PACKAGE LEAFLET: INFORMATION FOR THE USER

Aulin 100 mg tablets, 100 mg granules for oral suspension

Nimesulide
Please read all of this leaflet carefully before taking this medicine.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
If any of the side effects worsens, or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What Aulin is and what it is used for
Before you take Aulin
How to take Aulin
Possible side effects
How to store Aulin
Further information

1. WHAT AULIN IS AND WHAT IT IS USED FOR

Aulin is a non-steroidal anti-inflammatory drug ("NSAID") with analgesic properties. It is used for the
treatment of acute pain and menstrual pain.
Before prescribing Aulin, your doctor will evaluate the potential benefits this medicine may provide you
against the risk of developing adverse effects.

2. BEFORE TAKING AULIN

Do not use Aulin if:

you are hypersensitive (allergic) to nimesulide or to any of the excipients of Aulin (listed in section 6 at the end of this leaflet)
you have previously experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs):
wheezing, tightness in the chest, shortness of breath (asthma)
nasal congestion due to growths on the nasal mucosa (nasal polyps)
skin rash / itchy rash (urticaria)
sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, which may cause breathing difficulties (angioedema)
you have previously had reactions following treatment with NSAIDs such as:
gastrointestinal or intestinal bleeding
stomach or intestinal ulcers (perforations)

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you have recently had, or have previously had, gastric or duodenal ulcer or bleeding (at least two episodes of ulcer or bleeding);
you have had cerebral haemorrhage (stroke);
you have any other bleeding disorder or a condition due to a blood coagulation defect;
you suffer from hepatic insufficiency;
you are taking other medicines known to affect the liver, e.g. paracetamol or any other analgesic or treatment with NSAIDs;
you are taking drugs or have developed drug or other substance dependence;
you are a heavy habitual drinker (of alcohol);
you have previously had a liver-related reaction to nimesulide;
you suffer from severe renal insufficiency not requiring dialysis;
you suffer from severe heart failure;
you have fever or influenza (general aching sensation, malaise, chills or tremors, or high temperature);
you are in the last trimester of pregnancy;
you are breastfeeding.

Do not give Aulin to a child under 12 years of age.
Warnings
Medicines such as Aulin may be associated with a slight increase in the risk of heart attack (myocardial
infarction) or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed
the recommended dose or duration of treatment.
If you have heart problems, a history of stroke, or think you may be at risk of these conditions (for example, if
you have high blood pressure, diabetes or high cholesterol, or if you smoke), you should discuss your treatment with your
doctor or pharmacist.
If severe allergic reactions occur during treatment, stop taking Aulin and
inform your doctor at the first sign of skin rash, lesions of soft tissues (mucous membranes), or any other
symptoms of allergy.
Stop treatment with Aulin immediately if gastrointestinal bleeding (black stools) or
ulcer in the digestive tract (causing abdominal pain) occurs.
Take special care with Aulin
If symptoms indicating liver disorder occur during treatment with nimesulide, you must
stop taking nimesulide and inform your doctor immediately. Symptoms indicating liver disorder include
loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and dark urine.
If you have previously suffered from peptic ulcers, gastric or intestinal bleeding, or inflammatory bowel diseases
such as ulcerative colitis or Crohn's disease, inform your doctor before taking Aulin.
If fever and/or flu-like symptoms (general aching sensation, malaise, chills or tremors) occur during treatment with Aulin,
stop taking the product and inform your doctor.
If you suffer from mild heart conditions, high blood pressure, circulatory or kidney problems, inform your
doctor before taking Aulin.
If you are elderly, your doctor may carry out regular checks to ensure that Aulin does not cause problems
to your stomach, kidneys, heart or liver.
If you plan to start a pregnancy, inform your doctor because Aulin may reduce fertility.
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
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Other medicines and Aulin
If you are taking any of the following medicines, which may interact with Aulin:

Corticosteroids (medicines used to treat inflammatory conditions),
Medicines to thin the blood (anticoagulants, e.g. warfarin, or antiplatelet agents, aspirin or other salicylates),
Antihypertensives or diuretics (medicines to control blood pressure or heart conditions),
Lithium, used to treat depression and similar disorders,
Selective serotonin reuptake inhibitors (medicines used to treat depression),
Methotrexate (medicine used to treat rheumatoid arthritis and cancer),
Cyclosporine (medicine used after organ transplantation or to treat immune system disorders),
make sure your doctor or pharmacist knows you are taking these medicines before starting Aulin.

