Posela

Package Leaflet: Information for the User

POSELA, 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 or pharmacist.
• 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, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Package 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 strongyloidiasis (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 forms of the parasite. 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 you against any of these infections. It does not work against adult parasites.

POSELA should only be taken when the doctor has proven or suspects that you may have a parasitic infection.

2. Important information before taking POSELA

When not to take POSELA

if you are 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 you have ever had any of the following after taking ivermectin:

• severe skin rash or skin peeling or blisters or ulcers in the mouth.

If any of the above applies to you, do not take POSELA.

In case of doubt, consult your doctor or pharmacist before taking POSELA.

Warnings and precautions

Before taking 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 you experience any of the symptoms of severe skin reactions listed in section 4.

Before taking POSELA, tell 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 Loa loaparasite, 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 volvulusco-infection may lead to a risk of potentially serious side effects.

If any of the above applies 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, have recently taken, or might take, including those obtained without a prescription.

Taking POSELA with food, drink, and alcohol

Not applicable.

Pregnancy and breastfeeding

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

Driving and using machines

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

Avoid driving and operating machinery if you experience such symptoms.

3. How to take POSELA

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.

Taking this medicine

• This medicine should be taken orally.
• In the case of use in children under six years of age, the tablet should be crushed before administration.
• You should take the number of tablets prescribed by your doctor at once, with 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 consists of a single dose.

• You should 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 strongyloidiasis

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 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 of inability to determine the patient's weight, the ivermectin dose should be determined based on the patient's height:

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 can be confirmed after 4 weeks.
• Your doctor may decide to administer a second dose within 8 to 15 days.

If 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 disturbances of consciousness or coma.

If you take too much of this medicine, contact your doctor immediately.

Missing a dose of POSELA

Always follow your doctor's instructions. Do not take a double dose to make up for a missed dose.

If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

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

• 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 around the 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 loainfection. The following side effects may occur during treatment with this medicine:

Allergic reactions

If you experience an allergic reaction, you should seek medical help immediately. Symptoms may include:

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

If you experience any of the above side effects, you 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
• disturbances of consciousness or coma.

The following side effects depend on the purpose of using POSELA and also on whether you have any other infections.

Patients with intestinal strongyloidiasis (anguillulosis)may have 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 strongyloidiasis (anguillulosis), adult worms may be found in the stool.

Patients with microfilariasis caused by Wuchereria bancroftimay have 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 - you may feel dizzy or faint
• chills
• dizziness
• pain or discomfort in the testicle.

Patients with scabiesmay have the following side effects:

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

Patients with severe Loa loainfectionmay have the following side effects:

• abnormal brain function
• neck or back pain
• bleeding in the whites of 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 have 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
• changes in vision and other eye problems, such as infection, redness, or unusual sensations
• bleeding in the whites of the eyes or swelling of the eyelids
• possibility of worsening asthma.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your 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

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 POSELA

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton. The expiry date (EXP) refers to the last day of the month.

Do not store above 25°C.

Store in the original package to protect from light.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What POSELA contains

• The active substance is ivermectin. One tablet contains 3 mg of ivermectin.
• The other ingredients (excipients) are: microcrystalline cellulose (E 460), maize 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, 6, 8, 10, 12, 16, or 20 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

SUBSTIPHARM
24 rue Erlanger
75016 Paris
France

Manufacturer

EUROPEENNE DE PHARMACOTECHNIE - EUROPHARTECH
Rue Henri Matisse
63370 Lempdes
France
To obtain more detailed information, please contact the representative of the marketing authorization holder.

Mercapharm Sp. z o.o.
ul. Świętopełka 39
81-524 Gdynia
e-mail: [email protected]

Date of last revision of the package leaflet: 10/2024.