PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.) Zimbabwe · MCAZ

CYCLOPAM

DICYCLOMINE HYDROCHLORIDE; SIMETHICOME

2006/16.4/4423 SUSPENSION 10; 40MG/5ML 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.
2006/16.4/4423
Registration date
2006-05-16
Expiry date
2027-12-31
Status
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
Active ingredient
DICYCLOMINE HYDROCHLORIDE; SIMETHICOME
Dosage form
SUSPENSION
Strength
10; 40MG/5ML
Pack size
-
Therapeutic class
-
ATC class (WHO)
A03AA - Synthetic anticholinergics, esters with tertiary amino group
RxNorm RxCUI
3361
Manufacturer / MAH
Indoco Remedies
Applicant / LTR
INDOCO REMEDIES LTD
Country of origin
-
Manufacturer location
166, CST Road, Kolivery Village, MMRDA Area, Kalina, Santacruz East, Mumbai, Maharashtra 400098, India

Source: Medicines Control Authority of Zimbabwe · fetched 2026-04-18 08:22:06 · updated 2026-10-18 04:30:06

Disclaimer: This information is sourced from Medicines Control Authority of Zimbabwe (Zimbabwe). 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 simethicome

Simethicone is a medication used to relieve discomfort caused by excess gas in the stomach and intestines.

What it treats

  • stomach gas (flatulence)
  • bloating
  • indigestion

How it works

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

Who it's for

It is suitable for adults and children who experience 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: simethicome

Simethicone is an anti-foaming agent that is used to relieve symptoms of excess gas in the gastrointestinal tract. It works by reducing the surface tension of gas bubbles, allowing them to coalesce and be eliminated more easily. It is commonly used in the treatment of conditions associated with bloating, discomfort, and flatulence.

Indications

  • Relief of gas-related symptoms such as bloating
  • Flatulence
  • Discomfort from excess gas in the gastrointestinal tract

Dosage

Children: Refer to the BNF for Children for specific dosing information.

Adults: Refer to the BNF for specific dosing information.

Mechanism of action

Simethicone acts as an antifoaming agent by reducing the surface tension of gas bubbles in the stomach and intestines. This action allows smaller gas bubbles to combine into larger bubbles that can be expelled more easily, thus alleviating discomfort caused by gas buildup.

Pharmacodynamics

Simethicone does not get absorbed into the bloodstream; it works locally within the gastrointestinal tract. The reduction of surface tension helps to alleviate the symptoms of gas-related discomfort by promoting the passage of gas through the digestive system.

Pharmacokinetics

Simethicone is not absorbed from the gastrointestinal tract and is excreted unchanged in the feces. Its onset of action is typically rapid, with effects usually being felt within minutes after administration. The duration of action can vary depending on the dose and the individual patient's gastrointestinal motility.

Adverse effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
  • Abdominal discomfort

Precautions

  • Use caution in patients with a known hypersensitivity to simethicone or any component of the formulation.
  • Consult a healthcare professional if symptoms persist after use.

Pregnancy

Simethicone is generally considered safe to use during pregnancy as it is not absorbed systemically.

Breast-feeding

Simethicone is not absorbed into the bloodstream and is considered safe for use during breastfeeding.

Storage

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

Formulations

  • Chewable tablets
  • Softgels
  • Liquid suspension

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.

This drug in other countries

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