AULIN gel 3% 50g
Aulin gel
Product Aulin Gel contains the active substance nimesulide, which belongs to a group of drugs with anti-inflammatory and pain-relieving action NSAIDs.
Aulin Gel is used to relieve pain and swelling in:
- Soft tissue damage (sprains, hemorrhagic injuries);
- Tendon injuries;
AULIN gel 3% 50 g
Leaflet: Information for the user
AULIN 3% w/w gel AULIN 3% w/w Gel
Nimesulide
Nimesulide
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 7 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains:
1. What is Aulin gel and what is it used for
2. What you need to know before using Aulin Gel
3. How to use Aulin gel
4. Possible side effects
5. How to store Aulin gel
6. Contents of the package and additional information
1. What is Aulin gel and what is it 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 injury (such as sprains, bleeding injury);
an injury to the tendon 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 using 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.
Do not use Aulin Gel if any of the above applies to you. If you are not sure, ask 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 breastfeeding.
Children and adolescents
Aulin gel should not be used in children under 12 years of age.
Other medicines and Aulin gel
Aulin gel is applied externally and as such no interactions with other systemically administered drugs are known or expected. Do not apply to the skin with other topically applied preparations.
Pregnancy and breastfeeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Aulin gel is not indicated for use during pregnancy and breastfeeding.
Aulin gel contains methylhydroxybenzoate (E218) and propylhydroxybenzoate (E216). They can cause allergic reactions (possibly of the delayed type).
This can 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.
Usually the amount is 3 g of gel (a 6 to 7 cm strip squeezed out of the tube).
Use 2 or 3 times daily.
Use the medicine for 7 to 15 days. If 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.
Use of the drug
Massage the gel onto the painful and draining area. Wash your hands after use.
Do not take this medicine by mouth. If you accidentally swallow it, see your doctor or the nearest hospital emergency room immediately.
Do not use the gel on broken skin if you have a cut, scratch or skin infection.
Do not put gel in your eyes. If this happens, rinse them with clean water.
Do not use any creams or ointments on your treated skin. This can prevent your medicine from working properly.
Do not expose 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 dressing.
Aulin gel may temporarily cause a yellow discoloration of the treated skin as well as clothing that comes into contact with the treated area.
If you have used 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 catch up by applying more gel than normal.
If you have any further questions related to 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.
Adverse reactions 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 oedema, swelling of your face, lips, tongue or throat, or difficulty breathing.
Stop using the gel if you experience any of the following side effects:
Itching, reddening of the skin or rash (these side effects are common, affecting less than 1 in 10 people).
Reporting adverse reactions
If you get any side effects, tell your doctor or pharmacist. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system:
Medicines Executive Agency,
Damyan Gruev St. No. 8,
1303 Sofia,
phone: +359 2 8903417,
website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5 How to store AULIN gel
Keep this medicine out of the reach of children.
Do not use after the expiry date which is stated on the tube and carton after 'use by:'. The expiration date corresponds to the last day of the specified month.
Do not store at a temperature above 30°C. Always replace the cap on the tube as soon as possible after using it.
Shelf life after first opening: 14 days.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What does Aulin gel contain?
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 what it contains in the package
Aulin gel is a homogeneous pale yellow gel without foreign particles. It is available in 50g and 100g tubes.
Not all types of packaging can be put on sale.
Marketing Authorization Holder:
Angelini Pharma Bulgaria EOOD, Bulgaria.
Manufacturer:
Helsinn Birex Pharmaceuticals Ltd., Italy.
Date of last revision of leaflet: February 2017.
