Posela

Leaflet accompanying the packaging: information for the user

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

POSELA(IVERMECTIN SUBSTIPHARM)

3 mg, tablets

Ivermectinum
POSELA and IVERMECTIN SUBSTIPHARM 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 packaging 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 infections called strongyloidosis (anguillulosis) caused by the parasite Strongyloides stercoralis.
• It is used to treat blood infections 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 skin mites (scabies) that can be found in the patient's skin and cause severe itching. POSELA should only be taken when the doctor has proven or suspects that the patient may have scabies.

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

POSELA should only be taken when the doctor has proven 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, peeling, or blisters in the mouth after taking ivermectin.
• If the above circumstances apply to the patient, they should not take POSELA.

In case of doubts, before starting treatment with POSELA, the patient should consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with POSELA, the patient should discuss it with their doctor.

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 attention immediately if they experience any symptoms of severe skin reactions listed in section 4.

Before starting treatment with POSELA, the patient should inform 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 apply to the patient (or the patient is unsure), they should discuss it with 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 plan to take, including those available without a prescription.

Using 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 on 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 such symptoms occur, the patient should avoid driving and operating machines.

3. How to take POSELA

This medicine should always be taken according to the doctor's or pharmacist's recommendations. In case of doubts, the patient should consult a 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.

In case it is not possible to determine the patient's weight, 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 the medicine recommended by the doctor. After taking too much of this medicine, some patients have experienced disturbances 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 recommendations. They should not take a double dose to make up for a missed dose.

In case of any further doubts about taking this medicine, the patient 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 attention immediately if they notice any of the following symptoms:

• red, flat, plate-like, or round spots on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. The occurrence of such severe 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 attention immediately. Symptoms may include:

• sudden fever
• sudden skin reactions (such as rash or itching) or other severe skin reactions
• difficulty breathing. If any of the above side effects occur, the patient should seek medical attention 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
• disturbances of consciousness or coma.

The following side effects depend on the purpose of using POSELA 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 found 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 while 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
• swelling of 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 Monitoring of Adverse Reactions to Medicinal Products, 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.

By reporting side effects, more information can be collected on the safety of the 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 specified month.

Store in a temperature below 25°C.

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 packaging and other information

What POSELA contains

• The active substance of the medicine 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 what the packaging contains

The medicine is in the form of a round, white or almost white, flat tablet.

The packaging contains 4 or 8 tablets.

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

Marketing authorization holder in the Netherlands, the country of export:

SUBSTIPHARM
24 rue Erlanger
75016 Paris
France

Manufacturer:

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 the Netherlands, the country of export:RVG 120488

Parallel import authorization number: 243/24

Date of leaflet approval: 14.06.2024

[Information about the trademark]