Pepcid AC 10 mg Film-coated Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Famotidine

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

A02BA; A02BA03

INN (International Name):

Famotidine

Dosage:

10 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

H2-receptor antagonists; famotidine

Authorization status:

Marketed

Authorization date:

1996-09-24

Patient Information leaflet

_FAMOTIDINE_
_ACID CONTROL_
_10MG FILM-COATED TABLETS_
READ ALL OF THIS LEAFL ET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Always take this medicine exactly as described in this
leafl et or as your doctor or pharmacist has told you.
■ Keep this leafl et. You may need to read it again.
■ Ask your pharmacist if you need more information or
advice.
■ If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leafl et. See section 4.
▶
■ You must talk to a doctor if you do not feel better or
if you feel worse after 14 days.
WHAT IS IN THIS LEAFL ET:
1. What Pepcid AC is and what it is used for
2. What you need to know before you take Pepcid AC
3. How to take Pepcid AC
4. Possible side effects
5. How to store Pepcid AC
6. Contents of the pack and other information
1 WHAT PEPCID AC IS AND WHAT IT IS
USED FOR
Pepcid AC tablets are for the short-term symptomatic relief
of heartburn, indigestion (dyspepsia) and excess acid. They
can prevent these symptoms when they follow a meal or
beverage (drink) known to trigger them. Pepcid AC taken
before the evening meal can also prevent night-time
symptoms which disturb sleep when this is associated with
food or drink.
Pepcid AC provides relief from the symptoms of heartburn
and indigestion with just one small tablet. It has been
clinically proven to control excess stomach acid for nine
hours throughout the day and for 12 hours throughout
the night. The active ingredient in your medicine is
famotidine. This belongs to a group of medicines known
as “H2 blockers”. Unlike antacids which neutralise acids,
famotidine controls the production of excess acid and
treats the cause of pain and discomfort.
You must talk to a doctor if you do not feel better or if you
feel worse after 14 days.
2 WHAT YOU NEED TO KNOW BEFORE
YOU TAKE PEPCID AC
This medicine is suitable for most people, but a few people
should not use it. If you are in any doubt, talk to your
d

Summary of Product characteristics

Health Products Regulatory Authority
24 May 2022
CRN00CY5M
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pepcid AC 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg famotidine
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pale-rose, rounded-square tablet with FA10 engraved on one side.
4 CLINICAL PARTICULARS
4.1 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.
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 (10mg) 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 _
Health Products Regulatory Authority
24 May 2022
CRN00CY5M
Page 2 of 7
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, famot