Registered Malawi · PMRA

UNOCLAM COMBINATION PRODUCT TABLET

WITHANIA SOMNIFERA, BACOPA MONNIERI, NARDOSTACHYS EXTRACTS

PMPB/PL455/37 TABLET

What it does

Bacopa is a natural supplement often used to support brain health and cognitive function.

Commonly used for: memory improvement, cognitive enhancement, anxiety relief

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.

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.
PMPB/PL455/37
Registration date
11/10/2016
Expiry date
30/06/2017
Status
Registered
Active ingredient
WITHANIA SOMNIFERA, BACOPA MONNIERI, NARDOSTACHYS EXTRACTS
Dosage form
TABLET
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:43 · updated 2026-09-29 04:33:06

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

About bacopa

Bacopa is a natural supplement often used to support brain health and cognitive function.

What it treats

  • memory improvement
  • cognitive enhancement
  • anxiety relief

How it works

Bacopa is believed to help improve brain function and reduce stress by supporting the nervous system.

Who it's for

Bacopa is suitable for adults looking to enhance their memory and reduce anxiety.

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

About extracts

Extracts are natural substances obtained from plants or herbs, often used for their potential health benefits.

What it treats

  • various health conditions
  • natural remedies
  • herbal supplements

How it works

Extracts may contain active compounds that can have various effects on the body, supporting overall health or targeting specific issues.

Who it's for

People looking for natural alternatives or supplements for health improvement.

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

About monnieri

Monnieri is a natural supplement often used to support cognitive function and memory.

What it treats

  • cognitive enhancement
  • memory improvement

How it works

Monnieri is believed to help improve brain function by enhancing blood flow and reducing stress.

Who it's for

Monnieri may be suitable for adults looking to boost their memory and cognitive abilities.

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

About nardostachys

Nardostachys is a natural product that may have various health benefits.

What it treats

  • digestive problems
  • anxiety
  • stress relief

How it works

Nardostachys is believed to support overall well-being and may help improve mood and digestion.

Who it's for

It is often used by individuals looking for natural remedies for stress, anxiety, or digestive issues.

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

About somnifera

Somnifera is a natural herb that may help promote relaxation and support sleep.

What it treats

  • insomnia
  • sleep disturbances
  • anxiety

How it works

Somnifera is believed to help calm the mind and body, making it easier to fall asleep.

Who it's for

Adults looking for natural support for better sleep and relaxation.

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

About withania

Withania is a natural herb often used to help improve overall health and well-being.

What it treats

  • stress relief
  • anxiety reduction
  • improving energy
  • supporting immune health

How it works

Withania may help the body adapt to stress and improve mental and physical performance.

Who it's for

It may be suitable for adults looking for natural support for stress and fatigue.

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

Clinical monograph: bacopa

Bacopa, also known as Bacopa monnieri, is an herb traditionally used in Ayurvedic medicine. It is primarily recognized for its potential cognitive-enhancing properties, particularly in improving memory, learning, and overall brain function. Bacopa is also known for its adaptogenic properties, which may help the body manage stress and anxiety. It is commonly marketed in supplement form, often as a nootropic, to enhance cognitive performance.

Indications

  • Cognitive enhancement
  • Memory improvement
  • Anxiety reduction
  • Stress management

Dosage

Children: Refer to a healthcare professional or the BNF for Children for appropriate dosing in children, as specific pediatric dosing guidelines are not well-established.

Adults: Refer to specific product instructions, as doses can vary widely between formulations. Clinical studies typically use doses ranging from 300 to 600 mg of standardized Bacopa extract per day.

Mechanism of action

Bacopa monnieri is believed to exert its effects through several mechanisms, including the modulation of neurotransmitter levels, particularly serotonin and acetylcholine. The active compounds, known as bacosides, are thought to enhance synaptic transmission and promote neuronal growth. Additionally, Bacopa has antioxidant properties, which may protect against oxidative stress and inflammation in the brain, further supporting cognitive function.

Pharmacodynamics

The pharmacodynamic effects of Bacopa are primarily related to its cognitive-enhancing capabilities. Clinical studies have suggested that Bacopa may improve attention, memory, and information processing speed. Its anxiolytic effects may reduce stress and anxiety levels, contributing to an overall improvement in mental clarity and focus. The onset of cognitive-enhancing effects may take several weeks of consistent use.

