Ivermectin Difa

Package leaflet: Information for the user

Ivermectin Difa 3 mg tablets

ivermectin
Generic medicine
Please read all of this leaflet carefully before you take this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ivermectina Difa is and what it is used for

Ivermectina Difa contains the active substance ivermectin. This is a type of medicine used to treat infections caused by certain parasites.
It is used to treat:

• an intestinal infection called intestinal strongyloidiasis (threadworm infection). It is caused by a type of roundworm called “Strongyloides stercoralis”.
• a blood infection called microfilaraemia caused by “lymphatic filariasis”. It is caused by an immature worm called “Wuchereria bancrofti”. Ivermectina Difa does not act against adult worms, but only against immature worms.
• skin mites (scabies). This occurs when tiny mites burrow under the skin. It can cause severe itching. Ivermectina Difa should only be taken when your doctor is certain or suspects that you have scabies.

Ivermectina Difa does not prevent any of these infections. It does not act against adult worms.
Ivermectina Difa should only be taken when your doctor has confirmed or suspects the presence of a parasitic infection.

2. What you need to know before taking Ivermectin Difa

Do not take Ivermectin Difa:

• if you are allergic to ivermectin or to any of the other ingredients of this medicine (listed in section 6); signs of an allergic reaction to a medicine may include rash, difficulty breathing, or fever.
• if you have ever developed a severe skin rash or skin peeling, or a rash with blisters and/or mouth ulcers after taking ivermectin.

Generally, if unusual symptoms occur suddenly after taking any
medicine, such as skin rash, hives, or fever, you may be allergic to that
medicine.
Warnings and precautions
Talk to your doctor or pharmacist before taking Ivermectin Difa.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with ivermectin treatment. Stop using ivermectin and consult a doctor immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
In particular, consult your doctor:

• if you have a weakened immune system (immune disorder)
• if you live or have lived in areas of Africa where there are cases of human parasitic infection with the filarial worm Loa loa, also known as the eye worm
• if you currently live or have lived in areas of Africa.

The combined use of diethylcarbamazine citrate (DEC) to treat a co-infection with
Onchocerca volvulus may increase the risk of adverse reactions, sometimes potentially severe.
If you fall into any of these categories (or if you are unsure), consult your doctor or pharmacist before taking
Ivermectin Difa.
Ivermectin Difa is not indicated for the prevention of tropical parasitic infestations. It is not effective against adult parasitic worms and should only be used on medical advice when parasitic infestation is confirmed or strongly suspected.
Children
The safety of Ivermectin Difa has not been evaluated in pediatric patients weighing less than 15 kg.
Other medicines and Ivermectin Difa
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding

• Talk to your doctor immediately before taking Ivermectin Difa if you are pregnant or could become pregnant. If you are pregnant, it should be taken only if clearly necessary. Your doctor will decide together with you.
• If you are breastfeeding or planning to breastfeed, inform your doctor. This is because Ivermectin Difa is excreted in breast milk. Your doctor may decide to start treatment one week after the birth of your baby.

If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
The effect of Ivermectin Difa on the ability to drive and use machines has not been studied. It cannot be ruled out that some patients may experience adverse effects such as dizziness, somnolence, tremor, or feeling faint, which could affect the ability to drive or operate machinery.
If you experience such symptoms, avoid driving or operating machinery.

3. How to take Ivermectin Difa

Take this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Method of administration

• Take this medicine by mouth.
• In children under 6 years of age, the tablets must be crushed before swallowing.
• Take the number of tablets prescribed by your doctor all at the same time, in a single dose, with water on an empty stomach. No food should be taken two hours before or two hours after administration, as the effect of food on the absorption of the medicine in the body is not known.

Dosage
Treatment consists of a single dose.

• Take the number of tablets prescribed by your doctor, all at the same time.
• The dose depends on the disease and on body weight or height.
• Your doctor will tell you how many tablets you should take.

Treatment of gastrointestinal strongyloidiasis (threadworm infection)

• The usual dose is:

Treatment of lymphatic filariasis caused by Wuchereria bancrofti

• The usual dose is:

• This is repeated every 6 months or every 12 months.
• Alternatively, if weight is not available, the dosage may be determined by the patient's height, as follows:

Treatment of human scabies

• Take a dose of 200 micrograms per kilogram of body weight. Your doctor will tell you how many tablets to take.
• You will not know whether the treatment has been successful until 4 weeks have passed.
• Your doctor may decide to prescribe a second single dose within 8–15 days.

