Betadine Vag

Package Leaflet: Information for the User

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Betadine VAG (Betadine 200 mg), 200 mg, vaginal capsules

Povidone iodine
Betadine VAG and Betadine 200 mg are different trade names for the same medicine.

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.

• You should keep this leaflet, so you can read it again if you need to.
• If you need advice or more information, you should speak to a pharmacist.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, you should contact your doctor.

Table of Contents of the Leaflet

• 1. What is Betadine VAG and what is it used for
• 2. Important information before using Betadine VAG
• 3. How to use Betadine VAG
• 4. Possible side effects
• 5. How to store Betadine VAG
• 6. Contents of the pack and other information

1. What is Betadine VAG and what is it used for

Betadine VAG is intended for vaginal use only. Betadine VAG contains povidone iodine as the active substance. Povidone iodine is a complex of iodine with povidone - after vaginal application, it releases iodine. Iodine acts on Gram-positive and Gram-negative bacteria, viruses, fungi, and some protozoa.
Indications for use
Betadine VAG is indicated for the treatment of vaginal infections.
Betadine VAG is used in adult women and in girls after puberty.
If after 7 days there is no improvement or you feel worse, you should contact your doctor.

2. Important information before using Betadine VAG

When not to use Betadine VAG

• if you are allergic to povidone iodine or any of the other ingredients of this medicine (listed in section 6),
• if your thyroid gland does not work properly (you have a known hyperthyroidism or other symptomatic thyroid disorders - see "Warnings and precautions"),
• before, during, and after treatment with radioactive iodine and scintigraphy,
• in herpetic-like skin inflammation (so-called herpetic dermatitis of Duhring),
• in girls before puberty (before the first menstrual period),
• in pregnant and breastfeeding women,
• if you are using products containing mercury, as concomitant use of Betadine VAG with products containing mercury may cause skin damage.

You should discuss the use of Betadine VAG with your doctor or pharmacist if you experience any of the following symptoms:

• Irregular vaginal bleeding
• Abnormal vaginal bleeding or spotting
• Ulcers, blisters, or sores on the vagina or vulva
• Lower abdominal pain
• Pain or difficulty urinating.

If any of the following symptoms occur in the case of vaginal infections, you should contact your doctor before using Betadine VAG:

• Fever or chills
• Nausea or vomiting
• Diarrhea.

Warnings and precautions

Before starting treatment with Betadine VAG, you should discuss it with your doctor or pharmacist.

• Patients with pre-existing kidney failure should consult their doctor before using Betadine VAG.
• You should avoid regular use of Betadine VAG capsules when taking lithium-containing medications.
• Prolonged use of povidone iodine-containing medications (Betadine VAG) may cause skin irritation, and in rare cases, severe skin reactions. If irritation or hypersensitivity occurs, you should stop using the medicine and contact your doctor immediately (see section 4. Possible side effects).
• The use of povidone iodine (Betadine VAG) may lead to temporary skin discoloration at the application site, which is caused by the color of the medicine itself.
• The medicine may cause false-positive results in some laboratory tests, such as detecting hidden blood in stool or urine and detecting glucose in urine.
• If after 7 days there is no improvement, you should contact your doctor.
• If within 6 months you experience more than 2 vaginal infections, you should contact your doctor.

Children and adolescents

Betadine VAG is contraindicated for use in girls before puberty.

Betadine VAG and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken (including those without a prescription) and about any medicines you plan to take.
Products containing mercury (see "When not to use Betadine VAG"), silver, hydrogen peroxide, and taurolidine may interact with povidone iodine and should not be used concomitantly.
Concomitant use of Betadine VAG with wound care products containing enzymatic ingredients leads to reduced efficacy of both medicines, so they should not be used concomitantly.
Betadine VAG should not be used concomitantly with reducing agents or alkali metal salts.
Medicines containing povidone iodine (Betadine VAG) used before or after the use of antiseptic agents containing octenidine may cause transient dark discoloration in diseased areas, so they should not be used concomitantly.
During the use of povidone iodine, there may be a decrease in iodine uptake by the thyroid gland, which may disrupt the results of some diagnostic tests of thyroid function [(e.g. thyroid scintigraphy, PBI (protein-bound iodine) determination, radioactive iodine diagnostics] and may prevent planned thyroid treatment with iodine (radioiodine therapy). To obtain objective scintigraphy results, it is recommended to ensure a sufficiently long period (at least 4 weeks) after the end of treatment with Betadine VAG.

Pregnancy, breastfeeding, and fertility

Pregnancy
The use of povidone iodine-containing capsules in pregnant women is contraindicated, as absorbed iodine may pass through the placental barrier.
Breastfeeding
The use of Betadine VAG capsules is contraindicated in breastfeeding women, as absorbed iodine may pass into breast milk (see section 5.2).
Fertility
There are limited data on the effect of povidone iodine on fertility in humans. Betadine VAG capsules have spermicidal properties. Therefore, their use is not recommended in women who plan to become pregnant.
If you think you may be pregnant or plan to have a child, you should consult your doctor or pharmacist before using this medicine.

