In 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- Other information

AULIN 100 mg Tablets
AULIN 100 mg Granules for oral solution

The active ingredient is nimesulide.

The other ingredients are:
- Aulin tablets:
Sodium dioctyl sulfosuccinate, hydroxypropylcellulose, lactose, sodium amidoglycolate, microcrystalline cellulose, hydrogenated vegetable oil and magnesium stearate.

- Aulin granules for oral solution:
Cetomacrogol, saccarosis, maltodextrine, citric acid and orange flavour.

MARKET AUTHORIZATION HOLDER
Angelini Farmacêutica, Lda
Rua João Chagas 53, Piso 3,
1495-072 Algés

Under license of:
Helsinn Healthcare, S.A.
Switzerland

1- WHAT AULIN IS AND WHAT IT IS USED FOR?

Pharmacotherapeutic class:
9.1.7. - Non-steroidal anti-inflammatory drug - sulphanilamide derivatives

Aulin is a non-steroidal anti-inflammatory drug (NSAID), whose active substance is nimesulide, with analgesic and antipyretic properties, acting as an inhibitor of cyclooxygenase enzyme in the synthesis of prostaglandins.

Aulin is available under the form of tablets and granules for oral solution. To be administered by oral route.
- Packages with 14, 30 and 60 tablets.
- Packages with 14, 30 and 60 tablets.

Aulin is indicated in the treatment of the following situations:
- Treatment of acute pain.
- Symptomatic treatment of painful osteoarthrosis.
- Primary dysmenorrhoea.

2- BEFORE YOU TAKE AULIN

Do not take Aulin if:
- You have hypersensitivity to nimesulide or any of its excipients.
- You have history of hypersensitivity reactions (bronchospasm, rhinitis or urticaria) to acetylsalicylic acid or to other non-steroidal anti-inflammatory drugs.
- You have a gastric or duodenal active ulcer, history of recurrent ulcer or gastroduodenal bleeding, cerebrovascular bleeding or other active bleedings or haemorrhagic diseases.
- You have severe coagulation diseases.
- You have severe renal impairment.
- You have hepatic impairment.
- You are in the third trimester of pregnancy or you are breastfeeding.
Aulin should not be administered to children younger than 12 years.

Take special care with Aulin:
You should always inform your doctor about all the drugs you are taking.
When taking Aulin you should bear in mind the possibility of occurrence of the following drug interactions:
- Aulin may decrease the effect of diuretics, namely furosemide.
- The concomitant administration with warfarin, anticoagulants or platelet antiaggregants, including acetylsalicylic acid, carries an increased risk of hemorrhagic complications.
- When Aulin is prescribed to a patient on lithium therapeutics, a close monitoring of lithium levels should be performed, since NSAIDs may decrease its renal clearance, with the subsequent increase of plasma levels and toxicity.
- Caution should be exercised when using Aulin in association with drugs known to be involved in hepatic injury cases.
- Caution should be exercised if nimesulide is used in a period of less than 24 hours before or after the treatment with methotrexate because serum levels of methotrexate may rise and lead to an increase of its toxicity.
- Due to its effect on renal prostaglandins, nimesulide, may increase nephrotoxicity of cyclosporins.
- The undesirable effects may be reduced using Aulin during the shortest period possible.
- Elderly patients are particularly susceptible to adverse reactions. These patients should be regularly assessed by their doctor.
- Aulin must be carefully used in patients with gastrointestinal diseases including history of peptic ulcer, gastrointestinal bleeding, ulcerous colitis or Crohn disease. Bleeding or ulceration/ gastrointestinal perforation may occur at any time during the treatment with or without symptoms or previous history of gastrointestinal events.
- Precautions should be taken in patients with renal or cardiac impairment, since the use of
Aulin may deteriorate the renal function. In case of deterioration, treatment should be interrupted.
- The hepatic function should be carefully evaluated in patients treated with Aulin referring symptoms compatible with hepatic lesion (anorexia, nauseas, vomits, abdominal pain, fatigue, dark urine) and/or which develop changes in hepatic function exams. These patients should not take nimesulide.
- The simultaneous administration of drugs known as hepatotoxics and alcohol abuse have to be avoided during treatment with Aulin since they may increase the risk of hepatic reactions.
- During treatment with Aulin patients should be advised not to take other analgesics. It is not recommended the simultaneous use of different NSAIDs.
- Nimesulide should be used with caution in patients with hemorrhagic predisposition, since it may interfere with platelets’ function.
- NSAIDs may mask a fever related a subjacent bacterial infection.
- The use of Aulin may affect females’ fertility, thus, it is not recommended in women who are trying to get pregnant. Aulin interruption should be considered in women who have difficulties in getting pregnant or who are being investigated for infertility.

