NIMESULENE 100 mg Granulki Do Sporządzania Zawiesiny Doustnej

Treść ulotki

1. NIMESULENE 100 mg granules for oral suspension
   1. What is NIMESULENE and what is it used for
   2. What you need to know before taking NIMESULENE
   3. How to take NIMESULENE
   4. Possible side effects
   5. How to store NIMESULENE
   6. Contents of the pack and other information

NIMESULENE 100 mg granules for oral suspension

Nimesulide

Read this leaflet carefully before using 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What NIMESULENE is and what it is used for
• 2. What you need to know before you take NIMESULENE
• 3. How to take NIMESULENE
• 4. Possible side effects
• 5. How to store NIMESULENE
• 6. Contents of the pack and other information

1. What is NIMESULENE and what is it used for

NIMESULENE contains nimesulide and is an anti-inflammatory drug 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 subjects (over 12 years of age).
Before prescribing NIMESULENE, the doctor will assess the potential benefits this medicine can
give you compared to the risk of developing undesirable 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 had any of the following symptoms after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs):
• Wheezing (noise) in breathing, feeling of tightness in the chest, shortness of breath (asthma).
• Nasal congestion due to protuberances (growths) of the internal nasal mucosa (nasal polyps).
• Skin rashes (change in color and texture of the skin that becomes covered with red spots or bumps) and hives (sudden appearance on the skin of raised areas of varying sizes, usually very itchy).
• 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).
• If you have had adverse effects in the past following treatments with NSAIDs such as:
• Loss of blood from the stomach or intestines.
• Ulcers (perforations) in the stomach or intestines (gastric or intestinal bleeding).
• If you have recently had a stomach or duodenal ulcer or have had them in the past (at least two episodes of ulcer or bleeding).
• If you have had a brain hemorrhage (stroke).
• If you have any other bleeding problems or problems due to a blood clotting defect.
• If you suffer from liver failure (malfunctioning liver).
• If you are taking other medicines known to have a toxic effect on the liver, e.g. paracetamol or any other analgesic or NSAID treatment.
• If you are taking drugs or have developed a dependence on drugs or other substances.
• If you are a heavy regular drinker (of alcohol).
• If you have had a reaction in the past to the active substance (nimesulide) that affected the liver.
• If you suffer from severe kidney failure (malfunctioning kidneys).
• If you suffer from severe heart failure.
• If you have a fever or flu (feeling of general malaise, discomfort, chills or tremors, or high temperature).
• If you are in the last trimester of pregnancy.
• If you are breastfeeding (see “Pregnancy, breastfeeding and fertility”).

Do not take NIMESULENE or tell your doctor before taking Nimesulene

• If you have developed a fixed drug eruption (round or oval patches with redness and swelling of the skin, skin rash with blisters, hives and a feeling of itching) after taking nimesulide. Do not administer NIMESULENE to children under 12 years of age (see “Children”).

Warnings and precautions
Talk to 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 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 NIMESULENE and inform your doctor at the first appearance of skin rashes, soft tissue (mucous membrane) lesions or any other symptom of allergy.
Immediately stop treatment with NIMESULENE in the presence of gastrointestinal bleeding (with black stools) or ulcer of the digestive tract (causing abdominal pain).
Take special care if:

• during treatment with NIMESULENE, symptoms indicative of a liver disorder appear. In this case, you should stop taking NIMESULENE and immediately inform your doctor. Symptoms indicative of a liver disorder are loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and dark urine. In rare cases, an association between NIMESULENE and severe liver reactions, including some very serious fatal cases, has been reported (see section 4 “Possible side effects”).
• you have suffered from a peptic ulcer (erosion of the inner lining of the stomach or duodenum), blood loss from the stomach or intestines, or inflammatory bowel diseases such as ulcerative colitis or Crohn's disease. In this case, you should 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 ulcer, especially if complicated by bleeding or perforation (see “Do not take NIMESULENE”) and in the elderly.
During treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of gastrointestinal events, gastrointestinal bleeding, ulceration and perforation have been reported, which can be fatal. If gastrointestinal bleeding or ulcers occur, treatment with NIMESULENE should be discontinued.

