OVIXAN 1 mg /G Cream

Зміст інструкції

1. Ovixan 1 mg/g cream
   1. What is OVIXAN and what is it used for
   2. What you need to know 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

Ovixan 1 mg/g cream

mometasone furoate
Equivalent medicine (only for 30 g tube)

Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What OVIXAN is and what it is used for
• 2. What you need to know 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 ingredient mometasone furoate and is a corticosteroid for topical use. Topical corticosteroids are divided into four categories, based on dosage and efficacy: mildly potent, moderately potent, potent and very potent. Mometasone furoate belongs to the category of “potent” corticosteroids.

Adults and children over 6 years of age:
OVIXAN has an anti-inflammatory effect and reduces itching. OVIXAN is used to reduce the symptoms associated with inflammatory skin conditions that can be treated with a corticosteroid, for example, psoriasis (excluding widespread plaque psoriasis) and other types of dermatitis. This medicine does not cure the skin condition you have, but it relieves the symptoms.

2. What you need to know before using OVIXAN

Do not use OVIXAN

• if you are allergic to mometasone furoate, to other corticosteroids or to any of the other ingredients of this medicine (listed in section 6).
• for other skin diseases that may worsen, in particular for rosacea (a skin disease of the face), acne, skin rashes (dermatitis) around the mouth, skin atrophy, itching in the genital area and around the anus, diaper rash, bacterial infections such as impetigo, tuberculosis (a lung disease), syphilis (a sexually transmitted disease), infections

viral such as mouth ulcers, shingles, chickenpox, athlete's foot (scaling and
redness of the skin of the feet, associated with itching) or Candidainfection in the genital area, with
possible presence of secretions or itching, or for other skin diseases.

• if you have recently experienced adverse events after a vaccination (e.g. after the administration of an influenza vaccine).
• on wounds or on ulcerated skin.

Warnings and precautions

• Inform your doctor if you are pregnant, even if suspected, or if you are breastfeeding.
• Immediately inform your doctor if you develop irritation or hypersensitivity during the use of OVIXAN.
• As with all potent topical corticosteroids, treatment should not be discontinued abruptly. If a prolonged treatment is interrupted, a relapse may occur in the form of a skin infection with severe redness and burning, even intense. This condition can be prevented by reducing the treatment gradually, e.g. by applying the cream less frequently before stopping therapy.
• Treatment of psoriasis with this medicine may worsen skin problems (e.g. a pustular form of this disease may develop, characterized by the appearance on the skin of many small ulcers). The doctor will have to monitor the course of your disease periodically, as this type of treatment requires careful monitoring.
• OVIXAN should not be applied to damaged skin.
• Do not apply this cream to the eyelids. Be careful and avoid contact of the cream with the eyes.
• Contact your doctor if you experience blurred vision or other visual disturbances.

Other medicines and OVIXAN
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
ask your doctor or pharmacist for advice before taking this medicine.
Treatment with OVIXAN during pregnancy or breastfeeding may only begin after receiving
instructions from your doctor.
If the doctor prescribes the use of the cream during pregnancy or breastfeeding, you should avoid using
large amounts and should apply the cream only for a short period of time. OVIXAN should not be
applied to the breast or the surrounding skin areas during breastfeeding.

OVIXAN contains propylene glycol and cetostearyl alcohol
OVIXAN cream contains propylene glycol, which may cause skin irritation, and cetostearyl alcohol, which
may cause local skin reactions (e.g. contact dermatitis).

3. How to use OVIXAN

OVIXAN is intended for cutaneous (external) use. OVIXAN can only be used on the skin.

• Always use OVIXAN exactly as your doctor has instructed. If you have any doubts, consult your doctor or pharmacist.
• Your doctor will need to monitor the treatment periodically.
• Do not apply the cream to the face unless your doctor has prescribed it.
• Avoid contact of the cream with the eyes.
• To reduce the risk of adverse events, do not cover the treated area with gauze or bandages unless you have received these instructions from your doctor.