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking Aulin or any other medicine.

Aulin must not be used during the last trimester of pregnancy. It may cause problems for the baby and delivery.
If you are planning a pregnancy, inform your doctor as Aulin may reduce fertility.
If you are in the first or second trimester of pregnancy, do not exceed the dose or duration of treatment prescribed by your doctor.

Aulin must not be used during breastfeeding.
Driving and using machines
Do not drive or operate machinery if Aulin causes you dizziness or drowsiness.
Important information about some excipients of Aulin
Aulin tablets and oral suspension granules contain sugars. If your doctor has informed you that you have
an intolerance to certain sugars, contact him/her before using this medicine.

3. HOW TO USE AULIN

Always take Aulin exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
To reduce unwanted effects, the lowest effective dose for the shortest necessary duration should be used to control symptoms.
The usual dose is one 100 mg tablet or one sachet of 100 mg granules for oral suspension, taken twice daily. Use Aulin for the shortest possible time and for no longer than 15 days in a single treatment cycle.
For oral use.
Aulin 100 mg granules: the granules must be dissolved in a glass of water.
It is recommended to take Aulin 100 mg tablets (or 100 mg granules) after meals.
If you take more Aulin than you should:
If you take or think you have taken more Aulin than prescribed (overdose), contact your doctor or go to hospital immediately. Take any remaining medicine with you. In case of overdose, you may experience one or more of the following symptoms: drowsiness, nausea, stomach pain, gastric ulcer, breathing difficulties.
If you forget to take Aulin:
Do not take a double dose to make up for the missed dose.
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4. POSSIBLE ADVERSE REACTIONS

Like all medicines, Aulin may cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, stop taking the medicine and inform your doctor immediately, as they could indicate a rare but serious adverse reaction requiring urgent medical attention:

stomach discomfort or pain, loss of appetite, nausea (feeling unwell), vomiting, gastrointestinal or intestinal bleeding, or black stools;
skin reactions such as rashes or redness;
wheezing or shortness of breath;
yellowing of the skin or eyes (jaundice);
unexpected change in the amount or color of urine;
swelling of the face, feet, or legs;
persistent fatigue.

General adverse effects associated with non-steroidal anti-inflammatory drugs (NSAIDs):
The use of certain NSAIDs may be associated with a slight increase in the risk of arterial thrombosis (e.g., heart attack [myocardial infarction] or stroke), particularly at high doses and with long-term treatment.
Fluid retention (edema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID therapy.
The most commonly observed adverse effects with NSAIDs involve the gastrointestinal tract (gastrointestinal effects):

gastric and duodenal ulcers;
intestinal wall perforation or gastrointestinal bleeding (sometimes fatal, especially in elderly patients).

Adverse reactions that may occur with Aulin are:

Common (may affect more than 1 in 100 patients): diarrhea, nausea, vomiting, mild changes in blood test values indicating liver function abnormalities.
Uncommon (may affect up to 1 in 100 patients): shortness of breath, dizziness, increased blood pressure, constipation, flatulence, heartburn (gastritis), itching, skin rashes, increased sweating, swelling (edema), gastrointestinal or intestinal bleeding; duodenal or gastric ulcers, and perforated ulcers.
Rare (may affect up to 1 in 1,000 patients): anemia, decreased white blood cells in the blood, increased levels of certain white blood cells (eosinophils) in the blood, changes in blood pressure, hemorrhage, painful urination or urinary retention, blood in the urine, increased potassium levels in the blood, feelings of anxiety or restlessness, nightmares, blurred vision, increased heart rate, hot flushes, skin redness, skin inflammation (dermatitis), malaise, fatigue.
Very rare (may affect up to 1 in 10,000 patients): severe skin reactions (known as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) causing skin rashes and severe malaise; kidney failure or inflammation (nephritis); disturbances in brain function (encephalopathy); reduced platelet count in the blood, leading to subcutaneous bleeding or bleeding elsewhere in the body, black stools due to bleeding; liver inflammation (hepatitis), sometimes severe, causing jaundice and bile flow obstruction; allergic reactions, including severe reactions with collapse and breathing difficulties, asthma, decreased body temperature, dizziness, headache, insomnia, stomach pain; indigestion, mouth burning, itching (urticaria); facial swelling and swelling of surrounding areas, visual disturbances.

