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AQUA-BAN TABLETS

Active substance(s): AMMONIUM CHLORIDE / CAFFEINE ANHYDROUS / AMMONIUM CHLORIDE / CAFFEINE ANHYDROUS / AMMONIUM CHLORIDE / CAFFEINE ANHYDROUS

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Aqua-Ban Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ingredients
Ammonium Chloride
Caffeine

mg/tablet
325
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.

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 THE
AUTHORISATION
Date of first authorisation:
Date of latest renewal:

10

11 May 2001.
22 October 2003.

DATE OF REVISION OF THE TEXT
06/04/2009

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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