OXSORALEN 10 mg Capsules

Contents of the leaflet

1. Leaflet included in the packaging: patient information
   1. Table of contents of the leaflet:
2. What is Oxsoralen and what is it used for
   1. Indications
3. Important information before taking Oxsoralen
   1. When not to take Oxsoralen:
   2. Warnings and precautions
   3. Children and adolescents
   4. Oxsoralen and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Oxsoralen contains sorbitol
4. How to take Oxsoralen
   1. Use in children and adolescents
   2. Description of PUVA procedures:
   3. Using a higher dose of Oxsoralen than recommended
   4. Missing a dose of Oxsoralen
5. Possible side effects
   1. Reporting side effects
6. How to store Oxsoralen
7. Contents of the packaging and other information
   1. What Oxsoralen contains
   2. Marketing authorization holder and manufacturer

Leaflet included in the packaging: patient information

Oxsoralen,10 mg, soft capsules
(8-Methoxypsoralen)
You should carefully read the contents of the leaflet before taking the medicine, as it contains
important information for the patient.

• You should keep this leafletso that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to you for a specific reason. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Oxsoralen and what is it used for

Oxsoralen is a soft capsule containing the active substance methoxsalen, which inhibits excessive proliferation of skin cells. Methoxsalen does not work alone - it is activated by long-wave UV radiation (ultraviolet radiation) emitted by special lamps or by sunlight.

Indications

Oxsoralen is indicated for the treatment of severe psoriasis (as part of so-called PUVA therapy). PUVA photochemotherapy (PUVA = Psoralen + UV-A) is a treatment that involves taking capsules prescribed by a doctor, followed by exposure to UV-A radiation emitted by special lamps (see also section 3. How to take Oxsoralen).

2. Important information before taking Oxsoralen

When not to take Oxsoralen:

• during pregnancy or breastfeeding

Warnings and precautions

Before starting treatment with Oxsoralen, you should discuss it with your doctor or pharmacist. You should inform your doctor before taking Oxsoralen:

• tar therapy
• therapy with arsenic preparations
• therapy with UV-B or X-ray radiation
• PUVA therapy may be used in the following cases, only if the doctor decides that it is absolutely necessary

PUVA therapy can only be performed by specialized centers with trained personnel and appropriate equipment. During treatment with Oxsoralen, sexually active men and women of childbearing age should use effective contraceptive methods. You should carefully follow the doctor's instructions, including all required tests (eyes, blood morphology, liver and kidney function). There is a suspicion that in patients with epilepsy, the flickering of fluorescent UV-A lamps may trigger seizures. How to avoid skin and eye damage Oxsoralen causes the skin all over the body to become more sensitive to sunlight (UV-A radiation) or artificial light with similar properties to sunlight. A mild skin reaction (redness) is a desired effect and indicates that the treatment is working. Discomfort after exposure can be alleviated by using moisturizing creams or lotions. Daylight also contains a certain amount of long-wave UV radiation, so you should take precautions during treatment with Oxsoralen to minimize the risk of side effects, especially on the eyes and skin. You should avoid prolonged exposure to the sun and UV radiation, even through window glass. If unprotected skin is exposed to sunlight (even in the shade) after taking Oxsoralen, it can cause severe sunburn. You should avoid prolonged exposure to the sun and UV radiation, even through window glass, for 24 hours before and at least 8 hours after taking Oxsoralen. You should not sunbathe during the entire treatment period. Oxsoralen should not be used as a tanning aid. Using the medicine contrary to its intended use may lead to life-threatening sunburn, skin damage, and increased risk of skin cancer. In men, the external genitalia should be carefully covered during exposure, due to the risk of squamous cell skin cancer in these areas of the body. In women, the genitalia should be covered if exposure occurs in a lying position. To protect the eyes, due to the risk of damage, you should wear well-fitting sunglasses that protect against UV-A radiation for at least the first 8 hours after taking Oxsoralen. You should inform your doctor about kidney function disorders, as this may require a longer period of protection from sunlight than recommended for all patients.

Children and adolescents

Oxsoralen is contraindicated in children under 12 years of age (see "When not to take Oxsoralen").

Oxsoralen and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine. You should not take Oxsoralen during pregnancy or breastfeeding. If you become pregnant, treatment with Oxsoralen should be discontinued. It can be resumed only after the breastfeeding period.

Driving and using machines

Oxsoralen has no or negligible influence on the ability to drive and use machines.

Oxsoralen contains sorbitol

Anidrisorb, one of the components of the capsule shell, contains sorbitol. If you have previously been diagnosed with intolerance to certain sugars, you should consult your doctor before taking the medicine.

