Purprep 7.25 mg/ml + 633 mg/ml cutaneous solution in single-dose container

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

PurPrep 7.25 mg/ml + 633 mg/ml cutaneous solution in single-dose container

For adults, adolescents and children aged 1 year and older

iodine/isopropyl alcohol

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What PurPrep is and what it is used for
2. What you need to know before using PurPrep
3. How to use PurPrep
4. Possible adverse effects
5. How to store PurPrep

Pack contents and additional information

1. What PurPrep is and what it is used for

PurPrep is a sterile cutaneous solution containing iodine in the form of povidone-iodine and isopropyl alcohol as active ingredients. The cutaneous solution is available in a plastic applicator with a sponge tip at one end.

PurPrep is an antiseptic used for disinfection of intact skin prior to invasive medical procedures (including surgery) to help reduce microorganisms (bacteria and yeasts) that may cause infections. PurPrep is indicated for use in adults, adolescents, and children aged 1 year and older.

2. What you need to know before using PurPrep

Do not use PurPrep

1. If you are allergic to iodine in the form of povidone-iodine, isopropyl alcohol, or any of the other components of this medicine (listed in section 6).
2. In children under 1 year of age.
3. In patients with dermatitis herpetiformis.
4. In patients with hyperthyroidism and other thyroid disorders.

Warnings and precautions

Talk to your doctor or nurse before using PurPrep.

PurPrep is for single use and for external use only on intact skin.

PurPrep must not be administered to individuals with a potential history of allergy to povidone-iodine compounds.

Do not use PurPrep:

1. Near the eyes or mucous membranes, as it may cause irritation. If accidental contact occurs, wash immediately with abundant water.
2. On open skin wounds or as a skin cleanser.
3. In direct contact with neural tissue or the middle ear.

If symptoms of an anaphylactic reaction occur, application of PurPrep must be stopped immediately.

If the solution is vigorously applied to very fragile or sensitive skin, or after repeated use, application site reactions such as pruritus, erythema, rash, papules, and vesicles may occur (see section 4). At the first sign of any of these reactions, application of PurPrep must be discontinued.

Prolonged contact with the skin should be avoided.

Saturated materials such as cloths or gowns must be removed before using PurPrep. Do not allow the solution to pool. When applying occlusive dressings to areas previously exposed to PurPrep, care must be taken to ensure there is no excess product before dressing application.

The solution is flammable. PurPrep should be used in a well-ventilated area. Do not use ignition sources such as cigarettes, open flames, or intense heat sources until the skin is completely dry.

Thyroid disorders and renal insufficiency

PurPrep should be used with caution in patients with thyroid disorders (e.g., hyperthyroidism, mild nodular goiter) and in patients with renal insufficiency due to prolonged elimination time. Very rare cases of iodine-containing povidone-iodine-induced hyperthyroidism have been reported.

With repeated applications, increased drug absorption, skin irritation, and thyroid disorders may occur (see sections 3 and 4). If surgery is required in the days following PurPrep application, the healthcare professional should consider using a preoperative antiseptic that does not contain povidone-iodine or ensure close monitoring of thyroid function.

Children

PurPrep is contraindicated in children under 1 year of age due to increased iodine absorption that may occur following topical application of iodine in the form of povidone-iodine on the immature skin of premature newborns.

The use of alcohol-based solutions for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates (see section 4).

Other medicines and PurPrep

Inform your doctor or nurse if you are using, or have recently used, any other medicines, specifically:

• A vaccine or skin test injection (patch test for allergies).
• Proteins such as those present in blood, which may affect efficacy.
• Disinfectants containing mercury, due to the risk of chemical burns from mercury iodide formation.
• Certain antiseptics (octenidine), as a dark discoloration may occur in treated areas.
• Hydrogen peroxide or taurolidine, as oxidation may reduce drug activity.
• Disinfectants containing silver or wound dressings that may form silver iodide.
• Lithium therapy; rare cases of hypothyroidism have been reported.
• Thyroid function test results may be affected.

Pregnancy, breastfeeding, and fertility

PurPrep should be used with caution during pregnancy or breastfeeding, as minimal absorption of iodine into the mother's bloodstream may occur even through intact skin, and it may be excreted in human milk.

