Summary of medicine characteristics - SUPERDRUG SENNA 7.5 MG TABLETS 12 YEARS PLUS, LLOYDS PHARMACY SENNA 7.5 MG TABLETS 12 YEARS PLUS, SAINSBURYS HEALTHCARE SENNA 7.5 MG TABLETS 12 YEARS PLUS, CARE SENNA 7.5 MG TABLETS 12 YEARS PLUS, POTTERS SENNA CONSTIPATION RELIEF 7.5 MG TABLETS 12 YEARS
1 NAME OF THE MEDICINAL PRODUCT
Almus Senna 7.5 mg Tablets 12 Years Plus
Aspar Senna 7.5 mg Tablets 12 Years Plus
Lloyds Pharmacy Senna 7.5 mg Tablets 12 Years Plus
Sainsbury’s Healthcare Senna 7.5 mg Tablets 12 Years Plus
Healthpoint Senna 7.5 mg Tablets 12 Years Plus
Care Senna 7.5 mg Tablets 12 Years Plus
Accord Senna 7.5 mg Tablets 12 Years Plus
Superdrug Senna 7.5 mg Tablets 12 Years Plus
Potter’s Senna Constipation Relief 7.5 mg Tablets 12 Years Plus
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Alexandrian Senna fruit (Cassia senna L. (C. acutifolia Delile) fruit) corresponding to 7.5 mg hydroxyanthracene glycosides, calculated as sennoside B.
3 PHARMACEUTICAL FORM
Tablet.
An uncoated biconvex greenish tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Used for the 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.
New users should start with the lowest dose and increase it to the maximum dose if necessary. Once regularity has been regained, dosage should be reduced and can usually be stopped.
Adults and the elderly: Take two tablets at bedtime when required.
Children over 12 years: One tablet at bedtime when required.
Should not be used in children or adolescents under the age of 12 years (See Section 4.3).
Not to be used for more than 1 week. Usually it is sufficient to take this medicinal product up to two to three times during that week.
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 pharmacist should be consulted.
See also section 4.4 Special warnings and precautions for use.
4.3 Contraindications
Hypersensitivity to the active ingredient or to any of the excipients.
Not to be used at the same time as other laxatives.
4.4 Special warnings and precautions for use
If there is no bowel movement after three days, a doctor or pharmacist should be consulted.
Do not exceed the stated dose.
Prolonged use may precipitate the onset of an atonic, non-functioning colon.
Prolonged excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.
Patients with kidney disorders should be aware of possible electrolyte imbalance.
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 pod preparation concomitantly.
Like all laxatives, Senna 7.5 mg Tablets 12 Years Plus 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 potential or existing intestinal blockage (ileus).
Long-term use of stimulant laxatives should be avoided, as use for more than a brief period of treatment may lead to impaired function of the intestine and dependence on laxatives. If laxatives are needed every day the cause of the constipation should be investigated. This product should only be used if a therapeutic effect cannot be achieved by a change of diet or the administration of bulk forming agents.
When products containing senna pod preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.
If the symptoms worsen during the use of the medicinal product, a doctor or a pharmacist should be consulted.
Intestinal loss of fluids may promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) Senna 7.5 mg Tablets 12 Years Plus should be discontinued and only be restarted under medical supervision.
Stimulant laxatives including (Senna 7.5 mg Tablets 12 Years Plus) do not help with weight loss. They can cause dehydration. Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage and, in extreme cases, death. A doctor should be consulted if dehydration occurs.
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, 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 lactationPregnancy
The use during pregnancy is contraindicated because of experimental data concerning a genotoxic risk of several anthranoids, e.g. emodin and aloeemodin.
The use during lactation is contraindicated because after administration of anthranoids, active metabolites, such as rhein were excreted in breast milk in small amounts.
Studies on the effects on fertility have not been carried out (see section 5.3).
4.7 Effects on ability to drive and use machines
No studies on the effect on the ability to drive and use machines have been performed.
4.8 Undesirable effects
Hypersensitivity reactions (pruritus, urticaria, local or generalized exanthema) may occur.
This product 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 overdose. In such cases dose reduction is necessary.
Chronic use 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).
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.
If other adverse reactions not mentioned above occur, a doctor or a qualified health care practitioner should be consulted.
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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9 Overdose
4.9 OverdoseThe major symptoms of overdose/abuse are griping pain and severe diarrhoea with consequent losses of fluid and electrolytes, 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 overdoses of anthranoid containing medicinal products may lead to toxic hepatitis.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmaco-therapeutic group: contact laxatives
ATC-code: A 06 AB
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 resulting in accelerated colonic transit.
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 low.
5.3 Preclinical safety data
5.3 Preclinical safety dataThere are no preclinical data available for senna/sennosides or preparations thereof. It can be assumed that data obtained with senna pods can be transferred to senna/sennosides preparations.
In a 90-day rat study, senna pods were administered at dose levels from 100 mg/kg up to 1,500 mg/kg (human equivalence dose of 16–242 mg/kg). The hyperplastic lesions of the forestomach epithelium were reversible as well. 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 fore stomach 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 discolouration 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.
Senna pods, extracts thereof and several hydroxyl anthracene derivatives with the exception of, sennosides, rhein and sennidins, were mutagenic and genotoxic in several in vitro test systems, however for senna and aloe-emodin this was not proven in in vivo systems.
In long term carcinogenicity studies with senna pods effects on kidneys and colon/caecum were reported.
6.1 List of excipients
Magnesium Stearate
Fennel Seed
Croscarmellose Sodium
Calcium Hydrogen Phosphate Dihydrate
Microcrystalline Cellulose
Colloidal Anhydrous Silica
6.2 Incompatibilities
None known.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original container.
6.5 Nature and contents of container
6.5 Nature and contents of containerPVC/ PVdC/ aluminium blister packs of 12, 20, 24, 50, 60 and 100 tablets.
HDPE/LDPE bottles of 24, 50 and 100 tablets.
6.6 Special precautions for disposal Not applicable.