Scavertin

Package Leaflet: Information for the User

Scavertin, 3 mg, tablets

Ivermectin

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

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

Table of Contents of the Package Leaflet

• 1. What is Scavertin and what is it used for
• 2. Important information 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 is Scavertin and what is it used for

Scavertin contains the active substance ivermectin. The medicine is used to treat infections caused by certain parasites.

It is used to treat:

• intestinal infection, also known as anguillulosis (strongyloidiasis). It is caused by a type of roundworm called Strongyloides stercoralis.
• blood infection called microfilariasis due to "lymphatic filariasis". It is caused by an immature form of the worm, called Wuchereria bancrofti. Scavertin does not work on mature forms, only on immature forms of the worms.
• skin disease (scabies) caused by mites. This happens when small mites burrow under the skin. It can cause intense itching. Scavertin should only be taken when a doctor has confirmed scabies or suspects that the patient has scabies.

Scavertin does not prevent the occurrence of one of these infections.It does not work against mature forms of the worms.

Scavertin should only be taken when a doctor has confirmed or suspects a parasitic infection.

2. Important information before taking Scavertin

When not to take Scavertin

Warnings and precautions

Before taking Scavertin, discuss it with your doctor or pharmacist.

Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with ivermectin. You should stop taking ivermectin and seek medical attention immediately if you experience any of the symptoms of severe skin reactions listed in section 4.

In particular, tell your doctor if you:

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

Taking ivermectin with a medicine called diethylcarbamazine citrate (DEC) to treat concurrent Onchocerca volvulus infection may sometimes cause a risk of potentially serious side effects.

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

Scavertin is not intended to prevent tropical parasitic infections. It is not effective against mature forms of parasites and should only be used on the advice of a doctor when a parasitic infection has been confirmed or is suspected.

Children

The safety of Scavertin in children with a body weight below 15 kg has not been established.

Elderly

Clinical studies with ivermectin did not include a sufficient number of patients aged 65 and over to determine whether these patients respond differently to treatment than younger patients. In other reported clinical experiences, no differences in response to treatment were found between elderly and younger patients. In general, treatment of elderly patients requires caution, due to the higher frequency of decreased liver, kidney, or heart function, concomitant diseases, and the use of other medicines.

Scavertin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about any medicines you plan to take.

As a rule, before taking any medicine, consult your doctor or pharmacist.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

If you are pregnant, do not take Scavertin unless your doctor advises you to.

Breastfeeding

Scavertin passes into human milk.

If you are breastfeeding, inform your doctor and do not take this medicine unless your doctor advises you to.

Before taking any medicine, consult your doctor or pharmacist.

Fertility

In rats, Scavertin at a dose up to 3 times the maximum recommended dose in humans, equivalent to 200 micrograms/kg body weight (approximately 12 mg/m2 per day), did not show any adverse effects.

Driving and using machines

The effect of Scavertin on the ability to drive and use machines has not been studied.

In some patients, it cannot be ruled out that side effects such as dizziness, drowsiness, feeling unsteady, or a feeling of spinning may affect the ability to drive and use machines.

If such symptoms occur, avoid driving and using machines.

3. How to take Scavertin

Always take this medicine exactly as your doctor or pharmacist has told you.

If you are not sure, ask your doctor or pharmacist.

Dosage

Treatment of intestinal infection (anguillulosis)

The recommended dose is 200 micrograms of ivermectin per kilogram of body weight, taken orally in a single dose.

Treatment of microfilariasis caused by Wuchereria bancrofti (lymphatic filariasis)

The recommended dose for mass treatment campaigns for microfilariasis (caused by lymphatic filariasis) due to Wuchereria bancrofti is approximately 150 to 200 micrograms of ivermectin per kilogram of body weight, taken orally in a single dose every 6 months.

In endemic areas where treatment can only be given once every 12 months, the recommended dose is 300 to 400 micrograms per kilogram of body weight to maintain adequate suppression of microfilariasis in treated patients.

Alternatively, and if it is not possible to determine the patient's body weight, the ivermectin dosage for mass treatment campaigns can be determined based on the patient's height as follows:

Treatment of scabies in humans

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

What to consider during scabies treatment

Anyone who comes into contact with the patient, especially family members and partners, should see a doctor as soon as possible. The doctor will decide whether these people should also be treated.

If people who come into contact with an infected patient are not treated immediately, there is a risk that they may re-infect the patient with scabies.

Hygiene rules should be followed to prevent re-infection (e.g., keeping fingernails short and clean) and official guidelines for washing clothes and bedding should be strictly followed.

If you feel that the effect of Scavertin is too strong or too weak, talk to your doctor or pharmacist.

Method of administration

Tablets for oral use.

Always follow the dosage recommended by your doctor. If you are not sure, 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 at the same time as a single dose.

