Altacite Plus
Peckforton Pharmaceuticals
1. Name of the medicinal product
Altacite Plus Suspension
Asda Indigestion Liquid
Sainsbury's Spearmint Indigestion Liquid
2. Qualitative and quantitative composition
Each 5ml contains 500mg of Hydrotalcite light and 125mg of Dimethicone (activated)
3. Pharmaceutical form
Suspension
4. Clinical particulars
4.1 Therapeutic indications
Altacite Plus Suspension is indicated for the symptomatic relief of the following conditions: - Dyspepsia: flatulence and abdominal: hyperacidity; gastritis: peptic ulceration; heartburn especially when associated with oesophagitis or hiatus hernia and heartburn and pregnancy.
4.2 Posology and method of administration
Route of administration: Oral
Adults
10ml suspension between meals and at bedtime.
Elderly:
No specific recommendations in the elderly.
Children (8-12 years)
Half the adult dose.
4.3 Contraindications
None known
4.4 Special warnings and precautions for use
None Known
4.5 Interaction with other medicinal products and other forms of interaction
Altacite Plus may reduce intestinal absorption of tetracycline's
4.6 Pregnancy and lactation
For Co-simalcite 125/500 no clinical data on exposed pregnancies are available
Caution should be exercised when prescribing to pregnant women
4.7 Effects on ability to drive and use machines
Not applicable
4.8 Undesirable effects
Side effects are uncommon. Diarrhoea and vomiting have been reported but have ceased on withdrawal of the therapy.
4.9 Overdose
Overdose has not been reported. 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 administration of Hydrotalcite at therapeutic dosage for a continuous period of 28 days.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Dimethicone is inert oil, which is tissue adherent and water repellent, it is therefore a mucosal protective and anti-foaming agent, which can reduce flatulence.
5.2 Pharmacokinetic properties
No data on pharmacokinetic studies of Altacite Plus Suspension are available. The active ingredients imethicone and activated imethicone are not generally absorbed.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber, which are additional to that already included in the other sections of the SmPC.
6. Pharmaceutical particulars
6.1 List of excipients
Sodium carboxymethylcellulose, tween 80, sorbitan mono-oleate, sorbitan tristearate, glyceryl monostearate, aerosil, methylcellulose 2500, microcystalline cellulose, bronopol, spearmint polvaromas 077, saccharin sodium, chloroform and purified water.
6.2 Incompatibilities
None known
6.3 Shelf life
3 years. After first opening the container, discard the contents 28 days after opening.
6.4 Special precautions for storage
Store between 4°C and 25°C
6.5 Nature and contents of container
High-density polyethylene bottles with standard jaypour caps or amber glass bottles with tamper evident polyethylene screw cap fitted with a polyethylene coated wool seal. Bottle of 500ml as a pharmacy item or 100ml (and 250ml) as a general sales item.
6.6 Special precautions for disposal and other handling
Not applicable
7. Marketing authorisation holder
Peckforton Pharmaceuticals Ltd.
Crewe Hall Crewe,
Cheshire,
CW1 6UL
8. Marketing authorisation number(s)
PL 15760/0002
9. Date of first authorisation/renewal of the authorisation
03/06/1999/10/09/2004
10. Date of revision of the text
31/3/2015 |
