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Permethrin Lotion 5% W/W

Document: leaflet MAH GENERIC_PL 44673-0052 change

Leaflet

Permethrin Lotion 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’ll 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 Permethrin Lotion 5% w/w does

•    Before you use Permethrin Lotion 5% w/w

•    How to use you medicine

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

•    Looking after Permethrin Lotion 5% w/w

What is in your medicine?

•    The active ingredient is permethrin 1% w/w

•    The other ingredients are Purified water, polysorbate 20, sorbitan laurate, imidurea, disodium edentate, propylene glycol, sodium hydroxide, propyl p-hydroxybenzoate (E 216), methyl p-hydroxybenzoate (E 218) and carbomer

Makers of Permethrin Lotion 5% w/w

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

•    Product licence holder: GlaxoSmithKline Consumer Healthcare (UK) Trading Limited, Brentford, Middlesex TW8 9GS.

What Permetbrin 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, l00ml or 200ml

Before you use Permethrin Lotion 5% w/w

Don't start using Permethrin Lotion 5% w/w if:

•    You are allergic to medicines containing permethrin, pyrethroids or pyrethrins, chrysanthemums or any of the other ingredients listed under 'What is in your medicine?'

•    You are 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 does 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 I 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 are 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 itself 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 are not sure about anything related to this medicine, ask your doctor or pharmacist.

This leaflet was revised July 2016

FURTHER INFORMATION

Deal with scabies mites effectively - understand them first.

What is scabies?

Scabies is a very irritating rash which usually appears beneath and around the armpits, on the forearms, around the waist, on the hips, on and between the thighs, on the calves and back of the ankles. It is caused by a mite which enters the skin and lives just beneath the surface. It is the body's reaction to this mite and its eggs which causes the rash and intense irritation.

Who suffers from scabies:

Getting scabies is not as bad as you think; anyone can catch it. It is not a sign of uncleanliness, or poor health habits. The mite does not discriminate against age, sex, wealth, profession or race. So, it is wise to learn how to treat it successfully. Anyone with whom there is skin contact could be a donor.

How does someone get scabies?

Scabies is transmitted by skin to skin contact when the mites pass from person to person. This happens most frequently during the commonest of contact - holding hands.

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, e.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 arc discovered then they should be treated at the same time.

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