DIACALM TABLETS - summary of medicine characteristics

DiaCalm tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains:

56 mg of extract (as dry extract) from Valerian Root (Valeriana officinalis L.) (3–6:1),

Extraction solvent: ethanol 70% (v/v)

120 mg of extract (as dry extract) from St. John's Wort Herb (Hypericum perforatum L.) (3.5–6:1), Extraction solvent: ethanol 60% (m/m)

Each coated tablet also contains

Sucrose (171.4 mg) and glucose (15.9 mg) (See Section 4.4.’Special warnings and precautions for use.’

For a full list of excipients, see section 6.1.

Coated tablets, green, round, biconvex, smooth and glossy surface

4.1

Therapeutic indications

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

4.2 Posology and method of administration

For oral use only.

Adults and the elderly

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

One tablet to be taken one to three times daily.

To relieve sleep disturbances due to mild anxiety:

One tablet to be taken half an hour before going to sleep.

The tablets should be swallowed whole with some liquid.

The maximum recommended daily dose is 3 tablets.

This product is not recommended for use in children or adolescents under 18 years of age (see section 4.4 special warnings and precaution for use).

As the effects of this product may not occur immediately, the product should be taken continuously for 2–4 weeks.

If symptoms worsen, or persist after using the product for 4 weeks, a doctor or qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to any of the active ingredients or any of the excipients.

Concomitant use with any of the medicines specified in section 4.5.

This is because St. John’s Wort (Hypericum perforatum) has been shown to induce the cytochrome P450 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 some of these medicines.

In addition, pharmacodynamic interactions have also been identified with antidepressants, particularly the SSRI antidepressants (paroxetine, sertraline), nefazodone, or buspirone and with the triptan group of medicines.

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

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

If symptoms worsen, or persist after using the product for 4 weeks, a doctor or qualified healthcare practitioner should be consulted.

This product is intended for relief of slightly low mood, mild anxiety and of sleep disturbances due to 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 increased sensitivity to sunlight (photosensiti­zation) by St. John’s Wort. Persons using this product should avoid excessive sunbathing or the use of sunbeds or solariums.

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

This product 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 anaestesia (see section 4.5).

4.5 Interaction with other medicinal products and other forms of interaction

Only limited data on pharmacological interactions of valerian root with other medicinal products are available. Clinically relevant interactions with drugs metabolised by CYP2D6, CYP3A4/5, CYP1A2 or CYP2E1 pathway has not been observed. Additive effects with hypnotics and other sedative drugs cannot be excluded and therefore co-medication is not recommended as a general precaution.

The effect of Valerian may be potentiated by alcohol. Excessive concomitant consumption of alcohol should therefore be avoided.

Substances in St. John’s Wort have been shown to induce the cytochrome P450 (CYP)- isoenzymes CYP1A2, CYP2C19, 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.

The concomitant use of ciclosporin, tacrolimus for systemic use, amprenavir, indinavir or 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, fexofenandine, benzodiazepines, methadone, simvastatin, digoxin, finasteride) because a reduction in 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 (paroxetine, sertraline), nefazodone, or buspirone 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.

This product 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, use of this product 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

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

4.8 Undesirable effects

Gastrointestinal disorders (e.g. dyspepsia, anorexia, nausea, diarrhoea, constipation and abdominal cramps); allergic skin reaction (e.g. rash, urticaria, pruritis); fatigue and restlessness may occur. 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 occur, a doctor or 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

5   PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not required as per Article 16 c (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.

5.3 Preclinical safety data

The extracts of St. John's Wort and Valerian root were not mutagenic in a bacterial mutation assay.

Reproductive toxicity and carcinogenicity studies have not been performed.

6.1 List of excipients

Extract excipients:

maltodextrin

liquid glucose, spray-dried

silica, colloidal anhydrous

Tablet core:

cellulose microcrystalline

cellulose, powdered

croscarmellose sodium

silica, colloidal anhydrous

stearic acid 50

talc

Tablet coating:

sucrose

talc

calcium carbonate E170

acacia, spray dried

tragacanth

titanium dioxide E171

liquid glucose, spray dried

iron(III)-oxide hydrate E172 (= yellow iron oxide) iron(II,III)-oxide 80 E172 (= black iron oxide) carnauba wax

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 30°C. Keep the blister in the outer carton.

6.5 Nature and contents of container

PVC/PVDC-aluminium blisters. Original packs of 30, 60, 90, or 100 coated tablets.

Not all pack size may be marketed.

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Schwabe Pharma (UK) Ltd.

Alexander House, Mere Park, Dedmere Road,

Marlow SL7 1FX