PEPCID AC Film-coated tablet Ref.[7822] Active ingredients: Famotidine

Posology

Adults and children 16 years of age or older

Dosage: 10mg.

Dosage interval:

1 tablet (10mg) for symptomatic relief of heartburn, indigestion (dyspepsia) and excess acid.

or

1 tablet (10mg) taken 15 minutes prior to meals to prevent these symptoms.

or

1 tablet (10 mg) taken within one hour before the evening meal for prevention of nocturnal symptoms.

Maximum intake in 24 hours: 2 tablets (20mg).

The maximum treatment period is 2 weeks.

Special populations

Elderly

No dosage adjustment is necessary for the elderly.

Paediatric populations

Pepcid AC is not recommended for use in children less than 16 years of age. The safety and effectiveness of oral famotidine have not been established in paediatric patients.

Renal Impairment

A dosage adjustment may be necessary in patients with a creatinine clearance less than 10 mL/min. Patients with renal impairment should consult a physician before use (please refer to section 4.4 – Special Warnings and Special Precautions for Use).

Hepatic Impairment

No dosage adjustment is required in hepatic impairment.

Method of administration

For oral use. The tablets should be swallowed whole with a glass of water and not chewed.

The adverse reactions in overdose cases are similar to the adverse reactions encountered in normal clinical experience (see section 4.8).

The usual measures to remove unabsorbed material from the gastro-intestinal tract, clinical monitoring and supportive therapy should be employed. Patients with Zollinger-Ellison syndrome have tolerated doses up to 800 mg/day for more than a year without development of significant side effects.

3 years.

Store in the original package.

PVC/PE/PVDC/Al blisters of 6, 12 and 18 tablets.

Not all pack sizes may be marketed.

No special requirements.