Benylin Non-Drowsy Dry Coughs, Syrup Dextromethorphan hydrobromide 7.5mg/5ml

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Dextromethorphan hydrobromide

제공처:

Johnson & Johnson (Ireland) Limited

ATC 코드:

R05DA; R05DA09

INN (International Name):

Dextromethorphan hydrobromide

복용량:

7.5 mg/5ml

약제 형태:

Syrup

처방전 유형:

Product not subject to medical prescription

치료 영역:

Opium alkaloids and derivatives; dextromethorphan

승인 상태:

Marketed

승인 날짜:

1994-11-10

환자 정보 전단

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
Always use 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 if you feel
worse after 5 days.
What is in this leaflet
1. What Benylin Non-Drowsy Dry Coughs Syrup is and what it is
used for
2. What you need to know before you use Benylin Non-Drowsy
Dry Coughs Syrup
3. How to use Benylin Non-Drowsy Dry Coughs Syrup
4. Possible side-effects
5. How to store Benylin Non-Drowsy Dry Coughs Syrup
6. Contents of the pack and other information
1 WHAT BENYLIN NON-DROWSY DRY COUGHS SYRUP IS
AND WHAT IT IS USED FOR
Benylin Non-Drowsy Dry Coughs Syrup is a medicine which is
used to help relieve dry, irritating coughs. The liquid contains
dextromethorphan hydrobromide which is an antitussive to help
stop persistent coughing.
The medicine is for use in adults and children aged
12 years and over.
2 WHAT YOU NEED TO KNOW BEFORE YOU USE BENYLIN
NON-DROWSY DRY 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.
This medicine can lead to dependence. Therefore the treatment
should be of short duration
X DO NOT USE BENYLIN NON-DROWSY DRY COUGHS SYRUP …
■
If you have ever had a
BAD REACTION
to dextromethorphan or any
of the other ingredients.
■
If you suffer from
LUNG DISEASE
.
■
If you are taking, or have taken in the last two weeks,
DRUGS FOR
DEPRESSION
known as Monoamine Oxidase Inhibitors (MAOIs).
■
If you are taking selective serotonin re-uptake inhibitors (used to
treat
DEPRESSION
and
ANXIETY
such as fluoxetine, paroxetine and
sertraline).
■

제품 특성 요약

Health Products Regulatory Authority
09 March 2022
CRN009ZZ4
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Benylin Non-Drowsy Dry Coughs, Syrup
Dextromethorphan hydrobromide 7.5mg/5ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
BENYLIN Non-Drowsy Dry Coughs, Syrup contains dextromethorphan
hydrobromide 7.5 mg in each 5 ml.
Each 5 ml of BENYLIN Non-Drowsy Dry Coughs, Syrup also contains:
Sorbitol solution (70%) E420
325 mg
Sucrose
1625 mg
Glucose
2380 mg
Sodium
4.4 mg
Ethanol
236 mg
Sodium benzoate
25 mg
Propylene glycol
2.7 mg
Invert sugar
6.7mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Syrup
A clear amber coloured syrup with a characteristic smell of peaches.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BENYLIN Non-Drowsy Dry Coughs, Syrup is indicated for the relief of
non-productive irritating cough.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS AND CHILDREN 12 YEARS AND OVER:
Oral. 15 mg (10 ml syrup) 3-4 times a day.
Maximum daily dose: 40 ml syrup
CHILDREN UNDER 12 YEARS:
This product is contraindicated in children under the age of 12 years
(See section 4.3).
HEPATIC DYSFUNCTION
Due to the extensive hepatic metabolism of dextromethorphan, caution
should be exercised in the presence of hepatic
impairment (See sections 4.4 and 5.2).
4.3 CONTRAINDICATIONS
This product is contraindicated in individuals with known
hypersensitivity to dextromethorphan or to any of the excipients
listed in section 6.1.
Dextromethorphan should not be used in patients taking monoamine
oxidase inhibitors (MAOIs), or within 14 days of stopping
MAOI treatment (see section 4.5). There is a risk of serotonin
syndrome with the concomitant use of dextromethorphan and
MAOIs and the concomitant use of these medications may cause a rise in
blood pressure and / or hypertensive crisis (see
section 4.5).
Health Products Regulatory Authority
09 March 2022
CRN009ZZ4
Page 2 of 7
This product is contraindicated in patients taking serotonin reuptake
inhibitors (SSRIs, see section 4.