Taking Aulin with drinks or food:
Alcohol abuse has to be avoided during treatment with Aulin since it may increase the risk of hepatic reactions.

Pregnancy:
Ask your doctor or pharmacist before taking any drug. Aulin is contraindicated in the third trimester of pregnancy.
Aulin is not recommended to women who are trying to get pregnant.
Since there are no adequate data available on the use of drugs containing nimesulide in pregnant women, it is not recommended the prescription of the drug during the first two trimesters of pregnancy.

Lactation:
Ask your doctor or pharmacist before taking any drug.
As it is not known whether nimesulide is excreted in breast milk, Aulin is contraindicated during lactation.

Ability to drive and use of machines:
The effects of Aulin on the ability to drive and use machines were not studied. However, patients who experience dizziness, vertigo or drowsiness after taking Aulin, should refrain from driving or using machines.

Important information about the excipients of Aulin:
If you were informed by your doctor that you are intolerant to some sugars, contact him before taking this medicine.

3. HOW TO TAKE AULIN?

Aulin should be used during the shortest time possible, according to the clinical situation.
Always take Aulin according to the doctor’s instructions. If you have any doubts, ask your doctor or pharmacist.

Adults: tablets and granules for oral solution: 1 tablet or 1 sachet of Aulin, bid, after meals.

Elderly: It is not necessary to reduce the daily dose in elderly patients

Children (<12 years): Aulin is contraindicated in these patients

Teenagers (from 12 to 18 years): according to the kinetic profile in adults and the pharmacodynamic characteristics of nimesulide, it is not necessary to adjust the dosage in these patients.

Renal impairment: It is not necessary to adjust the dosage in patients with mild to moderate renal impairment. In case of severe renal impairment, Aulin is contraindicated.

Hepatic impairment: the use of Aulin in patients with hepatic impairment is contraindicated.

If you take more Aulin than you should:
As with any other medicine, the previously recommended doses should not be exceeded. However, if by chance you take much more than the recommended dose, contact your doctor or go to the nearest Hospital.
Symptoms after an acute overdosage of NSAID are usually limited to lethargy, drowsiness, nauseas, vomits and epigastric pain and they are generally reversible with support treatment. It may occur gastrointestinal haemorrhage. Although rare, hypertension, acute renal impairment, respiratory depression and coma may occur. Anaphylactic reactions were reported with the therapeutic ingestion of NSAID and these may occur after an overdosage.
After an overdosage with a NSAID, patients should be submitted to a symptomatic and support treatment. There are no specific antidotes.

If you forgot to take Aulin:
In this situation you should resume as soon as possible the posological scheme previously established by your doctor. Do not take two doses to compensate for the dose you forgot.

4. POSSIBLE SIDE EFFECTS
Like with all medicines, Aulin may cause side effects. The following side effects were reported:

Blood diseases:
Rare: Anaemia and Eosinophily (increase of the number of eosinophils in the blood).

Immune system diseases: Rare: Hipersensitivity.

Metabolism and nutrition diseases:
Rare: Hypercaliemia (increase of potassium values).

Psychiatric disorders:
Rare: Anxiety, Nervousness, Nightmares.

Nervous system diseases:
Not frequent: Dizziness.

Vision disorders:
Rare: Blurred vision.

Cardiopathies:
Rare: Tachycardia (acceleration of the cardiac rhythm).

Vasculopathies:
Not frequent: Hypertension (increase of blood pressure).
Rare: Bleeding, changes in blood pressure, flushes.

Respiratory diseases:
Not frequent: Dyspnoea (difficulty in breathing).

Gastrointestinal diseases:
Frequent: Diarrhoea, Nauseas, Vomits
Not frequent: Constipation, Flatulence, Gastritis (inflammation of stomach mucosa)

Disorders of cutaneous and subcutaneous tissues:
Not frequent: Pruritus (itching), cutaneous eruption, sweat increase.
Rare: Erythema (skin redness), Dermatitis (inflammation of the skin).

Renal and urinary diseases:
Rare: Dysuria (Painful or difficult urination), Hematuria (presence of blood in the urine), urinary retention
(impossibility in eliminating urine).

General disorders:
Not frequent: Oedema.
Rare: Malaise, Asthenia (decrease of strength).

Diagnostic complementary exams:
Frequent: Increase of hepatic enzymes.

If you notice any side effects not mentioned in this leaflet, please inform you doctor or pharmacist.

5. HOW TO STORE AULIN

Do not use after the expiry term stated on the package.

Keep it in the sale package protected from heat and humidity, at a temperature below 25ºC.

Keep the medicines out of reach and sight of children.

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