Freederm Treatment 4% w/w Gel

Keep this leaflet. You may need to read it again.

Ask your doctor or pharmacist if you need more information or advice.

1. What Freederm Treatment Gel is and what it is used for
2. Before you use Freederm Treatment Gel
3. How to use Freederm Treatment Gel
4. Possible side effects
5. How to store Freederm Treatment Gel
6. Further information

Freederm Treatment Gel is not known to affect, or to be affected by, any other medicines.

There are no specific restrictions to using Freederm Treatment Gel during pregnancy or breast-feeding. Vitamin B derivative requirements, such as nicotinamide, are increased during pregnancy and infancy.

However, although there are no known potential risks, as with any medicine caution should be exercised, particularly in the first three months of pregnancy. Ask your doctor or pharmacist for advice before taking any medicine.

Using this product is not known to affect your ability to drive or use machinery.

Apply the gel twice daily over and around the affected skin areas as follows:

• Wash the area.
• Gently pat the skin dry (avoid rubbing as this may aggravate the skin).
• Apply a thin film of gel, and gently massage it in.

Continue using the gel twice daily in this way for as long as necessary (unless irritation occurs - see Section 4). Depending on the severity of your acne, it can take several weeks for the skin’s normal repair process to work before you see a real improvement in your skin.

The product may cause irritation if it gets into the eyes or mouth. Rinse affected areas with plenty of water. If rinsing one eye, take care to avoid washing product into the other eye. If irritation persists tell your doctor or pharmacist.

Do not worry if you occasionally forget to use this product, just carry on using it when you remember.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: 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.

The active ingredient is nicotinamide (4% w/w).

The other ingredients are aluminium magnesium silicate, hypromellose, citric acid, macrogol lauryl ether, ethanol and purified water.

• The product is a translucent gel.
• The product is available in tubes containing 25g of gel.

Acne is a skin disorder that occurs mainly on the face, back and chest. It affects a high proportion of both sexes, most commonly between the ages of 14 and 20, although it can last well into adulthood or even occur for the first time in adults. The early stages of acne often involve blackheads and whiteheads (doctors refer to these as ‘comedones’). These can develop into red or inflamed pimples or spots (‘papules’) which often contain pus (so-called ‘pustules’). In a few severe cases, groups of spots may become very inflamed and form cysts. Acne is a very common skin complaint, affecting about 70% of teenagers. Whether you have just a few spots, or a hundred, it tends to be regarded as acne.

Acne is not caused by eating too many sweets, chocolate or fatty foods (although healthy eating and a healthy lifestyle is good for your general health). Neither is it caused by not washing properly (although a good skin care routine is an important part of treatment). The exact cause of acne is not fully understood, but we do know that it involves the hair follicles in our skin and their associated oil-producing glands (the so-called “pilosebaceous units”). Often around the onset of puberty, hormones stimulate increased production of sebum (oil) by these glands.

Although normally this sebum flows out to lubricate the skin, when too much of it is produced it can become trapped within the pilosebaceous units where it forms a dark coloured plug or ‘blackhead’ where the opening is wide, or a light coloured plug or ‘whitehead’ where the opening is narrow. Inflammatory acne begins when a common type of skin bacteria called P. acnes – which is normally harmless – starts to break down the trapped sebum.

This process releases chemicals that cause inflammation in the surrounding skin, and leads to redness and the formation of ‘angry’ or inflamed-looking pimples and spots. These feel sore and tender, frequently contain pus and eventually burst open onto the skin before settling down. If the inflammation is deep in the hair duct, or if the spot is squeezed too early or aggressively, the pus can rupture into the skin and cause even more inflammation, and in extreme cases can even cause scarring.

• Take care to cleanse your skin thoroughly and regularly, but try not to clean too aggressively as this can make matters worse.
• Many acne patients find their skin becomes excessively dry. If this happens, ask your doctor or a pharmacist about suitable skin moisturisers.
• Carefully follow the instructions supplied with any medication you are using, as this will give you the best chance of clearing your condition.
• When using treatments applied to the skin, you will need to treat all the involved skin area, not just each individual spot.
• Try to avoid picking or severely squeezing your spots because this can make matters worse and lead to scarring.
• Persevere with treatment because it can take several weeks for the skin’s normal repair process to work.

To listen to or request a copy of this leaflet in Braille, large print or audio, please call free of charge: 0800 198 5000 (UK only).

Please be ready to give the following information: Freederm Treatment Gel, 00173/0398.

This is a service provided by the Royal National Institute of Blind People (RNIB).