Scavertin

Patient Information Leaflet

Scavertin, 3 mg, tablets
Ivermectinum
Please read all of this leaflet carefully before taking this medicine, because it contains
important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Leaflet Contents

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

1. What Scavertin is and what it is used for

Scavertin contains an active substance called ivermectin. This medicine is used to treat infections
caused by certain parasites.
Scavertin is used to treat:

• Intestinal infection known as strongyloidiasis (threadworm infection). This is caused by a type of roundworm called Strongyloides stercoralis.
• Blood infection known as microfilaria due to lymphatic filariasis. This is caused by the immature form of a worm called Wuchereria bancrofti. Scavertin does not act against adult forms, but only against immature stages of the worms.
• Skin disease (scabies) caused by mites. This occurs when tiny mites burrow under the skin, which may cause intense itching. Scavertin should only be taken when a doctor has diagnosed scabies or suspects that you have scabies.

Scavertin does not prevent the occurrence of any of these infections. It does not act against adult
forms of the worms.
Scavertin should only be taken when a doctor has diagnosed or suspects a parasitic infection.

2. Important information before taking Scavertin

When not to take Scavertin

• if the patient is allergic to ivermectin or to any of the other ingredients of this medicine (listed in section 6). Usually, if unusual symptoms such as rash, hives or fever occur suddenly after taking any medicine, it may be suspected that the patient is allergic to that medicine.
• if the patient has ever experienced the following after administration of ivermectin: severe skin rash, peeling of the skin, blisters and (or) mouth ulcers.

Warnings and precautions
Before starting to take Scavertin, discuss this with your doctor or pharmacist.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred with ivermectin treatment. Ivermectin should be discontinued and immediate medical attention sought if any symptoms of severe skin reactions occur, as listed in section 4.
In particular, inform your doctor if the patient:

• has a weakened immune system (immune deficiency),
• lives or has lived in regions of Africa where human infection with the filarial worm Loa loa, also known as the eye worm, occurs,
• currently lives or has lived in certain regions of Africa.

Concomitant use of a medicine called diethylcarbamazine citrate (DEC) in the treatment of co-existing Onchocerca volvulus infection may sometimes pose a risk of potentially severe adverse reactions.
If any of the above apply to the patient (or the patient is unsure), consult a doctor or pharmacist before taking Scavertin.
Scavertin is not intended for the prevention of infections caused by tropical parasites. It is not effective against adult forms of parasites and should only be used on a doctor's advice when parasitic infection has been confirmed or is reasonably suspected.

Children
The safety of Scavertin in children weighing less than 15 kg has not been established.

Elderly people
Clinical studies with ivermectin have not included sufficient numbers of individuals aged 65 years and older to determine whether they respond differently from younger patients. In other reported clinical experiences, no differences in response to treatment between elderly and younger patients have been observed. Generally, treatment of elderly patients requires caution due to the higher likelihood of decreased liver, kidney or heart function, co-existing diseases, and concomitant use of other medications.

Scavertin and other medicines
Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In general, always consult a doctor or pharmacist before taking any medicine.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor or pharmacist before taking this medicine.

Pregnancy
If the patient is pregnant, she should not take Scavertin unless otherwise advised by a doctor.

Breastfeeding
Scavertin passes into human milk.
If the patient is breastfeeding, she should inform her doctor and should not take this medicine unless otherwise advised. Consult a doctor or pharmacist before taking any medicine.

Fertility
In rats, Scavertin at doses up to 3 times higher than the maximum recommended human dose of 200 micrograms/kg body weight (corresponding mg/m² per day) showed no adverse effects.

Driving and operating machinery
The effect of Scavertin on the ability to drive and operate machinery has not been studied.
In some patients, adverse reactions such as dizziness, somnolence, unsteadiness or sensation of spinning cannot be excluded, which may affect the ability to drive and operate machinery.
If such symptoms occur, driving and operating machinery should be avoided.

3. How to take Scavertin

This medicine should always be taken according to the instructions given by your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.
Dosage
Treatment of intestinal anguillulosis (strongyloidiasis)
The recommended dose is 200 micrograms of ivermectin per kilogram of body weight, taken orally
as a single dose. The approximate dose based on body weight is:

Treatment of microfilaraemia caused by Wuchereria bancrofti (lymphatic filariasis)
The recommended dose for mass treatment campaigns of microfilaraemia (caused by lymphatic
filariasis) due to the human filarial worm (Wuchereria bancrofti) is approximately 150 to
200 micrograms of ivermectin per kilogram of body weight, administered as a single oral dose
every 6 months.
In endemic areas where treatment can be administered only once every 12 months, the recommended
dose is 300 to 400 micrograms per kilogram of body weight to maintain adequate suppression of
microfilaraemia in treated patients.
The approximate dose calculated according to body weight is:

Alternatively, and if the patient's body weight cannot be determined, ivermectin dosing in the context of mass treatment campaigns may be based on the patient's height as follows:

Treatment of scabies in humans

• The dose should be 200 micrograms per kilogram of body weight.
• The patient will not know whether the treatment was effective for 4 weeks.
• The doctor may decide to administer a second single dose within 8 to 15 days.

What else should be considered during scabies treatment?
Everyone who has had contact with the patient, especially family members and sexual partners, should
seek medical advice as soon as possible.
The doctor will decide whether these individuals should also be treated. If people who have been in contact with the infected patient are not promptly treated, there is a risk that they may re-infect the patient with scabies.
Hygiene measures should be followed to prevent re-infection (e.g. keeping fingernails short and clean) and official recommendations for cleaning clothes and bedding must be strictly observed.
If you feel that the effect of Scavertin is too strong or too weak, consult your doctor or pharmacist.

