Geroxalen (Oxsoralen) methoxsalen 10 Mg 50 Capsules

GEROXALEN Capsule

It is taken orally.

Active ingredient
 8-methoxypsoralen

Excipients
Titanium dioxide.

1. What GEROXALEN (Oxsoralen) is and what it is used for

It is used in the treatment of severe and very severe psoriasis vulgaris (psoriasis).

GEROXALEN is available in boxes of 50 capsules, each capsule containing 10 mg of 8-methoxypsoralen, in blisters of 10 capsules.

2. How to use GEROXALEN (Oxsoralen)?

GEROXALEN (Oxsoralen) is taken orally.

The capsule in the blister bag is pushed out and swallowed whole.

Take the capsules one hour before the UVA application, preferably with some milk or dry bread.
Instructions for proper use and dose/frequency of administration

One hour after ingestion, a light test with different UVA doses should be performed to determine the lowest dose at which the light is damaging (the lowest dose that produces a rash). This will be the first treatment dose.

Initially the treatment will be once a day, but it is often carried out four times a week. After two successful days of treatment, treatment should be interrupted for one day.

10mg 20mg 30mg

40 mg (up to 50 mg)

In patients less sensitive to UV light, the dosage may be increased to avoid prolonged exposure. The determined dosage should be taken 1 hour before UVA irradiation.

As soon as the patient is relieved of symptoms and clinical signs subside, treatment is resumed with intermittent doses: PUVA therapy is administered twice a week for the first month, then once a week for the following month. If the patient still has no symptoms at the end of these two months of treatment, the treatment may be discontinued because long-term improvement is expected in these cases.

The total dose of 8-methoxypsoralen and UV-A radiation should be kept as low as possible. Habit:

The habit has not been reported. However, due to increased pigmentation (skin discoloration) during treatment, any necessary increase in radiation dose should be made slowly and gradually. The amount and duration of dose increases should be selected based on the light test results.

If you have the impression that the effect of GEROXALEN (Oxsoralen) is too strong or weak, talk to your doctor or pharmacist.

3. What are the possible side effects?

Like all medicines, there may be side effects in people who are sensitive to the substances contained in GEROXALEN (Oxsoralen).

If you notice any of the following, tell your doctor immediately or go to the nearest hospital emergency department:

• the formation of prominent skin tumors with scaly cells (this risk is especially high in the male genital area, but female patients cannot be excluded from this rule).

Up to 40 kg 40 - 50 kg 50 - 60 kg Over 60 kg

dosage

Body weight

This side effect occurs after long-term PUVA therapy and is a serious side effect. Emergency medical attention may be required.

Geroxalen_KT_v2_0709 4

Tell your doctor if you notice any of the following:

• headache,

• irritability,

• insomnia,

• nausea,

• vomiting

• skin redness,

• skin blisters,

• itching,

• sunburn-like rashes and blistering skin rashes, including second-degree burns (only observed with overdose of UVA radiation: the dose should never be increased over two consecutive days, as these symptoms do not reach their peak until 48-72 hours after application)

• lightening of hair color (fully reversible when GEROXALEN (Oxsoralen) use is temporarily discontinued)

These are mild side effects of GEROXALEN (Oxsoralen) and these side effects are rare.

The following side effects may occur in long-term PUVA therapy:

• hyperkeratosis (excessive hardening of a layer of the skin),

• premature aging of the skin,

• the formation of color changes in the form of small spots and spots on the skin,

• occasional changes in blood count,

• liver and kidney damage.

• the risk of developing skin cancer increases. This risk is especially high in the genital area of ​​male patients. However, it should not be ignored for female patients as well.

These symptoms are also mild side effects of GEROXALEN and appear after long-term treatment.

If you notice that you are pregnant during treatment, inform your doctor immediately.

4. Things to consider before using GEROXALEN (Oxsoralen)

DO NOT USE GEROXALEN (Oxsoralen) in the following conditions

• hypersensitivity to psoralens,

• in severe liver and kidney failure,

• in diseases that cause hypersensitivity to light [porphyria (a hereditary disease characterized by the excessive presence of a substance called porphyrin in the body), xeroderma pigmentosum (a type of hereditary hypersensitivity reaction in the skin seen in childhood), polymorphous photodermatoses (a type of skin disease caused by light) ) as],

• in lupus erythematosus (a type of immune system disease),

• in albinism (congenital whiteness of the skin, especially the hair)

• in invasive melanoma (malignant tumor with disseminated dark color on the skin) or skin tumors with scaly cells,