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

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

Famotidine; Magnesium hydroxide; Calcium carbonate

Inapatikana kutoka:

JNTL Consumer Health I (Ireland) Limited

ATC kanuni:

A02BA; A02BA53

INN (Jina la Kimataifa):

Famotidine; Magnesium hydroxide; Calcium carbonate

Dawa fomu:

Chewable tablet

Eneo la matibabu:

H2-receptor antagonists; famotidine, combinations

Idhini hali ya:

Marketed

Idhini ya tarehe:

2000-09-29

Taarifa za kipeperushi

Famotidine 10 mg, Magnesium hydroxide 165 mg, Calcium carbonate 800 mg
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 your 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 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).
• You have severe kidney problems.
• You are allergic to other H2 blockers (medicines which control the
production of excess
stomach acid).
WARNING 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 symptoms have recently
changed.
• Too much calcium in your blood.
• Too muc

Tabia za bidhaa

Health Products Regulatory Authority
22 March 2024
CRN00DHCM
Page 1 of 8
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
hepati