VAGIFORTE® PLUS PACKAGE INSERT
SCHEDULING STATUS: 0
PROPRIETARY NAME (AND DOSAGE FORM): VAGIFORTE® PLUS capsules and tablets
COMPOSITION: Each capsule contains 45 mg comprising Lactobacillus acidophilus, Bifidobacterium bifidum and Bifidobacterium longum (in a lyophilised form), which yield in total not less than 3 billion (3 x 109) viable cells. Each tablet contains 15 mg of Lactobacillus acidophilus, Bifidobacterium bifidum and Bifidobacterium longum (in a lyophilised form), which yield not less than 1 billion (109) viable cells.
PHARMACOLOGICAL ACTION: VAGIFORTE® PLUS capsules and tablets contain a mixture of lyophilised lactic acid bacteria namely, Lactobacillus acidophilus, Bifidobacterium bifidum and Bifidobacterium longum which are natural inhabitants of the human vagina and intestinal tract. VAGIFORTE® PLUS is administered to restore and maintain the normal vaginal flora (mainly lactic acid bacteria) frequently destroyed by broad-spectrum antibiotics, the use of disinfectants, soaps and deodorants. Lactic acid bacteria control the overgrowth of pathogenic microorganisms in the human digestive tract and prevent their potential transfer to the uro-genital tract. Administration of high doses of these bacteria helps to prevent the development of vaginosis (bacterial vaginal infections) and of vaginitis (vaginal thrush caused by Candida albicans), frequently associated with the broad-spectrum antibiotic treatment.
INDICATIONS: VAGIFORTE® PLUS capsules and tablets are indicated primarily for the treatment of vaginal thrush induced by antibiotic treatment or the excessive use of strong soaps, disinfectants and deodorants, for the restoration of the bacterial flora occurring naturally in the human vagina and for the prevention of transfer of Candida albicans (a natural intestinal inhabitant) to the vagina. Some forms of vaginosis also respond to the treatment with VAGIFORTE® PLUS.
CONTRA-INDICATIONS: None known
DOSAGE AND DIRECTIONS FOR USE: One capsule to be taken once daily with water (preferably on an empty stomach, 30 minutes before breakfast), Complete the 5 day oral capsule course (before using the vaginal tablets). One vaginal tablet to be inserted into the vagina in the evening, before bedtime for the next 5 days. The full course can be repeated if necessary.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Large doses may cause loose stools in some individuals.
WARNING AND SPECIAL PRECAUTIONS: The 5 day oral capsule course must be completed before inserting the vaginal tablets for the next 5 days. This will alleviate any possible burning sensation or irritation of the vaginal mucosa in the event that the vaginal tablets are inadvertently used during the first 5 days of the course.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Loose stools whereupon the administration of VAGIFORTE® PLUS should be discontinued temporarily.
INDENTIFICATION: White and maroon capsules containing white to cream coloured, granular material with a slight lactic acid smell. White, long-oval tablets.
PRESENTATION: 5 white and maroon capsules, and 5 white tablets in a blister strip, packed in a unit carton.
STORAGE CONDITIONS: Store in a cool, dry place below 25oC.
KEEP OUT OF REACH OF CHILDREN.