NIZATIDINE Capsule, hard (2016)
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Περιεχόμενα
Name of the medicinal product
Nizatidine 150 mg Capsules, hard.
Qualitative and quantitative composition
Each capsule contains 150 mg of nizatidine. Excipient with known effect: Each capsule contains Allura red. For the full list of excipients, see section 6.1.
Pharmaceutical form
Capsule, hard. Hard gelatin capsules containing white to off-white powder with a light yellow body and dark yellow cap. The body has NZ 150 and the cap has G, both printed in black.
Therapeutic indications
For the treatment of the following diseases where reduction of gastric acid is indicated: Duodenal ulcer Benign gastric ulcer Prevention of duodenal or benign gastric ulcer recurrence Gastric oesophageal ...
Posology and method of administration
Posology Adults For treatment of duodenal ulcer: the recommended daily dose is 300 mg in the evening. Treatment should continue for four weeks, although this period may be reduced if healing is confirmed ...
Contraindications
Hypersensitivity to the active substance, any other H<sub>2</sub>-receptor antagonists or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
As nizatidine is partially metabolised by the liver and principally excreted by the kidneys, patients with impaired liver or kidney function should be treated with caution. (see section 4.2.) Symptomatic ...
Interaction with other medicinal products and other forms of interaction
There is evidence that oral nizatidine does not affect the serum levels of concomitantly-administered aminophylline, theophylline, chlordiazepoxide, diazepam, lidocaine, phenytoin, ibuprofen, metoprolol, ...
Pregnancy and lactation
Pregnancy The safety of nizatidine for use during pregnancy has not been established. Animal studies have shown no evidence of impaired fertility or teratogenicity attributable to nizatidine. Nizatidine ...
Effects on ability to drive and use machines
There is no influence of nizatidine on the ability to drive or use machines.
Undesirable effects
In large scale clinical trials, sweating and urticaria were significantly more common in nizatidine-treated patients when compared with placebo. In these trials, 1.9% of treated patients experienced somnolence, ...
Overdose
Symptoms There is little experience of overdose in humans. Tested at very high doses in animals, nizatidine has been shown to be relatively non-toxic. Animal studies suggest that cholinergic-type effects, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD), H<sub>2</sub>-receptor antagonists ATC code: A02BA04 Mechanism of action Nizatidine is a potent, selective, ...
Pharmacokinetic properties
Bioavailability of orally administered nizatidine is not significantly influenced by food intake, anticholinergic agents or antacids. Absorption Absorption of nizatidine after oral administration is rapid ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
List of excipients
Capsule Contents: Croscarmellose sodium Starch pregelatinised Talc Magnesium stearate Capsule Composition: Titanium dioxide (E171) Gelatin Quinoline yellow (E104) Allura red (E129) Yellow iron oxide (E172) ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
High density polyethylene bottles with polypropylene snap-on caps containing 28 or 30 capsules or PVC/Aluminium blister packs containing 28 or 30 capsules. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Generics [UK] Ltd t/a Mylan, Station Close, Potters Bar, Herts, EN6 1TL
Marketing authorization number(s)
PL 04569/0471
Date of first authorization / renewal of the authorization
Date of first authorisation: 17/07/2002 Date of latest renewal: 12/03/2009
Date of revision of the text
06/2016
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