Ivermectin 3mg tablets

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• if you are allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction to a medicine can include skin rash, difficulty breathing or fever.
• If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking ivermectin.

Do not take Ivermectin if the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Ivermectin.

Talk to your doctor or pharmacist before taking Ivermectin.

Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with ivermectin treatment. Stop using ivermectin and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.

In particular, check with your doctor or pharmacist before taking your medicine if:

• you have a weak immune system .
• you live or have spent time in parts of Africa where people get infected with a type of worm called with the “Loa loa“ filarial worm also called eye-worm.
• you live or have spent time in African areas. The use of DEC (diethylcarbamazine citrate) if you are infected with “Onchocerca volvulus” may result in increased risk of side effects which may sometimes be serious.

If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before taking Ivermectin.

Ivermectin is not approved for use as a treatment for suspected or confirmed COVID-19. Such use may lead to a delay in the diagnosis and /or receiving the appropriate treatment, increasing the risk of harmful effects of COVID-19.

It is not known if it is safe to use Ivermectin in children who weigh under 15 kg.

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.

• Talk to your doctor straight away before taking Ivermectin if you are pregnant or might become pregnant. If you are pregnant, it should be taken only if clearly needed. You and your doctor will decide this.
• Talk to your doctor if you are breast-feeding or intend to breast-feed. This is because Ivermectin is passed into breast milk. Your doctor may decide to start your treatment one week after the birth of your child.

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

You may feel dizzy, sleepy, shaky or like you are spinning after taking Ivermectin. If this happens, do not drive or use any tools or machines.

• Take this medicine by mouth.
• For children less than 6 years of age and weighing at least 15 kg, crush the tablets before swallowing.
• Take the number of tablets your doctor has prescribed all at the same time with water on an empty stomach. Do not eat any food within two hours before or after taking the tablets. This is because it is not known how food affects how your body absorbs the medicine.

Treatment is a single dose.

• Take the number of tablets your doctor has prescribed all at the same time.
• The dose depends on your illness and your weight or your height.
• Your doctor will tell you how many tablets you need to take.

Treatment of gastrointestinal strongyloidiasis (anguillulosis)

The recommended dosage is 200 μg ivermectin per kg body weight, taken orally as a single dose. For guidance, the dose based on body weight is:

BODY WEIGHT (kg): 15 to 24

DOSE (number of 3 mg tablets): One

BODY WEIGHT (kg): 25 to 35

DOSE (number of 3 mg tablets): Two

BODY WEIGHT (kg): 36 to 50

DOSE (number of 3 mg tablets): Three

BODY WEIGHT (kg): 51 to 65

DOSE (number of 3 mg tablets): Four

BODY WEIGHT (kg): 66 to 79

DOSE (number of 3 mg tablets): Five

BODY WEIGHT (kg): ≥ 80

DOSE (number of 3 mg tablets): Six

Treatment of microfilaraemia caused by Wuchereria bancrofti (lymphatic filariasis)

The recommended dosage for mass treatment campaigns in Wuchereria bancrofti microfilaraemia (lymphatic filariasis) is approximately 150 to 200 μg ivermectin per kg body weight, taken as a single oral dose every 6 months.

In endemic areas where treatment can only be administered once every 12 months, the recommended dosage is 300 to 400 μg per kg body weight to maintain adequate suppression of microfilaraemia in treated patients.

For guidance, the dose based on body weight is:

BODY WEIGHT (kg): 15 to 25

DOSE administered every months (number of 3 mg tablets): One

DOSE administered every 12 months (number of 3 mg tablets): Two

BODY WEIGHT (kg): 26 to 44

DOSE administered every 6 month (number of 3 mg tablets): Two

DOSE administered every 12 months (number of 3 mg tablets): Four

BODY WEIGHT (kg): 45 to 64

DOSE administered every 6 month (number of 3 mg tablets): Three

DOSE administered every 12 months (number of 3 mg tablets): Six

BODY WEIGHT (kg): 65 to 84

DOSE administered every 6 month (number of 3 mg tablets): Four

DOSE administered every 12 months (number of 3 mg tablets): Eight

Alternatively and in the absence of a set of weighing scales, the ivermectin dosage for administration in mass treatment campaigns can be determined by the patient's height, as follows:

