PANADOL COLD & FLU NIGHT RELIEF PE tablet blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

chlorphenamine maleate, Quantity: 2 mg; phenylephrine hydrochloride, Quantity: 5 mg; paracetamol, Quantity: 500 mg

Beschikbaar vanaf:

Haleon Australia Pty Ltd

INN (Algemene Internationale Benaming):

chlorphenamine maleate,Paracetamol,Phenylephrine hydrochloride

farmaceutische vorm:

Tablet, uncoated

Samenstelling:

Excipient Ingredients: stearic acid; microcrystalline cellulose; purified talc; pregelatinised maize starch; brilliant blue FCF; povidone; sodium lauryl sulfate; potassium sorbate; maize starch; sunset yellow FCF

Toedieningsweg:

Oral

Eenheden in pakket:

24

Prescription-type:

(S2) Pharmacy Medicine

therapeutische indicaties:

For the temporary relief of cold & flu symptoms such as headache, runny or blocked nose, sore throat, body aches and pain to help you rest. Reduces fever.

Product samenvatting:

Visual Identification: Green capsule-shaped tablets with flat edges; Container Type: Blister Pack; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

Autorisatie-status:

Licence status A

Autorisatie datum:

2008-10-14

Productkenmerken

Panadol Cold & Flu Night Relief PE Tablets
AUSTRALIAN PRODUCT INFORMATION
PANADOL COLD & FLU NIGHT RELIEF PE (PARACETAMOL, PHENYLEPHRINE
HYDROCHLORIDE, CHLORPHENAMINE MALEATE) TABLETS
1
NAME OF THE MEDICINE
Paracetamol
Phenylephrine Hydrochloride Chlorphenamine Maleate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients per tablet:
Paracetamol 500 mg
Phenylephrine hydrochloride 5 mg
Chlorphenamine maleate 2 mg
Excipients with known effect:
Each tablet contains potassium sorbate as preservative
For the full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Green capsule-shaped tablets with flat edges.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the temporary relief of cold & flu symptoms such as headache,
runny or blocked nose, sore
throat, body aches and pain to help you rest. Reduces fever.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ _
_Adults and children aged 12 years and over: _
_ _
2 tablets at bedtime with water. Maximum 2 tablets in 24 hours.
May cause drowsiness.
Do not use for more than a few days at a time in adults except on
medical advice.
Should not be used for more than 48 hours for children aged 12 – 17
except on medical advice.
Do not give to children under 12 years of age.
Do not exceed the stated dose or frequency of dosing.
The lowest dose necessary to achieve efficacy should be used for the
shortest duration possible.
Should not be used with other medicines containing paracetamol,
phenylephrine, chlorphenamine,
Panadol Cold & Flu Night Relief PE Tablets
decongestants or antihistamines, including cough and cold medicines.
RENAL AND HEPATIC IMPAIRMENT
Patients who have been diagnosed with liver or kidney impairment must
seek medical advice before
taking this medication. The restrictions related to the use of such
combinations in these patients is
primarily a consequence of the paracetamol and chlorphenamine content
of the product. (SEE 4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE).
4.3
CONTRAINDICATIONS
This product is contraindicated in patients:
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