Benylin Chesty Coughs Original oral solution

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Diphenhydramine hydrochloride; Levomenthol

Disponível em:

McNeil Products Ltd

Código ATC:

R06AA52

DCI (Denominação Comum Internacional):

Diphenhydramine hydrochloride; Levomenthol

Dosagem:

2.8mg/1ml ; 400microgram/1ml

Forma farmacêutica:

Oral solution

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Invalid to prescribe in NHS primary care

Resumo do produto:

BNF: 03090200; GTIN: 5010123639037 5010123731465

Folheto informativo - Bula

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
■
This medicine contains sucrose and liquid
glucose. If you have been told by your
doctor that you have an intolerance to some
sugars contact your doctor before taking this
medicinal product. Contains 3.5 g glucose
per 5 ml. This should be taken into account
in patients with diabetes mellitus.
■
This medicinal product contains 5 vol %
ethanol (alcohol), i.e. up to 200 mg per dose,
equivalent to 5 ml beer, 2 ml wine per 5 ml.
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.
■
Ponceau 4R (E124) may cause allergic
reactions.
■
This medicinal product contains 16.61 mg
sodium per 5 ml. To be taken in
consideration by patients on a controlled
sodium diet.
3 HOW TO TAKE THIS
MEDICINE
CHECK THE TABLE THAT FOLLOWS TO SEE
HOW MUCH MEDICINE TO TAKE.
■
For oral use only.
■
Do not take more than the stated dose shown.
2 BEFORE TAKING THIS
MEDICINE
This medicine is suitable for most people but a few
people should not use it. If you are in any doubt, talk
to your doctor or pharmacist.
DO NOT USE THIS MEDICINE…
■
If you have ever had a BAD REACTION to any of
the ingredients.
■
If you have had a COUGH for a few weeks that
may be caused by ASTHMA, or a cough which
brings up a lot of mucus (phlegm).
■
If you are taking, or have taken in the last
two weeks, DRUGS FOR DEPRESSION known as
Monoamine Oxidase Inhibitors (MAOIs).
■
For children under 12 years old.
If any of these apply to you, GET ADVICE FROM A
DOCTOR OR PHARMACIST WITHOUT USING BENYLIN
CHESTY COUGHS ORIGINAL.
TALK TO YOUR DOCTOR OR PHARMACIST…
■
If you suffer from LIVER or KID

Características técnicas

OBJECT 1
BENYLIN CHESTY COUGHS (ORIGINAL)
Summary of Product Characteristics Updated 08-Aug-2014 | McNeil
Products Ltd
1. Name of the medicinal product
Benylin Chesty Coughs (Original)
2. Qualitative and quantitative composition
Each 5 ml contains:-
Diphenhydramine hydrochloride
14.0 mg
L-menthol
2.0 mg
3. Pharmaceutical form
Syrup.
A clear red syrup
4. Clinical particulars
4.1 Therapeutic indications
BENYLIN CHESTY COUGHS (ORIGINAL) is indicated for the relief of cough
and associated
congestive symptoms.
4.2 Posology and method of administration
For oral use
ADULTS AND CHILDREN AGED 12 YEARS AND OVER:
One 10 ml dose of syrup 4 times a day.
Maximum daily dose: 40 ml syrup.
CHILDREN UNDER 12 YEARS:
Benylin Chesty Coughs (Original) is contraindicated in children under
the age of 12 years (see section
4.3).
THE ELDERLY:
As for adults above (see Pharmacokinetics - The elderly).
Hepatic dysfunction
Caution should be exercised if moderate to severe hepatic dysfunction
is present (see Pharmacokinetics -
Hepatic dysfunction).
Renal dysfunction
It may be prudent to increase the dosage interval in subjects with
moderate to severe renal failure (see
Pharmacokinetics - Renal dysfunction).
Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.3 Contraindications
BENYLIN CHESTY COUGHS (ORIGINAL) is contraindicated in individuals
with known
hypersensitivity to the product or any of its constituents.
Benylin Chesty Coughs (Original) is contraindicated in individuals
with chronic or persistent cough, such
as occurs with asthma, or where cough is accompanied by excessive
secretions, unless directed by the
physician.
Benylin Chesty Coughs (Original) 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.
Not to be used in children under the age of 12 years.
4.4 Special warnings and precautions for use
This product may cause drowsiness. If affected individuals should not
drive or operate