CalCough Infant 750microlitres/5ml syrup

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Glycerol

Διαθέσιμο από:

McNeil Products Ltd

Φαρμακολογική κατηγορία (ATC):

A06AX01

INN (Διεθνής Όνομα):

Glycerol

Δοσολογία:

150microlitre/1ml

Φαρμακοτεχνική μορφή:

Oral solution

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 03090200; GTIN: 3574660518948

Φύλλο οδηγιών χρήσης

3
+
months
Dry & Tickly Cough Relief
3
+
months
COLOUR
& SUGAR
FREE
SYRUP
INFANT
GLYCEROL
Apple flavour
S
P
O
O
N
SYRUP
INFANT
GLYCEROL
INFAN
16-0423
HOW TO USE THIS MEDICINE
Check the information below to see how
much medicine to give.
• For oral use only.
• Do not give more medicine than the
carton (and/or label) tells you to.
Babies under 3 months
Children from 3 months to 5 years
Do not give to babies under 3 months.
AGE
HOW MUCH
CHILDREN 3 MONTHS TO
One 5 ml spoonful
1 YEAR
CHILDREN 1 - 5 YEARS
Two 5 ml spoonfuls
•
Give the dose 3 or 4 times within 24 hours,
if needed.
• If symptoms persist for more than 3 days,
consult your doctor.
IF ANYONE HAS TAKEN TOO MUCH
If anyone has taken too much of this product,
contact a doctor or your nearest Accident &
Emergency Department (Casualty), taking
this pack with you.
IF YOU FORGET TO GIVE THE MEDICINE
If you forget a dose, give the next dose when
needed. DO NOT give a double dose.
TALK TO YOUR DOCTOR OR PHARMACIST
If your child has an intolerance to some sugars.
SOME OF THE INGREDIENTS CAN CAUSE
PROBLEMS
• This product contains maltitol. If you have
been told by your doctor that your child has
an intolerance to some sugars, contact your
doctor before using this product. This should
be taken into account in patients with
diabetes.
• Maltitol may have a mild laxative effect.
Calorific value 2.3 kcal/g maltitol.
POSSIBLE SIDE-EFFECTS
This medicine is unlikely to cause side-effects
unless your child is allergic to the ingredients.
If your child experiences any side-effects or you
are not sure about anything, talk to your doctor
or pharmacist.
Reporting of side-effects:
If you get any side-effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side-effects not listed on this carton. You can also
report side-effects directly via the Yellow Card
Scheme at: www.mhra.gov.uk/yellowcard
By reporting side-effects you can help provide
more information on the safety of this medicine.
STORING THIS MEDICINE
Keep out of the sight and reach of childr

Αρχείο Π.Χ.Π.

OBJECT 1
CALCOUGH INFANT SYRUP
Summary of Product Characteristics Updated 22-Apr-2016 | McNeil
Products Ltd
1. Name of the medicinal product
Benylin Children's Apple Flavour Cough Syrup or CalCough Infant Syrup
or Benylin Infant's Cough
Syrup
2. Qualitative and quantitative composition
Active ingredient
Glycerol
% v/v
15.0
ml/5ml
0.75
Excipient with known effect: Maltitol liquid (E965)
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Syrup
A clear colourless syrup with an apple flavour.
4. Clinical particulars
4.1 Therapeutic indications
For the relief of dry tickly coughs.
4.2 Posology and method of administration
Posology
Children 3 months - 1 year: one 5ml spoonful three to four times a
day.
Children 1 to 5 years: two 5ml spoonfuls three to four times a day.
Children under 3 months: not recommended.
Method of administration
For oral use.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the ingredients
listed in section 6.1.
Not recommended for children under 3 months.
Patients with rare hereditary problems of fructose intolerance should
not take this medicine.
4.4 Special warnings and precautions for use
If symptoms persist for more than 3 days consult your doctor.
Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of
interaction
No clinically significant drug interactions.
4.6 Fertility, pregnancy and lactation
Not applicable.
4.7 Effects on ability to drive and use machines
No or negligible influence.
4.8 Undesirable effects
Maltitol may have a mild laxative effect.
REPORTING OF SUSPECTED ADVERSE REACTIONS
Reporting suspected adverse reactions after authorisation of the
medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are
asked to report any suspected adverse reactions via the Yellow Card
Scheme at:
www.mhra.gov.uk/yellowcard
4.9 Overdose
Overdosage with this product may possibly cause diarrhoea. Treatment
sh