Registered Tanzania · TMDA

Calmettes Nite

Valerian Hydroalcoholic Extract 125 mg

TAN 20 HM 0302 Tablets 125

What it does

This medicine is an extract that is used for various health conditions.

Commonly used for: general health improvement, nutritional support

Read more in plain English ↓

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

Ask about this medicine

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

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
TAN 20 HM 0302
Registration date
2025-07-08
Expiry date
2030-07-07
Status
Registered/Compliant
Active ingredient
Valerian Hydroalcoholic Extract 125 mg
Dosage form
Tablets
Strength
125
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Vemedica
Country of origin
NETHERLANDS
Manufacturer location
Verrijn Stuartweg 60, 1112 AX Diemen, Netherlands

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:52:35 · updated 2026-10-19 03:00:45

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

About extract

This medicine is an extract that is used for various health conditions.

What it treats

  • general health improvement
  • nutritional support

How it works

The extract may provide health benefits by supplying essential nutrients or compounds that support bodily functions.

Who it's for

This medicine is suitable for individuals looking to improve their overall health or address specific nutritional needs.

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

About hydroalcoholic

Hydroalcoholic solutions are used for various medicinal purposes, often as a solvent or preservative in other medications.

What it treats

  • used as a solvent in medicines
  • used in skincare products
  • used in hand sanitizers

How it works

Hydroalcoholic solutions contain both water and alcohol, which helps dissolve certain substances and can also kill germs.

Who it's for

Generally suitable for adults and children, but specific uses may vary.

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

About valerian

Valerian is a natural supplement often used to promote relaxation and improve sleep quality.

What it treats

  • insomnia
  • anxiety

How it works

Valerian is believed to work by increasing levels of a calming substance in the brain, helping to reduce anxiety and promote better sleep.

Who it's for

Valerian is typically used by adults who experience difficulty sleeping or feel anxious.

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

Clinical monograph: extract

Extracts are concentrated preparations obtained from plants, herbs, or other natural sources through various extraction methods such as solvent extraction, steam distillation, or cold pressing. They are used for their therapeutic properties in herbal medicine and can contain a variety of bioactive compounds including alkaloids, flavonoids, terpenes, and essential oils. The specific effects and uses of an extract depend on its source material and the compounds it contains.

Indications

  • General wellness support
  • Anti-inflammatory effects
  • Antioxidant activity
  • Digestive aid
  • Support for immune function

Dosage

Children: Paediatric dosing should be determined based on the specific extract and its intended use. Consultation with a healthcare provider is recommended for accurate dosing.

Adults: Dosage varies widely depending on the specific extract and formulation. It is essential to follow the manufacturer's instructions or consult a healthcare professional for appropriate dosing.

Mechanism of action

The mechanism of action of herbal extracts can vary significantly based on their constituents. Commonly, they exert their effects through multiple pathways including modulation of neurotransmitter systems, interference with inflammatory processes, or direct antioxidant activity. Some extracts may activate certain receptors or inhibit enzymes related to disease processes.

Pharmacodynamics

The pharmacodynamics of extracts is complex due to the presence of multiple active compounds which can have synergistic or antagonistic effects. These compounds may influence cellular signaling pathways, alter gene expression, or modulate immune response. The overall pharmacological profile is determined by the specific composition of the extract, its concentration, and the biological target it interacts with.

Pharmacokinetics

The pharmacokinetics of extracts involves absorption, distribution, metabolism, and excretion of the active compounds. Generally, herbal extracts are absorbed in the gastrointestinal tract, with bioavailability influenced by factors such as formulation, the presence of food, and individual metabolic differences. Compounds may undergo hepatic metabolism, and elimination can occur through urine or feces, depending on their chemical nature.

Pregnancy

Consult a healthcare professional before use, as the safety of the extract during pregnancy has not been established.

Breast-feeding

Consult a healthcare professional before use, as the safety of the extract during breastfeeding has not been established.

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.

Clinical monograph: hydroalcoholic

Hydroalcoholic solutions are mixtures of water and alcohol, commonly ethanol, used for various applications including antiseptics, solvents, and extraction processes. In the medical field, hydroalcoholic preparations are often employed in the formulation of tinctures and other topical preparations that leverage the antibacterial and antifungal properties of alcohol. The concentration of alcohol in these solutions typically affects the efficacy of the product, influencing its ability to denature proteins and disrupt microbial cell membranes.

