Pepcid AC 10 mg Film-coated

  • Name:

    Pepcid AC 10 mg Film-coated

  • Company:
    info
  • Active Ingredients:

    Famotidine

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 10/10/19

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Summary of Product Characteristics last updated on medicines.ie: 10/10/2019

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Johnson & Johnson (Ireland) Ltd

Johnson & Johnson (Ireland) Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name ACTIFED 30 mg/1.25 mg per 5 ml Syrup Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name ACTIFED 60 mg / 2.5 mg Tablets Active Ingredients Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Arret 2mg Hard Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Benylin Children's Chesty Coughs Active Ingredients Guaifenesin
Medicine Name Benylin Children's Dry Coughs Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Cough Medicine Syrup Active Ingredients Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Day and Night Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Dry Coughs Syrup Active Ingredients Dextromethorphan Hydrobromide, Diphenhydramine Hydrochloride, Levomenthol
Medicine Name Benylin Dual Action Dry Syrup Active Ingredients Dextromethorphan Hydrobromide, Pseudoephedrine Hydrochloride, triprolidine hydrochloride
Medicine Name Benylin Four Flu Tablets Active Ingredients Diphenhydramine Hydrochloride, Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Benylin Non- Drowsy for Chesty Coughs Active Ingredients Guaifenesin, Levomenthol
Medicine Name BENYLIN Non-Drowsy Dry Coughs, Syrup Active Ingredients Dextromethorphan Hydrobromide
Medicine Name Benylin Phlegm Cough plus Decongestant Syrup Active Ingredients Guaifenesin, Pseudoephedrine Hydrochloride
Medicine Name Benylin Phlegm Cough Syrup Active Ingredients Guaifenesin, Levomenthol
Medicine Name Calpol 120mg/5ml Infant Oral Suspension Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (bottle) Active Ingredients Paracetamol
Medicine Name Calpol Infant 120mg/5ml Sugar Free Oral Suspension (sachets) Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus 250mg/5ml Oral Suspension Active Ingredients Paracetamol
Medicine Name CALPOL SIX PLUS 250mg/5ml SUGAR/COLOUR FREE ORAL SUSPENSION Active Ingredients Paracetamol
Medicine Name CALPOL Six Plus Fastmelts 250 mg Paracetamol OrodispersibleTablets Active Ingredients Paracetamol
Medicine Name Daktarin 2% w/w Cream Active Ingredients Miconazole nitrate
Medicine Name Daktarin 2% w/w Cutaneous Powder Active Ingredients Miconazole nitrate
Medicine Name DAKTARIN 20mg/g Oral Gel Active Ingredients Miconazole
Medicine Name Imodium 2 mg Capsules Active Ingredients Loperamide Hydrochloride
Medicine Name Imodium Instants 2mg Orodispersible Tablets Active Ingredients Loperamide Hydrochloride
1 - 0 of 66 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 10 October 2019 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 10 October 2019 PIL

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 9 September 2019 PIL

Reasons for updating

  • Change to name of medicinal product

Updated on 9 September 2019 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Updated on 11 March 2019 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Improved presentation of PIL

Updated on 23 October 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 17 September 2018 SmPC

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category: Supply through pharmacy only

Updated on 15 February 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

MA Transfer from McNeil Healthcare (Ireland) Limited to Johnson & Johnson (Ireland) Ltd.

 

Updated on 15 February 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 9 August 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 9 August 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 3 July 2017 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Added text has been highlighted, removed text has been highlighted and struck through:

4.2 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 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.

4.3 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

 

2-

 

receptor antagonists.

Hypersensitivity to any component of this product

 

 

.Hypersensitivity to famotidine or to

 

any of the excipients listed in section 6.1.

4.4 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 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.

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.

Paediatric use

Safety and efficacy are not established for children.

Use in elderly

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.

4.5 Interaction with other medicinal products and other forms of interaction

No drug interactions of clinical importance have been identified.

 

 

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:

- Rilpivirine,

- Cyanocobalamine,

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

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.

Concomitant use of aluminium hydroxide/magnesium hydroxide at the usual doses does not

influence the pharmacodynamics or bioavailability of Pepcid AC.

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.

4.6

 

Fertility, Ppregnancy and lactation

 

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.

Pregnancy

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

 

 

otto the mother outweighs the possible risks to the

 

developing foetus.

Lactation

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.

4.7 Effects on ability to drive and use machines

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).

4.8 Undesirable effects

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 (

 

 

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.

