Benylin Cough Medicine Syrup; Diphenhydramine hydrochloride 14 mg Levomenthol 1.1 mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOL

Available from:

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

ATC code:

R06AA52

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE 14 mg/5ml LEVOMENTHOL 1.1 mg/5ml

Pharmaceutical form:

SYRUP

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 14 mg/5ml LEVOMENTHOL 1.1 mg/5ml

Prescription type:

OTC

Therapeutic area:

ANTIHISTAMINES FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2006-08-10

Patient Information leaflet

DIPHENHYDRAMINE HYDROCHLORIDE 14MG/5ML,
LEVOMENTHOL 1.1MG/5ML
Cough Medicine
Syrup
■
This medicine can be used to relieve coughing and for
the relief of allergic conditions and reactions.
■
This medicine is for use by adults and children aged 12
years and over.
■
DO NOT USE THIS MEDICINE:
■
There are some people who should not use this medicine.
_To find out if you are one of them see section 2_
■
If you have ever had a BAD REACTION to any of the
ingredients. _For the list of ingredients see section 6_
■
SPEAK TO YOUR DOCTOR:
■
If you suffer from any of the conditions mentioned in
section 2. _See section 2_
■
If you are taking any other medicines. _See section 2_
■
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. _See section _
_3_
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE
THIS MEDICINE. Keep the leaflet: you might need it again.
Ask your pharmacist if you need more information or
advice.
Go to see your doctor if your symptoms worsen or do
not improve after a few days.
1 WHAT THE MEDICINE IS FOR
Benylin Cough Medicine is a medicine which is used to
relieve coughing and for the relief of allergic conditions and
reactions.The liquid contains diphenhydramine which is an
antihistamine that helps relieve coughing and dry secretions
in the nose and chest and levomenthol which helps you
breathe more easily by relieving congestion.
The medicine is for use in 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.
If any of these apply to you, GET ADVICE FROM A DOCTOR
OR PHARMACIST WITHOUT USING BENYLIN COUGH
MEDICINE.
TALK TO YOUR DOCTOR OR PHARMACIST…
■
If you suffer from LIVER or KIDNEY PROBLEMS
■
If you suffer from ASTHMA, A PERSISTENT COUGH
that may be caused by smoking, chronic bronchitis
or emphysema, or a cough which brings up a lot
of mucu

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Benylin Cough Medicine Syrup
Diphenhydramine hydrochloride 14 mg
Levomenthol 1.1 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
Diphenhydramine hydrochloride 14 mg
Levomenthol 1.1 mg
Each 5ml also contains:
Glucose Syrup 3.49mg
Sucrose 1.0g
Ethanol 0.26ml
Ponceau 4R (E124) 0.25mg
Sodium 16.42mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Syrup.
Clear red syrup with a taste characteristic of menthol.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
(a)
Properties
Fixed combination of anti-histamine with anti-tussive activity and
carminative.
(b)
Indications for use
In the symptomatic relief of non-productive cough and of allergic
conditions and reactions.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use.
2 ADULT AND CHILDREN OVER 12 YEARS OF AGE
One or two 5 ml spoonfuls three to four times daily.
Not recommended for children under 12 years. [see section 4.3]
4.3
CONTRAINDICATIONS
Benylin Cough Medicine is contra-indicated in individuals with
hypersensitivity to diphenhydramine, levomenthol
or to any of the excipients listed in section 6.1.
Benylin Cough Medicine should not be used in children under the age of
12
years.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not use with any other product containing diphenhydramine, even one
used
on skin (see Section 4.5).
Patients with moderate to severe renal or hepatic dysfunction should
exercise
caution when using this product (see Section 5.2).
Patients with the following conditions should be advised to consult a
physician
before using Benylin Cough Medicine:
•
Acute or chronic bronchial asthma, a persistent or chronic cough such
as occurs with smoking,
chronic bronchitis
or emphysema or where
cough is accompanied by excessive secretions
•
Narrow angle glaucoma
•
Prostatic enlargement (hyperplasia/hypertrophy) with
urinary retention
This product may act as a cerebral stimulant in children and
occasionally in
adults. Symptoms of overdosage