Sennosides 7.5 mg Tablets Adults

For the short term relief of occasional constipation.

For oral use only

Adults and the elderly: Swallow one to two tablets at night.

Should not be used in children or adolescents under the age of 18 years.

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.

The pharmaceutical form must allow lower dosages.

Duration of use

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 the 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.

Hypersensitivity to the active substance or to any of the excipients.

Cases of intestinal obstructions and stenosis, atony, appendicitis, inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis), abdominal pain of unknown origin, severe dehydration state with water and electrolyte depletion.

Not to be used at the same time as other laxatives.

Pregnancy and lactation (see section 4.6 and 5.3).

Do not exceed the stated dose.

Should not be used in children or adolescents under the age of 18 years.

If there is no bowel movement after three days, a doctor or pharmacist should be consulted

Prolonged use may precipitate the onset of an atonic, non-functioning colon.

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.

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. In patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients) Sennosides 7.5 mg Tablets Adults should be discontinued and only be restarted under medical supervision.

Stimulant laxatives (including Sennosides 7.5 mg Tablets Adults) 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.

Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking Sennosides 7.5 mg Tablets Adults concomitantly.

Like all laxatives, Sennosides 7.5 mg Tablets Adults 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).

When products containing senna/sennoside preparations are administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.

Excipient Warning:

This product contains lactose monohydrate. One tablet contains 15.82 mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine

If the symptoms worsen, or persist during the use of the medicinal product, a doctor or a pharmacist should be consulted.

Hypokalaemia (resulting from long-term laxative abuse) potentiates the action of cardiac glycosides and interacts with antiarrhythmic medicinal products. Concomitant use with diuretics, adrenocorticosteroids and liquorice may enhance loss of potassium

The use during pregnancy is contraindicated because of experimental data concerning a genotoxic risk of several anthranoids, e.g. emodin and aloe- emodin.

Lactation

The use during lactation is contraindicated because after administration of anthranoids, active metabolites, such as rhein were excreted in breast milk in small amounts.

Fertility

No fertility data are available (See section 5.3 Preclinical safety data).

No studies on the effect on the ability to drive and use machines have been performed

Hypersensitivity:

Hypersensitivity reactions (pruritis, urticaria, local or generalized exanthema) may occur.

Gastrointestinal disorders:

This product may produce abdominal pain and spasm and diarrhoea (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.

Furthermore, chronic use may cause pigmentation of the intestinal mucosa (pseudomelanosis coli), which usually recedes when the patient stops taking the preparation.

Kidney and urinary tract symptoms:

Long term use may lead to disorders in water equilibrium and electrolyte metabolism and may result in albuminuria and haematuria.

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 (cannot be estimated from the available data).

If other adverse reactions not mentioned above occur, a doctor or pharmacist should be consulted

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

The major symptoms of overdose/abuse are griping pain and severe diarrhoea with consequent losses of fluid and electrolytes. Diarrhoea may especially cause potassium depletion, which may lead to cardiac disorders and muscular asthenia, particularly where cardiac glycosides, diuretics, adrenocorticosteroids or liquorice 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 overdose of anthranoid containing medicinal products may lead to toxic hepatitis.

Pharmacotherapeutic group: Contact laxatives ATC Code: A 06 AB06

1,8-dihydroxyanthracene derivatives possess a laxative effect. The β -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.

The β-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). Aglycones 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.

There 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 of up to 1500 mg/kg (human equivalence dose of 16-242 mg/kg). 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.

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.

Lactose monohydrate

Anhydrous calcium hydrogen phosphate

Maize starch

Magnesium stearate

None Known

36 months

This product does not require any special temperature storage conditions.

Store in the original packaging.

60 tablets packed in PVC/PVDC/ALU foil blisters, contained in a carton

No special requirements