Patient Information Leaflet

Aulin 100 mg, granules for oral suspension
Nimesulidum
Please read the entire leaflet carefully before taking this medicine, as it contains
important information for the patient.

Keep the leaflet for future reference.
Consult your doctor or pharmacist if you have any doubts.
This medicine has been prescribed for a specific individual. Do not give it to others. The medicine may harm another person, even if their symptoms are identical.
If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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

1. What Aulin is and what it is 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 prescribing Aulin, the doctor will assess whether the benefits of treatment outweigh the risk of adverse effects.

2. Important information before using Aulin

Do not use Aulin if:

you are allergic (hypersensitive) to nimesulide or any of the other ingredients of this medicine (listed in section 6 at the end of this leaflet);
you have previously experienced any of the following symptoms after taking acetylsalicylic acid or other NSAIDs:
- wheezing, chest tightness, shortness of breath (asthma);
- nasal obstruction due to swelling (nasal polyps);
- skin rash or urticaria;
- sudden swelling of the skin or mucous membranes, e.g. around the eyes, face, lips, mouth or throat, or difficulty breathing (angioedema);
you have been treated with NSAIDs and experienced:
- gastrointestinal bleeding;
- perforation of the stomach or intestines;
you have or have had gastric or intestinal ulcers or bleeding (ulcers or bleeding occurring at least twice);
you have had cerebral haemorrhage (stroke);
you have bleeding disorders or any problems related to impaired blood coagulation;
you have liver function impairment;
you are taking other medicines with proven hepatotoxic effects, e.g.: paracetamol, other analgesics or other NSAIDs;
you are taking drugs causing dependence or are addicted to drugs or other substances;
you regularly abuse alcohol;
you have previously experienced liver disorders after taking nimesulide;
you have severe renal insufficiency and are not undergoing dialysis;
you have severe heart failure;
you have fever or flu-like symptoms (generalised muscle pain, malaise, chills, elevated body temperature);
you are a woman in the last 3 months of pregnancy;
you are a woman during breastfeeding.

Do not administer Aulin to children under 12 years of age.
Warnings
Taking medicines such as Aulin may be associated with a small increased risk of heart attack or stroke. This risk increases with long-term use of high doses. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, a history of stroke, or suspect you are at risk of these conditions (e.g. high blood pressure, diabetes, high cholesterol levels or smoking), discuss your treatment plan with your doctor or pharmacist.
In case of severe allergic reactions, immediately discontinue Aulin and contact your doctor at the first sign of skin rash, soft tissue damage (mucosal membrane damage), or any other allergic symptoms.
Do not use this medicine or inform your doctor before taking Aulin if you have ever developed a persistent rash (circular or oval-shaped skin redness and swelling, blisters, urticaria and itching) after taking nimesulide.
Immediately discontinue Aulin if gastrointestinal bleeding (causing tarry stools) or gastrointestinal ulceration (causing abdominal pain) occurs.
Precautions
If symptoms indicating liver dysfunction occur during treatment with nimesulide, discontinue nimesulide immediately and inform your doctor without delay. Symptoms indicating liver dysfunction include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue or dark urine.
If you have ever had gastrointestinal ulcers, gastrointestinal bleeding, or inflammatory bowel diseases such as ulcerative colitis or Crohn's disease, inform your doctor before using Aulin.
If fever and/or flu-like symptoms (generalised muscle pain, malaise, chills) occur during treatment with Aulin, discontinue the medicine and inform your doctor.
If you have mild heart disease, high blood pressure, circulatory or kidney problems, inform your doctor before using Aulin.
During treatment of elderly patients, periodic check-ups may be necessary so that the doctor can ensure Aulin is not worsening the condition of the stomach, kidneys, heart or liver.
If you are planning pregnancy, inform your doctor, as Aulin may adversely affect fertility.
If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.
Aulin and other medicines
Inform your doctor or pharmacist before taking Aulin if you are taking any of the following medicines:

Corticosteroids (medicines used to treat inflammatory conditions),
Anticoagulants (blood-thinning medicines, 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 in the treatment of depression and similar disorders),
Selective serotonin reuptake inhibitors (medicines used to treat depression),
Methotrexate (used in the treatment of rheumatoid arthritis and cancer),
Cyclosporine (a medicine used after transplantation or in the treatment of immune system disorders).

Pregnancy, breastfeeding and effects on fertility
Before using Aulin or any other medicine, consult your doctor or pharmacist.

Inform your doctor if you are planning 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 both the patient and the child, and may cause delivery to occur later or last longer than expected.
Do not take Aulin during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. Taking Aulin for longer than a few days from week 20 of pregnancy may cause kidney problems in the unborn child, which may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If longer-term treatment is needed, your doctor may recommend additional monitoring.