• during treatment with NIMESULENE, fever and/or flu-like symptoms (feeling of general malaise, discomfort, chills or tremors) appear. In this case, you should stop taking the product and inform your doctor.
• you suffer from mild heart problems, high blood pressure, circulatory problems or kidney problems. In this case, you should inform your doctor before taking NIMESULENE.
• you are elderly. In this case, your doctor may subject you to regular checks to ensure that NIMESULENE does not cause problems with your stomach, kidneys, heart or liver.
• you are planning 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 been reported very rarely in association with the use of NSAIDs. Patients appear to be at higher risk in the early stages of therapy: the onset of the reaction occurs in most cases within the first month of treatment. NIMESULENE should be discontinued at the first appearance of a skin reaction (of the skin), mucous membrane lesion or any other sign of allergy.

The use of NIMESULENE may impair female fertility and is not recommended in women trying 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
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
If you are taking any of the following medicines, inform your doctor because these may interact with NIMESULENE:

• Corticosteroids (drugs used to treat inflammatory conditions); these drugs increase the risk of ulceration or gastrointestinal bleeding.
• Medicines to thin the blood (anticoagulants, e.g. warfarin, or antiplatelet agents, aspirin or other salicylates); NSAIDs may increase the effects of anticoagulants. Patients receiving warfarin or similar anticoagulant agents have a higher risk of bleeding complications if treated with NIMESULENE. The association is therefore not recommended and is contraindicated in patients with severe blood clotting disorders (see “Do not take NIMESULENE”). If the association cannot be avoided, carefully monitor anticoagulant activity.
• Antihypertensives or diuretics (drugs for controlling blood pressure or heart disorders); NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients

with impaired renal function (e.g. dehydrated patients or elderly patients with impaired renal function) concomitant administration of an ACE inhibitor and NSAIDs may exacerbate renal impairment. The administration of these drugs in combination should be carried out with caution, especially in elderly patients.

• Lithium, used to treat depression and similar disorders (NSAIDs lead to an increase in lithium levels in the blood with a consequent increase in its toxicity).
• Selective serotonin reuptake inhibitors (drugs used to treat depression); these drugs increase the risk of bleeding in the stomach and intestines.
• Methotrexate (a drug used to treat rheumatoid arthritis and cancer); caution is required if NIMESULENE is taken less than 24 hours before or after methotrexate treatment because methotrexate levels in the blood may increase and therefore the toxicity of this drug may be greater.
• Cyclosporine (a drug used after a transplant or for the treatment of immune system disorders); NSAIDs such as NIMESULENE may increase the negative effects of cyclosporine on the kidneys.
• Furosemide; the 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, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
NIMESULENE may reduce your fertility and is not recommended in women trying to conceive (see “Warnings and precautions”).
NIMESULENE should not be used during the last trimester of pregnancy (see "Do not take NIMESULENE"). It can cause problems for the baby (cardiopulmonary toxicity and renal dysfunction) and at the time of delivery (possible prolongation of bleeding time, decrease in platelet aggregation which can also occur at very low doses and inhibition of uterine contractions leading to delayed or prolonged labor).
The risk of abortion, heart malformation and gastroschisis (defect of the abdominal wall in which the intestine and sometimes other organs develop outside the fetal abdomen) is higher after the use, in the first phase of pregnancy, of an NSAID. It has been considered that the risk increases with the dose and duration of therapy.
NIMESULENE should not be used during breastfeeding (see “Do not take NIMESULENE”).

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

NIMESULENE 100 mg granules for oral suspension contains sucrose
If you have been diagnosed with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take NIMESULENE

Take this medicine following exactly the instructions of 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, twice a day after meals.
Use NIMESULENE for the shortest possible period and for no more than 15 days in a single cycle of
treatment.

