Patient leaflet - Hydrocortisone 1.0% w/w cream
1. WHAT HYDROCORTISONE CREAM IS AND WHAT IT IS USED FOR
The name of your medicine is: Hydrocortisone 1.0% w/w Cream
It is used for the treatment of irritant dermatitis, allergic contact dermatitis, insect bite reactions and mild to moderate eczema.
Hydrocortisone Cream 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. The percentage of active ingredient that is sometimes included on product packaging does not indicate potency. Hydrocortisone Cream is classed as a strong/very strong corticosteroid. Your healthcare professional will prescribe or advise a steroid of the appropriate potency for your condition.
2. BEFORE YOU USE HYDROCORTISONE CREAM
Do not use:
- 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 to do so by a 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 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 cream 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.
If you are unsure, or if you any have further questions, talk to your doctor or pharmacist before using Hydrocortisone Cream.
Important information about some of the ingredients of Hydrocortisone Cream:
This medicine contains propylene glycol, which may cause skin irritation, and parahydroxybenzoates (preservatives), which may cause allergic reactions (possibly delayed).
3. HOW TO USE HYDROCORTISONE CREAM
Always use Hydrocortisone Cream 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.
Directions for use:
Adults and children aged 10 years and over:
- Wash your hands before and after application, unless used for treating the hands.
- Use the cream sparingly over a small area once or twice a day.
- Rub in gently until the cream disappears.
- If you forget to use your cream 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 of time 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, as well as benefits, Hydrocortisone Cream can cause side effects. Most of these 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 cream immediately, and talk to your doctor.
Other side effects that may occur:
- Slight stinging sensation.
- Thinning of the skin.
- Reddish purple lines (stretch marks).
- Steroid induced acne.
- Problems when stopping use of this medicine (topical steroid withdrawal syndrome).
Steroid withdrawal reaction: If used for 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.
If any of these side effects occur, you should consult your doctor or pharmacist.
5. HOW TO STORE HYDROCORTISONE CREAM
Keep out of the reach and sight of children.
Store below 25ºC and protect from light.
Do not use Hydrocortisone Cream after the expiry date which is stated on the tube and carton. The expiry date refers to the last day of that month.
Ask your pharmacist how to dispose of medicines no longer required.
6. FURTHER INFORMATION
What Hydrocortisone Cream contains: The active substance is hydrocortisone 1.0% w/w.
The other ingredients are glyceryl monostearate, isopropyl myristate, polypropylene-15-stearyl ether, synthetic beeswax (contains wool alcohol), propylene glycol, aluminium magnesium silicate, polyoxytheylene-10-stearyl ether, polysorbate 80, citric acid monohydrate, nipasept sorbate (contains parahydroxybenzoates: E215, E217 and E219 and deionised water.
What Hydrocortisone Cream looks like and contents of the pack:
This medicine is a soft white cream, contained in a tube with a screw cap. The tube is presented in a carton with an information leaflet.
Each tube contains 25g, 30g, 40g or 50g of Hydrocortisone Cream.
PL 48259/0005
Marketing Authorisation Holder:
Northumbria Pharma Limited
Netpark
Thomas Wright Way
Sedgefield
County Durham
TS21 3FD
UK
Manufacturer:
Pharmasol Limited
North Way, Walworth Industrial Estate, Andover, SP10 5AZ, UK.