Zantac 75

Negara: Malta

Bahasa: Inggris

Sumber: Medicines Authority

Bahan aktif:

RANITIDINE

Tersedia dari:

Chefaro Ireland DAC The Sharp Building, Hogan Place, Dublin 2,, Ireland

Kode ATC:

A02BA02

INN (Nama Internasional):

RANITIDINE 75 mg

Bentuk farmasi:

FILM-COATED TABLET

Komposisi:

RANITIDINE 75 mg

Jenis Resep:

OTC

Area terapi:

DRUGS FOR ACID RELATED DISORDERS

Status otorisasi:

Withdrawn

Tanggal Otorisasi:

2006-09-18

Selebaran informasi

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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 associated with dyspepsia.
•
if you have kidney or liver problems.
•
if you suffer from l

Karakteristik produk

HEALTH PRODUCTS REGULATORY AUTHORITY
_Date Printed 21/07/2017_
_CRN 2194481_
_page number: 1_
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Zantac 75mg Film-coated Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zantac 75 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
DOSAGE IN ADULTS (INCLUDING THE ELDERLY) AND CHILDREN 16 YEARS OF AGE
OR OLDER:
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.
CHILDREN:
Not recommended for children under 16 years of age.
4.3
CONTRAINDICATIONS
Known hypersensitivity to any component of the preparation.
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
(creatine 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.
HEALTH PRODUCTS REGULATORY AUTHORITY
_Date Printed 21/07/2017_
_CRN 2194481_
_page number: 2_
The following patients are advised to seek their doctor’s advice
before taking ranitidine products:
Patients with renal impairmen