Neutropenia

System Organ Class  (SOC)

Frequency

Adverse Drug Reaction  (Preferred Term)

Blood and lymphatic  system disorders

Immune system  disorders

Metabolism and  nutrition disorders

Psychiatric disorders

Nervous system  disorders

Common*

Headache Dizziness

Dysgeusia

Rare*

Somnolence

Cardiac disorders

Respiratory , thoracic  and mediastinal

Very rare

Agranulocytosis

Leucopenia**

Very rare

Pancytopenia**

Thrombocytopenia Hypersensitivity (AnaphylaxisAnaphylactic reaction, Angioedema,

Bronchospasm)

Uncommon

AnorexiaDecreased appetite

Very rare

Agitation

Anxiety disorder Confusional state Depression Disorientation Hallucination Insomnia

Libido decreased

Mental disorder

Uncommon

 

Very rare

 

 

 

 

 

Very rare

 

 

Very rare

Generalised tonic-clonic seizure

(particularly in patients with impaired renal function) Paraesthesia

Seizure

Atrioventricular block (with H2- receptor antagonists administered intravenously)

Interstitial lung disease

(sometimes fatal)

disorders

 

Gastrointestinal

Common

Constipation

disorders

 

Diarrhoea

 

Uncommon

Abdominal discomfort and pain

 

 

Abdominal distension

 

 

Dry mouth

 

 

Flatulence

 

 

Nausea and /or

 

 

Vomiting

 

Rare

Abdominal pain upper

Hepatobiliary disorders

Rare

Worsening of existing hepatic

 

 

diseaseLiver disorder**

 

Very rare

Cholestatic jaundice

 

 

Hepatitis

Skin and subcutaneous

Uncommon

Rash

tissue disorders

 

Pruritus

 

 

Urticaria

 

Very rarely

Alopecia

 

 

Stevens-Johnson syndrome / Toxic epidermal necrolysis

 

 

(sometimes fatal)

Musculoskeletal and

Very rare

Arthralgia

connective tissue

 

Muscle spasms

disorders

 

 

Reproductive system

Rarely

Gynaecomastia***

and breast disorders

Very rare

Erectile dysfunction

General disorders and

Uncommon

Asthenia

administration site

 

Fatigue

conditions

Very rare

Chest discomfort

 

Rare

Malaise

Investigations

Very rare

Liver enzyme

 

 

abnormalitiesHepatic 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 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. 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.

 

4.9 Overdose

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).

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.

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: H2 Receptor Antagonist, ATC code: A 02 BA

 

03.

 

Pepcid AC is a potent competitive H

 

2-receptor antagonist. Pepcid AC has a rapid onset of

 

action and, at the recommended doses, has a long duration of action and is highly

effective at relatively low blood concentrations.

Duration of action, plasma concentration and urinary recovery are dose related.

Pepcid AC reduces the acid and pepsin content, as well as the volume of basal, nocturnal

and stimulated gastric secretion.

In clinical trials, Pepcid AC provided effective and rapid symptom relief. When

administered 15 minutes before a test meal, famotidine reduced symptoms that would

otherwise have been expected. Administration of famotidine before an evening meal

prevented nocturnal acid-related symptoms and therefore prevented symptom-related

interference with sleep.

After oral administration

 

, a dose-response relationship was clearly demonstrated for

 

doses from 0.5 to 10 mg famotidine in terms of raising gastric pH between and after

meals. Famotidine doses of 2.5 to 10 mg were demonstrated to produce a statistically

significant effect on gastric pH as compared to placebo. The onset of effect for the 5 and

10 mg doses was seen at approximately 1.5 hours post-dose, while that of the 2.5 mg

dose was not seen until 2.5 hours post-dose.

The maximum effect, as measured by peak mean pH value, occurred at 3.5 hours. The

activity of the 5 and 10 mg doses continued until approximately 9 hours post-dose in

daytime studies. Additionally, two night-time studies demonstrated that famotidine

10mg statistically significantly increased gastric pH for 12 hours post-dose as compared

to placebo. Famotidine is well tolerated at these dose levels.

Systemic effects of famotidine in the CNS, cardiovascular, respiratory or endocrine

systems were not noted in clinical pharmacology studies. Serum hormone levels,

including prolactin, cortisol, thyroxine (T

 

4) and testosterone were not altered after

 

treatment with famotidine.













































































































































































Updated on 16 November 2015 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Implementation of Famotidine PRAC updates to Section 4.8 

 frequency uncommon:
flatulence 
 frequency very rare:

alopecia

 

 

Updated on 12 November 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 14 September 2015 PIL

Reasons for updating

  • Addition of information on reporting a side effect.

Updated on 7 August 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Addition of the following text to Section 4.8

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. 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.

Updated on 20 July 2011 PIL

Reasons for updating

  • Correction of spelling/typing errors

Updated on 1 February 2011 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 26 January 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Licence tranfer to McNeil Healthcare (Ireland) Limited and subsequent change to the MA number.

Updated on 3 September 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 25 August 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only