ZANTAC 75 DISSOLVE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
10-05-2024
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Active ingredient:
RANITIDINE HYDROCHLORIDE
Available from:
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
Dosage:
75 Milligram
Pharmaceutical form:
Tablets Effervescent
Authorization date:
2000-12-20
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 75 Dissolve 75mg Effervescent Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75 mg ranitidine as ranitidine hydrochloride.
Excipients: Each tablet contains 164.01mg of sodium, 15mg of aspartame and less than 15mg of sorbitol.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Effervescent tablet.
White to pale yellow, round, flat bevel-edged tablet engraved ‘GX EK1’ on one side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The short-term symptomatic relief of acid indigestion and heartburn.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
One Zantac 75 effervescent tablet should be dissolved in water (_see 6.6 Instructions for Use/Handling_) and taken when
symptoms occur, day or night.
Maximum intake in 24 hours: 2 tablets (150 mg). The maximum treatment period is two weeks.
It is not necessary to take the tablets with food.
Patients are advised to consult their doctor if symptoms persist, get worse or continue for 14 days.
CHILDREN:
The use of Zantac 75 Dissolve effervescent tablets in children under 16 years of age is not recommended.
4.3 CONTRAINDICATIONS
Known hypersensitivity to ranitidine or any other component of the preparation.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Treatment with histamine H
2
-antagonist may mask symptoms associated with carcinoma of the stomach and may
therefore delay diagnosis of the condition.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/03/2010_
_CRN 2079310_
_page number: 1_
SEVERE RENAL IMPAIRMENT
Ranitidine is excreted through the kidney and so plasma levels of the drug are increased in patients with severe ren
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