Zantac 75 Dissolve 75mg Effervescent Tablets

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Ranitidine

Dostupné z:

Chefaro Ireland DAC

ATC kód:

A02BA; A02BA02

INN (Medzinárodný Name):

Ranitidine

Dávkovanie:

75 milligram(s)

Forma lieku:

Effervescent tablet

Typ predpisu:

Product not subject to medical prescription

Terapeutické oblasti:

H2-receptor antagonists; ranitidine

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2000-12-20

Súhrn charakteristických

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.
SEVERE RENAL IMPAIRMENT
Ranitidine is excreted through the kidney and so plasma levels of the
drug are increased in patients with severe renal
impairment.
Zantac 75 Dissolve effervescent tablets are not suitable for these
patients.
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