Lemsip Dry Cough 0.25ml/5ml Oral Solution

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Glycerol

Verfügbar ab:

Reckitt Benckiser Ireland Ltd

ATC-Code:

R05X

INN (Internationale Bezeichnung):

Glycerol

Dosierung:

0.25  ml/5ml

Darreichungsform:

Oral solution

Verschreibungstyp:

Product not subject to medical prescription

Therapiebereich:

OTHER COLD PREPARATIONS

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2006-04-07

Gebrauchsinformation

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING -
LABEL
1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF
ADMINISTRATION
Lemsip Dry Cough 0.25ml/5ml Oral Solution
2.
METHOD OF ADMINISTRATION
For oral use
3.
EXPIRY DATE
EXP
4.
BATCH NUMBER
BN
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
0.25ml/5ml
6.
OTHER
For the symptomatic relief of dry tickly coughs and sore throats
DIRECTIONS
HOW MUCH TO TAKE: Adults & Children 12 and over: 2 x 5ml spoonfuls
(10ml) per dose, 3 or
4 times daily. Children 1-12 years: 5ml spoonful per dose, 3 or 4
times daily.
Do not give to children aged less than 1 year. If you take too much
medicine contact your
doctor or pharmacist for advice.
Symptoms of overdose may include headache, nausea, vomiting,
diarrhoea, thirst, dizziness,
confusion and palpitations. Erosion of the teeth and mouth irritation
is possible with citric
acid overdose
WARNINGS
FOR SAFE USE: KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
If symptoms persist consult your doctor. Do not take this medicine if
you are intolerant to
sugar. Contains 3.3 g of sucrose and 500 mg invert sugars per 5ml.
This should be taken into
account in patients with diabetes mellitus. If you have been told by
your doctor that you
have an intolerance to some sugars, contact your doctor before taking
this medicinal
product.
Warnings: Each 5ml dose contains 0.04mg of ethanol (alcohol).
This medicine contains less than 1 mmol sodium (23 mg) per dose, that
is to say essentially
‘sodium-free.
Contains parahydroxybenzoates which may cause allergic reactions
(possibly delayed).
Contains benzyl alcohol which may cause allergic reactions. Do not use
for more than a
week in young children (less than 3 years old), unless advised by your
doctor or pharmacist.
Ask your doctor or pharmacist for advice if you are pregnant or breast
feeding or have liver
or kidney disease. This is because large amounts of benzyl alcohol can
build-up in your body
and may cause side effects (called “metabolic acidosis”).
SIDE EFFECTS: Tell your doc

Fachinformation

Health Products Regulatory Authority
25 January 2022
CRN00CH35
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lemsip Dry Cough 0.25ml/5ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5ml oral solution contains 0.25 ml Glycerol.
Excipients with known effects:
Sodium 0.83 mg / 5 ml dose. Maximum daily dose (MDD) = 6.64 mg
Ethanol 0.05 ml / 5 ml dose (0.04 mg / 5 ml dose)
Sucrose 3.3 g / 5 ml dose. Maximum daily dose (MDD) = 26.48 g
Invert sugar 500 mg / 5 ml dose. Maximum daily dose (MDD) = 4 g
Benzyl Alcohol (trace amounts present in Lemon Oil Terpeneless)
Parahydroxybenzoates and their esters (contains sodium ethyl
p-hydroxybenzoate (E215), sodium propyl p-hydroxybenzoate
and sodium methyl p-hydroxybenzoate (E219)
For the full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution
Clear yellow solution, with characteristic lemon odour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic relief of dry tickly coughs and sore throats.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY:
The lowest effective dose should be used for the shortest duration
necessary to relieve symptoms and a healthcare
professional should be consulted if symptoms persist or worsen.
ADULTS AND CHILDREN OVER 12: Two 5ml spoonfuls, three or four times
daily.
CHILDREN 1-12 YEARS: One 5ml spoonful, three or four times daily.
CHILDREN AGED LESS THAN 1 YEAR: Not suitable (see section 4.3)
No special dose is required for elderly patients.
METHOD OF ADMINISTRATION:
Oral
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substances or any of the excipients
listed in section 6.1
Do not give to children under 1 year.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Citrates should not be taken together with aluminium hydroxide or
aluminium-containing antacids in patients with end-stage
renal disease unless consulted with healthcare professional (see
section 4.5)
Health Products Regulatory Authority
25 January 2022
CRN00CH35
Page 2 of 4
This medicine contains less than