Medicines such as Aulin may be associated with a slight increase in the risk of heart attack (myocardial infarction) or stroke.
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Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. You can also report adverse reactions directly via the national reporting system:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AULIN

Keep Aulin out of the sight and reach of children.
Do not use Aulin after the expiry date stated on the carton after the word “exp.”. The expiry date refers to the last day of the month.
Aulin tablets and oral suspension granules: these medicines do not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Aulin contains
Aulin 100 mg tablets
1 tablet contains:
Active substance: nimesulide 100 mg.
Excipients: sodium docusate, hydroxypropylcellulose, monohydrate lactose, sodium carboxymethylamido A, microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate.

Aulin 100 mg granules for oral suspension
1 sachet contains:
Active substance: nimesulide 100 mg.
Excipients: macrogol cetostearyl ether, sucrose, dried spray-dried glucose syrup, anhydrous citric acid, maize starch, orange flavouring.

Description of the appearance of Aulin and contents of the pack
Tablets: Round, white/light yellow tablets contained in thermoformed PVC/aluminum blisters. Packs containing 6, 9, 10, 15, 20 and 30 tablets. Not all pack sizes may be marketed.

Granules: Yellow granular powder contained in 2 g sachets made of aluminum, paper and polyethylene, or aluminum, paper, polyethylene and Surlyn®. Packs containing 6, 9, 14, 15, 18 and 30 sachets. Not all pack sizes may be marketed.

Marketing Authorization Holder and manufacturers responsible for batch release

For any information regarding this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Marketing Authorization Holder
Helsinn Birex Pharmaceuticals Ltd
Damastown
Mulhuddart - Dublin 15 - Ireland
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Concessionaire for sale
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO – A.C.R.A.F. S.p.A. – Viale Amelia, 70 – 00181 ROMA

Manufacturers responsible for batch release
Aulin 100 mg tablets
Patheon Italia S.p.A., Viale G.B. Stucchi 110, 20900 Monza (MB), Italy.
Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddart, Dublin 15, Ireland.
Boehringer Ingelheim Ellas A.E., 5th km Paiania – Markopoulo, Koropi, Attiki, 19400, Greece.
Mipharm S.p.A., Via Bernardo Quaranta 12, 20141 Milano (MI), Italy.
Angelini Pharma Česká Republika s.r.o., Páteřní 7, 635 00 Brno, Czech Republic.
Farmácia Martin a.s., Sklabinská 28, 036 01 Martin, Slovak Republic.
Aziende Chimiche Riunite Angelini Francesco ACRAF SPA, Via Vecchia del Pinocchio, 22, 60100
Ancona, Italy.

Aulin 100 mg granules for oral suspension
Patheon Italia S.p.A., Viale G.B. Stucchi 110, 20900 Monza (MB), Italy.
Helsinn Birex Pharmaceuticals Ltd, Damastown, Mulhuddart, Dublin 15, Ireland.
Mipharm S.p.A., Via Bernardo Quaranta 12, 20141 Milano (MI), Italy.
Angelini Pharma Česká Republika s.r.o., Páteřní 7, 635 00 Brno, Czech Republic.
Farmácia Martin a.s., Sklabinská 28, 036 01 Martin, Slovak Republic.
Aziende Chimiche Riunite Angelini Francesco ACRAF SPA, Via Vecchia del Pinocchio, 22, 60100
Ancona, Italy.

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