Boots Pharmaceuticals Dry Cough & Congestion Relief Oral Solution Dextromethorphan Hydrobromide 10 mg/5 mlPseudoephedrine Hydroc

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Dextromethorphan hydrobromide; Pseudoephedrine hydrochloride

Dostupné z:

The Boots Company Plc

ATC kód:

R05DA; R05DA20

INN (Medzinárodný Name):

Dextromethorphan hydrobromide; Pseudoephedrine hydrochloride

Dávkovanie:

10 / 30 mg/5ml

Forma lieku:

Oral solution

Typ predpisu:

Product not subject to medical prescription

Terapeutické oblasti:

Opium alkaloids and derivatives; combinations

Stav Autorizácia:

Not marketed

Dátum Autorizácia:

1999-11-26

Príbalový leták

INFORMATION FOR THE USER
Dry Cough & Congestion Relief Oral Solution
Dextromethorphan Hydrobromide 10 mg/5 ml, Pseudoephedrine
Hydrochloride 30 mg/5 ml
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
This medicine is available without prescription to treat minor
conditions.
However, you still need to take it carefully to get the best results
from it.

Keep this leaflet, you may need to read it again

Ask your pharmacist if you need more information or advice
WHAT THIS MEDICINE IS FOR
This medicine contains Dextromethorphan, a cough suppressant, which
acts to reduce coughing. It
also contains Pseudoephedrine, a decongestant, which acts to relieve a
blocked nose.
It can be used to relieve symptoms of dry and tickly coughs, blocked
sinuses and catarrh. Dry coughs
do not produce phlegm or mucus on the chest.
For children, simple treatments should be tried first before you give
this medicine. Further
information on “TREATING COUGHS AND COLDS IN CHILDREN” is provided
at the end of this leaflet.
BEFORE YOU TAKE THIS MEDICINE
This medicine can be taken by adults and children of 6 years and over.
However, some people should
not take this medicine or should seek the advice of their pharmacist
or doctor first.

DO NOT TAKE:

IF YOU ARE ALLERGIC to any of the ingredients in this medicine (see
“What is in this medicine”)

IF YOU ARE ALLERGIC TO OTHER DECONGESTANTS

IF YOU HAVE SEVERE KIDNEY PROBLEMS

IF YOU HAVE HEART OR BLOOD VESSEL DISEASE

IF YOU HAVE HIGH BLOOD PRESSURE (including that due to a tumour near
your kidney)

IF YOU HAVE DIABETES

IF YOU HAVE AN OVERACTIVE THYROID

IF YOU HAVE RAISED PRESSURE IN THE EYE (glaucoma)

IF YOU HAVE DIFFICULTY BREATHING

IF YOU HAVE A LONG-TERM COUGH or one which produces lots of phlegm

IF YOU ARE HAVING AN ASTHMA ATTACK

IF YOU HAVE DIFFICULTY IN PASSING URINE

IF YOU ARE TAKING ANY OF THESE MEDICINES:
-
Monoamine oxidase inhibitors or moclobemide (for depression), or have
taken them in th

Súhrn charakteristických

Health Products Regulatory Authority
19 February 2020
CRN00955K
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Boots Pharmaceuticals Dry Cough & Congestion Relief Oral Solution
Dextromethorphan Hydrobromide 10 mg/5 ml
Pseudoephedrine Hydrochloride 30 mg/5 ml
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredients
per 5 ml
Pseudoephedrine hydrochloride
30 mg
Dextromethorphan hydrobromide
10 mg
Excipients: also contains 2.65g sucrose per 5ml, 77.76mg ethanol 96%
per 5ml and 14.78mg sodium per 5ml.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Oral Solution
A clear, yellow, viscous liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the relief of dry, tickly coughs and the symptoms of nasal
congestion associated with blocked sinuses and catarrh.
For children aged 6 to 12 years: For the relief of dry, tickly coughs
and the symptoms of nasal congestion associated with
blocked sinuses and catarrh when simple measures have failed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Adults and children 12 years and over: Two 5ml spoonfuls to be taken
three times a day.
Elderly: The normal adult dose is appropriate in the elderly.
Children 6-12 years: One 5ml spoonful to be taken three times a day.
This medicine is contraindicated in children under 6 years of age (See
section 4.3)
Children of 6-12 years of age: Not to be used for more than 5 days
without the advice of a doctor. Parents and carers should
seek medical attention if the child's condition deteriorates during
treatment.
Warning: Do not exceed the stated dose.
Keep out of the sight and reach of children.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or any of the excipients.
Health Products Regulatory Authority
19 February 2020
CRN00955K
Page 2 of 7
Severe renal impairment.
Cardiovascular disease including hypertension and ischaemic heart
disease.
Diabetes mellitus.
Phaeochromocytoma.
Hyperthyroidism.
Closed angle glaucoma.
Prostatic enlargement (patients wit