OVIXAN 1 mg /G Cream

Contents of the leaflet

1. Package Leaflet: Information for the User
   1. Read the package leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet:
2. What is Ovixan and what is it used for
3. Important information before using Ovixan
   1. When not to use Ovixan
   2. Warnings and precautions
   3. Ovixan and other medicines
   4. Pregnancy, breast-feeding, and fertility
   5. Ovixan contains propylene glycol (E1520) and cetearyl alcohol
4. How to use Ovixan
   1. Dosage:
   2. Adults, including the elderly:
   3. Use in children (from 2 years of age):
   4. Children under 2 years of age:
   5. Ovixan is not recommended for use in children under 2 years of age.
   6. Using more Ovixan than you should
   7. Missing a dose of Ovixan
   8. Stopping the use of Ovixan
5. Possible side effects
   1. Additional side effects in children and adolescents
   2. Reporting side effects
6. How to store Ovixan
7. Contents of the pack and other information
   1. What Ovixan contains
   2. What Ovixan looks like and contents of the pack
   3. Marketing authorization holder and manufacturer
   4. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   5. Other sources of information

Package Leaflet: Information for the User

Ovixan, 1 mg/g, cream
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 experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the 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 topical use.
Corticosteroids for topical use are divided into four classes depending on their potency and effect: mild, moderate, potent, and very potent.
Mometasone furoate belongs to the class of "potent corticosteroids".
Adults and children from 2 years of age:
Ovixan has anti-inflammatory and anti-itching effects. Ovixan is used to reduce symptoms of inflammatory skin diseases that should be treated with glucocorticosteroids, e.g., psoriasis (except for widespread psoriasis vulgaris) and some types of eczema. The medicine does not cure the skin disease but alleviates the symptoms.

2. Important information before using Ovixan

When not to use Ovixan

• on wounds and skin ulcers.

Warnings and precautions

Before starting to use Ovixan, discuss it with your doctor, pharmacist, or nurse.

• Tell your doctor if you are pregnant, think you may be pregnant, or are breast-feeding.
• Inform your doctor immediately if you experience irritation or hypersensitivity during the use of Ovixan.
• As with all potent topical corticosteroids, do not stop using the medicine suddenly. If you stop the treatment too quickly, the disease may come back with redness, stinging, and burning. This can be prevented by gradually reducing the treatment, e.g., by applying the cream less often before stopping the treatment.
• Treatment of psoriasis with this medicine may cause worsening of skin symptoms (e.g., the appearance of pustular psoriasis with numerous small ulcers on the skin). The doctor must regularly monitor the patient, as this type of treatment requires close observation.
• Ovixan must not be used on damaged skin.
• Do not use the cream on the eyelids. Be careful not to get the cream in 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, as well as any medicines you plan to take.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, 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 breast-feeding may only be started on the advice of a doctor.
If your doctor advises you to use the cream during pregnancy or breast-feeding, avoid using large amounts and use the cream for a short time only. Do not use Ovixan on the breast or surrounding skin areas during breast-feeding.

Ovixan contains propylene glycol (E1520) and cetearyl alcohol

This medicine contains 250 mg of propylene glycol (E1520) per 1 gram of cream. Propylene glycol may cause skin irritation. This medicine contains cetearyl alcohol, which may cause local skin reactions (e.g., contact dermatitis).

3. How to use Ovixan

Ovixan can only be used on the skin.
This medicine should always be used as directed by your doctor. If you are unsure, ask your doctor or pharmacist.
Your doctor should regularly monitor your treatment.
Do not use the cream on the face unless your doctor has told you to do so.
Be careful not to get the cream in your eyes.
Unless your doctor has told you to do so, do not cover the treated skin areas with bandages or dressings. This is to minimize the risk of side effects.

Dosage:

Apply a thin layer of cream to the affected skin areas once a day. Use the cream only in small amounts. The amount of cream that fits on the tip of an adult finger (from the tip of the finger to the first joint) is enough to treat an area of skin the size of two adult hands. Never use more than this and do not apply the cream more often than your doctor has told you to.

Adults, including the elderly:

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

Use in children (from 2 years of age):

• Do not use the cream in children under 2 years of age unless your doctor has told you to do so.
• Do not apply the cream to an area larger than 10% of the child's body surface.

Children under 2 years of age:

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

Using more Ovixan than you should

If you accidentally swallow the medicine, it is unlikely to cause any problems.
If you do not follow your doctor's instructions and use the cream too often or for too long, talk to your doctor or pharmacist.

Missing a dose of Ovixan

If you forget to apply the cream at the right time, do so as soon as you remember, and then continue with your normal schedule. Do not apply a double dose or use the cream twice a day to make up for the missed dose.

Stopping the use of Ovixan

If you have been using the cream for a long time, do not stop using it suddenly, as this may be harmful to you. Gradually reduce the dose of the medicine as advised by your doctor.
If you have any further questions about 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 reported in children and adults using topical corticosteroids include:
Very rare (may affect up to 1 in 10,000 people):

• Folliculitis
• Itching
• Stretch marks or "spider veins"
• Burning sensation

Frequency not known (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 can cause 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 (purpura).

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

Additional side effects in children and adolescents

Particularly in children treated with corticosteroid creams and ointments, the medicine may be absorbed through the skin, leading to a condition called Cushing's syndrome, which includes many symptoms, including a rounded face and weakness.
During prolonged use in children, growth suppression may occur. Your doctor will help prevent this risk by prescribing the smallest effective dose of corticosteroid to treat your symptoms under control.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ovixan

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the tube and carton after "Expiry date". The expiry date refers to the last day of the month.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ovixan contains

• The active substance is mometasone furoate.
• The other ingredients are: propylene glycol (E1520), cetearyl alcohol, purified coconut oil, stearic acid, macrogol stearate, glycerol monostearate 40-55, sodium citrate, anhydrous citric acid, and purified water.

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

What Ovixan looks like and contents of the pack

Ovixan, 1 mg/g, cream is a white, odorless cream in a laminated aluminum tube with a polypropylene cap.
Pack sizes:
Tubes containing 15 g, 30 g, 35 g, 70 g, 90 g, or 100 g of cream, packaged in a cardboard box.
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
Manufacturer
Bioglan AB
Lichtenheldt GmbH – Werk I
Borrgatan 31
Industriestraße 7 - 11
211 24 Malmö
23812 Wahlstedt
Sweden
Germany

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

Date of last revision of the leaflet:11.2024

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