Pharmacokinetics

Bacopa is typically taken orally, and its pharmacokinetics can vary based on formulation and individual metabolism. The active components are absorbed in the gastrointestinal tract, and peak plasma concentrations usually occur within 1 to 2 hours post-ingestion. Bacopa is metabolized in the liver, and its metabolites are excreted primarily through the kidneys. The half-life of Bacopa's active constituents is not well-established, and further research is needed to elucidate its complete pharmacokinetic profile.

Adverse effects

  • Gastrointestinal distress
  • Nausea
  • Diarrhea
  • Fatigue
  • Dry mouth
  • Increased bowel movements

Interactions

  • May interact with sedatives and other central nervous system depressants
  • Potential interaction with thyroid medications due to its possible thyroid-stimulating effects

Precautions

  • Use with caution in individuals with a history of gastrointestinal disorders
  • Caution in individuals with thyroid disorders due to potential effects on thyroid function
  • Not recommended for use in pregnant or breastfeeding women without medical supervision

Pregnancy

Bacopa is not recommended during pregnancy due to insufficient safety data.

Breast-feeding

Use of bacopa during breastfeeding is not recommended due to limited safety information.

Storage

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

Formulations

  • Capsules
  • Tablets
  • Liquid extracts
  • Powder

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: extracts

Extracts are concentrated forms of active ingredients derived from plants, herbs, or other biological sources. They are used in various therapeutic applications, including herbal medicine, nutritional supplements, and as flavoring agents. The extraction process typically involves solvents to isolate the desired compounds, enhancing their potency and bioavailability.

Indications

  • Herbal medicine for various ailments
  • Nutritional supplementation
  • Flavoring agents in food
  • Support for digestive health
  • Management of stress and anxiety

Dosage

Children: Paediatric dosing is dependent on the specific extract and should be determined based on the product guidelines or consulting a healthcare professional familiar with herbal medicine.

Adults: Dosage varies widely based on the specific extract and condition being treated. Refer to product-specific guidelines or consult relevant pharmacological literature for appropriate dosing.

Mechanism of action

The mechanism of action of extracts varies depending on the source material and the specific compounds present. Common mechanisms include modulation of neurotransmitter systems, anti-inflammatory effects, antioxidant activity, and interaction with various cellular pathways. For example, flavonoids in plant extracts may exert antioxidant effects by scavenging free radicals, while alkaloids may influence neurotransmitter receptors.

Pharmacodynamics

The pharmacodynamics of extracts depends on their composition. They may exhibit various effects, such as anti-inflammatory, analgesic, antimicrobial, and immunomodulatory activities. The pharmacological effects are often dose-dependent, with lower doses providing therapeutic benefits and higher doses potentially leading to adverse effects. The time course of action can also vary, with some extracts providing rapid relief and others requiring chronic use to achieve efficacy.

Pharmacokinetics

The pharmacokinetics of extracts depend on the specific compounds and their properties, including solubility, stability, and absorption. Typically, active constituents are absorbed in the gastrointestinal tract and may undergo first-pass metabolism in the liver. The distribution of compounds can vary, affecting their bioavailability and the duration of action. Elimination routes may include renal excretion or metabolic conversion to inactive forms.

Pregnancy

Safety during pregnancy varies depending on the specific extract. Consult specific extract guidelines.

Breast-feeding

Safety during breastfeeding varies depending on the specific extract. Consult specific extract guidelines.

Storage

Store in a cool, dry place away from direct sunlight, and 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: monnieri

Monnieri, commonly known as Bacopa monnieri, is a perennial herb that has been used in traditional Ayurvedic medicine for its cognitive-enhancing properties. It is often referred to as Brahmi and is reputed for its potential to improve memory, learning, and overall cognitive function. Bacopa monnieri is also believed to possess antioxidant, anti-inflammatory, and neuroprotective effects.

Indications

  • Cognitive enhancement
  • Memory improvement
  • Anxiety reduction
  • Stress relief
  • Neuroprotection

Dosage

Children: Pediatric dosing information is not well established. It is recommended to consult specific guidelines or a healthcare professional for appropriate dosing in children.

Adults: Dosage can vary based on the formulation and concentration of Bacopa monnieri extract. Generally, doses range from 300 mg to 600 mg of standardized extract per day, taken in divided doses. It is advisable to refer to specific product guidelines for precise dosing.

