Magnesium Hydroxide/ Aluminium Hydroxide/ Simeticone

Registered South African indications:

• Flatulence
• Dyspepsia
• Heartburn
• Hyperacidity
• Gastritis
• Oesophageal reflux 
• Peptic ulceration

Contraindications

• Hypersensitivity to the active ingredient or any of the excipients in this combination product
• Renal impairment
• Severely debilitated patients
• Hypophosphataemia
• Fructose intolerance
• Glucose-galactose malabsorption (tab)
• Sucrase-isomaltase insufficiency (tab)

Cautions

• Pregnancy
• Hepatic impairment
• Elderly
• Risk of phosphate depletion
• Low-phosphorous diets
• Patients with porphyria undergoing hemodialysis
• Diabetes mellitus (tab)

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

Flatulence
Dyspepsia
Heartburn
Hyperacidity
Gastritis
Oesophageal reflux
Peptic ulceration

Magnesium Hydroxide/ Aluminium Hydroxide/ Simeticone
200/200/25 (mg)

• Oral (tab): 2-4 tab, 8hrly; Max: 16 tab/24hrs
  OR
• Oral (tab): 1-2 tab, 6hrly

Should be administered 20 minutes to 1 hour after meals and/or at bedtime. Can be administered as required depending on indication 

Tablets are to be well chewed

Magnesium Hydroxide/ Aluminium Hydroxide/ Simeticone
200/225/25 (mg/5ml)

• Oral (sus): 10-20ml, 8hrly; Max: 80ml/24hrs
  OR
• Oral (sus): 5-10ml, 8hrly 

Should be administered 20 minutes to 1 hour after meals and/or at bedtime. Can be administered as required depending on indication

Bottle must be shaken before use

Not established for use in children below 12 years

Pregnancy

• Caution
• Safety in pregnancy has not been established

Breastfeeding

• Compatible
• Because of the limited maternal absorption when used as recommended, minimal amounts, if any, of aluminium hydroxide and magnesium salt combinations are expected to be excreted into breastmilk
• Simeticone is not absorbed from the gastrointestinal tract. No effect on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to aluminium hydroxide, magnesium hydroxide and simeticone is negligible

Renal Impairment

• Contraindicated 

Hepatic Impairment

• Caution; no information available

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warning

Central Nervous System

• Drowsiness
• Confusion
• Loss of reflexes
• Coma

Cardiovascular Disorders

• Hypotension
• Cardiac dysrhythmias
• Cardiac arrest

Gastrointestinal Disorders

• Diarrhoea
• Constipation
• Abdominal pain

Genitourinary Disorders

• Hypercalciuria

Endocrine and Metabolic Disorders

• Hypermagnesemia
• Hyperaluminemia
• Hypophosphatemia
• Thirst

Musculoskeletal Disorders

• Increased bone resorption
• Osteomalacia
• Muscle weakness

Skin and Subcutaneous Tissue Disorders

• Pruritus
• Urticaria 
• Angioedema
• Flushing

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity reactions
• Anaphylactic reactions

• Tetracyclines
• Vitamins
• Ketoconazole
• Hydroxychloroquine
• Chloroquine
• Chlorpromazine
• Rifampicin
• Cefdinir
• Cefpodoxime
• Levothyroxine
• Rosuvastatin
• Polystyrene sulphonate
• Salicylates
• Citrates
• Quinidine
• H2 antagonists
• Atenolol
• Diflunisal
• Digoxin
• Biphosphonates
• Ethambutol
• Fluoroquinolones
• Ciprofloxacin
• Glucocorticoids
• Indomethacin
• Isoniazid
• Lincosamides
• Metoprolol
• Phenothiazine
• Neuroleptics
• Penicillamine  
• Propranolol
• Iron salts

None routine

Coadministration with medicines

• Magnesium hydroxide/ aluminium hydroxide/ simeticone should not be taken simultaneously with other medicines as it may interfere with their absorption if taken within one hour

Magnesium hydroxide/ aluminium hydroxide/ simeticone is a balanced mixture of magnesium hydroxide (a fast acting antacid), aluminium hydroxide (a slow acting antacid) and simeticone (an antiflatulent/antifoaming agent).

Magnesium Hydroxide/ Aluminium Hydroxide/ Simeticone 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

COMBINATION PREPARATIONS

Aluminium Hydroxide/ Magnesium Hydroxide/ Simeticone

Tablet 200mg/200mg/20mg

• Gelusil-s (Pharma Dynamics)

Tablet 200mg/200mg/25mg

• Maalox Plus (Sanofi)

Suspension (per 5ml) 225mg/200mg/25mg

• Maalox Plus (Sanofi)