TOPAL chewable tablets

1. Name Of The Medicinal Product

TOPAL chewable tablets.

2. Qualitative And Quantitative Composition

Dried aluminium hydroxide 30 mg

Magnesium carbonate (light) 40 mg

Alginic acid 200 mg

This product contains 11 mg sodium, 220 mg lactose and 880 mg sucrose per tablet.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Chewable tablet.

Round, off-white or light cream coloured, 18mm diameter, flat faced bevel-edged chewable tablet, with a score-line on one face. The score-line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical Particulars

4.1 Therapeutic Indications

Relief of discomfort due to gastric reflux or mucosal irritation in conditions such as:

• Heartburn

• Reflux oesophagitis

• Hiatus hernia

• Gastritis

• Acid dyspepsia.

4.2 Posology And Method Of Administration

Oral route.

Adults including the elderly: 1 to 3 tablets 4 times a day.

Children: half the adult dose.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Due to the presence of lactose, and sucrose patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Care should be taken if used by patients with diabetes mellitus or low sugar diet because of the sugar content: sucrose 880 mg, lactose 220 mg.

This product contains 11 mg sodium per tablet: take into account for patients with strict low sodium diet.

Aluminium hydroxide may:

- cause constipation due to its astringent action; this effect may be balanced by the cathartic effect of the magnesium salts,

- may lead to phosphate depletion, particularly in patients on a low phosphate diet, e.g. malnutrition.

- cause delayed or decrease the absorption of certain drugs used in combination; see section 4.5.

Use with caution in chronic dialysed patients because of risk of encephalopathy due to aluminium.

In the presence of renal insufficiency magnesium salts may cause central nervous depression

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Antacids may interfere with and cause delayed or decreased absorption of certain drugs, e.g. acetylsalicylic acid, indometacin, antituberculosis drugs (ethambutol, isoniazide), tetracyclines, quinolones (ciprofloxacin), penicillamine, chloroquine, ketoconazole, antihistaminics H2, difluinsal, digoxin, bisphosphonates, glucocorticoids, phenothiazinic neuroleptics, sulpiride, iron salts, thyroid hormones.

It is recommended that antacids are not administered at the same time as these medicines but taken at least 2 hours later.

4.6 Pregnancy And Lactation

There are no adequate data from the use of TOPAL tablets in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal and foetal development, parturition and post-natal development: see section 5.3.

The potential risk for humans is unknown. TOPAL tablets should not be used during pregnancy unless clearly necessary.

4.7 Effects On Ability To Drive And Use Machines

Not relevant.

4.8 Undesirable Effects

Body System	Adverse Reactions (frequency not known)
Metabolism and nutrition disorders	Phosphate decreased in case of prolonged treatment or overdose.
Gastrointestinal disorders	Constipation Diarrhoea.

4.9 Overdose

Treatment should be symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Other drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)./Alginic acid

ATC code: A02BX13.

Formation of a supernatant gel on the surface of the gastric fluid (lighter than water). This coats the cardio-tuberosity zone (shown by fibre optic endoscopy) and rises up into the oesophagus if reflux occurs.

Able to coat the mucosa.

5.2 Pharmacokinetic Properties

Rapid (within 6 to 14 minutes) and persistent (lasting 2 to 4 hours) action confirmed by a double-blind, crossover placebo-controlled study.

5.3 Preclinical Safety Data

No information further to that contained in other sections of the SPC is included.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose

Lactose monohydrate

Silica gel

Povidone

Citric acid monohydrate

Sodium hydrogen carbonate

Caramel flavour

Vanillin

Strawberry flavour

Magnesium stearate.

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

3 years.

6.4 Special Precautions For Storage

Do not store above 30°C. Keep the blisters in the outer carton in order to protect from moisture.

6.5 Nature And Contents Of Container

PVC/Aluminium blister card strips containing 14 tablets.

Box of 14 tablets containing one blister card

Box of 28 tablets containing two blister cards

Box of 42 tablets containing three blister cards

Not all pack sizes will be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Pierre Fabre Limited

Hyde Abbey House

23 Hyde Street

Winchester

Hampshire

SO23 7DR

United Kingdom

8. Marketing Authorisation Number(S)

PL 00603/021

9. Date Of First Authorisation/Renewal Of The Authorisation

Date of first authorisation: 2 August 1979

Date of last renewal: 16 October 2003

10. Date Of Revision Of The Text

13 October 2009