Indications

  • Topical antiseptic
  • Disinfectant
  • Solvent for pharmaceutical preparations
  • Extraction medium for herbal medicines

Dosage

Children: Refer to specific product guidelines for concentration and application methods. Use with caution in children, and consult a healthcare professional for appropriate formulations.

Adults: Refer to specific product guidelines for concentration and application methods. For topical antiseptic use, apply liberally to the affected area as needed.

Mechanism of action

The mechanism of action of hydroalcoholic solutions primarily involves the denaturation of proteins and disruption of cell membranes in microbial organisms. Ethanol interacts with the lipid bilayer of the cell membrane, leading to increased permeability and ultimately cell lysis. Additionally, alcohol can precipitate proteins, which leads to the inactivation of enzymes and structural proteins essential for microbial survival.

Pharmacodynamics

Hydroalcoholic solutions exhibit broad-spectrum antimicrobial activity, effective against bacteria, viruses, and fungi. The effectiveness is influenced by the concentration of alcohol, with concentrations between 60-90% being optimal for antimicrobial activity. The presence of water in the solution facilitates the penetration of alcohol into cells, enhancing its bactericidal and virucidal effects.

Pharmacokinetics

When applied topically, hydroalcoholic solutions are minimally absorbed through the skin. However, when ingested, ethanol is rapidly absorbed from the gastrointestinal tract, reaching peak plasma concentrations in about 30 to 90 minutes. The distribution is wide throughout body tissues, and ethanol is primarily metabolized in the liver through alcohol dehydrogenase and acetaldehyde dehydrogenase pathways. The elimination half-life varies based on the amount consumed and individual metabolism, typically averaging around 2 to 4 hours.

Pregnancy

Hydroalcoholic solutions are generally avoided during pregnancy due to the potential risks associated with alcohol exposure to the developing fetus.

Breast-feeding

Caution is advised when using hydroalcoholic solutions during breastfeeding, as alcohol can pass into breast milk and may affect the infant.

Storage

Store in a cool, dry place away from direct sunlight and heat sources. Ensure tightly closed to prevent evaporation.

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: valerian

Valerian is a herbal supplement derived from the root of the Valeriana officinalis plant. It has been traditionally used for its sedative and anxiolytic properties, commonly marketed for the treatment of insomnia, anxiety, and stress-related conditions. The efficacy of valerian in promoting sleep and reducing anxiety has been supported by various studies, although results can be variable, and it may take several days of use to experience its full effects.

Indications

  • Insomnia
  • Anxiety disorders
  • Stress-related symptoms
  • Restlessness
  • Muscle tension

Dosage

Children: Refer to a pediatric dosing reference or guidelines, as specific pediatric dosing has not been established.

Adults: Refer to specific guidelines for dosage, as doses can vary based on the formulation and indication.

Mechanism of action

Valerian is thought to exert its effects primarily through modulation of the GABA (gamma-aminobutyric acid) neurotransmitter system. It is believed to increase the levels of GABA in the synaptic cleft, enhancing GABAergic transmission, which results in sedative effects. Additionally, valerian contains various compounds, including valerenic acid, which may influence other neurotransmitter systems and have anti-anxiety properties.

Pharmacodynamics

The pharmacodynamic effects of valerian include sedation, anxiolysis, and muscle relaxation. These effects are most pronounced at doses typically used for therapeutic purposes. The onset of action may vary, with some users reporting effects within an hour, while others may require several days of consistent use. Tolerance can develop with prolonged use, and withdrawal symptoms may occur upon abrupt discontinuation after long-term use.

Pharmacokinetics

Valerian is absorbed from the gastrointestinal tract, with peak plasma concentrations occurring approximately 1-2 hours after oral administration. The bioavailability may be affected by factors such as the preparation method and individual metabolism. Valerian is metabolized in the liver, primarily via phase I reactions, and is excreted through the urine. The half-life of its active components can vary, influencing dosing intervals and duration of action.

Adverse effects

  • Headache
  • Dizziness
  • Gastrointestinal disturbances
  • Daytime drowsiness
  • Allergic reactions

Interactions

  • CNS depressants may enhance sedative effects
  • Alcohol may increase sedation
  • Benzodiazepines may have additive effects

Precautions

  • Use with caution in patients with liver disorders
  • Avoid use in children without medical supervision
  • Discontinue use if adverse effects occur

Pregnancy

Safety during pregnancy has not been established; use only if clearly needed.

Breast-feeding

Safety during breastfeeding has not been established; use with caution.

Storage

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

Formulations

  • Dried root
  • Tinctures
  • Capsules
  • Tablets
  • Liquid extracts

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

This drug in other countries

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