Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

Keep this You may need to read it again.

• If you have questions about the medicine, ask your health care
• This medicine has been prescribed for you Do not pass it on to others. It may harm them, even if their signs of illness seem to be the same as yours.
• If you are concerned about any side effects, talk to your health care This includes unwanted effects not listed in this leaflet. See section 4.

What is in this leaflet

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

1.What IVERSTAR is and what it is used for

IVERSTAR contains a medicine called ivermectin. It is used to treat two types of infection caused by tiny worms (filaria):

      On its own, for river blindness (onchocerciasis), an infection caused by a worm called Onchocerca volvulus that affects your skin, glands (lymph nodes) and eyes

      With other medicines to treat lymphatic filariasis caused by worms called Wuchereria bancrofti, Brugia malayi, or Brugia timori, which cause fever, cough and wheezing, swelling of the lymph nodes, swollen limbs or genitals, and kidney problems

In these infections, IVERSTAR kills the immature worms in your blood, which can be passed on to

other people by a blood-sucking insect that bites you and then bites someone else. By killing the immature worms, IVERSTAR also prevents the spread of the disease in your community. However, it does not

work against adult worms, so you may need to take the medicine each year, until all the worms in your body have gone.

IVERSTAR is also used to treat:

      an infection in your gut called intestinal strongyloidiasis. This is caused by a roundworm called

Strongyloides stercoralis.

IVERSTAR may be given with another medicine as part of a community programme to deal with other worm infections of the gut.

      skin mites (scabies). This is when tiny mites burrow under your skin and cause severe itching.

IVERSTAR is used for severe or crusted scabies (when your skin develops thick crusts

infested with many mites). It can also be given for milder scabies if direct treatment of the skin with permethrin cream or lotion has not worked or cannot be used.

2.What you need to know before you take IVERSTAR

Do not take IVERSTAR

medicine (listed in section 6).

if you are allergic to ivermectin or any of the other ingredients of this

If you are not sure, talk to your health care provider before taking IVERSTAR.

Warnings and precautions

Talk to your health care provider before taking IVERSTAR. Before starting treatment with [NT007 trade name], tell your health care provider about all your medical history, including:

      if you have a weakened immune system. The medicine may not work as well if this is the case.known as Loa loa. You may be at higher risk of side effects, including effects on the brain and nerves.

      if you have a symptom of river blindness (onchocerciasis) called sowda (itching and darkening of the skin in a part of the body such as an arm or leg). You may be at higher risk of allergic reactions affecting your skin when the medicine kills the immature worms in your body.

If any of the above apply to you (or you are not sure), talk to your health care provider before taking [NT007 trade name].

IVERSTAR does not kill every type of worm or parasite and only kills the immature forms of worms causing river blindness (onchocerciasis) and lymphatic filariasis. It should only be used on the advice of a health care provider.

This medicine should not be used in people who are seriously ill. Your health care provider may check your general health before you are given IVERSTAR.

Children

IVERSTAR is not recommended for use in children who weigh less than 15 kg or are less than 90 cm tall.

Other medicines and IVERSTAR

Tell your health care provider if you are using, have recently used or might use any other medicines. In particular, tell your health care provider if you take warfarin (to prevent blood clots).

In general, you should check with your health care provider before taking any medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your health care provider and ask them for advice before taking this medicine.

Pregnancy

If you are pregnant, do not take IVERSTAR unless your health care provider has instructed you to. It is not known if this medicine can harm the unborn baby.

Breast-feeding

IVERSTAR passes into breast milk in small amounts. If you are breast-feeding, ask your health care provider whether you should take this medicine. If you have just given birth, you may be asked to wait a week before taking the medicine.

Fertility

This medicine is not expected to affect fertility.

Driving and using machines

The effect of IVERSTAR on the ability to drive and use machines has not been studied. Some

patients may get side effects such as feeling dizzy, sleepy or unsteady (a spinning sensation). If you get any of these side effects, do not drive or use machinery.

3.How to take IVERSTAR

Always take this medicine exactly as your health care provider has told you. Check with your health care provider if you are not sure.

IVERSTAR is available as tablets to take by mouth in a single dose. Swallow the tablets with a little clean drinking water. Take the dose on an empty stomach, at least 2 hours after you last ate, and do not eat anything for 2 hours afterwards.

The number of tablets to take depends on your height or weight as well as the condition you are being treated for. Your healthcare provider will tell you how many tablets you need take.

River blindness (onchocerciasis) and lymphatic filariasis

If you are being treated as part of a community programme for river blindness or lymphatic filariasis then you will normally be given a single dose of IVERSTAR once a year.

The dose is usually worked out based on your height:

In some countries, this dose may be given twice a year to treat river blindness. Your health care provider will explain the details of the programme in your area.

Alternatively, for river blindness the dose is sometimes worked out based on your weight in kg:

Small children less than 90 cm high or weighing less than 15 kg should not be given IVERSTAR.

When used in community programmes to treat lymphatic filariasis, IVERSTAR is given together with other medicines. You should also read the patient leaflet for any other medicines you are given.

Intestinal strongyloidiasis (worm infection of the gut)

The recommended dose of IVERSTAR is a single dose based on your weight in kg:

When used as part of community programmes to control several types of gut worm infection that can be picked up from contact with soil, IVERSTAR is given with another medicine, albendazole. You

should also read the patient leaflet for any other medicines you are given.

Scabies

For scabies, IVERSTAR is given as a single dose equivalent to 200 micrograms (0.2 mg) per kg of your body weight. For severe or crusted scabies, the dose is repeated once after 1 to 2 weeks.

Scabies passes readily to people you come into close contact with. Everyone who comes into contact with you, especially members of your family and partners, should visit a health care provider as soon as possible. The health care provider will decide whether these persons should also be treated for scabies. If infected contact persons are not also treated promptly, there is a danger that they could re-infect you with scabies.

You should follow hygienic measures to prevent reinfection (i.e. keeping fingernails short and clean) and clothes, towels and bedding should be thoroughly cleaned according to official recommendations, either by heat (using hot water, using a hot iron or a clothes drier) or by placing them inside sealed bags for at least a week to ensure that any remaining mites die. Your health care provider can advise you on how to do this.

If you take more IVERSTAR than you should

As you will normally only need a single dose of IVERSTAR, which will be worked out by your

health care provider, it is unlikely that you will take too much of the medicine. If you think you have done so, contact your health care provider straight away for advice.