HEIGHT (in cm): 90 to 119

DOSE administered every 6 month (number of 3 mg tablets): One

DOSE administered every 12 months (number of 3 mg tablets): Two

HEIGHT (in cm): 120 to 140

DOSE administered every 6 month (number of 3 mg tablets): Two

DOSE administered every 12 months (number of 3 mg tablets): Four

HEIGHT (in cm): 141 to 158

DOSE administered every 6 month (number of 3 mg tablets): Three

DOSE administered every 12 months (number of 3 mg tablets): Six

HEIGHT (in cm): > 158

DOSE administered every 6 month (number of 3 mg tablets): Four

DOSE administered every 12 months (number of 3 mg tablets): Eight

Treatment of human scabies

• Take a dose of 200 micro-grams for each kilogram of body weight.
• You will not know if the treatment has been successful for 4 weeks.
• Your doctor may decide to give you a second single dose within 8 to 15 days.

What else must you observe when you are treated for scabies

Everyone who comes into contact with you, especially members of your family and partners, should visit a doctor as soon as possible. The doctorwill decide whether these persons should also be treated. 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 you should follow official recommendations regarding the cleaning of clothing and bedding closely.

If you have the impression that the effect of Ivermectin is too strong or too weak talk to your doctor or pharmacist.

It is important to take the dose that your doctor prescribed. Decreased alertness including coma have been reported in patients with overdosage of ivermectin.

If you take more Ivermectin than you should, talk to a doctor straight away.

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

Try to take Ivermectin as prescribed. Do not take a double dose to make up for a forgotten dose. If you have any further questions on the use of this medicine, ask your doctor or pharmacist

If you have an allergic reaction see a doctor straight away. The signs may include:

• sudden fever
• sudden skin reactions (such as rash or itching) or other serious skin reactions
• difficulty breathing

See a doctor straight away if you notice any of the side effects above.

• reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• liver disease (acute hepatitis)
• changes in some laboratory tests (increase of liver enzymes, increase of bilirubin on blood, increase of eosinophils)
• blood in urine
• decrease in alertness including coma.

The side effects below depend on what you are taking Ivermectin for. They also depend on whether you have any other infections.

People with intestinal strongyloidiasis (anguillulosis) may have the following side effects:

• feeling unusually weak
• loss of appetite, stomach pain, constipation or diarrhoea
• nausea or vomiting
• feeling sleepy or dizzy
• shaking or tremors.

Also, in intestinal strongyloidiasis (anguillulosis), adult round worms may be found in your stools.

People with microfilaraemia due to lymphatic filariasis caused by “Wuchereria bancrofti” may have the following side effects:

• sweating or fever
• headache
• feeling unusually weak
• muscle, joint and general body pains
• loss of appetite, nausea
• pain in your stomach (abdominal and epigastric pain)
• cough or sore throat
• discomfort when breathing
• low blood pressure when getting or standing up - you may feel dizzy or light-headed
• chills
• dizziness
• pain or discomfort in your testicles.

People with scabies may have the following side effects:

• itching (pruritus) may get worse at the start of treatment. This does not usually last long.

People with heavy infection of the worm “Loa loa” may have the following side effects:

• abnormal brain function
• neck or back pain
• bleeding in the whites of your eyes (also known as red eye)
• being short of breath
• loss of control of your bladder or your bowels
• difficulty standing or walking
• mental status changes
• feeling drowsy or confused
• not responding to other people or going into a coma.

People infected with the worm “Onchocerca volvulus” which causes river blindness may have the following side effects:

• itching or rash
• joint or muscle pains
• fever
• nausea or vomiting
• swelling of lymph nodes
• swelling, especially of the hands, ankles or feet
• diarrhoea
• dizziness
• low blood pressure (hypotension). You may feel dizzy or light-headed when standing up
• fast heart rate
• headache or feeling tired
• changes to your vision and other eye problems such as infection, redness or unusual feelings
• bleeding in the whites of your eyes or swelling of your eye lids
• asthma may get worse.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

This medicine is presented as round, white tablets with no marks.

It is presented in blister packs packed in boxes containing 1, 4, 8, 10 or 20 tablets.

It is presented in HDPE bottle with silica gel dessicant containing 250 tablets.

Blisters are packed in folding carton box.

Bottle is packed in folding carton box.

Not all pack sizes may be marketed.