Pepcid AC 10 mg Film-coated

or

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

nocturnal symptoms.

Special populations

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)

No dosage adjustment is required in hepatic impairment.

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

chewed.

Hypersensitivity to any component of this product

Patients over 50 who are experiencing heartburn for the first time and patients of any age

who have noticed unintentional weight loss should consult a physician before using the

product.

If patients have difficulty swallowing, or abdominal discomfort persists they should seek

medical advi

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, melaena (black stools), choking or chest pain.

Since Pepcid is excreted primarily by the kidney, caution should be observed in patients

with impaired renal function. Patients with renal impairment should consult a physician

before using the product. A reduction in daily dosage should be considered if creatinine

clearance falls below 10 mL/min.

Safety and efficacy are not established for children.

When Pepcid was administered to elderly patients in clinical trials, no increase in the

incidence or change in the type of drug-related side effects was observed. No dosage

adjustment is required based on age.

No drug interactions of clinical importance have been identified.

Indocyanine green as an index of hepatic blood flow and/or hepatic drug extraction has

been tested and no significant effects have been found.

Studies in patients stabilized on phenprocoumon therapy have shown no pharmacokinetic

interaction with famotidine and no effect on the pharmacokinetic or anticoagulant

activity of phenprocoumon.

Alterations of gastric pH may affect the bioavailability of certain drugs resulting in a

decrease in the absorption of atazanavir.

The absorption of ketoconazole and itraconazole could be reduced. Ketoconazole should

be given 2 hours before famotidine administration. Patients should consult a physician

before using this product together with itraconazole. Concomitant use of famotidine with

the antifungal agent itraconazole results in significantly reduced peak and trough plasma

concentrations of itraconazole, which may result in reduced antifungal efficacy.

Due to its H2-antagonist effect, famotidine may also decrease the absorption of the

following compounds:

- Rilpivirine,

- Cyanocobalamine,

- Most of tyrosines kinase inhibitors (excluding vandetanib, imatinib).

Famotidine may decrease the absorption of

The administration of probenecid can delay the elimination of famotidine. Concomitant

use of probenecid and famotidine should be avoided.

The concomitant use of sucralfate should be avoided within two hours of the famotidine

dose.

Animal studies have demonstrated that the drug crosses the placenta and is excreted in

breast milk. No teratogenic effect was noted although there were some delays in

maturation at high doses. There is no experience of use during pregnancy in human

beings.

Pepcid AC is not recommended for use in pregnancy. Before a decision is made to use

Pepcid AC during pregnancy, the physician should weigh the potential benefits from the

drug against the possible risks involved. There are no adequate and well-controlled

studies in pregnant women. This product should not be used during pregnancy unless the

potential benefit of treatment

Famotidine is secreted in human milk; therefore breast-feeding mothers should either

stop breast-feeding or not take the drug. Famotidine is distributed in breast milk. A risk

to newborns / infants cannot be excluded. A decision must be made whether to

discontinue breast-feeding or to discontinue / abstain from therapy with famotidine

taking into account the benefit of breast-feeding for the infant and the benefit of therapy

for the mother.

In clinical trials with famotidine, there has been no observed impairment of the ability to

drive or operate machinery.

Some patients have experienced adverse reactions such as dizziness and headache while

taking famotidine. Patients should be informed that they should avoid driving vehicles or

operating machinery or doing activities which require prompt vigilance if they

experience these symptoms (see section 4.8).

Pepcid AC has been shown to be generally well tolerated. Side effects reported in >1%

of patients were headache and dizziness. These occurred with comparable frequency in

patients treated with placebo.

Other side effects reported even less frequently included dry mouth, nausea and/or

vomiting, constipation, diarrhoea, abdominal discomfort or distension, anorexia,

fatigue, rash, pruritus, and urticaria, liver enzyme abnormalities, cholestatic jaundice,

anaphylaxis, angioedema, arthralgia. Pancytopenia, leucopenia, and isolated cases of

worsening of existing hepatic disease have been reported; however, a causal

relationship to therapy with famotidine has not been established. No clinically

significant increase in endocrine or gonadal function has been reported.

Gynaecomastia has been reported rarely. In most cases that were followed up, it was

reversible on discontinuing treatment.

Flatulence has been reported with a frequency of “uncommon”.

Alopecia has been reported very rarely.

Adverse drug reactions (ADRs) identified during clinical trials and post-marketing

experience with famotidine are listed below by System Organ Class (SOC). The

frequencies are defined in accordance with current guidance, as:

Very Common (

* not significantly greater than placebo (p<0.05)

** A causal relationship to therapy with famotidine has not been established

*** Reversible on discontinuing treatment

There is no experience to date with overdosage. The adverse reactions in overdose cases

are similar to the adverse reactions encountered in normal clinical experience (see section

4.8).