SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Aqua-Ban Tablets

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Ingredients    mg/tablet

Ammonium Chloride    325

Caffeine    100

For a full list of excipients, see section 6.1.

3    PHARMACEUTICAL FORM

Gastro-resistant tablet.

Blue, circular, film coated tablet.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

As a mild diuretic for the relief of pre-menstrual water retention.

4.2    Posology and method of administration

For oral use.

Women with premenstrual water retention: Swallow 2 tablets three times a day after meals starting 4 or 5 days before expected period until period begins.

Do not take for more than 5 days.

This product is intended only for women experiencing the menstrual cycle and is therefore unsuitable for children or the elderly.

4.3 Contraindications

Not to be taken if hepatic or renal function impaired. Hypersensitivity to the active substances or to any of the excipients.

4.4    Special warnings and precautions for use

If symptoms worsen or do not improve after 5 days, contact a doctor.

4.5    Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed.

4.6    Pregnancy and lactation

Aqua-Ban should not be indicated for use in pregnancy or breast-feeding.

4.7    Effects on ability to drive and use machines

Aquaban Tablets have no influence on the ability to drive and use machines.

4.8    Undesirable effects

May cause abdominal pain, nausea, vomiting, thirst, headaches and nervousness. If affected, discontinue use.

4.9    Overdose

Large doses of ammonium chloride may cause a profound acidosis and hypokalaemia which should be treated symptomatically. Large doses of caffeine may cause arousal and anxiety. Gastric lavage and aspiration is recommended together with symptomatic treatment.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Diuretics, ATC code: C03 Both active ingredients are mild diuretics.

5.2    Pharmacokinetic properties

A study has confirmed the in vivo    effectiveness of the enteric coating and

release of the active ingredients.

Preclinical safety data

No data.

6    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Core:

Magnesium Stearate E572 Microcrystalline Cellulose E460i Povidone

Coating:

Acryl-eeze 93020523 Blue (containing Methacrylic Acid Copolymer Type C, Talc E553b, Titanium Dioxide E171, Triethyl Citrate E1505, FD&C Blue #2 E132, Colloidal Anhydrous Silica, Sodium Bicarbonate E500, Sodium Lauryl Sulphate, Iron Oxide Yellow E172)

Hypromellose E464 Talc E553b

Simethicone Emulsion (containing 30% simethicone USP, stearate emulsifiers, sorbic acid E200, benzoic acid E210, thickeners and water)

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

2 years

6.4    Special precautions for storage

Keep out of the reach and sight of children.

Do not store above 25 °C.

6.5    Nature and contents of container

Foil backed blister strip containing 30 tablets.

6.6 Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

G. R. Lane Health Products Limited

Sisson Road

Gloucester

GL2 0GR

United Kingdom

Tel: +44 (0)1452 524012

Fax: +44 (0)1452 507930

Email: info@laneshealth.com

8.    MARKETING AUTHORISATION NUMBER

PL 01074/0013

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 11 May 2001.

Date of latest renewal:    22 October 2003.

10 DATE OF REVISION OF THE TEXT

06/04/2009