During pregnancy and breastfeeding, PurPrep, like all iodine-containing preparations, should only be administered after careful medical assessment of the risk-benefit ratio.

Driving and use of machines

PurPrep has no or negligible influence on the ability to drive and use machines.

3. How to use PurPrep

The antiseptic solution of the PurPrep system is contained within the plastic applicator. Your doctor or nurse will select the appropriate applicator size based on the procedure site and the area to be covered. The medicine is for cutaneous use. Your doctor or nurse will rub the sponge onto your skin, covering the cutaneous area that needs to be prepared. Depending on the medical procedure, more than one applicator may be used.

PurPrep is only used on intact skin, and each applicator is for single use only.

If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

Very rare serious side effects include anaphylaxis (may affect up to 1 in 10,000 people).

If you experience swelling of the face, lips, tongue or throat, wheezing or difficulty breathing, feeling faint or dizzy, a strange metallic taste in the mouth, or collapse, you may be having an anaphylactic reaction. Stop using PurPrep and speak to your doctor or pharmacist immediately.

Rarely, other allergic-type skin reactions and sensitization have been reported (may affect up to 1 in 1,000 people). If you experience any of the following symptoms, application of the product must be stopped immediately: pruritus, erythema, skin rash, papules, vesicles, dry or inflamed skin, and contact dermatitis.

Very rare cases of hyperthyroidism and angioedema may occur (may affect up to 1 in 10,000 people). The following possible adverse effects have been described with PurPrep after prolonged use, application over large surface areas, or application on non-intact skin (frequency cannot be estimated from the available data):

• Chemical and thermal burns associated with the use of alcohol-based solutions
• Exfoliative dermatitis
• Hypothyroidism in specific patient populations
• Metabolic acidosis
• Electrolyte imbalance
• Renal failure

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of PurPrep

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label or carton following EXP. The expiry date refers to the last day of the month indicated.

PurPrep is flammable. Do not store at temperatures above 30 °C. Avoid exposing the container and its contents to open flames during use, storage, and disposal.

Store in the original packaging; PurPrep is sterile unless the seal has been broken.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of PurPrep

1. The active substances are iodine and isopropyl alcohol.

Each 1 ml of solution contains 7.25 mg of iodine (72.5 mg as povidone-iodine) and 633 mg of isopropyl alcohol.

1 applicator containing 10.5 ml of solution contains 76.1 mg of iodine (761 mg as povidone-iodine) and 6646 mg of isopropyl alcohol.

1 applicator containing 26 ml of solution contains 188.4 mg of iodine (1884 mg as povidone-iodine) and 16456 mg of isopropyl alcohol.

1. The other components are methylmethacrylate-methacrylic acid copolymer (1:2), acrylates/octylacrylamide copolymer, (macrogol 400), 2-amino-2-methyl-1-propanol (95 %) and purified water.

Appearance of PurPrep and contents of the pack

PurPrep is a cutaneous solution supplied in 2 applicators containing 10.5 ml or 26 ml of solution.

The solution is hermetically sealed within a type I glass ampoule housed in a single-use sterile applicator.

The 10.5 ml applicator contains 1 type I glass ampoule, while the 26 ml applicator contains 2 type I glass ampoules of 13 ml each. When the applicator is activated, the solution flows from the glass ampoule(s) into the foam located at the top of the applicator body for cutaneous application.

The packaging consists of a lid material sealed to a polymeric film, creating a pouch-like package around the applicator. The applicator in its final packaging is sterilized with ethylene oxide.

Pack sizes:

1 applicator containing 10.5 ml of cutaneous solution.

25 applicators each containing 10.5 ml of cutaneous solution.

1 applicator containing 26 ml of cutaneous solution.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Becton Dickinson France
11 Rue Aristide Bergès
38800 Le Pont de Claix
France

Customer contact for adverse events or medical information inquiries: 900 938 914

Manufacturer:

BD Infection Prevention B.V.
Erembodegem-Dorp 86
Erembodegem 9320
Belgium

Local Representative:

Becton Dickinson
Camino de Valdeoliva, s/n
28750 – San Agustín del Guadalix (Madrid)
Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany: PurPrep 7.25 mg/ml + 633 mg/ml Lösung zur Anwendung auf der Haut im Einzeldosisbehältnis

Italy: PurPrep 7.25 mg/ml + 633 mg/ml soluzione cutanea in contenitore monodose

Spain: PurPrep 7.25 mg/ml + 633 mg/ml solución cutánea en envase unidosis

France: PerPrup 7.25 mg/ml + 633 mg/ml solution cutanée en récipient unidose.