Aulin must not be used during breastfeeding.
Driving and operating machinery
Do not drive or operate machinery if Aulin causes dizziness or drowsiness in you.
Aulin contains glucose and sucrose
Aulin contains sugars. If you have previously been diagnosed with intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to use Aulin

Aulin should always be used as directed by the physician. If in doubt, consult your doctor or pharmacist.
Adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to relieve symptoms.
The usual dose is one 100 mg sachet twice daily. Aulin should be used for the shortest time possible, not longer than 15 days in a single, uninterrupted treatment cycle.
For oral use.
Dissolve the granulate in a glass of water.
It is recommended to take Aulin after meals.
Taking more Aulin than recommended
In case of overdose or suspected overdose of Aulin, seek immediate medical attention by contacting a doctor or hospital. Bring all remaining medicines with you.
Symptoms of overdose may include: drowsiness, nausea, abdominal pain, gastric bleeding, or difficulty breathing.
Missing a dose of Aulin
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, Aulin may cause adverse effects, although not everyone experiences them.
If any of the following symptoms occur, stop taking the medicine
and contact your doctor immediately, as these symptoms may indicate a rare,
serious adverse reaction which may require urgent medical intervention:

indigestion or abdominal pain, loss of appetite, nausea, vomiting, gastrointestinal bleeding or black stools,
skin disorders such as rash or redness,
wheezing or shortness of breath (dyspnoea),
yellowing of the skin and whites of the eyes (jaundice),
unexpected changes in the amount or colour of urine,
swelling of the face, feet or legs,
persistent feeling of fatigue.

General adverse effects associated with non-steroidal anti-inflammatory drugs (NSAIDs)
Prolonged use of certain non-steroidal anti-inflammatory drugs (NSAIDs) at high doses may be associated with a small increased risk of arterial thrombosis (e.g. myocardial infarction or stroke).
Fluid retention (oedema), high blood pressure (hypertension) and heart failure have been reported in association with NSAID therapy.
The most commonly observed gastrointestinal adverse effects (gastrointestinal disorders):

gastric and upper small intestine ulceration (gastric and/or duodenal ulcer),
intestinal wall perforation or gastrointestinal bleeding (sometimes fatal, particularly in elderly patients).

Adverse effects that may occur during treatment with Aulin include:

Frequent (more than 1 in 100 people): diarrhoea, nausea, vomiting, minor changes in liver enzyme activity.
Uncommon (less than 1 in 100 people): dyspnoea (shortness of breath), dizziness, increased blood pressure, constipation, flatulence, gastritis (inflammation of the gastric mucosa), pruritus, rash, sweating, oedema, gastrointestinal bleeding, duodenal ulceration and perforation, gastric ulceration and perforation.
Rare (less than 1 in 1,000 people): anaemia, decreased white blood cell count, eosinophilia (increased levels of a specific type of white blood cells, so-called eosinophils), changes in blood pressure, bleeding, painful urination and urinary retention, haematuria, increased blood potassium levels, feeling of restlessness and anxiety, nightmares, blurred vision, palpitations, hot flushes, skin redness, dermatitis, malaise, asthenia (fatigue).
Very rare (less than 1 in 10,000 people): severe skin reactions (e.g. erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis) leading to blistering of the skin and severe malaise; renal failure or inflammatory state (nephritis); brain function disorders (encephalopathy); decreased platelet count leading to subcutaneous or other internal bleeding; black stools due to bleeding; hepatitis, sometimes severe, leading to jaundice and cholestasis; allergic reactions including collapse and wheezing; asthma; hypothermia; dizziness; headache; somnolence; abdominal pain; dyspepsia; stomatitis (inflammation of the oral mucosa); itchy rash (urticaria), facial and periorbital oedema; visual disturbances.
Frequency not known: persistent erythema (may appear as round or oval macular redness and swelling of the skin, urticarial blisters, pruritus).

Use of medicines such as Aulin may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
Reporting of adverse effects
If any adverse effects occur, including any possible adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to: Department of Monitoring Adverse Drug Reactions, 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 effects can also be reported to the marketing authorisation holder.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Aulin

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

6. Contents of the package and other information

What Aulin contains
The active substance is nimesulid.
Other ingredients are: sucrose, maize starch, spray-dried liquid glucose, macrogol cetostearyl ether, anhydrous citric acid, orange flavour.

What Aulin looks like and contents of the pack
Aulin is a yellow granular powder for oral suspension. It is packed in 2 g quantities into multi-layer sachets made of: Paper/Aluminium/LDPE/Surlyn or sachets made of: Aluminium/Paper/LDPE.
The outer carton contains 6, 9, 15 or 30 sachets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Angelini Pharma Česká republika s.r.o.
Palachovo náměstí 799/5, 625 00 Brno
Czech Republic

Manufacturers:
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 Authorisation Holder:
Angelini Pharma Polska Sp. z o.o.
Aleje Jerozolimskie 181B, 02-222 Warsaw
Tel. (22) 70 28 200
E-mail: [email protected]