Stressless Tablets

1. Name Of The Medicinal Product

STRESSLESS™ TABLETS

2. Qualitative And Quantitative Composition

Hops 45 mg; Scullcap 45 mg; Dry Extract Valerian (5:1) 20 mg; Dry Extract Vervain (3:1) 30 mg.

3. Pharmaceutical Form

Tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

1	A herbal remedy traditionally used for the relief of nerve strain and nervous tension due to the stress and strain of modern life.
2	A herbal remedy traditionally used for the progressive relief of mild anxiety.
3	A herbal remedy used for the temporary relief of the nervous strain of giving up tobacco smoking.

4.2 Posology And Method Of Administration

To be taken by mouth.

For adults and the elderly: Two tablets three times a day. In severe cases, three tablets three times a day for two weeks, then two tablets three times a day.

Children 8 – 12: One tablet twice a day at the discretion of the practitioner.

For withdrawal symptoms of tobacco addiction: Three tablets three times a day.

4.3 Contraindications

Do not use if sensitive to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Because it contains sucrose, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None established. However, particularly if Stressless is taken with alcohol, the effect of hypnotics or sedatives may be increased, and the central nervous depressant activity of neuroleptics, antidepressants or anaesthetics may theoretically be prolonged. In addition, Stressless may theoretically inhibit or potentiate the effects of antiepileptics and antihypertensives.

4.6 Pregnancy And Lactation

Because data on use during pregnancy and lactation are not available, as a general precaution Stressless is not recommended.

4.7 Effects On Ability To Drive And Use Machines

Stressless may theoretically slow reaction times, so caution is recommended before driving or operating machinery. The sedative effect of alcohol consumption may be enhanced by taking Stressless.

4.8 Undesirable Effects

None established under the recommended conditions of use.

4.9 Overdose

Overdose may cause drowsiness. This should resolve on discontinuing treatment.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Each herbal ingredient is classified as a herbal relaxant.

5.2 Pharmacokinetic Properties

No special information.

5.3 Preclinical Safety Data

No special information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose; Talc; Potato Starch; Magnesium Stearate; Kaolin; E171.

6.2 Incompatibilities

None.

6.3 Shelf Life

36 months.

6.4 Special Precautions For Storage

None.

6.5 Nature And Contents Of Container

White plastic container with tamper-evident cap, containing 75 tablets.

6.6 Special Precautions For Disposal And Other Handling

None.

7. Marketing Authorisation Holder

Diomed Herbals

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK

8. Marketing Authorisation Number(S)

17418/0002.

9. Date Of First Authorisation/Renewal Of The Authorisation

7 December 2010.

10. Date Of Revision Of The Text

March 2008.