BUCCASTEM Buccal Tablet 3 Milligram
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
06-05-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
PROCHLORPERAZINE MALEATE
थमां उपलब्ध:
Alliance Pharmaceuticals Ltd.
डोज़:
3 Milligram
फार्मास्यूटिकल फॉर्म:
Buccal Tablet
प्राधिकरण की तारीख:
2009-12-18
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Buccastem 3mg Buccal Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each buccal tablet contains 3 mg prochlorperazine maleate.
Excipients: Each buccal tablet contains at least 47mg sucrose.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Buccal tablet
Pale yellow, round, biconvex, buccal tablet, with ‘J1’ on one face.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the management of acute vertigo, such as is associated with Meniere’s Syndrome, nausea and vomiting, and
migraine.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
To be placed in the buccal cavity.
Adults and children over 12 years: One tablet taken twice a day.
Children under 12 years: Not recommended.
The course of treatment should not exceed two weeks in duration.
4.3 CONTRAINDICATIONS
Buccastem is contraindicated in patients with impaired liver function, existing blood dyscrasias and known
hypersensitivity to the active ingredient.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Phenothiazines should only be used with great caution in patients with a history of jaundice.
Patients receiving phenothiazines over a prolonged period require regular and careful surveillance with particular
attention to potential for inducing eye change, effects on haemopoiesis, liver dysfunction, myocardial conduction
effects, particularly if other concurrently administered drugs also have potential effects on these symptoms.
Phenothiazines may induce drowsiness. Persons taking these drugs should not drive or operate machinery unless the
drug has been shown not to interfere with physical or mental ability.
Use of phenothiazines at high (relative or absolute) doses may induce extrapyramidal side-effects, dyskinesia,
akathisia, dystonia.
IRISH MEDICINES BOAR
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