Summary of Product Characteristics (SmPC) - Senease Twelve Years Plus 7.5 mg/5 ml syrup
1 NAME OF THE MEDICINAL PRODUCT
Senease Twelve Years Plus 7.5mg/5ml Syrup
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 ml of oral syrup contains sennosides, as calcium salts, equivalent to 7.5 mg hydroxyanthracene glycosides, calculated as sennoside B.
Each 5 ml of oral syrup contains 1650 mg maltitol syrup (E965), 8 mg methyl parahydroxybenzoate (E218), and 0.6 mg propyl parahydroxybenzoate (E216).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Syrup
Amber colour homogeneous syrupy clear liquid without sedimentation.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For 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: one to two 5 ml spoonfuls at night.
A higher dose may be prescribed under medical guidance. The maximum recommended daily dose of hydroxyanthracene glycosides is 30 mg (20ml). 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, to the maximum dose for each age group, if necessary, by one half of the initial dose each day. Once regularity has been regained the dosage should be reduced and can usually be stopped.
If no bowel action has occurred after three days a doctor or pharmacist should be consulted.
Duration of use
Not to be used for more than one week.
Normally it is sufficient to take this medicinal product up to two to three times during that week. 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
Hypersensitivity to the active substance or to any of the excipients. Not to be used the same time as other laxative agents.
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 state with water and electrolyte depletion.
Pregnancy and lactation (see section 4.6 and 5.3) Children under 12 years of age
4.4 Special warnings and precautions for use
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.
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.
Contains maltitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Each 5 ml of syrup can provide up to 3.2 kcal and this should be taken into account in patients with diabetes mellitus.
Methyl and propyl parahydroxybenzoate may cause allergic reactions (possibly delayed).
This medicine contains 0.09 mmol (or 3.51 mg) potassium per 5 ml. To be taken into consideration by patients with reduced kidney function or patients on a controlled potassium diet.
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 this product concomitantly.
Like all laxatives, this product 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).
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. 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 and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia.
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.
Patients with kidney disorders should be aware of possible electrolyte imbalance.
When administering this product to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.
Stimulant laxatives (including Senease 7.5mg/5ml Syrup Twelve Years Plus) do not help in long-term 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.
If the symptoms worsen during the use of the medicinal product, a doctor or a pharmacist should be consulted.
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, are excreted in breast milk in small amounts.
Fertility
There is no data on the effects of the product on fertility. (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
Adverse events which have been associated with sennosides 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 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
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: stimulant laxatives ATC-code: A 06 AB
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. 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 junction and stimulation of secretion of water and electrolytes into the lumen of the colon (secretagogue effect) resulting in enhanced concentration of fluid and electrlytes 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). 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.
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-effectlevel (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
Xanthan gum
Liquid maltitol (E965)
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Potassium sorbate
Simeticone
Citric acid monohydrate
Mixed fruit flavour
Purified water
6.2 Incompatibilities
Not applicable
6.3 Shelf life
Unopened: 36 Months
Opened: 6 Months
6.4 Special precautions for storage
Store in the original container.
Do not refrigerate or freeze.
In-use storage conditions: Do not refrigerate or freeze.
6.5 Nature and contents of container
Amber coloured glass bottle with a white opaque polypropylene child-resistant cap containing 100 ml or 150ml or 200 ml or 500 ml syrup along with a 5 ml CE marked measuring spoon.
Not all pack sizes may be marketed
6.6 Special precautions for disposal
No special requirements
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 36722/0130
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
20/03/2023
10 DATE OF REVISION OF THE TEXT
18/12/2025