Coldrex PE Phenylephrine Cough, Cold & Flu

Pays: Nouvelle-Zélande

Langue: anglais

Source: Medsafe (Medicines Safety Authority)

Ingrédients actifs:

Guaifenesin 100mg;  ; Paracetamol 250mg;  ;  ;  ; Phenylephrine hydrochloride 5mg;  ;  

Disponible depuis:

Haleon New Zealand ULC

DCI (Dénomination commune internationale):

Guaifenesin 100 mg

forme pharmaceutique:

Film coated tablet

Composition:

Active: Guaifenesin 100mg   Paracetamol 250mg       Phenylephrine hydrochloride 5mg     Excipient: Colloidal silicon dioxide Lactose monohydrate Maize starch Microcrystalline cellulose Opadry white OY-LS-28913 Potassium sorbate Povidone Pregelatinised maize starch Purified talc Purified water Stearic acid

Unités en paquet:

Blister pack, white opaque PVC/LDPE/PVDC/Al blisters, 16 tablets

classe:

General sale

Type d'ordonnance:

General sale

Fabriqué par:

Zhejiang Haizhou Pharmaceutical Co Ltd

indications thérapeutiques:

Effective, temporary relief of pain and discomfort associated with cold & flu symptoms: headache, blocked or runny nose, painful sinuses, sore throat, chesty productive cough, shivers, aches and pains. Reduces fever.

Descriptif du produit:

Package - Contents - Shelf Life: Blister pack, white opaque PVC/LDPE/PVDC/Al blisters - 16 tablets - 36 months from date of manufacture stored at or below 25°C

Date de l'autorisation:

2005-04-20

Notice patient

COLDREX
® PE PHENYLEPHRINE COUGH,
COLD & FLU CAPLETS
_250 MG PARACETAMOL / 100 MG GUAIFENESIN / 5 MG PHENYLEPHRINE
HYDROCHLORIDE_
CONSUMER MEDICINE INFORMATION
_PLEASE READ THIS INFORMATION BEFORE YOU START USING THIS MEDICINE. _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about COLDREX PE
PHENYLEPHRINE COUGH,
COLD & FLU. It does not contain
all the available information.
It does not take the place of talking
to your pharmacist or doctor.
All medicines have risks and
benefits.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT COLDREX PE
PHENYLEPHRINE
COUGH, COLD & FLU
IS USED FOR
Paracetamol is used for the fast
effective temporary relief of pain and
discomfort associated with sinus pain
or headache.
Paracetamol works to stop the pain
messages from getting through to the
brain. It also acts in the brain to
reduce fever.
Guaifenesin has an expectorant
action. It is thought to reduce sputum
viscosity by increasing the volume
and water content of the bronchial
secretion, thereby facilitating the
expectoration of sputum.
Phenylephrine HCl works to reduce
nasal stuffiness.
ASK YOUR PHARMACIST OR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT THIS
MEDICINE.
Your pharmacist or doctor may have
given it for another reason
BEFORE YOU USE
COLDREX PE
PHENYLEPHRINE
COUGH, COLD & FLU
Taking too much paracetamol can
cause serious harm to your liver.
_ _
_WHEN YOU MUST NOT USE IT _
DO NOT USE COLDREX PE
PHENYLEPHRINE COUGH,
COLD & FLU IF YOU HAVE AN
ALLERGY TO:

Any medicine containing
paracetamol, Guaifenesin,
phenylephrine HCl or other
medicines for the relief of cough
and colds, congestion or blocked
nose

Any of the ingredients listed at
the end of this leaflet
DO NOT USE COLDREX PE
PHENYLEPHRINE COUGH,
COLD & FLU:

If you are taking any other
prescription or non-prescription
medicines containing
paracetamol to treat pain, fever,
symptoms of cold and flu, or to
aid sleep

If you are allergic t

Résumé des caractéristiques du produit

COLDREX
®
PE COUGH COLD & FLU – DATA SHEET Page 1 of 13
COLDREX
® PE PHENYLEPHRINE COUGH, COLD & FLU
DATA SHEET
Paracetamol (BP) 250 mg, Phenylephrine hydrochloride (BP) 5 mg,
Guaifenesin BP 100
mg
PRESENTATION
White film-coated capsule-shaped tablets (caplets) with flat edges and
a B engraved on
one side.
INDICATIONS
Effective, temporary relief of pain and discomfort associated with
cold & flu symptoms:
headache, blocked or runny nose, painful sinuses, sore throat, chesty,
productive
cough, shivers, aches and pains. Reduces fever.
DOSAGE AND ADMINISTRATION
Adults and children aged 12 years and over
2 tablets every four to six hours as necessary. Maximum of 8 tablets
in 24 hours.
Do not use for more than a few days at a time in adults without
medical advice.
Do not use for more than 48 hours in children aged 12 to 17 except on
medical advice.
Do not use in children below the age of 12.
Take with water or other fluid.
_ _
Do not exceed the stated dose or frequency of dose.
The lowest dose necessary to achieve efficacy should be used.
Should not be used with other medicines containing paracetamol,
guaifenesin or
phenylephrine or if using other cough, cold and decongestant products.
Minimum dosing interval: 4 hours.
COLDREX
®
PE COUGH COLD & FLU – DATA SHEET Page 2 of 13
RENAL AND HEPATIC IMPAIRMENT
Patients who have been diagnosed with liver or kidney impairment must
seek medical
advice before taking this medication. (See WARNINGS AND PRECAUTIONS.)
CONTRAINDICATIONS
This product is contraindicated in patients:
•
with a previous history of hypersensitivity to paracetamol,
guaiphenesin,
phenylephrine hydrochloride, other medicines, foods, preservatives or
dyes or
any of the excipients.
•
who are taking, or have taken within the last two weeks, monoamine
oxidase
inhibitors. (See INTERACTIONS.)
WARNINGS AND PRECAUTIONS
Medical advice should be sought before taking this product in patients
with these
conditions:

Asthma

Bronchitis

Chronic obstructive pulmonary disease (COPD)

Emphysema

Smoke