MYPRODOL CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS CODEINE PHOSPHATE 10 mg IBUPROFEN 2OO mg PARACETAMOL 250 mg

Authorization status:

Registered

Authorization date:

1987-07-05

Patient Information leaflet

_ _
03 August 2021 Page 1 of 10 PATIENT INFORMATION LEAFLET FOR
MYPRODOL CAPSULES
SCHEDULING STATUS
S3
MYPRODOL CAPSULES, 10 MG/200 MG/250 MG, CAPSULES
CODEINE PHOSPHATE, IBUPROFEN, PARACETAMOL
SUGAR FREE
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
MYPRODOL CAPSULES is available without a doctor’s prescription, for
you to treat a mild illness.
Nevertheless, you still need to use MYPRODOL CAPSULES
carefully to get the best results from
it.
•
Keep this leaflet. You may need to read it again.
•
Do not share MYPRODOL CAPSULES with any other person.
•
Ask your healthcare provider or pharmacist if you need more
information or advice.
•
You must see a doctor if your symptoms worsen or do not improve after
three days.
WHAT IS IN THIS LEAFLET
1. What MYPRODOL CAPSULES is and what it is used for
2. What you need to know before you take MYPRODOL CAPSULES
3. How to take MYPRODOL CAPSULES
4. Possible side effects
5. How to store MYPRODOL CAPSULES
6. Contents of the pack and other information
1. WHAT MYPRODOL CAPSULES IS AND WHAT IT IS USED FOR
This medicine contains Codeine. Codeine belongs to a group of
medicines called opioid
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03 August 2021 Page 2 of 10
analgesics which act to relieve pain.
This medicine also contains Ibuprofen. Ibuprofen, a non-steroidal
anti-inflammatory medicine
(NSAID), also acts to reduce swelling (inflammation).
This medicine also contains paracetamol. Paracetamol, an analgesic,
acts to relieve pain.
This medicine can be used for the short-term treatment of mild to
moderate pain (with or without
fever).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE MYPRODOL CAPSULES
DO NOT TAKE MYPRODOL CAPSULES
•
If you are hypersensitive (allergic) to codeine, ibuprofen or
paracetamol or any of the other
ingredients of MYPRODOL CAPSULES (listed in section 6).
•
If you have liver or kidney problems.
•
If you have heart failure.
•
If you have had a bleeding stomach ulcer after taking a non-steroidal
anti-inflammatory
medicine (NSAID) (you may have been sick an

Summary of Product characteristics

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03 August 2021 Page 1 of 15
PROFESSIONAL INFORMATION FOR
MYPRODOL CAPSULES
SCHEDULING STATUS:
S3
1. NAME OF THE MEDICINE
MYPRODOL CAPSULES, 10 MG/200 MG/250 MG, CAPSULES
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains
Codeine phosphate 10 mg
Ibuprofen 200 mg
Paracetamol 250 mg
Sugar free
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsules.
Hard gelatin capsule of size ‘0. The cap is opaque green and the
body is opaque red. "RIO" is printed
in black on both the cap and body. Contents of the capsule are fine
white granular powder.
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03 August 2021 Page 2 of 15
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
MYPRODOL CAPSULES are indicated for the relief of mild to moderate
pain of inflammatory origin with
or without fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
“DO NOT EXCEED THE RECOMMENDED DOSE.”
_ADULTS_
One to two capsules four hourly and not more than twelve capsules per
twenty-four hours. Consult
your doctor if no relief is obtained with the recommended dosage.
Use the lowest effective dose for the shortest possible duration of
treatment.
_PAEDIATRIC POPULATION _
Not recommended for children under twelve years of age.
4.3 CONTRAINDICATIONS
•
Heart failure,
•
Impaired hepatic and renal function,
•
Peptic ulceration,
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03 August 2021 Page 3 of 15
•
History of gastrointestinal perforation, ulceration or bleeding (PUBs)
related to previous NSAIDs,
including MYPRODOL CAPSULES,
•
Cardiovascular disease,
•
Hypersensitivity to any of the active ingredients,
•
Contraindicated in respiratory depression, especially in the presence
of cyanosis and excessive
bronchial secretion, after operations on the biliary tract, 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,
•
Contraindicated in patients taking monoamine oxidase inhibitors or
within fourteen days of stopping
such tr