Patient leaflet - Hydrocortisone 1.0% w/w ointment (15 g Pack)
1. WHAT HYDROCORTISONE OINTMENT IS AND WHAT IT IS USED FOR
The name of your medicine is: Hydrocortisone 1.0% w/w Ointment.
It is used for the treatment of irritant dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema.
Hydrocortisone Ointment is one of a group of medicines called topical steroids. “Topical” means they are put on the skin. Topical steroids reduce the redness and itchiness of certain skin problems.
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. Be aware the percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Hydrocortisone Ointment is classed as a mild corticosteroid.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE HYDROCORTISONE OINTMENT
Do not use Hydrocortisone Ointment
- If you are allergic (hypersensitive) to corticosteroids, including hydrocortisone.
- If you are allergic to any of the other ingredients.
- If you suffer from a chronic skin disease (psoriasis) marked by itchy, scaly patches, unless instructed by your doctor.
If you are pregnant or breast feeding, unless instructed by your doctor.
- On broken or infected skin including cold sores, acne and athlete’s foot.
- On the face, eyes, anal or genital area.
If you are unsure, or if you have any further questions, talk to your doctor or pharmacist before using Hydrocortisone Ointment.
Important information about some of the ingredients of Hydrocortisone Ointment:
This medicine contains Wool Fat (lanolin), which may cause local skin reactions (e.g. contact dermatitis).
Warnings and precautions
Contact your doctor if you experience blurred vision or other visual disturbances.
If there is a worsening of your condition during use consult your prescriber – you may be experiencing an allergic reaction, have an infection of 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 cream/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.
3. HOW TO USE HYDROCORTISONE OINTMENT
Always use Hydrocortisone Ointment as explained in this leaflet. You should check with your doctor or pharmacist if you are not sure.
Precautions for use
- For external use only.
Do not use with bandages or dressings that do not allow the air to circulate to the affected area
(occlusive dressings).
- Refer to ‘Do not use’ information in Section 2.
Use in Adults and children aged 10 years and over
- Wash your hands before and after application, unless used for treating the hands.
- Use the ointment sparingly over a small area once or twice a day .
- Rub in gently until the ointment disappears.
- If you forget to use your ointment at the right time, use it as soon as you remember, then continue as before.
- Do not use for more than one week. If the condition does not improve after one week consult your doctor. If used for a longer period, you increase the possibility of absorption through the skin and therefore the likelihood of side effects.
Children under 10 years of age
Do not use without medical supervision.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects are rare, affecting less than 1 in 1000 patients.
If you have an allergic reaction (e.g., skin rash, burning, red or itchy skin) or allergic contact dermatitis, stop using the ointment immediately, and talk to your doctor.
Other side effects that may occur:
- Slight stinging irritation.
- Thinning of the skin.
- Reddish purple lines (stretch marks).
- Steroid induced acne.
- Blurred vision (Uncommon: may affect up to 1 in 100 people)
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 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.
If any of these side effects occur, you should consult your doctor or pharmacist.
Reporting of suspected adverse reactions
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: www.mhra.gov.uk/yellowcard or search for 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 HYDROCORTISONE OINTMENT
Keep out of the reach and sight of children.
Store below 25°C and protect from light.
Do not use Hydrocortisone Ointment after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Hydrocortisone Ointment contains
The active substance is hydrocortisone 1.0% w/w.
The other ingredients are White Soft Paraffin, Liquid Paraffin and Wool Fat (lanolin).
What Hydrocortisone Ointment looks like and contents of the pack
This medicine is an off-white translucent ointment, contained in a tube with a screw cap. The tube is presented in a carton with an information leaflet. Each tube contains 15 g of Hydrocortisone Ointment.
PL 25298/0461
Marketing Authorisation Holder
Brown & Burk UK Limited,
Micro House,
Bury Street,
Ruislip,
HA4 7TL
Manufacturer:
Pharmasol Limited.
North Way, Walworth Industrial Estate,
Andover, SP10 5AZ, UK.