PURPREP 7.25 mg/mL + 633 mg/mL CUTANEOUS SOLUTION IN SINGLE-DOSE CONTAINERS

Introduction

Package Leaflet: Information for the User

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

For adults, adolescents, and children aged 1 year or older

iodine/isopropyl alcohol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is PurPrep and what is it used for
2. What you need to know before you use PurPrep
3. How to use PurPrep
4. Possible side effects
5. Storage of PurPrep

Contents of the pack and additional information

1. What is PurPrep and what is it used for

PurPrep is a sterile cutaneous solution that contains 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 the disinfection of intact skin before invasive medical procedures (including surgery) to help reduce microorganisms (bacteria and yeasts) that can cause infections. PurPrep is indicated for adults, adolescents, and children aged 1 year or older.

2. What you need to know before you use 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

Consult 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 persons with potential allergies to povidone-iodine compound.

Do not use PurPrep:

1. near the eyes or mucous membranes, as it may cause irritation. If it accidentally occurs, it should be rinsed immediately with plenty of water.
2. on open cutaneous wounds or as a skin cleanser.
3. in direct contact with neural tissue and the middle ear

If symptoms of an anaphylactic reaction are detected, the application of PurPrep should be stopped immediately.

If the solution has been applied vigorously to very fragile or sensitive skin, or after repeated use, local skin reactions may occur, such as pruritus, erythema, skin rash, papules, and vesicles (see section 4). In the event of the first sign of any of these reactions, the application of PurPrep should be stopped.

Prolonged contact with the skin should be avoided.

Soaked materials, such as cloths or gowns, should be removed before using PurPrep. Do not allow the solution to accumulate. When occlusive dressings are to be applied to areas previously exposed to PurPrep, care should be taken to ensure that there is no excess product before applying the dressing.

The solution is flammable. When using PurPrep, it 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 disorder and renal insufficiency

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

With repeated applications, an increase in the absorption of the medicine, skin irritation, and thyroid disorders may occur (see sections 3 and 4). If a new operation is necessary in the days following the application of PurPrep, the healthcare professional should determine the use of a preoperative antiseptic that does not contain iodine in the form of povidone-iodine or perform close monitoring of thyroid function.

Children

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

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

Other medicines and PurPrep

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

• a vaccine or skin test injection (patch test for allergies).
• with proteins such as those present in blood, which may affect efficacy.
• disinfectants containing mercury, due to the risk of chemical burns after the formation of mercury iodide.
• certain antiseptics (octenidine), as a dark discoloration may occur in the treated areas.
• with hydrogen peroxide or taurolidine, as oxidation may weaken the drug's activity.
• with disinfectants containing silver or wound dressings that may form silver iodide.
• lithium therapy, rare cases of hypothyroidism have been reported.
• the results of certain thyroid tests 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 blood may occur even through intact skin, and its excretion into human milk.

During pregnancy and breastfeeding, PurPrep, like all iodine preparations, should only be administered after a very careful assessment of the risk/benefit ratio by the doctor.

Driving and using machines

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

3. How to use PurPrep

The antiseptic solution of the PurPrep system is inside the plastic applicator. Your doctor or nurse will select the appropriate applicator size based on the procedure site and area to be covered. The medicine is for cutaneous use. Your doctor or nurse will rub the sponge over your skin, covering the skin 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 used once.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Severe side effects are very rare and may 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 of fainting and dizziness, a strange metallic taste in the mouth, or collapse, you may be suffering from an anaphylactic reaction. Stop using PurPrep and talk to your doctor or pharmacist.

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

Very rare cases of hyperthyroidism and angioedema have been reported (may affect up to 1 in 10,000 people). The following possible side effects have been described with PurPrep after prolonged use, application over large areas, or on non-intact skin (the 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 insufficiency

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of PurPrep

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiry date is the last day of the month stated.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and additional information

Composition of PurPrep

1. The active ingredients 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 with 10.5 ml of solution contains 76.1 mg of iodine (761 mg as povidone-iodine) and 6646 mg of isopropyl alcohol.

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

1. The other ingredients are methyl methacrylate-methacrylic acid copolymer (1:2), octylacrylamide/acrylates 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 presented 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) to the foam located at the top of the applicator body for cutaneous application.

The packaging consists of a sealed cap material to a polymeric film that creates a bag-like package around the applicator. The applicator in the 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.

Not all 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

Contact for the customer in case of adverse events or to consult medical information 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)

This medicine 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 last revision of this leaflet: May 2023.

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

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This information is intended only for healthcare professionals:

Instructions for use of PurPrep:

1. PurPrep can be used in all age groups and patient populations aged 1 year or older.
2. Single-use applicator. With repeated applications, an increase in the absorption of the medicine, skin irritation, and thyroid disorders may occur.
3. PurPrep should only be applied after careful consideration in elderly patients with thyroid disorder.
4. For cutaneous use. For external use only.
5. Remove the applicator from the wrapper and hold it with the sponge facing down.
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 air dry completely.

PurPrep solution can 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 the PurPrep solution to air dry completely before proceeding with any medical procedure. Do not use during electrocauterization procedures 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 accumulate 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 that there is no excess product before applying the dressing.
• Do not use in children under 1 year of age due to the possibility 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 breastfed newborn.
• Do not use near the eyes or mucous membranes. If it comes into contact with the eye or mucous membranes, it should be rinsed immediately with plenty of water.
• Do not use on open cutaneous 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 and skin test injections (patch tests for allergies). In case of doubt, consult the manufacturer's documentation for the vaccine.
• Do not apply the solution vigorously to very fragile or sensitive skin. After repeated use, local skin reactions may occur, including reactions at the application site such as pruritus, erythema, skin rash, papules, and vesicles. In the event of the first sign of a local skin reaction, the application of PurPrep should be stopped.
• 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 the povidone-iodine compound.
• If symptoms of an anaphylactic reaction are detected, the application of PurPrep should be stopped immediately.
• Use with caution in patients with thyroid disorders (i.e., hyperthyroidism, mild nodular goiter) and in patients with renal insufficiency due to the prolonged elimination time.
• If a new operation is necessary in the days following the application of PurPrep, it is recommended to use a preoperative antiseptic that does not contain iodine in the form of povidone-iodine or to perform close monitoring of thyroid function.

Overdose treatment

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

Incompatibilities

Povidone-iodine may react with organic matter, such as proteins in the blood. It should not be used with reducing agents, silver, mercury, taurolidine, and 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 little absorption of iodine through intact skin.

Special precautions for disposal

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

Discard the applicator after use according to clinical waste procedures.

Consult the Summary of Product Characteristics of PurPrep for more detailed information.