Pv iodine 10%
Poland
Table of Contents
Patient Information Leaflet Included in the Packaging
PV JOD 10%
100 mg/g, solution
Povidonum iodinatum
PLEASE READ THIS LEAFLET CAREFULLY BEFORE USING THE MEDICINAL PRODUCT SINCE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor or pharmacist.
- KEEP THIS LEAFLET FOR FUTURE REFERENCE.
- IF YOU NEED ADVICE OR FURTHER INFORMATION, CONTACT YOUR PHARMACIST.
- IF YOU EXPERIENCE ANY ADVERSE REACTIONS, INCLUDING ANY POSSIBLE ADVERSE REACTIONS NOT LISTED IN THIS LEAFLET, TELL YOUR DOCTOR OR PHARMACIST. SEE SECTION 4.
- IF THERE IS NO IMPROVEMENT AFTER A FEW DAYS OR IF YOU FEEL WORSE, CONSULT YOUR DOCTOR.
Contents of the Leaflet
- What PV Jod 10% is and what it is used for
- Important information before using PV Jod 10%
- How to use PV Jod 10%
- Possible side effects
- How to store PV Jod 10%
- Contents of the pack and other information
1. What PV Jod 10% is and what it is used for
PV Jod 10% solution contains the active substance povidone iodine. When applied to the skin, this medicine acts against bacteria, fungi, and viruses.
Indications
PV Jod 10% is used for:
- Prevention and treatment of bacterial, fungal, and viral infections of the skin and mucous membranes (e.g. tinea, pyoderma, seborrheic dermatitis, boils, athlete's foot),
- Disinfection of wounds, especially superficial wounds, post-surgical wounds, burns, scabs, and ulcers, particularly of the lower leg,
- Skin antisepsis prior to surgical procedures,
- Disinfection of mucous membranes of the oral cavity 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 of the other ingredients of this medicine (listed in section 6),
- orally,
- in patients with impaired function or diseases of the thyroid gland,
- in children under 2 years of age,
- for prolonged periods,
- on extensive body surface areas (over 30%),
- in chronically ill patients,
- in patients with renal insufficiency,
- in patients concurrently treated with lithium products.
Warnings and precautions
Avoid contact with the eyes. The medicine may interfere with thyroid function tests. The medicine may cause false-positive results in certain laboratory tests, e.g. occult blood in faeces.
Consult a physician, even if the above warnings apply to conditions that occurred in the past.
Children
In children over 2 years of age, due to iodine absorption into the body, PV Jod 10% should be used with particular caution.
Do not use in children under 2 years of age.
Use of PV Jod 10% in patients with renal impairment
Do not use this medicine in patients with renal insufficiency.
Interaction of PV Jod 10% with other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to use.
This medicine may react with other medicines and products, especially those containing mercury, alkaline products, and sodium thiosulfate. Do not use in patients concurrently treated with lithium products. Do not use together with other medicines or products applied to the skin.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.
This medicine may be used during pregnancy only if the physician decides it is absolutely necessary.
Use of this medicine in pregnant women and women who are breastfeeding may cause developmental and functional disorders of the thyroid gland in the foetus and newborn.
Do not use for disinfecting nipple fissures during breastfeeding.
Driving and operating machinery
This medicine has no influence on the ability to drive or operate machinery.
3. How to use PV Jod 10%
This medicine should always be used exactly as described in the patient information leaflet or according to the instructions of a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.
PV Jod 10%, solution is intended for topical use only.
- For washing wounds and skin, use the medicine undiluted.
- For rinsing the mucous membranes of the mouth and vagina, dilute the medicine with boiled water in a ratio of 1 part medicine : 10 parts water. The solution should always be prepared immediately before use.
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Do not store the diluted solution.
Use once or several times daily.
Do not use for longer than 14 days.
Note:
When rinsing the mouth, take special care to avoid accidentally swallowing the medicine.
If you feel the effect of the medicine is too strong or too weak, consult your doctor.
Use of a higher than recommended dose of PV Jod 10%
Systematic absorption of iodine during prolonged use of the medicine on large skin areas, body wounds, or burns (over 30%) may lead to thyroid dysfunction with symptoms such as goitre, changes in body weight, and other symptoms such as metallic taste in the mouth, salivation, burning or stinging sensation in the mouth, eye irritation and eyelid swelling, pulmonary oedema, skin reactions, gastrointestinal disturbances, diarrhoea, metabolic acidosis (disturbance of acid-base balance), hypernatraemia (increased sodium concentration in blood), and kidney function disorders.
If you use more than the recommended dose, contact your doctor or pharmacist immediately.
In case of intentional or accidental ingestion of the medicine, seek medical advice immediately.
Missed dose of PV Jod 10%
Do not use a double dose to make up for a missed dose.
4. Possible adverse reactions
Like all medicines, this medicinal product may cause adverse reactions, although not everyone experiences them.
After application of the medicinal product, local skin reactions (irritations and allergic reactions) may occur.
Application over large surface areas of wounds and burns (over 30%) may lead to systemic adverse effects such as metabolic acidosis (vomiting, abdominal pain, rapid breathing), hypernatremia (increased sodium concentration in blood), and kidney function disorders. If any of the above symptoms occur, discontinue use of the product and contact your doctor.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in the package 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, Poland,
tel.: +48 22 49 21 301, fax: +48 22 49 21 309,
e-mail: [email protected].
Reporting of adverse reactions enables collection of further safety information regarding the use of the medicinal product.
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.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton.
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 required. Such practices help protect the environment.
6. Contents of the packaging and other information
What PV Jod 10% contains
- The active substance is povidone iodine. 1 g of solution contains 100 mg of povidone iodine.
- The other components (excipients) are: citric acid monohydrate, nonylphenol polyoxyethylene glycol ether (Rokofenol N-8), disodium phosphate dodecahydrate, purified water.
What PV Jod 10% looks like and contents of the pack
Brown glass bottle containing 10 ml or 20 ml of solution, with a polyethylene cap,
in a cardboard box.
Brown glass bottle containing 250 ml or 1000 ml of solution, with a polyethylene cap,
equipped with a patient leaflet label.
Marketing Authorisation Holder
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Medicinal product information
tel. (22) 742 00 22
email: [email protected]
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