Benylin Mucus Cough oral solution

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Guaifenesin; Levomenthol

Disponível em:

McNeil Products Ltd

Código ATC:

R05CA10

DCI (Denominação Comum Internacional):

Guaifenesin; Levomenthol

Dosagem:

20mg/1ml ; 220microgram/1ml

Forma farmacêutica:

Oral solution

Via de administração:

Oral

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 03090200; GTIN: 3574660497014 3574660572957

Folheto informativo - Bula

100 MG/5 ML ORAL SOLUTION
GUAIFENESIN
Q
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START USING THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this
leaflet or as your doctor, pharmacist or nurse has told
you.
Q
Keep this leaflet. You may need to read it again.
Q
Ask your pharmacist if you need more information or
advice.
Q
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.
Q
You must talk to a doctor if you do not feel better or
if you feel worse after 7 days.
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
BENYLIN
®
Mucus Cough Max Menthol Flavour
100 mg/5 ml Oral Solution contains guaifenesin which
is a type of medicine called an expectorant. It helps to
relieve chesty (productive) coughs by loosening phlegm
(mucus), making it easier to cough up and the cough
more productive.
The medicine is for use in adults and adolescents aged
12 years and over.
2 WHAT YOU NEED TO KNOW
BEFORE YOU TAKE THIS
MEDICINE
DO NOT TAKE THIS MEDICINE
Q
if you are ALLERGIC to guaifenesin or any of the
ingredients of this medicine (listed in section 6)._ _
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking this
medicine if you:
Q
have had a COUGH for more than 7 days or your
cough recurs or is accompanied by a FEVER, RASH
or PERSISTENT HEADACHE.
Q
have a PERSISTENT COUGH that may be caused by
ASTHMA.
Q
have a cough which brings up a lot of MUCUS
(phlegm).
Q
suffer from LIVER or KIDNEY PROBLEMS.
Q
are taking ALCOHOL.
CHILDREN
The safety and efficacy of Guaifenesin in children
aged under 12 years has not yet been established.
INTERFERENCE WITH LABORATORY TESTS
If you are undergoing urine tests

Características técnicas

OBJECT 1
BENYLIN MUCUS COUGH
Summary of Product Characteristics Updated 07-Oct-2016 | McNeil
Products Ltd
1. Name of the medicinal product
BENYLIN Chesty Coughs (Non-drowsy)
Benylin Mucus Cough
2. Qualitative and quantitative composition
Each 5ml of product contains 100 mg guaifenesin and 1.1 mg
levomenthol.
Also contains:
Ethanol
0.2595ml/5ml
Glucose
3492 mg/5ml
Sucrose
999 mg/5ml
Sodium
16.42 mg/5ml
Ponceau 4R (E124)
For full list of excipients, see Section 6.1.
3. Pharmaceutical form
Clear red syrup
4. Clinical particulars
4.1 Therapeutic indications
BENYLIN Chesty Coughs (Non-drowsy) is indicated for the symptomatic
relief of cough.
4.2 Posology and method of administration
ADULTS AND CHILDREN AGED 12 YEARS AND OVER:
Oral. Two 5 ml spoonfuls four times a day.
CHILDREN UNDER 12 YEARS:
This product is contraindicated in children under the age of 12 years
(see section 4.3).
THE ELDERLY:
As for adults.
HEPATIC/RENAL DYSFUNCTION
Experience with the use of this product suggests that normal adult
dosage is appropriate for mild to
moderate dysfunction. Caution should be exercised in severe hepatic
and severe renal impairment. [See
Pharmacokinetics].
Do not exceed the stated dose.
Keep out of the reach and sight of children.
4.3 Contraindications
This product is contraindicated in individuals with known
hypersensitivity to the product, or any of its
components.
Not to be used in children under the age of 12 years.
4.4 Special warnings and precautions for use
This product should not be used for persistent or chronic cough, such
as occurs with asthma, or where
cough is accompanied by excessive secretions, unless directed by a
physician.
Caution should be exercised when using the product in the presence of
severe renal or severe hepatic
impairment, [See Pharmacokinetics].
Patients with rare hereditary problems of fructose intolerance,
glucose-galactose malabsorption or
sucrase-isomaltase insufficiency should not take this medicine.
This medicinal product contains 5 vol % ethanol (alcohol), i.e. up to
200 mg per 5ml dose,