NIMESULIDE 100 mg Tablets

Зміст інструкції

1. NIMESULIDE PENSA 100 mg tablets, oral suspension granules
   1. WHAT IS NIMESULIDE PENSA AND WHAT IT IS USED FOR
   2. BEFORE YOU USE NIMESULIDE PENSA
   3. HOW TO USE NIMESULIDE PENSA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE NIMESULIDE PENSA
   6. FURTHER INFORMATION

NIMESULIDE PENSA 100 mg tablets, oral suspension granules

Nimesulide

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it to others. For other individualsthis medicine could be dangerous, even if their symptoms are the same as yours.
• If you notice worsening of undesirable effects, or an undesirable effect not mentioned in thisleaflet, inform your doctor or pharmacist.

Contents of this leaflet:

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

1. WHAT IS NIMESULIDE PENSA AND WHAT IT IS USED FOR

NIMESULIDE PENSA 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 NIMESULIDE PENSA, the doctor will assess the potential benefits this medicine
can give you compared to the risk of developing side effects.

2. BEFORE YOU USE NIMESULIDE PENSA

Do not use NIMESULIDE PENSA if

• you are hypersensitive (allergic) to nimesulide or any of the excipients of NIMESULIDE PENSA (listed at the end of this leaflet, in section 6);
• you have had allergic reactions (e.g. wheezing, runny or congested nose, urticaria) after taking aspirin or other non-steroidal anti-inflammatory drugs;
• you have had a reaction to nimesulide in the past that affected your liver;
• you are taking other medicines known to have an effect on the liver, e.g. paracetamol or any other analgesic or treatment with NSAIDs;
• you are taking drugs or have developed a dependence on drugs or other substances;
• you are a heavy habitual drinker (alcohol);
• you have a liver disease or an increase in liver enzymes (liver);
• you have, or have had in the past, a peptic ulcer (gastric or duodenal ulcer);
• you have had a cerebral haemorrhage (stroke);
• you have any other bleeding problem or blood coagulation defect;
• you have heart problems (heart failure) or a kidney disorder (poor kidney function) or a liver disorder;
• you have a fever or flu (general malaise, feeling unwell, chills or shivering or high temperature);
• you are in the last trimester of pregnancy;
• you are breastfeeding.
• if you have developed a fixed drug eruption in the past (round or oval patches with redness and swelling of the skin, skin rash with blisters, urticaria and feeling of itching) after taking nimesulide.

Do not give NIMESULIDE PENSA to a child under 12 years of age.

Take special care with NIMESULIDE PENSA

• If symptoms indicative of a liver disorder appear during treatment with nimesulide, you must 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, ulcerative colitis or Crohn's disease, you should inform your doctor before taking NIMESULIDE PENSA.
• If fever and/or flu-like symptoms (general malaise, feeling unwell, chills or shivering) appear during treatment with NIMESULIDE PENSA, you should stop taking the product and inform your doctor.
• If you suffer from heart or kidney disease, you should inform your doctor before taking NIMESULIDE PENSA; kidney function may worsen with treatment with NIMESULIDE PENSA.
• If you are elderly, your doctor may subject you to regular checks to ensure that NIMESULIDE PENSA does not cause problems with your stomach, kidneys, heart or liver.
• If you have an intolerance to certain sugars, contact your doctor before taking the medicine.
• If you are taking any of the following medicines, which may interact with NIMESULIDE PENSA:
• corticosteroids (drugs used for the treatment of inflammatory states)
• anticoagulants, e.g. warfarin or antiplatelet agents such as aspirin (drugs that prevent blood clot formation)
• selective serotonin reuptake inhibitors (drugs used in the treatment of depression)
• antihypertensives or diuretics (drugs for controlling blood pressure or heart)
• lithium, a drug used to control behavioral disorders
• methotrexate (a drug used to treat rheumatoid arthritis and cancer treatment)
• cyclosporine, a 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
NIMESULIDE PENSA.

• If a severe skin rash develops during treatment with nimesulide, stop treatment and consult your doctor.
• If gastrointestinal symptoms such as stomach pain, gastric bleeding or black stools develop, stop treatment immediately and consult your doctor.
• If you do not notice any benefit, tell your doctor. If you are planning a pregnancy, inform your doctor because NIMESULIDE PENSA may reduce fertility. Medicines such as NIMESULIDE PENSA 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 smoke), you should discuss your therapy
with your doctor or pharmacist.

Taking other medicines
Tell your doctor or pharmacist if you are taking or have recently taken other medicines, including
those available over the counter.

Pregnancy, breastfeeding and fertility
Consult your doctor or pharmacist before taking NIMESULIDE PENSA or any other medicine.

• If you are planning a pregnancy, inform your doctor as NIMESULIDE PENSA may decrease fertility.

