Paracodol 8mg/500mg effervescent tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Codeine phosphate; Paracetamol

Available from:

Bayer Plc

ATC code:

N02AJ06

INN (International Name):

Codeine phosphate; Paracetamol

Dosage:

8mg ; 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: 5010605188220

Summary of Product characteristics

OBJECT 1
PARACODOL TABLETS
Summary of Product Characteristics Updated 27-Feb-2018 | Bayer plc
1. Name of the medicinal product
Paracodol tablets
2. Qualitative and quantitative composition
Each soluble tablet contains:
Paracetamol DC
520.0 mg
(equivalent to paracetamol 500.0 mg)
Codeine Phosphate Hemihydrate
8.0 mg
For a full list of excipients see section 6.1
3. Pharmaceutical form
Soluble Tablet
4. Clinical particulars
4.1 Therapeutic indications
Paracodol Tablets (which contain codeine) are indicated in patients
older than 12 years of age for the
short term treatment of acute moderate pain (such as muscular and
rheumatic pains, headache, migraine,
neuralgia, toothache, period pains, aches and pains) which is not
considered to be relieved by other
analgesics such as paracetamol, ibuprofen or aspirin alone.
4.2 Posology and method of administration
Posology:
Tablets are to be dissolved in water before oral administration.
Adults:
1 - 2 tablets, which may be repeated every four to six hours with a
maximum of 8 tablets in 24 hours.
Elderly:
No current evidence for the alteration of the adult dose except where
there is impaired hepatic function
when dosage reduction may be necessary.
Children aged 12 - 18 years:
1 tablet, which may be repeated every four to six hours with a maximum
of 4 tablets in 24 hours.
Children under 12 years:
Paracodol Tablets (which contains Codeine) should not be used in
children under 12 years because of the
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.
4.3 Contraindications
• Hypersensitivity to paracetamol and/or other constituents.
• In women during breastfeeding (see section 4.6)
• In patients for whom it is known they are CYP2D6 ultra-rapid
metabolisers.
• In all paediatric patients (0-18 years of age) who undergo
tonsillectomy and/o