ADCO-DOL PAIN RELIEF POWDERS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Adcock Ingram Limited

Dosage:

See ingredients

Pharmaceutical form:

POWDER

Composition:

EACH POWDER CONTAINS ASPIRIN 500 mg CAFFEINE 32,5 mg PARACETAMOL 325 mg

Authorization status:

Registered

Authorization date:

1985-09-06

Patient Information leaflet

PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S0
ADCO-DOL PAIN RELIEF POWDERS, EACH SACHET CONTAINS:
Aspirin 500 mg
Paracetamol 325 mg
Caffeine 32.5 mg
Sugar free
READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR
YOU.
ADCO-DOL PAIN RELIEF POWDERS is available without a doctor’s
prescription, for you to
treat a mild illness. Nevertheless, you still need to use ADCO-DOL
PAIN RELIEF
POWDERS carefully to get the best results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share ADCO-DOL RELIEF POWDERS with any other person.
•
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 after
10 days.
1.WHAT ADCO-DOL PAIN RELIEF POWDERS IS AND WHAT IT IS USED FOR
ADCO-DOL PAIN RELIEF POWDERS combine the analgesic and antipyretic
action of aspirin
and paracetamol together with the anti-inflammatory action of aspirin.
ADCO-DOL PAIN RELIEF POWDERS is used for the relief of mild to
moderate pain and
fever.
2.
WHAT
YOU
NEED
TO
KNOW
BEFORE
YOU
TAKE
ADCO-DOL
PAIN
RELIEF
POWDERS.
DO NOT TAKE ADCO-DOL PAIN RELIEF POWDERS
•
If you are allergic to aspirin, paracetamol, caffeine or any of the
other ingredients of
ADCO-DOL PAIN RELIEF POWDERS (listed in section 6.1).
•
If you are suffering from renal diseases
•
If you have chronic gastritis.
•
If you have peptic ulcers and dyspepsia
•
If you have haemophilia or on an oral anticoagulant.
•
If you have heart failure
•
If you have history of gastrointestinal perforation (small holes in
the stomach),
ulceration or bleeding (PUBs) related to previous NSAIDs, including
ADCO-DOL PAIN
RELIEF POWDERS.
•
If you have active or history of recurrent
ulcer/haemorrhage/perforations.
•
If you are pregnant, do not use ADCO-DOL PAIN RELIEF POWDERS at 20
weeks
or later in your pregnancy unless specifically advised to do so by
your health care
professional because these medicines may cause problems in your unborn
baby.
•
If you ar

Summary of Product characteristics

PROPOSED PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS: S0
1.NAME OF MEDICINE
ADCO-DOL PAIN RELIEF POWDERS
STRENGTH
Each sachet of powder contains:
Aspirin 500 mg
Paracetamol 325 mg
Caffeine 32.5 mg
PHARMACEUTICAL FORM
Powder
2.QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each sachet of powder contains:
Aspirin
500 mg
Paracetamol 325 mg
Caffeine
32.5 mg
Sugar free
3.PHARMACEUTICAL FORM
Fine, homogenous, orange powder.
4.CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS:
ADCO-DOL PAIN RELIEF POWDERS is indicated for the relief of mild to
moderate pain and
fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Date of Approval: 30 November 2021
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ADULTS AND CHILDREN OVER 16 YEARS OLD: One sachet of powder to be
taken with water every
six hours as needed. For best results take the powder dry on the
tongue followed by a glass
of water.
Do not exceed four (4) doses per 24 hours.
Not to be taken by children under 16 years.
Use the lowest effective dose for the shortest possible duration of
treatment.
DO NOT EXCEED THE RECOMMENDED DOSE.
4.3 CONTRAINDICATIONS:
Hypersensitivity (allergy) to the medicine (paracetamol and aspirin).
ADCO-DOL PAIN RELIEF POWDER should not be taken by patients suffering
from:
- Renal disease, chronic gastritis, peptic ulcers, dyspepsia,
hemophilia or on an oral
anticoagulant
- Heart failure
- History of gastrointestinal perforation, ulceration or bleeding
(PUBs) related to previous
NSAIDs, including ADCO-DOL PAIN RELIEF POWDERS.
- Active or history of recurrent ulcer/haemorrhage/perforations.
- Avoid use of NSAIDs in women around 30 weeks gestation and later in
pregnancy due to
the risks of oligohydramnios/ foetal renal dysfunction and premature
closure of the foetal
ductus arteriosus.
- Not to be taken by children under 16 years.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE:
Do not use continuously for more than ten days without consulting your
doctor.
Consult your doctor if no relief is obtained with the recommended
dosage.
ASPIRIN:
Date of Approval: 30 November 2021
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