SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Potter’s Nodoff Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet contains: -

36 mg of extract (as dry extract) from Passion Flower (Passiflora incarnata L.) (equivalent to 126 mg - 162 mg Passion Flower herb)

Extraction Solvent: Methanol 80% v/v

Excipient(s): -

Each tablet contains 152 mg sorbitol. (See section 4.4 “Special warnings and precautions for use.”)

For a full list of excipients see section 6.1

3 PHARMACEUTICAL FORM

Tablet.

A light brown to brown round biconvex uncoated tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

A traditional herbal medicinal product used to aid to sleep, based on traditional use only.

4.2 Posology and method of administration

For oral use.

Adults and the elderly: Take two tablets early evening and two at bedtime.

The use 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 the symptoms persist, worsen or do not improve after 4 weeks during the use of the product, a doctor or a qualified healthcare practitioner should be consulted.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the symptoms persist, worsen or do not improve after 4 weeks during the use of the product, a doctor or a qualified healthcare practitioner should be consulted.

The use 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 contains sorbitol.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

4.5 Interaction with other medicinal products and other forms of interaction

Although no clinical data about interactions with synthetic sedatives are available, concomitant use with synthetic sedatives (such as benzodiazepines) is not recommended unless advised by a doctor.

4.6 Fertility, Pregnancy and lactation

Safety during pregnancy and lactation has not been established.

In the absence of sufficient data, the use during pregnancy and lactation is not recommended.

Tests on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

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

4.8 Undesirable effects

One case of hypersensitivity (vasculitis) and one case of nausea and tachycardia have been reported. The frequency is not known.

If other adverse reactions not mentioned above occur, a doctor or a qualified health care 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

No case of overdose has been reported.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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.

5.3 Preclinical safety data

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

6.1 List of excipients

Calcium Hydrogen Phosphate Sorbitol (E420)

Titanium Dioxide (E171)

Talc

Magnesium Stearate Brown Iron Oxide (E172) Vanillin Cocoa powder

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Three years.

6.4 Special precautions for storage

Do not store above 25°C. Keep in the original container.

6.5 Nature and contents of container

Tamper evident polyethylene/polyproylene pot packed in to a cardboard box: 28, 50, 60, 84 and 100 tablets.

PVC foil blister packs packed into a cardboard box: 30 and 60 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal

No special precautions for disposal.

MARKETING AUTHORISATION HOLDER

Soho Flordis UK Limited 1 Botanic Court,

Martland Park,

Wigan,

WN5 0JZ,

UK.

Trading as: Potters, Wigan WN5 0JZ

8    MARKETING AUTHORISATION NUMBER(S)

THR 44893/0012

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

27/03/2012

10 DATE OF REVISION OF THE TEXT

28/09/2015