ALLERGEX NON DROWSY TABLETS

Nazione: Sudafrica

Lingua: inglese

Fonte: South African Health Products Regulatory Authority (SAHPRA)

Commercializzato da:

Adcock Ingram Limited

Dosaggio:

See ingredients

Forma farmaceutica:

TABLET

Composizione:

EACH TABLET CONTAINS LORATADINE 10,0 mg

Stato dell'autorizzazione:

Registered

Data dell'autorizzazione:

2004-06-02

Foglio illustrativo

APPLICANT: ADCOCK INGRAM LIMITED
PROPRIETARY NAME: ALLERGEX TABLETS
DOSAGE FORM: TABLET
STRENGTH: EACH TABLET CONTAINS CHLORPHENIRAMINE MALEATE 4 MG
8 March 2024
Page 1 of 10
PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS:
ALLERGEX® TABLETS (4 MG)
Chlorphenamine maleate 4 mg
Contains sugar: Lactose 119,80 mg
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
ALLERGEX TABLETS is available without a doctor’s prescription, for
you to treat a mild
illness. Nevertheless, you still need to use ALLERGEX TABLETS
carefully to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share ALLERGEX TABLETS 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 ALLERGEX TABLETS is and what it is used for
2.
What you need to know before you take ALLERGEX TABLETS
3.
How to take ALLERGEX TABLETS.
4.
Possible side effects.
5.
How to store ALLERGEX TABLETS.
6.
Contents of the pack and other information
S2
APPLICANT: ADCOCK INGRAM LIMITED
PROPRIETARY NAME: ALLERGEX TABLETS
DOSAGE FORM: TABLET
STRENGTH: EACH TABLET CONTAINS CHLORPHENIRAMINE MALEATE 4 MG
8 March 2024
Page 2 of 10
1.
WHAT ALLERGEX TABLETS IS AND WHAT IT IS USED FOR
ALLERGEX TABLETS is used for the treatment of allergic and
anaphylactic conditions
such as hay fever, vasomotor rhinitis (allergy in the nose when the
small blood vessels in
the nose dilate causing nasal congestion), urticaria (itchy rash that
appears on the skin),
angioedema (swelling under the skin), drug reactions, contact
dermatitis, atopic
dermatitis, insect bites, pruritus and pruritus vulvae.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ALLERGEX TABLETS
DO NOT TAKE ALLERGEX TABLETS
•
If you are hypersensitive (allergic) to chlorphenamine maleate or any
of the other
ingredients of ALLERGEX TABLETS (listed in section 6)
•
If you suffer from recur

Scheda tecnica

APPLICANT: ADCOCK INGRAM LIMITED
PROPRIETARY NAME: ALLERGEX TABLETS
DOSAGE FORM: TABLET
STRENGTH: EACH TABLET CONTAINS CHLORPHENIRAMINE MALEATE 4 MG
8 March 2024
Page 1 of 8
PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS:
1. NAME OF MEDICINE
ALLERGEX® TABLETS (4 MG)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each tablet contains:
Chlorpheniramine maleate 4 mg
Contains sugar:
Lactose 119,80 mg
For a full list of excipients see section 6.1
3.
PHARMACEUTICAL FORM
Yellow, round, normal convex tablet, scored on one side and embossed
with A on the reverse
side.
S2
APPLICANT: ADCOCK INGRAM LIMITED
PROPRIETARY NAME: ALLERGEX TABLETS
DOSAGE FORM: TABLET
STRENGTH: EACH TABLET CONTAINS CHLORPHENIRAMINE MALEATE 4 MG
8 March 2024
Page 2 of 8
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS:
Allergic
and
anaphylactic
conditions
such
as
hay
fever,
vasomotor
rhinitis,
urticaria,
angioedema, drug reactions, contact dermatitis, atopic dermatitis,
insect bites, pruritus and
pruritus vulvae.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and children 12 years or older: One 4 mg ALLERGEX TABLET every
4 to 6 hours, up
to a maximum of 24 mg in 24 hours._ _
Children 6 to 12 years: 2 mg (Half a ALLERGEX TABLET) every 4 to 6
hours, up to a
maximum of 12 mg in 24 hours.
Children up to 6 years: Use is not recommended.
METHOD OF ADMINISTRATION
Oral administration
4.3 CONTRAINDICATIONS:
Hypersensitivity to Chlorpheniramine or to any of the excipients of
ALLERGEX TABLETS
listed in section 6.1.
Epilepsy, Acute attacks of asthma. Premature infants and new-born
babies.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Chlorphenamine maleate may produce epileptiform seizures in patients
with focal lesions of
the cerebral cortex. Allergic reactions and cross-sensitivity to
related drugs may be
produced. Because of its antimuscarinic properties chlorpheniramine
maleate should be
used with care in conditions such as narrow angle glaucoma, urinary
retention and prostatic
APPLICANT: ADCOCK INGRAM LIMITED
PROPRIETARY