PurPrep 8.3% w/w / 72.5% w/w cutaneous solution in single-dose container

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What PurPrep is and what it is used for
2. What you need to know before you use PurPrep
3. How to use PurPrep
4. Possible side effects
5. How to store PurPrep
6. Contents of the pack and other information

• If you are allergic to iodinated povidone, and isopropyl alcohol or any of the other ingredients of this medicine (listed in section 6).
• On children less than 1 year of age.
• On patients with dermatitis herpetiformis;
• On patients with hyperthyroidism and other thyroid dysfunction.

Talk to your doctor or nurse before PurPrep is used.

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

PurPrep should not be administered to anyone with a potential history of allergy to iodinated povidone compounds.

PurPrep must not be used:

• near eyes or mucous membranes, as it may cause irritation. If it accidentally occurs, it should be washed quickly with plenty of water.
• on open skin wounds or as a general skin cleanser.
• in direct contact with neural tissue and the middle ear

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

If the solution has been applied in an over-vigorous manner 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, applications of PurPrep should be stopped.

Prolonged skin contact should be avoided.

Soaked materials, such as drapes or gowns should be removed before use. The solution should not be allowed to pool. Where occlusive dressings are to be applied to areas previously exposed to PurPrep, care must be taken to ensure no excess product is present prior to application of the dressing.

The solution is flammable. When using PurPrep, use in a well-ventilated area. Do not use ignition sources such as cigarettes, naked flames or a strong heat source until the skin is completely dry.

Thyroid disorder and renal insufficiency

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

With repeated application, there may be a potential for increased drug absorption, skin irritation and thyroid disorder (see sections 3 and 4). If re-operation is necessary within a few days following the application of PurPrep, the use of a preoperative antiseptic that does not contain iodinated povidone, or close monitoring of thyroid function, should be determined by the clinician.

PurPrep is contraindicated on children less than 1 year due to an increased iodine absorption that can occur from topical administration of iodinated povidone to immature skin, especially in pre-term infants.

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

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

• a vaccine or skin test injection (patch test used to test for allergies).
• those that contain proteins such as those in blood which may impair efficacy.
• disinfectants containing mercury due to the risk of chemical burns following the formation of mercury iodide.
• certain antiseptics (octenidine), as dark discolouration can occur at the treated areas.
• those that contain hydrogen peroxide or taurolodine, as oxidation can weaken the activity of the drug.
• those that contain silver-containing disinfectants or wound dressings that can form silver iodine.
• lithium therapy, as rare instances of hypothyroidism have been reported.
• the results of certain thyroid tests may be affected.

Pregnancy, breast-feeding and fertility

PurPrep should be used with caution during pregnancy or breastfeeding, since absorption of iodine into the mother's blood (even through intact skin) and excretion into human breast milk may occur.

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

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

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

• The active substances are iodinated povidone and isopropyl alcohol.
  Each 1 ml solution contains 72.5 mg of iodinated povidone and 633 mg of isopropyl alcohol.
  Each applicator with 10.5 ml solution contains 761 mg of iodinated povidone (72.5 mg/ml) and 6646 mg of isopropyl alcohol (633 mg/ml).
• Each applicator with 26 ml solution contains 1884 mg of iodinated povidone (72.5 mg/ml) and 16456 mg of isopropyl alcohol (633mg/ml). The other ingredients are methacrylic acid-methyl methacrylate copolymer (1:2), acrylates / octylacrylamide copolymer, macrogol 400, 2-amino-2-methyl-1-propanol (95%) and purified water.

PurPrep is a cutaneous solution contained in applicators containing either 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 contains 2 type I glass ampoules of 13 ml each. When the applicator is activated, the solution is released from the glass ampoule(s) and allowed to flow into the foam on top of the applicator body for cutaneous application.

The packaging consists of a lidding material sealed to a polymeric film creating a “pouch-like" packet surrounding the applicator. The final packaged applicator is sterilised using ethylene oxide.

Pack sizes:

1 applicator containing 10.5 ml cutaneous solution.

25 applicators each containing 10.5 ml cutaneous solution.

1 applicator containing 26 ml cutaneous solution.

Not all pack sizes may be marketed

Customer contact for adverse events or medical information inquiries: 0800 0437 546