HYPERIDRINE - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

HYPERIDRINE Capsules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each capsule contains 300mg of St John’s Wort aerial parts (Hypericum perforatum

L.)

For full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Hard capsules.

Clear size 0 hard capsules.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Hyperidrine is a traditional herbal medicinal product used to relieve the symptoms of slightly low mood and mild anxiety, based on traditional use only.

4.2 Posology and method of administration

For oral use only. Adults and the Elderly: Take one capsule three times a day, swallowed with water.

A doctor or qualified healthcare practitioner should be consulted if symptoms worsen or do not improve after 6 weeks.

Not recommended for children or adolescents under 18 years (See Section 4.4 Special warnings and precautions for use).

4.3 Contraindications

Hypersensitivity to St John’s Wort or any of the excipients.

P atients with known dermal photosensitivity or those undergoing phototherapy or any photodiagnostic procedures.

Concomitant use with any of the medicines specified in section 4.5. This is because St. John’s wort (Hypericum performatum) has been shown to induce the cytochrome P450 isoenzymes CYP1A2, CYP2C19, CYP2C9 and CYP3A4 as well as the transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines including a possible decrease in the effectiveness of those medicines.

Pharmacodynamic interactions have also been identified with antidepressants, particularly the SSRI antidepressants and the triptan group of medicines.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Not recommended for children and adolescents under 18 years of age because data are not sufficient and medical advice should be sought.

If the condition worsens, or if symptoms persist for more than 6 weeks a doctor or a qualified healthcare practitioner should be consulted.

Hyperidrine is intended for the relief of symptoms of slightly low mood and mild anxiety. Patients with signs and symptoms of depression should consult a doctor for appropriate treatment.

In very rare cases, particularly in fair-skinned individuals, sunburn type reactions may occur on skin areas exposed to strong sunlight due to photosensitisation by St. John’s Wort. Patients taking Hyperidrine should avoid excessive sunbathing or the use of sunbeds or solariums.

Hyperidrine should be discontinued at least 10 days prior to elective surgery due to the potential for St.John’s Wort to interact with drugs used during general and regional anaesthesia.

4.5 Interaction with other medicinal products and other forms of interaction

Substances in St John’s Wort (Hypericum perforatum) have been shown to induce Cytochrome P450 isoenzymes CYP1A2, CYP2C19, CYP2C9 and CYP3A4 as well as the transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines leading to a potential decrease in the effectiveness of those medicines.

The concomitant use of ciclosporin, tacrolimus for systemic use, amprenavir, indinavir and other protease inhibitors, irinotecan and warfarin is contraindicated

Special care should be taken in case of concomitant use of all drug substances the metabolism of which is influenced by CYP1A2, CYP3A4, CYP2C9, CYP2C19 or P -glycoprotein (e.g. amitriptyline, fexofenadine, benzodiazepines, methadone, simvastatin, digoxin, finasteride), because a reduction of plasma concentration is possible.

Users of oral contraceptives taking St John’s Wort (Hypericum perforatum) may experience intracyclic menstrual bleeding and risk of contraception failure is increased.

Clinically significant pharmacodynamic interactions have also been identified with the SSRI antidepressants and the triptan group of medicines used to treat migraines. Due to the increased risk of undesirable effects associated with these interactions this product should not be used concomitantly with these types of Medicines.

Therefore, Hyperidrine (St John’s Wort) should not be taken concomitantly with the Medicines included in the following table.

4.6 Fertility, pregnancy and lactation

The safety of Hyperidrine (St John’s Wort) during pregnancy and lactation has not been established. In the absence of sufficient data, use during pregnancy and lactation is not recommended.

No studies on the effects on fertility have been performed.

4.7 Effects on ability to drive and use machines

No adequate studies on the effect on the ability to drive and use machines have been performed.

4.8 Undesirable effects

Gastrointestinal disorders including dyspepsia, anorexia, nausea, diarrhoea or constipation; allergic skin reactions such as rash, urticaria, pruritis; fatigue and restlessness have been reported.

The frequency is not known.

Fair-skinned individuals may react with intensified sunburn-like symptoms under intense sunlight or strong ultra-violet (UV) irradiation.

Other adverse reactions that have been reported include headaches, neuropathy, anxiety, dizziness and mania. If other adverse reactions not mentioned above occur, a doctor, pharmacist or a qualified healthcare practitioner should be consulted.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continual monitoring of the benefit/risk of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow card Scheme at www.mhra.gov.uk/yellowcard

4.9 Overdose

No cases of overdose have been reported.

After the intake of up to 4.5g dry extract per day for 2 weeks and additionally 15g dry extract just before hospitalisation seizures and confusion have been reported.

When a large overdose has occurred, phototoxic reactions may occur. The skin of the patient should be protected for 1–2 weeks from UV irradiation and sunlight. Outdoor activities should be restricted and clothes and/or sun block preparations used to protect the skin from sunlight. Symptomatic and supportive measures should be taken as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Herbal medicinal product for treatment of depressive disorders.

ATC Code: N06AX

The active constituents of Hyperidrine (St John’s Wort) have not been definitively established. However, hypericin, pseudohypericin hyperforin and the flavonoids are considered to have synergistic activity.

5.2 Pharmacokinetic properties

No definitive pharmacokinetic data available.

The active ingredients of Hyperidrine (St John’s Wort) can interact with other medicinal agents in two ways. Firstly, active ingredients in Hyperidrine (St John’s Wort) themselves are metabolised in the liver by the CYP3A isoenzymes, increase (induce) the activity of this enzyme so that it accelerates the elimination of other medicinal agents which are degraded by the same pathway. This leads to a consequent reduction in the plasma concentration and effectiveness of these other substances. Secondly, the active ingredients in Hyperidrine (St John’s Wort), like other type SRI or SSRI medicinal agents with an antidepressant action, can raise the concentration of serotonin in certain parts of the central nervous system so that this neurotransmitter can sometimes reach toxic levels, particularly when drugs containing St John’s Wort are combined with other antidepressants.

5.3 Preclinical safety data

Reverse mutation assays (Ames test) on bacteria indicated that the product was not mutagenic in Salmonella typhimurium (strains TA 98, TA 100, TA 1535 and TA 1537) mutation assays with or without metabolic activation.

Adequate tests on reproductive toxicity and carcinogenicity have not been performed.

Phototoxicity:

After oral application of dosages of 1800mg of an extract per day for 15 days the skin sensitivity against UVA was increased and the minimum dose for pigmentation was significantly reduced. In the recommended dosage, no signs of photoxicity are reported.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Hypromellose (Capsule shell).

6.2 Incompatibilities

Not Applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 25°C. Store in the original packaging.

6.5 Nature and contents of container

Duma 110ml HDPE plastic bottle and tamper evident threaded Duma cap. Duma

200ml HDPE plastic bottle and tamper evident press on Duma cap.

60 or 120 Capsules.

6.6 Special precautions for disposal and other handling There are no special precautions.

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