ACTAL 360 Milligram Tablets
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
19-04-2024
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:
ALEXITOL SODIUM
थमां उपलब्ध:
Seven Seas Ltd
INN (इंटरनेशनल नाम):
ALEXITOL SODIUM
डोज़:
360 Milligram
फार्मास्यूटिकल फॉर्म:
Tablets
प्राधिकरण का दर्जा:
Withdrawn
प्राधिकरण की तारीख:
2008-08-31
उत्पाद विशेषताएं
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Actal 360mg Orodispersible Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Alexitol Sodium 360mg.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Orodispersible Tablet
A round, flat bevel-edged tablet with ‘Actal’ embossed on both sides.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antacid.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Actal tablets are for oral administration only.
_Adults and Elderly: _Two tablets to be dissolved on the tongue up to 8 times per day. The dose may be repeated as
required. Do not take more than 16 tablets in 24 hours.
_Children: _Not suitable for children under 12 years of age.
4.3 CONTRAINDICATIONS
There are no known contraindications.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If symptoms persist, consult your doctor. Keep out of the reach of children.
Aluminium hydroxide may cause constipation due to its astringent action.
Aluminium hydroxide may lead to a phosphate depletion syndrome, particularly in patients on a low phosphate diet e.g.
malnutrition.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Antacids may reduce the absorption of other drugs, including tetracyclines, digoxin and vitamins.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/09/2007_
_CRN 2039484_
_page number: 1_
4.6 PREGNANCY AND LACTATION
There is inadequate evidence of safety of Actal in human pregnancy, but it has been in wide use for many years
without apparent ill consequence. However, careful consideration should be given before treating pregnant patients
with Actal, particularly during the first trimester.
4.7 EFFECTS ON ABILITY TO DRI
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