Sora Forte

Leaflet attached to the packaging: patient information

SORA FORTE 10 mg/ml, medicinal shampoo
Permethrinum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist or nurse.

• This leaflet should be kept in case it needs to be read again.
• If advice or additional information is needed, a pharmacist should be consulted.
• If the patient experiences any side effects, including any possible side effects not listed in the leaflet, they should inform their doctor or pharmacist or nurse. See section 4.
• If there is no improvement or the patient feels worse, they should contact their doctor.

Table of contents of the leaflet

• 1. What is Sora forte and what is it used for
• 2. Important information before using Sora forte
• 3. How to use Sora forte
• 4. Possible side effects
• 5. How to store Sora forte
• 6. Contents of the packaging and other information

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

Sora forte is a medicinal shampoo for external use on the hair of the head in cases of pediculosis. The medicine is used therapeutically in head lice infestations to remove parasites, as well as prophylactically in people who have direct contact with individuals diagnosed with head lice infestations.

Indications for use

Head lice infestations in adults and children over 3 years of age.
After about 10 days from the first treatment, the treatment should be repeated. If live parasites are found after the repeated treatment, a doctor should be consulted to decide on continuing treatment with another medicine.

2. Important information before using Sora forte

When not to use Sora forte:

Warnings and precautions

Before starting to use Sora forte, the patient should discuss it with their doctor or pharmacist.

• If the patient knows they are allergic to chrysanthemums or other plants of the asteraceae family, they should use Sora forte only after discussing it with their doctor.
• If the patient has symptoms of hypersensitivity (allergy) or a tendency to allergies, they should not use this medicine.
• Sora forte is intended for external use only.
• The medicine should be used only on the hair of the head.
• Do not use on eyebrows, eyelashes, or in pubic lice infestations.
• The medicine may cause eye and mucous membrane irritation. Contact between the medicine and the eyes, as well as the foam produced, should be avoided. If the medicine or foam comes into contact with the eyes, they should be rinsed thoroughly with water. If skin irritation symptoms occur, the use of the medicine should be discontinued, and the irritated areas should be rinsed with a large amount of water.
• For people who frequently use Sora forte (e.g., medical personnel), the use of protective gloves is recommended.

Children

The medicine should not be used in children under 3 years of age.

Sora forte and other medicines

The patient should inform their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
No studies have been conducted on the interaction of Sora forte with other medicines.
Do not use simultaneously with other medicines used to treat lice infestations.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before using this medicine.
As a precaution, Sora forte should not be used in pregnant women unless its use is recommended by a doctor.
Only a doctor can decide on the use of Sora forte during breastfeeding.

Driving and using machines

Sora forte does not affect 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 per gram of medicine, which may cause skin irritation.
The medicine contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possible late reactions).

3. How to use Sora forte

This medicine should always be used exactly as described in the patient leaflet or as directed by a doctor or pharmacist or nurse. In case of doubts, the patient should consult their doctor or pharmacist or nurse.
Adults and children over 3 years of age.
Sora forte is used as follows:

• Before using the medicine, the tube should be shaken several times.
• A sufficient amount of shampoo should be applied to the damp hair of the head, depending on the length and density of the hair, to thoroughly saturate the hair and scalp. The shampoo should then be evenly distributed, paying particular attention to the area behind the ears and the back of the head. It is assumed that 50 ml is sufficient to wash hair of medium length (hair to the shoulders).
• The hair should be massaged until a rich lather is obtained.
• To increase the effectiveness of the treatment, a single-use cap can be placed on the hair covered with shampoo.
• The resulting foam should be left on the hair for 10 minutes.
• Rinse the hair with water.
• Carefully comb the hair with the comb provided with the packaging to remove dead lice and eggs (nits).

Duration of use
After using the shampoo, lice may still move for 24 hours, which is a sign of the nervous system of the parasite being affected by permethrin, and not a sign of treatment ineffectiveness.
If live lice are found after 7-10 days of permethrin treatment, the treatment should be repeated.
If live lice are still found after 14-20 days, the patient should consult their doctor to consider alternative treatment options.
In parallel with the treatments, measures should be taken to remove lice from clothing and the environment.
Use in children under 3 years of age.
Do not use in children under 3 years of age due to insufficient data on safety.

Using more than the recommended dose of Sora forte

In case of using more than the recommended dose of Sora forte or ingesting the medicine, the patient should consult their doctor.

Stopping the use of Sora forte

In case of any further doubts about the use of this medicine, the patient should consult their doctor or pharmacist or nurse.

4. Possible side effects

Like all medicines, Sora forte can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people):

• itching, redness, rash.

Frequency not known(cannot be estimated from the available data):

• transient and mild skin reactions, most often in the form of burning, itching;
• disorders of skin sensation (paresthesia), such as tingling, pricking, burning of the skin;
• excitement, muscle tremors, skin hypersensitivity (these symptoms usually resolved within 24 hours).

Side effects observed in people who frequently use Sora forte (e.g., medical personnel) were related to the effect of permethrin on the nervous system.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should inform their doctor or pharmacist or nurse.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C,
02-222 Warsaw,
phone: 22 49-21-301,
fax: 22 49-21-309,
Website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Sora forte

The medicine should be stored out of sight and reach of children.
Store at a temperature below 25°C. Store in the original, tightly closed tube.
Do not use this medicine after the expiry date stated on the carton and tube.
The expiry date refers to the last day of the month.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Sora forte contains

• The active substance of the medicine is permethrin.
• 1 ml of shampoo contains 10 mg of permethrin.
• The other ingredients are: sodium lauryl ether sulfate, cocamidopropyl betaine, diethanolamide of fatty acids of coconut oil, isopropyl alcohol, propylene glycol, diazolidinyl urea, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), citric acid monohydrate, sodium citrate, ethylene glycol distearate, monoethanolamide of fatty acids of coconut oil, lauryl alcohol ethoxylate 10, hydrogenated castor oil, lauryl alcohol ethoxylate 2, fragrance, purified water.

What Sora forte looks like and what the packaging contains

Sora forte is a medicinal shampoo in the form of a white or cream-colored, pearlescent, homogeneous, thick gel.
The packaging of the medicine is: a tube containing 50 ml of medicinal shampoo, in a cardboard box.
A hygienic comb is attached to the packaging, which facilitates the removal of dead lice and eggs (nits).

Marketing authorization holder and manufacturer

Aflofarm Farmacja Polska Sp. z o.o.
Partyzancka Street 133/151
95-200 Pabianice
Phone: (42) 22-53-100
Date of last revision of the leaflet:20.10.2022
The following information is intended for healthcare professionals or healthcare workers only:
For people who frequently use Sora forte (medical personnel), the use of protective gloves is recommended. In these individuals, effects related to the effect of permethrin on the nervous system were observed, and usually manifested as a feeling of numbness of the body or skin, excitement, muscle tremors, skin hypersensitivity, mild itching, and burning. These symptoms usually resolved within 24 hours.