Registered Zambia · ZAMRA

Colicspam Oral Drops

Dicyclomine Hydrochloride 10 mg,Simethicone 40 mg

149/084 Oral Suspension 10 mg,40 mg alimentary tract and metabolism INN generic

What it does

Dicyclomine is a medication that helps relieve muscle spasms in the stomach and intestines.

Commonly used for: irritable bowel syndrome (IBS), stomach cramps, intestinal spasms

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
149/084
Registration date
2026-09-10
Expiry date
2031-09-09
Status
Registered/Compliant
Active ingredient
Dicyclomine Hydrochloride 10 mg,Simethicone 40 mg
Dosage form
Oral Suspension
Strength
10 mg,40 mg
Pack size
-
Therapeutic class
-
ATC class (WHO)
A03AA - Synthetic anticholinergics, esters with tertiary amino group
RxNorm RxCUI
3361
Manufacturer / MAH
Leben Laboratories Pvt Ltd
Country of origin
India
Manufacturer location
M3P7+C4H, Midc Phase 3 and 4, MIDC, Shivar, Maharashtra 444104, India

Source: Zambia Medicines Regulatory Authority · fetched 2026-09-14 03:40:21 · updated 2026-09-17 03:40:28

Disclaimer: This information is sourced from Zambia Medicines Regulatory Authority (Zambia). Always consult a qualified healthcare professional before using any medication.

About dicyclomine

Dicyclomine is a medication that helps relieve muscle spasms in the stomach and intestines.

What it treats

  • irritable bowel syndrome (IBS)
  • stomach cramps
  • intestinal spasms

How it works

It works by relaxing the muscles in the gut, which helps to ease pain and discomfort.

Who it's for

It is for adults and children who experience stomach or intestinal cramps.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About simethicone

Simethicone is a medicine that helps relieve discomfort caused by gas in the stomach and intestines.

What it treats

  • bloating
  • gas pain
  • flatulence

How it works

Simethicone works by breaking up gas bubbles in the stomach and intestines, making it easier for the body to eliminate them.

Who it's for

This medicine is suitable for adults and children experiencing gas-related discomfort.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: dicyclomine

BNF-referenced

Dicyclomine is an anticholinergic medication primarily used to treat functional gastrointestinal disorders, particularly irritable bowel syndrome (IBS). It works by relaxing the smooth muscles in the gastrointestinal tract, thereby reducing spasms and discomfort associated with digestive issues. Dicyclomine is often administered orally or via intramuscular injection, and is known for its relatively short duration of action, necessitating multiple daily doses.

Indications

  • Irritable bowel syndrome
  • Functional gastrointestinal disorders
  • Spasm of the gastrointestinal tract

Dosage

Children: Refer to the BNF for Children for appropriate pediatric dosing guidelines.

Adults: Typically, dicyclomine is administered in doses of 20-40 mg orally, taken 4 times daily, or 10-20 mg by intramuscular injection. Dicyclomine should not be given intravenously.

Mechanism of action

Dicyclomine exerts its effects through direct antimuscarinic activity at M1, M2, and M3 receptors, along with non-competitive antagonism of bradykinin and histamine. This results in a relaxation of smooth muscle, particularly in the ileum, leading to decreased contractions and alleviation of spasms. Its major action is a non-specific direct relaxant effect on smooth muscle rather than a competitive antagonism of acetylcholine.

Pharmacodynamics

Dicyclomine is classified as an anticholinergic drug, which is effective in relaxing smooth muscle in the intestines. Its onset of action provides symptomatic relief in conditions characterized by gastrointestinal spasm and discomfort. The drug is typically dosed multiple times throughout the day, reflecting its moderate duration of action.

Pharmacokinetics

Dicyclomine is absorbed after oral administration, with peak plasma concentrations usually occurring within 1 to 2 hours. It undergoes hepatic metabolism, and its metabolites are excreted primarily in the urine. The half-life of dicyclomine varies but is generally around 1-2 hours, which supports the need for multiple daily dosing.