Do not take NIMESULIDE PENSA in the last 3 months of pregnancy as it may harm the fetus
or cause problems with delivery. It can cause problems with the kidneys and heart of the unborn child. It can affect
your and your baby's tendency to bleed and delay or prolong labor more than expected.
You should not take NIMESULIDE PENSA during the first 6 months of pregnancy unless it is
absolutely necessary and recommended by your doctor.
If you need treatment during this period or while trying to become pregnant,
the lowest dose should be used for the shortest possible time. If taken for more than a few
days from the 20th week of pregnancy onwards, NIMESULIDE PENSA may cause kidney problems in the
unborn child that can lead to low levels of amniotic fluid surrounding the baby
(oligohydramnios) or may cause narrowing of a blood vessel (ductus arteriosus) in the baby's heart.
If treatment is necessary for more than a few days, your doctor may recommend
additional monitoring.
NIMESULIDE PENSA should not be used during breastfeeding.

Effects on ability to drive and operate machinery
Do not drive or operate machinery if NIMESULIDE PENSA causes you dizziness or drowsiness.

Important information regarding some excipients:
NIMESULIDE PENSA tablets contains lactose. If you have been diagnosed with an intolerance to
some sugars, contact your doctor before taking this medicine.
NIMESULIDE PENSA tablets contains less than 1 mmol (23mg) of sodium per tablet, i.e.
essentially ‘sodium-free’.
NIMESULIDE PENSA oral suspension granules contains sucrose. If you have been
diagnosed with an intolerance to some sugars, contact your doctor before taking this medicine.

3. HOW TO USE NIMESULIDE PENSA

Always take NIMESULIDE PENSA exactly as your doctor has instructed. If you have any doubts, ask your doctor or pharmacist. The usual dose is one 100 mg tablet or one 100 mg sachet of granules for oral suspension, twice a day after meals. Use NIMESULIDE PENSA for the shortest possible period and for no more than 15 days in a single treatment cycle.

If you take more NIMESULIDE PENSA than prescribed
If you take or think you have taken more NIMESULIDE PENSA than prescribed, contact your doctor or hospital immediately. Bring all the 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 NIMESULIDE PENSA
Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, NIMESULIDE PENSA can cause side effects, although they do not occur in
everyone.
If you experience any of the following symptoms, stop taking the medicine and inform your
doctor immediately 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, 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 colour of urine;
• swelling of the face, feet or legs;
• persistent fatigue. Medicines, such as NIMESULIDE PENSA, can be associated with a modest increase in the risk of heart attack (myocardial infarction) or stroke. Side effects that may occur with NIMESULIDE PENSA are:
• Common (may affect more than 1 in 100 people): diarrhoea, nausea, vomiting, slight changes in blood test values of liver function.
• Uncommon (may affect up to 1 in 100 people): bleeding of the stomach or intestine; ulcers of the duodenum or stomach and perforated ulcers; shortness of breath, dizziness, increased blood pressure, constipation, flatulence, heartburn (gastritis), itching, skin rashes, increased sweating, swelling (edema).
• Rare (may affect up to 1 in 1,000 people): anaemia, 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 discomfort; kidney failure or inflammation (nephritis); brain function disorders (encephalopathy); reduction in the number of platelets in the blood, causing subcutaneous or other bleeding, black stools due to bleeding, gastric or intestinal bleeding, duodenal or gastric ulcers, perforating ulcers; liver inflammation (hepatitis), sometimes very severe, causing jaundice and blockage of bile flow; allergies, including severe reactions with collapse and difficulty breathing, asthma, decreased body temperature, dizziness, headache, insomnia, stomach pains; indigestion, burning in the mouth, itching (urticaria); swelling of the face and surrounding areas, visual disturbances.
• Not known (frequency cannot be estimated from available data): Fixed drug eruption (may manifest with round or oval patches with redness and swelling of the skin), skin rash with blisters (urticaria), sensation of itching.

Reporting of side effects
If you experience any side effect, 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 https://ww.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help to provide more information on the safety of this medicine.

5. HOW TO STORE NIMESULIDE PENSA

Keep NIMESULIDE PENSA out of the reach and sight of children.
Do not use NIMESULIDE PENSA after the expiry date which is reported on the package after Expiry.
The expiry date indicated refers to the product in intact packaging, correctly
stored.
Tablets and oral suspension granules: no particular precautions for storage.

6. FURTHER INFORMATION

What contains NIMESULIDE PENSA 100 mg tablets

• The active ingredient is nimesulide 100 mg.
• The excipients are sodium dioctylsulfosuccinate, hydroxypropylcellulose, lactose, sodium starch glycolate, microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate

What contains NIMESULIDE PENSA 100 mg granules for oral suspension

• The active ingredient is nimesulide 100 mg.
• The excipients are cetomacrogol 1000, sucrose, maltodextrins, citric acid, orange flavour

Description of the appearance of NIMESULIDE PENSA 100 mg tablets and content of the pack
NIMESULIDE PENSA 100 mg tablets is a tablet coloured ivory white, round, biconvex.
The tablets are packaged in blisters in a cardboard box, containing 30 tablets.

Description of the appearance of NIMESULIDE PENSA 100 mg granules for oral suspension and content
of the pack
NIMESULIDE PENSA 100 mg granules for oral suspension is a granules coloured ivory white.
The granules are packaged in paper/aluminium/polyethylene sachets in a cardboard box, containing
30 sachets.

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Towa Pharmaceutical S.p.A. - Via Enrico Tazzoli, 6 - 20154 Milano - Italy
Manufacturer
Special Product’s Line S.p.A., Via Fratta Rotonda Vado Largo, 1 03012, Anagni (FR)