Benylin Children's Night Coughs oral solution

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Diphenhydramine hydrochloride; Levomenthol

Disponibbli minn:

McNeil Products Ltd

Kodiċi ATC:

R06AA52

INN (Isem Internazzjonali):

Diphenhydramine hydrochloride; Levomenthol

Dożaġġ:

1.4mg/1ml ; 110microgram/1ml

Għamla farmaċewtika:

Oral solution

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 03090200; GTIN: 5010123667740

Fuljett ta 'informazzjoni

■
_opioid analgesics_ (drugs used to RELIEVE
PAIN e.g. codeine, tramadol, morphine).
■
_antipsychotics_ (drugs used to treat MOOD
DISORDERS).
If you are not sure about any of the medicines your
child is taking, show the bottle or pack to your
pharmacist.
If any of these bullet points apply now or in the
past, TALK TO A DOCTOR OR PHARMACIST.
IF YOU ARE PREGNANT OR BREAST-FEEDING
The following advice is included in case an
older child or adult is taking the medicine:
■
Ask your doctor or pharmacist for advice
before taking this medicine if you are
pregnant or breast-feeding.
SPECIAL WARNINGS ABOUT THIS MEDICINE
■
This product can make some people feel
drowsy, dizzy or have blurred vision. Make
sure that your child is not affected if he or
she is going to do anything where they need
to be alert. Be especially careful if the child
is taking another medicine which may also
cause drowsiness.
■
If an older child or adult is taking the
medicine remember that this product may
cause drowsiness, dizziness or blurred vision.
Do not drive or operate machinery if you are
affected. Avoid alcoholic drink.
SOME OF THE INGREDIENTS CAN CAUSE
PROBLEMS
■
This medicine contains sorbitol 70% (non
crystalline). If you have been told by your
doctor that your child has an intolerance to
some sugars contact your doctor before taking
this medicinal product.
■
This medicinal product contains 5 vol %
ethanol (alcohol), i.e. up to 200 mg per
5 ml, equivalent to 5 ml beer, 2 ml wine per
5 ml. This can be harmful for those suffering
from alcoholism. To be taken into account in
pregnant or
breast-feeding women, children
and high-risk
groups such as patients with
liver disease or epilepsy.
■
This medicinal product contains 16.47 mg
sodium per 5 ml. To be taken in consideration
by patients on a controlled sodium diet.
2 BEFORE GIVING YOUR CHILD
THIS MEDICINE
This medicine is suitable for most children but a few
children should not use it. If you are in any doubt, talk to
your doctor or pharmacist.
X
DO NOT GIVE YOUR CHILD THIS MEDIC

Karatteristiċi tal-prodott

OBJECT 1
BENYLIN CHILDREN'S NIGHT COUGHS
Summary of Product Characteristics Updated 17-Mar-2010 | McNeil
Products Ltd
1. Name of the medicinal product
BENYLIN CHILDREN'S NIGHT COUGHS
2. Qualitative and quantitative composition
BENYLIN CHILDREN'S NIGHT COUGHS contains -
ACTIVE INGREDIENT
MG/5 ML
Diphenhydramine Hydrochloride
7.0 mg
Levomenthol
0.55 mg
3. Pharmaceutical form
A clear colourless syrup with no insoluble matter.
4. Clinical particulars
4.1 Therapeutic indications
BENYLIN CHILDREN'S NIGHT COUGHS is indicated for the relief of cough
and its congestive
symptoms, runny nose and sneezing, and in the treatment of hay fever
and other allergic conditions
affecting the upper respiratory tract. It is specially formulated for
children and contains no artificial dyes
or sucrose.
4.2 Posology and method of administration
Route of Administration: Oral
CHILDREN UNDER 6 YEARS:
BENYLIN CHILDREN'S NIGHT COUGHS is contraindicated in children under
the age of 6 years (see
section 4.3).
CHILDREN 6 TO 12 YEARS:
Two 5 ml spoonfuls every 6 hours
No more than four doses should be given in any 24 hours.
Not to be used for more than five days without the advice of a doctor.
Parents or carers should seek
medical attention if the child's condition deteriorates during
treatment.
Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.3 Contraindications
BENYLIN CHILDREN'S NIGHT COUGHS is contraindicated in individuals with
known
hypersensitivity to the product or any of its constituents.
BENYLIN CHILDREN'S NIGHT COUGHS should not be administered to patients
currently receiving
monoamine oxidase inhibitors (MAOI) or those patients who have
received treatment with MAOIs within
the last two weeks (see section 4.5).
Not to be used in children under the age of 6 years.
4.4 Special warnings and precautions for use
Diphenhydramine should not be taken by patients with susceptibility to
angle-closure glaucoma or
symptomatic prostatic hypertrophy unless directed by a doctor.
Alcohol or other potential sedating medicines