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
Ivermectinum
Posela and Ivermectin Substipharm are different trade names for the same medicine
Please read all of this leaflet carefully before taking this medicine, because it contains information important 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. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Leaflet 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 a substance called ivermectin. It is a medicine used to treat infections caused by certain parasites.
It is used to treat:

• Intestinal infection called strongyloidiasis (also known as anguillulosis) caused by the parasite Strongyloides stercoralis.
• Blood infection called microfilaria due to "lymphatic filariasis" caused by 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 mites (scabies), which may infest 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 does 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 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 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 occurred with ivermectin treatment. Treatment with ivermectin must be stopped and immediate medical help 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
• the patient lives or has lived in an area of Africa where human infection with the parasite Loa loa, also known as the eye worm, occurs
• the patient currently lives or has lived in an area 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 (or if the patient is unsure), the patient should talk to a doctor or pharmacist before taking Posela.

Children

The safety of Posela in children weighing less than 15 kg has not been established.

Posela and other medicines

Tell your doctor or pharmacist if the patient is taking, has recently taken or might take any other medicines, including those obtained without a prescription.

Taking Posela with food, drink or alcohol

Not applicable.

Pregnancy and breastfeeding

• If the patient is pregnant or suspects she may be pregnant, she must 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 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

This medicine should always be taken as directed by your doctor or pharmacist. If you have any
doubts, consult your doctor or pharmacist.
Taking this medicine

• This medicine should be 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 and 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 microfilaria 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.
• 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 Posela than prescribed
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 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 will experience them.
The patient should stop taking ivermectin and seek medical help immediately if they notice any of the following symptoms:

• Red, flat, disc-shaped or circular rashes on the trunk, often with blisters in the centre, peeling of the skin, and ulcers in the mouth, throat, nose, genital organs, and around the eyes. Such severe 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 occurrence is higher in individuals infected with multiple parasites, and particularly in cases of Loa loa infection. The following adverse reactions may occur during treatment with this medicine:

Allergic reactions
If the patient experiences an allergic reaction, they should seek medical advice 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, the patient should seek medical advice 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
• disturbances of consciousness or coma.

The following adverse reactions depend on the indication for which Posela is used, as well as on whether the patient has any other infections.

Individuals 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, in cases of intestinal strongyloidiasis (anguillulosis), adult worms may be present in the stool.

Individuals 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 aches
• 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.

Individuals with scabies may experience the following adverse reactions:

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

Individuals 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 falling into a coma.

Individuals 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
• 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, the patient should inform their doctor or pharmacist. 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.

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 blister and the outer carton. The expiry date refers to the last day of the stated month.
Do not store above 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 corn starch, butylhydroxyanisole (E 320), magnesium stearate (E 470b). What Posela looks like and contents of the pack This medicine is in the form of a round, white or almost white, flat-faced tablet. The pack contains 4, 8, 12, 16 or 20 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
Marketing authorisation number in Spain, country of export: RVG 120488
Parallel import authorisation number: 242/25