Posela

Patient Information Leaflet

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 for the same medicinal product.
Please read this leaflet carefully before taking this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please 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 other people, 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, pharmacist, or nurse. 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 called ivermectin. It is a medicine used to treat infections caused by certain parasites.
It is used to treat:

• Intestinal infection called intestinal strongyloidiasis (also known as anguillulosis) caused by the parasite Strongyloides stercoralis.
• Blood infection called microfilaraemia caused by lymphatic filariasis, which is 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 parasites.
• Skin infestation with mites (scabies), which may be present in 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 parasites.
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, skin peeling, blisters, or mouth ulcers.

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• If any of the above situations apply, the patient should not take POSELA.

If in doubt, consult a doctor or pharmacist before starting treatment with POSELA.
Warnings and precautions
Discuss with your doctor before starting treatment with POSELA.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred with ivermectin treatment. Ivermectin should be discontinued and immediate medical attention sought 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 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 reactions.

If any of the above apply to the patient (or the patient is unsure), they should discuss this 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.
POSELA with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available 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 should inform her doctor immediately before using 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 operating machinery
After taking this medicine, the patient may experience dizziness, somnolence, tremor, or vertigo.
If such symptoms occur, the patient should avoid driving and operating machinery.

3. How to take POSELA

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This medicine should always be taken exactly as prescribed by your doctor or pharmacist.
If in doubt, consult your doctor or pharmacist.

Taking this medicine

• This medicine is taken orally.
• For 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 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 DOSE when administered DOSE when administered
(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 body weight cannot be determined, the dose of ivermectin should be based on the patient's height:
HEIGHT DOSE when administered DOSE when administered
(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.

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

If you feel 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. In some patients, taking an excessive amount of this medicine has led to 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 about using this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences 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 rashes on the trunk, often with blisters in the center, peeling of the skin, and mucosal ulcers in the mouth, throat, nose, genital organs, and around the eyes. Such severe skin reactions 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 those infected with Loa loa. 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 concentration, increased eosinophil count)
• Blood in the urine
• Impaired consciousness or coma.

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

• Unusual weakness
• Loss of appetite, abdominal pain, constipation, or diarrhea
• Nausea or vomiting
• Drowsiness or dizziness
• Chills
  In addition, adult worms may be present in the stool in cases of intestinal strongyloidiasis (angiostrongyloidiasis).

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
• Lack of response to others or falling into a 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 the hands, ankles, or feet
• Diarrhea
• Dizziness
• Low blood pressure (hypotension). You may feel dizzy or lightheaded when standing up
• Rapid heartbeat
• Headache or feeling tired
• 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 adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring 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 helps provide more information on the safety of this medicine.

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5. How to store the medicine POSELA

Keep this medicine 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 stated month.
Store below 25°C.
Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging 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 corn starch, 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, flat bevelled tablet.
The pack contains 4, 8, 12, 16 or 20 tablets.
For more detailed information, please contact the responsible party 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:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in the Netherlands, country of export: RVG 120488
Parallel import licence number: 254/23
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