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1. Potters Cleansing Herb Tablets
2. Potters Cleansing Herb Tablets

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Cleansing Herb Tablets Senokot Dual Relief Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains: -

100 mg Senna Leaf Tinnevelly (Cassia angustifolia Vahl)

45 mg Cape Aloes (Aloe ferox Mill)

30 mg Cascara Bark (Rhamnuspurshianus D.C.)

30 mg Dandelion Root (Taraxacum officinale F.H. Wigg)

15 mg Fennel Fruit (Foeniculum vulgare var. dulce Miller)

Excipient(s):

Each tablet contains 100 mg of sucrose.(See section 4.4 Special warnings and precautions for use.)

For full list of excipients see Section 6.1.

3 PHARMACEUTICAL FORM

Tablet.

A brownish olive-green round biconvex tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the short-term relief of occasional constipation and bloating, based on traditional use only.

4.2 Posology and method of administration

For oral use.

Adults, the elderly: Take one or two tablets at bedtime when necessary.

Not recommended for use in children and adolescents underr 18 years of age (see section 4.3 Contraindications).

Duration of use:

Use for more than 1 - 2 weeks requires medical supervision.

If there is no bowel movement after three days a doctor should be consulted.

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

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

Known hypersensitivity to any of the active substances or to Apiaceae (Umbelliferae) (aniseed, caraway, celery, coriander and dill), anethole or to plants of the Asteraceae (Compositae) family.

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.

Obstructions of bile ducts, cholangitis, liver diseases, gallstones, active peptic ulcer and any other biliary diseases.

Children and adolescents under 18 years.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

This product contains sucrose. One tablet contains 100 mg of sucrose.

Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency should not take this medicine.

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

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.

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

Patients with kidney disorders should be aware of possible electrolyte imbalance.

The use in patients with renal failure and/or diabetes, and/or heart failure should be avoided because of possible risks due to hyperkalemia.

The use in children and adolescents under 18 years of age is not recommended due to lack of adequate data.

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 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

There are no reports of undesirable or damaging effects during pregnancy and on the foetus when used at the recommended dosage.

Experimental data show a genotoxic risk of several anthranoids, e.g. aloe-emodin, emodin, frangulin, chrysophanol and physcion, use is not recommended during pregnancy.

Lactation

There are no data on the use of the product during lactation.

Use during breastfeeding is not recommended as there are insufficient data on the excretion of metabolites in breast milk.

After administration of other anthranoids, active metabolites, such as rhein, are excreted in breast milk in small amounts. A laxative effect in breast fed babies has not been reported.

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

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

Hypersensitivity reactions (pruritis, urticaria, local or generalized exanthema) may occur. Allergic reactions to fennel, affecting the skin or the respiratory system, may occur.

This product may produce abdominal pain and spasm and passage of liquid stools, in particular in patients with irritable colon. However, these symptoms may also occur generally as a consequence of individual overdose. In such cases dose reduction is necessary.

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.

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

Epigastric pain and hyperacidity may occur.

The frequency of the undesirable effects is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9 Overdose

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 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

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and on carcinogenicity have not been performed.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium Hydrogen Phosphate

Sucrose

Talc

Magnesium Stearate Sodium Starch Glycolate type A

6.2 Incompatibilities

Not applicable.

Shelf life

Three years.