Guaifenesin powder

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Guaifenesin

Tersedia dari:

J M Loveridge Ltd

Kode ATC:

n/a

INN (Nama Internasional):

Guaifenesin

Bentuk farmasi:

Not applicable

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 03090200

Selebaran informasi

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE HYDROCHLORIDE
500MG/200MG/10MG POWDER FOR ORAL SOLUTION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
ALWAYS TAKE THIS MEDICINE EXACTLY AS DESCRIBED IN THIS LEAFLET OR AS
YOUR DOCTOR OR
PHARMACIST HAVE TOLD YOU.
•
Keep this leaflet. You may need to read it again
•
Ask your pharmacist if you need more information or advice
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4
•
You must talk to a doctor if you do not feel better or if you feel
worse after 5 days.
The name of your medicine is
PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE
HYDROCHLORIDE 500MG/200MG/10MG POWDER FOR ORAL SOLUTION.
It will be referred to
as
PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE
throughout the remainder of
the leaflet.
WHAT IS IN THIS LEAFLET
1. What Perrigo Paracetamol/Guaifenesin/Phenylephrine
is and what it is used for
2. What you need to know before you take Perrigo
Paracetamol/Guaifenesin/Phenylephrine
3. How to take Perrigo Paracetamol/Guaifenesin/Phenylephrine
4. Possible side effects
5. How to store Perrigo Paracetamol/Guaifenesin/Phenylephrine
6. Contents of the pack and other information
1. WHAT PERRIGO PARACETAMOL/GUAIFENESIN/PHENYLEPHRINE IS AND WHAT
IT IS USED FOR
THIS MEDICINE CONTAINS:
•
PARACETAMOL
which is a pain reliever (analgesic) and helps reduce your temperature
when you have a fever
•
GUAIFENESIN
which is an expectorant to help loosen phlegm
• PHENYLEPHRINE
which is a decongestant to reduce swelling in the passages of the
nose to help you breathe more easily.
These sachets are used for the short term symptomatic relief of colds
and flu including
aches and pains, headache, blocked nose and sore throat, chills and
fever, and for
relief from chesty coughs.
You must talk to a doctor if you do not feel better or if you feel
wor

Karakteristik produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Perrigo Paracetamol/Guaifenesin/Phenylephrine Hydrochloride
500mg/200mg/10mg
powder for oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT
MG/SACHET
Paracetamol
500
Guaifenesin
200
Phenylephrine hydrochloride
10
Excipient(s) with known effect
Sucrose 2077 mg
Aspartame (E951) 12 mg
Sodium citrate (E331) 500 mg (contains 117.3 mg sodium)
Sodium cyclamate (E952) 100 mg (contains 11.5 mg sodium)
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for oral solution.
Sachets containing the drug product, an off-white powder with a
characteristic
citrus/menthol odour.
The reconstituted solution is opalescent yellow with a characteristic
citrus/menthol
odour.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short term symptomatic relief of colds and flu including aches
and pains,
headache, blocked nose and sore throat, chills and fever, and for
relief from chesty
coughs.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults, the elderly and children aged 12 years and over:
One sachet every four hours as required. Do not exceed 4 sachets (4
doses) in
any 24 hour period.
Do not give to children under 12 years old.
Seek medical advice if symptoms persist for more than 5 days.
Method of administration
For oral use after dissolving the contents of the sachet in a standard
mug of
hot, but not boiling water (250 ml). Allow to cool to a drinkable
temperature.
Drink all of the solution within 1½ hours.
4.3
CONTRAINDICATIONS
• Hypersensitivity to paracetamol, guaifenesin, phenylephrine
hydrochloride
or to any of the excipients listed in section 6.1
• Pregnancy and breastfeeding
• Hepatic or severe renal impairment
• Heart disease and cardiovascular disorders, including severe
haemolytic
anaemia
• Hypertension
• Hyperthyroidism
• Diabetes
• Phaeochromocytoma
• Those taking tricyclic antidepressants (see section 4.5)
• Those currently taking other paracetamol-containing products (se