Package leaflet: Information for the patient

Nimesulide Mylan Generics 100 mg tablets, granules for oral suspension

nimesulide
Generic Medicine
Read this leaflet carefully before 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 could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Nimesulide Mylan Generics is and what it is used for

Nimesulide Mylan Generics contains the active substance nimesulide. Nimesulide Mylan Generics is a non-steroidal anti-inflammatory drug (NSAID) with analgesic properties.
Nimesulide Mylan Generics is indicated for the treatment of acute pain and menstrual pain.
Before prescribing Nimesulide Mylan Generics, your doctor will evaluate the potential benefits this medicine may provide you against the risk of developing adverse effects.

2. What you need to know before taking Nimesulide Mylan Generics

Do not take Nimesulide Mylan Generics

if you are allergic to nimesulide or to any of the other ingredients of this medicine (listed in section 6);
if you have previously had an allergic reaction (shortness of breath, runny or blocked nose, hives) after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs (NSAIDs);
if you have previously had a reaction to nimesulide that caused liver problems;
if you are taking other medicines known to be harmful to the liver, e.g. paracetamol, other painkillers, or other non-steroidal anti-inflammatory drugs;
if you are using drugs or have developed drug or other substance dependence;
if you are a heavy, regular drinker (alcohol);
if you have liver disease or elevated liver enzymes;
if you have a peptic ulcer (gastric or duodenal ulcer) or have had one in the past;
if you have had stomach or intestinal bleeding;
if you have had a cerebral haemorrhage (stroke);
if you have any other bleeding disorder or a condition due to a blood clotting defect;
if you have severe heart failure;
if you have severe renal failure (poor kidney function);
if you have hepatic failure (poor liver function);
if you have fever or flu-like symptoms (general malaise, discomfort, chills or shivering, or fever);
if you are in the last trimester of pregnancy;
if you are breastfeeding;
if 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 Mylan Generics to a child under 12 years of age.
Warnings and precautions
Talk to your doctor or pharmacist before taking Nimesulide Mylan Generics.
Be especially careful with Nimesulide Mylan Generics if:

during treatment you develop a severe, potentially life-threatening skin reaction. You must stop taking Nimesulide Mylan Generics at the first sign of skin rash, skin peeling, blisters, or bleeding of the lips, eyes, mouth, nose, or genitals, or any other symptom of an allergic reaction;
during treatment with Nimesulide Mylan Generics symptoms indicating liver disorder occur. These symptoms include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue, and dark urine. You must stop taking Nimesulide Mylan Generics and contact your doctor immediately;
during treatment with Nimesulide Mylan Generics you develop fever and/or flu-like symptoms (general malaise, discomfort, chills or shivering). You must stop taking the medicine and contact your doctor;
during treatment with Nimesulide Mylan Generics you experience stomach or intestinal problems (bleeding or peptic ulcer). You must stop taking the medicine and contact your doctor;
you have previously suffered from peptic ulcer, gastric or intestinal bleeding, ulcerative colitis, or Crohn’s disease. You must inform your doctor before taking Nimesulide Mylan Generics;
you are elderly. Your doctor may carry out regular checks to ensure that Nimesulide Mylan Generics does not cause problems with your stomach, kidneys, heart, or liver;
you have kidney problems. You must inform your doctor before taking Nimesulide Mylan Generics, as kidney function may worsen during treatment with Nimesulide Mylan Generics;
you have heart or circulatory 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 levels, or smoke). Medicines such as Nimesulide Mylan Generics may be associated with a slight 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.

Stop treatment with Nimesulide Mylan Generics immediately if gastrointestinal bleeding (black stools) or ulcer (cause of abdominal pain) occurs.
Children
Nimesulide Mylan Generics is not recommended in children under 12 years of age.
Other medicines and Nimesulide Mylan Generics
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, as they may interact with Nimesulide Mylan Generics:

corticosteroids (medicines used to treat inflammatory conditions);
medicines to thin the blood (anticoagulants, e.g. warfarin, antiplatelet agents, aspirin, or other salicylates);
antihypertensive or diuretic medicines (for controlling blood pressure or heart conditions);
lithium, used to treat depression or similar disorders;
medicines used to treat depression, known as selective serotonin reuptake inhibitors (SSRIs);
methotrexate (a medicine used to treat rheumatoid arthritis and cancer);
cyclosporine (a medicine used after organ transplantation or to treat immune system disorders).

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Nimesulide Mylan Generics during the last three months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your and your baby's tendency to bleed and may delay or prolong labour more than expected. You should not take Nimesulide Mylan Generics during the first six months of pregnancy unless absolutely necessary and under medical advice. If treatment is needed during this period or when trying to conceive, the lowest effective dose for the shortest possible time should be used. From week 20 of pregnancy, Nimesulide Mylan Generics may cause kidney problems in the fetus if taken for more than a few days, leading to reduced levels of amniotic fluid surrounding the baby (oligohydramnios) or causing constriction 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.
Breastfeeding
Do not take Nimesulide Mylan Generics while breastfeeding.
Fertility
Nimesulide Mylan Generics may cause fertility problems in women. Therefore, if you are planning to become pregnant, inform your doctor, as Nimesulide Mylan Generics may reduce fertility.
Driving and using machines
Nimesulide Mylan Generics may cause dizziness or drowsiness. If this occurs, avoid driving or operating machinery.
Nimesulide Mylan Generics 100 mg tablets contain lactose, sodium, and hydrogenated castor oil
Lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.
Sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.
Hydrogenated castor oil
May cause gastrointestinal discomfort and diarrhoea.
Nimesulide Mylan Generics 100 mg oral granules for oral suspension contain sucrose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Nimesulide Mylan Generics

