NEUREXAN TABLETS - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Neurexan tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

1 tablet (301.5 mg) contains:

Excipient with known effect:

Contains lactose monohydrate.

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Tablets

Neurexan tablets are white to yellow-white, round, flat with beveled edges.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

A homeopathic medicinal product used within the homeopathic tradition for the supportive treatment of nervous restlessness and associated sleep disturbances.

4.2 Posology and method of administration

For oral use only

Posology

Adults and the elderly:

Take 1 tablet 3 times daily

Adults and the elderly:

If needed, 1 tablet may be taken every Î4 to 1 hr., up to 12 times for the first 24 hours.

Method of administration

The tablets should be allowed to dissolve slowly in the mouth at least 30 minutes before meals.

Duration of use

If the condition worsens or if symptoms do not improve within 7 days, consult a doctor or qualified healthcare practitioner.

This product is not recommended for use in children or adolescents under 18 years of age (See Section 4.4 Special warnings and precautions for use).

4.3 Contraindications

Hypersensitivity to the active substances or any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

Do not exceed the stated dose.

If the condition worsens or if symptoms do no improve within 7 days, consult a doctor or qualified healthcare practitioner.

Do not use if seal is broken

This product contains lactose: Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-lactose malabsorption should not take this medicine.

This product is intended for the relief of symptoms associated with nervous restlessness and associated sleep disturbances. Patients with signs and symptoms of depression should seek medical advice for appropriate treatment.

Paediatric population

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

4.5 Interaction with other medicinal products and other forms of interaction None known

4.6 Fertility, pregnancy and lactation

No studies on the safety of this product during pregnancy and lactation have been performed. Therefore the use of this product during pregnancy and lactation should be avoided unless under the guidance of a doctor.

Studies on the effects on fertility have not been performed.

4.7 Effects on ability to drive and use machines

Neurexan has no or negligible influence on the ability to drive and use machines.

4.8 Undesirable effects

There have been a small number of post-marketing reports of allergic reactions with symptoms such as skin rash, itching and hives. The frequency of these effects is not known.

If other adverse effects are experienced, a doctor or a 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

No cases of overdose have been reported. Symptomatic and supportive measures should be taken as appropriate.

5.1

Not applicable.

5.2

Not applicable.

5.3

Preclinical safety data Not applicable.

6.1

Lactose monohydrate

Magnesium stearate

6.2

Not applicable

6.3 Shelf life

60 months

Shelf life after first opening: 1 year

6.4 Special precautions for storage

This medicinal product does not require any special storage conditions.

Store in the original container.

6.5 Nature and contents of container

Polypropylene container with tamper-evident polypropylene cap, in a cardboard box Pack size: 50 or 100 tablets

6.6 Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Biologische Heilmittel Heel GmbH

Dr. Reckeweg Strasse 2–4

D – 76532 – Baden Baden

Tel : 00 49 72 21 501 00

Fax : 00 49 72 21 501 210

e-mail : info@heel.de

8 MARKETING AUTHORISATION NUMBER(S)

NR 08927/0017

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15/04/2013