Betadine vag

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Betadine VAG (Betadine 200 mg), 200 mg, globules
Povidone iodine
Betadine VAG and Betadine 200 mg are different trade names for the same medicinal product.
Please read this leaflet carefully 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 a
physician or pharmacist.

• Keep this leaflet so that it can be read again if necessary.
• If advice or further information is needed, consult a pharmacist.
• If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a physician or pharmacist. See section 4.
• If there is no improvement after 7 days of treatment, or if the patient feels worse, contact a physician.

Contents of the leaflet

1. What Betadine VAG is and what it is 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 Betadine VAG is and what it is 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; when administered vaginally, it releases iodine. Iodine acts against Gram-positive and Gram-negative bacteria, viruses, fungi, and some protozoa.
Indications
Betadine VAG is indicated for the treatment of vaginal infections.
Betadine VAG is used in adult women and in girls after puberty.
If there is no improvement after 7 days, or if the patient feels worse, contact a physician.

2. Important information before using Betadine VAG

When not to use Betadine VAG

• if the patient is allergic to povidone-iodine or to any of the other ingredients of this medicine (listed in section 6),
• if the patient has thyroid dysfunction (e.g. hyperthyroidism or other symptomatic thyroid disorders – see section "Warnings and precautions"),
• before, during, and after radioactive iodine therapy or scintigraphy,
• in dermatitis herpetiformis (so-called Duhring's disease),
• in girls before puberty (before the onset of first menstruation),
• in pregnant and breastfeeding women,
• if the patient is using products containing mercury, because concomitant use of Betadine VAG with mercury-containing products may cause skin damage.

Consult your doctor or pharmacist before using Betadine VAG if any of the following symptoms occur:

• Irregular vaginal bleeding
• Abnormal vaginal bleeding or blood-stained discharge
• Ulcers, blisters, or sores in the vagina or vulva
• Lower abdominal pain
• Pain or difficulty urinating

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

• Fever or chills
• Nausea or vomiting
• Diarrhea

Warnings and precautions
Before starting to use Betadine VAG, discuss it with your doctor or pharmacist.

• Patients with pre-existing renal impairment should consult a doctor before using Betadine VAG.
• Avoid regular use of Betadine VAG suppositories if taking medications containing lithium salts.
• Prolonged use of medicines containing povidone-iodine may cause skin irritation and, in rare cases, severe skin reactions. If irritation or hypersensitivity occurs, discontinue use immediately and contact your doctor (see section 4. Possible side effects).
• Use of povidone-iodine (Betadine VAG) may cause temporary skin discoloration at the site of application due to the inherent color of the medicine.
• The medicine may cause falsely positive results in certain laboratory tests, such as occult blood in stool or urine, and glucose detection in urine.
• If there is no improvement after 7 days, contact your doctor.
• If more than 2 vaginal infections occur within 6 months, the patient should contact her doctor.

Children and adolescents
Betadine VAG is contraindicated in girls before puberty.

Betadine VAG and other medicines
Tell your doctor or pharmacist about all medicines you are currently using, have recently used, or plan to use (including those available without a prescription).

Products containing mercury (see section "When not to use Betadine VAG"), silver, hydrogen peroxide, and taurolidine may interact with povidone-iodine and should not be used simultaneously.

Concomitant use of Betadine VAG with enzymatic wound treatment products reduces the efficacy of both medicines; therefore, they should not be used together.

Do not use Betadine VAG simultaneously with reducing agents or alkali metal salts.

Use of povidone-iodine-containing medicines (Betadine VAG) before or after antiseptics containing octenidine may cause transient dark discoloration of affected areas; therefore, they should not be used simultaneously.

During povidone-iodine use, iodine uptake by the thyroid may be reduced, which may interfere with diagnostic tests of thyroid function (e.g. thyroid scintigraphy, PBI [protein-bound iodine], radioactive iodine diagnostics) and may prevent planned radioactive iodine therapy. To obtain reliable results in thyroid scintigraphy, a sufficiently long interval (at least 4 weeks) should be ensured after discontinuation of Betadine VAG treatment.

Betadine VAG may cause falsely positive results in certain diagnostic tests (e.g. detection of blood in stool or glucose in urine). Inform your doctor about the use of Betadine VAG before undergoing laboratory tests.

Pregnancy, breastfeeding, and fertility

Pregnancy
Use of povidone-iodine suppositories in pregnant women is contraindicated, as absorbed iodine may cross the placental barrier.

Breastfeeding
Use of Betadine VAG suppositories is contraindicated in breastfeeding women, as absorbed iodine may pass into breast milk (see section 5.2).

Fertility
Limited data are available on the effect of povidone-iodine on human fertility. Betadine VAG suppositories have spermicidal properties. Therefore, their use is not recommended in women planning pregnancy.

