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VITADOX EVENING PRIMROSE OIL SOFTGEL CAPSULES

Evening primrose oil/gamma linolenic acid

FDA/SD.255-060968 Evening primrose oil/gamma linolenic acid 1300mg/120mg musculo-skeletal system

What it does

Evening primrose oil is a natural supplement often used to support women's health and skin conditions.

Commonly used for: premenstrual syndrome (PMS), eczema, breast pain (mastalgia), menopausal symptoms

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

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Sourcing - Kenya only

Registration & product details

Registration no.
FDA/SD.255-060968
Registration date
2025-06-12
Expiry date
2030-07-01
Status
Valid
Active ingredient
Evening primrose oil/gamma linolenic acid
Strength
1300mg/120mg
Pack size
-
Therapeutic class
-
ATC class (WHO)
M05BX - Other drugs affecting bone structure and mineralization
RxNorm RxCUI
2123186
Manufacturer / MAH
Guangzhou Jiabei HengHui
Country of origin
-

Source: Food and Drugs Authority · fetched 2026-04-18 08:37:31 · updated 2026-10-20 04:00:03

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About evening

Evening primrose oil is a natural supplement often used to support women's health and skin conditions.

What it treats

  • premenstrual syndrome (PMS)
  • eczema
  • breast pain (mastalgia)
  • menopausal symptoms

How it works

Evening primrose oil contains essential fatty acids that may help reduce inflammation and improve skin health.

Who it's for

Adults, particularly women experiencing PMS or skin issues.

Cautions

  • • Consult a healthcare provider if you are pregnant, breastfeeding, or taking other medications.
  • • May cause mild digestive upset in some people.

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

About gamma

Gamma is a medication used to treat various conditions, particularly those related to nerve pain and certain mood disorders.

What it treats

  • nerve pain (neuropathic pain)
  • anxiety disorders
  • seizures (epilepsy)

How it works

Gamma helps to stabilize electrical activity in the brain and affects certain chemicals that send signals in the nervous system.

Who it's for

It is generally prescribed for adults and sometimes for children, depending on their specific condition.

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

About linolenic

Linolenic is a type of fatty acid that is important for overall health, particularly for heart health.

What it treats

  • high cholesterol (hyperlipidemia)
  • heart disease (cardiovascular disease)
  • inflammation

How it works

Linolenic helps to lower bad cholesterol levels and reduce inflammation in the body.

Who it's for

Linolenic is suitable for adults looking to improve their heart health and reduce inflammation.

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

About primrose

Primrose is a plant-based supplement often used for various health conditions.

What it treats

  • eczema (atopic dermatitis)
  • premenstrual syndrome (PMS)
  • menopausal symptoms
  • rheumatoid arthritis

How it works

Primrose is thought to help improve skin health and relieve symptoms related to hormonal changes.

Who it's for

Primrose may be suitable for adults looking for natural remedies for skin issues or hormonal symptoms.

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

Clinical monograph: evening

Evening primrose oil is derived from the seeds of the evening primrose plant (Oenothera biennis) and is commonly used as a dietary supplement. It contains gamma-linolenic acid (GLA), an omega-6 fatty acid that is believed to have anti-inflammatory properties. It is often used for conditions such as premenstrual syndrome (PMS), eczema, and rheumatoid arthritis, among others.

Indications

  • Premenstrual syndrome (PMS)
  • Eczema (atopic dermatitis)
  • Rheumatoid arthritis
  • Breast pain (mastalgia)
  • Menopausal symptoms

Dosage

Children: Refer to established guidelines or consult a healthcare professional for appropriate dosing in children. Specific dosing recommendations are not well established.

Adults: Refer to established guidelines or consult a healthcare professional for appropriate dosing. Typical doses range from 500 mg to 3000 mg of evening primrose oil per day, depending on the condition being treated.

Mechanism of action

Evening primrose oil exerts its effects primarily through the presence of gamma-linolenic acid (GLA). GLA is converted in the body into prostaglandins, which are compounds that help regulate inflammation and other physiological processes. By increasing the levels of prostaglandins, GLA may help to alleviate symptoms associated with inflammation and hormonal imbalances.

