International reference: 1 US FDA recall for this ingredient

Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing. (composition)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Tanzania.

Registered Tanzania · TMDA

VENOSMIL

Gelatin Capsule Composition of the body capsule: Composition of th %,Hidrosmin 200 mg/6 mL,Magnesium Stearate (For Lubrication) 2 mg/6 mL

TAN 23 HM 0480 Capsules 20MG INN generic

What it does

Body refers to the physical structure of a person, which plays a crucial role in overall health and wellbeing.

Commonly used for: general health, physical fitness, wellbeing

Read more in plain English ↓

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

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Registration & product details

Registration no.
TAN 23 HM 0480
Registration date
2023-09-20
Expiry date
2028-09-19
Status
Registered/Compliant
Active ingredient
Gelatin Capsule Composition of the body capsule: Composition of th %,Hidrosmin 200 mg/6 mL,Magnesium Stearate (For Lubrication) 2 mg/6 mL
Dosage form
Capsules
Strength
20MG
Pack size
-
Therapeutic class
-
RxNorm RxCUI
4716
Manufacturer / MAH
faesFAES Farma, S.a
Applicant / LTR
Faes Farma, S.A
Country of origin
SPAIN
Manufacturer location
Planta 5°, Edificio 2, Parque Empresarial Cristalia, C. Vía de los Poblados, 3, Hortaleza, 28033 Madrid, Spain

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:38:27 · updated 2026-10-19 03:00:44

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About body

Body refers to the physical structure of a person, which plays a crucial role in overall health and wellbeing.

What it treats

  • general health
  • physical fitness
  • wellbeing

How it works

The body functions through various systems working together, including the muscular, circulatory, and nervous systems, to maintain health.

Who it's for

Everyone, as maintaining a healthy body is important for all ages.

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

About composition

Composition is a medication that is used to treat various health conditions.

What it treats

  • general health support
  • nutritional deficiencies

How it works

Composition provides essential nutrients that the body needs to function properly.

Who it's for

It is suitable for individuals needing nutritional support or those with specific dietary requirements.

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

About gelatin

Gelatin is a substance often used in various food products and supplements. It is derived from animal collagen and is commonly used to help improve joint health and support digestion.

What it treats

  • joint pain
  • digestive health
  • skin elasticity

How it works

Gelatin helps to provide structure to the body, supporting joints, skin, and digestive tract by providing essential proteins.

Who it's for

Gelatin is suitable for people looking to support their joint health, improve skin appearance, or enhance digestion.

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

About hidrosmin

Hidrosmin is a medication that helps improve blood flow and reduce swelling in the legs.

What it treats

  • chronic venous insufficiency
  • varicose veins
  • swelling in the legs

How it works

Hidrosmin works by strengthening the blood vessels and improving circulation, which helps to relieve discomfort and swelling.

Who it's for

It is suitable for adults who experience symptoms related to poor blood flow in the legs.

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

Clinical monograph: Gelatin

BNF-referenced

Gelatin is a plasma substitute derived from protein obtained from plasma, serum, or normal placentas, with at least 95% of the protein being albumin. It is used to restore blood volume in patients with low blood volume conditions such as hypovolemic shock, burns, and during cardiopulmonary bypass procedures. Gelatin solutions can be isotonic, containing 3.5-5% protein, or concentrated, containing 15-25% protein.

Indications

  • Low blood volume
  • Hypovolemic shock
  • Burns
  • Cardiopulmonary bypass

Dosage

Children: Initially 10-20 mL per kilogram. Adjust according to the patient's condition and response, using 3.5-4% solution. Use under specialist supervision to mitigate the risk of fluid overload.

Adults: Dose according to requirements, typically administered intravenously. Consult product literature for specific dosing guidance.

Mechanism of action

Gelatin acts as a plasma expander by increasing the oncotic pressure in the vascular compartment, which helps to retain fluid within the bloodstream and restore circulating blood volume. This mechanism aids in maintaining blood pressure and improving tissue perfusion.

Pharmacodynamics

Gelatin solutions increase blood volume and improve hemodynamic stability in patients experiencing hypovolemic conditions. By drawing water into the vascular space, they help to counteract the effects of low blood volume, such as hypotension and compromised organ perfusion.

Pharmacokinetics

Gelatin is administered intravenously, and its effects can be observed relatively quickly. The half-life and the metabolic clearance depend on the formulation and concentration of the solution. Gelatin is gradually metabolized by macrophages and eliminated by the renal system. Close monitoring of fluid balance is essential, particularly in patients with cardiac or renal impairment.

Contra-indications

  • Severe liver disease
  • History of circulatory disease
  • Severe cardiac disease

Adverse effects

  • Fever
  • Flushing
  • Nausea
  • Urticaria
  • Rare or very rare shock

Interactions

  • Calcium salts

Precautions

  • Monitor cardiovascular and respiratory function
  • Correct dehydration when administering
  • Administer slowly to avoid rapid rise in blood pressure and cardiac failure
  • Increased capillary permeability

Pregnancy

Consult product literature for specific guidance regarding use in pregnancy.

Breast-feeding

Consult product literature for specific guidance regarding use in breastfeeding.

Storage

Store at controlled room temperature, protect from light. Refer to product-specific storage instructions.

