INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo LAXADOR SENNA 7,5 MG TABLETS (tablets)
SCHEDULING STATUS:
S0

PROPRIETARY NAME
(and dosage form):

LAXADOR SENNA 7,5 MG TABLETS (tablets)

COMPOSITION:
Each tablet contains:
Calcium Sennosides equivalent to 7,5 mg Sennosides.

PHARMACOLOGICAL CLASSIFICATION:
A 11.5 Laxatives.

PHARMACOLOGICAL ACTION:
Sennosides A and B are anthroquinone glycosides.
Promotes bowel movement by stimulating gut motility by direct actions on the intestines.
Pharmacokinetics:
Anthraquinone glycosides are hydrolysed by bacterial action in the colon following oral ingestion, to give free anthraquinones which promote bowel movement by increasing colonic peristalsis. They are poorly absorbed from the small bowel and produce colonic contractions as well as induce water and electrolyte secretion.
Senna acts within 6 to 12 hours of oral administration. Active compounds are absorbed to a variable degree from the colon and excreted in bile, saliva, breast milk and urine.

INDICATIONS:
LAXADOR SENNA 7,5 MG TABLETS is indicated for the short-term relief of functional constipation.

CONTRA-INDICATIONS:
Hypersensitivity to sennosides A and B.
Children below the age of 6 years.
LAXADOR SENNA 7,5 MG TABLETS should not be used when the following medical problems/conditions exist: intestinal obstruction, undiagnosed abdominal symptoms, symptoms of appendicitis, undiagnosed rectal bleeding, congestive heart failure, abdominal pain, nausea and vomiting.

WARNINGS:
LAXADOR SENNA 7,5 MG TABLETS must not be used for a period longer than 7 days, unless recommended by a doctor.
LAXADOR SENNA 7,5 MG TABLETS must not be used unnecessarily e.g. as a tonic or to cleanse the system, or if a bowel movement is missed for 1 or 2 days.
Frequent or prolonged use of LAXADOR SENNA 7,5 MG TABLETS may result in dependence and loss of normal bowel function.
Weakness, incoordination and orthostatic hypotension may be exacerbated due to significant electrolyte and water loss if LAXADOR SENNA 7,5 MG TABLETS is used repeatedly.
It is important to consult your doctor under the following circumstances:
  If a change in bowel habit persisting for longer than 2 weeks is noted, LAXADOR SENNA 7,5 MG TABLETS should not be used before consultation.
  Rectal bleeding or failure to have a bowel movement after use of LAXADOR SENNA 7,5 MG TABLETS may indicate a serious condition. Discontinue use and consult a doctor.
  If a skin rash develops while using LAXADOR SENNA 7,5 MG TABLETS, stop use and consult a doctor.

INTERACTIONS:
LAXADOR SENNA 7,5 MG TABLETS should not be taken within 2 hours of other medication.
This product should not be used concomitantly with potassium-loosing diuretics. Chronic use or overuse of LAXADOR SENNA 7,5 MG TABLETS may decrease serum potassium concentrations by promoting excessive potassium loss from the intestine. They may, therefore, combine to produce severe hypokalemia.

PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy has not been demonstrated.
The sennosides in LAXADOR SENNA 7,5 MG TABLETS may be distributed into breast milk and may cause loose stools in nursing infants.

DOSAGE AND DIRECTIONS FOR USE:
Adults and children over 12 years:
2 to 4 tablets once a day with a glass of water.
Children 6 to 12 years:
1 to 2 tablets once a day with a glass of water.
Not recommended for children under the age of 6.
Discontinue use and consult a doctor if medicine has no effect after using for a week.
LAXADOR SENNA 7,5 MG TABLETS must only be used as directed and must not be used unnecessarily (see “WARNINGS”). The recommended dosages must not be exceeded. Best taken at bedtime.

As a Laxative:
It is recommended that the lowest dose be used initially, thereafter, the dose can be increased daily until a comfortable laxative effect is achieved, this will vary from one individual to the other.
While using laxatives, it is recommended to drink at least 6-8 full glasses of water daily as this will assist in softening the stools.
If constipation is not relieved after three days, LAXADOR SENNA 7,5 MG TABLETS must be discontinued and a doctor consulted.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Gastrointestinal disorders:
More frequent
Mild abdominal discomfort such as colic or cramps.
Prolonged use or overdosage may result in diarrhoea, excessive loss of water and electrolytes and possible atonic (desensitized) non-functioning colon.
Renal and urinary disorders:
Less frequent
Discolouration of urine. Sennosides may result in a pink to red, red to violet, or red to brown discolouration of alkaline urine, and a yellow to brown discolouration of acid urine. The use of LAXADOR SENNA 7,5 MG TABLETS may therefore interfere with certain diagnostic tests.
Metabolism and nutrition disorders:
Less frequent at normal dose
Acute overdosage of chronic misuse may result in an electrolyte (potassium) imbalance.
Skin and subcutaneous tissue disorders:
Less frequent
Skin rash may occur.
Central nervous system:
Less frequent
Confusion.
Cardiovascular system:
Less frequent
Irregular heartbeat.
Musculoskeletal:
Less frequent
Muscle cramps, unusual tiredness or weakness.

Precautions:
LAXADOR SENNA 7,5 MG TABLETS must be used with care in patients with inflammatory bowel disease.
Not to be used more often than recommended.
Overuse or extended use may cause dependency.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
(See “SIDE-EFFECTS AND SPECIAL PRECAUTIONS”.)
Treatment is symptomatic and supportive. Beware of dehydration and hypokalemia and other electrolyte abnormalities.

IDENTIFICATION:
A round, speckled, greyish-brown to greenish-brown, biconvex tablet with a faint cocoa odour.

PRESENTATION:
Blister packs with a sheet of gold aluminium foil; each blister containing 15 tablets.
Polypropylene securitainers with a filler; each securitainer containing 12 tablets.

STORAGE INSTRUCTIONS:
Store below 25ºC in an airtight container.
Protect from light and moisture.
Keep the container (securitainer) well closed.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
39/11.5/0261

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
PHARMACARE LIMITED
Building 12, Healthcare Park, Woodlands Drive, Woodmead, Sandton, 2148

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
21 February 2006

308676 071021        Harry’s Printers K38103 A08

New addition to this site: June 2008
Source: Pharmaceutical Industry

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