Benylin Chesty Coughs Non-Drowsy

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

GUAIFENESIN, LEVOMENTHOL

Available from:

McNeil Products Limited

ATC code:

R05CA03

INN (International Name):

GUAIFENESIN, LEVOMENTHOL

Pharmaceutical form:

SYRUP

Composition:

GUAIFENESIN 100 milligram(s)/5 millilitre ; LEVOMENTHOL 1.1 milligram(s)/5 millilitre

Prescription type:

OTC

Therapeutic area:

COUGH AND COLD PREPARATIONS

Authorization status:

Authorised

Authorization date:

2006-08-10

Patient Information leaflet

■
 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. The ethanol content should 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 16.42 mg 
  sodium per 5 ml. To be taken into 
consideration by patients on a controlled 
sodium diet.
3
   HOW TO TAKE THIS 
MEDICINE
CHECK THE TABLE BELOW TO SEE HOW 
MUCH MEDICINE TO TAKE.
■
 For oral use only.
■
 Do not use more than the stated dose shown. 
CHILDREN UNDER 12 YEARS
This medicine is not recommended for 
children under 12 years old. 
ADULTS AND CHILDREN AGED 12 YEARS 
AND OVER
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.
■
 For a child under 12 years of age.
If any of these apply to you, GET ADVICE FROM A 
DOCTOR OR PHARMACIST WITHOUT USING BENYLIN 
CHESTY COUGHS NON-DROWSY.  
TALK TO YOUR DOCTOR OR PHARMACIST…
■
 If you suffer from LIVER or KIDNEY PROBLEMS.
■
 If you have been told by your doctor that you 
have an intolerance to some sugars. 
■
 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 ALCOHOL. 
If you are not sure about any of the medicines you are 
taking, show the bottle or pack to your pharmacist.
If any of these bullet points apply to you now or in the 
past, TALK TO A DOCTOR OR PHARMACIST.
IF YOU ARE PREGNANT OR BREAST-FEEDING
■
 Ask your doctor or pharmacist for advice before 
taking this medicine if you are pregnant or 
breast-

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
PRODUCT SUMMARY
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.
2
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, equivalent to approximately 5 ml beer, 2 ml wine per 5