Benylin Chesty Coughs Non-Drowsy oral solution

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Guaifenesin; Levomenthol

Διαθέσιμο από:

McNeil Products Ltd

Φαρμακολογική κατηγορία (ATC):

R05CA10

INN (Διεθνής Όνομα):

Guaifenesin; Levomenthol

Δοσολογία:

20mg/1ml ; 220microgram/1ml

Φαρμακοτεχνική μορφή:

Oral solution

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 03090200; GTIN: 5010123703745 5010123727703

Φύλλο οδηγιών χρήσης

LOT EXP
5
010123
703745
Guaifenesin & Levomenthol
Guaifenesin & Levomenthol
Soothing effect
Deep penetrating relief
F310173
14-0122
SAFETY!
check that the cap is securely
engaged at all times
1. WHAT THE MEDICINE IS FOR
2. BEFORE TAKING THIS MEDICINE
Benylin Chesty Coughs Non-Drowsy 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.
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.
• 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.
• 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.
SOME OF THE INGREDIENTS CAN CAUSE PROBLEMS
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
Benylin Chesty Coughs Non-Drowsy is a clear red syrup,
available in 150 ml and 300 ml glass bottles.
MARKETING AUTHORISATION HOLDER: McNeil Products Ltd,
Maidenhead, Berkshire, SL6 3UG, UK.
PL 15513/0056 MA 100/00307
AGE
DOSE
WHAT THE MEDICINE LOOKS LIKE
THE

Αρχείο Π.Χ.Π.

OBJECT 1
BENYLIN CHESTY COUGHS (NON-DROWSY)
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 m