Driving and using machines

The medicine has no effect on the ability to drive and use machines.

3. How to use Betadine VAG

Betadine VAG should always be used exactly as described in the patient leaflet or as directed by your doctor or pharmacist. If you are unsure, you should consult your doctor or pharmacist.
Vaginal application.
Do not heat before application.
Betadine VAG is intended for use in adult women and in girls after puberty.
Adults
It is recommended to use 1 capsule vaginally once a day for 7 days. If there is no improvement, you should consult your doctor.
It is recommended to moisten the capsule before use and then insert it deeply into the vagina in the evening before going to bed.
Application of the capsule:

• You should separate one capsule from the strip by tearing it off along the perforation at the "V" cut.
• Hold the plastic tabs with both hands and pull them apart to remove the capsule from the packaging.

It is also recommended to use sanitary pads during treatment.
It is essential to moisten the capsule before insertion to ensure maximum dissolution of the active substance and avoid local irritation. Discontinuation of treatment is not necessary even after menstrual bleeding occurs.

Use in children and adolescents

Betadine VAG is contraindicated for use in girls before puberty.

Using more than the recommended dose of Betadine VAG

Betadine VAG is intended for vaginal use only.

When used according to the instructions, there is no risk of overdose.
In case of local overdose, it is recommended to remove the inserted capsule.
If you use more than the recommended dose of Betadine VAG or accidentally swallow a capsule, you should contact your doctor immediately.
Excess iodine in the body may cause goiter, thyroid dysfunction.
Symptoms of acute iodine poisoning are:

• renal failure and lack of urine production (anuria),
• circulatory failure (shock),
• breathing difficulties (pulmonary edema),
• metabolic disorders.

If you notice any of the following symptoms of systemic toxicity, you should seek medical help immediately:

• renal dysfunction (including anuria),
• rapid heartbeat (tachycardia),
• low blood pressure (hypotension),
• circulatory collapse,
• breathing difficulties (laryngeal edema leading to asphyxia or pulmonary edema),
• seizures,
• fever,
• metabolic acidosis,
• hyperthyroidism or hypothyroidism (see section 4. - "Possible side effects", frequency "very rare" and "frequency not known").

Missing a dose of Betadine VAG

You should continue treatment as before and use the medicine as soon as possible.
You should not use a double dose to make up for a missed dose.

Stopping the use of Betadine VAG

To prevent the recurrence of the disease and ensure complete cure of the infection, you should not stop treatment before the end of 7 days.
If you have any further doubts about the use of this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

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

In case of the following side effects, you should stop using Betadine VAG and contact your doctor immediately

using Betadine VAG and contact your doctor immediately.
Rare side effects (occurring in less than 1 in 1000 patients):

• Hypersensitivity reactions.

Very rare side effects (occurring in less than 1 in 10,000 patients):

• Anaphylactic reaction (a severe allergic reaction causing difficulty breathing, dizziness, and low blood pressure).
• Angioedema (a severe allergic reaction causing swelling of the face or throat).

Additionally, the following may occur:

Rare (occurring in less than 1 in 1000 patients):
skin inflammation (so-called contact dermatitis with symptoms such as redness, small blisters, and itching).
Very rare (occurring in less than 1 in 10,000 patients):
hyperthyroidism (excessive thyroid activity causing increased appetite, weight loss, sweating, faster heartbeat, or restlessness) in patients with a history of thyroid disease.
Side effects with unknown frequency(based on available data, the frequency of their occurrence cannot be determined):

• After prolonged or more intensive use of povidone iodine, hypothyroidism (insufficient thyroid activity causing fatigue, weight gain, slower heartbeat) may occur,
• renal dysfunction, acute renal failure,
• electrolyte disturbances (imbalance of fluids and salts in the blood),
• metabolic acidosis (a condition of increased blood acidity that may cause rapid breathing, disorientation, or lethargy),
• abnormal blood osmolality (refers to the degree of blood concentration) may occur after taking very large amounts of povidone iodine,
• transient skin discoloration at the application site.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Betadine VAG

Store in the refrigerator (2°C-8°C), in the original packaging.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Betadine VAG contains

The active substance of the medicine is povidone iodine.
Each capsule contains 200 mg of povidone iodine.
The other ingredient of the medicine is macrogol 1000.

What Betadine VAG looks like and what the pack contains

The medicine is in the form of capsules. Each capsule is uniform, brown-red in color, torpedo-shaped, approximately 33 mm long, and approximately 12 mm in diameter. The packaging of the medicine contains 7 capsules (1 blister pack of PVC/PE), placed in a cardboard box.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Romania, the country of export:

Egis Pharmaceuticals PLC
Keresztúri út 30-38
H-1106 Budapest, Hungary

Manufacturer:

Egis Pharmaceuticals PLC
Mátyás király út 65, H-9900 Körmend, Hungary

Parallel importer:

InPharm Sp. z o.o., ul. Strumykowa 28/11, 03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw
Marketing authorization number in Romania, the country of export:1351/2008/01

Parallel import authorization number: 448/24

Date of leaflet approval: 31.12.2024

[Information about the trademark]