Skip to Content

The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

CALIFIG CALIFORNIA SYRUP OF FIGS

PDF options:  View Fullscreen   Download PDF

PDF Transcript

SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Califig California Syrup of Figs.

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Constituents

Quantity per mg

Specification

Senna
(as alcoholic extract of

2.5

HSE

Senna Leaf EP 11.7% w/v)

3

PHARMACEUTICAL FORM
Syrup

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Califig California Syrup of Figs is recommended for the relief of Constipation.

4.2.

Posology and Method of Administration
Dosage schedules: Adults

1 to 2 tablespoonfuls (15-30ml) per day
Children
Age 1-3 years: ½ to 1 teaspoonful (2.5-5.0ml) per day
Age 3-6 years: 1 to 2 teaspoonfuls (5.0-10.0ml) per day
Age 6-15 years: 1½ to 3 teaspoonfuls (7.5-15.0ml) per day
Route of Administration: Oral

4.3.

Contra-Indications
Califig California Syrup of Figs is contraindicated in acute abdominal pain,
severe obstruction prior to clearance, anorexia nervosa and in individuals
experiencing a sudden change in bowel habits.

4.4.

Special Warnings and Precautions for Use
If laxatives are needed every day or there is persistent abdominal pain consult
your doctor. Califig California Syrup of Figs contains 52g of Sucrose/100ml.

4.5.

Interactions with other Medicaments and other forms of Interaction
None stated.

4.6.

Pregnancy and Lactation
There is inadequate evidence of the safety of the product in human pregnancy,
although the active ingredient has been in use for many years without apparent
ill consequence. Although anthraquinone laxatives are excreted in breast milk
they are unlikely to affect the nursing infant.

4.7.

Effects on Ability to Drive and Use Machines
None stated.

4.8.

Undesirable Effects

None stated.

4.9.

Overdose
Due to the nature of the product overdosage is unlikely. Effects related to an
excessive laxative effect are likely to occur.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Senna is a stimulant laxative the active constituents being anthraquinone glycosides.
The glycosides are hydrolysed by colonic bacteria and the active anthrone liberated
gradually into the colon. The active ingredient acts by increasing intestinal motility
due to local irritation of the mucosa or to selective stimulation of the intramural nerve
plexus of the intestinal smooth muscle. The active ingredient may also exert its effect
by stimulating the accumulation of water and electrolytes into the colonic lumen.

5.2.

Pharmacokinetic Properties
Naturally occurring anthraquinone laxatives are poorly absorbed from the
small intestine due to the lipophilic character of their sugar moeity. After
removal of the sugar and reduction to the anthrol by colonic bacteria,
absorption occurs to a moderate degree. Excretion is by way of bile, saliva,
milk, urine and faeces.

5.3.

Preclinical Safety Data
The product has been available many years with no adverse reports recorded.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Figs, Extract Of Malt, Ginger Extract, Sucrose, Sodium Benzoate, Sodium Methyl Phydroxy Benzoate, Sodium Methyl P-Hydroxy Benzoate (Ex-Aqueous Soft Extract)
Sodium Propyl P-Hydroxy Benzoate, Purified Water, Ethyl Alcohol, Cassia Oil,
Clove Oil, Peppermint Oil.

6.2.

Incompatibilities
None

6.3.

Shelf Life
24 months.

6.4.

Special Precautions for Storage
Store in a cool place.

6.5.

Nature and Contents of Container
White flint, soda lime glass bottle with tamper evident LDPE closure
containing 55 and 110 ml of Califig California Syrup of Figs.

6.6.

Instruction for Use/Handling
No specific instructions required.

7

MARKETING AUTHORISATION HOLDER
Seven Seas Limited
Trading as Merck Consumer Health
Hedon Road

Marfleet
Kingston-Upon-Hull
HU9 5NJ

8

MARKETING AUTHORISATION NUMBER(S)
PL 01932/0027

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
27/10/2006

10

DATE OF REVISION OF THE TEXT
April 2005

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide