Diosmectite

Registered South African indications:

• Treatment of acute diarrhoea, in addition to oral rehydration
• Symptomatic treatment of chronic functional diarrhoea
• Symptomatic treatment of pain associated with functional bowel diseases

Registered South African contraindications

• Hypersensitivity to the active ingredient or any of its excipients

South African recommendations

Caution in the following patient groups

• Pregnancy
• Breastfeeding mothers
• Renal impairment
• Hepatic impairment
• Elderly
• Use diosmectite cautiously in patients with a history of severe chronic constipation
• Avoid use in infants and children under 2 years old. For acute diarrhoea, the preferred treatment is oral rehydration solution (ORS)

Children above 2 years

• In cases of acute diarrhoea, use in conjunction with oral rehydration solution (ORS) to prevent dehydration
• Avoid chronic use of diosmectite

Adults and rehydration

• Rehydration may be necessary, either orally through ORS or intravenously
• The volume of rehydration should match the severity of diarrhoea, considering the patient's age and specific needs

Patient precautions

• Patients should rehydrate with adequate salty or sweet fluids to compensate for the fluid loss from diarrhoea. Adults typically require 2 litres of water daily
• Maintain food intake during diarrhoea, avoiding certain foods like raw vegetables, fruits, green vegetables, spicy dishes, and frozen foods or drinks
• Recommend grilled meats and rice

Hypersensitivity reactions

• Be aware of potential hypersensitivity reactions, such as rashes, hives, itching, and angioedema, in patients treated with diosmectite

Glucose content

• Contains glucose; not suitable for patients with rare hereditary glucose-galactose malabsorption

Propylene glycol content

• Each sachet of diosmectite includes 0.128mg of propylene glycol (E1520)
• The total daily intake amounts to 0.512mg if the maximum recommended dosage of 4 sachets per day is consumed

Absorption interference

• Diosmectite's absorbent properties may affect the absorption time and/or rate of other medicines. Administer other medicines at least two hours before diosmectite administration

Effects on ability to drive and use machines

• No studies have been conducted on the impact of this medicine on the ability to drive or operate machinery
• It is anticipated that this medicine has a negligible or no effect on these activities

Forms avail. in SA and covered in this monograph: pdr

South African registered indications and dosages

Treatment of acute diarrhoea, in addition to oral rehydration

• Oral (pdr): 9g (3 sachets), daily: Treatment duration: 7 days

Symptomatic treatment of chronic functional diarrhoea
Symptomatic treatment of pain associated with functional bowel diseases

• Oral (pdr): 9g (3 sachets), daily

The contents of the sachet must be mixed in suspension, just before use. The contents of the sachet can be mixed into half a glass of water

Paed. forms avail. in SA and covered in this monograph: pdr

South African registered indications and dosages

Treatment of acute diarrhoea, in addition to oral rehydration

Oral (pdr)

• Younger than 2 years: Avoid use
• 2 years and older: 12g (4 sachets), daily for 3 days; Then: 6g (2 sachets), daily for 4 days

In infants and children below 2 years, the use of diosmectite should be avoided. The reference treatment in acute diarrhoea is oral rehydration solution (ORS)

In children above 2 years, acute diarrhoea must be treated in conjunction with early administration of an oral rehydration solution (ORS), to avoid dehydration. The chronic use of diosmectite should be avoided

The contents of the sachet can be mixed in a feeding bottle of 50ml of water to be given at intervals during the day, or mixed with semi-liquid food, such as broth, compote, puree, baby food

Pregnancy 

South African recommendations

• Caution; not recommended
• There is limited data (less than 300 pregnancies) on the use of diosmectite in pregnant women. Studies in animals are insufficient to conclude on reproductive toxicity. Diosmectite is not recommended during pregnancy

Breastfeeding

South African recommendations

• Caution; not recommended
• There is limited data on the use of diosmectite during breastfeeding. Diosmectite is not recommended during breastfeeding

Fertility

South African recommendations

• The effect on fertility in humans has not been studied

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

South African recommendations

• Caution; no information available

Gastrointestinal Disorders

• Constipation
• Flatulence
• Vomiting

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Rash
• Pruritus
• Angioedema

Immune, Blood and Lymphatic System Disorders

• Allergic reactions

No information available

None routine

Diosmectite is insoluble in water and is used as an intestinal absorbent. 

Diosmectite is available in several formulations. Please note the list below gives examples of products which are available and is not necessarily comprehensive. The listing of a product does not constitute endorsement of the product by EMGuidance; likewise, failure to list a product does not imply that EMGuidance disapproves of the product. This information is put together on the basis of the National Government's Medicines Price Registry at the time of publication

Powder (per sachet) 3g

• Smecta (Pharmaplan)

Powder (per sachet) 3g

• Smecta strawberry (Pharmaplan)