MYPRODOL® CAPSULES

Valsts: Dienvidāfrikas Republika

Valoda: angļu

Klimata pārmaiņas: South African Health Products Regulatory Authority (SAHPRA)

Pieejams no:

Adcock

Lietošanas instrukcija

MYPRODOL CAPSULES - DUAL LANGUAGE - PIL
ADCOCK INGRAM LIMITED, SA
TEXT REVISION
R-1/28.05/18.06.12(RK)
INTERNAL APPROVAL ISSUED ON
CD ISSUED ON
1210284 (WOA)
PRINTED ON 56 - 60 GSM MAPLITHO PAPER.
SINGLE - BLACK
160 X 240 MM (OPEN SIZE)
85%
REASON FOR CHANGE:
ITEM CODE:
CUSTOMER:
ADCOCK INGRAM LIMITED
ARTWORK SCALE:
SUPERSEDED ITEM CODE:
COMPONENT:
DIMENSION:
COLOUR SCHEME:
SPECIFICATION:
PDC
HEAD - TT/PDC
HEAD - TECH. SERVICES /PRODUCTION
HEAD CQA/QA
Prepared by:
Date:
Checked by:
Date:
Approved by:
Date:
Authorized by:
Date:
ADC/MYP/PIL/02
\\192.168.1.32\pdc\Artworks\Adcock\Product\Myprodol\PIL\1210284.ai
SCHEDULING STATUS:
S3
PROPRIETARY NAME:
MYPRODOL
® CAPSULES
(AND DOSAGE FORM)
(CAPSULE)
COMPOSITION:
Each capsule contains:
Codeine phosphate
10 mg
Ibuprofen
200 mg
Paracetamol
250 mg
Sugar free
PHARMACOLOGICAL CLASSIFICATION:
A:2.8 Analgesic combinations
PHARMACOLOGICAL ACTION:
MYPRODOL CAPSULES have an analgesic, anti-inflammatory and antipyretic
action.
INDICATIONS:
MYPRODOL CAPSULES are indicated for the relief of mild to moderate
pain of inflammatory origin with or without fever.
CONTRAINDICATIONS:
Impaired hepatic and renal function, peptic ulceration or a history of
such ulceration. 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 treatment.
Caution is advised in those patients who are receiving coumarin
anticoagulants.
Patients who are sensitive to aspirin should not be given MYPRODOL
CAPSULES.
WARNINGS:
The safety of continuous administration of MYPRODOL CAPSULES has not
been established for a period greater than four