RANITIDINE

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

RANITIDINE HYDROCHLORIDE

Disponible des:

Focus Pharmaceuticals Ltd

Codi ATC:

A02BA02

Designació comuna internacional (DCI):

RANITIDINE HYDROCHLORIDE

Dosis:

150 mg/10ml

formulario farmacéutico:

Oral Solution

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

ranitidine

Estat d'Autorització:

Not Marketed

Data d'autorització:

2008-01-11

Informació per a l'usuari

-
if you are diabetic
-
if
you have any problems with your immune system.
If you are not sure if any of the above apply to you,
talk to your doctor or pharmacist before using this
medicine.
OTHER MEDICINES AND RANITIDINE ORAL SOLUTION
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines. This
includes medicines that you buy without a prescription
and herbal medicines. This is because Ranitidine Oral
Solution can affect the way some other medicines
work. Also some other medicines can affect the way
Ranitidine Oral Solution works.
In particular tell your doctor or pharmacist if you are
taking any of the following medicines:
• Non-Steroidal Anti-Inflammatory (NSAID)
medicines, for pain and inflammation
• lidocaine, a local anaesthetic
• propranolol, procainamide or
n-acetylprocainamide, for heart problems
• diazepam, for worry or anxiety problems
• phenytoin, for epilepsy
• theophylline, for breathing problems (asthma)
• warfarin, for thinning your blood
• glipizide, for lowering blood glucose
• atazanavir or delavirdine, for treating HIV infection
• triazolam, for insomnia
• gefitnib, for lung cancer
• ketoconazole, an anti-fungal medicine, sometimes
used for treating thrush
• sucralfate for treating stomach ulcers.
Midazolam is a medicine that may be given to you just
before you have an operation. Tell the doctor you are
taking Ranitidine Oral Solution before your operation in
case he or she wants to give you midazolam.
If you are not sure if any of the above apply to you,
talk to your doctor, pharmacist or nurse before taking
Ranitidine Oral Solution.
PREGNANCY, BREAST-FEEDING AND FERTILITY
If you are pregnant or breast-feeding, think you may
be pregnant or are planning to have a baby, ask
your doctor, pharmacist or nurse for advice before
taking this medicine. You should not take this
medicine unless your doctor advises it is essential.
DRIVING AND USING MACHINES
The amount of alcohol in a large dose of Ranitidine
Oral Solution may affe

Fitxa tècnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ranitidine 150mg/10ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 10ml contains 150mg Ranitidine as ranitidine hydrochloride.
Excipients with known effect:
Sorbitol, liquid (non crystallising): 3000mg per 10ml
Sodium: 19.28mg per 10ml
Ethanol (96%):800mg per 10ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral Solution
Clear pale yellow liquid with an odour of peppermint.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In adults Ranitidine 150mg/10ml Oral Solution is indicated for:
the treatment of duodenal ulcer and benign gastric ulcer, including
that associated with non-steroidal anti-
inflammatory agents.
the prevention of NSAID associated duodenal ulcers.
the treatment of post-operative ulcer, Zollinger-Ellison Syndrome and
oesophageal reflux disease including long
term management of healed oesophagitis.
Other patients with chronic episodic dyspepsia, characterised by pain
(epigastric or retrosternal) which is related
to meals or disturbs sleep but is not associated with the preceding
conditions may benefit from ranitidine
treatment.
the following conditions where reduction of gastric secretion and acid
output is desirable; the prophylaxis of
gastro-intestinal haemorrhage from stress ulceration in seriously ill
patients, the prophylaxis of recurrent
haemorrhage in patients with bleeding peptic ulcers and before general
anaesthesia in patients considered to be at
risk of acid aspiration (Mendelson's Syndrome), particularly obstetric
patients during labour.
CHILDREN (3 TO 18 YEARS)
Short term treatment of peptic ulcer
Treatment of gastro-oesophageal reflux, including reflux oesophagitis
and symptomatic relief of gastro-
oesophageal reflux disease.
See section 4.4. Special warnings and precautions for use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology:
ADULTS
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___