Scaver

Patient Information Leaflet

SCAVER 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 pass it on to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What SCAVER is and what it is used for

SCAVER 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 (also known as threadworm infection). It is caused by a type of roundworm called Strongyloides stercoralis.
• a blood infection called microfilaria due to lymphatic filariasis. It is caused by an immature worm called Wuchereria bancrofti. SCAVER does not act against adult worms, but only against immature worms.
• skin mites (scabies). This occurs when tiny mites burrow under the skin and may cause severe itching. SCAVER should be taken only when your doctor is certain or suspects that you have scabies.

SCAVER does not prevent any of these infections. It does not act against adult worms. SCAVER should be taken only on the advice of a doctor when a parasitic infection is certain or suspected.

2. What you need to know before taking SCAVER

Do not take SCAVER

• 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 may include skin rash, difficulty breathing, or fever.

Do not take SCAVER if any of the above applies to you. If you are unsure, consult your doctor or
pharmacist before taking SCAVER.
Warnings and precautions
Talk to your doctor or pharmacist before taking SCAVER.
In particular, check with your doctor or pharmacist before taking the medicine:

• if you have a weakened immune system
• if you live or have lived in areas of Africa where there are cases of human parasitic infestation with the filarial worm Loa loa, also known as the eye worm
• if you currently live or have lived in areas of Africa. The use of diethylcarbamazine citrate (DEC) to treat a co-infection with Onchocerca volvulus may increase the risk of side effects, sometimes potentially serious.

If any of these situations apply to you (or if you are unsure), consult your doctor or pharmacist before
taking SCAVER.
Children
It is not known whether the use of SCAVER is safe in pediatric patients with body weight below 15 kg.
Elderly patients
Clinical studies with ivermectin have not included a sufficient number of subjects aged 65 years or
older to determine whether they respond differently from younger subjects. Other reported clinical
experience has not identified differences in responses between elderly and younger patients. In general,
treatment of elderly patients should be cautious due to the greater frequency of reduced liver, kidney, or
heart function, as well as concomitant diseases or other drug therapies.
Other medicines and SCAVER
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Pregnancy and breastfeeding

• If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor immediately before taking SCAVER. If you are pregnant, you should take this medicine only if clearly necessary. Your doctor will decide together with you.
• If you are breastfeeding or planning to breastfeed, consult your doctor. SCAVER passes into breast milk. Your doctor may decide to start treatment one week after the baby's birth. If you are pregnant, think you might be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines
While taking SCAVER, you may experience dizziness, somnolence, tremor, or vertigo. If this occurs, do
not drive and do not operate tools or machinery.

3. How to take SCAVER

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

• Take this medicine by mouth.
• In children under 6 years of age, crush the tablets before swallowing.
• Take the number of tablets prescribed by your doctor all at the same time with water on an empty stomach. Do not consume any food two hours before or two hours after taking the tablets, as the influence of food on the absorption of the medicine in the body is unknown.

Dosage
The treatment consists of a single administration.

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

For gastrointestinal strongyloidiasis (ancylostomiasis):
The usual dose is:

For microfilaria due to lymphatic filariasis - caused by Wuchereria bancrofti:
The usual dose is:

To be repeated every 6 months or every 12 months.
Alternatively, if weight is not available, the dose can be determined based on the patient's height
as follows:

For scabies:

• Take a dose of 200 micrograms per kilogram of body weight.

This corresponds to:

• 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 think that the effect of SCAVER is too strong or too weak, consult your doctor or
pharmacist.
If you take more SCAVER than you should
If you take more SCAVER than prescribed, contact your doctor immediately.
If you forget to take SCAVER
Try to take SCAVER as prescribed. Do not take a double dose to make up for a forgotten dose.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects are usually not serious and do not last long. They may be more likely to occur in individuals infected with various parasites. This is particularly 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 severe skin reactions
• breathing difficulties
  If you notice any of the side effects listed above, consult a doctor immediately.

Other side effects:

• Liver disease (acute hepatitis). Changes in certain laboratory tests (elevated liver enzymes, increased blood bilirubin, increased eosinophils).
• Blood in the urine

The side effects listed below depend on the reason for which you are taking SCAVER. They may also depend on other ongoing infections.

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

• unusual weakness
• loss of appetite, stomach pain, constipation or diarrhea
• nausea or vomiting
• drowsiness or dizziness
• agitation or tremors
• decrease in the number of white blood cells (leucopenia)
• decrease in red blood cells or hemoglobin in the blood (anemia). In addition, in cases of intestinal strongyloidiasis (threadworm infection), adult roundworms may be found in the stool.

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

• sweating or fever
• headache
• unusual weakness
• muscle, joint, and generalized body pain
• 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. This is usually short-lived.

People with a severe infection by the worm "Loa loa" 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
• altered mental state
• feeling drowsy or confused
• unresponsiveness 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
• diarrhea
• dizziness
• low blood pressure (hypotension). You may feel dizzy or lightheaded when standing
• rapid heart rate
• headache or feeling of fatigue
• vision changes 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, pharmacist, or nurse. You can also report side effects directly via the national reporting system at 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 SCAVER

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

6. Package contents and other information

What SCAVER contains

• The active substance is ivermectin. Each tablet contains 3 mg of ivermectin. The other components are microcrystalline cellulose (E460), pregelatinized corn starch, butylhydroxyanisole (E320), anhydrous citric acid (E330), magnesium stearate (E572).

Description of the appearance of SCAVER and pack contents
SCAVER are white, round tablets with the code “A300” imprinted on one side.
The tablets are available in boxes containing blister strips of 1, 4, 10 or 20 tablets.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Holder
S.F. Group S.r.l.
Via Tiburtina, 1143
00156 Rome
Italy

Manufacturer
CORIPHARMA EHF.
Reykjavíkurvegur 78
Hafnarfjörður IS-220
Iceland

This medicinal product is authorized in the European Economic Area countries under the following names:
Netherlands: Ivermectine Sigillata 3 mg tabletten
Germany: Ivermectin Sigillata 3 mg Tabletten
France: Ivermectine Sigillata
Italy: SCAVER