Senna 7.5mg Tablets
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Senna 7.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 203mg of Senna leaf (Cassia senna L. (C. acutifolia Delile) or Cassia angustifolia Vahl) corresponding to 7.5 mg hydroxyanthracene glycosides, calculated as sennoside B.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Greenish - brown biconvex tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For short term relief of occasional constipation.
4.2 Posology and method of administration
For oral use only
The correct individual dose is the smallest required to produce a comfortable soft-formed motion
Adults, the elderly and children over 12 years of age:
Two tablets equivalent to 15 mg hydroxyanthracene derivatives, calculated as sennoside B, to be taken at night.
Not recommended for use in children under 12 years of age Duration of use
Use for more than 1-2 weeks requires medical supervision.
If there is no bowel movement after three days a doctor should be consulted.
If laxatives are needed every day, or abdominal pain persists a doctor should be consulted.
If symptoms persist during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.
4.3 Contraindications
Hypersensitivity to senna or to any of the excipients listed in section 6.1
Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory colon diseases (e.g. Crohn’s disease, ulcerative colitis); abdominal pain of unknown origin; severe dehydration states with water and electrolyte depletion.
Children under 12 years of age
4.4 Special warnings and precautions for use
Do not exceed the stated dose
Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking senna leaves concomitantly.
Like all laxatives, senna leaves should not be taken by patients suffering from faecal impaction and undiagnosed, acute or persistent gastro-intestinal complaints, e.g. abdominal pain, nausea and vomiting, unless advised by a doctor, because these symptoms can be signs of a potential or existing intestinal blockage (ileus).
If laxatives are needed every day the cause of the constipation should be investigated. Long-term use of laxatives should be avoided.
If stimulant laxatives are taken for longer than a brief period of treatment, this may lead to impaired function of the intestine and dependence on laxatives. and precipitate the onset of an atonic non-functioning colon.
Senna leaf preparations should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents.
When senna leaf preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.
Prolonged and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.
Patients with kidney disorders should be aware of possible electrolyte imbalance.
Intestinal loss of fluids may promote dehydration. Symptoms may include thirst and oliguria.
Laxatives do not help in long-term weight loss.
4.5 Interaction with other medicinal products and other forms of interaction
Hypokalaemia (resulting from long term laxative abuse) potentiates the action of cardiac glycosides and interacts with antiarrhythmic medicinal products, with medicinal products which induce reversion to sinus rhythm (e.g. quinidine) and with medicinal products inducing QT-prolongation. Concomitant use with other medicinal products inducing hypokalaemia (e.g. diuretics, adrenocorticosteroids and liquorice root) may enhance electrolyte imbalance
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage.
However, as a consequence of experimental data concerning a genotoxic risk of several anthranoids, e.g. emodin and aloe-emodin, use is not recommended during pregnancy.
Lacatation
Use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk.
Small amounts of active metabolites (rhein) are excreted in breast milk. A laxative effect in breast fed babies has not been reported
Fertility
Studies on the effects on fertility have not been carried out.
4.7 Effects on ability to drive and use machines
None known
4.8 Undesirable effects
Temporary mild griping may occur during adjustment of the dosage.
Hypersensitive reactions (pruritus, urticaria, local or generalised exanthema) may occur..
Senna leaves may produce abdominal pain and spasm and passage of liquid stools, in particular in patients with irritable colon. However, these symptoms may also occur generally as a consequence of individual overdosage. In such cases dose reduction is necessary.
Chronic use/abuse may lead to disorders in water equilibrium and electrolyte metabolism. and may result in albuminuria and haematuria
Furthermore, chronic use may cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually recedes when the patient stops taking the preparation.
Yellow or red-brown (pH dependent) discolouration of urine by metabolites, which is not clinically significant, may occur during the treatment.
The frequency is not known.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard
4.9 Overdose
The major symptoms are griping pain and severe diarrhoea with consequent losses of fluid and electrolyte, which should be replaced.
Diarrhoea may especially cause potassium depletion, which may lead to cardiac disorders and muscular asthenia, particularly where cardiac glycosides, diuretics, adrenocorticosteroids or liquorice root are being taken at the same time.
Treatment should be supportive with generous amounts of fluid. Electrolytes, especially potassium, should be monitored. This is especially important in the elderly.
Chronic ingested overdoes of anthranoid containing medicinal products may lead to toxic hepatitis.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Contact laxatives
ATC Code: A06A B06
1,8-dihydroxyanthracene derivatives possess a laxative effect. The P-O-linked glycosides (sennosides) are not absorbed in the upper gut; they are converted by bacteria of the large intestine into the active metabolite (rhein anthrone). There are two different mechanisms of action:
1. Stimulation of the motility of the large intestine (stimulation of peristaltic contractions and inhibition of local contractions) resulting in accelerated colonic transit, thus reducing fluid absorption.
2. Influence on secretion processes by two concomitant mechanisms viz. inhibition of absorption of water and electrolytes (Na+, Cl-) into the colonic epithelial cells (antiabsorptive effect) and increase of the leakiness of the tight junctions and stimulation of secretion of water and electrolytes into the lumen of the colon (secretagogue effect) resulting in enhanced concentrations of fluid and electrolytes in the lumen of the colon.
Defaecation takes place after a delay of 8-12 hours due to the time taken for transport to the colon and metabolisation into the active compound.
