AQUA-BAN TABLETS - summary of medicine 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.

Excessive intake of caffeine (e.g. coffee, tea, chocolate and some canned drinks) should be avoided while taking this product.

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

When this product is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as tremor, insomnia, dizziness, nervousness, restlessness, anxiety, irritability, sweating, headaches, palpitations, tachypnoea, gastrointestinal disturbances and diuresis.

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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for “MHRA yellowcard” in the Google Play or Apple App Store.

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.

5.3 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 THEAUTHORISATION

Date of first authorisation:

11 May 2001.

22 October 2003.

Date of latest renewal: