PRODUCT DESCRIPTION

NATROCEUTICS ASHWAGANDHA is an Ayurvedic remedy to assist with relief from stress. It is an adaptogenic herb that may help the body to resist physiological stress.

RECOMMENDED USAGE

Adults and children over 12 years - 2 capsules per day for the first 30 days. Thereafter , take 1 to 2 capsules per day as needed or as recommended by your healthcare professional. Avoid use in children younger than 12 years.

COMPOSITION

OTHER INGREDIENTS

Brown rice flour, magnesium stearate and silicon dioxide in a clear vegetable . Sugar free

DOES NOT CONTAIN

Sugar

STORAGE

Store at or below 25°C. Keep in outer container until required for use. Protect from light and moisture.

PRODUCT FORM

Capsule

WARNINGS/CONTRAINDICATION

• Patients with hypersensitivity to ashwagandha or any of the other components of the formulation (see Section 2 Qualitative and Quantitative Composition and Section 6.1 List of excipients)
• Pregnancy (see Section 4.6 Fertility, Pregnancy, and Lactation).
• Ashwagandha may have immunostimulant effects. Until more is known, use in patients with autoimmune diseases, such as multiple sclerosis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA) or others, should be avoided. Alternatively, NATROCEUTICS ASHWAGANDHA should be used with caution while patients are carefully monitored for exacerbations (see also Section 4.5 Interactions with other medicines and other forms of interaction).
• NATROCEUTICS ASHWAGANDHA has sedative effects and might cause additive central nervous system depression when taken in conjunction with anaesthetic agents and other medicines used in the perioperative period (see Section 4.5 Interactions with other medicines and other forms of interaction). Advise patients to discontinue NATROCEUTICS ASHWAGANDHA at least 2 weeks prior to elective surgical procedures.
• Human and animal research has shown that ashwagandha stimulate thyroid hormone synthesis or secretion and hence NATROCEUTICS ASHWAGANDHA should be used with caution in patients with hyperthyroidism or those receiving treatment with thyroid hormones (see Section 4.5 Interactions with other medicines and other forms of interaction). Advise such patients to stop taking NATROCEUTICS ASHWAGANDHA when they experience symptoms of hyperthyroidism (e.g., unintentional weight loss, tachycardia, dysrhythmias, palpitations, increased appetite, and nervousness, anxiety, or irritability) and to report to their treating doctor.
• Interactions with other medicines and other forms of interaction Interaction with Medicines ANTIDIABETIC MEDICINES: Preliminary clinical evidence has indicated that ashwagandha might lower blood glucose levels and hence NATROCEUTICS ASHWAGANDHA should be used with caution by those receiving treatment with antidiabetic medicines. Advise patients to regularly monitor blood glucose levels when treatment with NATROCEUTICS ASHWAGANDHA is initiated or discontinued.
• BENZODIAZEPINES: NATROCEUTICS ASHWAGANDHA may increase the sedative effects of benzodiazepines. Preliminary evidence has indicated that ashwagandha might have an additive effect with diazepam and clonazepam, which may also occur with other benzodiazepines.
• CENTRAL NERVOUS SYSTEM DEPRESSANTS: Given its sedative properties, NATROCEUTICS ASHWAGANDHA may potentiate the effects of barbiturates, other sedatives, and anxiolytics (see Section 4.4 Special warnings and precautions for use).
• IMMUNOSUPPRESSANTS: Since ashwagandha may have immunostimulant properties, NATROCEUTICS ASHWAGANDHA may decrease the effects of immunosuppressants (see Section 4.4 Special warnings and precautions for use). Preliminary evidence has shown that ashwagandha might decrease immunosuppression caused by cyclophosphamide
• THYROID HORMONE: Concomitant use of NATROCEUTICS ASHWAGANDHA with thyroid hormones may result in additive therapeutic and adverse effects. Preliminary clinical research has indicated that ashwagandha boosts thyroid hormone synthesis and secretion (see Section 4.4 Special warnings and precautions for use).
• Interaction with Herbs and Supplements Concomitant use of NATROCEUTICS ASHWAGANDHA with other herbs and supplements with sedative properties might enhance therapeutic and adverse effects.
• Interactions with Laboratory Tests Ashwagandha contains withaferin A which is similar in structure to digoxin and thus people taking NATROCEUTICS ASHWAGANDHA might display falsely elevated digoxin levels when digoxin levels are determined with fluorescence polarizationimmunoassays (FPIA), microparticle enzyme immunoassays (MEIA) or the Abbott Digoxin III assay. The Beckman assay for digoxin appears to be only minimally affected, while the Roche Tina-Quant turbidimetric inhibition immunoassay is only affected by very high ashwagandha levels, equivalent to plasma levels following an overdose.
• Fertility, pregnancy, and lactation NATROCEUTICS ASHWAGANDHA is contraindicated in pregnancy (see Section 4.3 Contraindications). Ashwagandha has abortifacient effects. Use during breastfeeding should be avoided due to lack of sufficient reliable information. The effect on fertility is unknown
• Effects on ability to drive and use machines NATROCEUTICS ASHWAGANDHA has sedative properties and may adversely affect a person’s ability to perform tasks requiring alertness and concentration. These include, but are not limited to, driving, operating machinery or leisure activities such as rock climbing. Users should be advised to determine how NATROCEUTICS ASHWAGANDHA affects them before they engage in these activities
• Ashwagandha appears to be well tolerated when taken orally. The most common side effects are gastrointestinal in nature and include diarrhoea, gastrointestinal upset, nausea, and vomiting. These side effects do not occur commonly with the recommended dosage of NATROCEUTICS ASHWAGANDHA.
• Gastrointestinal disorders Frequency unknown:* Diarrhoea, gastrointestinal upset, nausea, vomiting, abdominal pain, gastritis, flatulence.
• Hepatobiliary disorders Frequency unknown: Liver injury (in doses ranging from 450 to 1350 mg daily).
• Skin and subcutaneous tissue disorders Frequency unknown: Dermatitis.