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

ULCER GEL MAX

SIMETHICONE 30% EMULSION

2021/16.1/6158 INJECTABLE; INJECTION 83.33ML/5ML INN generic

What it does

Emulsion is a mixture used to deliver medicine effectively, often in a liquid form.

Commonly used for: skin conditions, hydration of the skin, medication delivery

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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.
2021/16.1/6158
Registration date
2021-07-28
Expiry date
2027-12-31
Status
PRESCRIPTION PREPARATIONS 9TH SCHEDULE, (P.P.)
Active ingredient
SIMETHICONE 30% EMULSION
Dosage form
INJECTABLE; INJECTION
Strength
83.33ML/5ML
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Plus Five Pharmaceuticals
Country of origin
-
Manufacturer location
17181 Nketa Dr, Bulawayo, Zimbabwe

Source: Medicines Control Authority of Zimbabwe · fetched 2026-04-18 08:22:11 · updated 2026-09-20 04:30:12

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

About emulsion

Emulsion is a mixture used to deliver medicine effectively, often in a liquid form.

What it treats

  • skin conditions
  • hydration of the skin
  • medication delivery

How it works

Emulsions help mix oil and water, making it easier for the body to absorb the medication.

Who it's for

Suitable for individuals needing topical treatment for skin issues or hydration.

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: emulsion

Emulsions are mixtures of two immiscible liquids, typically oil and water, stabilized by emulsifying agents. They are commonly used in pharmaceuticals to improve the solubility of lipophilic drugs, enhance drug absorption, and facilitate the delivery of nutrients. Emulsions can be administered orally, parenterally, or topically, depending on their formulation.

Indications

  • Nutritional support in patients unable to consume food orally
  • Parenteral nutrition
  • Drug delivery for lipophilic medications
  • Topical applications for skin conditions

Dosage

Children: Refer to specific product guidelines and clinical protocols for paediatric dosing.

Adults: Refer to specific product guidelines and clinical protocols for adult dosing.

Mechanism of action

Emulsions work by reducing the surface tension between the oil and water phases, allowing for the formation of stable droplets. This process is mediated by emulsifying agents, which can be surfactants or natural polymers that stabilize the emulsion and prevent phase separation. The absorption and bioavailability of drugs within the emulsion can be enhanced due to the increased surface area for absorption.

Pharmacodynamics

The pharmacodynamics of emulsions vary based on their composition and formulation. The presence of emulsifying agents can influence the release profile of the active ingredients, allowing for controlled or sustained release. Emulsions can also enhance the solubility of poorly water-soluble drugs, improving their therapeutic effects and minimizing side effects related to high concentrations of active ingredients.

Pharmacokinetics

The pharmacokinetics of emulsions depend on their route of administration and the specific properties of the drug contained within the emulsion. After administration, emulsions can be rapidly absorbed due to their small droplet size, leading to quicker onset of action. The distribution, metabolism, and excretion of the drug will follow the pharmacokinetic principles applicable to the active ingredients, influenced by their solubility and the emulsion's formulation.

Pregnancy

The safety of emulsions during pregnancy depends on the specific type and formulation. Consult relevant guidelines and specific product information.

Breast-feeding

Emulsions may be used while breastfeeding, but specific product information should be consulted to ensure safety.

Storage

Store at room temperature, away from light and moisture. Specific formulations may have unique storage requirements.

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: 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.