3. How to take Oxsoralen

This medicine should always be taken according to the doctor's or pharmacist's instructions. In case of doubts, you should consult a doctor or pharmacist. PUVA therapy with Oxsoralen and UV-A radiation can only be performed by medical personnel specially trained for this purpose and having access to appropriate equipment. Dosage If the doctor does not recommend otherwise, the recommended dose is:

Body weight

Oxsoralen dose

up to 40 kg 1 capsule (10 mg)

• 40-50 kg 2 capsules (20 mg)
• 50-60 kg 3 capsules (30 mg) over 60 kg 4 to a maximum of 5 capsules (40 mg, maximum up to 50 mg)

In patients who show low sensitivity to UV radiation, the doctor may decide to increase the dose to avoid too long exposure.

Use in children and adolescents

Oxsoralen is contraindicated in children under 12 years of age. Method of administration

Description of PUVA procedures:

Before starting therapy, a proper sensitivity test to light is necessary to determine the appropriate dose of radiation and exposure time. Before the test, you should take the prescribed dose of Oxsoralen exactly at the time specified by the doctor. After an hour of taking the capsule, exposure to a small dose of UV-A radiation begins. Then, the patient is exposed to increasing doses of UV-A radiation until a slight redness of the skin indicates that the treatment has started. The determined radiation dose will be used during treatment, unless the doctor decides that it is necessary to adjust the radiation dose. Oxsoralen capsules should be taken with a glass of milk or with food. Exposure to UV-A radiation begins about 1 hour after taking the capsule. During exposure to UV-A radiation, the eyes must be completely covered with a shield that does not allow any light to pass through (see also "How to avoid skin and eye damage" in section 2). Duration of treatment At the beginning of treatment, it should be performed once a day, no more than four times a week. First, you should take the prescribed dose of Oxsoralen. Then, after an hour, UV-A radiation exposure follows. After two consecutive days of exposure, a one-day break in treatment is necessary - one day without the procedure is required. If there is a need to change the exposure dose, the doctor may recommend repeating the sensitivity tests. The doctor will individually determine the breaks in treatment and the total duration of therapy.

Using a higher dose of Oxsoralen than recommended

Acute overdose of the medicine causes nausea, severe vomiting, and dizziness. You should induce vomiting and stay in a dark room for at least 24 hours. Monitoring of cardiovascular system function is recommended.

Missing a dose of Oxsoralen

Since Oxsoralen capsules are part of PUVA therapy, you should inform your doctor before exposure that the prescribed dose of the medicine has been missed. You should not take a double dose of the medicine. In case of questions about the medicine, you should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Oxsoralen can cause side effects, although not everybody gets them. Uncommon(may occur in less than 1 in 100 people):

• headache, nervousness, insomnia
• nausea and vomiting immediately after taking Oxsoralen; this effect may be reduced by taking the medicine with milk or food
• reactions to light, such as redness, rash, and itching after exposure. If redness is more severe or blisters appear, you should inform your doctor before the next exposure. Overdose of UV-A radiation can cause sunburn, and in severe cases, blisters and redness.

Rare(may occur in less than 1 in 1000 people):

• discoloration of hair, which is completely reversible after stopping treatment

Very rare(may occur in less than 1 in 10,000 people):

• changes in blood test results (especially during long-term treatment)
• kidney damage (especially during long-term treatment)
• liver damage (especially during long-term treatment)

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

• During long-term therapy, excessive keratinization of the skin, premature aging of the skin, and skin spots occur.

The risk of skin cancer increases. This is especially true for external male genitalia, but it cannot be ruled out in women (see also "How to avoid skin and eye damage" in section 2).

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should inform your doctor or pharmacist. 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 Al. Jerozolimskie 181 C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 e-mail: [email protected] Thanks to reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Oxsoralen

Store in a temperature below 30°C. Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the given month. Medicines should not be disposed of via wastewater or household waste. You should ask your 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 Oxsoralen contains

• The medicine contains the active substance methoxsalen. One soft capsule contains 10 mg of methoxsalen.
• Other ingredients of the medicine are: Macrogol 400 Propylene glycol Gelatin Glycerol 85% Titanium dioxide (E171) Anidrisorb 85/70: sorbitol, sorbitan, mannitol, superior Polyols.

What Oxsoralen looks like and what the packaging contains: The medicine is in the form of soft capsules. The packaging contains 50 soft capsules (5 blisters Al/PVC/PVDC containing 10 capsules each), placed in a cardboard box.

Marketing authorization holder and manufacturer

G.L. Pharma GmbH Schloßplatz 1 A-8502 Lannach Austria G.L. Pharma GmbH Sp. z o.o. Branch in Poland Al. Jana Pawła II 61 01-031 Warsaw Poland Tel: 022/ 636 52 23; 636 53 02 Fax: 022/ 636 50 76