Isotrex Gel
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Assessed against UK PIL dated July 2012 |
APPROVED By Nafisa Potrick at |
28/01/2014- 13.22pm |
Isotrex® Gel
(isotretinoin)
1621
23.01.14[13]
PATIENT INFORMATION LEAFLET
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.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in the leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Isotrex Gel is and what it is used for
2. Before you use Isotrex Gel
3. How to use Isotrex Gel
4. Possible side effects
5. How to store Isotrex Gel
6. Further information
1. WHAT ISOTREX GEL IS AND WHAT IT IS USED FOR
The name of your medicine is Isotrex Gel. Isotrex Gel contains an active ingredient called isotretinoin.
- Isotretinoin is similar to Vitamin A. It works by helping the skin so that blocked pores are less likely. This helps prevent spots.
Isotrex Gel is used to treat acne (spots) in young people who are going through or have gone through puberty, and in adults. It is not for use by children who have not started puberty. Isotrex helps to:
- loosen blackheads and whiteheads so that they come out more easily
- stop new blackheads, whiteheads and spots from forming
- lower the number of red, swollen acne spots.
2. BEFORE YOU USE ISOTREX GEL Do not use Isotrex Gel if:
- if you are allergic (hypersensitive) to isotretinoin or any of the other ingredients in Isotrex (listed in Section 6)
- If you are pregnant, if you think you could be pregnant, or if you are planning to become pregnant
- If you are breast-feeding
* Tell your doctor if any of these apply to you. Don't use Isotrex.
Take special care with Isotrex Gel
Before you use Isotrex Gel, your doctor needs to know:
- if you or any of your close family have had skin cancer
- if you have had problems tolerating this or similar medicines in the past (you have found them too irritating for your skin)
- if you have:
- eczema,
- redness of the skin, broken blood vessels and tiny pimples usually in the centre of the face (rosacea)
- redness and soreness around your mouth (perioral dermatitis).
Isotrex may further irritate these conditions.
- if you have skin reactions in the sunlight
* Check with your doctor if you think any of these may apply to you.
Take care not to use too much gel especially where it could run into your eyes or build up in the angles of your nose, skin folds, or other areas of the skin that do not require treatment.
Only use Isotrex on your skin. Keep it away from areas such as your mouth, lips, and eyes.
Don’t use Isotrex on any irritated areas of skin. For example if you have cuts or grazes, or sunburn.
Don’t use too much Isotrex on sensitive areas of skin such as the neck.
Isotrex Gel can cause skin irritation when used with other medicines used to treat acne. If your skin becomes irritated, reduce the amount of times you use Isotrex Gel, or stop using it until the irritation goes away.
Stop using Isotrex Gel all together if the irritation does not go away.
Important information about some of the ingredients of Isotrex Gel
Isotrex Gel contains butylated hydroxytoluene (E321). This can cause local skin reactions e.g. contact dermatitis, reddening or flaking of skin. It can also cause irritation to your eyes and mucous membranes such as the lining of your nose.
Other medicines and Isotrex
Tell your doctor or pharmacist if you are taking any other medicines, if
you've taken any recently, or if you start taking new ones. This includes medicines obtained without a prescription.
In particular, tell your doctor or pharmacist:
- if you are using benzoyl peroxide (another acne treatment). If used at the same time, it may make Isotrex less effective. You may need to use these medicines at different times of the day (for example, one in the morning and the other at bedtime).
- if you are using any other acne treatment. If used at the same time, it may make skin irritation worse. If your skin becomes very irritated, you may need to use Isotrex less often or stop using it for a short period to allow your skin to recover and then re-start treatment. Stop treatment and see your doctor if skin irritation does not improve.
* Check with your doctor or pharmacist if you think any of these may apply to you.
Pregnancy and breast-feeding
Don’t use Isotrex Gel if you are pregnant.
- Tell your doctor if you are pregnant or planning to become pregnant
- Use a reliable method of contraception properly to prevent pregnancy, while you are using Isotrex Gel
- If you do become pregnant during treatment with Isotrex Gel, tell your doctor.
Don’t breast-feed while you are using Isotrex Gel. Discuss with your doctor whether you choose to breast-feed or to use Isotrex Gel.
