Vesarco

Package leaflet: Information for the user

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

• 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 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 or pharmacist. See section 4.

Leaflet contents

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

1. What Vesarco is and what it is used for

Vesarco contains the active substance ivermectin. It is a medicine used to treat infections caused by certain parasites.
It is used to treat:

• Intestinal infection called intestinal strongyloidiasis (also known as anguillulosis), caused by the parasite Strongyloides stercoralis.
• Blood infection called microfilaria, caused by "lymphatic filariasis". This is caused by immature forms of the parasite Wuchereria bancrofti. Vesarco acts against the immature forms of the parasite and does not act against adult parasites.
• Skin mites (scabies). These mites may be present in the patient's skin and cause intense itching. Vesarco should only be taken when a doctor has confirmed or suspects that the patient may have scabies.

Vesarco will not protect the patient against any of these infections. It does not act against adult parasites.
Vesarco should only be taken when a doctor has confirmed or suspects that the patient may have a parasitic infection.

2. Important information before using Vesarco

When not to use Vesarco

• If the patient is allergic to ivermectin or any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction may include skin rash, difficulty breathing, or fever.
• If the patient has ever experienced the following after taking ivermectin: severe skin rash, skin peeling, blisters, or mouth ulcers. In general, if any unusual or sudden symptoms occur after taking any medicine—such as rash, hives, or fever—an allergy to that medicine should be suspected.

If any of the above situations apply to the patient, Vesarco should not be taken.
If in doubt, consult a doctor or pharmacist before starting Vesarco.

Warnings and precautions

Talk to your doctor before starting treatment with Vesarco.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with ivermectin treatment. If any symptoms of serious skin reactions listed in section 4 occur, stop taking ivermectin immediately and seek medical help without delay.

Before starting treatment with Vesarco, inform your doctor about your medical history. Tell your doctor if the patient:

• has a weakened immune system;
• has a known impairment of the blood-brain barrier due to dysfunction of a specific transport protein (P-glycoprotein, P-gp);
• lives or has lived in regions of Africa where infections with the parasite Loa loa, also known as the eye worm, occur;
• currently lives or has lived in regions of Africa.

Concomitant use of diethylcarbamazine citrate (DEC) in the treatment of co-infection with Onchocerca volvulus may increase the risk of potentially serious adverse reactions.

If any of the above situations apply to the patient (or if the patient is unsure), they should discuss this with a doctor or pharmacist before taking Vesarco.

Vesarco is not intended for the prevention of tropical parasitic infections. It is not effective against adult forms of intestinal parasites and should only be used under medical prescription when parasitic infection is confirmed or strongly suspected.

Children

It is not known whether the use of Vesarco is safe in children weighing less than 15 kg.

Elderly patients

Clinical studies with ivermectin did not include a sufficient number of patients aged 65 years and older to determine whether their response differs from that of younger patients. Available clinical data do not indicate differences in treatment response between elderly and younger patients.

In general, treatment in elderly patients should be conducted with caution, taking into account the higher likelihood of impaired liver, kidney, or heart function, as well as the presence of concomitant diseases or use of other medicinal products.

Vesarco and other medicines

Inform your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those obtained without a prescription, as well as any medicines the patient plans to take.

Pregnancy and breastfeeding

Pregnancy
If the patient is pregnant, she should not take this medicine unless specifically instructed by a doctor.
If the patient is pregnant, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.

Breastfeeding
Vesarco passes into human milk. If the patient is breastfeeding, she should inform her doctor and should not use this treatment unless otherwise clearly advised by a doctor.

Before taking any medicine, consult a doctor or pharmacist.

Driving and operating machinery

After taking this medicine, the patient may experience dizziness, somnolence, tremor, or vertigo.
If such symptoms occur, avoid driving or operating machinery.

3. How to use Vesarco

This medicine should always be taken exactly as directed by the doctor or pharmacist. In case of
doubt, consult the doctor or pharmacist.
Dosage
Treatment of intestinal strongyloidiasis
Approximately, the dose based on body weight is:

Treatment of microfilaraemia caused by Wuchereria bancrofti
Approximately, the dose dependent on body weight is:

This regimen is repeated every 6 or every 12 months.
Alternatively, if weight is not available, the dose of ivermectin used in mass chemotherapeutic campaigns can be determined based on the patient's height, as follows:

Treatment of human scabies

• The dose is 200 micrograms of ivermectin per kilogram of body weight.
• Treatment efficacy may be confirmed after 4 weeks.
• The physician may decide to administer a second single dose within 8 to 15 days.

