RHINETON 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:

Ranbaxy (SA) (Pty) Ltd

投薬量:

See ingredients

医薬品形態:

SYRUP

構図:

EACH 5,0 ml SYRUP CONTAINS CHLORPHENIRAMINE MALEATE 2,0 mg

認証ステータス:

Registered

承認日:

2008-09-12

情報リーフレット

PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S2
RHINETON SYRUP 2 mg/5 ml
Chlorpheniramine maleate
Contains sugar: Liquid glucose 1,6 g per 5 ml
Preservatives:
Methyl hydroxybenzoate 0,12 % _m/v _
Propyl hydroxybenzoate 0,016 % _m/v _
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING RHINETON
SYRUP
RHINETON SYRUP is available without a doctor’s prescription.
Nevertheless, you still need to
use RHINETON SYRUP carefully to get the best results from it.

Keep this leaflet. You may need to read it again.

Do not share RHINETON 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.
What is in this leaflet
1.
What RHINETON SYRUP is and what it is used for
2.
What you need to know before you take RHINETON SYRUP
3.
How to take RHINETON SYRUP
4.
Possible side effects
5.
How to store RHINETON SYRUP
6.
Contents of the pack and other information
1.
WHAT RHINETON SYRUP IS AND WHAT IT IS USED FOR
Rhineton syrup is used to relieve or prevent the symptoms of hay fever
and other types of
allergy. Rhineton syrup may also be used to prevent cough.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RHINETON SYRUP
DO NOT TAKE RHINETON SYRUP :

If you are hypersensitive (allergic) to chlorpheniramine maleate or
any of the other
ingredients of Rhineton syrup (listed in section 6).

If your child is a premature infant or neonate.

If you are experiencing acute attacks of asthma.

If you suffer from epilepsy (recurrent seizures or fits).
WARNINGS AND PRECAUTIONS
TAKE SPECIAL CARE WITH RHINETON SYRUP:

If you have narrow angle glaucoma, urinary retention and prostatic
hypertrophy.

This medicine may cause some people to become drowsy or less alert
than they are
normally.

Make sure you know how you react to Rhineton syrup before you drive,
use machines, or do
anything else that could be dangerous if you are not alert.

Rhineton syrup may add to the effects of alcohol and other CN

製品の特徴

PROFESSIONAL INFORMATION
SCHEDULING STATUS
S2
1.
NAME OF THE MEDICINE
RHINETON SYRUP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml contains:
Chlorpheniramine maleate 2 mg
Preservatives:
Methyl hydroxybenzoate 0,12 % _m/v _
Propyl hydroxybenzoate 0,016 % _m/v_
Contains Sugar:
Liquid glucose 1,6 g/5 ml
For full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Syrup
A grape-red coloured syrup with a grape flavour.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of conditions responsive to antihistaminic therapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS
5 ml - 20 ml daily in divided doses.
CHILDREN
1-2 YEARS
2,5 ml (
1
/
2
medicine measure) orally twice daily.
2-5 YEARS
2,5 ml (
1
/
2
medicine measure) orally every 4 to 8 hours to a maximum of 15 ml
daily.
6-12 YEARS
5 ml (1 medicine measure) orally every 4 to 8 hours to a maximum of 30
ml daily.
METHOD OF ADMINISTRATION
Oral administration.
4.3 CONTRAINDICATIONS
RHINETON SYRUP is contra-indicated in:

In neonates and lactation (see Section 4.6).

Paediatrics – Not recommended for newborn or premature infants
because it causes
anticholinergic side effects such as excitation of the central nervous
system and increased
tendency towards convulsions.

Epilepsy.

Acute attacks of asthma.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
THIS MEDICINE MAY LEAD TO DROWSINESS AND IMPAIRED CONCENTRATION THAT
MAY BE AGGRAVATED
BY SIMULTANEOUS INTAKE OF ALCOHOL AND OTHER CENTRAL NERVOUS SYSTEM
DEPRESSANTS. PATIENTS
SHOULD BE ADVISED, PARTICULARLY IN THE INITIATION THERAPY, AGAINST
TAKING CHARGE OF VEHICLES
OR MACHINERY OR PERFORMING POTENTIALLY HAZARDOUS TASKS WHERE LOSS OF
CONCENTRATION COULD
LEAD TO ACCIDENTS.
Avoid use of alcohol or CNS depressants.
Inform your physician if taking other medications (see Section 4.5).
Drowsiness may occur (see Section 4.4).
Geriatrics – Dizziness, confusion and hypotension is more likely to
occur in geriatric patients
taking antihistamines.
EXCEPT UNDER SPECIAL CIRCUMSTANCES RHINETON