Home | About the eMC | Help | Mobile

eMC - trusted, up to date and comprehensive information about medicines

Search medicine/company name only

Search full document

Advanced search

Medicine name A-Z | Active ingredient A-Z | Pharmaceutical company A-Z | Latest medicine updates | Yellow card report

Peckforton Pharmaceuticals

Crewe Hall, Crewe, Cheshire, CW1 6UL, UK

Telephone: +44 (0)1270 582 255
Fax: +44 (0)1270 582 299
E-mail: med.info@peckforton.com
WWW: http://www.peckforton.com

Medical Information Direct Line: +44 (0)1270 582 255
Medical Information Fax: +44 (0)1270 582 299

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Summary of Product Characteristics last updated on the eMC: 20/02/2008

SPC	Hydrotalcite Suspension

Table of Contents

1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
Administrative Data
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
10. DATE OF REVISION OF THE TEXT
11. Legal Category

Go to top of the page

1. NAME OF THE MEDICINAL PRODUCT

Hydrotalcite Suspension.

Go to top of the page

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 5ml contains 500mg of Hydrotalcite Light.

Go to top of the page

3. PHARMACEUTICAL FORM

Suspension

Go to top of the page

4. CLINICAL PARTICULARS

Go to top of the page

4.1 Therapeutic indications

Use as an antacid Hydrotalcite is indicated for symptomatic relief in the following conditions: peptic ulceration; dyspepsia; hyperacidity; gastritis, heartburn, especially when associated with reflux oesophagitis or hiatus hernia, and heartburn in pregnancy.

Go to top of the page

4.2 Posology and method of administration

DOSAGE:

Adults

10ml between meals and at bedtime or as directed by the physician.

Elderly:

No specific recommendations.

Children (6-12 years)

Half the adult dose.

Children under 6 years:

Not recommended.

ADMINISTRATION:

Oral

Go to top of the page

4.3 Contraindications

None known

Go to top of the page

4.4 Special warnings and precautions for use

None stated

Go to top of the page

4.5 Interaction with other medicinal products and other forms of interaction

Hydrotalcite suspension may interfere with the intestinal absorption of tetracyclines.

Go to top of the page

4.6 Pregnancy and lactation

For Hydrotalcite no clinical data on exposed pregnancies are available

Caution should be exercised when prescribing to pregnant women

Go to top of the page

4.7 Effects on ability to drive and use machines

None known.

Go to top of the page

4.8 Undesirable effects

Side effects are uncommon. Diarrhoea and vomiting have been reported.

Go to top of the page

4.9 Overdose

There is no evidence of absorption of Hydrotalcite in man. Investigations in healthy human volunteers have shown no elevation of serum aluminium or magnesium levels on administering of Hydrotalcite at therapeutic dosage for a continuous period of 28 days.

The sodium content of Hydrotalcite is 0.22mmol per 5ml.

Go to top of the page

5. PHARMACOLOGICAL PROPERTIES

Go to top of the page

5.1 Pharmacodynamic properties

Raising the pH of gastric contents to above 3.5 significantly reduces the pain and discomfort of acid associated symptoms, especially heartburn, dyspepsia, peptic ulceration, gastritis, and reflux oesophagitis. Hydrotalcite, buffering in the range of pH 3-5 over two hours, combines those properties of magnesium and aluminium based antacids in producing effective rises in pH over a considerable period.

Go to top of the page

5.2 Pharmacokinetic properties

Not applicable

Go to top of the page

5.3 Preclinical safety data

Not applicable.

Go to top of the page

6. PHARMACEUTICAL PARTICULARS

Go to top of the page

6.1 List of excipients

Sorbitol USP, Carmellose Sodium BP, Veegum Regular, Sodium Propyl Hydroxybenzoate BP, Sodium Butyl Hydroxybenzoate BP, Hydrogen Peroxide 30% solution EP*, Crème de Menthe 1951 and Purified Water.

*Quantity includes an average of 70ppm.

Go to top of the page

6.2 Incompatibilities

None known

Go to top of the page

6.3 Shelf life

24 Months.

Go to top of the page

6.4 Special precautions for storage

Store between 25^°C and 4^°C . Do not freeze.

Go to top of the page

6.5 Nature and contents of container