ADCO-DOL 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 45,0 mg CODEINE PHOSPHATE 10,0 mg DOXYLAMINE SUCCINATE 5,0 mg PARACETAMOL 450 mg

Authorization status:

Registered

Authorization date:

1989-04-08

Patient Information leaflet

PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S2
ADCO-DOL TABLETS 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.
ADCO-DOL is available without a doctor’s prescription, for you to
treat a mild illness.
Nevertheless, you still need to use ADCO-DOL carefully to get the best
results from it.
•
Keep this leaflet. You may need to read it again.
•
Do not share ADCO-DOL 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.
WHAT IS IN THIS LEAFLET:
1.
What ADCO-DOL is and what it is used for
2.
What you need to know before you take ADCO-DOL
3.
How to take ADCO-DOL
4.
Possible side effects
5.
How to store ADCO-DOL
6. Contents of the pack and other information
Date of Approval: 28 September 2021
1 of 8
1. WHAT ADCO-DOL IS AND WHAT IT IS USED FOR:
ADCO-DOL 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 and fever.
ADCO-DOL is used for symptomatic relief of mild to moderate pain, pain
associated with tension,
and fever in adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ADCO-DOL
Do not take ADCO-DOL:
•
If you are hypersensitive (allergic) to any of the above listed
ingredients of ADCO-DOL.
•
If you have respiratory depression (unusual breathing), especially in
the presence of
cyanosis (blueish discolourisation of skin) and excessive bronchial
secretion.
•
After operations on the biliary tract, acute alcoholism, head injuries
and conditions in which
intracranial (inside skull) pressure is raised.
•
It should not be given during an attack of bronchial asthma or in
heart failure secondary to
chronic lung disease.
WARNINGS AND PRECAUTIONS
Special care should be taken with ADCO-DOL
• This product co

Summary of Product characteristics

PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE
SCHEDULING STATUS:
S2
1. NAME OF MEDICINE
ADCO-DOL
STRENGTH
Each tablet contains:
Codeine phosphate 10 mg
Doxylamine succinate 5 mg
Paracetamol 450 mg
Caffeine 45 mg
PHARMACEUTICAL FORM:
Tablet
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
Date of approval: 28 September 2021
1 of 13
3. PHARMACEUTICAL FORM
Yellow, circular, flat tablet, scored on one side only, and embossed
with "ADCO" above and
"DOL" below the score line.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS:
ADCO-DOL tablets for adults:
Symptomatic relief of mild to moderate pain, pain associated with
tension, and fever.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children over 12 years: One or two tablets repeated four
hourly if necessary. Do
not exceed eight tablets per day.
“DO NOT EXCEED THE RECOMMENDED DOSE.
4.3 CONTRAINDICATIONS:
Sensitivity to 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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Date of approval: 28 September 2021
2 of 13
Paracetamol dosages in excess of those recommended may cause severe
liver damage.
Patients suffering from liver or kidney disease should take
paracetamol under medical
supervision.
The effects of atropine and tricyclic antidepressants may be enhanced
This medicine may lead to drowsiness and impaired concentration which
is aggravated by the
simultaneous intake of alcohol or other central nervous system
dep