POSELA

Package leaflet: Information for the user

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
POSELA (IVERMECTIN SUBSTIPHARM)
3 mg, tablets
Ivermectinum
POSELA and IVERMECTIN SUBSTIPHARM are different trade names of the same medicinal product.
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any doubts, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

1. What POSELA is and what it is 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 POSELA is and what it is used for

POSELA contains an active substance called ivermectin. It is a medicine used to treat infections caused by certain parasites.
It is used to treat:

• Intestinal infection known as intestinal strongyloidiasis (anguillulosis) caused by the parasite Strongyloides stercoralis.
• Blood infection known as microfilaria caused by "lymphatic filariasis" due to infection with immature forms of the parasite Wuchereria bancrofti. POSELA acts against immature forms of the parasite. It does not act against adult parasites.
• Skin infestation with mites (scabies), which may reside in the patient's skin and cause intense itching. POSELA should only be taken when 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 act against adult parasites.
POSELA should only be taken when the doctor has confirmed or suspects that the patient may have a parasitic infection.

2. Important information before using POSELA

When not to use 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 may include skin rash, difficulty breathing, or fever.
• If the patient has ever experienced severe skin rash, skin peeling, blisters, or oral ulcers after taking ivermectin.
• If any of the above apply, the patient must not take POSELA.

If in doubt, consult a doctor or pharmacist before starting treatment with POSELA.
Warnings and precautions
Discuss this with your doctor before starting treatment with POSELA.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred with ivermectin treatment. Discontinue ivermectin and seek immediate medical help if any symptoms of severe skin reactions (listed in section 4) occur.
Before starting treatment with POSELA, inform your doctor if the patient:

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

If any of the above apply (or if the patient is unsure), discuss this with a doctor or pharmacist before taking POSELA.
Children
The safety of POSELA in children weighing less than 15 kg has not been established.
Other medicines and POSELA
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including medicines obtained without a prescription, as well as any medicines the patient plans to take.
Food, drink and alcohol with POSELA
Not applicable.
Pregnancy and breastfeeding

• If the patient is pregnant or suspects she may be pregnant, she should inform her doctor immediately before using this medicine. This medicine should be used during pregnancy only if clearly necessary. The decision will be made by the patient and her doctor during consultation.
• If the patient is breastfeeding or planning to breastfeed, she should consult her doctor. This is because this medicine passes into breast milk. The doctor may decide to start treatment one week after childbirth. If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her doctor or pharmacist before using this medicine.

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

3. How to take POSELA

This medicine should always be taken as directed by the doctor or pharmacist. In case of
doubt, consult your doctor or pharmacist.
Taking this medicine

• This medicine should be taken orally.
• When administering to 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 water, on an empty stomach. Do not eat for two hours before or after taking the tablets. This is because it is not known how food affects the absorption of the medicine in the body.

What dose of medicine to take
Treatment consists of a single dose.

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

Treatment of intestinal strongyloidiasis
Recommended dose:
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 microfilaraemia caused by Wuchereria bancrofti
Recommended dose:
BODY WEIGHT DOSING when given DOSING when given
(kg) every 6 months every 12 months
(number of 3 mg tablets) (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 regimen is repeated every 6 or every 12 months.
If it is not possible to determine the patient's body weight, the ivermectin dose should be determined based on the patient's height:
HEIGHT DOSING when given DOSING when given
(cm) every 6 months every 12 months
(number of 3 mg tablets) (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 scabies

• The dose is 200 micrograms of ivermectin per kilogram of body weight. Your doctor will tell you how many tablets to take.
• Treatment efficacy may 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, consult your doctor or pharmacist.
Taking more than the recommended dose of POSELA

Take exactly the dose prescribed by your doctor. After taking an excessive amount of this medicine, some patients have experienced disturbances of consciousness or coma.
If you have taken 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 doubts regarding the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The patient should stop taking ivermectin and seek medical help immediately
if any of the following symptoms occur:

• Red, flat, disc-shaped or circular spots on the trunk, often with blisters in the centre, peeling of the skin, 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).

Adverse reactions are usually not serious and do not last long. The likelihood of their occurrence
is higher in individuals infected with multiple parasites, and particularly in case of Loa loa infection.
The following adverse reactions may occur during treatment with this medicine:
Allergic reactions
If the 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. If any of the above adverse reactions occur, medical advice should be sought immediately.

Other adverse reactions

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

The following adverse reactions depend on the indication for which the medicine POSELA is used, as well as on
whether the patient has any other infections.
Patients with intestinal strongyloidiasis ( anguillulosis ) may experience the following adverse reactions:

• unusual weakness
• loss of appetite, abdominal pain, constipation or diarrhoea
• nausea or vomiting
• drowsiness or dizziness
• chills. Additionally, adult worms may be present in the stool in case of intestinal strongyloidiasis ( anguillulosis ).

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

• sweating or fever
• headache
• 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) 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 in the whites of the eyes (also known as eye redness)
• shortness of breath
• loss of bladder or bowel control
• difficulty standing or walking
• changes in mental state
• drowsiness or confusion
• unresponsiveness to others or progressing to 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
• diarrhoea
• dizziness
• low blood pressure (hypotension). You may feel dizzy or lightheaded when standing up
• 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 eyelid swelling
• possible worsening of asthma.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store the medicine POSELA

Keep this 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 stated month.
Store below 25°C.
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), pregelatinized starch, corn, butylhydroxyanisole (E 320), magnesium stearate (E 470b).

What Posela looks like and contents of the pack
This medicine is a round, white or almost white, biconvex tablet.
The pack contains 4 or 8 tablets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in the Netherlands, 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
Poland
Repackaged by:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Marketing authorisation number in the Netherlands, country of export: RVG 120488
Parallel import authorisation number: 243/24