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Permethrin Lotion 5% W/W

Document: leaflet MAH GENERIC_PL 00036-0097 change

Leaflet

Pcrmcthrin Loiion 5% w/w

Please read all of this leaflet carefully before you start to use your medicine. It contains important information. This medicine is available without a prescription for you to treat scabies without a doctor s help. You still need to use it carefully to get the maximum benefit from it.

   Keep this leaflet in a safe place as you may need to read it again.

•    Ask your pharmacist if you are not sure of anything or want to know more

•    You must see your doctor or pharmacist if your symptoms get worse or do not improve 10 days after you have used this product for the second time.

In this leaflet

•    What Pcrmcthrin Lotion 5% w/w does

•    Before you use Permethrin Lotion 5% w/w

•    1 low to use you medicine

•    What might happen while you are using Permethrin Lotion 5% w/w

•    rooking after Pcrmcthrin Lotion 5% w/w

What is in your medicine?

•    The active ingredient is permethrin 1% w/w

•    The other ingredients arc Purified water, polysorbatc 20, sorbitan lauratc, imidurca, disodium edentate, propylene glycol, sodium hydroxide, propyl p-hydroxybcn7.oatc (I: 216), methyl ;>-hydroxybcn7.oatc (E 218) and carbomer

Makers of Permethrin Lotion 5% w/w

•    Manufacturers: Reedco Inc, IICO 4 Box 4013, Humacao, Puerto Rico

•    Product licence bolder: Stafford Miller Limited, Brentford, Middlesex TW8

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What Permethrin Lotion 5% w/w does

Permethrin Lotion 5% w/w contains permethrin which is an insecticide used to kill scabies mites and eggs. Each bottle of Permethrin Lotion 5% w/w contains either 50ml, 55ml, 60ml, 100ml or 200ml.

Before you use Permethrin Lotion 5% w/w Don’t stall using Permethrin Lotion 5% w/w if:

•    You are allergic to medicines containing pcrmcthrin, pyrethroids or pyrethnns, chrysanthemums or any of the other ingredients listed under ‘What is in your medicine?*

•    You arc going to treat a child who is under 2 years without speaking to your doctor first.

Ask your pharmacist for advice before you start to use your medicine if:

   You are pregnant, may become pregnant or breast feeding.

How to use your medicine

1. Before applying Permethrin Lotion 5% w/w. make sure that the skin is clean, dry and cool. Do not take a hot bath before treatment.

2.Shake the bottle well

3.Thoroughly massage the lotion into the skin from the neck to the soles of the feet. Make sure that you get the lotion in to the areas between the fingers and toes, under the fingernails and toenails, wrists armpits, genital area and buttocks. Normally you do not need to use the lotion on your face.

OR, if you are treating a child under 2 years of age:

Children between 2 months and 2 years of age should only be treated under medical supervision. Massage the lotion into the child’s whole body, including their neck, face, ears and scalp. This is because the scabies can affect the face of babies. Do not put the lotion around the mouth, as they may lick it off, or near the eyes. If some docs get into the child's eye, it may irritate them, so rinse immediately with water. If irritation persists, please consult your doctor.

When rubbed gently into the skin, Permethrin Lotion 5% w/w will disappear. You do not need to apply the lotion so that you can still see it. The following table shows you how much lotion would normally be used:

Adults and children over 12 years:

Up to one 50 ml bottle

Children:    5 to 12 years: Up to half of one 50ml bottle

2 months to 1 year: up to an eighth of one 50ml bottle

If the lotion does come into contact with your eyes, it may irritate them. Rinse with plenty of water. If irritation persists, seek medical advice as soon as possible.

4-Put on clean clothes. Young children should also wear mittens and socks.

5. Leave for 12 to 14 hours.

6. Have a shower or a bath, and wash your whole body with soap and water.

7. change into clean clothes.

One course of treatment is usually enough. However, if you see live scabies mites or new skin lesions after 7 to 10 days, you can use Permethrin Lotion 5% w/w again. If symptoms persist after the second treatment, speak to your doctor.

Note: A scabies infestation often causes itching, redness or swelling to the skin, which is not a reaction to Permethrin Lotion 5% w/w. However, if your rash gets worse while you are using the lotion, or does not start to disappear after you have washed the lotion off, speak to your doctor or pharmacist.

You should put more lotion on your hands if you wash them during the treatment period.

The scabies may cause some itching for around 2 weeks after treatment. This is because of the allergic reaction that the eggs and mites cause. The itching will stop as the upper layer of skin naturally flakes off. You can ask your pharmacist for a cream or some tablets to help stop the itching.

Any member of the family/household, or anyone who has had skin contact with the patient, should also be check for scabies to avoid reinfestations.

What to do if you swallow some of the medicine.

If you, or someone else, accidentally swallow some of this medicine, tell your doctor as soon as possible.

What might happen while you arc using Permethrin Lotion 5% w/w

Sometimes people can get a rash or feel a burning or stinging sensation when using Permethrin Lotion 5% w/w. These do not happen very often, are usually mild and normally disappear after you wash off the lotion. If your reaction gets worse or you notice that you have a different reaction, tell your doctor or pharmacist. Treatment of scabies may itsel f result in continues or increased irritation for a short while, showing redness of the skin or rash. The itching may continue for up to 2 weeks after treatment because of the allergic reaction that the eggs and mites can cause.

Looking after Permethrin Lotion 5% w/w

Keep your medicine below 30 °C. Keep this bottle in the carton.

Do not use after the ‘use by date’ given on the box and the bottle.

Remember to keep all medicines in a safe place where children cannot see or reach them.

|FOR EXTERNAL USE only!

If you have any questions or arc not sure about anything related to this medicine ask your doctor or pharmacist.

This leaflet was revised October 2004.

What signs should I look for?

In people with normal immune systems (i.e. the majority of the general population) scabies produces classical symptoms. The most common is a widespread itchy rash which is particularly severe at night, or when the body is warm, c.g. after exercise or a warm bath. The classical scabies rash is widespread and can affect almost any part of the body. In adults it is absent from the centre of the chest and back and the head, but in infants the rash may be found in these places. In addition, you may also find skin lesions - wavy, threadlike, very small, slightly elevated lesions between the fingers, on the elbows, hands and wrists. Other common sites of infestation are on the stomach, thighs, genital areas and buttocks.

Should other family members be checked?

Yes. If one member of your family has scabies, anyone who has had skin contact with them should be checked for scabies. If symptoms are discovered then they should be treated at the same time.

Stafford Miller