AULIN 100 mg Tabletki

Treść ulotki

1. Aulin 100 mg tablets
   1. WHAT IS AULIN AND WHAT IS IT USED FOR
   2. BEFORE TAKING AULIN
   3. HOW TO USE AULIN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE AULIN
   6. OTHER INFORMATION

Aulin 100 mg tablets

Aulin 100 mg granules for oral suspension
Nimesulide

Read 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. In fact, this medicine could be dangerous for other individuals, even if their symptoms are the same as yours.
• If any of the side effects gets worse, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What Aulin is and what it is used for
• 2. Before you take Aulin
• 3. How to take Aulin
• 4. Possible side effects 5 How to store Aulin
• 6. Further information

1. WHAT IS AULIN AND WHAT IS IT 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, the doctor will assess the potential benefits this medicine can give you compared to
the risk of side effects.

2. BEFORE TAKING AULIN

Do not use Aulin if:

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

1 of 6

• you have recently had a gastric or duodenal ulcer or bleeding, or have had them in the past (at least two episodes of ulcer or bleeding);
• you have had a cerebral hemorrhage (stroke);
• you have any other bleeding problems or problems due to a blood clotting defect;
• you suffer from liver failure;
• you are taking other medicines known to have an effect on the liver, e.g. paracetamol or any other analgesic or NSAID treatment;
• you are taking drugs or have developed a dependence on drugs or other substances;
• you are a heavy habitual drinker (of alcohol);
• you have had a reaction to nimesulide in the past that affected the liver;
• you suffer from severe renal failure that does not require dialysis;
• you suffer from severe heart failure;
• you have a fever or flu (feeling of general malaise, discomfort, chills or tremor, 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 like 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 treatments. 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 (e.g. if
you have high blood pressure, diabetes or high cholesterol or if you smoke), you should discuss your therapy 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 rashes, soft tissue lesions (mucous membranes) or any other
symptom of allergy.
Immediately stop treatment with Aulin in the presence of bleeding (with black stools) or
ulcer in the digestive tract (causing abdominal pain).

Take special care with Aulin
If symptoms indicative of a liver disorder appear during treatment with nimesulide, you should
stop taking nimesulide and immediately inform your doctor. Symptoms indicative of a
liver disorder are loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and dark urine.
If you have suffered from peptic ulcers, gastric or intestinal bleeding, or inflammatory bowel diseases
such as ulcerative colitis or Crohn's disease, you should inform your doctor before taking Aulin.
If fever and/or flu-like symptoms (feeling of
general malaise, discomfort, chills or tremor) occur during treatment with Aulin, stop taking the product and
inform your doctor.
If you suffer from mild heart problems, high blood pressure, circulatory problems or kidney problems, you should inform
your doctor before taking Aulin.
If you are elderly, your doctor may subject you to regular checks to ensure that Aulin does not cause problems
to the stomach, kidneys, heart or liver.
If you are planning to become pregnant, inform your doctor because Aulin may reduce fertility.
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
2 of 6

Other medicines and Aulin
If you are taking any of the following medicines, which may interact with Aulin:

• Corticosteroids (drugs used to treat inflammatory conditions),
• Medicines to thin the blood (anticoagulants, e.g. warfarin, or antiplatelet agents, aspirin or other salicylates),
• Antihypertensives or diuretics (drugs for controlling blood pressure or heart disorders),
• Lithium, used to treat depression and similar disorders,
• Selective serotonin reuptake inhibitors (drugs used to treat depression),
• Methotrexate (drug used to treat rheumatoid arthritis and cancer treatment),
• Cyclosporine (drug used after a transplant or for the treatment of immune system disorders), make sure your doctor or pharmacist knows that you are taking these medicines before taking Aulin.

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

• Aulin should 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 decrease fertility.
• If you are in the first or second trimester of pregnancy, do not exceed the dose and duration of treatment prescribed by your doctor.

Aulin should not be used during breastfeeding.

Driving and using machines
Do not drive or use machines if Aulin makes you dizzy or sleepy.

Important information about some excipients of Aulin
Aulin tablets and oral suspension granules contain sugars. If you have been told by your doctor
that you have an intolerance to certain sugars, contact them before using this medicine.