Take this medicine exactly as your doctor or pharmacist has told you. If you are
unsure, consult your doctor or pharmacist.
The recommended dose is 1 tablet or sachet of 100 mg twice daily, after meals.
Take Nimesulide Mylan Generics for the shortest possible duration and for no longer than 15 days in a single
treatment cycle.
For oral use.
Nimesulide Mylan Generics 100 mg granules: the granules must be dissolved in a glass of water.
It is recommended to take Nimesulide Mylan Generics 100 mg tablets (or 100 mg granules) after meals.
If you take more Nimesulide Mylan Generics than you should
If you (or someone else) have taken an excessive dose of Nimesulide Mylan Generics, or if you suspect that a
child has taken an excessive dose, contact a doctor immediately.
Symptoms of overdose include: drowsiness, stupor, nausea, vomiting, stomach problems (pain, gastric ulcer, gastrointestinal bleeding), high blood pressure, kidney problems, breathing difficulties, and coma.
In case of accidental ingestion of an excessive dose of this medicine, contact a doctor immediately or go to the nearest hospital Emergency Department.
Take this leaflet, any remaining medicine, and its container with you to the hospital or doctor so they know which medicine has been taken.
If you forget to take Nimesulide Mylan Generics
If you forget to take a dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take a double dose to make up for the forgotten 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 gets them.
If any of the following symptoms occur, stop taking the medicine 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 or intestinal bleeding, or black stools;
Skin reactions such as rash 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 tiredness.

Side effects that may occur with Nimesulide Mylan Generics are:
Common (may affect up to 1 in 10 people)
Diarrhoea, nausea, vomiting, increased liver enzymes.
Uncommon (may affect up to 1 in 100 people)
Dizziness, high blood pressure, breathlessness, constipation, bloating (intestinal gas), stomach or intestinal bleeding, duodenal or gastric ulcer, perforated ulcers, itching, skin rash, increased sweating, fluid retention.
Rare (may affect up to 1 in 1,000 people)
Decreased red blood cells, increased levels of a type of white blood cells (eosinophilia), hypersensitivity reactions, increased blood potassium levels, anxiety, nervousness, nightmares, blurred vision, rapid heartbeat, bleeding, changes in blood pressure, hot flushes, skin redness, skin rash, difficulty urinating, blood in urine, malaise, unusual weakness.
Very rare (may affect up to 1 in 10,000 people)
Decreased platelets, decreased levels of all blood cells (pancytopenia), purpura (diseases characterised by red skin spots), sudden potentially life-threatening allergic reaction (anaphylaxis), headache, drowsiness, Reye's syndrome (a brain disorder), visual disturbances, asthma, breathing difficulties (bronchospasm), stomach inflammation, abdominal pain, indigestion, mouth inflammation (stomatitis), blood in stools, liver disorders (hepatitis, sometimes severe, jaundice, bile flow obstruction), urticaria, swelling of face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema), facial swelling, serious skin condition affecting the mouth and other body parts (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), reduced urine output, interstitial nephritis (a kidney disease), lowered body temperature.
Not known (frequency cannot be estimated from the available data)
Bleeding from the stomach, oesophagus or duodenum with vomiting (haematemesis), worsening of colon inflammation and Crohn’s disease (a chronic inflammatory bowel disease).
Drug-induced fixed eruption (may present as round or oval patches with redness and swelling of the skin), skin rash with blisters (urticaria), sensation of itching.

With the use of non-steroidal anti-inflammatory drugs (NSAIDs), the following side effects may also occur:

Slight increase in the risk of myocardial infarction or stroke (apoplectic stroke), particularly with high doses and prolonged treatment;
Reduced heart function (heart failure).

In association with NSAID treatment, fluid retention (oedema), high blood pressure (hypertension), and heart failure have been reported.
The most commonly observed side effects with NSAIDs involve the gastrointestinal tract (gastrointestinal effects):

Gastric and duodenal ulcers;
Perforation of intestinal walls or gastric or intestinal bleeding (sometimes fatal, especially in elderly patients).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may 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 Nimesulide Mylan Generics

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Nimesulide Mylan Generics contains
Nimesulide Mylan Generics 100 mg tablets
The active substance is nimesulide.
Each tablet contains 100 mg of nimesulide.
The other components are: sodium dioctyl sulfosuccinate, hydroxypropylcellulose, lactose, sodium starch glycolate, microcrystalline cellulose, hydrogenated castor oil, magnesium stearate.
Nimesulide Mylan Generics 100 mg granules for oral suspension
The active substance is nimesulide.
Each sachet contains 100 mg of nimesulide.
The other components are: cetomacrogol 1000, sucrose, maltodextrins, citric acid, orange flavour.

Description of the appearance of Nimesulide Mylan Generics and package contents
NIMESULIDE MYLAN GENERICS tablets: pack containing 30 tablets of 100 mg.
NIMESULIDE MYLAN GENERICS granules for oral suspension: pack containing 30 sachets of 100 mg.

Marketing Authorization Holder
Mylan S.p.A., Via Vittor Pisani 20, 20124 Milano
Manufacturers
Fine Foods & Pharmaceuticals N.T.M. S.p.A., Via Grignano 43, 24041 Brembate (BG)
Lamp San Prospero S.p.A., Via della Pace, 25/A, 41030 San Prospero S/S (MO)