Senna - Senna Alexandrina

What is it used for?

• [(Traditionally) used in Herbal Medicine as a] stimulant laxative [Source note 1].

• (Used in Herbal Medicine for the) short-term relief of occasional constipation (EMA 2018a,b; Mills and Bone 2005; ESCOP 2003; WHO 1999).

• (Used in Herbal Medicine to) promote(s) bowel movement (by direct action on the large intestine) [Source note 2].

• The above uses can be combined on the product label if from the same traditional or non-traditional system of medicine (e.g. Used in Herbal Medicine as a stimulant laxative for short-term relief of occasional constipation).

• For multi-ingredient products

  • To prevent the product from being represented as a "traditional medicine", any indicated traditional use claim must refer to the specific active ingredient(s) and recognized traditional system of medicine from which the claim originates when 1) both traditional and modern claims are present or 2) when claims originate from multiple systems of traditional medicine (e.g. Senna is traditionally used in Herbal Medicine as a stimulant laxative).

  • When ALL of the active ingredients (MIs) in the product are used within the SAME identified system of traditional medicine AND the product makes ONLY traditional claims, listing of MIs in the traditional claim(s) is not required

Who does this guide cover?

Adolescents 12-17 years and Adults 18 years and older [Source note 3]

How is it taken?

Oral

Which forms are covered?

this reference excludes foods or food-like dosage forms as indicated in the Compendium of references Guidance Document.

Quantities

Methods of preparation: Dry, Powdered, Non-Standardized Extracts (Dry extract, Tincture, Fluid extract, Decoction, Decoction concentrate, Infusion, Infusion concentrate)

0.5 - 3 grams of dried fruit and/or leaf, per day; and providing at least 0.5 g of dried fruit and/or leaf per single dose [Source note 4].

Methods of preparation: Standardized extracts (Dry extract, Tincture, Fluid extract, Decoction, Decoction concentrate, Infusion, Infusion concentrate)

15 - 30 milligrams of sennoside B (i.e. hydroxyanthracene derivatives calculated as sennoside B), per day; and providing at least 15 mg of sennoside B (i.e. hydroxyanthracene derivatives calculated as sennoside B) per single dose (EMA 2018a,b; Mills and Bone 2005).

How is it used?

• Start with 1 dose, 2 to 3 times per week and increase up to once daily if results are not observed (EMA 2018a,b; ESCOP 2003; WHO 1999).

• Take a few hours before or after taking other medications or health products [Source note 5].

• Allow at least 6 to 12 hours for laxative effect to occur (EMA 2018a,b; Berardi et al. 2002).

• Stimulant laxatives should only be used if occasional constipation cannot be improved by a change of diet or the administration of bulk forming laxatives (EMA 2018a,b).

Optional (for products which provide a dosage range)

The optimal dosage is the smallest dose required to produce a soft-formed stool (EMA 2018a,b; ESCOP 2003; Blumenthal et al. 2000; WHO 1999).

How long is it used?

Ask a healthcare professional for use beyond 7 days [Source note 6].

Warnings and precautions

• Ask a healthcare professional if symptoms persist or worsen.

• Ask a healthcare professional before use if you have a kidney disorder or a lazy bowel (EMA 2018a,b; Brinker 2010; Blumenthal et al. 2000; WHO 1999).

• Ask a healthcare professional before use if you are taking heart medications, corticosteroids, diuretics, or other health products that may contribute to electrolyte imbalance (EMA 2018a,b; Brinker 2010; Blumenthal et al. 2000; WHO 1999).

When should it be avoided?

• Do not use if you are pregnant or breastfeeding (EMA 2018a,b; Brinker 2010; Blumenthal et al. 2000).

• Do not use if you have inflammatory bowel disease, fever or any undiagnosed gastrointestinal trouble (EMA 2018a,b; Gardner and McGuffin 2013; Brinker 2010; WHO 1999).

Possible side effects

Stop use if hypersensitivity/allergy or diarrhoea occurs (EMA 2018a,b; Blumenthal et al. 2000; WHO 1999).

Storage

Must be established in accordance with the requirements described in the applicable product regulations.