If the patient suspects she may be pregnant or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.

Driving and operating machinery
This medicine has no effect on the ability to drive or operate machinery.

3. How to use Betadine VAG

Betadine VAG should always be used exactly as described in the patient information leaflet, or
as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
For vaginal use only.
Do not warm before application.
Betadine VAG is intended for use in adult women and in girls after puberty.
Adults
It is recommended to use 1 vaginal globule once daily for 7 days. If there is no improvement, consult your doctor.
It is recommended to moisten the globule before use, then insert it deeply into the vagina in the evening before going to bed.
Application of the globule:

• Separate one globule from the strip by tearing along the perforation at the "V" cut mark.
• Hold the plastic tabs with both hands and pull apart to remove the globule from the packaging.

The use of sanitary pads during treatment is also recommended.
It is important to moisten the globule before insertion to ensure maximum dissolution of the active substance and to avoid local irritation. Treatment need not be interrupted even if menstrual bleeding occurs.
Use in children and adolescents
Betadine VAG is contraindicated in girls before puberty.
Use of a higher than recommended dose of Betadine VAG
Betadine VAG is intended for vaginal use only.
When used as directed, there is no risk of overdose.
In case of local overdose, it is recommended to remove the inserted globule.
If a larger than recommended dose of Betadine VAG is used, or if the globule is accidentally swallowed, contact your doctor immediately.
Excess iodine in the body may cause goiter or thyroid dysfunction.
Symptoms of acute iodine poisoning include:

• kidney failure and lack of urine production (anuria),
• circulatory failure (collapse),
• breathing difficulties (pulmonary edema),
• metabolic disturbances.

In case any of the following signs of systemic toxicity are observed, seek immediate medical help:

• kidney 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 may also develop (see section 4. "Possible side effects", frequencies "very rare" and "frequency not known").

Missed dose of Betadine VAG
Continue treatment as before and use the missed dose as soon as possible.
Do not use a double dose to make up for a missed dose.
Discontinuation of Betadine VAG
To prevent recurrence of the disease and ensure complete eradication of infection, do not stop treatment before the full 7-day course is completed.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone experiences them.
If any of the adverse reactions listed below occur, discontinue use of Betadine VAG immediately
and contact your doctor without delay.
Uncommon adverse reactions (occur in fewer than 1 in 1,000 patients):

• Hypersensitivity reactions.

Very rare adverse reactions (occur in fewer than 1 in 10,000 patients):

• Anaphylactic reaction (a life-threatening allergic reaction causing breathing difficulties, dizziness, and drop in blood pressure).
• Angioedema (a serious allergic reaction causing swelling of the face or throat).

In addition, the following may occur:
Uncommon (occur in fewer than 1 in 1,000 patients):
Skin inflammation (so-called contact dermatitis, with symptoms such as redness, small blisters, and itching).
Very rare (occur in fewer than 1 in 10,000 patients):
Hyperthyroidism (overactivity of the thyroid gland causing increased appetite, weight loss, sweating, rapid heartbeat, or restlessness) in patients with a history of thyroid disease.
Adverse reactions with unknown frequency (based on available data, the frequency cannot be estimated):

• Hypothyroidism (underactivity of the thyroid gland causing fatigue, weight gain, slower heartbeat) may occur after prolonged or intensive use of povidone-iodine,
• Kidney function disorders, acute kidney failure,
• Electrolyte imbalances (lack of balance of fluids and salts in the blood),
• Metabolic acidosis (a condition of increased blood acidity which may cause rapid breathing, disorientation, or lethargy),
• Abnormal blood osmolality (refers to the degree of blood concentration) may occur after ingestion of very large amounts of povidone-iodine,
• Transient skin discoloration at the site of application.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Betadine VAG

Store in a refrigerator (2°C–8°C), in the original packaging.
Keep the medicine out of the 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 stated month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such practices will help protect the environment.

6. Contents of the package and other information

What Betadine VAG contains
The active substance is povidone-iodine.
Each globule contains 200 mg of povidone-iodine.
The other component of the medicine is: macrogol 1000.

What Betadine VAG looks like and contents of the pack
The medicine is in the form of globules. Each globule is uniform, brownish-red in colour, torpedo-shaped, approximately 33 mm in length and approximately 12 mm in diameter. The pack contains 7 globules (1 blister made of PVC/PE foil), placed in a cardboard box.
For further detailed information, please contact the responsible party or the parallel importer.

Responsible party 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 in:
InPharm Sp. z o.o. Services sp. k., ul. Chełmżyńska 249, 04-458 Warsaw

Marketing authorisation number in Romania, the country of export: 1351/2008/01
Parallel import licence number: 448/24