DEMAZIN ANTI-ALLERGY SYRUP

国: 南アフリカ

言語: 英語

ソース: South African Health Products Regulatory Authority (SAHPRA)

から入手可能:

Bayer (Pty) Ltd û Isando

投薬量:

See ingredients

医薬品形態:

SYRUP

構図:

EACH 5,0 ml SYRUP LORATADINE 5,0 mg

認証ステータス:

Registered

承認日:

2000-02-02

情報リーフレット

iNova Pharmaceuticals (Pty) Ltd
Demazin Syrup
Chlorphenamine maleate 1,25 mg/5 ml
Phenylephrine Hydrochloride 2,5 mg/5ml
S2
SCHEDULING STATUS
DEMAZIN SYRUP
CHLORPHENAMINE MALEATE 1,25 MG/5 ML
PHENYLEPHRINE HYDROCHLORIDE 2,5 MG/5ML
CONTAINS SUGAR (SUCROSE) 550 MG/ML
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
DEMAZIN Syrup is available without a doctor’s prescription, for you
to treat a mild illness.
Nevertheless, you still need to use DEMAZIN Syrup carefully to get the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share DEMAZIN Syrup with any other person.
•
Ask your health care provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
7 days.
WHAT IS IN THIS LEAFLET
1. What DEMAZIN Syrup is and what it is used for
2. What you need to know before you take DEMAZIN Syrup
3. How to take DEMAZIN Syrup
4. Possible side effects
5. How to store DEMAZIN Syrup
6. Contents of the pack and other information
iNova Pharmaceuticals (Pty) Ltd
Demazin Syrup
Chlorphenamine maleate 1,25 mg/5 ml
Phenylephrine Hydrochloride 2,5 mg/5ml
1.
WHAT DEMAZIN SYRUP IS AND WHAT IT IS USED FOR
DEMAZIN syrup belongs to a group of medicines called “Preparations
for the common cold, including
nasal decongestants and antihistaminics”.
DEMAZIN Syrup provides relief of nasal congestion and other symptoms
associated with sinusitis, hay
fever, nasal allergies or other respiratory allergies.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEMAZIN SYRUP
Do not take DEMAZIN Syrup:
•
if you are hypersensitive (allergic) to chlorphenamine maleate,
phenylephrine hydrochloride or
any of the other ingredients of DEMAZIN Syrup (listed in section 6)
•
if you are receiving antidepressants called monoamine oxidase
inhibitors, or within 14 days of
you stopping such treatment
•
if you are pregnant or breastfeeding (see section
PREGNANCY, BREASTFEEDING AND FERTILITY
)
•
if you suffer from severe hig

製品の特徴

iNova Pharmaceuticals (Pty) Ltd
Demazin Syrup
Chlorphenamine maleate 1,25 mg/5 ml
Phenylephrine Hydrochloride 2,5 mg/5ml
S2
SCHEDULING STATUS
1 NAME OF THE MEDICINE
DEMAZIN, 1,25 mg and 2,5 mg, syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains 1,25 mg chlorphenamine maleate and 2,5 mg
phenylephrine hydrochloride.
Preservatives: Methylparaben 0,05 % m/v and Propylparaben 0,01 % m/v
Contains: sugar (sucrose) 550 mg/ml. Alcohol free.
For full list of excipients, see
SECTION 6.1
.
3 PHARMACEUTICAL FORM
Syrup
A clear, blue syrup with an aromatic odour and sweet taste, free from
foreign matter.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
DEMAZIN Syrup provides relief of nasal congestion and other symptoms
associated with sinusitis, hay
fever, nasal allergies or other respiratory allergies.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults: 10 ml every three or four hours.
iNova Pharmaceuticals (Pty) Ltd
Demazin Syrup
Chlorphenamine maleate 1,25 mg/5 ml
Phenylephrine Hydrochloride 2,5 mg/5ml
PAEDIATRIC POPULATION
Children: Two to three years: 2,5 to 5 ml every three or four hours.
Three to six years: 5 to 10 ml every three or four hours.
REFER TO SECTION 4.4.
ELDERLY POPULATION
Dose reduction may be required
(REFER TO SECTION 4.4)
.
METHOD OF ADMINISTRATION
Take orally.
4.3 CONTRAINDICATIONS
Sensitivity to any of the ingredients is a contraindication for the
use of DEMAZIN Syrup.
DEMAZIN Syrup is contraindicated in children under 2 years of age.
DEMAZIN Syrup should not be given to patients receiving monoamine
oxidase inhibitors or within 14
days of termination of such treatment.
Not recommended for use in pregnancy and lactation
(REFER SECTION 4.6)
.
Severe hypertension or ischaemic heart disease.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
DEMAZIN Syrup should be used with caution in patients with
hyperthyroidism; cardiovascular disease
such as ischaemic heart disease, arrhythmia or tachycardia; occlusive
vascular disorders, including
arteriosclerosis, hypertension or aneurysms; diabe