PVP-JOD-

PVP-Iodine-ratiopharm ointment

Important notes (mandatory information)

PVP-JOD-ratiopharm Ointment. Active ingredient: Povidone-iodine Areas of application: for repeated, temporary superficial application to cuts and abrasions, burns and scalds, infected and superinfected skin diseases, pressure sores (decubitus), open leg ulcers (ulcus cruris) and certain bacterial skin inflammations (pyodermas).

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

PVP-Jod-ratiopharm Ointment 100 mg/g
Active ingredient: Povidone-iodine

Read the entire package leaflet carefully because it contains important information for you. This medicine is available without a prescription. However, to achieve the best possible treatment results, PVP-Jod-ratiopharm must be used as directed.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you must see a doctor in any case.
• 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.

This package leaflet contains

1. WHAT IS PVP–JOD–RATIOPHARM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING PVP–JOD–RATIOPHARM?
3. HOW SHOULD PVP–JOD–RATIOPHARM BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD PVP–JOD–RATIOPHARM BE STORED?
6. FURTHER INFORMATION

1. WHAT IS PVP-JOD-RATIOPHARM AND WHAT IS IT USED FOR?

PVP-Jod-ratiopharm contains povidone-iodine, an active ingredient from the group of disinfecting wound treatment agents. PVP-Jod-ratiopharm is used for repeated, temporary superficial application to cuts and abrasions, burns and scalds, infected and superinfected skin diseases, pressure sores (decubitus), open leg ulcers (ulcus cruris) and certain bacterial skin inflammations (pyodermas).

2. WHAT SHOULD YOU CONSIDER BEFORE USING PVP-JOD-RATIOPHARM?

PVP-Jod-ratiopharm must not be used:

• if you are hypersensitive (allergic) to iodine (iodine allergy) or any of the other ingredients of PVP–Jod–ratiopharm,
• in thyroid diseases,
• in the case of treatment with radioactive iodine (radioiodine therapy),
• in dermatitis herpetiformis Duhring (rare skin disease with burning, itching and various skin manifestations, especially on the arms, legs, shoulders and buttocks),
• in newborns and infants up to the age of 6 months,
• during pregnancy and breastfeeding.

Special care should be taken when using PVP-Jod-ratiopharm

Due to the oxidizing effect of povidone-iodine, various diagnostic tests can lead to false results (including o-toluidine and guaiac resin for hemoglobin or glucose determination). Under the administration of povidone-iodine, the iodine uptake of the thyroid gland may be reduced. This can lead to disturbances in certain thyroid tests such as thyroid scintigraphy (nuclear medicine examination of the thyroid gland), PBI determination (indirect determination method for thyroid hormones) and radioiodine diagnostics (nuclear medicine examination of thyroid function), as well as making planned radioiodine therapy (treatment with radioactive 131iodine) impossible. A waiting period of at least 1 - 2 weeks after discontinuation of povidone-iodine treatment should be observed before a new scintigram is taken. For further precautions, see "Side effects". Due to the risk of burns caused by mercury iodide, povidone-iodine must not be used simultaneously or in short succession with mercury compounds (contained in some other wound disinfectants). Make sure that PVP-Jod-ratiopharm does not come into contact with textiles. Stains can generally be removed with water and soap, in stubborn cases with ammonia (sal ammoniac) or sodium thiosulfate (fixer).

Children

PVP-Jod-ratiopharm must not be used in newborns and infants up to the age of 6 months.

When using PVP-Jod-ratiopharm with other medicines

Please inform your doctor or pharmacist if you are taking/using or have recently taken/used other medicines, even if they are non-prescription medicines. Iodine reacts with mercury to form highly corrosive mercury iodide. The povidone-iodine complex is effective at pH values between 2 and 7. It is to be expected that the complex will react with protein and certain other organic compounds, thereby impairing its effectiveness. Enzymatic wound treatment agents must not be used at the same time, as the enzyme component becomes ineffective. Povidone-iodine must not be used with taurolidine and hydrogen peroxide. Regular use of PVP-Jod-ratiopharm should be avoided during simultaneous lithium therapy.

Pregnancy and breastfeeding

PVP-Jod-ratiopharm must not be used during pregnancy and breastfeeding. Accidental ingestion by the infant by mouth, e.g. during treatment of inflamed breasts, must also be strictly avoided.

3. HOW SHOULD PVP-JOD-RATIOPHARM BE USED?

Always use PVP-Jod-ratiopharm exactly as described in this package leaflet. Please ask your doctor or pharmacist if you are not sure. Unless otherwise prescribed by your doctor, generally apply the ointment evenly to the affected skin areas one to several times a day. If necessary, a bandage can then be applied.

