4.1. Therapeutic indications

For the short-term relief of occasional constipation

4.2. Posology and method of administration

For oral administration.

The correct individual dose is the smallest required to produce a comfortable soft-formed motion.

Adults, the elderly and children over 12 years: Swallow one to two tablets at night

Should not be used in children or adolescents under the age of 12 years (see section 4.3).

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.

If no bowel action has occurred after three days of progressively increased dosage, a medical examination should be considered.

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.

4.3. Contraindications

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

Not to be used at the same time as other laxative agents.

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

Children under 12 years of age.

Pregnancy and lactation (see section 4.6 and 5.3).

4.4. Special warnings and precautions for use

If the symptoms worsen during the use of the medicinal product or there is no bowel movement after three days, a doctor or pharmacist should be consulted.

If laxatives are needed every day, or abdominal pain persists, a doctor should be consulted.

If laxatives are needed every day the cause of the constipation should be investigated. Long-term use of laxatives should be avoided.

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

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 leaf preparations concomitantly.

Like all laxatives, Senokot 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. 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.

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) Senokot should be discontinued and only be restarted under medical supervision.

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

Stimulant laxatives (including Senokot) do not help with weight loss.

The leaflet will state:

“Before you take this medicine” section

Does this help with weight loss?

Stimulant laxatives (including Senokot) do not help with weight loss. They do not reduce the absorption of calories or nutrients. They can cause watery stools (diarrhoea), abdominal cramps and dehydration. Dehydration can seem like weight loss.

Overuse of laxatives may damage your health by:

• Causing disturbances of electrolyte and mineral balances. Sodium, potassium, magnesium, and phosphorus are electrolytes and minerals that are present in very specific amounts necessary for proper functioning of the nerves and muscles, including those of the colon and heart. Upsetting this delicate balance can cause incorrect functioning of these vital organs.

• Severe dehydration may cause tremors, weakness, blurry vision, fainting, kidney damage, and, in extreme cases, death. Dehydration often requires medical treatment.

• Overuse of laxatives can cause the colon to stop reacting to usual doses of laxatives so that larger and larger amounts of laxatives may be needed to produce bowel movements.

• Laxative dependency occurs from overuse.

The label will state:

Front of pack:

• Does not help with weight loss.

• Overuse can be harmful.

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

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 reast milk in small amounts.

Fertility

There are no data on the effects of the product on fertility.

4.7. Effects on ability to drive and use machines

None known

4.8. Undesirable effects

Adverse events which have been associated with senna at OTC doses in short-term use are given below, tabulated by system organ class and frequency.

In the treatment of chronic condition, under long-term treatment, additional adverse effects may occur.

Adverse events table

System Organ Class

Frequency

Adverse Events

Immune System Disorders

Not known

Hypersensitivity, urticaria, asthma, hypogammaglobulinaemia

Metabolism and Nutrition Disorders

Not known

Hypokalaemia1, cachexia

Gastrointestinal Disorders

Not known

Abdominal pain2, abdominal spasm2, diarrhoea2, gastrointestinal tract mucosal pigmentation3

Skin and Subcutaneous Tissue Disorders

Not known

Pruritus, local or generalised exanthema

Musculoskeletal and Connective Tissue Disorders

Not known

Finger clubbing, tetany and hypertrophic osteoarthropathy

Renal and Urinary Disorders

Not known

Chromaturia4

Description of Selected Adverse Reactions

1 Prolonged use of laxatives resulting in diarrhoea and subsequently hypokalaemia.

2 in particular in patients with irritable colon. Symptoms may also occur generally as a consequence of individual overdosage. In such cases dose reduction is necessary.

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

4 Yellow or red-brown (pH dependent) discolouration of urine by metabolites, which is not clinically significant, may occur during the treatment.

Chronic use may lead to disorders in water equilibrium and electrolyte metabolism and may result in albuminuria and haematuria.'

The frequency is not known (cannot be estimated from the available data).

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner 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 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

Symptoms

Where diarrhoea is severe, conservative measures are usually sufficient; generous amounts of fluid, especially fruit drinks, should be given.

The 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

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.