Date of the most recent review of this leaflet: May 2023.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

Instructions for use of PurPrep:

1. PurPrep may be used in all age groups and patient populations aged 1 year and older.
2. Single-use applicator. With repeated applications, increased drug absorption, skin irritation, and thyroid disorders may occur.
3. PurPrep should only be used with careful consideration in elderly patients with thyroid disorders.
4. For cutaneous use. External use only.
5. Remove the applicator from the packaging and hold it with the sponge facing downward.
6. Squeeze the wings or press the lever once to activate the applicator and release the antiseptic.
7. Do not pinch or pump repeatedly in an attempt to accelerate foam saturation.
8. Press the sponge against the patient's skin to apply the antiseptic solution.
9. Once the solution is visible on the skin, use a gentle back-and-forth motion for 30 seconds to prepare the area.
10. Allow the treated area to dry completely by air.

PurPrep solution may be left on the skin after the procedure.

Maximum coverage areas:

• 10.5 ml: 25 cm x 30 cm
• 26 ml: 50 cm x 50 cm

Precautions for use:

• Allow PurPrep solution to dry completely by air before performing any medical procedure. Do not use during electrocautery or with other ignition sources until the skin is completely dry. Do not use while smoking or near open flames or intense heat sources.
• Do not use excessive amounts and do not allow the solution to pool in skin folds or under the patient, or drip onto sheets or other materials in direct contact with the patient.
• When occlusive dressings are to be applied to areas previously exposed to PurPrep, care should be taken to ensure no excess product remains before dressing application.
• Do not use in children under 1 year of age due to the risk of excessive skin irritation and iodine absorption. Daily use of iodine in newborns may increase blood iodine levels. PurPrep may cause chemical burns in neonates.
• Use with caution in breastfeeding women due to the possibility of transient hypothyroidism in the nursing newborn.
• Do not use near the eyes or mucous membranes. If contact occurs, rinse immediately and thoroughly with water.
• Do not use on open skin wounds or as a general skin cleanser. Do not use on broken or damaged skin, or in direct contact with neural tissue or the middle ear.
• Alcohol should not come into contact with certain vaccines or skin test injections (patch tests). In case of doubt, consult the vaccine manufacturer's documentation.
• Do not apply the solution vigorously on very fragile or sensitive skin. With repeated use, local skin reactions may occur, including application site reactions such as pruritus, erythema, rash, papules, and vesicles. At the first sign of a local skin reaction, discontinue use of PurPrep.
• Do not use in patients with known hypersensitivity to PurPrep solution or any of its components, especially in patients with a history of possible allergic reactions to iodine-containing compounds such as povidone-iodine.
• If symptoms of an anaphylactic reaction are observed, administration of PurPrep must be stopped immediately.
• Use with caution in patients with thyroid disorders (e.g., hyperthyroidism, mild nodular goiter) and in patients with renal impairment due to prolonged elimination time.
• If surgery is required in the days following PurPrep application, it is advisable to use a preoperative antiseptic that does not contain iodine in the form of povidone-iodine, or to closely monitor thyroid function.

Treatment of overdose

In case of accidental ingestion of large quantities of the product, initiate symptomatic and supportive treatment, with special attention to renal and thyroid function.

Incompatibilities

Iodine in the form of povidone-iodine may react with organic material, such as proteins in blood. It should not be used with reducing agents, silver, mercury, taurolidine, disinfectants containing silver, octenidine, hydrogen peroxide, or in patients receiving concomitant lithium therapy.

Absorption of iodine from povidone-iodine through intact or damaged skin may interfere with thyroid function tests. However, there is minimal absorption of iodine through intact skin.

Special precautions for disposal

The solution is flammable. Do not store at temperatures above 30 °C. Avoid exposing the container and its contents to open flames during use, storage, and disposal.

Dispose of the applicator after use according to clinical waste procedures.

Refer to the Summary of Product Characteristics of PurPrep for more detailed information.