Package leaflet: Information for the user

NIMESULENE 100 mg granules for oral suspension

Nimesulide
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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 only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What NIMESULENE is and what it is used for
What you need to know before taking NIMESULENE
How to take NIMESULENE
Possible side effects
How to store NIMESULENE
Contents of the pack and other information

1. What NIMESULENE is and what it is used for

NIMESULENE contains nimesulide and is an anti-inflammatory medicine belonging to the class of NSAIDs (Non-Steroidal Anti-Inflammatory Drugs), with analgesic properties.
NIMESULENE is used for the treatment of acute pain and menstrual pain in adult and adolescent patients (over 12 years of age).
Before prescribing NIMESULENE, your doctor will assess the potential benefits this medicine may provide against the risk of developing adverse effects.
NIMESULENE should only be prescribed as a second-line treatment.

2. What you need to know before taking NIMESULENE

Do not take NIMESULENE

If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
If you have experienced any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs):
Wheezing (noisy breathing), tightness in the chest, shortness of breath (asthma).
Nasal congestion due to protrusions (outgrowths) of the nasal mucosa (nasal polyps).
Skin rashes (changes in skin color and texture, appearing as red spots or bumps) and urticaria (sudden appearance on the skin of raised areas of varying size, usually very itchy).
Sudden swelling of the skin or mucous membranes, such as around the eyes, face, lips, mouth or throat, which may cause difficulty breathing (angioedema).
If you have previously experienced adverse effects during treatment with NSAIDs such as:
Bleeding from the stomach or intestines.
Stomach or intestinal ulcers (perforations) (gastric or intestinal hemorrhages).
If you have recently had or have previously had gastric or duodenal ulcers or bleeding (at least two episodes of ulcer or bleeding).
If you have had a cerebral hemorrhage (stroke).
If you have any other bleeding disorder or a condition due to a blood coagulation defect.
If you suffer from hepatic insufficiency (liver dysfunction).
If you are taking other medicines known to have a toxic effect on the liver, e.g. paracetamol or any other analgesic or treatment with NSAIDs.
If you are using drugs or have developed drug or other substance dependence.
If you are a heavy habitual drinker (of alcohol).
If you have previously had a reaction to the active substance (nimesulide) affecting the liver.
If you suffer from severe renal insufficiency (kidney dysfunction).
If you suffer from severe heart failure.
If you have fever or influenza (general malaise, chills or tremors, or elevated temperature).
If you are in the last trimester of pregnancy.
If you are breastfeeding (see "Pregnancy, breastfeeding and fertility").

Do not take NIMESULENE or inform your doctor before taking Nimesulene

If you have previously developed fixed drug eruption (round or oval patches with redness and swelling of the skin, skin eruptions with blisters, urticaria and itching) after taking nimesulide. Do not administer NIMESULENE to children under 12 years of age (see "Children").

Warnings and precautions
Consult your doctor or pharmacist before taking NIMESULENE.
The use of NIMESULENE may be associated with a modest 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 (e.g. if you have high blood pressure, diabetes, high cholesterol or if you smoke), discuss your treatment with your doctor or pharmacist.
If severe allergic reactions occur during treatment, stop taking NIMESULENE and inform your doctor at the first sign of skin rash, soft tissue lesions (mucous membranes) or any other allergy symptoms.
Immediately discontinue treatment with NIMESULENE in case of gastrointestinal bleeding (black stools) or ulcer of the digestive tract (causing abdominal pain).
Exercise particular caution if:

During treatment with NIMESULENE, symptoms indicating liver disorder occur. In this case, you must stop taking NIMESULENE and immediately inform your doctor. Symptoms indicating liver disorder include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and dark urine. Rare cases of serious hepatic reactions, including some very severe fatal cases, have been reported in association with NIMESULENE (see section 4 "Possible side effects").
You have previously suffered from peptic ulcer (erosion of the inner lining of the stomach or duodenum), bleeding from the stomach or intestines, or inflammatory bowel diseases such as ulcerative colitis or Crohn's disease. In this case, inform your doctor before taking NIMESULENE.

The risk of gastrointestinal bleeding, ulceration and perforation is higher with increasing doses
of NSAIDs in patients with a history of ulcers, especially if complicated by hemorrhage or perforation
(see "Do not take NIMESULENE") and in elderly patients.
During treatment with all NSAIDs, at any time, with or without warning symptoms or previous history of gastrointestinal events, gastrointestinal bleeding, ulceration and perforation have been reported, which may be fatal. If gastrointestinal bleeding or ulcers occur, treatment with NIMESULENE must be discontinued.