Formulations

  • 5% solution for infusion
  • 20% solution for infusion
  • Concentrated solution (15-25% protein)
  • Isotonic solution (3.5-5% protein)
BNF 85 (British National Formulary) p.1181 BNF for Children 2019-2020 p.638 PubChem / pathway

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: body

Body, or the human body, is the physical structure of a human being, composed of various systems that work together for maintaining life. It comprises organs, tissues, and cells, which interact through complex biochemical processes to support functions such as metabolism, growth, reproduction, and response to the environment.

Dosage

Children: Refer to specific drug guidelines for dosing information.

Adults: Refer to specific drug guidelines for dosing information.

Mechanism of action

The body operates through various biological mechanisms that involve the interaction of hormones, neurotransmitters, and enzymes. These interactions regulate numerous physiological processes including homeostasis, immune response, and metabolic pathways.

Pharmacodynamics

Pharmacodynamics in the context of the body involves understanding how different substances affect bodily functions. This can include the action of drugs, nutrients, and other chemical agents, which can modify physiological responses through receptor binding, enzyme activity modulation, or ion channel regulation.

Pharmacokinetics

Pharmacokinetics refers to how substances are absorbed, distributed, metabolized, and excreted within the body. Factors such as blood flow, tissue permeability, and enzymatic activity play crucial roles in determining how long a drug remains active in the body, its efficacy, and potential for toxicity.

Pregnancy

Consult healthcare provider before use, as safety during pregnancy may vary based on specific conditions.

Breast-feeding

Consult healthcare provider before use, as safety during breastfeeding may vary based on specific conditions.

Storage

Store in a cool, dry place away from direct sunlight and moisture.

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: composition

Composition is a term that generally refers to the formulation of a drug, including its active ingredients and excipients. Active ingredients are the components of a drug that provide the intended therapeutic effect, while excipients are inactive substances that serve as the vehicle for the active ingredients. The composition of a drug affects its pharmacokinetics, pharmacodynamics, stability, and overall efficacy.

Dosage

Children: Refer to the specific drug formulation and BNF for Children for appropriate dosing information.

Adults: Refer to the specific drug formulation and BNF for appropriate dosing information.

Mechanism of action

The mechanism of action of a drug depends on its specific active ingredients. Generally, drugs interact with biological systems through various pathways, such as binding to receptors, inhibiting enzymes, or altering cellular processes. This interaction leads to a therapeutic effect, which can vary widely depending on the drug's composition.

Pharmacodynamics

Pharmacodynamics refers to the effects of a drug on the body and the mechanisms through which these effects occur. The pharmacodynamic profile of a drug is influenced by its composition, including the potency of active ingredients, the affinity to specific receptors, and the ability to cross biological membranes. The overall therapeutic effect is determined by how these components interact with the body's biological systems.

Pharmacokinetics

Pharmacokinetics involves the absorption, distribution, metabolism, and excretion of a drug. The composition of a drug affects its pharmacokinetics; for instance, solubility, stability, and formulation type can influence absorption rates. Different formulations may have varying bioavailability, which is crucial for achieving therapeutic effects. Metabolism can be influenced by the presence of excipients or other components that affect enzymatic activity.

Pregnancy

Consult healthcare provider. The safety of composition during pregnancy has not been established.

Breast-feeding

Consult healthcare provider. It is unknown if composition is excreted in human milk.

Storage

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

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: hidrosmin

BNF-referenced

Hidrosmin is a flavonoid compound, primarily derived from the Dioscorea species, known for its venotonic properties. It is utilized in the treatment of chronic venous insufficiency, hemorrhoids, and other vascular disorders due to its ability to improve venous tone and reduce capillary permeability.

Indications

  • Chronic venous insufficiency
  • Hemorrhoids
  • Varicose veins
  • Lymphedema

Dosage

Children: Paediatric dosing information for hidrosmin is not readily available; therefore, it is recommended to consult the BNF for Children or a healthcare professional for appropriate dosing in children.

Adults: For adults, the typical dosage of hidrosmin is 500 mg to 1000 mg taken orally, usually divided into two or three doses per day. It is advisable to refer to specific guidelines or the BNF for further details regarding dosing adjustments based on individual patient needs.

Mechanism of action

Hidrosmin exerts a venotonic effect by enhancing venous tone, which is mediated through a combination of increased venous return and reduced venous distensibility. This is thought to be due to its action on the vascular smooth muscle, promoting contraction and thereby improving venous drainage. Additionally, it may decrease capillary permeability and inhibit inflammatory mediators, contributing to its effectiveness in venous disorders.

Pharmacodynamics

Pharmacodynamically, hidrosmin improves microcirculation and reduces venous stasis, which can alleviate symptoms associated with venous insufficiency such as pain, swelling, and heaviness in the legs. Its anti-inflammatory properties may also play a role in reducing discomfort associated with hemorrhoids and other inflammatory vascular conditions.

Pharmacokinetics

Hidrosmin is well absorbed after oral administration, with peak plasma concentrations typically occurring within 1-2 hours. It undergoes extensive hepatic metabolism, resulting in several metabolites that may also contribute to its therapeutic effects. The elimination half-life is approximately 4-6 hours, and it is primarily excreted through the urine.

Pregnancy

There is limited data on the use of hidrosmin during pregnancy. It should only be used if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

There is insufficient information on the excretion of hidrosmin in human milk. Caution should be exercised when administering to breastfeeding women.

Storage

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

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: hidrosmin

PubChem CID 3087722

Molecular formula: C30H36O16

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.