Pharmacodynamics

The pharmacodynamic effects of evening primrose oil are attributed to its fatty acid composition, particularly GLA. It has been shown to modulate inflammatory responses, enhance skin barrier function, and may influence hormonal regulation, providing symptomatic relief in conditions like PMS and eczema. The anti-inflammatory effect may also contribute to its use in managing conditions like rheumatoid arthritis.

Pharmacokinetics

Evening primrose oil is absorbed in the gastrointestinal tract and metabolized by the liver. The bioavailability of GLA may vary among individuals and can be influenced by dietary factors. The half-life of GLA is not well-defined in the literature. The oil is generally well-tolerated, but gastrointestinal side effects may occur in some users.

Pregnancy

Limited data is available on the use of evening primrose oil during pregnancy. Caution is advised.

Breast-feeding

Evening primrose oil is generally considered safe during breastfeeding, but consult a healthcare provider for personalized advice.

Storage

Store in a cool, dry place, 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: gamma

Gamma-aminobutyric acid (GABA) is a neurotransmitter in the central nervous system, primarily known for its inhibitory effects. It plays a crucial role in reducing neuronal excitability throughout the nervous system, making it significant in the modulation of muscle tone and anxiety levels. Gamma is often utilized in various forms, including as a supplement for its potential calming effects.

Indications

  • Anxiety disorders
  • Epilepsy
  • Muscle spasms
  • Sleep disorders
  • Neuropathic pain

Dosage

Children: Refer to specific pediatric dosing guidelines based on clinical indications and formulations available.

Adults: Refer to specific product guidelines or clinical protocols as dosages may vary based on the formulation and intended use.

Mechanism of action

GABA exerts its effects by binding to GABA receptors (specifically GABA-A and GABA-B receptors) in the brain. The binding leads to the opening of ion channels that allow the influx of chloride ions into the neuron, resulting in hyperpolarization of the neuron and decreased likelihood of action potential firing. This mechanism is pivotal in reducing anxiety, seizures, and muscle spasms.

Pharmacodynamics

The primary pharmacodynamic effect of GABA is its ability to inhibit neurotransmission, leading to sedation, relaxation, and anticonvulsant effects. GABA is also involved in various physiological processes, including the regulation of muscle tone and the modulation of mood.

Pharmacokinetics

GABA has a limited ability to cross the blood-brain barrier when administered orally, which may affect its bioavailability and efficacy as a therapeutic agent. It is primarily metabolized in the brain and liver, with its effects being influenced by the overall balance of excitatory and inhibitory neurotransmitters in the central nervous system. The half-life of GABA varies based on the route of administration and individual patient factors.

Contra-indications

  • Hypersensitivity to gamma-aminobutyric acid or any component of the formulation
  • Severe respiratory depression
  • Acute or severe liver disease
  • Myasthenia gravis
  • Pregnancy (unless under specific medical advice)

Adverse effects

  • Drowsiness
  • Dizziness
  • Ataxia
  • Nausea
  • Vomiting
  • Hypotension
  • Respiratory depression
  • Dependence potential
  • Withdrawal symptoms upon discontinuation

Interactions

  • CNS depressants (e.g., alcohol, benzodiazepines) may enhance sedative effects
  • Antidepressants may have additive effects leading to increased sedation
  • Medications that affect liver enzymes may alter gamma metabolism

Precautions

  • Use with caution in patients with a history of substance abuse
  • Monitor for signs of respiratory depression, especially in the elderly or those with pre-existing respiratory conditions
  • Gradual dose reduction is recommended to minimize withdrawal symptoms

Pregnancy

Not recommended unless the potential benefit justifies the potential risk to the fetus. Consult healthcare provider.

Breast-feeding

Use with caution. Gamma may be excreted in breast milk. Monitor infant for sedation.

Storage

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

Formulations

  • Oral tablets
  • Oral solutions
  • Injectable forms

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: linolenic

Linolenic acid is an omega-3 fatty acid that plays a crucial role in human health. It is a polyunsaturated fatty acid (PUFA) that is considered essential because the body cannot synthesize it. Linolenic acid is primarily found in plant oils, such as flaxseed oil, chia seeds, and walnuts. It is known for its anti-inflammatory properties and its potential benefits in cardiovascular health and brain function.

Indications

  • Cardiovascular disease prevention
  • Hyperlipidemia
  • Inflammatory conditions
  • Cognitive decline
  • General nutritional supplementation

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations based on age and condition.

