SUMMARY OF PRODUCT CHARACTERISTICS 1    NAME OF THE MEDICINAL PRODUCT

Valerina Night-Time film-coated tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains:

60 mg of extract (as dry extract) equivalent to 420-600 mg of Valerian root (Valeriana officinalis L.).

Extraction solvent: Ethanol 60% V/V.

65 mg of extract (as dry extract) equivalent to 293-553mg of Hops strobile (Humulus lupulus L.).

Extraction solvent: Ethanol 70% V/V.

17.5 mg of extract (as dry extract) equivalent to 124-200 mg of Lemon Balm leaf (Melissa officinalis L).

Extraction solvent: Ethanol 60% V/V.

Excipient(s): One tablet contains 278 mg of lactose monohydrate.

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Film-coated tablet

Round, biconvex, off-white tablets.

4    CLINICAL PARTICULARS

4.1

4.2 Posology and method of administration

For oral short term use only.

Adults and the elderly

2 tablets L2- 1 hour before bed time. If necessary 1-2 additional tablets can be taken earlier in the evening.

The tablets should be swallowed whole with liquid.

As treatment effects may not be apparent immediately, Valerina Night-Time should be taken for at least 2 - 4 weeks continuously.

If symptoms worsen or do not improve after 4 weeks a doctor or qualified healthcare practitioner should be consulted.

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

4.3 Contraindications

Hypersensitivity to Valerian, Hops, Lemon balm or to any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

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

One tablet contains 278 mg lactose monohydrate.

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

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

4.5 Interaction with other medicinal products and other forms of interaction

Valerian extract: Only limited data on pharmacological interactions with other medicinal products are available. Clinically relevant interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP1A2 or CYP 2E1 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.

Hops extract and Lemon Balm extract: No data on interactions are presently known.

The effect of the product may be potentiated by alcohol. Excessive consumption of alcohol should therefore be avoided.

4.6 Pregnancy and lactation

Safety during pregnancy and lactation has not been established. Due to the lack of data, use during pregnancy and lactation is not recommended.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

Gastrointestinal symptoms, such as nausea and abdominal cramps, may occur after ingestion of valerian root preparations. The frequency is not known.

There are no known adverse effects with Hops or Lemon Balm.

If other adverse reactions not mentioned above 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 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 at: www.mhra.gov.uk/yellowcard.

4.9 Overdose

Valerina Night-Time: No cases of overdoses have been reported.

Valerian root at a dose of approximately 20 g (equivalent to 50 tablets) caused benign symptoms (fatigue, abdominal cramp, chest tightness, lightheadedness, hand tremor and mydriasis), which disappeared within 24 hours. If symptoms arise, treatment should be supportive.

After intake of very high doses of Valerian root over several years (daily consumption corresponding to approximately 30 g of the drug) withdrawal symptoms (delirium) have been reported.

Hops extract and Lemon Balm extract: No cases of overdose have been reported. Symptomatic and supportive measures should be taken as appropriate.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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

Pharmacokinetic properties

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

5.3 Preclinical safety data

Melissa extract: Data from in vitro and animal studies indicate that a water extract of Melissa officinalis may inhibit the activity of thyroid stimulating hormone (TSH). The clinical relevance of these findings is not known.

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed with the Valerian, Hops and Lemon Balm extracts.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Extract excipients

Lactose monohydrate Cellulose

Colloidal anhydrous silica

Tablet core Lactose monohydrate Potato Starch Magnesium Stearate

Tablet coating Hypromellose Titanium Dioxide Macrogol 6000 Paraffin, hard

6.2 Incompatibilities

Not applicable.

Shelf life

2 years

6.4 Special precautions for storage

Do not store above 25 °C. Keep in original package

6.5 Nature and contents of container

Each cardboard carton of 40 tablets consists of 2x20 foil strip blister packs Each cardboard carton of 60 tablets consists of 3x20 foil strip blister packs Each cardboard carton of 80 tablets consists of 4x20 foil strip blister packs

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Pharbio Medical International AB Box 715

SE-194 27 Upplands Vasby Sweden

8    MARKETING AUTHORISATION NUMBER(S)

THR 15525/0008

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

19/11/2010

10    DATE OF REVISION OF THE TEXT

03/03/2015