BOTANOVA FILM-COATED TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

BOTANOVA, Film-coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:

60 mg of extract (as dry extract) from St John's Wort Herb (Hypericum perforatum L.) (4.6–6.5:1),

Extraction solvent: ethanol 38% (m/m);

28 mg of extract (as dry extract) from Valerian Root (Valeriana officinalis L.) (3.85.6:1),

Extraction solvent: ethanol 40% (m/m);

32 mg of extract (as dry extract) from Passion Flower Herb (Passiflora incarnata L.) (6.25–7.1:1),

Extraction solvent: ethanol 60% (m/m)

Each film-coated tablet also contains:

Lactose monohydrate (90.5 mg) and glucose (10.4 mg).

For a full list of excipients, see section 6.1.

Film-coated tablets.

Light blue, biconvex, round, film coated tablets.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Traditional herbal medicinal product used to relieve slightly low mood and mild anxiety, and sleep disturbances due to symptoms of mild anxiety, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only.

Adults and the elderly

To help relieve symptoms of slightly low mood and mild anxiety:

Two tablets to be taken one to three times daily.

To relieve sleep disturbances due to symptoms of mild anxiety:

Two tablets to be taken before going to sleep.

The tablets should be swallowed whole with some liquid.

The maximum daily dose is 6 tablets

The use of this product in children and adolescents under 18 years of age is not recommended. (See Section 4.4. Special warnings and precautions for use)

Duration of use

If symptoms persist or worsen after 6 weeks of using the medicinal product, a doctor or qualified healthcare practitioner should be consulted

4.3 Contraindications

Hypersensitivity to any of the active ingredients 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 (Hypericum perforatum) has been shown to induce the cytochrome P450 isoenzymes CYP1A2, 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 some of these medicines.

P harmacodynamic 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

The recommended dose should not be exceeded.

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

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

In very rare cases, particularly in light-skinned persons, sun burn 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 medicines used during general and regional anaesthesia (see Section 4.5)

Patients with rare glucose-galactose malabsorption and/or with rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Substances in St John’s Wort have been shown to induce the cytochrome P450 (CYP) isoenzymes CYP1A2, CYP2C9, and CYP3A4 and the drug transport protein P-glycoprotein. This results in pharmacokinetic interactions with a large number of medicines leading to a potential decrease in the effectiveness of some of these medicines. Clinically significant interactions have been reported with, for example: warfarin, cyclosporin, HIV Protease inhibitors, theophylline, digoxin, oral contraceptives, and anticonvulsants. 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.

In accordance with the above considerations, BOTANOVA should not be taken concomitantly with the medicines included in the table below.

4.6 Fertility, pregnancy and lactation

Safety during pregnancy and lactation has not been established. In the absence of sufficient data, taking BOTANOVA 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

May impair the ability to drive and use machines. Affected patients should not drive or operate machinery.

4.8 Undesirable effects

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

Gastrointestinal symptoms, such as nausea, vomiting, abdominal cramps, dyspepsia, constipation and diarrhoea may occur. The frequency is not known.

Additionally allergic skin reactions (e.g. rash, urticaria, pruritus) fatigue and restlessness may occur.

Other adverse reactions that have been reported include anorexia, headaches, neuropathy, anxiety, dizziness and mania.

The frequency is not known.

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

No cases have been documented for overdose of BOTANOVA. If any symptoms arise, treatment should be supportive.

There are 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 one week from UV irradiation. 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.

Valerian root at a dose of approximately 20g caused symptoms such as fatigue, abdominal cramp, chest tightness, light-headedness, hand temor and mydriasis, which disappeared within 24 hours.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antidepressive and anxiolytic traditional herbal medicinal product

ATC code: NO6AP51

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

5.2 Pharmacokinetic properties

Not required as per Article 16c(1)(a)(iii) of Directive 2001/83/EC as amended.

No studies of the pharmacokinetics of the total extract have been carried out. Studies of the pharmacokinetics of specific constituents of St John's Wort (hypericin, pseudohypericin) considered marker substances indicate that onset of absorption is approximately 0.3 to 2.6 hours after oral dosing, and that the blood plasma concentrations of these constituents of St John’s Wort are dose-related.

Valerian Root and Passion Flower Herb

No specific studies of Valerian Root extract and Passion Flower Herb extract are available.

5.3 Preclinical safety data

There is no evidence that BOTANOVA, or its constituent herbal extracts, exert any toxic effects. The traditional-use of the individual constituent herbs, as well as the clinical use BOTANOVA have not revealed significant evidence of any toxicity. Modern standard tests performed on BOTANOVA revealed no evidence of any genotoxicity. Tests on reproductive toxicity and carcinogenicity have not been performed on extracts of St. John's wort, Passion flower or Valerian.

6.1

Excipients of the herbal preparation:

Lactose monohydrate glucose, liquid, spray-dried maltodextrin silica, colloidal anhydrous.

Excipients of the tablet:

Lactose monohydrate silica, colloidal anhydrous talc;

magnesium stearate

povidone K30 glycerol (85 per cent) croscarmellose sodium.

Excipients of the film coating:

Basic butylated methacrylate copolymer talc

titanium dioxide (E 171)

indigo carmine laquer (E 132)

macrogol 6000 magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years.

6.4 Special precautions for storage

Do not store above 30°C. Keep the Blister in the outer carton in order to protect from light.

6.5 Nature and contents of container

Aluminium/PVC/Aclar-blisters; containing 20 film-coated tablets per blister.

Original packs of

60 and 100 film-coated tablets

6.6 Special precautions for disposal No special requirements.

7 MARKETING AUTHORISATION HOLDER

PASCOE pharmazeutische Präparate GmbH

Schiffenberger Weg 55

D-35394 Giessen, Germany

Phone +49 (0) 641–7960–0

Fax +49 (0) 641–7960–109

e-mail: info@pascoe.de

8 MARKETING AUTHORISATION NUMBER(S)

THR 14369/0007

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

08/08/2016