Zantac 75mg Film-coated Tablets

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Ranitidine

Beschikbaar vanaf:

Chefaro Ireland DAC

ATC-code:

A02BA; A02BA02

INN (Algemene Internationale Benaming):

Ranitidine

Dosering:

75 milligram(s)

farmaceutische vorm:

Film-coated tablet

Prescription-type:

Product not subject to medical prescription

Therapeutisch gebied:

H2-receptor antagonists; ranitidine

Autorisatie-status:

Marketed

Autorisatie datum:

1998-11-13

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZANTAC 75MG FILM-COATED TABLETS
ranitidine (as hydrochloride)
Please read all of this leaflet carefully before you start to take
this medicine because it contains
important information for you.
This medicine is available without prescription. However, you still
need to take Zantac 75 tablets
carefully to get the best results from them.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
You must contact a doctor if your symptoms worsen or do not improve
after 14 days.
-
If any of the side effects get serious or if you notice any side
effect not listed in this leaflet, please
tell your doctor or pharmacist.
IN THIS LEAFLET:
1. What Zantac 75 tablets are and what are they used for
2. Before you take Zantac 75 tablets
3. How to take Zantac 75 tablets
4. Possible side effects
5. How to store Zantac 75 tablets
6. Further information
1.
WHAT ZANTAC 75 TABLETS ARE AND WHAT ARE THEY USED FOR
Each tablet contains 75mg of ranitidine (as hydrochloride). Ranitidine
belongs to a group of
medicines known as histamine H2 antagonists.
The stomach contains hydrochloric acid which helps to digest your
food.
Sometimes your stomach produces too much acid. This excess acid can
lead to the conditions known
as heartburn and dyspepsia (acid indigestion). Zantac 75 tablets are
for the short-term relief of the
symptoms of heartburn, excess acid and dyspepsia (acid indigestion).
2.
BEFORE YOU TAKE ZANTAC 75 TABLETS
DO NOT TAKE ZANTAC 75 TABLETS:
•
• if you are allergic to ranitidine or any of the other ingredients
listed in Section 6.
•
• if you suffer from a rare condition called porphyria.
Take special care and consult your doctor before you take Zantac 75
tablets:
•
• if you are middle aged or older and have acid indigestion symptoms
for the first time or
symptoms that have recently changed.
•
• if you have been told you have a peptic ulcer (“stomach” or
“duodenal”).
•
• if you have unintended weight loss

Productkenmerken

Health Products Regulatory Authority
19 September 2019
CRN0093Z1
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zantac 75mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 75mg ranitidine as ranitidine hydrochloride.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (Tablet).
Five sided biconvex, pink film coated tablet with Z engraved on one
side and 75 on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The short-term symptomatic relief of acid indigestion and heartburn.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS (INCLUDINGTHEELDERLY)AND CHILDREN 16 YEARS OFAGEOROLDER:
One Zantac 75 tablet should be taken when symptoms appear, day or
night.
Maximum intake in 24 hours: 2 tablets (150mg). The maximum treatment
period is two weeks. It is not necessary to take the
tablets with food.
Patients are advised to consult their doctor or pharmacist if symptoms
persist, get worse or continue for 14 days.
_Paediatric population_
Not recommended for children under 16 years of age.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Treatment with a histamine H2-antagonist may mask symptoms associated
with carcinoma of the stomach and may therefore
delay diagnosis of the condition.
Ranitidine is excreted via the kidney and so plasma levels of the drug
are increased in patients with renal impairment
(creatinine clearance less than 50ml/min). Ranitidine products are not
suitable for these patients without medical supervision.
Rare clinical reports suggest that ranitidine may precipitate acute
porphyric attacks. Ranitidine should therefore be avoided in
patients with a history of acute porphyria.
The following patients are advised to seek their doctor's advice
before taking ranitidine products:
Health Products Regulatory Authority
19 September 2019
CRN0093Z1
Page 2 of 7
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Patients with rena