Method of administration
Oral tablets.
Always follow the dosage prescribed by your doctor. In case of doubt, consult your doctor or pharmacist. In children under 6 years of age, the tablets should be crushed before swallowing.
Treatment consists of a single dose. The prescribed number of tablets should be taken simultaneously as a single dose. The tablets should be taken on an empty stomach, with water. No food should be consumed for two hours before or after taking this medicine, as the effect of food on its absorption is unknown.

Overdose of Scavertin
Take exactly the dose prescribed by your doctor. Decreased level of consciousness, including coma, has been reported in some patients after overdose of ivermectin.
If an excessive dose of Scavertin has been taken, contact your doctor immediately.

Missed dose of Scavertin
Always follow your doctor's instructions. Do not take a double dose to make up for a missed dose.
If you have any further questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are usually not severe and do not last long. They are more likely to occur in individuals infected with multiple parasites. This is particularly relevant in individuals infected with the Loa loa worm. The following adverse reactions may occur during treatment with this medicine:

Allergic reactions
The patient should stop taking ivermectin and seek immediate medical help if any of the following symptoms occur:

• sudden fever;
• sudden skin reactions (such as rash or itching) or other severe skin reactions;
• difficulty breathing;
• red, flat, disc-shaped or circular patches on the trunk, often with blisters in their center, skin peeling, and mucosal ulcers in the mouth, throat, nose, genital organs, and eyes. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Other adverse reactions

• liver disease (acute hepatitis);
• blood in the urine;
• changes in the results of certain laboratory tests (increased liver enzyme activity, increased blood bilirubin levels, increased eosinophil count);
• decreased level of consciousness, including coma.

The following adverse reactions depend on the indication for which Scavertin is used, as well as on whether the patient has any other infections.

In patients with intestinal strongyloidiasis (strongyloidiasis), the following adverse reactions may occur:

• unusual weakness;
• loss of appetite, abdominal pain, constipation, or diarrhea;
• nausea or vomiting;
• drowsiness or dizziness;
• chills or tremors;
• decreased number of white blood cells (leukopenia);
• decreased number of red blood cells or hemoglobin, the red pigment in blood (anemia). In intestinal strongyloidiasis (strongyloidiasis), adult roundworms may be present in the stool.

In patients with microfilaria due to lymphatic filariasis caused by Wuchereria bancrofti, the following adverse reactions may occur:

• sweating or fever;
• headache;
• unusual weakness;
• muscle, joint, and general body pain;
• loss of appetite, nausea;
• abdominal pain (abdominal and epigastric pain);
• cough or sore throat;
• breathing discomfort;
• low blood pressure upon standing (orthostatic hypotension) – dizziness or near-fainting may occur;
• chills;
• dizziness;
• pain or discomfort in the testicles.

In patients with scabies, the following adverse reactions may occur:

• increased itching (pruritus) at the beginning of treatment. This is usually short-lived.

In patients with heavy infection with the parasite Loa loa, the following adverse reactions may occur:

• abnormal brain function;
• neck or back pain;
• bleeding in the eye sclera (also known as red eyes);
• shortness of breath;
• loss of bladder or bowel control;
• difficulty standing or walking;
• changes in mental status;
• drowsiness or confusion;
• unresponsiveness to others or progressing to coma.

In patients infected with the parasite Onchocerca volvulus , which causes river blindness, the following adverse reactions may occur:

• itching or rash;
• visual disturbances and other eye problems, such as infection, redness, or unusual sensations;
• joint or muscle pain;
• fever;
• swelling, especially in hands, ankles, or feet;
• swollen lymph nodes;
• nausea or vomiting;
• diarrhea;
• low blood pressure (hypotension). Dizziness or near-fainting may occur upon standing;
• dizziness;
• rapid heartbeat;
• headache or feeling of fatigue;
• bleeding in the eye sclera or eyelid swelling;
• worsening of asthma.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181 C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Scavertin

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following:
"EXP". The expiry date refers to the last day of the specified month.
The batch number is indicated on the blister and carton following "Lot".
Store below 25 °C.
Keep in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the package and other information

What Scavertin contains

• The active substance is ivermectin. One tablet contains 3 mg of ivermectin.
• The other ingredients are: microcrystalline cellulose (type 102), pregelatinized starch, citric acid (E 330), butylated hydroxyanisole (E 320), magnesium stearate (E 470b).

What Scavertin looks like and contents of the pack
White, round, flat tablet with beveled edges.
Scavertin 3 mg is available in blisters packed in cardboard boxes.
Pack sizes are 4, 6, 8, 10, 12, 16 and 20 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Orifarm Healthcare A/S
Energivej 15
5260 Odense S
Denmark
Manufacturer
Orifarm Generics A/S
Energivej 15
5260 Odense S
Denmark
For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orifarm Healthcare Sp. z o.o.
ul. Przyokopowa 31
01-208 Warsaw
Poland
[email protected]
This medicinal product is authorised in the European Economic Area countries under the following names:
Denmark Ivermectin Orifarm
Finland Ivermectin Orifarm
Germany Ivermectin Orifarm
Norway Ivermectin Orifarm Healthcare
Poland Scavertin
Sweden Ivermectin Orifarm