Ovixan 1 mg / g cream mometasone furoate
What Ovixan Is And What It Is Used For
Ovixan contains the active substance mometasone furoate and is a cortisone preparation for topical use. Cortisone preparations for topical use are divided into four classes depending on strength and effect: mild-acting, medium-acting, strong-acting, and extra-strong. Mometasone furoate belongs to the class of “strong-acting cortisone preparations”.
Adults and children over 6 years:
Ovixan has an anti-inflammatory effect and reduces itching. Ovixan is used to reduce symptoms associated with inflammatory skin diseases that can be treated with a cortisone preparation e.g. psoriasis (except widespread plaque psoriasis) and certain types of dermatitis. It does not cure your skin disease, but it does relieve your symptoms.
Mometasone furoate contained in Ovixan may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What You Need To Know Before Using Ovixan
Do Not Use Ovixan
- If you are allergic to mometasone furoate, other cortisone preparations, or any of the other ingredients of this medicine (listed in section 6).
- Other skin diseases that can be aggravated especially rosacea (skin disease of the face)
- Acne
- Rash around the mouth (dermatitis)
- Skin loss
- Itching in the abdomen and around the anal opening
- Diaper rash
- Bacterial infections such as smallpox
- Tuberculosis (lung disease), and syphilis (sexually transmitted disease) )
- Viral infections such as cold sores, shingles, chickenpox, athlete’s foot (red, itchy, scaly skin on the feet),
- Candida – infection of the abdomen that can cause discharge and itching or other skin infections.
- If you have recently had a side effect after vaccination (for example against the flu).
- On wounds or on damaged skin.
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before using Ovixan.
- Tell your doctor if you are pregnant, think you may be pregnant, or are breastfeeding.
- Tell your doctor immediately if you experience skin irritation or hypersensitivity when using Ovixan.
- As with all topical steroids for topical use, treatment should not be stopped abruptly. If long-term treatment is stopped, you can get relapses in the form of skin infections with
- Intense redness
- Stinging
- Burning sensations
This can be counteracted by gradually reducing the treatment, e.g. by using cream one less often before the treatment ends.
- Treatment of psoriasis with this medicine may worsen skin problems (eg a form of psoriasis, with many small blisters on the skin, may occur). Your doctor should regularly check the development of your symptoms as this type of treatment requires close monitoring.
- Ovixan should not be used on damaged skin.
- Do not use the cream on the eyelids. Be careful and avoid getting cream in your eyes.
Contact a 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 or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Treatment with Ovixan during pregnancy or breastfeeding should only be started as directed by your doctor.
If your doctor prescribes the Ovixan cream use one during pregnancy or breastfeeding, you must avoid using large amounts and only use cream one for a short period. Ovixan should not be applied to the breasts or nearby skin areas when 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 (eg contact dermatitis).
How To Use Ovixan
- Ovixan is intended for cutaneous ( external ) use. Ovixan cream should only be used on the skin.
- Always Ovixan cream uses exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
- Your doctor should check your treatment regularly.
- Do not use the cream on the face without a doctor’s prescription.
- Avoid getting eye cream.
You should not cover the treated area with a compressor bandage unless your doctor has given you such instructions. This is to reduce the risk of possible side effects.
Dosage:
Gently apply a thin layer of cream on the affected skin areas once a day. You should only use a small amount of cream. One click of cream on the fingertip (from the fingertip to the first joint of an adult) is enough to cover an area equivalent to the size of two adult hands. Never use larger amounts, and not more often, than directed by your doctor or pharmacist.
Adults and the elderly:
- Do not use a cream on large areas (over 20% of the skin surface) or for a long time.
Use For Children And Adolescents
Use in children (6 years and older):
- Do not use the cream on children over 6 years without your doctor prescribing it.
- Do not use the cream on more than 10% of the baby’s skin surface.
Children under 6 years:
Ovixan cream is not recommended for children under 6 years.
If You Use More Ovixan Than You Should
If you accidentally swallow the cream, it should not cause any side effects. If you have ingested too much medicine or if e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice.
If you have not followed your doctor’s instructions and have used the cream too often and/or for a long period, you should consult a doctor or pharmacist.
If You Forget To Use Ovixan
If you forget to apply cream one at a time you are going to do it, do it as soon as you remember and then continue as before. Do not use double amounts and do not apply the cream twice in one day to compensate for forgotten treatment.
If You Stop Using Ovixan
Do not stop treatment suddenly if you have been using the cream for a long time, as this can be harmful. The treatment should be phased out gradually, according to the doctor’s instructions.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
Possible Ovixan Cream Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects in children and adults that have been reported with the use of cortisone preparations for topical use include:
Very rare Ovixan cream side effects (may affect up to 1 in 10,000 people):
- Inflamed hair follicles in the skin
- Itching
- Increased number of superficial blood vessels or spider veins
- Burning sensation
Has been reported Ovixan cream side effects (occur in an unknown number of users):
- Pain or other reactions in the treated area
- Secondary infection (an infection that occurs during or after treatment of another infection or disease)
- Puffy blisters on the face
- Paresthesia (abnormal or numb feeling on the skin)
- Dimsyn
- Changes in skin color
- Skin maceration (softening and whitening of the skin)
- Miliaria (heat rash, very itchy rash)
- Inflammation (including acne-like reactions)
- Skin thinning
- Irregular spots or streaks on the skin
- Abnormal hair growth
- Increased sensitivity
- Dryness
Increased use, treatment of larger skin areas, long-term use, and treatment with compresses can increase the risk of side effects.
Cortisone preparations can affect the body’s normal hormone production. This is more likely when using high doses for a longer period.
Additional side effects are in children
In particular, children treated with creams and ointments containing corticosteroids can absorb the product through the skin, which can lead to a disease called Cushing’s syndrome. This syndrome has many symptoms, including the development of a rounder face and weakness.
Growth in children can be inhibited by long-term use. Your doctor will prevent this risk by prescribing the lowest possible steroid dose necessary to treat the symptoms.
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 tube and the carton after EXP. The expiration date is the last day of the specified month.
- No special storage instructions.
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 to protect the environment.
Contents Of The Package And Other Information
Content Declaration
The active substance is mometasone furoate. Ovixan 1 mg cream 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)
- The citric acid (for pH adjustment)
- Purified water
See section 2 “Ovixan contains propylene glycol and cetostearyl alcohol”.
What The Medicine Looks Like And Contents Of The Pack
- Ovixan 1 mg cream is a white, odorless cream in an aluminum-laminated plastic tube made of polyethylene with a white screw cap made of polypropylene.
- Pack sizes: Tubes containing 15 g, 30 g, 35 g, 70 g, 90 g, or 100 g cream.
- Not all packaging may be marketed.
Marketing Authorization Holder and Manufacturer
| Marketing Authorisation HolderGalenica ABPA Hanssons väg 41205 12 MalmöSweden | ||
| ManufacturerBioglan ABBorrgatan 31211 24 MalmöSweden | ManufacturerPaul W. Beyvers GmbHSchaffhausener Str. 26-34D-12099 BerlinGermany | ManufacturerLichtenheldt GmbH – Work IIndustriestraße 7 – 1123812 WahlstedtGermany |