Ask your doctor or pharmacist for advice before taking any medicine, while you are pregnant or breast-feeding.
3. HOW TO USE ISOTREX GEL
Always use Isotrex Gel exactly as your doctor has told you to.
Check with your doctor or pharmacist if you're not sure.
- Use Isotrex Gel once or twice each day. Your doctor will tell you how to use the medicine.
- It can take 6 to 8 weeks before you see the benefits of Isotrex Gel.
- You should keep using the medicine until your doctor tells you otherwise.
How to apply Isotrex Gel
1. Wash your hands.
2. Completely remove any make-up.
3. Wash the area with a mild soap and warm water, and dry gently.
4. Put a thin layer of gel on the affected skin, using your fingertips, and smooth in.
5. Apply to all of the area of your skin which has acne, not just each spot.
6. Wash your hands after using the gel.
If you use more Isotrex than you should
If you use too much Isotrex, or use it more frequently than you should, it may cause redness, peeling or irritation of your skin. If this happens, use the gel less often or stop using it for a few days and then start again. Using more gel than you should will not help your spots clear up more quickly.
If you accidentally swallow Isotrex
The ingredients of Isotrex should not be harmful if swallowed in small amounts.
- If you accidentally get Isotrex in your mouth, rinse at once with plenty of water
- Talk to a doctor if you swallow a lot of Isotrex.
If you forget to use Isotrex Gel
- Do not apply a double dose to make up for a missed dose
- Apply the next dose at the usual time.
Sunlight
Using Isotrex can make your skin more sensitive to sunlight.
When you are using Isotrex you need to:
- protect your skin from the sun. You can do this by using sunscreen and wearing clothes to stop you getting sunburnt
- avoid using sun beds (sun lamps) or spending a long time in the sun.
* If you do get sunburnt, stop using Isotrex until your skin is better.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Isotrex Gel can cause side effects, although not everybody gets them.
Serious skin reactions:
- severe burning, peeling, redness or itching of your skin.
* Stop using Isotrex and see a doctor straight away, if you notice any of the side effects above - you may need urgent medical treatment.
Very common side effects (at least 1 in 10 people are affected):
These effects can occur on the area of skin where you use the gel. If they cause you a problem, try using Isotrex less often, or stop using it for a few days until the irritation goes away, then start again. Stop using Isotrex if the irritation does not go away:
- redness or peeling of your skin, especially during the first few weeks of use
- slight stinging or skin pain
- skin irritation or tenderness
- skin burning sensation
- dry skin
- itching
Other side effects
Other side effects have occurred in a very small number of people but their exact frequency is unknown:
- darkening or lightening of skin
- sensitivity to sunlight
* Tell your doctor or pharmacist if any of the side effects listed become severe or troublesome, or if you notice any side effects not listed 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 ISOTREX GEL
Do not store above 25oC.
Do not use Isotrex Gel after the expiry date printed on the tube and the carton.
Keep out of the sight and reach of the children.
If your doctor tells you to stop using your medicine, take any that are left back to your pharmacist.
If your gel becomes discoloured or shows any other signs of deterioration please contact your doctor or pharmacist before taking this medicine
6. FURTHER INFORMATION What Isotrex Gel contains
Each 1 g of gel contains 0.5 mg of Isotretinoin as the active ingredient.
The other ingredients are hyprolose, butylated hydroxytoluene and ethanol
What Isotrex Gel looks like and the contents of the pack
Isotrex Gel is available as a white/blue sealed tube fitted with a plastic screw cap, containing a clear, greenish-yellow gel with an odour of ethanol. Isotrex Gel is comes in a pack size of 30 g.
MANUFACTURER AND PRODUCT LICENECE HOLDER
Isotrex Gel is manufactured by Stiefel laboratories (Ireland) Ltd, Finisklin Industrial Estate, Sligo, Ireland and is Procured from within the EU by the Product Licence holder Star Pharmaceuticals Ltd., 5 Sandridge close, Harrow, Middlesex HA1 1XD. Repackaged by Servipharm Ltd.
| POM | | PL No: 20636/1621
Leaflet revision and issue date (Ref) 23.01.14[13]
Isotrex is a registered trademark of Stiefel Laboratories, Inc.