Ovixan

PACKAGE LEAFLET

Package leaflet: Information for the user

Ovixan 1 mg/g cream

mometasone furoate
Generic medicine (only for the 30 g tube)
Please 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, consult 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 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 categories according to potency and efficacy: low potency, moderate potency, high potency, and very high potency. Mometasone furoate belongs to the category of "high potency" corticosteroids.
Adults and children over 6 years of age:
OVIXAN has anti-inflammatory effects and reduces itching. OVIXAN is used to relieve symptoms associated with inflammatory skin diseases 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 disease you have, but it helps to relieve its 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, particularly rosacea (a facial skin condition), acne, rashes (dermatitis) around the mouth, skin atrophy, genital or perianal itching, diaper rash, bacterial infections such as impetigo, tuberculosis (a lung disease), syphilis (a sexually transmitted disease), viral infections such as mouth ulcers, herpes simplex, chickenpox, athlete’s foot (peeling and redness of the skin of the feet, associated with itching), or Candida infection in the genital area, possibly associated with discharge or itching, or for other skin diseases.

• if you have recently experienced adverse events following vaccination (e.g. after administration of an influenza vaccine).

• on wounds or ulcerated skin.

Warnings and precautions

• Inform your doctor if you are pregnant, even if you only suspect pregnancy, or if you are breastfeeding.
• Inform your doctor immediately if you develop irritation or hypersensitivity during treatment with OVIXAN.
• As with all potent topical corticosteroids, treatment should not be stopped abruptly. If prolonged treatment is discontinued suddenly, a relapse may occur in the form of a skin infection with marked redness and intense burning. This condition can be prevented by gradually reducing treatment, for example by applying the cream less frequently before stopping therapy completely.
• Treatment of psoriasis with this medicine may cause a worsening of skin problems (e.g. a pustular form of the disease may develop, characterized by the appearance of numerous small skin ulcers). Your doctor should periodically monitor your condition, as this type of treatment requires careful supervision.
• OVIXAN must 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
Inform 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, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Treatment with OVIXAN during pregnancy or breastfeeding should only begin after receiving specific instructions from your doctor.
If your doctor prescribes the cream during pregnancy or breastfeeding, you should avoid using large amounts and apply the cream only for a short period of time. OVIXAN must not be applied to the breasts or 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 for cutaneous (external) use only. OVIXAN may only be used on the skin.

• Always use OVIXAN exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
• Your doctor should monitor your treatment periodically.
• Do not apply the cream to the face unless specifically instructed by your doctor.
• 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 specifically instructed by your doctor.

Administration:
Carefully apply a thin layer of cream once daily to the affected skin areas. The amount of cream used should be minimal: an amount referred to as a "fingertip unit" (FTU), corresponding to the length from the tip of an adult's fingertip to the first joint, is sufficient to cover an area equal to twice the surface of an adult's hand. Never use a larger amount, and do not apply this medication more frequently than recommended by your doctor or pharmacist.

Adults, including elderly patients:

• Do not apply the cream to extensive areas (more than 20% of body surface area) or for prolonged periods.

Use in children (from 6 years of age onwards):

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

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 adverse effects.
If you have not followed your doctor's instructions and have used the cream too frequently and/or for a prolonged period, consult your doctor or pharmacist for advice.

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

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. Treatment should be gradually tapered off, following your doctor's instructions.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Side effects reported during the use of corticosteroids for cutaneous 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 capillaries
• Burning sensation

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

• Pain or other reactions at the application site
• Secondary infections (infections occurring during or after treatment of another infection or disease)
• Facial ulcers
• Paresthesia (abnormal sensations or numbness of the skin)
• Blurred vision
• Changes in skin colour
• Skin maceration (skin becomes paler and soft, soggy)
• Miliaria (sweat rash) (skin redness caused by heat, itchy eruptions)
• Inflammations (including development of acne-like skin reactions)
• Skin thinning
• Appearance of irregular streaks or patches on the skin
• Excessive hair growth
• Increased skin sensitivity
• Dry skin

Frequent use, treatment of larger skin areas, prolonged use, and use under occlusive dressing may increase the risk of side effects.

Corticosteroids may affect the body's normal hormone production. This is more likely to occur with high doses administered over a prolonged period of time.

Additional side effects in children
In particular, in children treated with corticosteroid creams and ointments, the product may be absorbed through the skin, which can lead to a condition known as Cushing's syndrome. This syndrome is characterised by several symptoms, including muscle weakness and a rounded facial appearance. Prolonged use may suppress growth in children. The doctor will try to prevent this risk by prescribing the lowest possible dose of corticosteroids required to achieve adequate symptom control.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may also report side effects directly via 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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What OVIXAN contains

• The active substance is mometasone furoate. Each gram of OVIXAN cream contains 1 mg of mometasone furoate.
• The other components 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 odourless white cream contained in a plastic tube made of
laminated polyethylene with aluminium, fitted 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
Manufacturer Manufacturer
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 EEA Member States under the following names: