Posela

Leaflet attached to the packaging: information for the user

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

POSELA(Iverscab)

3 mg, tablets

Ivermectin
POSELA and Iverscab are different trade names for the same medicine.

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is POSELA and what is it used for

POSELA 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 strongyloidosis (anguillulosis) caused by the parasite Strongyloides stercoralis.
• It is used to treat blood infection called microfilariasis caused by the parasite Wuchereria bancrofti, which causes lymphatic filariasis. POSELA works against the immature forms of the parasite. It does not work against adult parasites.
• It is used to treat scabies, which can cause severe itching. POSELA should only be taken if the doctor has confirmed or suspects that the patient may have scabies.

POSELA will not protect the patient against any of these infections. It does not work against adult parasites.

POSELA should only be taken if the doctor has confirmed or suspects that the patient may have a parasitic infection.

2. Important information before taking POSELA

When not to take POSELA

• 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 to the medicine may include skin rash, difficulty breathing, or fever.
• If the patient has ever experienced severe skin rash, skin peeling, or blisters or ulcers in the mouth after taking ivermectin.
• If any of the above applies to the patient, they should not take POSELA.

In case of doubt, the patient should consult their doctor or pharmacist before taking POSELA.

Warnings and precautions

The patient should discuss this with their doctor before taking POSELA.

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

Before taking POSELA, the patient should tell their doctor about their medical history if they:

• have a weakened immune system
• live or have lived in a region of Africa where people are infected with the Loa loa parasite, also known as the eye worm
• currently live or have lived in Africa. The combined use of diethylcarbamazine citrate (DEC) in the treatment of Onchocerca volvulus co-infection may lead to a risk of potentially serious side effects.

If any of the above applies to the patient (or if the patient is unsure), they should talk to their doctor or pharmacist before taking POSELA.

Children

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

POSELA and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription.

Taking POSELA with food, drink, and alcohol

This is not applicable.

Pregnancy and breastfeeding

• If the patient is pregnant or may be pregnant, they should inform their doctor before taking this medicine. If the patient is pregnant, they should only take this medicine if it is absolutely necessary. The patient and doctor will decide this during consultation.
• If the patient is breastfeeding or plans to breastfeed, they should consult their doctor. The reason is that this medicine passes into breast milk. The doctor may decide to start treatment after one week from the birth of the child. If the patient is pregnant, breastfeeding, or thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.

Driving and using machines

After taking this medicine, the patient may experience dizziness, drowsiness, tremors, or a feeling of spinning.

If the patient experiences any of these symptoms, they should avoid driving and using machines.

3. How to take POSELA

This medicine should always be taken exactly as advised by the doctor or pharmacist. If the patient is unsure, they should consult their doctor or pharmacist.

Taking this medicine

• This medicine should be taken orally.
• In the case of children under six years of age, the tablet should be crushed before administration.
• The patient should take the number of tablets prescribed by the doctor at once, with water, on an empty stomach. The patient should not eat anything two hours before or after taking the tablets. The reason is that it is not known how food affects the absorption of the medicine in the body.

What dose to take

Treatment involves a single dose.

• The patient should take the number of tablets prescribed by the doctor at once.
• The dose depends on the type of disease and the patient's weight and height.
• The doctor will tell the patient how many tablets to take.

Treatment of strongyloidosis

BODY WEIGHT (kg) DOSE (number of 3 mg tablets)

15 to 24
one
25 to 35
two
36 to 50
three
51 to 65
four
66 to 79
five
≥ 80
six
Treatment of microfilariasis caused by Wuchereria bancrofti

BODY WEIGHT (kg)

DOSE when administered every 6 months (number of 3 mg tablets)

DOSE when administered every 12 months (number of 3 mg tablets)

15 to 25
one
two
26 to 44
two
four
45 to 64
three
six
65 to 84
four
eight
This scheme is repeated every 6 or 12 months.