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.
The symptoms associated with acute NSAID overdose are usually limited to drowsiness, lethargy, nausea, vomiting
and pain in the upper and central abdomen, generally resolvable with appropriate therapy. Bleeding from the stomach and
intestines may occur. It is also possible, albeit
rarely, to experience high blood pressure, acute renal failure, respiratory failure and coma. Anaphylactic reactions (severe
rapidly appearing allergic reaction) have been reported after ingestion of NSAIDs at therapeutic doses, which could also
manifest after overdose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following symptoms, stop treatment with NIMESULENE 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 unwell), vomiting, gastrointestinal bleeding, or black stools.
• Skin reactions (of the skin) such as rashes or redness.
• Wheezing (noise) 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.

In rare cases, an association between NIMESULENE and serious liver reactions, including some very serious and
fatal cases, has been reported (see “Warnings and precautions”).
The use of some NSAIDs, particularly at high doses and with long-term treatment, may be
associated with a modest increase in the risk of closure of arterial blood vessels (thrombosis) which
may cause, for example, heart attack (myocardial infarction) or stroke.
Edema (fluid retention), hypertension
(high blood pressure) and heart failure have been reported in association with NSAID treatment.
The side effects that may occur with NIMESULENE are:

• Common (may affect more than 1 in 100 people): Diarrhea, 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 (production of air at the level of the stomach and

intestine), itching, skin rashes, increased sweating, swelling (edema), bleeding from the stomach or intestine, ulcers of the duodenum and stomach with perforation.

• Rare (may affect up to 1 in 1,000 people): Anemia (decrease in red blood cells in the blood), increase in some white blood cells in the blood (eosinophilia), hypersensitivity reactions, changes in blood pressure, bleeding, pain during urination or urinary retention, blood in the urine, increased potassium in the blood, anxiety or nervousness, nightmares, blurred vision, increased heart rate, hot flashes, skin redness (erythema), skin inflammation (dermatitis), malaise, fatigue.
• Very rare (may affect up to 1 in 10,000 people): Decreased platelets, decreased of all blood cells (pancytopenia), purpura (diseases characterized by reddish skin spots), a sudden, potentially fatal allergic reaction (anaphylaxis), headache, drowsiness, Reye's syndrome (a brain disease), visual disturbances, asthma, difficulty breathing (bronchospasm), inflammation of the stomach (gastritis), abdominal pain, indigestion, inflammation of the mouth (stomatitis), blood in the stool (melena), liver disorders (hepatitis, sometimes very serious), jaundice, blockage of the bile flow, hives, swelling of the face, lips, mouth, tongue or throat that can cause difficulty swallowing and breathing (angioedema), swelling of the face, severe skin condition affecting the mouth and other parts of the body (erythema multiforme), rare skin condition with blisters and bleeding of lips, eyes, mouth, nose and genitals (Stevens Johnson syndrome), severe skin reaction (toxic epidermal necrolysis), inability of the bladder to empty (urinary retention), altered kidney function (renal failure), decreased urine output (oliguria), interstitial nephritis (a kidney disease), lowering of body temperature.
• Not known (frequency cannot be estimated on the basis of available data): Fixed drug eruption (may manifest with round or oval patches with redness and swelling of the skin), skin eruption with blisters (urticaria), sensation of itching.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 medicine does not require any particular storage conditions.
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date that is reported on the packaging after “Exp.” The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to eliminate
medicines that you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NIMESULENE contains
1 sachet contains:

Active ingredient: nimesulide 100 mg.

Other components: sucrose, orange flavour, citric acid, maltodextrin, cetomacrogol.

Description of the appearance of NIMESULENE and contents of the pack
Light yellow-coloured granular powder - 30 sachets in a cardboard box.

Marketing Authorisation Holder
Laboratori Guidotti S.p.A. - Via Livornese, 897 – PISA – La Vettola
Distributor for sales:
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)