Adults: Refer to specific clinical guidelines for dosing recommendations based on the condition being treated. Generally, dietary intake should include sources rich in linolenic acid, such as flaxseed oil or walnut oil.

Mechanism of action

Linolenic acid exerts its effects through its incorporation into cell membranes, influencing membrane fluidity and function. It serves as a precursor for the synthesis of eicosanoids, which are signaling molecules that mediate various physiological processes, including inflammation and immune response. Additionally, it activates the peroxisome proliferator-activated receptor (PPAR), which plays a role in lipid metabolism and inflammation regulation.

Pharmacodynamics

Linolenic acid contributes to the regulation of lipid metabolism and has been shown to lower triglyceride levels in the blood. It also has anti-inflammatory effects that may reduce the risk of chronic diseases such as atherosclerosis, rheumatoid arthritis, and other inflammatory conditions. The conversion of linolenic acid to eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in the body further enhances its beneficial effects on cardiovascular and neurological health.

Pharmacokinetics

Linolenic acid is absorbed in the gastrointestinal tract, and its bioavailability is influenced by dietary fat intake. Once absorbed, it is transported in the bloodstream bound to lipoproteins. It can be metabolized in the liver to longer-chain fatty acids, such as EPA and DHA. The half-life of linolenic acid in the body is variable and depends on dietary intake and metabolic demands. The elimination is primarily through metabolic conversion and incorporation into cellular structures.

Adverse effects

  • Diarrhea
  • Nausea
  • Abdominal pain
  • Bloating
  • Allergic reactions

Precautions

  • Use with caution in patients with a history of allergies to fish or shellfish.
  • Monitor for gastrointestinal discomfort in patients taking high doses.

Pregnancy

Consult a healthcare provider before use, as safety during pregnancy is not fully established.

Breast-feeding

Consult a healthcare provider before use, as safety during breastfeeding is not fully established.

Storage

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

Formulations

  • Capsules
  • Liquid oil

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: primrose

Primrose, commonly derived from the seeds of the evening primrose plant (Oenothera biennis), is primarily used as a dietary supplement. It is rich in gamma-linolenic acid (GLA), an omega-6 fatty acid believed to have various health benefits, including anti-inflammatory properties. It is often marketed for conditions such as eczema, premenstrual syndrome (PMS), and rheumatoid arthritis.

Indications

  • Eczema
  • Premenstrual syndrome (PMS)
  • Rheumatoid arthritis
  • Menopausal symptoms
  • Skin disorders

Dosage

Children: Refer to specific product guidelines, as dosages can vary based on formulation and indication.

Adults: Refer to specific product guidelines, as dosages can vary based on formulation and indication.

Mechanism of action

Gamma-linolenic acid (GLA) is metabolized to prostaglandin E1, which exerts anti-inflammatory effects. This pathway involves the conversion of GLA to dihomo-gamma-linolenic acid (DGLA), which is a precursor for the synthesis of anti-inflammatory prostaglandins, helping to modulate inflammatory responses in the body.

Pharmacodynamics

GLA is thought to alter the metabolism of arachidonic acid, leading to decreased production of pro-inflammatory eicosanoids. This can help alleviate symptoms associated with inflammatory conditions, and the fatty acids present in primrose may also contribute to skin barrier function and hydration, making it beneficial for skin-related disorders.

Pharmacokinetics

After oral administration, GLA is absorbed in the gastrointestinal tract, with peak plasma concentrations typically occurring within a few hours. It is then distributed throughout the body, where it can be incorporated into cell membranes. The metabolism of GLA involves conversion into various metabolites, including DGLA, and it is excreted mainly through urine and feces. The half-life of GLA can vary based on individual metabolism and dietary factors.

Adverse effects

  • Gastrointestinal upset
  • Nausea
  • Diarrhea
  • Headache
  • Allergic skin reactions

Interactions

  • May enhance the effects of anticoagulants
  • May interact with antipsychotic medications

Precautions

  • Use with caution in individuals with bleeding disorders
  • Monitor for potential allergic reactions

Pregnancy

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

Breast-feeding

Safety during breastfeeding has not been established. Consult a healthcare provider before use.

Storage

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

Formulations

  • Oil
  • Capsules
  • Tablets

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.