What else the patient should do during scabies treatment
Every person who has contact with the patient—especially family members and partners—should
seek medical advice as soon as possible. The physician will decide whether these individuals also
require treatment.
If infected individuals in the patient's environment are not promptly treated, there is a risk that
the patient will become reinfected with scabies.
The patient should follow hygiene measures to prevent reinfection (e.g. keep fingernails short and clean) and strictly adhere to official recommendations regarding cleaning of clothing and bed linen.
If the patient feels that the effect of Vesarco is too strong or too weak, they should consult their
physician or pharmacist.
Method of administration
How to take the tablets
The tablets should be taken orally.
For children under 6 years of age, the tablets should be crushed before swallowing.
Take the tablets with water on an empty stomach.
Do not eat any food for two hours before taking the tablets or for two hours after taking them. This is important because it is not known how food affects the absorption of the medicine by the body.
How many tablets to take
Treatment consists of a single dose.
The physician will inform the patient how many tablets they need to take.
All prescribed tablets should be taken at the same time.
The dose depends on the type of disease and the patient's body weight or height.
Use of more than the recommended dose of Vesarco
The medicine should be taken exactly as prescribed by the physician.
In some patients, taking an excessive amount of this medicine has led to disturbances of consciousness
or coma.
If an excessive amount of this medicine is taken, contact a physician or pharmacist immediately.
Missed dose of Vesarco
Always follow the physician's instructions. Do not take a double dose to make up for a missed dose.
If you have any further doubts regarding the use of this medicine, consult your physician or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Adverse reactions are usually not serious and do not last long. They may occur more frequently in individuals
co-infected with multiple parasites simultaneously. This particularly applies to patients infected with
the Loa loa worm.

The following adverse reactions may occur when using this medicine:
Allergic reactions
If a patient experiences an allergic reaction, medical advice should be sought immediately. Symptoms may include:

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

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

• red, flat, disc-shaped or circular patches on the trunk, often with blisters in the center, peeling of the skin, and mucosal ulcers in the mouth, throat, nose, genital organs, 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 adverse reactions
asthma
difficulty walking
eye problems, such as: infection, redness, or unusual sensations
abdominal pain
constipation
sore throat
liver disease (acute hepatitis)
changes in certain laboratory tests (increased liver enzyme activity, increased blood bilirubin levels, increased eosinophil count)
blood in urine
excessive sweating
feeling of unusual weakness
loss of consciousness or coma

The following adverse reactions depend on the indication for which Vesarco is used. Their occurrence may also depend on the presence of other parasitic infections.

Patients with intestinal strongyloidiasis (angiostrongyloidiasis) may experience the following adverse reactions:

• feeling of unusual weakness
• loss of appetite, abdominal pain, constipation, or diarrhea
• nausea or vomiting
• drowsiness or dizziness
• tremors or seizures
• decreased number of white blood cells (leukopenia)
• decreased number of red blood cells or hemoglobin levels (anemia)
  Additionally, adult roundworms may be present in the stool in cases of intestinal strongyloidiasis (angiostrongyloidiasis).

Patients with microfilaria due to lymphatic filariasis caused by Wuchereria bancrofti may experience the following adverse reactions:

• sweating or fever
• headache
• feeling of unusual weakness
• muscle, joint, and general body pain
• loss of appetite, nausea
• abdominal pain (abdominal and epigastric pain)
• cough or sore throat
• discomfort during breathing
• low blood pressure upon standing – dizziness or lightheadedness may occur
• chills
• dizziness
• pain or discomfort in the testicle.

Patients with scabies may experience the following adverse reactions:

• itching (pruritus), which may worsen at the beginning of treatment. Usually, it does not last long.

Patients with severe infection caused by Loa loa may experience the following adverse reactions:

• abnormal brain function
• neck or back pain
• bleeding into the eye sclera (also known as eye redness)
• shortness of breath
• loss of bladder or bowel control
• difficulty standing or walking
• changes in mental status
• drowsiness or disorientation
• unresponsiveness to others or falling into a coma.

Patients infected with Onchocerca volvulus , which causes river blindness, may experience the following adverse reactions:

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

Reporting adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +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 Vesarco

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister pack and the outer carton.
The expiry date (EXP) refers to the last day of the stated month.
Do not store above 25°C.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to safely dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Vesarco contains

• The active substance is ivermectin. One tablet contains 3 mg of ivermectin.
• The other ingredients (excipients) are: microcrystalline cellulose, citric acid, butylhydroxyanisole, pregelatinized maize starch, colloidal anhydrous silica, magnesium stearate.

What Vesarco looks like and contents of the pack
Vesarco is a white or almost white, round, biconvex tablet with a diameter of approximately 5 mm.
Tablets are available in cardboard boxes containing blisters made of OPA–Aluminium–PVC foil with 4, 6, 8 or 10 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Aristo Pharma Sp. z o.o.
ul. Baletowa 30
02-867 Warsaw
tel: +48 22 855 40 93

Manufacturer
Laboratorios Medicamentos Internacionales, S.A.
Calle De La Solana 26
28850 Torrejón de Ardoz, Madrid
Spain
Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Czech Republic: Ivermectin Aristo
Germany: Ivermectin Aristo 3 mg Tabletten
Netherlands: Ivermectin Aristo 3 mg tabletten
Poland: Vesarco
Spain: Ivermectina Aristo 3 mg comprimidos EFG