Aulin

Leaflet attached to the packaging: patient information

Aulin100 mg, granules for oral suspension preparation
Nimesulide

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

• The leaflet should be kept in case it needs to be read again.
• In case of any doubts, the doctor or pharmacist should be consulted.
• This medicine has been prescribed specifically for one person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.

Table of contents of the leaflet:

• 1. What is Aulin and what is it used for
• 2. Important information before taking Aulin
• 3. How to take Aulin
• 4. Possible side effects
• 5. How to store Aulin
• 6. Package contents and other information

1. What is Aulin and what is it used for

Aulin is a non-steroidal anti-inflammatory drug (NSAID) with analgesic properties,
used in the treatment of acute pain and painful menstruation.
Before the doctor prescribes Aulin, they will consider whether the benefits of taking the medicine outweigh the risk of side effects.

2. Important information before taking Aulin

When not to take Aulin

• wheezing, chest tightness, shortness of breath (asthma);
• nasal congestion due to swelling (nasal polyps);
• skin rash or hives;
• sudden skin or mucous membrane swelling, e.g. swelling around the eyes, face, lips, mouth or throat, difficulty breathing (angioedema);
• stomach or intestinal bleeding;
• perforation of the stomach or intestine;
• in women in the last 3 months of pregnancy;
• in women during breastfeeding.

Aulin should not be given to children under 12 years of age.

Warnings

Taking medicines like Aulin may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk increases with long-term use of high doses of the medicine. Do not exceed the recommended dose and duration of treatment.
If the patient has heart problems, has had a stroke or suspects that they are at risk of these disorders (e.g. high blood pressure, diabetes, high cholesterol or smoking), they should discuss their treatment with their doctor or pharmacist.
In the event of serious allergic reactions, at the first sign of skin rash, soft tissue damage (mucous membrane damage) or any other symptoms of allergy, Aulin should be discontinued and a doctor consulted.
Aulin should not be taken or the doctor should be informed before taking Aulin if the patient has ever experienced persistent redness (circular or oval patchy redness and swelling of the skin, blisters, hives and itching) after taking nimesulide.
Treatment with Aulin should be stopped immediately if bleeding (causing black stools) or gastrointestinal ulcers occur.

Precautions

If symptoms occur during nimesulide treatment that indicate liver disorders, nimesulide should be discontinued and the doctor informed immediately. Symptoms indicating liver disorders are loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue or dark urine.
If the patient has ever had stomach ulcers, gastrointestinal bleeding, inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, they should inform their doctor before taking Aulin.
If fever and/or flu-like symptoms (generalized muscle pain, malaise, chills) occur during treatment with Aulin, the medicine should be discontinued and the doctor informed.
If the patient has mild heart disease, high blood pressure, circulation problems or kidney problems, they should inform their doctor before taking Aulin.
During treatment of elderly patients, periodic visits may be necessary to ensure that Aulin does not worsen the condition of the stomach, kidneys, heart or liver.
If the patient plans to become pregnant, they should inform their doctor, as Aulin may adversely affect fertility.
If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.

Aulin and other medicines

If the patient is taking any of the following medicines:

• Corticosteroids (medicines used to treat inflammatory conditions),
• Blood thinners (anticoagulants, e.g. warfarin, antiplatelet agents, acetylsalicylic acid or other salicylates),
• Antihypertensive or diuretic medicines (medicines used to regulate blood pressure or heart function),
• Lithium, which is used to treat depression and similar diseases,
• Selective serotonin reuptake inhibitors (medicines used to treat depression),
• Methotrexate (used to treat rheumatoid arthritis and cancer),
• Cyclosporin (a medicine used after transplantation or to treat immune system disorders), the doctor or pharmacist should be informed before taking Aulin.

Pregnancy, breastfeeding and fertility

Before taking Aulin or any other medicine, the doctor or pharmacist should be consulted.

• The doctor should be informed about planned pregnancy, as Aulin may adversely affect fertility.
• Aulin should not be taken during the last 3 months of pregnancy, as it may harm the unborn baby and cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may affect the patient's and their baby's tendency to bleed and cause the delivery to be later or longer than expected.
• Aulin should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and recommended by the doctor. If the patient needs treatment during this period or when trying to become pregnant, the smallest possible dose should be used for the shortest possible time. Taking Aulin for more than a few days during the period from the 20th week of pregnancy may cause kidney problems in the unborn baby, which can lead to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the baby's heart. If the patient needs treatment for more than a few days, the doctor may recommend additional monitoring.

Aulin should not be taken during breastfeeding.

Driving and operating machinery

The patient should not drive or operate machinery if Aulin causes dizziness or drowsiness.

Aulin contains glucose and sucrose

Aulin contains sugars. If the patient has previously been diagnosed with intolerance to certain sugars, they should contact their doctor before taking the medicine.

3. How to take Aulin

Aulin should always be taken according to the doctor's instructions. In case of doubts, the doctor or pharmacist should be consulted.
Side effects can be minimized by using the smallest effective dose for the shortest necessary period to alleviate symptoms.
Usually, one 100 mg sachet is taken twice a day. Aulin should be taken for the shortest possible time, not longer than 15 days in a single, uninterrupted treatment cycle.
For oral use.
The granules should be dissolved in a glass of water.
It is recommended to take Aulin after meals.