Mechanism of action

The active compounds in Bacopa monnieri, primarily bacosides, are thought to enhance synaptic transmission and promote neuronal growth by increasing the levels of certain neurotransmitters such as serotonin and acetylcholine. This action may contribute to improved cognition and memory retention. Additionally, Bacopa monnieri may exert an adaptogenic effect, helping the body to cope with stress.

Pharmacodynamics

Bacopa monnieri exhibits various pharmacological activities, including antioxidant activity, which helps to protect neuronal cells from oxidative stress. Its ability to enhance learning and memory is supported by its modulation of neurotransmitter systems and its effects on neuroplasticity. Moreover, it may contribute to reduced anxiety and improved mood, further supporting cognitive performance.

Pharmacokinetics

Bacopa monnieri is usually administered orally, and its bioactive compounds undergo extensive metabolism in the liver. The absorption of its constituents can be influenced by food intake, with better absorption noted when taken with meals. The elimination half-life of the active ingredients is variable, and the onset of effects may take several weeks of consistent use to become apparent due to the cumulative nature of its benefits.

Adverse effects

  • Gastrointestinal upset
  • Nausea
  • Diarrhea
  • Headache
  • Insomnia
  • Irritability

Interactions

  • May enhance the effects of anticoagulants
  • May interact with antidiabetic medications
  • Potential interaction with sedatives or central nervous system depressants

Precautions

  • Use with caution in individuals with thyroid disorders
  • Monitor blood sugar levels in diabetic patients

Pregnancy

Safety during pregnancy has not been established, consult a healthcare provider before use.

Breast-feeding

Safety during breastfeeding is not well established; consult a healthcare provider.

Storage

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

Formulations

  • Capsules
  • Powder
  • Extract

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: nardostachys

Nardostachys jatamansi, commonly known as nardostachys, is a perennial herb native to the Himalayan region. It has been traditionally used in Ayurvedic and traditional medicine for its potential therapeutic properties, including its use as an anxiolytic, anti-inflammatory, and neuroprotective agent. The plant contains various chemical constituents, including sesquiterpenes, which may contribute to its medicinal effects. Nardostachys is often utilized in the treatment of stress-related disorders, insomnia, and as a general tonic.

Indications

  • Anxiety disorders
  • Insomnia
  • Stress-related conditions
  • Neuroprotection
  • Inflammatory conditions

Dosage

Children: Refer to a healthcare professional or appropriate pediatric dosing references for children, as specific dosing information is not established.

Adults: Dosage for adults varies based on the formulation and intended use, typically ranging from 500 mg to 1500 mg daily, depending on the extract and concentration. Refer to specific product guidelines for dosing.

Mechanism of action

Nardostachys exhibits its effects primarily through modulation of the central nervous system. The active compounds, such as valeranones and jatamansone, may influence neurotransmitter systems, particularly GABAergic pathways, leading to anxiolytic and sedative effects. Additionally, its anti-inflammatory properties are attributed to the inhibition of pro-inflammatory cytokines and the modulation of oxidative stress pathways.

Pharmacodynamics

The pharmacodynamic effects of nardostachys include anxiolytic, sedative, and neuroprotective actions. It may enhance GABA activity, leading to a calming effect on the nervous system. The anti-inflammatory properties help in reducing inflammation and may be beneficial in conditions characterized by oxidative stress. Its tonic properties support overall well-being and may improve cognitive function and mood.

Pharmacokinetics

The pharmacokinetics of nardostachys are not extensively studied, but it is believed that the active constituents are absorbed through the gastrointestinal tract after oral administration. The metabolism and excretion pathways remain unclear due to limited clinical data. However, like many herbal remedies, the bioavailability may be influenced by the formulation and the presence of other compounds.

Pregnancy

There is insufficient data on the safety of nardostachys during pregnancy. Use with caution and consult a healthcare professional.

Breast-feeding

Limited information is available regarding the excretion of nardostachys in breast milk. It is advisable to consult a healthcare professional before use.

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: somnifera

Somnifera, commonly known as Ashwagandha, is a herb used in traditional Ayurvedic medicine. It is classified as an adaptogen, meaning it helps the body manage stress. The root and leaf extracts of the plant are utilized for their purported health benefits, including anxiety reduction, improved sleep quality, and enhanced cognitive function.

Indications

  • Anxiety
  • Stress management
  • Insomnia
  • Cognitive enhancement
  • General well-being

Dosage

Children: Refer to specific product guidelines for dosing. Pediatric dosing should be approached with caution and under professional guidance.

