EXPECTALIN WITH CODEINE* LIQUID

Pays: Afrique du Sud

Langue: anglais

Source: South African Health Products Regulatory Authority (SAHPRA)

Disponible depuis:

Johnson & Johnson (Pty) Ltd û East London

Dosage:

See ingredients

forme pharmaceutique:

LIQUID

Composition:

EACH 5 ml LIQUID CONTAINS AMMONIUM CHLORIDE 125 mg CODEINE PHOSPHATE 10 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg

Statut de autorisation:

Registered

Date de l'autorisation:

1995-05-12

Notice patient

Johnson & Johnson (Pty) Ltd
EXPECTALIN WITH CODEINE
Liquid
12,5 mg diphenhydramine hydrochloride
10,0 mg codeine phosphate
125,0 mg ammonium chloride
DATE OF APPROVAL: 12.05.2022
Page 1 of 12
EXPECTALIN WITH CODEINE
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S2
EXPECTALIN WITH CODEINE LIQUID
DIPHENHYDRAMINE HYDROCHLORIDE / CODEINE PHOSPHATE / AMMONIUM CHLORIDE
CONTAINS SUGAR ALCOHOL: EACH 5 ML CONTAINS 2,5 G SORBITOL.
CONTAINS SWEETENER: EACH 5 ML CONTAINS 1,5 MG SACCHARIN SODIUM AND 20
MG SODIUM
CYCLAMATE.
SUGAR FREE.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
EXPECTALIN WITH CODEINE is available without a doctor’s
prescription, for you to treat a mild
illness.
Nevertheless, you still need to use EXPECTALIN WITH CODEINE carefully
to get the best results
from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share EXPECTALIN WITH CODEINE with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see your doctor if your symptoms worsen or do not improve
after 3 days.
WHAT IS IN THIS LEAFLET
1.
What EXPECTALIN WITH CODEINE is and what it is used for.
2.
What you need to know before you use EXPECTALIN WITH CODEINE.
3.
How to use EXPECTALIN WITH CODEINE.
Johnson & Johnson (Pty) Ltd
EXPECTALIN WITH CODEINE
Liquid
12,5 mg diphenhydramine hydrochloride
10,0 mg codeine phosphate
125,0 mg ammonium chloride
DATE OF APPROVAL: 12.05.2022
Page 2 of 12
4.
Possible side effects.
5.
How to store EXPECTALIN WITH CODEINE.
6.
Contents of the pack and other information.
1.
WHAT EXPECTALIN WITH CODEINE IS AND WHAT IT IS USED FOR
EXPECTALIN WITH CODEINE is a medicine which is used to help relieve
coughing and related
congestion symptoms in adults. The liquid contains diphenhydramine (an
antihistamine) that
helps relieve coughing and dry secretions in the nose and levomenthol
which helps you breathe
more easily by relieving congestion. It also contains ammonium
chloride, an expectorant, that
helps loosen m

Résumé des caractéristiques du produit

Johnson & Johnson (Pty) Ltd
EXPECTALIN WITH CODEINE
Liquid
12,5 mg diphenhydramine hydrochloride
10,0 mg codeine phosphate
125,0 mg ammonium chloride
DATE OF APPROVAL: 12.05.2022
Page 1 of 20
PROFESSIONAL INFORMATION FOR EXPECTALIN WITH CODEINE
SCHEDULING STATUS
S2
1.
NAME OF THE MEDICINE
EXPECTALIN WITH CODEINE LIQUID
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL contains:
Diphenhydramine hydrochloride
12,5 mg
Codeine phosphate
10,0 mg
Ammonium chloride
125,0 mg
_ _
_Excipients with known effect: _
Preservative:
Sodium benzoate
0,5 % _m/v _
Contains sugar alcohol: Each 5 mL contains 2,5 g sorbitol.
Contains sweetener: Each 5 mL contains 1,5 mg saccharin sodium and 20
mg sodium cyclamate.
Sugar free.
Alcohol free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Liquid.
A clear, light brown liquid with a raspberry odour and taste.
Johnson & Johnson (Pty) Ltd
EXPECTALIN WITH CODEINE
Liquid
12,5 mg diphenhydramine hydrochloride
10,0 mg codeine phosphate
125,0 mg ammonium chloride
DATE OF APPROVAL: 12.05.2022
Page 2 of 20
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
EXPECTALIN WITH CODEINE is indicated for the relief of cough.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
A maximum of four doses per day should not be exceeded.
Shake the bottle before use.
Adults 18 years and older:
One to two 5 mL medicine measures every four hours.
Use the lowest effective dose for the shortest duration.
DO NOT USE FOR LONGER THAN 3 DAYS.
4.3
CONTRAINDICATIONS
Known hypersensitivity to diphenhydramine hydrochloride, codeine
phosphate, ammonium chloride
or to any of the other ingredients in EXPECTALIN WITH CODEINE (see
section 6.1).
Neither diphenhydramine hydrochloride nor codeine phosphate should be
used with monoamine
oxidase inhibitors (MAOIs) or within 14 days of stopping treatment
with monoamine oxidase
inhibitor (see section 4.5).
Contraindicated during acute asthmatic attacks, in the presence of
acute alcoholism, head injuries
and raised intracranial pressure, and in patients with impaired