Perrigo Cold & Flu Multi-Relief CapsulesParacetamol 500mg, Guaifenesin 100mg, Phenylephrine 6.1mg

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Διαθέσιμο από:

Wrafton Laboratories Ltd. t/a Perrigo

Φαρμακολογική κατηγορία (ATC):

N02BE; N02BE51

INN (Διεθνής Όνομα):

Paracetamol; Guaifenesin; Phenylephrine hydrochloride

Δοσολογία:

500/100/6.1 milligram(s)

Φαρμακοτεχνική μορφή:

Capsule, hard

Τρόπος διάθεσης:

Product not subject to medical prescription

Θεραπευτική περιοχή:

Anilides; paracetamol, combinations excl. psycholeptics

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2009-02-20

Φύλλο οδηγιών χρήσης

Package Leaflet: Information for the user
Perrigo Cold & Flu Multi-Relief Capsules
Paracetamol 500mg,
Guaifenesin 100mg,
Phenylephrine 6.1 mg
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.
This medicine is available without prescription, however, you still
need to use this
product carefully to get the best results from it. Keep this leaflet
as you may need to
read it again. Ask your pharmacist if you need more information or
advice.
WHAT IS IN THIS LEAFLET:
1. What this medicine is and what it is used for
2. What you need to know before you take this medicine
3. How to take this medicine
4. Possible side effects
5. How to store this medicine
6. Contents of the pack and other information
1) WHAT THIS MEDICINE 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 capsules are used for the relief of the symptoms of colds and
flu and the pain
and congestion of sinusitis, including aches and pains, headache,
blocked nose and
sore throat, chills and feverishness (high temperature). They can also
loosen stubborn
mucus (phlegm) and provide relief from chesty coughs.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE THIS MEDICINE IF YOU:
•
HAVE EVER HAD AN ALLERGIC REACTION to paracetamol, guaifen

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perrigo Cold & Flu Multi-Relief Capsules
Paracetamol 500mg, Guaifenesin 100mg, Phenylephrine 6.1mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Ingredient
mg/Capsule
Paracetamol
500
Guaifenesin
100
Phenylephrine hydrochloride
6.1
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard.
Dark blue/dark green hard gelatin capsules containing the drug
product, an off-white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of symptoms associated with colds and flu and the pain
and congestion of sinusitis, including aches and
pains, headache, blocked nose and sore throat, chills, lowering of
temperature, and to loosen stubborn mucous and
provide relief from chesty coughs.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral.
Take capsules with water. Swallow whole, do not chew. For all
indications:
Adults, the elderly and children aged 16 years and over:
Two capsules every 4-6 hours when necessary to a maximum of 4 doses in
24 hours.
Children under 16 years:
Do not give to children under 16 years of age.
Dosage should not be continued for longer than 3 days without
consulting a doctor.
4.3 CONTRAINDICATIONS
Hypersensitivity to paracetamol, guaifenesin or phenylephrine or any
of the other ingredients.
Hepatic or severe renal impairment, hypertension, hyperthyroidism,
diabetes, heart disease or those taking tricyclic
antidepressants or beta-blocking drugs and those patients who are
taking or have taken, within the last two weeks,
monoamine oxidase inhibitors (see section 4.5).
Phaeochromocytoma.
Prostatic enlargement or urinary retention.
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