Iladek Tablets

ILADEK 3 tablet contains ivermectin. This is a type of medicine which is used for infections caused by some parasites.

It is used to treat:

• an infestation of the intestine called intestinal strongyloidosis (anguillulose). It is caused by a type of roundworm called Strongyloides stercoralis;
• an infestation of blood called microfilaraemia due to lymphatic filariasis. It is caused by an immature worm called Wuchereria bancrofti;
• onchocerciasis, a disease caused by infestation with a parasite: the Onchocerca volvulus filariae;
• skin mites (scabies). This is when tiny mites burrow under your skin. This can cause you severe itching.

The safety and effectiveness of ivermectin for the treatment of COVID-19 has not been established.

Do not take:

• If you are hypersensitive (allergic) to ivermectin or any of the other ingredients of ILADEK 3 (listed in section 6). Symptoms of an allergic reaction to a medicine may include skin rash, difficulty breathing of fever.

Warnings and precautions

Tell your doctor or health care provider before taking ILADEK 3.

Take special care with ILADEK 3:

• If you have a deficient immune system,
• If you live or have lived in parts of Africa where there are cases of human parasitic infestation with the Loa loa filarial worm also called eye-worm,
• If you currently live or have lived in parts of Africa. The use of diethylcarbamazine citrate (DEC) to treat Onchocerca volvulus infestation may increase the risk of adverse effects that can sometimes be serious.

Children

The safety of using ivermectin in children weighing less than 15 kg has not been evaluated.

Other medicines and ILADEK 3

Always tell your health care provider if you are taking any other medicine (This includes all complementary or traditional medicines).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.

• If you are pregnant, do not take ILADEK 3 tablet. The decision will be made in agreement with your doctor.
• If you are breastfeeding or intend to breastfeed, as ILADEK 3 passes into breast milk. Your doctor may decide to start your treatment one week after the birth of your child.

Driving and using machines

You may feel side effects such as dizziness, drowsiness, or feeing shaky or like you are spinning after taking ILADEK 3. If you experience such symptoms, avoid driving vehicles or operating machinery.

Do not share medicines prescribed for you with any other person.

Always take ILADEK 3 exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Take ILADEK 3 orally
• In children less than 6 years, tablets should be crushed before swallowing.
• Take the number of tablets prescribed by your doctor at one time, with water and on an empty stomach. No food should be taken 2 hours before or after administration because the influence of diet on the absorption of the medicine by your body is not known.
• The treatment consists of a single dose.
• The dose depends on your illness as well as your weight or height.
• Your doctor will tell you how many tablets to take.

Treatment of intestinal strongyloidiasis (anguillulosis)

The usual dose is:

ILADEK 3 can have side effects. Not all side effects reported for ILADEK 3 are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking ILADEK 3, please consult your health care provider for advice.

Side effects are usually not serious and do not last long. They may be more likely to happen in people infected with several parasites. This is particularly true if they have the worm Loa loa.

If any of the following happens, stop taking ILADEK 3 and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Sudden fever
• Sudden skin reactions (such as skin rash or itching) or other serious skin reactions
• Difficulty breathing

These are all very serious side effects. If you have them, you may have had a serious reaction to ILADEK 3. You may need urgent medical attention or hospitalisation.

Other side effects

• liver disease (acute hepatitis),
• modification of some laboratory tests (increase of liver enzymes,
• increase of bilirubin on blood, increase of eosinophil levels),
• presence of blood in urine.

These are all serious side effects. You may need urgent medical attention.

Store all medicines out of reach of children.

Store at or below 25 °C

Do not use after the expiry date stated on the blister and carton.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).