Patient Information Leaflet

SORA FORTE, 10 mg/ml, medicated shampoo
Permethrinum
Please read all of this leaflet carefully before using this medicine, as it contains important information for you.
This medicine should always be used exactly as described in this patient leaflet or as directed by your doctor, pharmacist, or nurse.

Keep this leaflet, as you may need to read it again.
If you need advice or further information, please consult your pharmacist.
If you experience any side effects, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
If there is no improvement after 14 days (live lice are still present) or if your condition worsens, consult your doctor.

Table of Contents

What Sora Forte is and what it is used for
Important information before using Sora Forte
How to use Sora Forte
Possible side effects
How to store Sora Forte
Contents of the pack and other information

1. What Sora Forte is and what it is used for

Sora Forte is a medicated shampoo for external use on the scalp hair, intended for the treatment of head lice infestation. It is used therapeutically in cases of head lice to eliminate parasites, and also prophylactically in individuals who have had direct contact with persons diagnosed with head lice.
Indications
Head lice infestation in adults and children over 3 years of age.
Approximately 10 days after the first treatment, the course should be repeated. If live parasites are still present after the second application, consult your doctor, who will decide whether to continue treatment with another medicinal product.

2. Important information before using Sora Forte

When not to use Sora Forte:

if the patient is allergic to permethrin, other pyrethroids, pyrethrins, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before starting treatment with Sora Forte, discuss it with your doctor or pharmacist.

If the patient is known to be allergic to chrysanthemums or other plants of the Asteraceae family, Sora Forte should only be used after consulting a doctor.
If the patient has symptoms of hypersensitivity (allergy) or a tendency towards allergies, this medicine should not be used.
Sora Forte is intended for external use only.
The medicine should be applied to scalp hair only.
Do not use on eyebrows, eyelashes, or in case of pubic lice.
Sora Forte may cause eye and mucous membrane irritation. Contact of the medicine and the foam formed with the eyes should be avoided. If the medicine or foam comes into contact with the eyes, rinse thoroughly with water. If skin irritation occurs, discontinue use and wash the affected areas thoroughly with plenty of water.
In individuals frequently using Sora Forte (e.g. medical personnel), the use of protective gloves is recommended.

Children
Sora Forte should not be used in children under 3 years of age.
Sora Forte and other medicines
Inform your doctor or pharmacist about all medicines currently used, recently used, or planned to be used.
No studies on interactions between Sora Forte and other medicines have been conducted.
Do not use simultaneously with other medicines used for the treatment of lice infestation.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicine.
As a precautionary measure, Sora Forte should not be used during pregnancy unless recommended by a doctor.
The decision on using Sora Forte during breastfeeding should be made exclusively by a doctor.
Driving and operating machinery
Sora Forte has no effect on the ability to drive or operate machinery.
Sora Forte contains propylene glycol, methyl parahydroxybenzoate and propyl parahydroxybenzoate
The medicine contains 3.675 – 4.095 mg of propylene glycol in each gram of product, which may cause skin irritation.
The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (delayed-type reactions possible).

3. How to use Sora Forte medicine

This medicine should always be used exactly as described in this patient information leaflet or as directed by your doctor, pharmacist, or nurse. If in doubt, consult your doctor, pharmacist, or nurse.

Adults and children over 3 years of age
Sora Forte should be used as follows:

Shake the tube several times before use.
Apply an appropriate amount of shampoo to damp hair, depending on hair length and thickness, so as to thoroughly saturate the hair and scalp. Then spread the shampoo evenly, paying particular attention to the areas behind the ears and at the back of the head. A volume of 50 ml is generally considered sufficient for washing medium-length hair (hair reaching the shoulders).
Massage the hair until a rich lather forms.
To enhance effectiveness, a disposable shower cap may be placed over the shampooed hair.
Leave the lather on the hair for 10 minutes.
Rinse hair thoroughly with water.
Carefully comb the hair with the comb provided in the package to remove dead lice and their eggs (nits).

Duration of treatment
After applying the shampoo, lice may still move for up to 24 hours. This is a sign of the nervous system of the parasite being affected by permethrin, not an indication of treatment failure.
If live lice are found 7–10 days after permethrin treatment, the treatment should be repeated.
If live lice are still present 14–20 days after treatment, consult your doctor, who will consider appropriate alternative treatment options.
Concurrently with treatment, measures should be taken to eliminate lice from clothing and the surrounding environment.

Use in children under 3 years of age
Do not use in children under 3 years of age due to insufficient safety data.

Use of more than the recommended dose of Sora Forte
If more than the recommended dose of Sora Forte is used or if the product is ingested, consult a doctor.

Discontinuing use of Sora Forte
If you have any further doubts regarding the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like any medicine, this product may cause adverse reactions, although not everyone will experience them.
Common (may occur in less than 1 in 10 people):

itching, redness, rash.

Frequency not known (cannot be estimated based on available data):

transient and mild skin reactions, most commonly as burning or itching;
disturbances in skin sensation (paresthesia), such as tingling, pricking, or burning of the skin;
excitation, muscle tremor, skin hypersensitivity (these symptoms resolved within 24 hours).

Adverse reactions observed in individuals undergoing treatments with permethrin (e.g.
medical personnel) were related to the effect of permethrin on the nervous system.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions 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 at 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sora Forte

Keep the medicine out of the sight and reach of children.
Store below 25°C. Keep in the original, tightly closed tube.
Do not use this medicine after the expiry date stated on the cardboard box and tube.
The expiry date refers to the last day of the specified month.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the package and other information

What Sora Forte contains

The active substance is permethrin.
1 ml of shampoo contains 10 mg of permethrin.
The other ingredients are: sodium laureth sulfate, cocamidopropyl betaine, cocofatty acid diethanolamide, isopropyl alcohol, propylene glycol, diazolidinyl urea, methylparaben (E 218), propylparaben (E 216), citric acid monohydrate, sodium citrate, glycol distearate, cocofatty acid monoethanolamide, lauryl alcohol ethoxylate 10, hydrogenated castor oil, lauryl alcohol ethoxylate 2, fragrance composition, purified water.

What Sora Forte looks like and contents of the pack
Sora Forte is a medicinal shampoo, in the form of a white or cream-colored, pearly, homogeneous, thick gel.
The packaging consists of a PE laminate tube, fitted with an LDPE collar, sealed with an aluminum membrane and a PP/PE cap, containing 50 ml of medicinal shampoo, packed in a cardboard box.
A polypropylene hygienic comb with a single-sided row of teeth made of stainless steel is included in the package.

Marketing authorisation holder and manufacturer
Aflofarm Farmacja Polska Sp. z o.o.
ul. Partyzancka 133/151
95-200 Pabianice
Tel. +48 42 22-53-100

The following information is intended exclusively for medical personnel or healthcare professionals:
When handling permethrin, the active substance in Sora Forte (e.g. medical personnel), the use of protective gloves is recommended. In such individuals, adverse effects related to the action of permethrin on the nervous system have been observed, usually manifesting as a sensation of body or skin numbness, excitation, muscle tremors, skin hypersensitivity, mild itching, and burning. These symptoms resolved within 24 hours.