Package leaflet: Information for the user

AulinDol, 30 mg/g, gel
Nimesulidum
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by
a doctor or pharmacist.

Keep this leaflet so that you can read it again if necessary.
If you need advice or further information, please consult your pharmacist.
If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 7 days, or if you feel worse, consult your doctor.

Table of contents of the leaflet:

What AulinDol is and what it is used for
Important information before using AulinDol
How to use AulinDol
Possible side effects
How to store AulinDol
Contents of the pack and other information

1. What AulinDol is and what it is used for

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

sprains,
tendon injuries known as "acute traumatic tendonitis".

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

2. Important information before using AulinDol

When not to use AulinDol

if the patient is allergic to the active substance (nimesulide) or to any of the other ingredients of this medicine (listed in section 6),
if the patient has allergy (hypersensitivity) to acetylsalicylic acid or to other medicines in the group of non-steroidal anti-inflammatory drugs,
in children under 12 years of age,
if the patient is in the last three months of pregnancy.

Do not use AulinDol if any of the situations described above apply to the patient.
If in doubt, consult a doctor or pharmacist before using this medicine.
Warnings and precautions
Before starting to use AulinDol, discuss with your doctor or pharmacist:

if the patient suffers from asthma,
if the patient has severe liver, kidney or heart disorders,
if the patient has gastrointestinal bleeding or gastric ulcer,
if the patient has blood clotting problems,
if the patient is pregnant or breastfeeding.

Children and adolescents
AulinDol must not be used in children under 12 years of age.
Interaction of AulinDol with other medicines
Since AulinDol is applied topically, no interactions with other systemically administered medicines are known or expected. Do not apply together with other topical medicines on the same skin area.
Pregnancy and breastfeeding
Oral formulations (e.g. tablets) of Aulin may cause adverse effects in the unborn child. It is unknown whether the same risk applies to AulinDol when applied to the skin.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
Do not use AulinDol during the last three months of pregnancy. AulinDol should not be used during the first six months of pregnancy unless absolutely necessary and specifically recommended by a doctor. If treatment is required during this period, the lowest possible dose for the shortest possible duration should be used.
The use of AulinDol is not recommended in women who are pregnant or breastfeeding.
AulinDol contains:
Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216). These may cause allergic reactions (including delayed-type reactions).
Such reactions may occur immediately or several days after application.

3. How to use AulinDol

This medicine should always be used exactly as described in this patient information leaflet or as directed by a doctor or pharmacist. If in doubt, consult a doctor or pharmacist.

Recommended dose
The required amount of gel depends on the size of the painful or swollen area.

Usually, 3 g of gel is applied (corresponding to 6–7 cm of gel squeezed from the tube).
Apply the gel 2 or 3 times daily.
Use the medicine for 7 to 15 days. If symptoms do not improve after 7 days, consult a doctor to determine further management.
If in doubt about the amount of medicine to use, consult a doctor or pharmacist.

Method of administration
Massage the medicine into the painful and swollen area. After applying the medicine, wash hands thoroughly.

Do not take orally. In case of accidental ingestion, seek immediate medical advice from a doctor or go to the nearest hospital emergency department.
Do not apply to damaged skin, wounds, abrasions, or inflamed skin conditions.
Do not apply the gel near the eyes. If the medicine comes into contact with the eyes, rinse them thoroughly with clean water.
Do not apply other creams or ointments to the treated area of skin, as they may interfere with the proper action of the medicine.
Avoid exposing the treated skin area to sunlight. Increased susceptibility to sunburn may occur.
Do not use under waterproof or occlusive dressings.
AulinDol may cause yellow staining of the treated skin and clothing in contact with the treated area.

Use of more than the recommended dose of AulinDol
Overdose is unlikely following skin absorption.
In case of accidental ingestion of AulinDol, seek immediate medical advice from a doctor.

Missed dose of AulinDol
If a dose of AulinDol is missed, apply it as soon as possible. Apply the next dose at the usual time. Do not apply a larger amount than usual to make up for the missed dose.

If you have any further doubts concerning the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Adverse reactions are usually mild.
Discontinue use of AulinDol and contact a doctor immediately if the patient
experiences an allergic reaction.

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

Stop taking the medicine if any of the following adverse reactions occur:

itching, skin redness or rash (these adverse reactions are common, occurring in less than 1 in 10 people).

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed
in this leaflet, inform a doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301,
fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this 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 the cardboard packaging after EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C. After each use, always close the tube with the cap immediately.
Shelf life after first opening: 14 days.
The batch number is indicated after the word Lot.
Medicines must 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: ethylene glycol monoethyl ether, caprylic/capric macrogol glycerides, 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 free from impurities. It is available in tubes of
50 g and 100 g. Not all pack sizes may be marketed.
Marketing Authorisation 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
The package leaflet in an appropriate format for visually impaired or blind persons is available at the premises of the marketing authorisation holder.