VAGI

VAGI C vaginal tablets

Important notes (mandatory information)

Vagi-C. Active ingredient: 250 mg ascorbic acid (vitamin C). Areas of application: Chronic or recurring bacterial infection of the vagina (amine colpitis, bacterial vaginosis, non-specific colpitis) of mild to moderate severity; normalisation of the disturbed vaginal flora.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vagi-C
Active ingredient: Ascorbic acid 250 mg/vaginal tablet

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, contact your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If your symptoms do not improve after 6 days or even get worse, contact your doctor.

What is in this leaflet

1. WHAT IS VAGI-C AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING VAGI-C?
3. HOW TO USE VAGI-C?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE VAGI-C?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS VAGI-C AND WHAT IS IT USED FOR?

Vagi-C is a vaginal therapeutic. It is used for chronic or recurring amine colpitis (bacterial vaginosis, non-specific colpitis) of mild to moderate severity; for normalisation of the disturbed vaginal flora.

2. WHAT SHOULD YOU CONSIDER BEFORE USING VAGI-C?

Vagi-C must not be used,

• if you are hypersensitive (allergic) to ascorbic acid (vitamin C) or any of the other ingredients of this medicine listed in section 6.
• if you suffer from fungal infections in the genital area. Here, acidification of the vagina does not bring any benefits, but can rather increase the discomfort, as fungi also grow quite well in an acidic environment.

Use of Vagi-C together with other medicines

Salicylates increase the excretion of vitamin C. Oestrogens improve the bioavailability of vitamin C. The effect of anticoagulants (medicines that inhibit blood clotting) is reduced by vitamin C. Please inform your doctor or pharmacist if you are taking/using or have recently taken/used any other medicines, even if they are non-prescription medicines.

Pregnancy and breast-feeding
Vagi-C may also be administered during pregnancy and breast-feeding. No damage to offspring has been observed in animal studies, even at high doses. It is important to ensure that hands are washed thoroughly before using Vagi-C to reduce the risk of ascending infection. Ask your doctor or pharmacist for advice before taking/using any medicine.

Driving and ability to operate machinery

No special precautions are required.

Other notes

Vitamin C falsifies the enzymatic glucose determination in urine, as well as the serum transaminase determination, the lactate dehydrogenase determination and the serum bilirubin determination. Interruption of the use of Vagi-C due to intermenstrual bleeding or menstrual bleeding is not necessary. Other underlying diseases or systemic infectious diseases are also not a contraindication for the use of Vagi-C. On the contrary, an additional intake of vitamin C may even be desirable, as the body's need is higher in stress situations.

3. HOW TO USE VAGI-C?

Always use this medicine exactly as described in this package leaflet. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, the usual dose is one vaginal tablet per day. The vaginal tablet is inserted deep into the vagina, preferably in the evening. For mild to moderate bacterial disorders of the vaginal flora, a 6-day treatment is usually sufficient. In case of severe disturbance of the vaginal flora with complete absence of lactobacillus flora or during pregnancy, a longer application over weeks is advisable. A repetition after the period increases the healing success. If necessary, Vagi-C can be administered daily for weeks and months. There is no evidence to suggest that the duration of use should be limited. Please talk to your doctor or pharmacist if you have the impression that the effect of Vagi-C is too strong or too weak. Since discolouration of the laundry - depending on the underlying disease and the type of textile materials - can never be completely ruled out, it is advisable to wear suitable laundry protection for the duration of the illness and its treatment.

If you have used more Vagi-C than you should

Overdose symptoms with vaginal use of vitamin C have not been reported to date. Accidental ingestion of the vaginal tablets is harmless.

If you forget to use Vagi-C

The application should be made as soon as possible.

If you stop using Vagi-C

If you stop treatment with Vagi-C prematurely, this may jeopardise the success of the treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Possible side effects

Occasionally, burning and itching in the vagina may occur after using Vagi-C. This is a phenomenon that is more or less observed with all vaginal therapeutics. The symptoms of burning and itching are caused by a fungal infection in some patients: It is known that about 10% of all women have a yeast colonisation of the vagina that does not yet cause any symptoms. A disturbed vaginal flora with high concentrations of certain anaerobic germs that produce yeast-inhibiting substances (such as diphenylamine, etc.) also suppresses the further multiplication of yeasts that may be present in individual cases. After normalisation of the vaginal flora by Vagi-C, in some cases there is an increased multiplication of yeasts, and this can then lead to a noticeable (symptomatic) fungal infection with corresponding symptoms. In very rare cases, hypersensitivity to one of the ingredients may occur. In this case, the preparation should no longer be used.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VAGI-C?

Keep this medicine out of the reach of children. Do not store above 25 °C. Store in the original container to protect the contents from moisture. Do not use the medicine after the expiry date which is stated on the carton and blister after "Use by". The expiry date refers to the last day of the month indicated. Do not use Vagi-C if you notice the following: If stored incorrectly, the vaginal tablets turn dark brown. Do not dispose of medicines in wastewater or household waste (regional differences). Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Vagi-C contains

The active ingredient is ascorbic acid. 1 vaginal tablet contains 250 mg ascorbic acid (vitamin C).
The other ingredients are: Lactose monohydrate, hypromellose, silicone resin, magnesium stearate (Ph. Eur.).

What Vagi-C looks like and contents of the pack

The white, oval vaginal tablets are available in packs of 6 vaginal tablets and 12 vaginal tablets.

Pharmaceutical entrepreneur

Taurus Pharma GmbH
Benzstr. 11
D-61352 Bad Homburg
Tel.: 06172/139683
Fax: 06172/171550
info@tauruspharma.de

Manufacturer

Artesan Pharma GmbH & Co. KG,
Wendlandstr. 1,
29439 Lüchow
Tel.: 05841/939-0
Fax: 05841/939-200

This leaflet was last revised in May 2014.

Source: Information from the package leaflet
Status: 02/2016
Active ingredient: 250 mg ascorbic acid (vitamin C). Areas of application: Chronic or recurring bacterial infection of the vagina (amine colpitis, bacterial vaginosis, non-specific colpitis) of mild to moderate severity; normalisation of the disturbed vaginal flora.