Posela

Package Leaflet: Information for the User

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

POSELA (IVERMECTIN SUBSTIPHARM), 3 mg, tablets

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

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

• Keep this leaflet, you may need to read it again.
• In case of any doubts, 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, pharmacist, or nurse. 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.
• blood infection called microfilariasis caused by "lymphatic filariasis" caused by infection with immature forms of the parasite Wuchereria bancrofti. POSELA works against the immature parasites. It does not work against adult parasites.
• 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

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• If the above circumstances apply to the patient, they should not take POSELA.

In case of doubt, before starting treatment with POSELA, consult a doctor or pharmacist.

Warnings and precautions

Before starting treatment with POSELA, discuss it with your doctor.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred with ivermectin treatment. Stop taking ivermectin and seek medical help immediately if any of the symptoms of severe skin reactions listed in section 4 occur.
Before starting treatment with POSELA, inform your doctor about your medical history if you:

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

If any of the above apply to you (or you are not sure), you should talk to your 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

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and any medicines you plan to take, including those obtained without a prescription.

Taking POSELA with food, drink, and alcohol

Not applicable.

Pregnancy and breastfeeding

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

Driving and using machines

After taking this medicine, you may experience dizziness, drowsiness, tremors, or a feeling of spinning.
In case of such symptoms, avoid driving and operating machines.

3. How to take POSELA

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This medicine should always be taken exactly as advised by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.

Taking this medicine

• This medicine should be taken orally.
• In case of use in children under six years of age, the tablet should be crushed before administration.
• Take the number of tablets prescribed by your doctor at once, with a glass of water, on an empty stomach. Do 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.

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

Treatment of strongyloidosis
The recommended dose is:

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
The recommended dose is:

BODY WEIGHT DOSE ADMINISTRATION every 6 months

DOSE ADMINISTRATION every 12 months (kg)

(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:
(number of 3 mg tablets)

HEIGHT DOSE ADMINISTRATION every 6 months

DOSE ADMINISTRATION every 12 months (cm)

(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

• The dose is 200 micrograms of ivermectin per kilogram of body weight. Your doctor will tell you how many tablets to take.
• The effectiveness of the treatment may be confirmed after 4 weeks. (number of 3 mg tablets)

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• Your doctor may decide to administer a second dose within 8 to 15 days.

In case you feel that the effect of POSELA is too strong or too weak, you should consult your doctor or pharmacist.

Taking a higher dose of POSELA than recommended

Take exactly the dose of POSELA that your doctor has prescribed. After taking too much of this medicine, some patients have experienced disorders of consciousness or coma.
In case of taking too much of this medicine, you should immediately contact your doctor.

Missing a dose of POSELA

Always follow your doctor's instructions. Do not take a double dose to make up for a missed dose.
In case of any further doubts about taking this medicine, consult your 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 spots 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 Loaloainfection. The following side effects may occur when taking this medicine:

Allergic reactions

If you experience an allergic reaction, you should immediately consult a doctor. Symptoms may include:

• sudden fever
• sudden skin reactions (such as rash or itching) or other serious skin reactions
• difficulty breathing. If you experience any of the above side effects, you should immediately consult a doctor.

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 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

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• nausea or vomiting
• feeling of drowsiness or dizziness
• chills In addition, in the case of strongyloidosis (anguillulosis), adult worms may be found in the stool.

Patients with microfilariasis caused by Wuchereriabancroftimay experience the following side effects:

• sweating or fever
• headache
• feeling of unusual weakness
• muscle, joint, and 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 - you may feel dizzy or faint
• 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 Loaloainfectionmay experience the following side effects:

• abnormal brain function
• neck or back pain
• bleeding in the eye proteins (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 Onchocercavolvulus, 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, you may feel dizzy or faint
• rapid heartbeat
• headache or feeling of fatigue
• vision changes and other eye problems, such as infection, redness, or unusual sensations
• bleeding in the eye proteins or swelling of the eyelids
• possibility of worsening asthma.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. 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, you can help provide more information on the safety of this medicine.

5. How to store POSELA

Keep the medicine out of the 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.
Medicines should not be disposed of via wastewater. Ask your 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 with a beveled edge.
The pack contains 4, 8, 12, 16, or 20 tablets.
For more detailed information, please contact the marketing authorization holder or the 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:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Netherlands marketing authorization number: RVG 120488

Parallel import authorization number: 254/23

Date of leaflet approval: 07.11.2023

[Information about the trademark]
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