Skip to Content

ASPAR COLD & FLU POWDERS

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

1.

NAME OF THE MEDICINAL PRODUCT
Mrs Cullens Powders
Abdine Analgesics Powders
Aspar Cold & Flu Powders
Asda Aspirin Powders

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Aspirin BP 600mg
Caffeine BP 62mg

3.

PHARMACEUTICAL FORM
Sachets of fine, white, free-flowing, crystalline powder

Clinical Particulars
4.1.

Therapeutic Indications

For the relief of headaches, colds, flu, neuralgia, period and rheumatic pains.

4.2.

Posology and Method of Administration
Adults: One powder every 3 or 4 hours.
Do not exceed 6 doses in any 24 hour period
Do not give to children under 12 years, and avoid up to and including 15 years of age if
feverish.
Dosage should not be continued for more than 3 days without consulting a doctor.

4.3.

Contra-indications
This product contains Aspirin. Aspirin is contraindicated in patients with active peptic
ulceration or a history of peptic ulceration.

4.4.

Special Warnings and Precautions for Use
Keep all medicines in a safe place out of reach of children.

Do not give to children under 12 unless your doctor tells you.
Do not exceed six doses in any 24 hour period.
There is a possible association between aspirin and Reye’s syndrome when given to children
with a fever. Reye’s syndrome is a very rare disease which affects the brain and liver, and
can be fatal. For this reason aspirin should not be given to children under 12 years and
should be avoided up to an including 15 years of age if feverish

4.5.

Interactions with other Medicaments and other forms of Interaction
Do not take if you have a stomach ulcer.

4.6.

Pregnancy and Lactation
None stated.

4.7.

Effects on Ability to Drive and Use Machines
None stated.

4.8.

Undesirable Effects
Aspirin may precipitate bronchospasm and induce asthma attacks or other hypersensivity
reactions in susceptible individuals.

4.9.

Overdose
The signs and symptoms of aspirin and caffeine overdosage are outlined below. If a patient
experiences the symptoms they should stop taking this medication immediately, avoid
caffeinated drinks and seek medical help. The symptoms of aspirin overdosage include
dizziness, tinnitus, deafness, sweating, nausea and vomiting, headache and mental
confusion. Symptoms of more severe intoxication or of acute poisoning after overdosage
include hyperventilation, fever, restlessness, ketosis, respiratory alkalosis and metabolic
acidosis. Depression of the CNS can lead to coma. Cardiovascular collapse and respiratory
failure may also occur. In children, drowsiness and metabolic acidosis commonly occur and
hypoglycaemia may be severe. Treatment of overdosage includes gastric lavage and forced
alkaline diuresis. Aspirin remaining in the stomach can be absorbed using activated
charcoal. Fluid and electrolyte therapy are important to ensure maintenance of hydration,
serum pH and serum potassium concentrations. Haemodialysis or haemoperfusion may be
required in severe cases.
The signs and symptoms of caffeine overdosage include insomnia, restlessness, excitement
which may progress to delirium, nausea, vomiting, abdominal pain and palpitations. Severe

overdosage or idiosyncrasy may lead to maniacal behaviour, diuresis, hyperthermia,
tachycardia, tachypnoea, electrolyte disturbances, convulsions and death. As with aspirin
overdosage, treatment is symptomatic and supportive. Gastric lavage followed by oral
administration of activated charcoal (repeated doses) has been recommended.
Haemodialysis and haemoperfusion will greatly enhance caffeine clearance from the serum.

Pharmacological Properties
5.1.

Pharmacodynamic Properties

Aspirin: Dose: 0.3 to 1g; Max. in 24 hours in divided doses. 4g. In acute-rheumatis, 4 to 8g daily
in divided doses. Aspirin has analgesic, anti-inflammatory, antipyretic and uricosuric actions. It is
used for the less severe types of pain such as headache, neuritis, acute and chronic rheumatoid
arthritis, myalagias and toothache. Aspirin is relatively ineffective in visceral pain. In the treatment
of minor febrile conditions, such as colds or influenza, aspirin is of value for the reduction of
temperature and relief of the headache and the joint and muscle pains, but has no effect on the
casual infection.
Caffeine:
Adult Dose: 100 to 300mg. Caffeine is administered in powder or tablets. It is frequently included
in analgesic preparations with aspirin or codeine. Caffeine acts on the nervous system, on muscle,
including cardiac muscle, and on the kidneys. Its action on the central nervous system in mainly on
the higher centre and it produces a condition of wakefulness and increased mental activity.

5.2.

Pharmacokinetic Properties
Asprin: Absorption of non-ionised aspirin occurs in the stomach. Acetylsalicylates and
salicylates are also readily absorbed from the intestine. Hydrolysis to salicylic acid occurs
rapidly in the intestine in the circulation.
Caffeine is absorbed readily after oral, rectal, or parenateral administration. Absorption
from the gastro-intestinal tract may be erratic.

5.3.

Preclinical Safety Data
None stated

Pharmaceutical Particulars
6.1.

List of Excipients

Calcium Phosphate BP
Saccharin Sodium BP

Sodium Lauryl Sulphate BP

6.2.

Incompatibilities
None stated

6.3.

Shelf Life
3 years

6.4.

Special Precautions for Storage
Store in a dry place at or below 25°C.

6.5.

Nature and Contents of Container
Triple foil laminate - Single dose sachet sealed on four sides. 4, 5, 8 or 10 sachets are
presented in a cardboard carton.

6.6.

Instruction for Use/Handling
None stated

7

MARKETING AUTHORISATION HOLDER
Cullen & Davison Ltd.
Killenaule Road
Fethard
Co. Tipperary
Ireland

8.

MARKETING AUTHORISATION NUMBER
PL 15873/0001

9.

DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

1 March 1997

10.

DATE OF (PARTIAL) REVISION OF THE TEXT
October 2002

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide