PYNSTOP 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 45 mg CODEINE PHOSPHATE 10 mg DOXYLAMINE SUCCINATE 5 mg PARACETAMOL 450 mg

Authorization status:

Registered

Authorization date:

1973-02-06

Patient Information leaflet

Date of Approval: 18 May 2023
Page 1 of 7
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
PYNSTOP, EACH TABLET CONTAINS:
CODEINE PHOSPHATE 10 MG
DOXYLAMINE SUCCINATE 5 MG
PARACETAMOL 450 MG
CAFFEINE 45 MG
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
PYNSTOP is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless, you still need to use PYNSTOP carefully to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share PYNSTOP 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 after
10 days..
WHAT IS IN THIS LEAFLET:
1. What PYNSTOP is and what it is used for
2. What you need to know before you take PYNSTOP
3. How to take PYNSTOP
4. Possible side effects
5. How to store PYNSTOP
6. Contents of the pack and other information
1. WHAT PYNSTOP IS AND WHAT IT IS USED FOR
PYNSTOP contains codeine phosphate, doxylamine succinate paracetamol
and caffeine
which belongs to a group of medicine referred to as analgesic
combinations(pain ,fever and
allergic medication).
S2
Date of Approval: 18 May 2023
Page 2 of 7
PYNSTOP is used for the symptomatic relief of mild to moderate pain
associated with
tension and fever.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYNSTOP TABLETS
DO NOT TAKE PYNSTOP
•
If you are allergic to codeine phosphate, doxylamine succinate
paracetamol and
caffeine, or any of the other ingredients of PYNSTOP tablets (listed
in section 6.1).
•
If you have severe liver function impairment
•
If you have respiratory depression
•
If you have bronchial asthma
•
If you have lung disease could lead to heart failure
•
If you have head injuries
•
If you have acute alcoholism
•
If you have just had a biliary tract operation.
•
If you are under the age of 12 years
WARNINGS AND PRECAUTIONS
Special care should be taken with PYNSTOP:
•
This product contains parac

Summary of Product characteristics

Date of Approval: 18 May 2023
Page 1 of 10
PROFESSIONAL INFORMATION
SCHEDULING STATUS:
S2
1. NAME OF THE MEDICINE
PYNSTOP
STRENGTH
Each tablet contains:
Codeine phosphate 10 mg
Doxylamine succinate 5 mg
Paracetamol 450 mg
Caffeine 45 mg
PHARMACEUTICAL FORM
Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Codeine phosphate 10 mg
Doxylamine succinate 5 mg
Paracetamol 450 mg
Caffeine 45 mg
Sugar free
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Green, circular, flat tablet with score line on one side and a
diameter of 12,7 mm.
Date of Approval: 18 May 2023
Page 2 of 10
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
PYNSTOP tablet for adults are indicated for the symptomatic relief of
mild to moderate pain
and pain associated with tension and fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Not recommended for children under twelve years.
Adults and children over 12 years: one or two tablets repeated four
hourly if necessary.
Do not exceed eight tablets per day.
Consult your doctor if no relief is obtained with the recommended
dosage.
DO NOT EXCEED THE RECOMMENDED DOSE
4.3. CONTRAINDICATIONS:
PYNSTOP tablets are contraindicated in:
•
Sensitivity (allergy) to the active ingredients.
•
Severe liver function impairment.
•
Respiratory depression, especially in the presence of cyanosis and
excessive
bronchial secretion.
•
During an attack of bronchial asthma.
•
Heart failure secondary to lung disease.
•
Head injuries and conditions in which intracranial pressure is raised.
•
The presence of acute alcoholism.
•
After operations on the biliary tract.
Date of Approval: 18 May 2023
Page 3 of 10
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
THIS PRODUCT CONTAINS PARACETAMOL WHICH MAY BE FATAL IN OVERDOSE. IN
THE EVENT OF
OVERDOSAGE OR SUSPECTED OVERDOSE AND NOTWITHSTANDING THE FACT THAT THE
PERSON
MAY BE DOCTOR, HOSPITAL OR POISON CENTRE MUST BE CONTACTED
IMMEDIATELY.
CODEINE: EXCEEDING THE PRESCRIBED DOSE, TOGETHER WITH PROLONGED AND
CONTINUOUS USE
OF THIS M