SENNOSIDES 7.5 MG TABLETS 12 YEARS PLUS, CENLAX 7.5 MG TABLETS 12 YEARS PLUS - summary of medicine characteristics

Summary of medicine characteristics - SENNOSIDES 7.5 MG TABLETS 12 YEARS PLUS, CENLAX 7.5 MG TABLETS 12 YEARS PLUS

SUMMARY OF PRODUCT CHARACTERISTICS

NAME OF THE MEDICINAL PRODUCT

CenLax 7.5mg Tablets 12 Years Plus

Sennosides 7.5mg Tablets 12 Years Plus

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains calcium sennosides equivalent to 7.5mg hydroxyanthracene glycosides, calculated as sennoside B.

Excipient(s) with known effect:

Each tablet contains 15.82mg of lactose monohydrate.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablet

Light green to brown colour, round, 8mm, convex shaped uncoated tablet, plain on both sides.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For the short term relief of occasional constipation.

4.2 Posology and method of administration

For oral use

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, the elderly and children over 12 years: Take one to two tablets at night.

Tablets should be swallowed whole with a glass of water.

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

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 a week.

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

Also see 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).

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.

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.

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).

Prolonged and excessive use may lead to fluid and electrolyte imbalance and hypokalaemia. Patients with kidney disorders should be aware of possible electrolyte imbalance.

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

Intestinal loss of fluids may promote dehydration. Symptoms may include thirst and oliguria. In patients suffering from fluid loss where dehydration may be harmful (eg renal insufficiency, elderly patients), CenLax should be discontinued and only be restarted under medical supervision.

When administering this product to incontinent adults, pads should be changed more frequently to prevent extended skin contact with faeces.

Stimulant laxatives (including CenLax) 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.

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

CenLax 7.5mg tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total 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. Concomitant use with other medicinal products inducing hypokalaemia (e.g. diuretics, adrenocorticosteroids and liquorice root) may enhance potassium 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.

Breastfeeding

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

The table below lists the adverse reactions identified through postmarketing surveillance by system organ class and frequency on the other the counter doses. The frequency grouping is defined using the following convention:

Very common (>1/10); Common (> 1/100 to <1/10); Uncommon (>1/1,000 to <1/100); Rare (> 1/10,000 to <1/1,000); Very Rare (< 1/10,000); and Not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

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

MedRA System Organ Class	Frequency	Adverse Reaction
Immune System disorders	Not known	Hypersensitivity, urticaria, asthma
Metabolism and Nutrition disorders	Not known	Hypokalaemia1
Gastrointestinal Disorders	Not known	abdominal pain, abdominal spasm, diarrhoea2 3, gastrointestinal track mucosal ‘ 3 3 3 pigmentation
Skin and Subcutaneous Tissue Disorders	Not known	Pruritus, local or generalised exanthema
Renal and Urinary Disorders	Not known	Chromaturia4

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.

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

Pharmacotherapeutic group: contact laxatives. ATC code: A06 AB06

Mechanism of Action

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 P—O—iinked 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 (anti-absorptive 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 (20mg sennosides), administered orally for 7 days, a maximum concentration of 100ng rhein/ml was found in the blood. An accumulation of rhein was not observed. Active metabolites, eg 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/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). 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 nor 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

Anhydrous calcium hydrogen phosphate

Maize starch

Magnesium stearate

6.2 Incompatibilities

Not applicable

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 packaging.

6.5 Nature and contents of container

PVC/PVDC-Aluminium Blister of 10, 20, 60 and 100 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.