Methixene Hydrochloride/ Dimethylpolysiloxane/ Cellulase/ Pepsin/ Glutamic Acid Hydrochloride/ Pancreatin/ Sodium Dehydrocholate

Registered South African indications:

• Abdominal cramps

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Untreated prostatic hypertrophy
• Severe intestinal atony
• Narrow-angle glaucoma

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly

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

Abdominal cramps associated with flatulence

Methixene hydrochloride/ Dimethylpolysiloxane/ Cellulase/ Pepsin/ Glutamic Acid Hydrochloride/ Pancreatin/ Sodium Dehydrocholate
1/40/600U/200/100/200/20 (mg)

• Oral (tab): 1-2 tabs, just before or with meals

Not established for use in children below 12 years

Recommendations for this combination product as per highest risk category when comparing individual active ingredients

Pregnancy

• Caution

Breastfeeding

• Caution; no information available (Methixene Hydrochloride)

Renal Impairment

• Caution; dose adjustment recommended (Methixene Hydrochloride)

Hepatic Impairment

• Caution; dose adjustment recommended (Methixene Hydrochloride)

Elderly

• Caution; no dose adjustment recommended (Methixene Hydrochloride)

Drugs in Sport

• Permitted - No warnings

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Methixene hydrochloride
Central Nervous System Disorders

• Drowsiness
• Sedation
• Confusion
• Hallucinations
• Memory disorders 
• Concentration disorders
• Motor incoordination
• Tremors
• Vertigo
• Restlessness
• Nervousness
• Insomnia

Cardiovascular Disorders

• Palpitations
• Hypotension 

Gastrointestinal Disorders

• Dry mouth
• Constipation

Genitourinary Disorders

• Urinary retention

Skin and Subcutaneous Tissue Disorders

• Rash
• Erythema
• Eczema
• Purpura
• Urticaria

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis 
• Angioedema 
• Decreased white blood cells
• Decreased platelets

Sensory Disorders

• Visual disorders

Dimethylpolysiloxane

• No information available

Pancreatin
Gastrointestinal Disorders 

• Abdominal pain
• Nausea and vomiting
• Constipation
• Abdominal distention
• Diarrhoea
• Strictures of the ileo-caecum and large bowel (fibrosing colonopathy) 

Skin and Subcutaneous Tissue Disorders 

• Rash
• Pruritus
• Urticaria

Immune, Blood and Lymphatic System Disorders 

• Hypersensitivity 
• Anaphylactic reactions

Combination products may have additional pharmacological effects not accounted for by the action of the individual ingredients

Methixene hydrochloride

• Alcohol
• Expectorants
• Mucolytic agents

Dimethylpolysiloxane

• No information available

Pancreatin

• No information available

None routine

Methixene Hydrochloride
Methixene hydrochloride is a histamine antagonist at the histamine-1 receptor. It is also a muscarinic cholinergic antagonist.

Dimethylpolysiloxane
Dimethylpolysiloxane acts by decreasing the surface tension in gas bubbles. In this way it prevents gas build-up in the gastrointestinal system.

Cellulase
This ingredient has no pharmacological effect.

Pepsin
This ingredient has no pharmacological effect.

Glutamic Acid Hydrochloride
This ingredient has no pharmacological effect.

Pancreatin
Pancreatin substitutes pancreatic enzymes if they are deficient. The capsules dissolve rapidly in the stomach releasing the enzyme in minimicrospheres. When the minimicrospheres reach the small intestine the coating rapidly disintegrates to release enzymes with lipolytic, amylolytic and proteolytic activity to ensure the digestion of fats, starches and proteins. The products of pancreatic digestion are then either absorbed directly, or absorbed following further hydrolysis by intestinal enzymes.

Sodium Dehydrocholate
This ingredient has no pharmacological effect.

COMBINATIONS PREPARATIONS

Methixene hydrochloride/ Dimethylpolysiloxane/ Cellulase/ Pepsin/ Glutamic acid hydrochloride/ Pancreatin/ Sodium dehydrocholate

Tablet 1mg/40mg/600U/200mg/100mg/200mg/20mg

• Spasmo-Canulase (GSK) originator