BETAPYN TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS CAFFEINE 50 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg

Authorization status:

Registered

Authorization date:

1974-06-05

Patient Information leaflet

DATE OF APPROVAL: 30 NOVEMBER 2021
S2
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
BETAPYN TABLETS
EACH TABLET CONTAINS:
Codeine phosphate 10 mg
Doxylamine succinate 5 mg
Paracetamol 450 mg
Caffeine anhydrous 50 mg
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
BETAPYN is available without a doctor’s prescription, for you to
treat a mild
illness. Nevertheless, you still need to use BETAPYN carefully to get
the
best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share BETAPYN with any other person.
•
Ask your pharmacist or healthcare provider 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 BETAPYN is and what it is used for
2.
What you need to know before you take BETAPYN
Sewela
Ramaphakela
Digitally signed by
Sewela Ramaphakela
Date: 2023.05.23
20:30:45 +02'00'
DATE OF APPROVAL: 30 NOVEMBER 2021
3.
How to take BETAPYN
4.
Possible side effects
5.
How to store BETAPYN
6.
Contents of the pack and other information
WHAT BETAPYN IS AND WHAT IT IS USED FOR
BETAPYN is a pain and fever combination of paracetamol with codeine
phosphate. Doxylamine succinate has sedating and antihistamine
properties.
In combination these all treat mild to moderate pain, tension and/or
fever.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BETAPYN TABLETS
Do not take BETAPYN:
•
if you are hypersensitive (allergic) to any of the above listed
ingredients
of BETAPYN.
•
if you have respiratory depression (unusually struggling to breathe),
especially in the presence of cyanosis (blueish discoloration of skin)
and are coughing up phlegm.
•
if you suffer from alcoholism, head injuries and conditions in which
intracranial (inside skull) pressure is raised.
•
if you or the person being treated is having an attack of bronchial
asthma or in heart failure secondary to chronic lung disease.
•
if your liver function is severely impaired.
•
Caffeine should be given with c

Summary of Product characteristics

PROFESSIONAL INFORMATION
SCHEDULING STATUS:
1. NAME OF THE MEDICINE
BETAPYN TABLETS
STRENGTH
Codeine phosphate
10 mg
Doxylamine succinate
5 mg
Paracetamol
450 mg
Caffeine anhydrous
50 mg
PHARMACEUTICAL FORM
Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each BETAPYN tablet contains:
Codeine phosphate
10 mg
Doxylamine succinate
5 mg
Paracetamol
450 mg
Caffeine anhydrous
50 mg
SUGAR FREE
For a full list of excipients see section 6.1
S2
Date of approval: 30 November 2021
Sewela
Ramaphakela
Digitally signed by
Sewela Ramaphakela
Date: 2023.05.09 10:56:54
+02'00'
3. PHARMACEUTICAL FORM
Tablets
Round, yellow, flat tablets, bisected on one side of 12,7 mm and
embossed with “BETAPYN”
on reverse side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the symptomatic treatment of mild to moderate pain and/or fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Adults and children over 12 years:
1 or 2 tablets taken orally, repeated 4-hourly if necessary. Do not
exceed 8 tablets per day.
DO NOT EXCEED THE RECOMMENDED DOSE.
4.3. CONTRAINDICATIONS:

Sensitivity to paracetamol or any of the components.

Severe liver function impairment.

Caffeine should be given with care to patients with peptic ulceration.

Safety of BETAPYN during pregnancy and lactation has not been
established.
Date of approval: 30 November 2021

BETAPYN is contraindicated in respiratory depression, especially in
the presence of
cyanosis and excessive bronchial secretion.

It is also contraindicated in the presence of acute alcoholism, head
injuries, and
conditions in which intracranial pressure is raised.

It should not be given during an attack of bronchial asthma or in
heart failure
secondary to chronic lung disease.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Patients suffering from liver or kidney disease should take
paracetamol under medical
supervision.
Dosages in excess of those recommended may cause severe liver damage.
CODEINE should be given with caution to patients with hypothyroidism,
adrenocortical
in