Administration:
Carefully apply a thin layer of cream once a day to the affected skin areas. The amount of
cream to be used should be minimal: an amount called “finger tip unit” is sufficient, corresponding to the
distal phalanx of an adult (from the fingertip to the first joint) to cover an area
corresponding to twice the hand of an adult. Never use a larger amount and do not apply this
medicine more frequently than recommended by your doctor or pharmacist.

Adults, including the elderly:

• Do not apply the cream to extensive areas (more than 20% of the skin surface) or for a prolonged period of time.

Use in children (6 years and older):

• Do not apply the cream to children over 6 years of age without a prescription from your doctor.
• Do not apply the cream to more than 10% of the child's body surface.

Children under 6 years of age:
The use of OVIXAN in children under 6 years of age is not recommended.
If you use more OVIXAN than you should
If you accidentally swallow the cream, this should not cause any adverse effects.
If you have not followed your doctor's instructions and have used the cream too often and/or for a prolonged
period of time, ask your doctor or pharmacist for advice.

If you forget to use OVIXAN
If you forget to apply the cream when you should, do so as soon as you remember and then continue as
before. Do not use a double dose and do not apply the cream twice in one day to make up for the
omission of treatment.

If you stop using OVIXAN
If you have been using the cream for a long time, do not stop treatment abruptly as this may be dangerous.
The treatment must be reduced gradually, following your doctor's instructions.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects reported during the use of corticosteroids for topical use in children and adults
include:

Very rare (may affect up to 1 in 10,000 people):

• Inflammation of the hair follicles
• Itching
• Increased superficial blood vessels or appearance of spider veins
• Burning sensation Not known (frequency cannot be estimated from available data)
• Pain or other reactions at the application site
• Secondary infections (infections that occur during or after treatment of another infection or disease)
• Facial ulcers
• Paresthesia (abnormal sensations or numbness of the skin)
• Blurred vision
• Changes in skin color
• Skin maceration (the skin becomes lighter in color and softer in texture)
• Miliaria (heat rash), (skin redness caused by heat, itchy rash)
• Inflammations (including the appearance of skin reactions similar to acne)
• Skin thinning
• Appearance of streaks or irregular spots on the skin
• Excessive hair growth
• Increased skin sensitivity
• Dry skin. More frequent use, treatment of larger skin areas, prolonged use, and treatment with an occlusive dressing can increase the risk of side effects.

Corticosteroids can affect the normal production of hormones by the body. This is
more likely to occur in the case of high doses given for a prolonged period of
time.

Additional side effects in children
In particular, in children treated with creams and ointments containing corticosteroids, the product may be
absorbed through the skin and this can cause a condition known as Cushing's syndrome. This
syndrome is characterized by many symptoms, including weakness and rounding of the facial features.
Prolonged use can inhibit growth in children. The doctor will try to prevent this risk
by prescribing the lowest possible dose of corticosteroids, in order to obtain controlled treatment of
symptoms.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, please tell your
doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
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 OVIXAN after the expiry date stated on the tube and carton after Exp. The expiry date
refers to the last day of that month.
No special storage precautions are required.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What OVIXAN contains

• The active ingredient is mometasone furoate. Each gram of OVIXAN cream contains 1 mg of mometasone furoate.
• The other ingredients are coconut oil, stearic acid, cetostearyl alcohol, macrogol stearate, glycerol monostearate 40-55, propylene glycol, sodium citrate (for pH adjustment), citric acid (for pH adjustment) and purified water.

See section 2, “OVIXAN contains propylene glycol and cetostearyl alcohol”.

Description of the appearance of OVIXAN and contents of the pack
OVIXAN 1 MG/G CREAM is an odorless white cream contained in a plastic tube of
polyethylene laminated with aluminum with a white polypropylene screw cap.
Pack sizes:
Tubes containing 15 g, 30 g, 35 g, 70 g, 90 g or 100 g of cream.
Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder
ABIOGEN PHARMA S.p.A.
Via Meucci, 36
Ospedaletto - PISA
Italy

ManufacturerManufacturer
Bioglan AB Paul W. Beyvers GmbH
Borrgatan 31 Schaffhausener Str. 26-34
211 24 Malmö D-12099 Berlin
Sweden Germany

This medicinal product is authorised in the Member States of the EEA with the following denominations: