PVP-Iodine AL Ointment

Important notes (mandatory information)

PVP-JOD AL Ointment. Active ingredient: Povidone-iodine. Areas of application: for application to skin and wounds, for repeated, time-limited use as an antiseptic for damaged skin such as decubitus (pressure sore), ulcus cruris (lower leg ulcer), superficial wounds and burns, infected and superinfected skin diseases.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

PVP-JOD AL Ointment
Active ingredient: Povidone-iodine 100 mg/g ointment

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you notice any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 2 – 5 days, contact your doctor.

What this package leaflet contains

1. WHAT IS PVP–JOD AL AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING PVP–JOD AL?
3. HOW IS PVP–JOD AL USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD PVP–JOD AL BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

PVP-JOD AL is an antiseptic (germicide) for application to skin and wounds, for repeated, time-limited use as an antiseptic for damaged skin such as decubitus (pressure sore), ulcus cruris (lower leg ulcer), superficial wounds and burns, infected and superinfected skin diseases.

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

PVP-JOD AL must not be used:

• if you are allergic to iodine or any of the other ingredients of this medicine listed in section 6.
• if you suffer from an overactive thyroid gland (hyperthyroidism) or another existing (manifest) thyroid disease.
• if you suffer from the very rare chronic skin inflammation dermatitis herpetiformis Duhring.
• if you have planned or have undergone radiation therapy of the thyroid gland with iodine (radioiodine therapy) (until the end of treatment).
• in very small premature babies (birth weight below 1500 g).

Warnings and precautions

Please talk to your doctor or pharmacist before using PVP-JOD AL. After thyroid diseases or in the case of a goiter, you should only use PVP-JOD AL for a longer period of time and over a large area (e.g. over 10% of the body surface and for longer than 14 days) on the express instructions of your doctor. Even after the end of therapy (up to 3 months), you should watch out for early symptoms of a possible overactive thyroid gland (see section 4. What side effects are possible?) and, if necessary, monitor your thyroid function. Regular use of PVP-JOD AL should be avoided during concomitant lithium therapy (see section 2.: Use of PVP-JOD AL together with other medicines). Due to the oxidizing effect of the active ingredient povidone-iodine, various diagnostic tests can give false-positive results during treatment with PVP-JOD AL (including toluidine and guaiac resin for determining hemoglobin or glucose in stool or urine). Povidone-iodine can affect the iodine uptake of the thyroid gland; this can lead to disturbances in diagnostic examinations of the thyroid gland (thyroid scintigraphy, PBI determination, radioiodine diagnostics) during treatment with PVP-JOD AL and make planned radioiodine therapy impossible. An interval of at least 1 - 2 weeks should be observed between discontinuing treatment with PVP-JOD AL and taking a new scintigram.

Children

In newborns and infants up to the age of 6 months, PVP-JOD AL should only be used on the express instructions of a doctor and to a very limited extent. In this case, monitoring of thyroid function is necessary. Accidental ingestion of PVP-JOD AL by the infant through the mouth must be avoided at all costs.

Elderly people

In elderly people, the risk of an iodine-induced overactive thyroid gland is increased. You should therefore only use PVP-JOD AL after consulting your doctor. In elderly patients with a goiter or a special predisposition to thyroid dysfunction, large-area and long-term use of PVP-JOD AL should only be carried out on the express instructions of a doctor. If necessary, thyroid function should be monitored.

Use of PVP-JOD AL together with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or intend to take any other medicines. It is to be expected that povidone-iodine, the active ingredient of PVP-JOD AL, will react with protein and various other organic substances, such as blood and pus components, which can impair its effectiveness. In the case of concomitant use of PVP-JOD AL and enzymatic wound treatment agents, the enzyme component is oxidized by the iodine and thus the effect of both medicines is weakened. Mutual weakening of the effect also occurs with concomitant use of PVP-JOD AL and silver-containing disinfectants, hydrogen peroxide or taurolidine. PVP-JOD AL must not be used at the same time or shortly afterwards with mercury-containing wound treatment or disinfectants, as a substance that damages the skin can form under certain circumstances from iodine and mercury. Patients who are being treated with lithium preparations should avoid regular, especially large-area use of PVP-JOD AL, as ingested iodine can promote the development of hypothyroidism, which is possible with lithium.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before using this medicine. During pregnancy and breast-feeding, PVP-JOD AL should only be used on the express instructions of a doctor and to a very limited extent. In this case, monitoring of thyroid function in the child is necessary. Accidental ingestion of PVP-JOD AL by the infant through the mouth at the breast of the nursing mother must be avoided at all costs.

Driving and using machines

There are no data on the effects on the ability to drive and use machines.

3. HOW IS PVP-JOD AL USED?

Always use this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure.

How and when should you use PVP-JOD AL?
Apply PVP-JOD AL ointment evenly to the damaged area one to several times a day. The brown coloration of PVP-JOD AL is a property of the preparation and indicates its effectiveness. Extensive discoloration indicates that the effectiveness of the preparation is exhausted.

How often and for how long should you use PVP-JOD AL?
In the case of repeated use, the frequency and duration of use depend on the present indication. PVP-JOD AL can be used one to several times a day. Wound treatment should be continued as long as there are still signs of inflammation. If your symptoms have not improved after several days (2 - 5 days) of regular use or if symptoms reappear after the end of treatment, please consult your doctor.

If you have used more PVP-JOD AL than you should

See section 4. What side effects are possible?

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, PVP-JOD AL can have side effects, although not everybody gets them.

The following frequency information is used to evaluate 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.

Possible side effects

Metabolism and nutrition disorders

Significant iodine uptake can occur with long-term use of PVP-JOD AL on extensive wound and burn surfaces. In individual cases, patients with a history of thyroid disease may develop an overactive thyroid gland (iodine-induced hyperthyroidism), sometimes with symptoms such as increased pulse rate or inner restlessness (see also section 2.: PVP-JOD AL must not be used).

Skin and subcutaneous tissue disorders

In very rare cases, hypersensitivity reactions of the skin can occur when using PVP-JOD AL, e.g. contact allergic reactions of the late type, which can manifest themselves in the form of itching, redness, blisters or the like.

Kidney and urinary tract disorders

After the use of larger amounts of povidone-iodine-containing medicines (e.g. in the treatment of burns), the occurrence of (additional) electrolyte and serum osmolarity disorders, impaired kidney function and acidification of the blood (metabolic acidosis) has been described.

Immune system disorders

Very rarely, systemic allergic reactions up to anaphylactic shock or angioedema (e.g. swelling of the face, limbs, lips, tongue and/or throat, difficulty swallowing, difficulty breathing, hives) can occur.

Reporting of side effects

If you notice any side effects, talk to 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 AL BE STORED?

Keep medicines out of the reach of children. Do not use this medicine after the expiry date which is stated on the folding box and tube after "Use by". The expiry date refers to the last day of the month. This medicinal product does not require any special storage conditions. PVP-JOD AL has a shelf life of 6 months after first use!

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What PVP-JOD AL contains

The active ingredient is povidone-iodine. 1 g of ointment contains 100 mg of povidone-iodine (average molecular weight 44,000) with a content of 10% available iodine. The other ingredients are: Macrogol 400, Macrogol 4000, Sodium hydroxide, Purified water.

What PVP-JOD AL looks like and contents of the pack

Reddish-brown ointment. PVP-JOD AL is available in packs of 25 g, 100 g and 300 g ointment.

Pharmaceutical entrepreneur

Aliud Pharma GmbH
Gottlieb-Daimler-Straße 19
D-89150 Laichingen
info@aliud.de

Manufacturer

Stada Arzneimittel AG
Stadastraße 2 - 18
61118 Bad Vilbel

This package leaflet was last revised in April 2015.

Source: Information on the packaging
Status: 10/2018
Active ingredient: Povidone-iodine. Areas of application: for application to skin and wounds, for repeated, time-limited use as an antiseptic for damaged skin such as decubitus (pressure sore), ulcus cruris (lower leg ulcer), superficial wounds and burns, infected and superinfected skin diseases.