Benylin Dry Coughs 7.5mg/5ml oral solution

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Dextromethorphan hydrobromide

Pieejams no:

McNeil Products Ltd

ATĶ kods:

R05DA09

SNN (starptautisko nepatentēto nosaukumu):

Dextromethorphan hydrobromide

Deva:

1.5mg/1ml

Zāļu forma:

Oral solution

Ievadīšanas:

Oral

Klase:

No Controlled Drug Status

Receptes veids:

Invalid to prescribe in NHS primary care

Produktu pārskats:

BNF: 03090100; GTIN: 5010123731441

Lietošanas instrukcija

DRY COUGHS
7.5MG/5ML SYRUP
DEXTROMETHORPHAN
Q
This medicine is used to help relieve dry, irritating
coughs.
Q
This medicine is for use by adults and children aged
12 years and over.
Q
DO NOT USE THIS MEDICINE:
Q
There are some people who should not use this medicine.
_To find out if you are one of them see section 2_
Q
If you have ever had a BAD REACTION to any of the
ingredients. _For the list of ingredients see section 6_
Q
SPEAK TO YOUR DOCTOR:
Q
If you suffer from any of the conditions mentioned
in section 2. _See section 2_
Q
If you are taking any other medicines. _See section 2_
Q
FOLLOW THE DOSAGE INSTRUCTIONS CAREFULLY. These are
shown in the table. _See section 3_
NOW READ THIS WHOLE LEAFLET CAREFULLY BEFORE YOU USE
THIS MEDICINE. Keep the leaflet: you might need it again.
1
WHAT THE MEDICINE IS AND
WHAT IT IS USED FOR
Benylin Dry Coughs 7.5mg/5ml 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 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…
Q
If you have ever had a bad reaction (e.g. RASH,
SWELLING OF THE FACE AND THROAT, DIFFICULTY
BREATHING) to dextromethorphan or any of the
other ingredients.
Q
If you suffer from LUNG DISEASE.
Q
If you are taking, or have taken in the last
two weeks, DRUGS FOR DEPRESSION known as
Monoamine Oxidase Inhibitors (MAOIs).
Q
If you are taking selective serotonin re-uptake
inhibitors (used to treat DEPRESSION and ANXIETY
such as fluoxetine, paroxetine and sertraline).
Q
For children under 12 years old.
If any of these apply to you, GET ADVICE FROM A DOCTOR
OR PHARMACIST WITHOUT USING BENYLIN DRY COUGHS
7.5MG/5ML SYRUP.
TALK TO YOUR DOCTOR OR PHARMACIST…
Q
If you suffer from LIVER or KIDNEY PROBLEMS.
Q
If

Produkta apraksts

OBJECT 1
BENYLIN DRY COUGHS 7.5MG / 5ML SYRUP
Summary of Product Characteristics Updated 16-Jan-2017 | McNeil
Products Ltd
1. Name of the medicinal product
BENYLIN DRY COUGHS 7.5mg/5ml Syrup
2. Qualitative and quantitative composition
Each 5 ml contains:
Dextromethorphan hydrobromide 7.5 mg
Each 5ml also contains:
Sucrose 1.6g
Liquid glucose 2.38g
Sorbitol 325mg
Ethanol 240mg
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Pale brown coloured, peach flavoured syrup.
4. Clinical particulars
4.1 Therapeutic indications
This product is indicated as an antitussive, for the relief of an
unproductive cough.
4.2 Posology and method of administration
ADULTS AND CHILDREN AGED 12 YEARS AND OVER:
POSOLOGY
10 ml syrup (15 mg dextromethorphan) 4 times a day.
Maximum daily dose: 40 ml syrup (60 mg dextromethorphan)
CHILDREN UNDER 12 YEARS:
This product is contraindicated in children under the age of 12 years
(see section 4.3).
THE ELDERLY (OVER 65 YEARS)
As for adults above.
Hepatic/renal dysfunction
Due to the extensive hepatic metabolism of dextromethorphan, caution
should be exercised in the
presence of moderate to severe hepatic impairment (see
Pharmacokinetics).
Do not exceed the stated dose.
Keep out of the sight and reach of children.
METHOD OF ADMINISTRATION
For oral use
4.3 Contraindications
This product is contraindicated in individuals with known
hypersensitivity to the active substance or to
any of the excipients.
This product is contraindicated in individuals who are taking, or have
taken, monoamine oxidase
inhibitors within the preceding two weeks.
Dextromethorphan, in common with other centrally acting antitussive
agents, should not be given to
subjects in, or at risk of developing respiratory failure.
This product is contraindicated in patients taking serotonin reuptake
inhibitors (SSRIs, see section 4.5).
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 administered to patients with chronic or
persistent cough