During treatment with NIMESULENE, fever and/or flu-like symptoms (general malaise, chills or tremors) occur. In this case, stop taking the product and inform your doctor.
You suffer from mild heart conditions, high blood pressure, circulatory or kidney problems. In this case, inform your doctor before taking NIMESULENE.
You are elderly. In this case, your doctor may perform regular checks to ensure that NIMESULENE does not cause problems to your stomach, kidneys, heart or liver.
You plan to become pregnant. In this case, inform your doctor because NIMESULENE may reduce your fertility (see "Pregnancy, breastfeeding and fertility").
You have an intolerance to certain sugars. Severe skin reactions, some of which have been fatal, have very rarely been reported in association with the use of NSAIDs. Patients appear to be at higher risk during the initial stages of therapy: the onset of the reaction usually occurs within the first month of treatment. NIMESULENE must be discontinued at the first sign of skin reaction, mucosal lesions or any other sign of allergy.

The use of NIMESULENE may impair female fertility and is not recommended in women attempting to conceive
(see "Pregnancy, breastfeeding and fertility").
Children
NIMESULENE is contraindicated in children under 12 years of age (see "Do not take NIMESULENE").
Other medicines and NIMESULENE
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicine.
If you are taking any of the following medicines, inform your doctor because they may interact with NIMESULENE:

Corticosteroids (medicines used to treat inflammatory conditions); these drugs increase the risk of gastrointestinal ulceration or bleeding.
Medicines to thin the blood (anticoagulants, e.g. warfarin, or antiplatelet agents, aspirin or other salicylates); NSAIDs may enhance the effects of anticoagulants. Patients receiving warfarin or similar anticoagulant agents have a higher risk of hemorrhagic complications (bleeding) when treated with NIMESULENE. Therefore, the combination is not recommended and is contraindicated in patients with severe coagulation disorders (see "Do not take NIMESULENE"). If the combination cannot be avoided, monitor anticoagulant activity closely.
Antihypertensives or diuretics (medicines for controlling blood pressure or heart conditions); NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with reduced kidney function (e.g. dehydrated patients or elderly patients with impaired renal function), the concomitant administration of an ACE inhibitor antihypertensive and NSAIDs may worsen kidney function. Administration of these drugs together should be done with caution, especially in elderly patients.
Lithium, used to treat depression and similar disorders (NSAIDs lead to increased blood levels of lithium, resulting in increased toxicity).
Selective serotonin reuptake inhibitors (medicines used to treat depression); these drugs increase the risk of stomach and intestinal bleeding.
Methotrexate (a medicine used to treat rheumatoid arthritis and cancer); caution is required if NIMESULENE is taken less than 24 hours before or after methotrexate treatment, as methotrexate blood levels may increase, thereby increasing the drug's toxicity.
Cyclosporine (a medicine used after organ transplantation or to treat immune system disorders); NSAIDs such as NIMESULENE may increase the nephrotoxic effects of cyclosporine.
Furosemide; concomitant use of furosemide and NIMESULENE requires caution in patients with kidney or heart disease. NIMESULENE transiently reduces the effect of furosemide on sodium excretion and, to a lesser extent, on potassium excretion, and reduces the diuretic response.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
NIMESULENE may reduce your fertility and is not recommended in women attempting to conceive
(see "Warnings and precautions").
NIMESULENE must not be used during the last trimester of pregnancy (see "Do not take NIMESULENE"). It may cause problems for the baby (cardiopulmonary toxicity and renal dysfunction) and during delivery (possible prolongation of bleeding time, reduced platelet aggregation which may occur even at very low doses, and inhibition of uterine contractions leading to delayed or prolonged labor).
If you are in the first or second trimester of pregnancy, do not exceed the dose or duration of treatment prescribed by your doctor.
The risk of miscarriage, congenital heart defects and gastroschisis (abdominal wall defect in which the intestine and sometimes other organs develop outside the fetal abdomen) is increased after use of an NSAID during early pregnancy. The risk is considered to increase with dose and duration of therapy.
NIMESULENE must not be used during breastfeeding (see "Do not take NIMESULENE").
Driving and using machines
Do not drive or operate machinery if NIMESULENE causes you dizziness or drowsiness.
NIMESULENE 100 mg oral granules for suspension contains sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

3. How to take NIMESULENE

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The usual dose is one 100 mg sachet of oral suspension granules, taken twice daily after meals.
Use NIMESULENE for the shortest possible duration and for no longer than 15 days in a single treatment cycle.

