Aulindol

Package Leaflet: Information for the Patient

AulinDol, 30 mg/g, Gel

Nimesulide

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor or pharmacist.

• Keep this leaflet, you may need to read it again.
• If you need advice or additional information, consult a pharmacist.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.
• If after 7 days there is no improvement or you feel worse, contact your doctor.

Table of Contents of the Leaflet:

• 1. What is AulinDol and what is it used for
• 2. Important information before using AulinDol
• 3. How to use AulinDol
• 4. Possible side effects
• 5. How to store AulinDol
• 6. Contents of the pack and other information

1. What is AulinDol and what is it used for

The name of the medicine is AulinDol. AulinDol contains the active substance nimesulide, which belongs to the group of nonsteroidal anti-inflammatory and analgesic drugs (NSAIDs).
AulinDol is used to relieve pain and swelling caused by:

• twists,
• tendon injuries called "acute traumatic tendonitis".

If after 7 days there is no improvement or you feel worse, contact your doctor.

2. Important information before using AulinDol

When not to use AulinDol

• if you are allergic to the active substance (nimesulide) or any of the other ingredients of this medicine (listed in section 6),
• if you are allergic (hypersensitive) to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs
• in children under 12 years of age,
• if you are in the last 3 months of pregnancy.

Do not use AulinDol if any of the above situations apply to you.
In case of doubt before using this medicine, consult a doctor or pharmacist.

Warnings and precautions

Before starting to use AulinDol, discuss it with your doctor or pharmacist:

• if you have asthma,
• if you have serious liver, kidney, or heart disorders,
• if you have stomach bleeding or stomach ulcers,
• if you have blood clotting problems,
• if you are pregnant or breastfeeding.

Children and adolescents

AulinDol should not be used in children under 12 years of age.

AulinDol and other medicines

Since AulinDol is used externally, no interactions with other medicines are known or expected.
Do not apply to the skin with other locally applied medicines.

Pregnancy and breastfeeding

Oral forms (e.g., tablets) of Aulin may cause side effects in the unborn child.
It is not known if the same risk applies to AulinDol used on the skin.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Do not use AulinDol in the last 3 months of pregnancy. Do not use AulinDol during the first 6 months of pregnancy, unless absolutely necessary and advised by a doctor. If treatment is necessary during this period, use the smallest dose for the shortest possible time.
AulinDol is not recommended for use in pregnant or breastfeeding women.

AulinDol contains:

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). They may cause allergic reactions (possible late reactions).
These reactions may occur immediately or after a few days.

3. How to use AulinDol

This medicine should always be used exactly as described in the package leaflet or as directed by a doctor or pharmacist. In case of doubt, consult a doctor or pharmacist.

Recommended dose

The amount of gel needed depends on the size of the painful or swollen area.

• Usually, 3 g of gel is applied (which corresponds to 6-7 cm of gel squeezed from the tube).
• Apply the gel 2 or 3 times a day.
• Use the medicine for 7 to 15 days. If symptoms do not improve after 7 days, contact your doctor to determine further action.
• In case of doubt about the amount of medicine to use, consult a doctor or pharmacist.

Method of application

Massage the medicine into the painful and swollen area. After applying the medicine, wash your hands thoroughly.

• Do not use orally. In case of accidental ingestion of the medicine, contact a doctor or go to the nearest hospital emergency department immediately.
• Do not apply to damaged skin, wounds, abrasions, or skin inflammation.
• Do not apply the gel near the eyes. In case of contact with the eyes, rinse them with clean water.
• Do not use any creams or ointments on the treated skin area. They may prevent the medicine from working properly.
• Do not expose the treated skin area to sunlight. There may be an increased risk of sunburn.
• Do not use under waterproof or airtight dressings.
• AulinDol may stain the treated skin yellow, as well as clothing that comes into contact with the treated area.

Using more than the recommended dose of AulinDol

Overdose of the medicine due to its absorption through the skin is unlikely.
In case of accidental ingestion of AulinDol, contact a doctor immediately.

Missing a dose of AulinDol

If you miss a dose of AulinDol, apply it as soon as possible. Next time, apply it at the usual time. Do not apply more than usual to make up for the missed dose.
In case of any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, AulinDol can cause side effects, although not everybody gets them.
Side effects are usually mild.

Stop using AulinDol and contact a doctor immediately if you experience an allergic reaction.

• symptoms of an allergic reaction include swelling of the face, lips, tongue, or throat, or difficulty breathing.

Stop using the medicine if you experience any of the following side effects:

• itching, redness of the skin, or rash (these side effects occur frequently, in less than 1 in 10 people).

Reporting side effects

If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store AulinDol

• Keep the medicine out of the sight and reach of children.
• Do not use AulinDol after the expiry date stated on the tube and carton after EXP. The expiry date refers to the last day of the month stated.
• Do not store above 30°C. After each use, close the tube with the cap.
• Shelf life after first opening: 14 days.
• The batch number is stated after the word Lot.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What AulinDol contains

• The active substance is nimesulide. 1 g of gel contains 30 mg of nimesulide.
• The other ingredients are: diethylene glycol monoethyl ether, caprylocapronic macrogolglycerides, carbomers, disodium edetate, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), triethanolamine, and purified water.

What AulinDol looks like and contents of the pack

AulinDol is a homogeneous, pale yellow gel without impurities. It is available in tubes of 50 g and 100 g. Not all pack sizes may be marketed.

Marketing authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B
02-222 Warsaw

Manufacturer

Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Via Vecchia del Pinocchio 22
60131 Ancona, Italy
Helsinn Birex Pharmaceuticals Limited
Damastown, Mulhuddart, Dublin 15
Ireland
COSMO S.p.A,
Via C. Colombo 1, 20045 Lainate (Milan)
Italy
A leaflet in a format suitable for the blind or partially sighted is available at the marketing authorization holder's premises.
Date of last revision of the leaflet:09.2024