Senease Twelve Years Plus 7.5 mg Tablets – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Senease Twelve Years Plus 7.5 mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each uncoated tablet contains sennosides (as calcium salts) equivalent to

7.5mg hydroxyanthracene glycosides, calculated as Sennoside B.

Each tablet also contains 16 mg lactose monohydrate

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Tablets

Light green to brown colour, round convex shaped uncoated tablet approx.

8.00 mm, plain on both sides.

4.1 Therapeutic indications

For the short-term relief of occasional constipation.

4.2 Posology and method of administration

For oral administration.

Posology:

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.

The maximum daily dose must not exceed 15mg sennosides.

Should not be used in children 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.

Use for more than 1 week requires medical supervision.

If the symptoms persist or worsen 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

Children under 12 years of age.

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

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 laxative agent

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 if 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.

Do not exceed the stated dose.

Should not be used in children under the age of 12 years

Like all laxatives, this product should not be taken by patients suffering from faecal impaction and undiagnosed, acute or persistent gastrointestinal 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.
• Patients taking cardiac glycosides, antiarrhythmic medicinal products, medicinal products inducing QT-prolongation, diuretics, adrenocorticosteroids or liquorice root, have to consult a doctor before taking this product concomitantly.
• Prolonged use may precipitate the onset of an atonic, non-functioning colon.
• 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) this product should be discontinued and only be restarted under medical supervision.

• When products containing senna/sennoside preparations are

  administered to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.

• Stimulant laxatives (including this product) do not help with weight loss.
• 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.

Excipient Warning:

This product contains lactose monohydrate. One tablet contains 16 mg lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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 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).

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 shortterm 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.

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.

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

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 balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme Website:

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmaco-therapeutic group: contact laxatives

ATC-code: A06 AB06

The sugar moiety of the sennosides is removed by bacteria in the large intestine releasing the active anthrone fraction. This stimulates peristalsis via the submucosal and myenteric nerve plexuses.

1,8-dihydroxyanthracene derivatives possess a laxative effect. The β-Ο-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. 1. stimulation of the motility of the large intestine resulting in accelerated colonic transit.
2. 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 metabolism into the active compound.

5.2 Pharmacokinetic properties

The action of the sennosides is colon specific and does not depend upon systemic absorption.

The β-Ο-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

There are no preclinical data available for senna leaves or preparations thereof. It can be assumed that data obtained with senna pods can be transferred to senna leaf 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 (except 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 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose

monohydrate

Maize starch

Calcium hydrogen phosphate

Magnesium stearate

6.2 Incompatibilities

None known

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

60 and 100 tablets packed in PVC/PVDC/foil blisters, contained in a carton.

100 tablets in a HDPE Container.

6.6 Special precautions for disposal

Not applicable

7 MARKETING AUTHORISATION HOLDER

Special Concept Development (UK) Limited T/A RxFarma,

Colonial Way,

Watford, Hertfordshire,

WD24 4YR, United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 36722/0083

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

18/06/2025

10 DATE OF REVISION OF THE TEXT

15/01/2026