oxidase inhibitor therapy, concurrent or within 14 days.
• In all paediatric patients (0-18 years of age) who undergo
tonsillectomy and/or adenoidectomy for