Patient leaflet - ISOTREX GEL
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. what you need to know before you use isotrex gel
Do not use Isotrex Gel:
- if you are allergic to isotretinoin or any of the other ingredients of this medicine (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
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- > Tell your doctor if any of these apply to you. Don’t use Isotrex.
Warnings and precautions
Talk to your doctor before using Isotrex Gel:
- 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
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- > 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.
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.
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– » If you do get sunburnt, stop using Isotrex until your skin is better.
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.
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- » Check with your doctor or pharmacist if you think any of these may apply to you.
Pregnancy, breast-feeding and fertility
DO NOT use Isotrex Gel if you are pregnant or thinking of becoming pregnant. Your doctor can give you more information.
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.
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.
3. how to use isotrex gel
Always use this medicine 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.
- This product is flammable. Keep the gel away from open fire and flames and all sources of ignition during and immediately after you’ve used it.
How to apply Isotrex Gel
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1. Wash your hands.
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2. Completely remove any make-up.
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3. Wash the area with a mild soap and warm water, and dry gently.
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4. Put a thin layer of gel on the affected skin, using your fingertips, and smooth in.
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5. Apply to all of the area of your skin which has acne , not just each spot.
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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.
4. Possible side effects
5. How to store Isotrex Gel
- Keep out of the sight and reach of children.
- Do not store above 25°C.
- Replace the cap securely after use.
- Do not use Isotrex Gel after the expiry date which is stated on the tube and carton (after exp). The expiry date refers to the last day of that month.
- This product should be used within two months of first opening. After two months, discard any unused portion.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other information the active substance is isotretinoin 0.05% w/w (0.05 g per 100 g gel).
- The other ingredients are hydroxypropylcellulose, butylated hydroxytoluene and ethanol.
What Isotrex Gel looks like and contents
Isotrex Gel comes in an aluminium tube with a white screw cap lid, containing 30g of a greenish-yellow gel.
Manufacturer
Manufactured by Stiefel Laboratories Ltd., Sligo, Ireland. Procured from within the EU and repackaged by the Product Licence Holder: G-Pharma Ltd, Salford M50 2PU.
Like all medicines, this medicine 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 (may affect more than 1 in 10 people):
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
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– slight stinging or skin pain
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– skin irritation or tenderness
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– skin burning sensation
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– dry skin
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– itching
Other side effects
Other side effects have occurred in a very small number of people but their exact frequency is unknown:
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– darkening or lightening of skin
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– sensitivity to sunlight
Reporting of side effects
If you get any side effects, talk to your doctor or 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: or search for MHRA Yellow Card in the Google Play or Apple App Store.
PL No. 16369/1564
Isotrex Gel
POM
Revision Date: 04/10/2018
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