1. What Aulin gel is and what it is used for
The name of your medicine is Aulin. The product contains an active substance called nimesulide, which belongs to a group of medicines with anti-inflammatory and pain-relieving effects (non-steroidal anti-inflammatory drugs (NSAIDs)).
Aulin gel is used to relieve pain and swelling in:
soft tissue injuries (such as sprains, injuries with bleeding)
a tendon injury called "acute traumatic tendinitis".
You should talk to your doctor if you do not feel better or if you feel worse after 7 days.
2. What you need to know before you use Aulin gel
Do not use Aulin gel:
if you are allergic (hypersensitive) to nimesulide or any of the other ingredients of this medicine (listed in section 6).
if you are allergic (hypersensitive) to aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).
if you are under 12 years of age.
if you are in the last 3 months of pregnancy
Do not use Aulin gel if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using this medicine.
Warnings and precautions
Talk to your doctor or pharmacist before using Aulin gel if:
you have asthma
you have severe liver, kidney or heart problems
you have bleeding or a stomach ulcer
you have problems with blood clotting
you are pregnant or breast-feeding.
Children and adolescents
Aulin gel should not be used in children under 12 years of age.
Other medicines and Aulin gel
Aulin gel is for external use and as such there are no known or expected interactions with other systemically administered medicines. Do not apply to the skin with other topical (local) applied preparations.
Pregnancy, breast-feeding and fertility
Oral forms (e.g. tablets) of Aulin gel may cause side effects in your unborn child. It is not known whether the same risk exists when Aulin gel is used on the skin.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. Do not use Aulin gel if you are in the last 3 months of pregnancy. Do not use Aulin gel during the first 6 months of pregnancy unless absolutely necessary and recommended by your doctor. If you need treatment during this period or while trying to get pregnant, the lowest possible dose should be used for the shortest possible time
Aulin gel is not indicated for use during pregnancy and breast-feeding unless absolutely necessary.
Aulin gel contains methyl hydroxybenzoate (E218) and propyl hydroxybenzoate (E216). They may cause allergic reactions (possibly delayed). This may happen immediately or after a few days.
3. How to use Aulin gel
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
How much to use
The amount of gel needed will vary depending on the size of the painful and draining area.
The usual amount is 3 g of gel (a 6 to 7 cm strip squeezed out of the tube)
Use 2 or 3 times each day.
Use the medicine for 7 to 15 days. If your symptoms do not improve after 7 days, contact your doctor for further treatment.
Ask your doctor or pharmacist if you are not sure how much to use.
Using the medicine
Massage the gel onto the painful and draining area. Wash your hands after using the gel.
This medicine is not intended for internal use. If you accidentally swallow it, contact your doctor or nearest hospital emergency department immediately.
Do not use the gel on broken skin if you have a cut, scratch or skin infection.
Do not get the gel in your eyes. If this happens, rinse your eyes with clean water.
Do not use any creams or ointments on your treated skin. This may prevent your medicine from working properly.
Do not expose the treated skin to direct sunlight. You are more likely to get a sunburn than usual.
Do not cover the treated skin with an airtight or waterproof bandage.
Aulin gel may temporarily cause a yellow discoloration of the treated skin, as well as clothing that is in contact with the treated area.
If you use more Aulin gel than you should
Overdose is unlikely when applied to the skin.
If you accidentally swallow Aulin gel, contact your doctor immediately.
If you forget to use Aulin gel
If you forget to use your gel, do it as soon as you remember. Then apply it again at the usual time. Do not try to make up for it by applying more gel than normal.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects are usually mild.
Stop using the gel immediately and see a doctor immediately if you develop an allergic reaction.
Signs of an allergic reaction include swelling, hives, swelling of your face, lips, tongue or throat, or difficulty breathing.
Stop using the gel if you get any of the following side effects:
itching, redness of the skin or rash (these side effects are common, affecting less than 1 in 10 people).
Reporting side effects
If you get any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
By reporting side effects, you can help to provide more information on the safety of this medicine.
5. How to store Aulin gel
Keep this medicine out of the reach and sight of children.
Do not use this medicine 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. Do not store above 30°C. Always replace the cap on the tube as soon as possible after use.
Shelf life after first opening: 14 days.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Aulin gel contains
The active substance is: nimesulide. Each 1 g of Aulin gel contains 30 mg of nimesulide.
The other ingredients are: purified water, diethylene glycol monoethyl ether, macrogolglycerides caprylocaprates, carbomers, disodium edetate, triethanolamine, methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216).
What Aulin gel looks like and contents of the pack
Aulin gel is a homogeneous pale yellow gel without foreign particles.
It is available in tubes of 50 g and 100 g.
Not all pack sizes may be marketed.