Contra-indications

  • Glaucoma
  • Myasthenia gravis
  • Severe ulcerative colitis
  • Obstructive uropathy
  • Severe hepatic impairment

Adverse effects

  • Dry mouth
  • Dizziness
  • Drowsiness
  • Nausea
  • Constipation
  • Blurred vision
  • Tachycardia

Interactions

  • Other anticholinergic drugs may increase the risk of side effects
  • CNS depressants may enhance drowsiness
  • Antacids may affect absorption

Precautions

  • Use with caution in patients with urinary retention
  • May exacerbate existing gastrointestinal obstruction
  • Caution in elderly patients due to increased sensitivity to anticholinergics
  • Monitor for signs of overdose, especially in children

Pregnancy

Dicyclomine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Consult healthcare professionals for guidance.

Breast-feeding

Dicyclomine may pass into breast milk. Caution is advised when administered to nursing women.

Storage

Store at room temperature, away from moisture and heat. Keep out of reach of children.

Formulations

  • Oral tablet (20 mg, 40 mg)
  • Injectable solution (10 mg/2 mL, 20 mg/2 mL)

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: simethicone

BNF-referenced

Simethicone is a medication that functions as an antifoaming agent, primarily used to relieve symptoms of excess gas in the gastrointestinal tract. It works by reducing the surface tension of gas bubbles, which helps them to coalesce and be expelled from the body. It is often utilized in the management of conditions characterized by bloating and discomfort due to gas, such as flatulence and gastroesophageal reflux disease.

Indications

  • Flatulence
  • Bloating
  • Gastroesophageal reflux disease
  • Functional dyspepsia

Dosage

Children: For children, refer to the BNF for Children for specific dosing recommendations.

Adults: The usual adult dose is 40 to 125 mg taken after meals and at bedtime, as needed.

Mechanism of action

Simethicone is a surfactant that decreases the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion. It acts by forming a film of low surface tension that promotes the coalescence of mucus-surrounded gas bubbles, allowing for easier passage of gas.

Pharmacodynamics

Simethicone decreases the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion. Its effects are generally short-lived, as it is typically administered as needed. The therapeutic index is wide since it is not absorbed systemically, making it safe for use in various patient populations.

Pharmacokinetics

Simethicone is not systemically absorbed following oral administration, which contributes to its safety profile. Due to its lack of systemic absorption, specific pharmacokinetic parameters such as half-life, clearance, and volume of distribution are not applicable.

Pregnancy

Simethicone can be used during pregnancy as there are no known risks associated with its use.

Breast-feeding

Simethicone is considered safe to use during breastfeeding, as it is not absorbed systemically.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

Formulations

  • Oral suspension
  • Chewable tablets
  • Soft gels

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: dicyclomine

PubChem CID 3042

Molecular formula: C19H35NO2

Mechanism of action

Dicyclomine achieves its action partially through direct antimuscarinic activity of the M1, M3, and M2 receptors; and partially through antagonism of bradykinin and histamine. Dicyclomine non-competitively inhibits the action of bradykinin and histamine, resulting in direct action on the smooth muscle, and decreased strength of contractions seen in spasms of the ileum. ...MAJOR ACTION APPEARS TO BE NONSPECIFIC DIRECT RELAXANT ACTION ON SMOOTH MUSLCE RATHER THAN COMPETITIVE ANTAGONISM OF ACH.

Pharmacodynamics

Dicyclomine is an anticholinergic drug used to relax the smooth muscles of the intestines. It's duration of action is not especially long as it is usually taken 4 times daily with individual doses of 20-40mg orally or 10-20mg by intramuscular injection. Dicyclomine should not be administered intravenously.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: simethicone

PubChem CID 6433516

Molecular formula: C6H18O4Si3

Mechanism of action

Simethicone is a surfactant that decreases the surface tension of gas bubbles in the gastrointestinal tract, more easily allowing gas to exit the body. The clinical use of simethicone is based on its antifoam properties. Silicone antifoams spread on the surface of aqueous liquids, forming a film of low surface tension and thus causing collapse of foam bubbles. Simethicone reportedly allows mucus-surrounded gas bubbles in the GI tract to coalesce and be expelled.

Pharmacodynamics

Simethicone decreases the surface tension of gas bubbles in the gastrointestinal tract, facilitating their expulsion. It has a short duration of action as it is generally given as needed, and a wide therapeutic index as it is not systemically absorbed.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.