Benylin Non-drowsy for Chesty Coughs Syrup; Guaifenesin 100mg/5ml Levomenthol 1.1mg/5ml

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

GUAIFENESIN, LEVOMENTHOL

Dostupno od:

Johnson & Johnson (Ireland) Limited Airton Road Tallaght, Dublin 24, Dublin, Ireland

ATC koda:

R05CA10

INN (International ime):

GUAIFENESIN 100 mg/5ml LEVOMENTHOL 1.1 mg/5ml

Farmaceutski oblik:

SYRUP

Sastav:

GUAIFENESIN 100 mg/5ml LEVOMENTHOL 1.1 mg/5ml

Tip recepta:

OTC

Područje terapije:

COUGH AND COLD PREPARATIONS

Status autorizacije:

Authorised

Datum autorizacije:

2006-08-10

Uputa o lijeku

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Non-Drowsy
Chesty Coughs Syrup
GUAIFENESIN 100 MG/5 ML
LEVOMENTHOL 1.1 MG/5 ML
Read all of this leaflet carefully before you start taking
this medicine because it contains important information
for you.
Always take this medicine exactly as described in this
leaflet or as your doctor or pharmacist have told you.
- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or
advice.
- 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.
- You must talk to a doctor if you do not feel better or
feel worse after 3 days.
WHAT IS IN THIS LEAFLET
1. What Benylin Non-Drowsy Chesty Coughs Syrup is
and what it is used for
2. What you need to know before you take Benylin
Non-Drowsy Chesty Coughs Syrup
3. How to take Benylin Non-Drowsy Chesty Coughs
Syrup
4. Possible side-effects
5. How to store Benylin Non-Drowsy Chesty Coughs
Syrup
6. Contents of the pack and other information
1 WHAT BENYLIN NON-DROWSY
CHESTY COUGHS SYRUP IS
AND WHAT IT IS USED FOR
Benylin Non-Drowsy Chesty Coughs Syrup is a
medicine which is used to help relieve chesty coughs.
It contains Guaifenesin (an expectorant) to help loosen
mucus (phlegm) from the lungs and make it easier to
cough up, and Levomenthol to help you breathe more
easily by easing congestion.
The medicine is for use in adults and children aged
12 years and over.
2 WHAT YOU NEED TO KNOW
BEFORE YOU TAKE BENYLIN
NON-DROWSY CHESTY
COUGHS SYRUP
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 TAKE BENYLIN NON-DROWSY
CHESTY COUGHS SYRUP…
■
If you are allergic to guaifenesin or levomenthol
or to any of the other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Benylin
Non-Drowsy Chesty Coughs Syrup...
■
If you suffer from LIVER or KID

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BENYLIN Non-drowsy for Chesty Coughs Syrup
Guaifenesin 100mg/5ml
Levomenthol 1.1mg/5ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mls contains 100 mg guaifenesin and 1.1 mg levomenthol
Excipients with known effect: Each 5ml contains:
Glucose liquid 3.5g
Sucrose 1g
Ponceau 4R (E124) 0.25mg
Sodium benzoate 10mg
Sodium 16.4mg per 5ml
Ethanol 0.7mg
Propylene glycol (E1520) 1.07mg
Invert sugar 6.75mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Syrup
Clear red syrup having a characteristic odour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
BENYLIN Non-drowsy for Chesty Coughs is indicated for the
symptomatic relief of productive cough.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN OVER 12 YEARS:
Oral. Two 5 ml spoonfuls four times a day.
CHILDREN UNDER 12 YEARS:
Not recommended (see section 4.3).
THE ELDERLY:
As for adults.
HEPATIC/RENAL DYSFUNCTION
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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].
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4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
BENYLIN Non-drowsy for Chesty Coughs should be not 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].
Benylin Non-Drowsy for Chesty Coughs should not be used in children
under the age
of 12 years.
This medicinal product contains 3.5 g glucose per 5ml, 1 g of sucrose
per 5ml and
6.75mg invert sugar per 5ml. This should be taken into account in
patients with
diabetes mellitus.
Patients with rare hereditary