Taking a higher dose of Aulin than recommended

In case of overdose or suspected overdose of Aulin, the doctor or hospital should be contacted immediately. All remaining medicines should be taken along.
In case of overdose, the following symptoms may occur: drowsiness, nausea, abdominal pain, stomach bleeding, or difficulty breathing.

Missing a dose of Aulin

A double dose should not be taken to make up for a missed dose.

4. Possible side effects

Like all medicines, Aulin can cause side effects, although not everybody gets them.
If any of the following symptoms occur, the medicine should be discontinued and the doctor informed immediately, as this symptom may indicate a rare, serious side effect that requires urgent medical attention:

• indigestion or abdominal pain, loss of appetite, nausea, vomiting, stomach or intestinal bleeding, or black stools,
• skin diseases, such as rash or redness,
• wheezing or shortness of breath (dyspnea),
• yellowing of the skin and whites of the eyes (jaundice),
• unexplained changes in urine quantity or color,
• swelling of the face, feet, or ankles,
• persistent fatigue.

General side effects of non-steroidal anti-inflammatory drugs (NSAIDs).

Taking some non-steroidal anti-inflammatory drugs (NSAIDs) in high doses for a long time may be associated with a small increased risk of arterial thrombosis (e.g. heart attack or stroke).
Fluid retention (edema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID treatment.
The most commonly observed side effects related to the gastrointestinal tract (gastrointestinal disorders):

• stomach and duodenal ulcers (gastric and/or duodenal ulcers),
• perforation of the intestine (perforation) or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

Side effects that may occur when taking Aulin are:

• Often (more than 1 in 100 people): diarrhea, nausea, vomiting, minor changes in liver enzyme activity.
• Uncommon (less than 1 in 100 people): shortness of breath (dyspnea), dizziness, elevated blood pressure, constipation, gas, gastritis (gastric mucosal inflammation), itching, rash, sweating, edema, gastrointestinal bleeding, ulcers, and perforation of the duodenum, ulcers, and perforation of the stomach.
• Rare (less than 1 in 1000 people): anemia, decreased white blood cell count, eosinophilia (increased eosinophils in the blood), changes in blood pressure, bleeding, painful urination, and urinary retention, hematuria, increased potassium levels in the blood, feeling of anxiety and fear, nightmares, blurred vision, rapid heartbeat, hot flashes, skin redness, skin inflammation, malaise, weakness (fatigue).
• Very rare (less than 1 in 10,000 people): severe skin reactions (e.g. erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) causing blisters on the skin and very poor general condition; kidney failure or inflammation (nephritis); brain disorders (encephalopathy); decreased platelet count causing subcutaneous or other bleeding; black stools due to bleeding; liver inflammation, sometimes very severe, causing jaundice and bile flow obstruction; allergies, including anaphylaxis and wheezing; asthma; hypothermia; dizziness; headaches; drowsiness; abdominal pain; indigestion; oral mucosal inflammation; itchy rash (hives), facial and periorbital edema; vision disorders.
• Frequency not known: persistent redness (may look like circular or oval patchy redness and swelling of the skin, blisters, hives, and itching).

Taking medicines like Aulin may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If any side effects occur, including any possible side effects not listed in the leaflet, the doctor or pharmacist should be informed. Side effects can be reported directly to: Department of Adverse Reaction Monitoring 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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Aulin

The medicine should be stored out of sight and reach of children.
There are no special precautions for storing the medicine.
The medicine should not be taken after the expiry date stated on the packaging.
The expiry date refers to the last day of the given month.

6. Package contents and other information

What Aulin contains

The active substance of Aulin is nimesulide.
The other ingredients are: sucrose, cornstarch, spray-dried glucose liquid, cetostearyl ether of macrogol, anhydrous citric acid, orange flavor.

What Aulin looks like and what the package contains

Aulin is a yellow granulated powder for oral suspension. It is packaged in 2 g sachets with: Paper/Aluminum/LDPE/Surlyn or sachets with: Aluminum/Paper/LDPE.
The outer packaging, a cardboard box, contains 6, 9, 15, or 30 sachets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Angelini Pharma Česká republika s.r.o.
Palachovo náměstí 799/5, 625 00 Brno
Czech Republic

Manufacturer:

Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddart, Dublin 15, Ireland.
Mipharm S.p.A., Via B. Quaranta, 12, 20141 Milan (MI), Italy.
Farmácia Martin a.s., Sklabinská 28, 036 01 Martin, Slovak Republic.
Aziende Chimiche Riunite Angelini Francesco ACRAF SPA, Via Vecchia del Pinocchio, 22, 60131 Ancona, Italy.
Dovema s.r.o., Bříství 172, Bříství 28915, Czech Republic.

Representative of the marketing authorization holder:

Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
tel. (22) 70 28 200
e-mail: [email protected]
Date of last update of the leaflet:June 2025