Package leaflet

NIMESULIDE PENSA 100 mg tablets, granules for oral suspension

Nimesulide
Please read this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.
If you have further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you personally. Do not give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
If you notice worsening of any side effects, or any side effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of this leaflet:

What NIMESULIDE PENSA is and what it is used for
Before you take NIMESULIDE PENSA
How to take NIMESULIDE PENSA
Possible side effects
How to store NIMESULIDE PENSA
Further information

1. WHAT NIMESULIDE PENSA IS 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, your doctor will evaluate the potential benefits this medicine may provide you against the risk of developing adverse effects.

2. BEFORE USING NIMESULIDE PENSA

Do not use NIMESULIDE PENSA if

you are hypersensitive (allergic) to nimesulide or to any of the excipients in NIMESULIDE PENSA (listed at the end of this leaflet, in section 6);
you have had allergic reactions (e.g. wheezing, runny nose or nasal congestion, hives) after taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs);
you have previously experienced a liver-related reaction to nimesulide;
you are currently taking other medicines known to affect the liver, such as paracetamol or any other analgesic or treatment with NSAIDs;
you are using drugs or have developed drug or substance dependence;
you are a heavy, regular drinker (alcohol);
you have liver disease or elevated liver enzymes;
you have or have previously had peptic ulcer (gastric or duodenal ulcer);
you have had a haemorrhagic stroke (haemorrhagic stroke);
you have any other bleeding disorder or coagulation defect;
you have heart problems (heart failure), kidney disorder (poor kidney function), or liver disorder;
you have fever or flu-like symptoms (general malaise, chills or tremors, or high temperature);
you are in the last trimester of pregnancy;
you are breastfeeding;
you have previously developed drug-induced fixed eruption (round or oval patches with redness and swelling of the skin, skin rash with blisters, hives, and itching) after taking nimesulide.

Do not give NIMESULIDE PENSA to a child under 12 years of age.
Exercise particular caution with NIMESULIDE PENSA

If symptoms indicating liver disorder occur during treatment with nimesulide, you must stop taking nimesulide and contact your doctor immediately. Symptoms suggesting liver disorder include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue, and dark urine. If you have previously suffered from peptic ulcers, gastrointestinal bleeding, ulcerative colitis, or Crohn's disease, inform your doctor before taking NIMESULIDE PENSA.
If fever and/or flu-like symptoms (general malaise, chills or tremors) occur during treatment with NIMESULIDE PENSA, stop taking the medicine and contact your doctor.
If you suffer from heart or kidney disease, inform your doctor before taking NIMESULIDE PENSA; kidney function may worsen during treatment with NIMESULIDE PENSA.
If you are elderly, your doctor may carry out regular checks to ensure that NIMESULIDE PENSA is not causing problems to your stomach, kidneys, heart, or liver.
If you have an intolerance to certain sugars, consult your doctor before taking this medicine.
If you are taking any of the following medicines, which may interact with NIMESULIDE PENSA:
corticosteroids (medicines used to treat inflammatory conditions)
anticoagulants, e.g. warfarin, or antiplatelet agents such as aspirin (medicines that prevent clot formation)
selective serotonin reuptake inhibitors (medicines used to treat depression)
antihypertensives or diuretics (medicines for blood pressure or heart control)
lithium, a medicine used to control behavioural disorders
methotrexate (a medicine used to treat rheumatoid arthritis and cancer)
cyclosporine, a medicine used after organ transplantation or to treat immune system disorders.

Ensure that your doctor or pharmacist knows you are taking these medicines before starting
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 occur, stop treatment immediately and consult your doctor.
If you do not notice any benefit, inform your doctor. If you are planning to become pregnant, inform your doctor, as NIMESULIDE PENSA may reduce fertility. Medicines such as NIMESULIDE PENSA may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. The risk is greater with higher 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 smoke), discuss your treatment with your doctor or pharmacist.
Taking other medicines
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those without a prescription.
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 reduce fertility.

