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Dicycloverine hydrochloride with alkalis and simeticone oral

Updated 2 Feb 2023 | Antimuscarinics

Presentation

Oral formulation of dicycloverine hydrochloride, aluminium hydroxide, light magnesium oxide and simeticone.

Drugs List

  • KOLANTICON gel
  • Therapeutic Indications

    Uses

    Dyspepsia
    Flatulent dyspepsia
    Gastritis
    Gastro-intestinal spasm
    Hiatus hernia
    Hyperacidity
    Irritable bowel syndrome
    Oesophagitis
    Peptic ulcer

    Dosage

    Adults

    10ml to 20ml every 4 hours as required.

    Children

    Children aged 12 to 18 years: 10ml to 20ml every 4 hours when required.

    Contraindications

    Children under 12 years
    Acute renal failure
    Benign prostatic hyperplasia
    Chronic renal failure
    Gastrointestinal atony
    Gastrointestinal obstruction
    Glaucoma
    Myasthenia gravis
    Obstructive uropathy
    Paralytic ileus
    Pyloric stenosis
    Severe ulcerative colitis

    Precautions and Warnings

    Low phosphate diet
    Predisposition to glaucoma
    Breastfeeding
    Hiatus hernia
    Pregnancy
    Renal impairment
    Ulcerative colitis

    Contains alcohol
    Risk of aluminium & magnesium accumulation in renal impairment
    Antacids should not be taken at the same time as other drugs
    May affect the absorption of concomitant oral drugs

    Use with caution in patients with hiatus hernia associated with reflux oesophagitis because anticholinergic drugs may aggravate this condition.

    In patients with renal impairment, magnesium salts may cause hypermagnesaemia. Signs of hypermagnesaemia include respiratory depression and loss of deep tendon reflexes due to neuromuscular blockade.

    Aluminium hydroxide in patients with low phosphate diets may lead to phosphate deficiency accompanied by increased bone resorption and hypercalciuria with the risk of osteomalacia.

    Aluminium hydroxide may be unsafe in patients with porphyria undergoing haemodialysis.

    It has been reported that ascorbic acid may enhance aluminium absorption.

    Pregnancy and Lactation

    Pregnancy

    Use dicycloverine hydrochloride with alkalis and simeticone as a combined product with caution during pregnancy.

    The manufacturer advises that dicycloverine hydrochloride with alkalis and simeticone as a combined product should only be used during pregnancy if treatment is clearly necessary.

    Available data following use of dicycloverine hydrochloride in human pregnancy (at doses up to 40mg/day) does not indicate an increased risk of foetal abnormalities if administered during the first trimester of pregnancy.

    At the time of writing there is no published data regarding the use of aluminium hydroxide, magnesium oxide and simeticone on exposed pregnancies. Potential risks are unknown.

    Lactation

    Use dicycloverine hydrochloride with alkalis and simeticone as a combined product with caution during breastfeeding.

    The manufacturer advises caution if dicycloverine is used when breastfeeding as it is not known if it is secreted in human milk.

    Available data indicates small amounts of magnesium is expressed in human milk, however any increase in magnesium load to a breast-fed infant is considered unlikely to significantly alter magnesium clearance from the neonate.

    Side Effects

    Blurred vision
    Constipation
    Decrease in serum phosphate
    Dry mouth
    Glaucoma (closed angle)
    Hypercalciuria
    Hypermagnesaemia
    Increased bone resorption
    Osteomalacia
    Urinary retention

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: May 2020

    Reference Sources

    Summary of Product Characteristics: Kolanticon Gel. Peckforton Pharmaceuticals. Revised February 2020.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 12 May 2020.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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