GSL: General Sales List
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PL 00173/0187.
PACKAGE LEAFLET Information for the user
Nicotinamide 4% w/w
Please read all of this leaflet carefully before using this product.
Keep this leaflet. You may need to read it again.
Ask your doctor or pharmacist if you need more information or advice.
In this leaflet:
1. What Freederm Gel is and what it is used for
2. Before you use Freederm Gel
3. How to use Freederm Gel
4. Possible side effects
5. How to store Freederm Gel
6. Further information
1. WHAT FREEDERM GEL IS AND WHAT IT IS USED FOR
2. BEFORE YOU USE FREEDERM GEL
Do not use Freederm Gel if you are allergic (hypersensitive) to nicotinamide or any of the other ingredients of Freederm Gel listed in Section 6.
Take care when using this product:
Using other medicines
Freederm Gel is not known to affect, or to be affected by, any other medicines.
Pregnancy and breast-feeding
There are no specific restrictions to using Freederm 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.
Driving and using machinery
Using this product is not known to affect your ability to drive or use machinery.
3. HOW TO USE FREEDERM GEL
For adults, children and the elderly:
Apply the gel twice daily over and around the affected skin areas as follows:
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.
If there is no improvement within 12 weeks, or if your condition gets worse at any stage, ask your doctor or pharmacist for advice.
If the product gets into the eyes or mouth
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.
If you forget to use this product
Do not worry if you occasionally forget to use this product, just carry on using it when you remember.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Although Freederm Gel has been specially designed for use on all skin types including problem skin, it can cause side effects, although not everybody gets them.
Stop using this product and tell your doctor or pharmacist if any side effect gets serious, or you notice any other side effects not mentioned in this leaflet.
Reporting of side effects
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.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE FREEDERM GEL
6. FURTHER INFORMATION ABOUT FREEDERM GEL
What Freederm Gel contains:
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.
What Freederm Gel looks like and contents of the pack
The Marketing Authorisation holder is
The Manufacturer is
This leaflet was last revised in
HEALTH EDUCATION INFORMATION
What is acne?
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.
What causes 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.
Important tips when treating acne
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 Gel, 00173/0187.
This is a service provided by the Royal National Institute of Blind People (RNIB).
Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
+44 (0)1462 458 866
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