Ovixan

Package Leaflet: Information for the User

Ovixan, 1 mg/g, skin solution
mometasone furoate

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

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

1. What is Ovixan and what is it used for

Ovixan contains the active substance mometasone furoate and is a corticosteroid for skin use. Corticosteroids for skin use are divided into four classes depending on their potency and effect: mild effect, moderate effect, potent effect, and very potent effect.
Mometasone furoate belongs to the class of "potent corticosteroids".
Adults and children over 2 years:
Ovixan has anti-inflammatory and anti-itching effects. Ovixan is used to reduce symptoms associated with inflammatory skin diseases that can be treated with corticosteroids, such as psoriasis (except for widespread psoriasis vulgaris) and some types of dermatitis. The medicine does not cure the skin disease, but relieves its symptoms.

2. Important information before using Ovixan

When not to use Ovixan

• on wounds and skin ulcers.

Warnings and precautions

• Tell your doctor if you are pregnant, think you may be pregnant, or are breastfeeding.
• Inform your doctor immediately if you experience irritation or hypersensitivity during the use of Ovixan.
• As with all potent topical corticosteroids, do not stop treatment abruptly. Stopping long-term treatment may cause a relapse of the disease in the form of skin inflammation with severe redness, stinging, and burning. This can be prevented by gradually reducing the treatment, e.g. by applying the solution less frequently before stopping the treatment.
• Treatment of psoriasis with this medicine may cause worsening of skin symptoms (e.g. a pustular form of the disease may appear with numerous small ulcers on the skin). The doctor must regularly monitor the occurrence of skin problems in the patient, as this type of treatment requires close observation.
• Ovixan should not be used on damaged skin.
• Do not apply the solution to the eyelids. Be careful not to get the solution into your eyes.
• If you experience blurred vision or other vision disturbances, contact your doctor.

Ovixan and other medicines

Tell your doctor or pharmacist about all medicines you are taking, or have recently taken, and about medicines you plan to take.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before using this medicine.
Treatment with Ovixan during pregnancy or breastfeeding may only be initiated on the advice of a doctor.
If your doctor advises you to use the solution during pregnancy or breastfeeding, avoid using large amounts and use the solution only for a short time. Do not apply Ovixan to the breasts or surrounding skin areas during breastfeeding.
Before using Ovixan, ask your doctor, pharmacist, or nurse for advice.

Ovixan contains propylene glycol (E1520)

This medicine contains 300 mg of propylene glycol (E1520) per 1 gram of skin solution, which corresponds to 279 mg of propylene glycol per 1 milliliter of skin solution. Propylene glycol may cause skin irritation.

3. How to use Ovixan

Ovixan can only be used on the skin.

• Always use this medicine exactly as your doctor or pharmacist has told you. If you are not sure, check with your doctor or pharmacist.
• Your doctor should regularly monitor your treatment.
• Do not use the solution on the face unless your doctor has told you to.
• Avoid getting the solution into your eyes.
• Unless your doctor has told you to, do not cover the treated skin areas with bandages or dressings. This is to reduce the risk of side effects.

Dosage:

Once a day, carefully apply a thin layer of the solution to the affected skin areas. Use only a small amount of the solution. The bottle has a dropper that makes it easier to dose the solution. Never use more than the dose your doctor has prescribed, and do not apply the solution more often than your doctor has told you to.

Adults, including the elderly:

Do not use the solution on large skin areas (more than 20% of the skin surface) or for a long period of time.

Use in children (aged 2 and over):

• Do not use the solution in children over 2 years of age without consulting a doctor.
• Do not use the solution on a skin surface exceeding 10% of the child's body surface.

Children under 2 years:

Ovixan is not recommended for use in children under 2 years of age.

If you use more Ovixan than you should

If you accidentally swallow the solution, it will cause side effects.
If you have not followed your doctor's instructions and have used the solution too frequently and/or for too long, consult your doctor or pharmacist.

Forget to use Ovixan

If you forget to apply the solution at the scheduled time, do so as soon as possible, and then continue with the prescribed dosage. Do not use a double dose or use the solution twice a day to make up for the missed dose.

Stopping Ovixan

If the solution has been used for a long time, do not stop using it abruptly, as this may harm you. Gradually reduce the dose of the medicine as advised by your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Ovixan can cause side effects, although not everybody gets them.
Side effects in children and adults reported during topical use of corticosteroids include:
Very rare (may affect up to 1 in 10,000 people):

• Folliculitis
• Itching
• Dilation of superficial blood vessels or spider veins
• Burning sensation

Not known (frequency cannot be estimated from the available data):

• Pain or other reactions at the application site
• Secondary infections (infections that occur during or after treatment of another infection or disease)
• Paresthesia (abnormal skin sensations or numbness)
• Blurred vision
• Changes in skin pigmentation
• Maceration of the skin (softening and whitening of the skin)
• Pruritus (itching that causes intense scratching)
• Acne-like skin inflammation
• Thinning of the skin
• Irregular spots or lines on the skin
• Excessive hair growth
• Hypersensitivity to mometasone
• Perioral dermatitis
• Recurring, deep folliculitis (furunculosis)
• Allergic contact dermatitis
• Skin irritation and dryness
• Rosacea-like skin inflammation on the face with redness, swelling, and blisters on the cheeks and nose
• Non-raised blue or purple spots on the skin (ecchymoses).

Increased use, treatment of large skin areas, long-term use, and use under occlusive dressings may increase the risk of side effects.
Corticosteroids may affect the normal production of hormones in the body. This is more likely to occur with long-term use of high doses.

Additional side effects in children

Especially in children treated with solutions, creams, and ointments containing corticosteroids, absorption of the medicine through the skin may occur, leading to a condition called Cushing's syndrome, which includes many symptoms, including moon face and weakness.
During long-term use in children, growth retardation may occur. The doctor will help avoid this risk by prescribing the smallest effective dose of corticosteroid to treat the patient's symptoms under control.

Reporting side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. Side effects can be reported directly to the Department of Pharmacovigilance 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, website: https://smz.ezdrowie.gov.pl.
Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ovixan

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and carton after "EXP". The expiry date refers to the last day of that month.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Ovixan contains

• The active substance is mometasone furoate. One gram of Ovixan skin solution contains 1 mg of mometasone furoate.
• The other ingredients are: propylene glycol (E1520), isopropyl alcohol, hydroxypropylcellulose, sodium dihydrogen phosphate dihydrate, concentrated phosphoric acid (for pH adjustment), and purified water.

See also section 2 "Ovixan contains propylene glycol (E1520)".

What Ovixan looks like and contents of the pack

Ovixan, 1 mg/g, skin solution is a colorless or slightly yellowish solution with low viscosity in a white polyethylene bottle with a dropper and a white polyethylene cap with a tamper-evident closure, in a cardboard box.
Pack sizes: 30 ml, 100 ml, and 2 x 100 ml
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Reig Jofre Sp. z o.o.
ul. Ostródzka 74N
03-289 Warsaw
Poland
e-mail: [email protected]
Manufacturer
Laboratorio Reig Jofré S.A.
Gran Capitán 10
Sant Joan Despí
08970 Barcelona
Spain
Lichtenheldt GmbH – Werk I
Industriestraße 7 - 11
23812 Wahlstedt
Germany

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of the leaflet:06.2025

Other sources of information

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: www.urpl.gov.pl