Pv Iod 10%

Leaflet included in the packaging: patient information

PV JOD 10%

100 mg/g, solution

Povidone-iodine
Read the leaflet carefully before using the medicine, as it contains
important information for the patient.
This medicine should always be used exactly as described in the patient leaflet or
as advised by a doctor or pharmacist.

• The leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist. See section 4.
• If there is no improvement after a few days or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is PV Jod 10% and what is it used for
• 2. Important information before using PV Jod 10%
• 3. How to use PV Jod 10%
• 4. Possible side effects
• 5. How to store PV Jod 10%
• 6. Package contents and other information

1. What is PV Jod 10% and what is it used for

PV Jod 10% solution contains the active substance povidone-iodine. The medicine works on bacteria, fungi, and viruses when applied to the skin.

Indications

PV Jod 10% is used:

• to prevent and treat skin and mucous membrane infections caused by bacteria, fungi, and viruses (ringworm, purulent and seborrheic inflammatory conditions, boils, foot fungus),
• for wound disinfection, especially superficial ones and after surgical procedures, as well as burns, scabs, and ulcers, especially on the legs,
• for skin disinfection before surgical procedures,
• for disinfection of the mucous membranes of the mouth and vagina.

2. Important information before using PV Jod 10%

When not to use PV Jod 10%:

• if the patient is allergic to povidone-iodine, iodine, or any other component of this medicine (listed in section 6),
• orally,
• in patients with thyroid function disorders and thyroid diseases,
• in children under 2 years of age,

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• for a long time,
• on large areas of the body (over 30%),
• in patients with chronic diseases,
• in patients with kidney failure,
• in patients being treated with lithium products at the same time.

Warnings and precautions

Avoid contact of the medicine with the eyes.
The medicine may interfere with thyroid function tests.
The medicine may cause false-positive laboratory test results, e.g., for detecting hidden blood in stool.
A doctor should be consulted, even if the above warnings concern past situations.

Children

In children over 2 years of age, due to the absorption of iodine into the body, the medicine should be used with particular caution.
Do not use in children under 2 years of age.

Using PV Jod 10% in patients with kidney function disorders

The medicine should not be used in patients with kidney failure.

PV Jod 10% and other medicines

The doctor or pharmacist should be informed about all medicines currently or recently used by the patient, as well as any planned to be used.
The medicine may interact with other medicines and products, especially those containing mercury, alkaline products, and sodium thiosulfate. Do not use in patients being treated with lithium products at the same time. Do not use with other medicines or products applied to the skin.

Pregnancy and breastfeeding

If the patient is pregnant, breastfeeding, or thinks they may be pregnant, they should consult a doctor or pharmacist before using this medicine.
The medicine may only be used during pregnancy if the doctor decides it is absolutely necessary.
Using the medicine in pregnant and breastfeeding women may cause developmental and thyroid function disorders in the fetus and newborn.
Do not use for nipple disinfection during breastfeeding.

Driving and operating machinery

The medicine does not affect the ability to drive and operate machinery.

3. How to use PV Jod 10%

This medicine should always be used exactly as described in the patient leaflet or as advised by a doctor or pharmacist. In case of doubt, a doctor or pharmacist should be consulted.
PV Jod 10% solution is intended for topical use.

• For wound and skin washing, the medicine is used undiluted.
• For rinsing the mucous membranes of the mouth and vagina, the medicine is used diluted with boiled water in a ratio of 1 part medicine to 10 parts water. The solution should always be prepared immediately before use.

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Diluted solution should not be stored.
Use once or several times a day.
Do not use for more than 14 days.
Warning:
When rinsing the mouth, particular caution should be taken to avoid accidentally swallowing the medicine.
If the patient feels that the effect of the medicine is too strong or too weak, they should consult a doctor.

Using a higher dose of PV Jod 10% than recommended

Systematic absorption of iodine in the case of long-term use of the medicine on large areas of skin, wounds, or burns (over 30%) may lead to thyroid function disorders with symptoms such as goiter, weight change, and other symptoms such as metallic taste in the mouth, salivation, burning or tingling sensation in the mouth, irritation and swelling of the eyelids, pulmonary edema, skin reactions, gastrointestinal disorders, diarrhea, metabolic acidosis (acid-base imbalance), hypernatremia (elevated sodium levels in the blood), and kidney function disorders.
In case of using a higher dose of the medicine than recommended, a doctor or pharmacist should be consulted immediately.
In case of intentional or accidental ingestion of the medicine, a doctor should be contacted immediately.

Missing a dose of PV Jod 10%

A double dose should not be used to make up for a missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
After using the medicine, local skin reactions (irritation and allergic reactions) may occur.
Using the medicine on large areas of wounds and burns (over 30%) may lead to general side effects, such as metabolic acidosis (vomiting, abdominal pain, rapid breathing), hypernatremia (elevated sodium levels in the blood), and kidney function disorders. If the above symptoms occur, the medicine should be discontinued and a doctor consulted.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to the Department of Post-Marketing Surveillance of the 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
e-mail: [email protected].
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store PV Jod 10%

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Store in closed containers, at a temperature below 25°C, to protect from light.
The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the box.
The expiry date refers to the last day of the given month.
Medicines should not be disposed of via wastewater or household waste. A pharmacist should be asked how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What PV Jod 10% contains

• The active substance of the medicine is povidone-iodine. 1 g of solution contains 100 mg of povidone-iodine.
• The other ingredients (excipients) are: citric acid monohydrate, nonylphenol polyoxyethylene glycol ether (Rokofenol N-8), disodium phosphate dodecahydrate, purified water.

What PV Jod 10% looks like and what the package contains

A brown glass bottle containing 10 ml or 20 ml of solution, with a polyethylene cap, in a cardboard box.
A brown glass bottle containing 250 ml or 1000 ml of solution, with a polyethylene cap, with a patient leaflet.

Marketing authorization holder

“PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK” S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicine information
tel. (22) 742 00 22
email: [email protected]

Date of last revision of the leaflet:

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