SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Aspar Herbal Sleep Aid Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains

50 mg of extract (as dry extract) from Valerian root (Valeriana officinalis L. )(5:1) Extraction solvent: ethanol 45%v/v

50 mg of extract (as dry extract) from Verbena herb (Verbena officinalis L.) (3:1) Extraction solvent: water

24 mg of extract (as dry extract) from Gentian root (Gentiana lutea L.) (5:1)

Extraction solvent: ethanol 100 % v/v

30 mg of Scullcap herb (Scutellaria lateriflora L.)

Each coated tablet contains 21 mg of sucrose (See section 4.4 ‘Special warnings and precautions for use’.)

For full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM

Coated tablets

Pale green-grey, round biconvex coated tablet

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used for the temporary relief of sleep disturbances and mild anxiety, based on traditional use only.

4.2 Posology and method of administration

For oral short term use only

For mild anxiety: Adults and the elderly: - Three tablets to be taken three times daily with the last dose being taken one hour before bedtime.

For sleep disturbances: Adults and the elderly:- Three tablets to be taken one hour before bedtime.

Maximum daily dose: 9 tablets

The use in children or adolescents under 18 years of age is not recommended (see Section4.4 ‘Special warnings and precautions for use’)

As treatment effects may not be immediately apparent, this product should be taken for 2 - 4 weeks continuously.

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

4.3 Contraindications

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

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

Contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-glacatose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

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

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

4.5 Interaction with other medicinal products and other forms of interaction

For Valerian root only limited data on pharmacological interactions with other medicinal products are available. Clinical relevant interaction with drugs metabolised by the CYP 2D6, CYP 3A4/5, CYP 1A2 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 unless advised by a doctor.

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

4.6 Fertility, 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. Studies on fertility have not been carried out.

4.7    Effects on ability to drive and use machines

May impair the ability to drive or operate machines. If affected do not drive or operate machines

4.8    Undesirable effects

Gastrointestinal symptoms e.g nausea, abdominal cramps may occur after ingestion of Valerian root preparations. The frequency is not known.

Gastrointestinal disorders have been observed with Gentian root. In rare cases, tachycardia and pruritus have been reported. Headaches may occur. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9 Overdose

Valerian root at a dose of approximately 20 g (equivalent to 35 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.

Symptomatic and supportive measures should be taken as appropriate.

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 16 c (1) (a) (iii) of Directive 2001/83/EC as amended.

5.3 Preclinical safety data

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed

For some xanthones which are among the constituents of Gentiana lutea, positive results were found in the AMES test (pre-incubation method).

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Powdered gum asafoetida

Sucrose

Talc

Magnesium stearate

Sodium starch glycollate Type A.

Tablet Coating:

Titanium dioxide (E171)

Iron oxide black (E172)

Yellow ferric oxide (E172)

Syrup.

6.2 Incompatibilities

None known

Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C

Store in the original package

6.5 Nature and contents of container

1. White high-density polyethylene tub.

Closure: White high-density polyethylene cap (tamper evident). Pack sizes: 100 and 200 tablets.

3. White opaque, polyvinyl chloride film, minimum thickness 250 pm, coated with 40g/m2 PVC

Closure: Aluminum foil of 20 pm thickness printed on the brighter side and coated on the dull side with a heat sealable lacquer.

Pack sizes: 24 and 60 tablets

Not all pack sizes may be marketed

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Aspar Pharmaceuticals

29-30 Capitol Way

Colindale

London

NW9 0EQ

8    MARKETING AUTHORISATION NUMBER(S)

THR 08977/0066

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

21/03/2013

10 DATE OF REVISION OF THE TEXT

21/03/2013