Source: Health Products Regulatory Authority (IE) Revision Year: 2019 Publisher: Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland
Cross sensitivity in this class of compounds has been observed. Therefore, famotidine should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.
Hypersensitivity to famotidine or to any of the excipients listed in section 6.1.
In clinical trials, patients with other underlying acid related gastro-intestinal diseases (e.g. duodenal ulcer, gastric ulcer) did not experience complications; in general, they did not exhibit a clinically significant deterioration in their condition.
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. Malignancy should be excluded, as treatment with famotidine may alleviate symptoms and delay 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, 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.
Pepcid AC does not interact with the cytochrome P450-linked drug metabolising enzyme system. Compounds metabolised by this system which have been tested in man have included warfarin, theophylline, phenytoin, diazepam, propranolol, aminopyrine and antipyrine. Famotidine does not appear to affect the disposition of these drugs when they are taken orally.
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:
Famotidine may decrease the absorption of Ulipristal.
Antacids may decrease the absorption of famotidine and lead to lower plasma concentrations of famotidine. Famotidine should therefore be taken 1 – 2 hours before the administration of an antacid.
Risk of loss of efficacy of calcium carbonate when co-administered as phosphate binder with famotidine in haemodialysis patients.
Famotidine does not affect blood alcohol levels following oral ingestion of ethanol.
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.
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 to the mother outweighs the possible risks to the developing foetus.
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.
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).
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 (≥1/10), Common (≥1/100, <1/10), Uncommon (≥1/1,000, <1/100), Rare (≥1/10,000, <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
ADRs are presented by frequency category based on incidence in adequately designed clinical trials or epidemiology studies.
Very rare: Agranulocytosis, Leucopenia**, Neutropenia, Pancytopenia**, Thrombocytopenia
Very rare: Hypersensitivity (Anaphylactic reaction, Angioedema, Bronchospasm)
Uncommon: Decreased appetite
Very rare: Agitation, Anxiety disorder, Confusional state, Depression, Disorientation, Hallucination, Insomnia, Libido decreased, Mental disorder
Common*: Headache, Dizziness
Uncommon: Dysgeusia
Rare*: Somnolence
Very rare: Generalised tonic-clonic seizure (particularly in patients with impaired renal function), Paraesthesia, Seizure
Very rare: Atrioventricular block (with H2-receptor antagonists administered intravenously)
Very rare: Interstitial lung disease (sometimes fatal)
Common: Constipation, Diarrhoea
Uncommon: Abdominal discomfort and pain, Abdominal distension, Dry mouth, Flatulence, Nausea and/or Vomiting
Rare: Liver disorder**
Very rare: Cholestatic jaundice, Hepatitis
Uncommon: Rash, Pruritus, Urticaria
Very rare: Alopecia, Stevens-Johnson syndrome/Toxic epidermal necrolysis (sometimes fatal)
Very rare: Arthralgia, Muscle spasms
Rare: Gynaecomastia***
Very rare: Erectile dysfunction
Uncommon: Asthenia, Fatigue
Very rare: Chest discomfort
Rare: Malaise
Very rare: Hepatic enzyme abnormal
* not significantly greater than placebo (p<0.05)
** A causal relationship to therapy with famotidine has not been established
*** Reversible on discontinuing treatment
No clinically significant increase in endocrine or gonadal function has been reported.
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. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.
Not applicable.
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