Aulin

Leaflet attached to the packaging: patient information

Aulin100 mg, tablets
Nimesulid

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

• Keep the leaflet, so you can read it again if you need to.
• Consult a doctor or pharmacist if you have any doubts.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What Aulin is and what it is used for

Aulin is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties, used to treat acute pain and painful menstruation.
Before prescribing Aulin, the doctor 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

• if you are allergic (hypersensitive) to nimesulid or any of the other ingredients of this medicine (listed in section 6 at the end of this leaflet);
• if you have ever had any of the following symptoms after taking acetylsalicylic acid or other NSAIDs:
• wheezing, chest tightness, shortness of breath (asthma);
• nasal congestion due to swelling (nasal polyps);
• skin rash or hives;
• sudden swelling of the skin or mucous membranes, e.g., swelling around the eyes, face, lips, mouth, or throat, difficulty breathing (angioedema);
• if you have been treated with NSAIDs and have experienced:
• stomach or intestinal bleeding;
• perforation of the stomach or intestine;
• if you have or have had stomach or intestinal ulcers or bleeding (ulcers or bleeding that have occurred at least twice);
• if you have had a brain hemorrhage (stroke);
• if you have bleeding disorders or any problems with blood clotting;
• in case of liver dysfunction;
• if you are taking other medicines with known hepatotoxic effects, such as paracetamol, other painkillers, or other NSAIDs;
• if you are taking drugs that can cause dependence or are dependent on drugs or other substances;
• if you regularly abuse alcohol;
• if you have had liver disorders after taking nimesulid;
• if you have severe kidney failure and have not been dialyzed;
• if you have severe heart failure;
• if you have a fever or flu (generalized muscle pain, malaise, chills, elevated body temperature);
• in women in the last 3 months of pregnancy;
• in women during breastfeeding.

Do not give Aulin 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 you have heart problems, have had a stroke, or suspect that you are at risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, or smoking), discuss your treatment with your doctor or pharmacist.
In case of severe allergic reactions, at the first sign of skin rash, soft tissue damage (mucosal damage), or any other symptoms of allergy, stop taking Aulin and contact your doctor.
Do not take this medicine or inform your doctor before taking Aulin if you have ever experienced persistent redness (circular or oval patchy redness and swelling of the skin, blisters, hives, and itching) after taking nimesulid.
Stop treatment with Aulin immediately if you experience bleeding (causing black stools) or gastrointestinal ulcers (causing abdominal pain).

Precautions

If you experience symptoms that indicate liver disorders while taking nimesulid, stop taking the medicine and immediately inform your doctor. Symptoms that indicate liver disorders include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue, or dark urine.
If you have ever had stomach ulcers, gastrointestinal bleeding, inflammatory bowel disease, such as ulcerative colitis or Crohn's disease, inform your doctor before taking Aulin.
If you experience fever and/or flu-like symptoms (generalized muscle pain, malaise, chills) while taking Aulin, stop taking the medicine and tell your doctor.
If you have mild heart disease, high blood pressure, circulation problems, or kidney problems, inform your 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 you plan to become pregnant, inform your doctor, as Aulin may adversely affect fertility.
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

Aulin and other medicines

If you are taking any of the following medicines:

• Corticosteroids (medicines used to treat inflammatory conditions),
• Blood-thinning medicines (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, used to treat depression and similar conditions,
• 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), inform your doctor or pharmacist before taking Aulin.

Pregnancy, breastfeeding, and fertility

Before taking Aulin or any other medicine, consult your doctor or pharmacist.

• Inform your doctor about planned pregnancy, as Aulin may adversely affect fertility.
• Aulin must not be used during the last 3 months of pregnancy, as it may harm the unborn child and cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may affect the tendency to bleed in the mother and her child and cause the delivery to be delayed or prolonged.
• Aulin should not be taken during the first 6 months of pregnancy, unless it is absolutely necessary and prescribed by a doctor. If you need treatment during this period or when trying to become pregnant, use the smallest dose 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 child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of the arterial duct (ductal constriction) in the child's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Aulin must not be used during breastfeeding.

Driving and using machines

Do not drive or operate machinery if Aulin causes dizziness or drowsiness.

Aulin contains lactose

Aulin contains sugars. If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Aulin

Aulin should always be taken as directed by your doctor. In case of doubt, consult your doctor or pharmacist.
Side effects can be minimized by using the smallest effective dose for the shortest duration necessary to relieve symptoms.
Usually, one 100 mg tablet is taken twice a day. Aulin should be used for the shortest time possible, not longer than 15 days in a single, uninterrupted treatment cycle.
For oral use only.
It is recommended to take Aulin after meals.

Overdose of Aulin

In case of overdose or suspected overdose of Aulin, contact your doctor or hospital immediately. Take all remaining medicines with you.
In case of overdose, the following symptoms may occur: drowsiness, nausea, abdominal pain, stomach bleeding, or difficulty breathing.

Missed dose of Aulin

Do not take a double dose 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 you experience any of the following symptoms, stop taking the medicine and immediately inform your doctor, 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 nonsteroidal anti-inflammatory drugs (NSAIDs).

Taking some nonsteroidal 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 duodenal ulcers),
• perforation of the intestine (perforation) or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

Side effects that may occur when taking Aulin include:

• 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, increased 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 unease and anxiety, 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 (hepatitis), 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; itching rash (hives), facial edema, and peripheral edema; vision disturbances.
• Frequency not known: persistent redness (may appear as 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 you experience any side effects, including any possible side effects not listed in the leaflet, tell your doctor or pharmacist. Side effects can be reported directly to: the 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 will help to gather more information on the safety of the medicine.

5. How to store Aulin

Keep the medicine out of sight and reach of children.
There are no special precautions for storing the medicine.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the month stated.

6. Contents of the pack and other information

What Aulin contains

The active substance of Aulin is nimesulid.
The other ingredients are: sodium docusate, hydroxypropyl cellulose, lactose monohydrate, carboxymethylcellulose sodium (type A), microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate.

What Aulin looks like and contents of the pack

Aulin is a white or light yellow, round tablet. The tablets are packaged in PVC/Aluminum blisters. The outer packaging, a cardboard box, contains 6, 15, or 30 tablets.
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 Bernardo 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 revision of the leaflet:June 2025