5.2 Pharmacokinetic properties
The P-O-linked glycosides (sennosides) are neither absorbed in the upper gut nor split by human digestive enzymes. They are converted by the bacteria of the large intestine into the active metabolite (rhein anthrone). Aglyca are absorbed in the upper gut. Animal experiments with radio-labeled rhein anthrone administered directly into the caecum demonstrated absorption < 10%. In contact with oxygen, rhein anthrone is oxidised into rhein and sennidins which can be found in the blood, mainly in the form of glucuronides and sulphates. After oral administration of sennosides, 3-6% of the metabolites are excreted in urine; some are excreted in bile. Most of the sennosides (ca. 90%) are excreted in faeces as polymers (polyquinones) together with 2-6% of unchanged sennosides, sennidins, rhein anthrone and rhein. In human pharmacokinetic studies with senna pods powder (20 mg sennosides), administered orally for 7 days, a maximum concentration of 100 ng rhein/ml was found in the blood. An accumulation of rhein was not observed. Active metabolites, e.g. rhein, pass in small amounts into breast milk. Animal experiments demonstrated that placental passage of rhein is small.
5.3 Preclinical safety data
There are no new, systematic preclinical tests for senna leaves or preparations thereof.
Data derive from investigations with senna pods. Since the spectrum of constituents of senna leaf and fruit is comparable these data can be transferred to senna leaves. Most data refer to extracts of senna pods containing 1.4 to 3.5% of anthranoids, corresponding to 0.9 to 2.3% of potential rhein, 0.05 to 0.15% of potential aloe-emodin and 0.001 to 0.006% of potential emodin or isolated active constituents, e.g. rhein or sennosides A and B. The acute toxicity of senna pods, specified extracts thereof, as well as of sennosides in rats and mice was low after oral treatment. As a result of investigations with parenteral application in mice extracts are supposed to possess a higher toxicity than purified glycosides, possibly due to the content of aglyca.
In a 90-day rat study, senna pods were administered at dose levels from 100 mg/kg up to 1,500 mg/kg. The tested drug contained 1.83 % sennosides A-D, 1.6 % potential rhein, 0.11 % potential aloe-emodin and 0.014 % potential emodin. In all groups epithelial hyperplasia of the large intestine of minor degree was found and was reversible within the 8-week recovery period. The hyperplastic lesions of the forestomach epithelium were reversible as well. Dose-dependent tubular basophilia and epithelial hypertrophy of the kidneys were seen at a dose of, or greater than 300 mg/kg per day without functional affection. These changes were also reversible. Storage of a brown tubular pigment led to a dark discoloration of the renal surface and still remained to a lesser degree after the recovery period. No alterations were seen in the colonic nervous plexus. A no-observable-effect-level (NOEL) could not be obtained in this study.
A 104-week study on rats of both genders did not reveal any carcinogenic effects with the same senna pods preparation at oral dosages of up to 300 mg/kg.
In addition a specified senna extract given orally for 2 years was not carcinogenic in male or female rats. The extract investigated contained approximately 40.8% of anthranoids from which 35% were sennosides, corresponding to about 25.2% of potential rhein, 2.3% of potential aloe-emodin and 0.007% of potential emodin and 142 ppm free aloe-emodin and 9 ppm free emodin.
Further 2-year studies on male and female rats and mice with emodin gave no evidence of carcinogenic activity for male rats and female mice, and equivocal evidence for female rats and male mice.
Sennosides displayed no specific toxicity when tested at doses up to 500 mg/kg in dogs for 4 weeks and up to 100 mg/kg in rats for 6 months. There are no data for herbal substance preparations available.
There was no evidence of any embryolethal, teratogenic or foetotoxic actions in rats or rabbits after oral treatment with sennosides. Furthermore, there was no effect on the postnatal development of young rats, on rearing behaviour of dams or on male and female fertility in rats. Data for herbal substance preparations are not available.
An extract and aloe-emodin were mutagenic in in vitro tests, sennoside A, B and rhein gave negative results. In vivo examinations of a defined extract of senna pods were negative.
A specified senna extract given orally for 2 years was not carcinogenic in male or female rats. The extract investigated contained approx. 40.8% of anthranoids from which 35% were sennosides, corresponding to about 25.2% of potential rhein, 2.3% of potential aloe-emodin and 0.007% of potential emodin and 142 ppm free aloe-emodin and 9 ppm free emodin.
Commercial laxative use as a risk factor in colorectal cancer was investigated in some clinical trials. Some studies revealed a risk for CRC associated with the use of anthraquinine-containing laxatives, some studies did not. However a risk was also revealed for constipation itself and underlying dietary habits. Further investigations are needed to assess the carcinogenic risk definitely..
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Maize starch Croscarmellose sodium Magnesium stearate
6.2 Incompatibilities
Not applicable
6.3 Shelf life
3 years.
6.4 Special precautions for storage
This medicinal product does not require any special storage conditions. Store in the original container.
6.5 Nature and contents of container
20, 50, 60, 100, 200 500 and 1000’s tablets in a polypropylene container with a polyethylene tamper evident, wadless closure.
Not all pack sizes may be marketed
6.6 Special precautions for disposal
No special requirements
7 MARKETING AUTHORISATION HOLDER
Chanelle Medical
Loughrea, Co. Galway, Ireland.
8 MARKETING AUTHORISATION NUMBER(S)
PL 13931/0032
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
21 Feb 2007
10 DATE OF REVISION OF THE TEXT
08/05/2015