Out of date information, search another

Kira Lowmood Relief

Out of date information, search another

Informations for option: Kira Lowmood Relief, show other option

SUMMARY OF PRODUCT CHARACTERISTICS

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).

One tablet contains 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 or any of the excipients.

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 (Hypericumperforatum) 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.

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

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.

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 (Hypericumperforatum) 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.

Co-administered drug	Interaction	Recommendations concerning coadministration
Anaesthetics /pre-operative medicines
Fentanyl Propofol Sevoflurane Midazolam	Reduced blood levels with risk of therapeutic failure	Based on the elimination half-lives of hypericin and hyperforin this product should be discontinued at least 10 days prior to surgery.
Analgesics
Tramadol	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Antianginals
Ivabradine	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Anti-arrhythmics
Amiodarone	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Antibacterials
Erythromycin	Reduced blood levels with	Do not take with this

Clarithromycin Telithromycin	risk of therapeutic failure.	product.
Anticoagulants
Warfarin Acenocoumarol	Reduced anticoagulant effect and need for increased dose.	Do not take with this product.
Antidepressants
Tricyclics eg. • Amitriptyline • Clomipramine MAOIs eg. • Moclobemide SSRIs eg. • Citalopram • Escitalopram • Fluoxetine • Fluvoxamine • Paroxetine • Sertraline Others eg. • Duloxetine • Venlafaxine	Increased serotonergic effects with increased incidence of adverse reactions.	Do not take with this product.
Antiepileptics
All drugs in this class including: • Carbamazepine • Phenobarbitone • Phenytoin • Primidone • Sodium valproate	Reduced blood levels with increased risk of frequency and severity of seizures.	Do not take with this product.
Antifungals
Itraconzole Voriconazole	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Antimalarials
Artemether	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.

Lumefantrine
Anti-Parkinsons
Rasagiline	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Antipsychotics
Aripiprazole	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Antivirals
HIV protease inhibitors: • Amprenavir • Atazanavir • Darunavir • Fosamprenavir • Indinavir • Lopinavir • Nelfinavir • Ritonavir • Saquinavir • Tipranavir	Reduced blood levels with possible loss of HIV suppression.	Do not take with this product.
HIV non-nucleoside reverse transcriptase inhibitors: • Efivarenz • Nevirapine • Delavirdine	Reduced blood levels with possible loss of HIV suppression.	Do not take with this product.
Anxiolytics
Buspirone	Increased serotonergic effects with increased incidence of adverse reactions.	Do not take with this product.
Aprepitant	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Barbiturates
Butobarbital Phenobarbital	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Bronchodilators
Theophylline	Reduced blood levels and loss of control of asthma	Do not take with this

	or chronic airflow limitation.	product.
Calcium channel blockers
Amlodipine Nifedipine Verapamil Felodipine	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Cardiac glycosides
Digoxin	Reduced blood levels and loss of control of heart rhythm or heart failure.	Do not take with this product.
CNS stimulants
Methyl phenidate	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Cytotoxics
Irinotecan Dasatinib Erlotinib Imatinib Sorafenib Sunitinib Etoposide Mitotane	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Hormonal contraceptives
Oral contraceptives Emergency hormonal contraception Hormonal implants, injections Transdermal patches, creams etc. Intra-uterine devices with hormones	Reduced blood levels with risk of unintended pregnancy and breakthrough bleeding.	Do not take with this product.
Hormone replacement therapy
Oral Transdermal patches Gels Vaginal rings	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.

Hormone antagonists
Exemestane	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Diuretics
Eplerenone	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
5HT agonists
Almotriptan Eletriptan Frovatriptan Naratriptan Rizatriptan Sumatriptan Zolmitriptan	Increased serotonergic effects with increased incidence of adverse reactions.	Do not take with this product.
Immunosupressants
Ciclosporin Tacrolimus	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Lipid regulating drugs
Simvastatin Atorvastatin	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Lithium	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Oral hypoglycaemic drugs
Gliclazide	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Proton pump inhibitors
Lansoprazole Omeprazole	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.
Thyroid hormones
Thyroxine	Reduced blood levels with risk of therapeutic failure.	Do not take with this product.

4.6 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.

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 Code: N06AX

ATC Group: Other antidepressants

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 pg/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

Shelf life

6.3

The shelf life is 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

Cassella-med GmbH & Co.KG (a company of the Klosterfrau Healthcare Group)

Gereonsmuehlengasse 1 50567 Cologne Germany

8 MARKETING AUTHORISATION NUMBER(S)

THR 29860/0004

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13/10/2010

10 DATE OF REVISION OF THE TEXT

06/07/2015