Duration of use

The frequency and duration of use depend on the healing process (e.g. the degree of fluid discharge from the wound). Please talk to your doctor or pharmacist if you have the impression that the effect of PVP-Jod-ratiopharm is too strong or too weak.

If you have used more PVP-Jod-ratiopharm than you should

Poisoning is not to be expected with external application as intended. If larger amounts of the ointment are accidentally ingested (e.g. by a child), the following poisoning symptoms may occur: pain in the upper abdomen, nausea, vomiting, diarrhea, increased thirst, abdominal cramps, rapid pulse, cyanosis, dizziness, drowsiness, signs of shock, delirium, circulatory collapse. In case of suspected poisoning, contact a doctor/emergency doctor immediately so that they can decide on the further course of action!

Medical measures in case of overdose

In the event of poisoning by oral ingestion of povidone-iodine, gastric lavage with starch suspension or 5% sodium thiosulfate solution should be performed, and treatment of water and electrolyte disturbances may be necessary. After absorption has already taken place, even after wound treatment, toxic serum iodine levels can be effectively reduced by peritoneal or hemodialysis. Further therapy depends on the underlying disease and other symptoms that may be present, such as metabolic acidosis and renal impairment, and follows general principles. Iodine-induced hyperthyroidism: Hyperthyroidism can be triggered in predisposed individuals by the absorption of normally harmless amounts of iodine. Therapy depending on the course of the disease: Mild forms may not require treatment, severe forms require thyrostatic therapy (which, however, is only effective with delay). In the most severe cases (thyrotoxic crisis), intensive therapy, plasmapheresis or thyroidectomy.

If you forget to use PVP-Jod-ratiopharm

Continue treatment as directed in the dosage instructions or as prescribed by your doctor (e.g. do not apply the ointment more frequently or more thickly).

If you stop using PVP-Jod-ratiopharm

If your doctor has specified a certain period of use, you should adhere to it in order not to jeopardize the success of treatment with PVP-Jod-ratiopharm. If you are unsure in such cases - e.g. because of side effects - please talk to your doctor before interrupting or prematurely ending treatment. If you have any further questions about the use of the medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, PVP-Jod-ratiopharm can have 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.

Immune system/skin

Very rare

• Hypersensitivity reactions of the skin, which can manifest themselves in the form of itching, redness, blisters, burning or the like (late-type contact allergic reactions)
• Acute allergic reactions of the immune system (anaphylactic reactions) involving other organs (e.g. skin, respiratory tract, circulatory system), acute skin or mucous membrane swellings (angioedema)
• Hypersensitivity reactions to the excipient macrogol (polyethylene glycol) In the case of prolonged treatment, a disturbance of wound healing as well as temporary pain, burning and a feeling of warmth may occur.

Hormonal system

In the case of large-scale or repeated application, especially on damaged skin, disturbances of thyroid function cannot be ruled out, especially in predisposed patients. In these cases, regular monitoring of thyroid function is therefore necessary.

Metabolism and nutrition/kidneys and urinary tract

Very rare

After application of larger amounts of povidone-iodine-containing medicines (e.g. in the treatment of burns), the occurrence of (additional) disturbances of the salt and acid-base balance (electrolyte and serum osmolarity disturbances), an impairment of kidney function and acidification of the blood (metabolic acidosis) have been described.

Reporting of side effects

If you notice any side effects, contact 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 to provide more information about the safety of this medicine.

5. HOW SHOULD PVP-JOD-RATIOPHARM BE STORED?

Keep medicines out of the reach of children. Do not use the medicine after the expiry date stated on the carton and label. The expiry date refers to the last day of the month. Do not use PVP-Jod-ratiopharm if you notice the following: Discoloration of the ointment is a sign that it is no longer effective.

6. FURTHER INFORMATION

What PVP-Jod-ratiopharm contains

The active ingredient is povidone-iodine.
1 g of ointment contains 100 mg of povidone-iodine (poly[1-vinyl-2-pyrrolidone]-iodine complex with a content of 10% available iodine).
The other ingredients are: Macrogol 400, Macrogol 4000, Purified water.

What PVP-Jod-ratiopharm looks like and contents of the pack

Brown, slightly translucent, viscous ointment with the smell of iodine. PVP-Jod-ratiopharm is available in packs of 25 g and 100 g ointment.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This package leaflet was last revised in December 2014.

Source: Information from the package leaflet
Status: 09/2017
Active ingredient: Povidone-iodine Areas of application: for repeated, temporary superficial application to cuts and abrasions, burns and scalds, infected and superinfected skin diseases, pressure sores (decubitus), open leg ulcers (ulcus cruris) and certain bacterial skin inflammations (pyodermas).