Do not take NIMESULIDE PENSA during the last 3 months of pregnancy, as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may affect your or your baby's tendency to bleed and may delay or prolong labour more than expected.
You should not take NIMESULIDE PENSA during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor.
If treatment is needed during this period or while trying to conceive, the lowest possible dose should be used for the shortest possible time. If taken for more than a few days from week 20 of pregnancy onwards, NIMESULIDE PENSA may cause kidney problems in the unborn child, leading 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 for more than a few days is required, your doctor may recommend additional monitoring.
NIMESULIDE PENSA must not be used during breastfeeding.
Effects on ability to drive and use machines
Do not drive or operate machinery if NIMESULIDE PENSA causes dizziness or drowsiness.
Important information about certain excipients:
NIMESULIDE PENSA tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
NIMESULIDE PENSA tablets contain less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
NIMESULIDE PENSA granules for oral suspension contain sucrose. If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. HOW TO USE NIMESULIDE PENSA

Always take NIMESULIDE PENSA exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. The usual dose is one 100 mg tablet or one 100 mg sachet of oral suspension granules, taken twice daily after meals. Use NIMESULIDE PENSA for the shortest possible duration and for no longer 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 go to the hospital immediately. Take any remaining medicine with you. In case of overdose, you may experience one or more of the following symptoms: drowsiness, nausea, stomach pain, gastric ulcer, breathing difficulties.

If you forget to take NIMESULIDE PENSA
Do not take a double dose to make up for a missed dose.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, NIMESULIDE PENSA may cause adverse reactions, although not everyone experiences them.
If any of the following symptoms occur, stop taking the medicine and inform your doctor immediately, as they could indicate a rare but serious adverse reaction requiring urgent medical attention:

stomach discomfort or pain, loss of appetite, nausea, vomiting, gastrointestinal bleeding, or black stools;
skin reactions such as rashes or redness;
wheezing or shortness of breath;
yellowing of the skin or eyes (jaundice);
unexpected changes in the amount or color of urine;
swelling of the face, feet, or legs;
persistent fatigue.

Medicines such as NIMESULIDE PENSA may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Adverse reactions that may occur with NIMESULIDE PENSA include:

Common (may affect more than 1 in 100 patients): diarrhea, nausea, vomiting, slight changes in blood test values indicating liver function.
Uncommon (may affect up to 1 in 100 patients): gastrointestinal bleeding; duodenal or gastric ulcers 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 patients): anemia, decreased white blood cells in blood, increased levels of certain white blood cells (eosinophils) in blood, changes in blood pressure, hemorrhage, pain during urination or urinary retention, blood in urine, increased potassium levels in blood, feelings 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 patients): severe skin reactions (known as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis) causing skin rashes and severe malaise; kidney failure or inflammation (nephritis); disturbances in brain function (encephalopathy); reduced platelet count in blood, leading to subcutaneous bleeding or bleeding elsewhere in the body, black stools due to bleeding, gastrointestinal bleeding, duodenal or gastric ulcers, perforating ulcers; liver inflammation (hepatitis), sometimes severe, causing jaundice and bile flow obstruction; allergic reactions, including severe reactions with collapse and breathing difficulties, asthma, reduced body temperature, dizziness, headache, insomnia, stomach pain; indigestion, mouth burning, itching (urticaria); facial swelling and swelling of surrounding areas, visual disturbances.
Not known (frequency cannot be estimated from available data): Drug-induced fixed eruption (may appear as round or oval patches with redness and swelling of the skin), skin rash with blisters (urticaria), sensation of itching.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting adverse reactions, you help 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 stated on the packaging after Exp.
The expiry date refers to the product in its original, unopened packaging, properly stored.
Tablets and oral suspension granules: no special storage precautions required.

6. OTHER INFORMATION

What NIMESULIDE PENSA 100 mg tablets contains

The active substance is nimesulide 100 mg.
The excipients are sodium dioctyl sulfosuccinate, hydroxypropylcellulose, lactose, sodium starch glycolate, microcrystalline cellulose, hydrogenated vegetable oil, magnesium stearate.

What NIMESULIDE PENSA 100 mg oral suspension granules contains

The active substance 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 contents of the pack
NIMESULIDE PENSA 100 mg tablets are white-ivory coloured, round, biconvex tablets.
The tablets are packed in blisters within a cardboard box containing 30 tablets.

Description of the appearance of NIMESULIDE PENSA 100 mg oral suspension granules and contents of the pack
NIMESULIDE PENSA 100 mg oral suspension granules is a white-ivory coloured granule.
The granules are packed in paper/aluminium/polyethylene sachets within a cardboard box containing 30 sachets.

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

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