Ranitidine 75mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ranitidine hydrochloride

Available from:

DE Pharmaceuticals

ATC code:

A02BA02

INN (International Name):

Ranitidine hydrochloride

Dosage:

75mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 01030100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RANITIDINE 75 MG FILM-COATED TABLETS
ranitidine (as hydrochloride)
For use in adults and adolescents from 16 years of age
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 have 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 a doctor if you do not feel better or if you feel
worse after 14 days.
WHAT IS IN THIS LEAFLET
1. What
_Ranitidine 75 mg_
is and what it is used for
2. What you need to know before you take
_Ranitidine 75 mg_
3. How to take
_Ranitidine 75 mg_
4. Possible side effects
5. How to store
_Ranitidine 75 mg_
6. Contents of the pack and other information
1. WHAT _RANITIDINE 75 MG_ IS AND WHAT IT IS USED FOR
_Ranitidine 75 mg _
belongs to a group of medicines known as H
2
-receptor antagonists which reduce the
amount of acid in your stomach.
_Ranitidine 75 mg_
is used for the short-term, symptomatic treatment of heartburn.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE _RANITIDINE 75 MG_
DO NOT TAKE _RANITIDINE 75 MG_:
-
if you are allergic (hypersensitive) to Ranitidine or any of the other
ingredients of this medicine
(listed in section 6).
_ _
_Ranitidine 75 mg_
may not be given to children under 16 years of age.
WARNING AND PRECAUTIONS
Talk to your doctor or pharmacist before taking
_ Ranitidine 75 mg_
:
-
if you have ever suffered from a stomach or intestinal ulcer.
-
if you are inadvertently losing weight in association with existing
indigestion problems.
-
if you suffer from kidney or liver problems, or any other illness
which requires regular medical
supervision.
-
if you suffer from any other illness, or are taking other medicines,
that your doctor has

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ranitidine 75mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 83.75 mg of ranitidine hydrochloride
equivalent to 75 mg of ranitidine.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Light pink, round, biconvex, film-coated tablets with embossment
“75” on one
side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ranitidine Tablets are indicated for the short-term symptomatic relief
of
heartburn.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Adults (including the elderly) and adolescents of 16 years of age and
older.
One Ranitidine 75mg tablet should be taken when symptoms occur, day or
night. Do not take more than two tablets in 24 hours.
Patients will be instructed not to take the tablets for more than 2
weeks
continuously. They must consult their doctor if symptoms deteriorate
or persist
after 2 weeks treatment.
Children under 16 years.
The tablets are 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.
•
Ranitidine tablets should not be given to children under 16 years of
age.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The possibility of malignancy should be excluded before commencement
of therapy
in patients with gastric ulcer as treatment with ranitidine may mask
symptoms of
gastric carcinoma.
Ranitidine is excreted via the kidney and so plasma levels of the drug
are increased
in patients with renal impairment.
Rare clinical reports suggest that ranitidine may precipitate acute
porphyric attacks.
Ranitidine should therefore be avoided in patients with a history of
acute porphyria.
In patients such as the elderly, persons with chronic lung disease,
diabetes or the
immunocompromised, there may be an increased risk of developing
community
acquired pneumonia.
A large epidemiological study showed an increased risk of developing
community
acquired pneumonia in cur