Posela

Patient Information Leaflet

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

• Keep this leaflet for future reference.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are similar.
• 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

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 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 microfilaraemia caused by "lymphatic filariasis" due to infection with immature forms of the parasite Wuchereria bancrofti. POSELA acts against the immature forms of the parasite. It does not act against adult forms of the parasite.
• Skin mites (scabies), which may infest the patient's skin and cause intense itching. POSELA should only be taken when a 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 forms of the parasite.
POSELA should only be taken when a doctor has confirmed or suspects that the patient may have a parasitic infection.

2. Important information before using the medicine 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 the following after taking ivermectin: severe skin rash, peeling of the skin, blisters or mouth ulcers.
• 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
Talk to your doctor before starting treatment with POSELA.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with ivermectin treatment. Treatment with ivermectin must be discontinued immediately and medical help sought without delay if any symptoms of severe skin reactions occur (as described in section 4).

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 can be 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 effects.

If any of the above apply to the patient (or if the patient is unsure), they should speak with a doctor or pharmacist before taking POSELA.
Children
The safety of POSELA in children with body weight below 15 kg has not been established.
Other medicines and POSELA
Tell your doctor or pharmacist about all medicines the patient is currently taking, has recently taken or might take, including those obtained without a prescription.
Taking POSELA with food, drink and alcohol
Not applicable.
Pregnancy and breastfeeding

• If the patient is pregnant or suspects she may be pregnant, she must inform her doctor immediately before taking this medicine. This medicine should be used during pregnancy only if clearly needed. 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
Dizziness, somnolence, tremor or vertigo may occur after taking this medicine.
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 the 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.
• The number of tablets prescribed by the doctor should be taken at once, swallowed with water, on an empty stomach. Do not eat anything 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 to take
Treatment consists of a single dose.

• The number of tablets prescribed by the doctor should be taken at once.
• The dose depends on the type of disease as well as the patient's body weight and height.
• The doctor will inform the patient 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 microfilaria caused by Wuchereria bancrofti
Recommended dose:
BODY WEIGHT DOSE when given DOSE 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 DOSE when given DOSE 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. The doctor will inform the patient how many tablets to take.
• The effectiveness of treatment may be confirmed after 4 weeks.
• The 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 POSELA than recommended
Take exactly the dose prescribed by the doctor. In some patients, overdose has led to
disturbances of consciousness or coma.
If too much of this medicine has been taken, contact a doctor immediately.
Missed dose of POSELA
Always follow the 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The patient should stop taking ivermectin and seek immediate medical help
if any of the following symptoms occur:

• red, flat, disc-shaped or round spots on the trunk, often with blisters in the center, peeling of the skin, mouth ulcers, ulcers in the throat, nose, genital organs, and around the eyes. The appearance 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 individuals infected with multiple parasites, and particularly in case of Loa loa infection. The following side effects 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 side effects occur, medical advice should be sought immediately.

Other side effects

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

The following side effects depend on the condition being treated with POSELA and also on whether the patient has any other infections.
Patients with intestinal strongyloidiasis ( anguillulosis ) may experience the following side effects:

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

Patients with microfilaraemia caused by lymphatic filariasis due to Wuchereria bancrofti may experience the following side effects:

• 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
• breathing discomfort
• 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 side effects:

• 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 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 bladder or bowels
• difficulty standing or walking
• changes in mental state
• drowsiness or confusion
• lack of response to others 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 hands, ankles or feet
• diarrhoea
• dizziness
• low blood pressure (hypotension). Upon standing, you may feel dizzy or lightheaded
• 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 side effects
If any side effects occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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 side effects helps to provide more information on the safety of this medicine.

5. How to store the medicine 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 stated month.
Store below 25°C, in the original packaging to protect from light.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. 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 maize starch, butylated hydroxyanisole (E 320), magnesium stearate (E 470b).

What Posela looks like and contents of the pack
This medicine is a round, white or almost white, flat bevelled tablet.
The pack contains 4 or 8 tablets.
For further information, please contact the marketing authorisation holder or parallel importer.
Marketing authorisation holder in Italy, 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 in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Italy, country of export: 048540025
Parallel import licence number: 257/24