Multi-Action Actifed Chesty Coughs oral solution

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Triprolidine hydrochloride; Pseudoephedrine hydrochloride; Guaifenesin

Διαθέσιμο από:

McNeil Products Ltd

Φαρμακολογική κατηγορία (ATC):

R01BA52

INN (Διεθνής Όνομα):

Triprolidine hydrochloride; Pseudoephedrine hydrochloride; Guaifenesin

Δοσολογία:

250microgram/1ml ; 6mg/1ml ; 20mg/1ml

Φαρμακοτεχνική μορφή:

Oral solution

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Never Valid To Prescribe As A VMP

Περίληψη προϊόντος:

BNF: 03090200; GTIN: 5010123708283

Φύλλο οδηγιών χρήσης

■
_Sympathomimetic drugs_ (_stimulants_ or _appetite _
_suppressants_ and drugs used to treat
CONGESTION and ASTHMA).
■
_Tricyclic antidepressants_ (used to treat
MOOD DISORDERS).
If you are not sure about any of the medicines
you are taking, show the bottle or pack to
your pharmacist.
If any of these bullet points apply to you now or
in the past, TALK TO A DOCTOR OR PHARMACIST.
IF YOU ARE PREGNANT OR BREAST-FEEDING
■
Ask your doctor or pharmacist for advice
before taking this medicine if you are pregnant
or breast-feeding.
SPECIAL WARNINGS ABOUT THIS
MEDICINE
■
This medicine may cause drowsiness. If
affected, do not drive or operate machinery.
AVOID ALCOHOLIC DRINK.
SOME OF THE INGREDIENTS CAN CAUSE
PROBLEMS
■
Each 5 ml of this medicine contains 2.5 g
of sucrose. This should be taken into account
in patients with diabetes mellitus. If you have
been told by your doctor that you have an
intolerance to some sugars, contact your
doctor before taking this medicine.
■
This medicine contains 7% v/v ethanol
(alcohol), which is up to 270 mg per 5 ml,
equal to 7 ml beer or 3 ml wine per 5 ml.
This can be harmful for those suffering from
alcoholism. The ethanol content should be
taken into account in pregnant or breast-
feeding women, children and high-risk groups
such as patients with liver disease and epilepsy.
■
Methyl hydroxybenzoate (E218) may cause
allergic reactions such as skin rash; this may
happen after a few days.
■
The colouring in this medicine may cause
allergic reactions.
■
This medicine is used to relieve the symptoms of colds
and flu including runny nose, watery eyes, nasal
congestion, blocked sinuses and a chesty cough.
■
This medicine is for use by adults and children aged
12 years and over.
■
DO NOT USE THIS MEDICINE:
■
There are some people who should not use this
medicine. _To find out if you are one of them See _
_Section 2_
c
■
If you have ever had a BAD REACTION to any of the
ingredients. _For the list of ingredients See Section 6_
c
■
SPEAK TO YOUR DOCTOR:
■
If you su

Αρχείο Π.Χ.Π.

OBJECT 1
MULTI-ACTION ACTIFED CHESTY COUGHS
Summary of Product Characteristics Updated 17-Mar-2010 | McNeil
Products Ltd
1. Name of the medicinal product
Multi-Action ACTIFED Chesty Coughs
2. Qualitative and quantitative composition
TRIPROLIDINE HYDROCHLORIDE
1.25 mg
PSEUDOEPHEDRINE HYDROCHLORIDE
30.0 mg
GUAIFENESIN
100.0 mg
3. Pharmaceutical form
Oral solution
4. Clinical particulars
4.1 Therapeutic indications
Multi-Action ACTIFED Chesty Coughs is indicated for the symptomatic
relief of upper respiratory tract
disorders accompanied by productive cough, which are benefited by the
combination of a histamine H
1
-
receptor antagonist, a decongestant of the mucous membranes of the
upper respiratory tract, especially the
nasal mucosa and sinuses, and an expectorant.
4.2 Posology and method of administration
ADULTS AND CHILDREN AGED 12 YEARS AND OVER:
Oral. 10 ml every 4-6 hours up to 4 times a day
CHILDREN UNDER 12 YEARS
Multi-Action ACTIFED Chesty Coughs is contraindicated in children
under the age of 12 years (see
section 4.3)
Multi-Action ACTIFED Chesty Coughs may be diluted 1:1 (1 in 2) or 1:3
(1 in 4) with unpreserved syrup
BP. These dilutions have a shelf life of 4 weeks if stored at 25
o
C.
USE IN THE ELDERLY
No specific studies have been carried out in the elderly. Experience
has indicated that normal adult
dosage is appropriate.
HEPATIC DYSFUNCTION
Caution should be exercised when administering Multi-Action ACTIFED
Chesty Coughs to patients with
severe hepatic impairment.
RENAL DYSFUNCTION
Caution should be exercised when administering Multi-Action ACTIFED
Chesty Coughs to patients with
moderate to severe renal impairment.
Do not exceed the stated dose.
Keep out the reach and sight of children.
4.3 Contraindications
Multi-Action ACTIFED Chesty Coughs is contraindicated in individuals
with known hypersensitivity to
the product, any of its components, or acrivastine.
Multi-Action ACTIFED Chesty Coughs is contraindicated in individuals
with severe hypertension or
severe coronary artery disease.
Multi-Action AC