Coldrex PE Phenylephrine Congestion Clear

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Paracetamol 500mg;  ; Phenylephrine hydrochloride 5mg equivalent to 4.1 mg phenylephrine

Available from:

Haleon New Zealand ULC

INN (International Name):

Paracetamol 500 mg

Dosage:

500mg/5mg

Pharmaceutical form:

Tablet

Composition:

Active: Paracetamol 500mg   Phenylephrine hydrochloride 5mg equivalent to 4.1 mg phenylephrine Excipient: Maize starch Microcrystalline cellulose Potassium sorbate Povidone Pregelatinised maize starch Purified talc Sodium laurilsulfate Stearic acid

Prescription type:

General sale

Manufactured by:

Granules India Limited

Therapeutic indications:

Label claim: Fast, effective temporary relief of cold and flu symptoms including headache, body aches and pain, blocked or runny nose, sore throat. Reduces fever.

Product summary:

Package - Contents - Shelf Life: Blister pack, Aclar (PVC/Al) or Triplex (PVC/PE/PVDC/Al) - 20 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2013-09-27

Patient Information leaflet

COLDREX
® PE
PHENYLEPHRINE
CONGESTION CLEAR
_Paracetamol 500 mg and Phenylephrine Hydrochloride 5 mg _
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 CONGESTION
CLEAR.
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. Your pharmacist or doctor
has weighed the risks of you taking
COLDREX PE PHENYLEPHRINE
CONGESTION CLEAR against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
PHARMACIST OR DOCTOR.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT COLDREX PE
PHENYLEPHRINE
CONGESTION CLEAR
IS USED FOR
COLDREX PE PHENYLEPHRINE
CONGESTION CLEAR is used for
the fast, effective temporary relief of
sinusitis symptoms including sinus
headache, sinus pain, and nasal
congestion. Reduces fever.
COLDREX PE PHENYLEPHRINE
CONGESTION CLEAR contain the
active ingredients paracetamol and
Phenylephrine hydrochloride
Paracetamol works to stop the pain
messages from getting through to the
brain. It also acts in the brain to
reduce fever.
Phenylephrine hydrochloride belongs
to a group of medicines called
sympathomimetic decongestants.
It works by reducing congestion in
the upper respiratory tract, including
the nose, nasal passages and sinuses,
and making it easier to breathe.
ASK YOUR PHARMACIST OR DOCTOR IF
YOU HAVE ANY QUESTIONS ABOUT THIS
MEDICINE.
Your pharmacist or doctor may have
given it for another reason.
This medicine is not addictive.
It is only available from your
pharmacist.
BEFORE YOU TAKE/GIVE
COLDREX PE
PHENYLEPHRINE
CONGESTION CLEAR
Taking too much paracetamol can
cause serious harm to your liver.
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE COLDREX PE
PHENYLEPHRINE
CONGESTION CLEAR IF YOU
HAVE AN ALLERGY TO:

any medicine containing
paracetamol or Phenylephrine
hydrochloride

any

Summary of Product characteristics

Page
1
of
11
COLDREX, PANADOL COLD & FLU and PANADOL SINUS
-Data Sheet
NEW ZEALAND DATA SHEET
1 PRODUCT NAMES
COLDREX
®
PE PHENYLEPHRINE SINUS
COLDREX
®
PE PHENYLEPHRINE CONGESTION CLEAR
PANADOL
®
COLD & FLU MAX + DECONGESTANT
PANADOL
®
SINUS PAIN & CONGESTION RELIEF
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Paracetamol (BP) 500 mg and Phenylephrine Hydrochloride (BP) 5 mg
CAS: 103-90-2
Paracetamol C
8
H
9
NO
2
CAS: 61-76-7
Phenylephrine Hydrochloride C
9
H
13
NO
2
. HCl
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
White capsule-shaped tablets (caplets) with flat edges, 17.7 mm, one
face embossed with sun
graphic within an oval.
4 CLINICAL PARTICULARS
4.1
Therapeutic indications
COLDREX PE Phenylephrine Sinus
PANADOL Sinus Pain & Congestion Relief PE
Fast, effective, temporary relief of sinusitis symptoms including
sinus headache, sinus pain,
nasal congestion.
Page
2
of
11
COLDREX, PANADOL COLD & FLU and PANADOL SINUS
-Data Sheet
COLDREX PE Phenylephrine Congestion Clear
Fast, effective temporary relief of cold and flu symptoms including
headache, body aches and
pain, blocked or runny nose, sore throat. Reduces fever
PANADOL Cold & Flu Max + Decongestant Tablet
Fast, effective temporary relief of cold and flu symptoms including
headache, body aches and
pain, blocked or runny nose, sore throat. Reduces fever.
4.2
Dose and method of administration
Adults and children aged 12 years and over
Two caplets every four to six hours as necessary, taken with water.
Maximum of 8 caplets
within 24 hours.
Do not use for more than a few days at a time in adults without
medical advice. Should not be
used for more than 48 hours in children aged 12 to 17 except on
medical advice.
Do not use in children under 12 years of age.
Do not exceed the stated dose or frequency of dose.
The lowest dose necessary to achieve efficacy should be used for the
shortest duration of
treatment.
Should not be used with other paracetamol-containing products,
decongestants or cough and
cold medicines.
D