ChloraPrep Clear

This medicine should always be used exactly as described in this leaflet or as your doctor, pharmacist, or nurse have told you.

• Keep this leaflet. You may need to read it again.
• Ask your doctor, pharmacist or nurse if you need more information or advice.
• 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.

What is in this leaflet:

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

• if you are allergic (hypersensitive) to chlorhexidine gluconate or any of the other ingredients of ChloraPrep, especially if you have a history of possible chlorhexidine-related allergic reactions (listed in section 6).

Talk to your doctor, pharmacist or nurse before using ChloraPrep.

ChloraPrep is for external use only.

ChloraPrep should not be used:

• near delicate linings (mucous membranes), as it may cause irritation. If it does get onto the delicate linings of the body passages, it should be washed quickly with plenty of water.
• on open skin wounds and broken or damaged skin.
• on the part of the ear that is inside the body (middle ear).
• in direct contact with neural tissue (for example brain and spinal cord tissue).

ChloraPrep must not come into contact with the eye due to the risk of visual damage. If it comes into contact with the eyes, wash out immediately and thoroughly with water. In case of any irritation, redness or pain in the eye, or visual disturbance, ask for medical advice promptly.

Serious cases of persistent corneal injury (injury to the surface of the eye) potentially requiring corneal transplant have been reported when similar products have accidentally come in contact with the eye during surgical procedures, in patients under general anaesthesia (deep painless sleep).

ChloraPrep may in rare cases cause severe allergic reactions, leading to a drop in blood pressure and even to unconsciousness. Early symptoms of a severe allergic reaction may be skin rash or asthma. If you notice these symptoms, stop using ChloraPrep and contact your doctor as soon as possible (see under section 4: “Possible side effects”).

ChloraPrep should only be applied to the skin gently. When the solution is applied in an over-vigorous manner to very fragile or sensitive skin or after repeated use, rash, inflammation, itching, dry and/or flaky skin and pain may occur. At the first sign of any of these reactions, applications of ChloraPrep 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.

The solution is flammable. Do not use ignition sources, naked flames or strong heat sources near the treated area until the skin is completely dry.

Use with care in newborn babies, especially those born prematurely. ChloraPrep may cause chemical skin burns.

Tell your doctor, pharmacist or nurse if you have recently had a vaccine or skin test injection (patch test used to test for allergies).

There are no studies with ChloraPrep in pregnant or lactating women.

Pregnancy

No effects during pregnancy are anticipated, since systemic exposure to chlorhexidine gluconate is negligible. ChloraPrep can be used during pregnancy.

Lactation

No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to chlorhexidine gluconate is negligible. ChloraPrep can be used during breast-feeding.

Fertility

The effects of chlorhexidine gluconate on human reproduction have not been studied.

ChloraPrep does not affect your driving or ability to 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:

United Kingdom

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 chlorhexidine gluconate and isopropyl alcohol.
  1 mL solution contains 20 mg of chlorhexidine gluconate (20 mg/mL) and 0.70 mL of isopropyl alcohol (0.70 mL/mL).
  1 applicator with 1 mL solution contains 20 mg of chlorhexidine gluconate (20 mg/mL) and 0.70 mL of isopropyl alcohol (0.70 mL/mL).
  1 applicator with 1.5 mL solution contains 30 mg of chlorhexidine gluconate (20 mg/mL) and 1.05 mL of isopropyl alcohol (0.70 mL/mL).
  1 applicator with 3 mL solution contains 60 mg of chlorhexidine gluconate (20 mg/mL) and 2.10 mL of isopropyl alcohol (0.70 mL/mL).
  1 applicator with 10.5 mL solution contains 210 mg of chlorhexidine gluconate (20 mg/mL) and 7.35 mL of isopropyl alcohol (0.70 mL/mL).
  1 applicator with 26 mL solution contains 520 mg of chlorhexidine gluconate (20 mg/mL) and 18.20 mL of isopropyl alcohol (0.70 mL/mL).
• The other ingredient is purified water.

The Frepp 1.5 mL applicator consists of a latex-free rectangular foam sponge attached to a plastic barrel which holds a glass ampoule containing the antiseptic solution. The 1 mL, 1.5 mL, 3 mL and 10.5 mL applicators consist of a latex-free round foam sponge attached to a plastic barrel which holds a glass ampoule containing the antiseptic solution. The 26 mL applicator consists of a latex-free square foam sponge attached to a plastic barrel which holds two glass ampoules containing the antiseptic solution. The sterile applicators are individually packaged in a film.

The packaging consists of a lidding material sealed to a polymeric film creating a “pouch-like" packet surrounding the applicator.

Pack Sizes:

Multipacks containing 60 applicators each containing 1 mL cutaneous solution.

Multipacks containing 20 applicators each containing 1.5 mL (Frepp) cutaneous solution.

1 applicator containing 1.5 mL cutaneous solution.

Multipacks containing 25 applicators each containing 1.5 mL cutaneous solution.

1 applicator containing 3 mL cutaneous solution.

Multipacks containing 25 applicators each containing 3 mL cutaneous solution.

1 applicator containing 10.5 mL cutaneous solution.

Multipacks containing 25 applicators each containing 10.5 mL cutaneous solution.

1 applicator containing 26 mL cutaneous solution.

Not all pack sizes may be marketed

The Marketing Authorisation holder of ChloraPrep is

Customer contact for adverse events or medical information inquiries: +44 800 043 7546

The Manufacturer of ChloraPrep is