HYDROCORTISONE 1.0% W/W CREAM (15GM PACK) - patient leaflet, side effects, dosage

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• You must contact a doctor if your symptoms worsen or do not improve after one week.
• This medicine is for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any side effect becomes more serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 1. What Hydrocortisone Cream is and what it is used for

• 2. Before you use Hydrocortisone Cream.

• 3. How to use Hydrocortisone Cream

• 4. Possible side effects

• 5. How to store Hydrocortisone Cream

• 6. Further information

1. what hydrocortisone cream is and what it is used for

The name of your medicine is:

Hydrocortisone 1.0% w/w Cream (15g Pack)

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.

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 your condition worsens during use consult a pharmacist or doctor – 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 a pharmacist or doctor. 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:

• 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 continuously for prolonged periods a withdrawal reaction may occur on 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 25°C 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 15g of Hydrocortisone Cream.

PL 48259/0004

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.

This leaflet was last revised in August 2021