PEPCID AC Film-coated tablet (2019)
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Περιεχόμενα
Name of the medicinal product
Pepcid AC 10mg Film-coated tablets.
Qualitative and quantitative composition
Each tablet contains 10mg Famotidine. For a full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablets. Pale-rose, rounded-square, film-coated tablet with FA10 engraved on one side.
Therapeutic indications
The short-term symptomatic relief of heartburn, indigestion (dyspepsia) and excess acid. Prevention of these symptoms when associated with meals including nocturnal symptoms.
Posology and method of administration
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 ...
Contraindications
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 H<sub>2</sub>-receptor antagonists. ...
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
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, ...
Pregnancy and lactation
Pregnancy 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 ...
Effects on ability to drive and use machines
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 ...
Undesirable effects
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 ...
Overdose
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 ...
Pharmacodynamic properties
Pharmacotherapeutic group: H<sub>2</sub> Receptor Antagonist ATC code: A02BA03 Pepcid AC is a potent competitive H<sub>2</sub>-receptor antagonist. Pepcid AC has a rapid onset of action and, at the recommended ...
Pharmacokinetic properties
Pepcid AC obeys linear kinetics. In pharmacokinetic studies in the elderly, no clinically significant age-related changes were detected. Compared to historical data from younger subjects, age does not ...
Preclinical safety data
The LD<sub>50</sub> of famotidine in CD-1 mice and Sprague-Dawley rats was in excess of 5g/kg (orally) and in excess of 400mg/kg intravenously. Extensive preclinical safety studies have been performed ...
List of excipients
Pregelatinised starch Cellulose, microcrystalline Talc Magnesium stearate Hydroxypropyl methylcellulose Hydroxypropylcellulose Titanium dioxide (E171) Carnauba wax Red ferric oxide (E172)
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
Store in the original package.
Nature and contents of container
PVC/PE/PVDC/Al blisters of 6, 12 and 18 tablets. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Johnson & Johnson (Ireland) Limited, Airton Road, Tallaght, Dublin 24, Ireland
Marketing authorization number(s)
PA 330/53/1
Date of first authorization / renewal of the authorization
Date of first authorisation: 24 September 1996 Date of last renewal: 24 September 2006
Date of revision of the text
4 Oct 2019
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