Kira Lowmood Relief – Summary of Product Characteristics (SmPC) for healthcare professionals

1 NAME OF THE MEDICINAL PRODUCT

Kira^® LowMood Relief

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:

450mg of extract (as dry extract) from St. John’s Wort aerial parts (Hypericum perforatum L.) (3 – 6 : 1) (equivalent to 1350 -2700 mg of St. John’s Wort). Extraction Solvent:

Methanol 80% (v/v).

Excipients with known effect: 19.15 mg lactose monohydrate and 42 mg of soy polysaccharides.

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Film-coated tablet.

Oval, yellow coated tablets with smooth, undamaged surface.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

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.

For adults and the elderly, take 1 tablet daily. The tablets should be swallowed whole with a little liquid. The tablets should not be chewed. The patient should consult a doctor or a qualified healthcare practitioner if symptoms worsen or do not improve after 6 weeks.

Kira LowMood relief tablets are not for use in children and adolescents under 18 years old. (See Section 4.4 Special warnings and precautions for use.)

4.3 Contraindications

Hypersensitivity to the active ingredient, soya, peanut or any of the excipients listed in section 6.1.

This medicine contains soya. Patients who are allergic to peanut or soya must not use this medicinal product.

Patients with known dermal photosensitivity or patients undergoing phototherapy or any photodiagnostic procedures.

This product should not be taken concomitantly with the medicines included in section 4.5. This is because St. John’s Wort (Hypericum perforatum) has been shown to induce the cytochrome P 450 isoenzymes CYP1A2, CYP2C19, CYP2C9 and CYP3A4 as well as transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines including leading to a possible decrease in the effectiveness of those medicines. In addition, pharmacodynamic interactions have also been identified with antidepressants, particularly the SSRI antidepressants and with the triptan group of medicines.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the condition worsens, or if symptoms persist for more than six weeks medical advice should be sought.

The use of this product in children or adolescents under 18 years old is not recommended because data are not sufficient and medical advice should be sought.

This product is intended for the relief of symptoms of slightly low mood and mild anxiety. Patients with signs and symptoms of depression should seek medical advice for appropriate treatment.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Note for diabetics: This medicines contains lactose, resulting in 0.33 kjoules in total.

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

This product should be discontinued at least 10 days prior to elective surgery due to the potential for interactions with medical products used during general and local anaesthesia (see section 4.5).

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 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 leading to 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, CYP2C19, CYP2C9, CYP3A4 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 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 this product should not be taken concomitantly with the medicines included in the table below.

4.6 Fertility, Pregnancy and lactation

The safety of the product during pregnancy and lactation has not been established. In the absence of sufficient data, the 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 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, constipation; allergic skin reaction 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 continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme:

Website: www.mhra.gov.uk/yellowcard

4.9 Overdose

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

There is no data on human overdose with St. John’s Wort. Where a large overdose has occurred, phototoxic reactions may occur. The skin of the patient should be protected for 1-2 weeks from UV light sources, irradiation and sunlight. Outdoor activities should be restricted and clothes and/or sun block preparations should be used to protect the skin from sunlight. Symptomatic and supportive measures should be taken as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

ATC Group: Other antidepressants

ATC code: N06AX

The active constituents of St. John’s Wort have not been definitively established. However, the phloroglucinol constituent hyperforin and constituents of the hypericin group are thought to play an important role in its activity.

5.2 Pharmacokinetic properties

Two different pathways of interaction are known for the active ingredients of St. John’s Wort and other drugs.

The active ingredients of St. John’s Wort are metabolised in the liver by the CYP3A4 isoenzyme which induces its activity. The induced activity of CYP3A4 causes the accelerated elimination of other drugs metabolised by this enzyme. This can lead to reduction of plasma levels and reduced effectiveness of these drugs.

Moreover, as any other SRI or SSRI the active ingredient of St. John’s Wort can increase the concentration of serotonin in certain parts of the central nervous system. This can lead to toxic levels of serotonin. This is particularly the case when drugs containing St. John’s Wort are combined with other antidepressants.

5.3 Preclinical safety data

The genotoxic potential of the dry extract was investigated in the bacterial reverse mutation test and was not mutagenic at concentrations of up to 5000 µg/plate under the test conditions described.

There is no information on any components within the drug product composition which gives cause for mutagenic concern. Tests on reproductive toxicity revealed equivocal results. Tests on the carcinogenic potential have not been performed. Phototoxicity:

After oral application of dosages of 1800 mg of an extract 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 phototoxicity are reported.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Excipients of the herbal extract:

Lactose monohydrate

Silica, colloidal anhydrous

Excipients of the tablet core:

Cellulose, microcrystalline

Soy polysaccharides

Long-chain partial glycerides

Silica, hydrophobic colloidal anhydrous

Excipients of the film-coating:

Hypromellose

Cellulose, microcrystalline

Stearic acid

Titanium dioxide E 171

Iron oxide hydrate E172 (yellow iron oxide)

Vanillin

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Do not store above 25°C. Store in the original packaging.

6.5 Nature and contents of container

Original packages containing 30 or 60 film-coated tablets. Kira LowMood relief tablets are packed in PVC/PVDC aluminium blisters and inserted into a carton.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Precision Healthcare Limited

89, High Street

Hadleigh

Ipswich

Suffolk, IP7 5EA

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

THR 43546/0001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

17/11/2016

10 DATE OF REVISION OF THE TEXT

01/08/2019