Pepcid Duo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg Calcium Carbonate 800mg

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Famotidine; Magnesium hydroxide; Calcium carbonate

Available from:

Johnson & Johnson (Ireland) Limited

ATC code:

A02BA; A02BA53

INN (International Name):

Famotidine; Magnesium hydroxide; Calcium carbonate

Dosage:

10/165/800 milligram(s)

Pharmaceutical form:

Chewable tablet

Prescription type:

Product not subject to medical prescription

Therapeutic area:

H2-receptor antagonists; famotidine, combinations

Authorization status:

Marketed

Authorization date:

2000-09-29

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PEPCID DUO CHEWABLE TABLETS
Famotidine 10mg, magnesium hydroxide 165mg, calcium carbonate 800mg
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Always take this medicine exactly as described in this leaflet or as
your doctor or pharmacist has told
you.
-
Keep this leaflet. 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 leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you feel
worse after 2 weeks.
WHAT IS IN THIS LEAFLET?
1.
What Pepcid Duo is and what it is used for
2.
What you need to know before you take Pepcid Duo
3.
How to take Pepcid Duo
4.
Possible side effects
5.
How to store Pepcid Duo
6.
Contents of the pack and other information
1.
WHAT PEPCID DUO IS AND WHAT IT IS USED FOR
Pepcid Duo is used for the short-term treatment of the symptoms of
heartburn and acid indigestion in
adults and adolescents of 16 years & over.
Pepcid Duo contains three active substances:
•
Famotidine is a medicine called a ‘H2 Antagonist (blocker)’. It
reduces acid production in your
stomach.
•
Magnesium hydroxide and calcium carbonate are ‘antacids’. They
neutralise the acid in your
stomach.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PEPCID DUO
DO NOT TAKE PEPCID DUO:
•
if you are allergic to famotidine, magnesium hydroxide, calcium
carbonate or any of the other
ingredients of this medicine (listed in section 6)
•
if you have severe kidney problems
•
if you are allergic to other H2 Antagonist (medicines which controls
the production of excess
stomach acid)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Pepcid Duo if you
have:
•
Indigestion and have also lost weight involuntarily
•
Stomach pain which does not go away
•
Indigestion for the first time, or if your sym

Summary of Product characteristics

Health Products Regulatory Authority
13 December 2023
CRN00DT7D
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pepcid Duo Chewable Tablets Famotidine 10mg Magnesium Hydroxide 165mg
Calcium Carbonate 800mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable tablet contains:
Famotidine 10.00 mg
Magnesium hydroxide 165.00 mg
Calcium carbonate 800.00 mg
Excipients with known effect:
Lactose monohydrate (62.31 mg/tablet), glucose monohydrate (642.61
mg/tablet) and benzyl alcohol (0.000238 mg/tablet).
Each tablet also contains maltodextrin (71.41mg/tablet) which contains
glucose.
For the full list of excipients, see section 6.1.
Note: 165 mg of magnesium hydroxide means 69.3 mg of elemental
magnesium and 800 mg of calcium carbonate means 320
mg of elemental calcium
3 PHARMACEUTICAL FORM
Chewable tablet.
Green coloured, mottled round chewable tablet with concave centre
debossed with P.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Pepcid Duo is indicated in short-term symptomatic treatment of
heartburn and acid regurgitations in adults and adolescents
16 years & over.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FOR ADULTS AND ADOLESCENTS (16 years & over).
Chew one tablet thoroughly when symptoms occur, and swallow preferably
with a glass of water. Do not exceed 2 tablets per
day.
Treatment duration is limited to 2 weeks (see section 4.4 Special
warnings and Precautions for use).
Paediatric population
The safety and efficacy of Pepcid Duo in children under 16 years of
age has not yet been established (no data are available).
Elderly
No dosage adjustment is required for the elderly.
Renal Impairment
This medicine is contraindicated in patients with severe renal failure
(see section 4.3 Contraindications).
Patients with renal impairment should consult their physician before
taking famotidine/antacid combination (Please refer to
section 4.4 Special warnings and precautions for use).
Hepatic Impairment
No dosage adjustment is required for famotidine/antacid combination in
hep