Adults: Refer to specific product guidelines for dosing. Dosages may vary based on the formulation and condition being treated.

Mechanism of action

Somnifera is believed to exert its effects through modulation of the hypothalamic-pituitary-adrenal (HPA) axis and reduction of cortisol levels. It may enhance the activity of gamma-aminobutyric acid (GABA) at the GABA receptors, contributing to its anxiolytic effects. Additionally, it may influence neurotransmitter systems, including serotonin and dopamine, promoting a balanced mood and mental clarity.

Pharmacodynamics

Somnifera exhibits a range of pharmacological effects including anti-anxiety, anti-stress, and antidepressant properties. Its adaptogenic properties help in enhancing physical and mental performance under stress. The herb has also been shown to possess anti-inflammatory and antioxidant effects, which may contribute to overall health benefits.

Pharmacokinetics

The active compounds in Somnifera, such as withanolides, are absorbed in the gastrointestinal tract. Peak plasma concentrations are generally reached within a few hours post-administration. The metabolism of these compounds is primarily through hepatic pathways, and they are excreted via urine and feces. The half-life of the active constituents can vary based on dosage and formulation.

Adverse effects

  • Drowsiness
  • Dizziness
  • Gastrointestinal upset
  • Allergic reactions

Interactions

  • May potentiate the effects of sedatives and hypnotics
  • Potential interaction with alcohol leading to increased sedation

Precautions

  • Use with caution in patients with a history of allergies
  • Monitor for excessive sedation
  • Caution in patients with respiratory conditions

Pregnancy

Insufficient evidence on safety, use with caution.

Breast-feeding

Limited data, use with caution and consult a healthcare provider.

Storage

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

Formulations

  • Powdered root
  • Capsules
  • Tablets
  • Tinctures

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: withania

Withania, commonly known as Ashwagandha, is an adaptogenic herb used in traditional medicine, particularly in Ayurvedic practice. It is known for its potential to enhance the body's resilience to stress and improve overall health. The active compounds in Withania, particularly withanolides, are believed to contribute to its therapeutic effects, including anti-inflammatory, antioxidant, and neuroprotective properties.

Indications

  • Stress management
  • Anxiety
  • Depression
  • Cognitive enhancement
  • Physical performance improvement
  • Anti-inflammatory conditions

Dosage

Children: Consult the BNF for Children for appropriate dosing information.

Adults: Dosage can vary by formulation, typically ranging from 300 mg to 600 mg of standardized extract per day, divided into two doses.

Mechanism of action

Withania acts through multiple mechanisms, including modulation of the hypothalamic-pituitary-adrenal (HPA) axis, which helps regulate the body's stress response. It may also influence the levels of neurotransmitters such as serotonin and gamma-aminobutyric acid (GABA), promoting an anxiolytic effect. Additionally, withanolides have been shown to interact with various cellular pathways, including those involved in inflammation and apoptosis.

Pharmacodynamics

Withania exhibits adaptogenic properties, aiding in the stabilization of physiological processes and promoting homeostasis. Its anti-inflammatory effects are attributed to the inhibition of pro-inflammatory cytokines and pathways, thus reducing oxidative stress. It also enhances cognitive function and physical performance, potentially via neuroprotective effects on neuronal cells.

Pharmacokinetics

The pharmacokinetics of Withania are characterized by its bioactive compounds being rapidly absorbed and distributed in the body. Withanolides are metabolized by the liver and excreted primarily through urine. The half-life of these compounds can vary, influencing dosing intervals and therapeutic effects. The variations in absorption and metabolism can be influenced by formulation and individual patient factors.

Adverse effects

  • Gastrointestinal upset
  • Drowsiness
  • Headache
  • Hypotension

Interactions

  • May enhance the effects of sedatives and other CNS depressants
  • Potential interaction with thyroid medications
  • May affect blood sugar levels, caution with antidiabetic drugs

Precautions

  • Use with caution in individuals with autoimmune diseases
  • Monitor blood sugar levels in diabetic patients
  • May cause drowsiness; caution when driving or operating heavy machinery

Pregnancy

Insufficient data on safety in pregnancy; use with caution.

Breast-feeding

Limited data available; consult a healthcare professional before use.

Storage

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

Formulations

  • Powdered root
  • Capsules
  • Liquid extract
  • Tincture

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.