The tablets should be taken on an empty stomach, with a glass of water.

No meals should be consumed for 2 hours before or after taking this medicine, as it is not known how food affects its absorption.

Taking a higher dose of Scavertin than recommended

Take exactly the dose of this medicine that your doctor has prescribed for you.

In some patients, decreased consciousness, including coma, has been reported after overdosing on ivermectin.

If you take more Scavertin than you should, contact your doctor immediately.

Missing a dose of Scavertin

Always follow your doctor's instructions.

Do not take a double dose to make up for a forgotten dose.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, Scavertin can cause side effects, although not everybody gets them.

Side effects are usually not serious and do not last long. They are more likely to occur in people infected with several parasites.

This is especially true for people infected with the Loa loa worm.

The following side effects may occur when taking this medicine:

Allergic reactions

You should stop taking ivermectin and seek medical attention immediately if you notice any of the following symptoms:

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

Other side effects

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

The following side effects depend on the purpose for which Scavertin is used. They also depend on whether the patient has any other infections.

In people with intestinal infection (anguillulosis), the following side effects may occur:

• feeling of unusual weakness;
• loss of appetite, abdominal pain, constipation, or diarrhea;
• nausea or vomiting;
• feeling of drowsiness or dizziness;
• chills or shivering;
• decreased white blood cell count (leukopenia);
• decreased red blood cell or hemoglobin count, red blood cell pigment (anemia). In the case of intestinal infection (anguillulosis), adult roundworms may be present in the stool.

In people with microfilariasis due to Wuchereria bancrofti (lymphatic filariasis), the following side effects may occur:

• sweating or fever;
• headache;
• feeling of unusual weakness;
• muscle, joint, or body aches;
• loss of appetite, nausea;
• abdominal pain (abdominal and epigastric pain);
• cough or sore throat;
• discomfort while breathing;
• low blood pressure when changing position to standing - dizziness or feeling of impending fainting may occur;
• dizziness;
• rapid heartbeat;
• headache or feeling of fatigue;
• bleeding in the whites of the eyes or swelling of the eyelids;
• worsening of asthma.

In people with scabies, the following side effects may occur:

• intensification of itching (pruritus) at the beginning of treatment. This usually does not last long.

In people with severe Loa loa infection, the following side effects may occur:

• abnormal brain function;
• neck or back pain;
• bleeding in the whites of the eyes (also known as red eyes);
• shortness of breath;
• loss of bladder or bowel control;
• difficulty standing or walking;
• changes in mental state;
• feeling of drowsiness or confusion;
• lack of response to other people or falling into a coma.

In people infected with Onchocerca volvulus, which causes river blindness, the following side effects may occur:

• itching or rash;
• vision changes and other eye problems, such as infection, redness, or unusual sensations;
• joint or muscle pain;
• fever;
• swelling, especially of the hands, ankles, or feet;
• swelling of the lymph nodes;
• nausea or vomiting;
• diarrhea;
• low blood pressure (hypotension). Dizziness or feeling of impending fainting may occur when changing position to standing;
• dizziness;
• rapid heartbeat;
• headache or feeling of fatigue;
• bleeding in the whites of the eyes or swelling of the eyelids;
• worsening of asthma.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products

Al. Jerozolimskie 181 C

PL-02 222 Warsaw

Tel.: +48 22 49 21 301

Fax: + 48 22 49 21 309

Website: https://smz.ezdrowie.gov.pl

Side effects can also be reported to the marketing authorization holder.

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

5. How to store Scavertin

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 blister and carton after "EXP".

The expiry date refers to the last day of that month.

The batch number is stated on the blister and carton after "Lot".

Store in a temperature below 25 °C.

Store in the original package 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.

These measures will help protect the environment.

6. Contents of the pack 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), butylhydroxyanisole (E 320), magnesium stearate (E 470b).

What Scavertin looks like and contents of the pack

White, flat tablet with beveled edges and round shape.

Scavertin 3 mg is available in blisters packaged in cardboard boxes.

Package sizes are 4, 8, 10, 12, 16, and 20 tablets.

Not all package sizes may be marketed.

Marketing authorization holder

Orifarm Healthcare A/S

Energivej 15

5260 Odense S

Denmark

Manufacturer

Orifarm Generics A/S

Energivej 15

5260 Odense S

Denmark

To obtain more detailed information on this medicine, please contact the local representative of the marketing authorization holder:

Orifarm Healthcare Sp. z o.o.

ul. Przyokopowa 31

01-208 Warsaw

Poland

info-PL@orifarm.com

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark

Ivermectin Orifarm

Finland

Ivermectin Orifarm

Germany

Ivermectin Orifarm

Norway

Ivermectin Orifarm Healthcare

Poland

Scavertin

Sweden

Ivermectin Orifarm

Date of last revision of the package leaflet: 17.10.2024