If the patient's weight cannot be determined, the ivermectin dose should be determined based on the patient's height:

DOSE when administered every 12 months (number of 3 mg tablets)

90 to 119
one
two
120 to 140
two
four
141 to 158
three
six
> 158
four
eight
Treatment of human scabies

HEIGHT DOSE when administered every 6 months (number of 3 mg tablets) (cm)

• The dose is 200 micrograms of ivermectin per kilogram of body weight. The doctor will tell the patient how many tablets to take.
• The effectiveness of the treatment can be confirmed after 4 weeks.
• The doctor may decide to administer a second dose within 8 to 15 days.

If the patient feels that the effect of POSELA is too strong or too weak, they should consult their doctor or pharmacist.

Taking a higher dose of POSELA than recommended

The patient should take exactly the dose of POSELA that the doctor has prescribed. After taking too much of this medicine, some patients have experienced disorders of consciousness or coma.

If the patient has taken too much of this medicine, they should contact their doctor immediately.

Missing a dose of POSELA

The patient should always follow the doctor's advice. They should not take a double dose to make up for a missed dose.

If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

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

The patient should stop taking ivermectin and seek medical help immediately if they notice any of the following symptoms:

• red, flat, plate-like, or round patches on the torso, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of such serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

Side effects are usually not serious and do not last long. The likelihood of occurrence is higher in people infected with multiple parasites, especially in the case of Loa loa infection. The following side effects may occur when taking this medicine:

Allergic reactions

If the patient experiences an allergic reaction, they should seek medical help immediately. Symptoms may include:

• sudden fever
• sudden skin reactions (such as rash or itching) or other serious skin reactions
• difficulty breathing. If the patient experiences any of the above side effects, they should seek medical help immediately.

Other side effects

• liver disease (acute hepatitis)
• changes in some laboratory tests (increased liver enzyme activity, increased bilirubin levels in the blood, increased eosinophil count)
• blood in the urine
• disorders of consciousness or coma.

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

Patients with intestinal strongyloidosis (anguillulosis)may experience the following side effects:

• feeling of unusual weakness
• loss of appetite, abdominal pain, constipation, or diarrhea
• nausea or vomiting
• feeling of drowsiness or dizziness
• chills. Additionally, in the case of strongyloidosis, adult worms may be present in the stool.

Patients with microfilariasis caused by Wuchereria bancroftimay experience the following side effects:

• 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 when breathing
• low blood pressure when standing up - the patient may experience dizziness or fainting
• chills
• dizziness
• pain or discomfort in the testicle.

Patients with scabiesmay experience the following side effects:

• itching (pruritus) may worsen at the beginning of treatment. It usually does not last long.

Patients with severe Loa loa infectionmay experience the following side effects:

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

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

• itching or rash
• joint or muscle pain
• fever
• nausea or vomiting
• swollen lymph nodes
• swelling, especially of the hands, ankles, or feet
• diarrhea
• dizziness
• low blood pressure (hypotension). When standing up, the patient may experience dizziness or fainting
• rapid heartbeat
• headache or feeling of fatigue
• changes in vision and other eye problems, such as infection, redness, or unusual sensations
• bleeding in the eyes or swelling of the eyelids
• possibility of worsening asthma.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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.

By reporting side effects, it is possible to gather more information on the safety of this medicine.

5. How to store POSELA

The medicine should be stored out of sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging.

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

Store in a temperature below 25°C, in the original packaging to protect from light.

Medicines should not be disposed of via wastewater. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What POSELA contains

• The active substance of POSELA is ivermectin. One tablet contains 3 mg of ivermectin.
• The other ingredients (excipients) are: microcrystalline cellulose (E 460), corn starch, butylhydroxyanisole (E 320), magnesium stearate (E 470b).

What POSELA looks like and contents of the pack

POSELA is a round, white or almost white, flat tablet.

The pack contains 4 or 8 tablets.

For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Italy, the country of export:

SUBSTIPHARM
24 rue Erlanger
75016 Paris
France

Manufacturer:

Depo-Pack S.R.L.
Via Morandi, 28

• 21047 – Saronno (VA)

Italy
EUROPEENNE DE PHARMACOTECHNIE - EUROPHARTECH
Rue Henri Matisse
63370 Lempdes
France

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Italy, the country of export:048540025

Parallel import authorization number: 257/24

Date of leaflet approval: 26.06.2024

[Information about the trademark]