INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo CULTURELLE VC (vaginal capsule)

SCHEDULING STATUS:
Not applicable

PROPRIETARY NAME
(and dosage form):

CULTURELLE VC (vaginal capsule)

COMPOSITION:
Each vaginal capsule contains a minimum of 10 x 107 viable lactic acid bacteria Lactobacillus acidophilus and Lactobacillus paracasei.
Alternatively known as
lactic acid bacteria or probiotics.
Other ingredients: Lactitol, hydroxypropyl methylcellulose, xanthan gum, magnesium stearate and titanium dioxide.

PHARMACOLOGICAL CLASSIFICATION:
A: 34 Other

PHARMACOLOGICAL ACTION:
Probiotics compete with pathogenic bacteria for sites (within the vaginal mucosa) thereby inhibiting the pathogenic bacteria from overgrowth and thus from establishing themselves.
The hydrocolloid enhances the ability of the lactic acid bacteria to adhere to the vaginal mucosa. This allows the probiotic bacteria to continue to colonise thereby having a positive effect.

INDICATIONS:
To prevent and reduce urogenital infections (e.g. recurrent vaginal thrush) by assisting in restoring the vaginal flora imbalance.

CONTRA-INDICATIONS:
No known contra-indications.
Safety using the applicator during pregnancy has not been established.

DOSAGE AND DIRECTIONS FOR USE:
FOR VAGINAL INSERTION ONLY.
Not to be swallowed.
One (1) capsule to be inserted into the vaginal tract at bedtime.
Continue treatment until the problem disappears. If the symptoms of itching or burning feeling do not improve or if the discharge does not improve after 7 days, consult your medical doctor.
Direction for use:
Wash the hands with warm water and soap. Remove one capsule from the aluminium blister
Option 1: Using the middle finger; insert one capsule deeply into the vaginal tract.
Option 2: Use with an applicator (Plunger A & Applicator B), see illustration on package insert:
  Gently pull out plunger A until it stops or it catches
  Place one capsule into the Applicator B
  Insert the applicator (containing the capsule), carefully and as deeply as possible into the vagina (preferably lying on your back as illustrated)
  Push plunger A until it stops - this will position the capsule into the vagina
  Remove applicator from vagina.
After using the applicator, remove plunger A completely by pulling it out of Applicator B. Wash it in warm (not boiling), soapy (not dish detergent) water. Rinse and dry carefully. This is important as it will assist in preventing reinfection.
Caution: The use of an Applicator is not recommended during pregnancy.
Or use as directed by your Healthcare Professional

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
No known side-effects.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
No known symptoms of overdosage.

IDENTIFICATION:
Opaque white to off white hard gelatine vegetable vaginal capsule without any coating.

PRESENTATION:
Aluminium blister packs of 12 capsules with an applicator.

STORAGE INSTRUCTIONS:
Store in a cool (below 25°C), dry place. Protect from moisture.
Keep out of reach of children

NAME AND BUSINESS ADDRESS:
Pharma Dynamics (Pty) Ltd
F02 Grapevine House
Steenberg Office Park
Westlake
7945

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 2002

DIRECTIONS FOR USING THE APPLICATOR
{Illustrated}
PLUNGER A
APPLICATOR B
1. Gently pull out plunger A until it stops or it catches.
2. Place one capsule into the Applicator B.
3. Insert the applicator (containing the capsule), carefully and as deeply as possible into the vagina (preferably lying on your back as illustrated)
4. Push plunger A until it stops - this will position the capsule into the vagina. Remove applicator from vagina.
5. Wash the applicator after use.
IMPORTANT NOTICE: The product may only be used during pregnancy when prescribed by a doctor. Pregnant women should follow the instructions of their doctor strictly. During pregnancy, insertion of the capsule should be done without using the applicator.
A034

Updated on this site: November 2002       
Source: Pharmaceutical Industry

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