3. HOW TO USE AULIN

Always take Aulin exactly as your doctor has instructed. If you have any doubts, ask your doctor or
pharmacist.
To reduce undesirable effects, the minimum effective dose should be used for the shortest time necessary to
control the symptoms.
The usual dose is one 100 mg tablet or one 100 mg sachet of granules for oral suspension, twice
a day. Use Aulin for the shortest possible period and for no more than 15 days in a single cycle of
treatment.
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
hospital immediately. Bring all remaining medicine with you. In case of overdose you will probably develop one
of the following symptoms: drowsiness, nausea, stomach pain, gastric ulcer, difficulty breathing.

If you forget to take Aulin:
Do not take a double dose to make up for a missed dose.
3 of 6

4. POSSIBLE SIDE EFFECTS

Like all medicines, Aulin may 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 it may indicate a rare, serious side effect that requires urgent medical attention:

• stomach discomfort or pain, loss of appetite, nausea (feeling sick), vomiting, gastric 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.

Side effects of a general nature of non-steroidal anti-inflammatory drugs (NSAIDs):
The use of some NSAIDs may be associated with a slight increase in the risk of blockage of the arteries
(thrombosis) such as heart attack (myocardial infarction) or stroke, particularly
with high doses and with long-term treatment.
Fluid retention (edema), high blood pressure (hypertension) and heart failure have been reported in association with NSAID treatment.
The most commonly observed side effects with NSAIDs concern the gastrointestinal tract (gastrointestinal effects):

• gastric and duodenal ulcers
• perforation of the intestinal walls or gastric or intestinal bleeding (sometimes fatal, especially in elderly patients).

The side effects that can occur with Aulin are:

• Common (may affect more than 1 in 100 people): diarrhea, nausea, vomiting, slight changes in blood test values of liver function.
• Uncommon (may affect up to 1 in 100 people): shortness of breath, dizziness, increased blood pressure, constipation, flatulence, heartburn (gastritis), itching, skin rashes, increased sweating, swelling (edema), bleeding of the stomach or intestine; ulcers of the duodenum or stomach and perforated ulcers.
• Rare (may affect up to 1 in 1,000 people): anemia, decrease in white blood cells in the blood, increase in some white blood cells (eosinophils) in the blood, changes in blood pressure, bleeding, pain during urination or urinary retention, blood in the urine, increased potassium in the blood, feeling of anxiety or nervousness, 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 people): severe skin reactions (known as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) causing skin rashes and severe illness; kidney failure or inflammation (nephritis); disturbances of brain function (encephalopathy); reduced number of platelets in the blood, causing subcutaneous bleeding or in other parts of the body, black stools due to bleeding; inflammation of the liver (hepatitis), sometimes very serious, causing jaundice and blockage of bile flow; allergies, including severe reactions with collapse and difficulty breathing, asthma, reduced body temperature, dizziness, headache, insomnia, stomach pains; indigestion, burning in the mouth, itching (urticaria); swelling of the face and surrounding areas, visual disturbances.

Medicines like Aulin may be associated with a slight increase in the risk of heart attack (myocardial
infarction) or stroke.
4 of 6

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or
pharmacist. You can also report side effects directly through the national reporting system
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects 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 which is reported on the carton after the words “exp.”. The expiry date
refers to the last day of the month.
Aulin tablets and granules for oral suspension: these medicines do not require any particular
storage conditions.
Medicines should 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 ingredient: nimesulide 100 mg. Excipients: sodium docusate, hydroxypropylcellulose, lactose monohydrate,
sodium carboxymethylcellulose A, microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate.

Aulin 100 mg granules for oral suspension
1 sachet contains:
Active ingredient: nimesulide 100 mg. Excipients: macrogol cetostearyl ether, sucrose, dried spray-granulated liquid glucose,
anhydrous citric acid, corn starch, orange flavour.

Description of the appearance of Aulin and contents of the pack
Tablets: Round tablets of white / light yellow colour contained in thermoformed blisters of
PVC/Aluminium. Pack sizes of 6, 9, 10, 15, 20 and 30 tablets. Not all pack sizes are
marketed.
Granules: Yellow granular powder contained in 2 g sachets made of aluminium, paper and polyethylene,
or aluminium, paper, polyethylene and Surlyn®. Pack sizes of 6, 9, 14, 15, 18 and 30 sachets. Not all
pack sizes are marketed.

Marketing Authorisation Holder and manufacturers responsible for batch release
For any information on this medicinal product, contact the local representative of the Marketing Authorisation Holder.

Marketing Authorisation Holder
Helsinn Birex Pharmaceuticals Ltd
Damastown
Mulhuddart - Dublin 15 - Ireland
5 of 6

Sales concessionaire
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.

6 of 6