BENYLIN FOUR FLU TABLETS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Johnson & Johnson (Pty) Ltd û East London

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg PARACETAMOL 500,O mg PSEUDOEPHEDRINE HYDROCHLORIDE 22,5 mg

Authorization status:

Registered

Authorization date:

2005-05-09

Patient Information leaflet

Johnson & Johnson (Pty) Ltd
BENYLIN FOUR FLU TABLETS Film-coated tablet
Each tablet contains:
12,5 mg Diphenhydramine HCL
22,5 mg Pseudoephedrine HCL
500,0 mg Paracetamol
DATE OF APPROVAL: 1 MARCH 2022
Page 1 of 11
PROPOSED PATIENT INFORMATION LEAFLET FOR BENYLIN FOUR FLU TABLETS
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
S2
BENYLIN FOUR FLU TABLETS
DIPHENHYDRAMINE HYDROCHLORIDE / PSEUDOEPHEDRINE HYDROCHLORIDE /
PARACETAMOL
SUGAR FREE.
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
BENYLIN FOUR FLU TABLETS is available without a doctor’s
prescription, for you to treat a
mild illness.
Nevertheless, you still need to give BENYLIN FOUR FLU TABLETS
carefully to get the best
results from it.
•
Do not share BENYLIN FOUR FLU TABLETS with any other person.
•
Keep this leaflet. You may need to read it again.
•
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 BENYLIN FOUR FLU TABLETS is and what it is used for.
2.
What you need to know before you take BENYLIN FOUR FLU TABLETS.
3.
How to take BENYLIN FOUR FLU TABLETS.
4.
Possible side effects.
5.
How to store BENYLIN FOUR FLU TABLETS.
6.
Contents of the pack and other information.
Johnson & Johnson (Pty) Ltd
BENYLIN FOUR FLU TABLETS Film-coated tablet
Each tablet contains:
12,5 mg Diphenhydramine HCL
22,5 mg Pseudoephedrine HCL
500,0 mg Paracetamol
DATE OF APPROVAL: 1 MARCH 2022
Page 2 of 11
1.
WHAT BENYLIN FOUR FLU TABLETS IS AND WHAT IT IS USED FOR
BENYLIN FOUR FLU TABLETS contains an analgesic (paracetamol), an
antihistamine
(diphenhydramine) and a decongestant (pseudoephedrine). It belongs to
a class of medicines
which is used to relieve the symptoms of colds and flu. BENYLIN FOUR
FLU TABLETS is used to
help relieve cough, congestion, fever and body pains. Paracetamol is
an analgesic and an
antipyretic which acts to relieve pain and fever (high temperature).
Diphenhydramine is an
ant

Summary of Product characteristics

Johnson & Johnson (Pty) Ltd
BENYLIN FOUR FLU TABLETS Film-coated tablets
Each film-coated tablet contains:
12,5 mg Diphenhydramine HCL
22,5 mg Pseudoephedrine HCL
500,0 mg Paracetamol
DATE OF APPROVAL: 1 March 2022
Page 1 of 21
PROFESSIONAL INFORMATION FOR BENYLIN FOUR FLU TABLETS
SCHEDULING STATUS
S2
1.
NAME OF THE MEDICINE
BENYLIN FOUR FLU TABLETS
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains:
Diphenhydramine hydrochloride
12,5 mg
Pseudoephedrine hydrochloride
22,5 mg
Paracetamol
500,0 mg
_ _
_Excipients with known effect: _
Contains Sunset Yellow FCF (E110).
Sugar free.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Orange, oval, biconvex film-coated tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Johnson & Johnson (Pty) Ltd
BENYLIN FOUR FLU TABLETS Film-coated tablets
Each film-coated tablet contains:
12,5 mg Diphenhydramine HCL
22,5 mg Pseudoephedrine HCL
500,0 mg Paracetamol
DATE OF APPROVAL: 1 March 2022
Page 2 of 21
For the relief of symptoms associated with colds and flu; including
coughing, fever, headache,
minor aches and pains and nasal congestion.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults, the elderly and children 12 years and older:
Two tablets four times daily. Do not exceed 8 tablets in 24 hours.
Children aged 6 to less than 12 years:
One tablet four times daily. Do not exceed 4 tablets in 24 hours.
Children under 6 years:
Not recommended.
For oral use only.
_ _
HEPATIC DYSFUNCTION
Caution should be exercised when administrating BENYLIN FOUR FLU
TABLETS to patients
with severe hepatic impairment.
RENAL DYSFUNCTION
Caution should be exercised when administering BENYLIN FOUR FLU
TABLETS to patients with
moderate to severe renal impairment.
_ _
4.3
CONTRAINDICATIONS
•
Hypersensitivity to diphenhydramine hydrochloride, pseudoephedrine
hydrochloride,
paracetamol or to any of the other ingredients in BENYLIN FOUR FLU
TABLETS (see
section 6.1)
•
Most types of cardiovascular disease, including angina and
h