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JACKSONS LITTLE HEALERS

Active substance(s): IPECACUANHA PREPARED / IPECACUANHA PREPARED / IPECACUANHA PREPARED

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Fennings Little Healers
Or
Jackson’s Little Healers

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Prepared Ipecacuanha 20 mg
For excipients, see 6.1

3

PHARMACEUTICAL FORM
Tablet
Light brown uncoated tablet.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
As an aid to expectoration for cough associated with colds and catarrh.

4.2

Posology and method of administration
For oral administration.
Adults and children over 12 years of age: Two tablets three times a day.
Not to be given to children under 12 years of age.

4.3

Contraindications
Hypersensitivity to any of the ingredients.

Not to be used in children under the age of 12 years.
This product contains a low dose of ipecacuanha which is potentially cardiotoxic and
should not be used by patients with cardiac disorders.
There are no known contra-indications associated with the use of Little Healers for
short periods in accordance with the label directions.

4.4

Special warnings and precautions for use
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this medicine.
The label will include the following warnings:“Do not exceed the stated dose”
“If symptoms persist for more than 5 days consult a doctor”
“If pregnant do not use without medical advice”
“Keep out of the reach and sight of children”

4.5

Interaction with other medicinal products and other forms of interaction
None in recommended doses.

4.6

Pregnancy and lactation
The product should not be used in pregnancy without medical advice.

4.7

Effects on ability to drive and use machines
None or negligible influence.

4.8

Undesirable effects
Gastric irritation may occasionally occur in sensitive individuals.
Ipecacuanha is an expectorant in small doses but large doses can produce vomiting
and diarrhoea.

4.9

Overdose
Ipecacuanha is an emetic. Large doses may cause vomiting, bloody diarrhoea,
mucosal erosions and albuminuria. Emesis can be produced with 20mg of total
alkaloid equivalent to 50 tablets.

The absorption of emetine, which is most likely if vomiting does not occur after the
administration of emetic doses of ipecacuanha, may give rise to adverse effects on the
heart, such as conduction abnormalities or myocardial infarction. These, combined
with dehydration due to vomiting may cause vasomotor collapse.
Activated charcoal is given after acute overdosage of ipecacuanha to delay absorption
followed if necessary by gastric lavage. Prolonged vomiting may be controlled by the
injection of antiemetics. Fluid and electrolyte imbalance should be corrected. ECG
monitoring is advisable and other symptomatic and supportive measures should be
provided.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
R05C A04 – Cough and Cold Preparations, Expectorants
Ipecacuanha is used as an expectorant.

5.2

Pharmacokinetic properties
Emetine hydrochloride is rapidly absorbed after oral administration and is
concentrated in the liver, kidneys, lungs and spleen, with slow excretion via urine.

5.3

Preclinical safety data
None stated.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Talc
Titanium Dioxide
Acacia Powder
Tragacanth Powder
Magnesium Stearate

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
As packaged for sale 36 months.

6.4

Special precautions for storage
Do not store above 25ºC. Keep the container tightly closed. Store in the original
packaging.

6.5

Nature and contents of container
Polypropylene tubes and caps containing 36 or 90 tablets. Tubes are packaged in a
carton.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
None stated.

7

MARKETING AUTHORISATION HOLDER
Crescent Pharma Ltd
Units 3 & 4, Quidhampton Business Units
Polhampton Lane
Overton
Hants
RG25 3ED
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 20416/0206

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
04/09/2007

10

DATE OF REVISION OF THE TEXT
11/05/2009

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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.

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