PEPCID

Posology Adults and children 16 years of age or older:

One tablet to be chewed for the relief of symptoms. No more than two tablets to be taken in 24 hours. Patients must seek medical advice if symptoms fail to respond, or if symptoms recur following self treatment with Pepcid. The maximum continuous treatment period is 6 days.

The patient should not purchase a second pack of tablets without the advice of a pharmacist or doctor. Elderly No dosage adjustment is necessary.

Paediatric population:

Children less than 16 years of age Not recommended. The safety and efficacy of oral famotidine/antacid combination in the paediatric population have not yet been established. Method of administration For oral use. Chew tablet well before swallowing.

Adverse drug reactions (ADRs) identified from clinical trials and during post- marketing experience with Famotidine/Magnesium hydroxide/Calcium carbonate are included in the table below.

The frequencies are provided according to the following convention:

Very common ≥1/10 Common ≥1/100 and < 1/10 Uncommon ≥1/1,000 and <1/100 Rare ≥1/10,000 and <1/1,000 Very rare <1/10,000 Not known (cannot be estimated from the available data) ADRs identified are presented by frequency category based on 1) incidence in adequately designed clinical trials or epidemiology studies, if available or 2) when incidence is unavailable, frequency category is listed as ‘Not known’.

05) Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

The following patient groups should consult a physician before taking this product: • Patients suffering from any other illness or taking any medications either physician-prescribed or self-prescribed. • Patients with pre-existing hypercalcaemia or hypermagnesaemia Gastric cancer and simple indigestion can have some symptoms in common.

Therefore, it is important that patients with symptoms such as unintentional weight loss, dysphagia, or anaemia, in addition to indigestion, or patients over 50 who are experiencing heartburn for the first time or with recently changed dyspeptic symptoms, should seek medical advice before starting any treatment, to avoid delay in investigation and diagnosis.

Patients should stop use and consult a physician if symptoms persist or worsen, or if they experience dysphagia, (difficulty swallowing) odynophagia (pain on swallowing), severe vomiting, melena (black stools), choking or chest pain.

Patients who are taking non-steroidal anti-inflammatory drugs, especially the elderly, should consult their doctor before taking these tablets. As Pepcid contains sucrose and lactose, it should not be taken by patients with fructose intolerance, glucose-galactose malabsorption syndrome, sucrase- isomaltase deficiency, lactase insufficiency or galactosaemia.

1. • Cross sensitivity in H2-receptor antagonists has been observed. Therefore, famotidine/antacid combination should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists. • Moderate or severe renal failure.

• Severe hepatic impairment.