this leaflet carefully before taking the medicine:
- Keep this leaflet. You may need to read it again.
- If you have any doubts, ask your doctor or pharmacist.
- This medicine was prescribed to you. You should not give it to
others: the medicine may be harmful to them even if they have the
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
100 mg Tablets
AULIN 100 mg Granules for oral solution
The active ingredient is nimesulide.
The other ingredients
- 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.
Angelini Farmacêutica, Lda
Rua João Chagas 53, Piso 3,
Helsinn Healthcare, S.A.
WHAT AULIN IS AND WHAT IT IS USED FOR?
- Non-steroidal anti-inflammatory drug - sulphanilamide derivatives
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.
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.
is indicated in the treatment of the following situations:
- Treatment of acute pain.
- Symptomatic treatment of painful osteoarthrosis.
- Primary dysmenorrhoea.
BEFORE YOU TAKE AULIN
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
- 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.
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
- 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
- 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.
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.
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.
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.
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?
should be used during the shortest time possible, according to the clinical
Always take Aulin according to the doctor’s instructions. If you
have any doubts, ask your doctor or pharmacist.
tablets and granules for oral solution: 1 tablet or 1 sachet of Aulin,
bid, after meals.
It is not necessary to reduce the daily dose in elderly patients
(<12 years): Aulin is contraindicated in these patients
(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.
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.
impairment: the use of Aulin in patients with hepatic impairment is
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.
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.
POSSIBLE SIDE EFFECTS
Like with all medicines, Aulin may cause side effects. The following side
effects were reported:
Rare: Anaemia and Eosinophily (increase of the number of eosinophils in
system diseases: Rare: Hipersensitivity.
and nutrition diseases:
Rare: Hypercaliemia (increase of potassium values).
Rare: Anxiety, Nervousness, Nightmares.
Not frequent: Dizziness.
Rare: Blurred vision.
Rare: Tachycardia (acceleration of the cardiac rhythm).
Not frequent: Hypertension (increase of blood pressure).
Rare: Bleeding, changes in blood pressure, flushes.
Not frequent: Dyspnoea (difficulty in breathing).
Frequent: Diarrhoea, Nauseas, Vomits
Not frequent: Constipation, Flatulence, Gastritis (inflammation of stomach
of cutaneous and subcutaneous tissues:
Not frequent: Pruritus (itching), cutaneous eruption, sweat increase.
Rare: Erythema (skin redness), Dermatitis (inflammation of the skin).
and urinary diseases:
Rare: Dysuria (Painful or difficult urination), Hematuria (presence of
blood in the urine), urinary retention
(impossibility in eliminating urine).
Not frequent: Oedema.
Rare: Malaise, Asthenia (decrease of strength).
Frequent: Increase of hepatic enzymes.
you notice any side effects not mentioned in this leaflet, please inform
you doctor or pharmacist.
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.
the medicines out of reach and sight of children.