If you take more NIMESULENE than you should
If you take or think you have taken more NIMESULENE than prescribed (overdose), contact your doctor immediately or go to the nearest hospital.
Symptoms associated with acute NSAID overdose are usually limited to drowsiness, lethargy, nausea, vomiting, and pain in the upper central part of the abdomen, which are generally resolved with appropriate treatment. Bleeding from the stomach and intestines may occur. High blood pressure, acute kidney failure, respiratory failure, and coma may also occur, although rarely. Anaphylactic reactions (severe, rapidly developing allergic reactions) have been reported after ingestion of NSAIDs at therapeutic doses and could also manifest following overdose.

If you forget to take NIMESULENE
Do not take a double dose to make up for the missed dose.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If any of the following symptoms occur, stop treatment with NIMESULENE and inform your doctor immediately, as they may indicate a rare but serious side effect requiring urgent medical attention:

Stomach discomfort or pain, loss of appetite, nausea (feeling unwell), vomiting, gastrointestinal bleeding, or black stools.
Skin reactions such as rashes or redness.
Wheezing (noisy breathing) or shortness of breath.
Yellowing of the skin or eyes (jaundice).
Unexpected change in the amount or colour of urine.
Swelling of the face, feet or legs.
Persistent fatigue.

Rare cases of serious liver reactions, including some fatal ones, have been reported in association with NIMESULENE (see "Warnings and precautions").
The use of some NSAIDs, particularly at high doses and with long-term treatment, may be associated with a small increased risk of arterial thrombotic events (blockage of blood vessels), which could lead, for example, to heart attack (myocardial infarction) or stroke (cerebrovascular accident).
Oedema (fluid retention), hypertension (high blood pressure), and heart failure have been reported in association with NSAID therapy.

Side effects that may occur with NIMESULENE are:

Common (may affect more than 1 in 100 people): Diarrhoea, nausea, vomiting, increased liver enzymes (indicative of liver function).
Uncommon (may affect up to 1 in 100 people): Shortness of breath, dizziness, increased blood pressure, constipation, flatulence (gas accumulation in the stomach and intestine), itching, skin rash, increased sweating, swelling (oedema), stomach or intestinal bleeding, duodenal or gastric ulcers with perforation.
Rare (may affect up to 1 in 1,000 people): Anaemia (reduced red blood cells), increased levels of certain white blood cells (eosinophilia), hypersensitivity reactions, changes in blood pressure, haemorrhage, pain during urination or urinary retention, blood in the urine, increased potassium levels in the blood, anxiety or nervousness, nightmares, blurred vision, increased heart rate, hot flushes, skin redness (erythema), skin inflammation (dermatitis), malaise, fatigue.
Very rare (may affect up to 1 in 10,000 people): Decreased platelet count, reduced counts of all blood cells (pancytopenia), purpura (conditions characterised by red skin spots), sudden potentially fatal allergic reaction (anaphylaxis), headache, drowsiness, Reye's syndrome (a brain disorder), visual disturbances, asthma, breathing difficulty (bronchospasm), stomach inflammation (gastritis), abdominal pain, indigestion, mouth inflammation (stomatitis), blood in stools (melena), liver disorders (hepatitis, sometimes severe), jaundice, bile flow obstruction, urticaria, swelling of the face, lips, mouth, tongue or throat causing difficulty in swallowing or breathing (angioneurotic oedema), facial swelling, severe skin condition affecting the mouth and other body parts (erythema multiforme), rare skin condition with blisters and bleeding of the lips, eyes, mouth, nose and genitals (Stevens-Johnson syndrome), severe skin reaction (toxic epidermal necrolysis), inability of the bladder to empty (urinary retention), impaired kidney function (renal failure), reduced urine output (oliguria), interstitial nephritis (a kidney disease), decreased body temperature.
Not known (frequency cannot be estimated from available data): Fixed drug eruption (may present as round or oval patches with redness and swelling of the skin), blistering skin rash (urticaria), itching sensation.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at 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 NIMESULENE

This medicinal product does not require any special storage conditions.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the packaging after "Exp.".The expiry date refers to the last day of that month.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What NIMESULENE contains
Each sachet contains:
Active substance: nimesulide 100 mg.
Other components: sucrose, orange flavour, citric acid, maltodextrin, cetomacrogol.
Description of the appearance of NIMESULENE and contents of the pack
Yellowish granular powder – 30 sachets in a cardboard box.
Marketing Authorization Holder
Laboratori Guidotti S.p.A. - Via Livornese, 897 – PISA – La Vettola
Selling Licensee:
F.I.R.M.A. S.p.A. – Via di Scandicci, 37 - Florence
Manufacturer
Laboratorios Menarini S.A.- C/Alfonso XII, 587, 08918 Badalona - Barcelona (Spain).
Fine Foods & Pharmaceuticals N.T.M. S.p.A. - Via Grignano, 43, 24041 Brembate BG (Italy)