If you feel that the effect of Ivermectin Difa is too strong or too weak, consult your doctor or pharmacist.
If you take more Ivermectin Difa than you should
It is important to take the dose prescribed by your doctor. Cases of reduced level of consciousness and coma due to overdose with ivermectin have been reported.
If you take more Ivermectin Difa than you should, consult your doctor immediately.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
If you forget to take Ivermectin Difa
Always follow your doctor's instructions. Do not take a double dose to make up for the missed dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Side effects are usually not serious and do not last long. They may be more likely to occur in people infected with multiple parasites. This is especially true in cases of infection caused by the worm “Loa loa”. After taking this medicine, the following side effects may occur:

Allergic reactions
If you experience an allergic reaction, consult a doctor immediately. Signs may include:

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

If you notice any of the side effects listed above, consult a doctor immediately.

Stop using ivermectin and consult a doctor immediately if you notice any of the following symptoms:

• reddish, flat spots, target-shaped or circular, on the trunk, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other side effects:

• liver disease (acute hepatitis)
• changes in certain laboratory tests (elevated liver enzymes, increased blood bilirubin, increased eosinophils)
• blood in the urine
• decreased level of consciousness, including coma

The side effects listed below depend on the reason why you are taking Ivermectina Difa. They may also depend on other ongoing infections.

People with intestinal strongyloidiasis (threadworm infection) may experience the following side effects:

• unusual feeling of weakness
• loss of appetite, stomach pain, constipation or diarrhoea
• nausea or vomiting
• drowsiness or dizziness
• agitation or tremors
• decreased number of white blood cells (leucopenia)
• decreased number of red blood cells or haemoglobin in the blood (anaemia). In addition, in case of intestinal strongyloidiasis (threadworm infection), adult roundworms may be found in the faeces.

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

• sweating or fever
• headache
• unusual feeling of weakness
• muscle pain, joint pain, and generalized body aches
• loss of appetite, nausea
• stomach pain (abdominal and epigastric pain)
• cough or sore throat
• discomfort during breathing
• low blood pressure when standing up or standing – you may feel dizzy or lightheaded
• chills
• dizziness
• pain or discomfort in the testicles

People with scabies may experience the following side effects:

• itching, which may worsen at the beginning of treatment. Usually short-lived.

People with a severe “Loa loa” worm infection may experience the following side effects:

• abnormal brain function
• neck or back pain
• bleeding in the white part of the eye (also known as red eye)
• shortness of breath
• loss of bladder or bowel control
• difficulty standing or walking
• changes in mental state
• feeling drowsy or confused
• unresponsiveness to stimuli or coma

People infected with the worm Onchocerca volvulus , which causes river blindness, may experience the following side effects:

• itching or skin rash
• joint or muscle pain
• fever
• nausea or vomiting
• swollen lymph nodes
• swelling, particularly in the hands, ankles or feet
• diarrhoea
• dizziness
• low blood pressure (hypotension). You may feel dizzy or lightheaded when standing
• rapid heart rate
• headache or feeling of fatigue
• changes in vision and other eye problems such as infection, redness or unusual sensations
• bleeding in the white part of the eye or swelling of the eyelids
• worsening of asthma

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ivermectin Difa

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, container, and carton.
The expiry date refers to the last day of that month.
This medicine does not require any special storage temperature.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. This will help protect the environment.

6. Pack contents and other information

What Ivermectin Difa contains

• The active substance is ivermectin. One tablet contains 3 mg of ivermectin.
• The other components are: Microcrystalline cellulose (E460), pregelatinized corn starch, citric acid (E330), butylated hydroxyanisole, magnesium stearate (E470b)

Description of the appearance of Ivermectin Difa and pack contents
This medicine is presented as white, round, unmarked tablets.
It is supplied in blisters packed in cartons containing 1, 4, 8, 10, 12 or 20 tablets.
It is also supplied in HDPE bottles containing 250 tablets with a silica gel desiccant.
The blisters are packed in a folding cardboard box.
The bottle is packed in a folding cardboard box.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Difa Cooper SpA
Via Milano 160,
21042 Caronno Pertusella (VA), Italy

Manufacturer
Laboratorios Liconsa, S.A.
Polígono Industrial Miralcampo, Avda. Miralcampo, 7
19200 Azuqueca de Henares – Guadalajara
Spain

Medical Valley Invest AB
Bradgardsvagen 28 2 Tr,
Hollviken, 236 32,
Sweden

This medicinal product is authorized in the European Economic Area countries under the following names: