Ovixan

Package leaflet: Information for the user

Ovixan, 1 mg/g, cutaneous solution
mometasone furoate
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Ovixan is and what it is 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 Ovixan is and what it is used for

Ovixan contains the active substance mometasone furoate and is a corticosteroid for topical use. Topical corticosteroids are divided into four classes according to their potency and effect: mild, moderate, potent, and very potent. Mometasone furoate belongs to the class of "potent corticosteroids".
Adults and children over 2 years of age:
Ovixan has anti-inflammatory and anti-pruritic effects. Ovixan is used to reduce symptoms associated with inflammatory skin diseases that can be treated with corticosteroids, such as psoriasis (excluding extensive plaque psoriasis) and certain types of dermatitis. Ovixan does not cure the skin disease but relieves its symptoms.

2. Information before using Ovixan

When not to use Ovixan

• if the patient is allergic to mometasone furoate, other corticosteroids, or any of the other ingredients of this medicine (listed in section 6).
• in case of other skin diseases which may worsen, particularly rosacea (a skin condition of the face), acne, perioral rash (inflammation of the skin), skin atrophy, genital and anal itching, diaper dermatitis, bacterial infections such as impetigo, tuberculosis (lung disease), syphilis (sexually transmitted disease), viral infections such as oral ulceration, shingles, chickenpox, athlete's foot (red, itchy and peeling skin on the feet), or Candida genital infection which may cause discharge and itching, or other skin conditions.
• if the patient has recently experienced adverse reactions after vaccination (e.g. against influenza).
• on wounds and skin ulcers.

Warnings and precautions

• Tell your doctor if the patient is pregnant, suspects she may be pregnant, or is breastfeeding.
• Inform your doctor immediately if the patient experiences irritation or hypersensitivity during use of Ovixan.
• As with all potent topical corticosteroids, treatment should not be stopped abruptly. After long-term treatment, discontinuation may lead to recurrence of the skin condition with severe redness, stinging and burning. This can be prevented by gradually reducing treatment, for example by applying the solution less frequently before stopping treatment.
• Treatment of psoriasis with this medicine may cause worsening of skin symptoms (e.g. pustular form of the disease with numerous small skin ulcers). The doctor must regularly monitor the patient for skin problems, as this type of treatment requires close observation.
• Ovixan should not be used on damaged skin.
• Do not apply the solution to the eyelids. Care should be taken to avoid contact of the solution with the eyes.
• If the patient experiences blurred vision or other visual disturbances, consult a doctor.

Ovixan with other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
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 a doctor or pharmacist before using this medicine.
Treatment with Ovixan during pregnancy or breastfeeding should only be initiated on a doctor's advice.
If a doctor prescribes the use of the solution during pregnancy or breastfeeding, large amounts should be avoided and the solution should be used only for a short period. Do not use Ovixan on the breasts or adjacent skin areas during breastfeeding.
Before using Ovixan, consult a doctor, pharmacist, or nurse.
Ovixan contains propylene glycol (E1520)
This medicine contains 300 mg of propylene glycol (E1520) per 1 gram of topical solution, equivalent to 279 mg of propylene glycol per 1 millilitre of topical solution. Propylene glycol may cause skin irritation.

3. How to use Ovixan

Ovixan should only be applied to the skin.

• This medicine should always be used as directed by a doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
• Your doctor should monitor your treatment regularly.
• Do not apply the solution to the facial skin unless specifically instructed by a doctor.
• Avoid contact of the solution with the eyes.
• Unless directed by a doctor, do not cover treated skin areas with compresses or bandages. This is to minimize the risk of adverse effects.

Dosage:
Apply a thin layer of the solution once daily to the affected skin areas carefully. Use only a small amount of the solution. The bottle is equipped with a dispenser to facilitate accurate dosing. Never use larger amounts or apply the solution more frequently than prescribed by your doctor.
Adults, including elderly patients:
Do not apply the solution over large areas of skin (greater than 20% of total body surface area) or for prolonged periods.
Use in children (aged 2 years and older):

• Do not use the solution in children over 2 years of age without medical advice.
• Do not apply the solution to areas exceeding 10% of the child's body surface area.

Children under 2 years of age:
Ovixan is not recommended for use in children under 2 years of age.
Accidental overdose of Ovixan
Accidental ingestion of the solution may cause adverse effects.
If the patient has not followed the doctor's instructions and has used the solution too frequently and/or for too long, consult a doctor or pharmacist immediately.
Missed dose of Ovixan
If the patient forgets to apply the solution at the scheduled time, apply it as soon as possible, then continue with the prescribed dosing schedule. Do not apply a double dose or use the solution twice in one day to make up for the missed dose.
Stopping treatment with Ovixan
If the solution has been used for a prolonged period, do not stop treatment abruptly, as this may be harmful. The dose should be gradually reduced according to the doctor's instructions.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Adverse effects reported in children and adults during topical application 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

Unknown frequency (cannot be estimated from available data):

• Pain or other reactions at the application site
• Secondary infections (infection occurring during or after treatment of another infection or illness)
• Paresthesia (abnormal skin sensations or numbness)
• Blurred vision
• Skin discoloration
• Maceration of the skin (softening and whitening of the skin)
• Prurigo (itchy nodular skin eruptions)
• Perioral dermatitis
• Recurrent, deep folliculitis (furunculosis)
• Allergic contact dermatitis
• Skin irritation and dryness
• Rosacea-like dermatitis of the face with redness, swelling, and blisters on the cheeks and nose
• Non-elevated blue or purple spots on the skin (purpura)

Increased use, treatment of large skin areas, prolonged use, and use under occlusive dressing may increase the risk of adverse effects.
Corticosteroids may affect the normal secretion of hormones in the body. This is more likely when high doses are used for a prolonged period.

Additional adverse effects occurring in children
Particularly in children treated with solutions, creams, and ointments containing corticosteroids, absorption of the drug through the skin may occur, leading to a condition called Cushing's syndrome, which includes various symptoms such as facial rounding and muscle weakness.
During long-term use in children, growth suppression may occur. The doctor will help avoid this risk by prescribing the lowest effective dose of corticosteroid required to control the patient's symptoms.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Ovixan

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle and carton under
"Expiry date (EXP)". The expiry date refers to the last day of the specified month.
Do not store above 30°C.
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 pack and other information

What Ovixan contains

• The active substance is mometasone furoate. One gram of Ovixan cutaneous solution contains 1 mg of mometasone furoate.
• Other ingredients are: propylene glycol (E1520), isopropyl alcohol, hydroxypropylcellulose, disodium 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, cutaneous solution is a colourless or slightly yellowish, low viscosity solution in a white polyethylene bottle with a dropper and a white polyethylene screw cap with a tamper-evident seal, packed in a cardboard box.
Pack sizes: 30 ml, 100 ml and 2 x 100 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area countries under the following names:

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