Perinal Cutaneous Spray

PACKAGE LEAFLET Information for the user

PERINAL™ CUTANEOUS SPRAY

hydrocortisone 0.2% w/w / lidocaine hydrochloride monohydrate 1.0% w/w

1. WHAT PERINAL CUTANEOUS SPRAY IS AND WHAT IT IS USED FOR

• Perinal Cutaneous Spray is a treatment to spray on and around your bottom (anus) to relieve painful and itchy symptoms caused, for example, by haemorrhoids (piles).
• Haemorrhoids are swollen or enlarged blood vessels that can be either internal (inside the anus) or external (outside the anus). They can cause varying degrees of pain, itch and irritation, particularly after going to the toilet.
• Perinal Cutaneous Spray is suitable for use by adults, the elderly and children over the age of 14. Children under the age of 14 may also use it if recommended by their doctor.
• The active ingredients are hydrocortisone and lidocaine hydrochloride. These work by:
  • reducing itching and inflammation (hydrocortisone), and;
  • relieving pain and discomfort (lidocaine hydrochloride).

2. BEFORE YOU USE PERINAL CUTANEOUS SPRAY

It is very important that you tell your doctor if:

• you have bleeding or persistent pain from your bottom (anus), especially if associated with having to go to the toilet more or less often than you have done in the past;
• if your stomach is unusually swollen or bloated, or;
• if you are losing weight.

Do not delay telling your doctor if you have any of the symptoms above, because you may need urgent treatment.

Do not use Perinal Cutaneous Spray:

• if you are allergic (hypersensitive) to hydrocortisone, lidocaine hydrochloride or any of the other ingredients of Perinal Cutaneous Spray listed in Section 6;
• internally (inside the anus);
• anywhere other than over and around the anal area;
• on broken or infected skin.

Take special care when using this product:

• Avoid using it continuously for more than 7 days, unless advised by your doctor.
• Keep the spray away from your eyes, nose and mouth.
• For children under the age of 14, only use Perinal Cutaneous Spray if recommended by a doctor.
• Contact your doctor if you experience blurred vision or other visual disturbances.

3. HOW TO USE PERINAL CUTANEOUS SPRAY

Use Perinal Cutaneous Spray only on and around your bottom (anus).

Prime the pump before use by pressing down on the top of the pump once or twice.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Perinal Cutaneous Spray can cause side effects, although not everybody gets them.

• You may feel a local tingling sensation after initial application. This is normal and only temporary.
• Rarely, individuals may experience more persistent discomfort and irritation, in which case they may be allergic to the spray’s ingredients and should stop using it.
• Topical corticosteroids are usually well tolerated when used in the right amount and for the correct length of time. However, prolonged, excessive use, particularly in children, can cause local skin thinning (making the skin damage easily) and adrenal suppression (a type of hormone imbalance that causes generalised effects on the body). Stopping treatment normally corrects these side effects.
• Hydrocortisone can cause blurred vision. The frequency of this is not known. If this happens, stop using this product and tell your doctor.
• Topical lidocaine is normally well tolerated and the amount in Perinal Cutaneous Spray is very small. However, if you feel dizzy, drowsy or experience difficulty breathing, you should stop using this product and seek medical attention.

If any of the side effects get serious, or you notice any other side effects not mentioned in this leaflet, stop using this product and tell your doctor or pharmacist.

5. HOW TO STORE PERINAL CUTANEOUS SPRAY

• Keep this medicine out of the sight and reach of children.
• Always replace the cap tightly after use.
• Do not store the product above 25°C.
• Do not use this medicine after the expiry date which is stated on the tube and carton after EXP. The expiry date refers to the last day of that month.
• Do not throw away any medicine via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION