Patient leaflet - Modrasone ointment
1. What Modrasone Ointment is and what it is used for
Modrasone ointment contains an active ingredient called alclometasone dipropionate which belongs to a group of medicines called topical corticosteroids. These medicines are used on the surface of the skin to reduce the redness and itchiness caused by certain skin problems.
In adults and children, Modrasone ointment is used to reduce redness and itchiness caused by certain skin problems (for example eczema and dermatitis):
- Eczema is a common skin disease, which causes the skin to become red and itchy.
- Dermatitis is a condition brought on by the skin reacting to outside agents e.g. detergents, causing the skin to become red and itchy.
Corticosteroid creams, ointments and other topical preparations come in four different potencies or strengths. These are known as mild, moderately potent, potent or very potent. Healthcare professionals will usually refer to topical corticosteroid potency rather than strength. A potent or strong corticosteroid has a much stronger effect than a mild corticosteroid when using the same amount. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Modrasone is classed as a moderate corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
2. What you need to know before you use Modrasone Ointment
Do not use Modrasone ointment:
- if you, or a child you are caring for are allergic to alclometasone dipropionate or any of the other ingredients of this medicine (listed in section 6).
- for any other skin problems as it could make them worse, especially rosacea (a skin condition affecting the face), acne, dermatitis (skin inflammation) around the mouth, cold sores, chickenpox, or skin infections (including bacterial, fungal and viral infections).
Warnings and precautions
Talk to your doctor or pharmacist before using Modrasone ointment:
If you are pregnant, think you may be pregnant or if you are breast-feeding (see section Pregnancy, breast-feeding and fertility).
- If you are applying the ointment on large areas of the body for prolonged periods of time, especially when treating children, since it may increase the absorption of the product and the risk of toxicity.
- If you are applying the ointment to covered parts of the body. Do not use this product under an occlusive dressing; the affected zone has to be in contact with the air and not covered by a dressing, tight clothes or similar. In infants, a nappy can act as an occlusive dressing. You should wash your skin before changing the dressing.
- If there is a worsening of your condition during use consult your prescriber - you may be experiencing an allergic reaction, have an infection or your condition requires a different treatment.
- If you experience a recurrence of your condition shortly after stopping treatment, within 2 weeks, do not restart using the ointment without consulting your prescriber unless your prescriber has previously advised you to do so.
- If your condition has resolved and on recurrence the redness extends beyond the initial treatment area and you experience a burning sensation, please seek medical advice before restarting treatment. Use this only on your skin. If irritation or sensitivity develops during use, stop using the product and talk to your doctor or pharmacist.
When using this product do not smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this medicine burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Modrasone ointment contains propylene glycol
Modrasone ointment contains 20mg propylene glycol per gram of ointment. Propylene glycol may cause skin irritation.
Do not use this medicine in babies less than 4 weeks old with open wounds or large areas of broken or damaged skin (such as burns) without talking to your doctor or pharmacist.
3. How to use Modrasone Ointment
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
For adults and children, apply a thin layer of Modrasone ointment to the affected area two or three times a day unless otherwise instructed by your doctor. Ask your doctor about the duration of the treatment. You must not use a large amount of Modrasone ointment on the same area for a long time (for example every day for many weeks or months).
Do not apply Modrasone ointment under a dressing, such as a plaster or bandage, as this makes it easier for the active ingredient to pass through the skin and possibly cause some unwanted effects.
Instructions for use:
- 1. Wash your hands.
- 2. Apply a thin film of the ointment and rub gently until it has all disappeared.
- 3. Wash your hands, unless the ointment is used to treat your hands.
Use in children
If the ointment is for your child, do not use it under a nappy, as this makes it easier for the active ingredient to pass through the skin and possibly cause some unwanted effects.
If you use more of Modrasone ointment than you should
Tell your doctor if:
- you use Modrasone ointment more often than you should, or on large areas of your body as it can affect some of your hormones.
- you have not followed the dosage instructions or your doctor’s advice and have used the ointment too frequently or for a longer time than prescribed.
- you (or somebody else) accidentally swallows the ointment, however it should not produce any undesirable effects.
If you forget to use Modrasone ointment
If you forget to use your ointment at the right time, use it as soon as you remember then carry on as before. Do not double the amount of ointment used to make up for a forgotten dose.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most people find that when the ointment is used correctly, it does not cause any problems. However, if you use more ointment than you should, particularly on your face, it can cause:
- Thinning of the skin, stinging, blistering, peeling, swelling, itching, burning, skin rash, dryness of the skin and you may notice red marks. This happens more easily in infants and children.
- Inflammation of the hair follicles, excessive hair growth, reduced skin pigmentation and allergic skin reactions.
- Dermatitis (skin inflammation), a condition brought on by the skin reacting to outside agent e.g. detergents, causing the skin to become red and itchy.
This happens more easily in infants and children.
Steroid withdrawal reaction: If used over prolonged periods a withdrawal reaction, which might appear to be different from the previous condition, may occur in some patients during treatment or within days to weeks after stopping treatment with some or all of the following features: redness of the skin which can extend beyond the initial area treated, a burning or stinging sensation, intense itching, peeling of the skin, oozing open sores. Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard or search for the MHRA Yellow Card in the Google Play or Apple App Store). By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Modrasone Ointment
Keep this medicine out of the sight and reach of children.
Do not use this ointment after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Do not store above 25°C.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Modrasone ointment contains
The active substance is alclometasone dipropionate 0.05% w/w.
The other ingredients are: hexylene glycol, propylene glycol monostearate, white beeswax and white soft paraffin.
What Modrasone ointment looks like and contents of the pack
Modrasone ointment is a colourless to light yellow ointment contained in a 50g aluminium tube with a screw cap.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Aspire Pharma Ltd
Unit 4, Rotherbrook Court
Bedford Road
Petersfield,Hampshire
GU32 3QG, United Kingdom
Manufacturer:
Schering-Plough Labo NV
Heist-op-den Berg
Belgium
This leaflet was last revised in July 2024.
1010326-P9.1