NIMESULIDE 100 mg Tabletki

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

Nimesulide Mylan Generics 100 mg tablets, granules for oral suspension

nimesulide

Equivalent Medicinal Product
Read this leaflet carefully before taking this medicine as 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 may be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Nimesulide Mylan Generics contains the active ingredient 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, the doctor will assess the potential benefits this
medicine can provide you with compared to the risk of developing undesirable 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 any of the other ingredients of this medicine (listed in section 6);
• if you have previously had an allergic reaction (difficulty breathing, runny or blocked nose, hives) after taking acetylsalicylic acid (aspirin) or other non-steroidal anti-inflammatory drugs;
• 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, such as paracetamol, other painkillers or other non-steroidal anti-inflammatory drugs;
• if you are taking drugs or have developed a dependence on drugs or other substances;
• if you are a heavy habitual drinker (alcohol);
• if you have a liver disease or an increase in liver enzymes (liver);
• if you have a peptic ulcer (gastric or duodenal ulcer) or have had one in the past;
• if you have had bleeding in the stomach or intestines;
• if you have had a brain haemorrhage (stroke);
• if you have any other bleeding problem or problem due to a blood clotting defect;
• if you have severe heart failure;
• if you have severe kidney failure (poorly functioning kidneys);
• if you have liver failure (poorly functioning liver);
• if you have a fever or flu (general feeling of malaise, discomfort, chills or shaking or fever);
• if you are in the last trimester of pregnancy;
• if you are breastfeeding;
• if you have previously 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 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 particularly careful with Nimesulide Mylan Generics if:

• during treatment you develop a severe skin reaction that could be fatal. You must stop taking Nimesulide Mylan Generics at the first sign of skin rash, skin peeling, blisters and bleeding of the lips, eyes, mouth, nose and genitals or any other symptom of an allergic reaction;
• during treatment with Nimesulide Mylan Generics, symptoms indicative of a liver disorder appear. These symptoms are loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue and dark urine. You should stop taking Nimesulide Mylan Generics and inform your doctor immediately;
• during treatment with Nimesulide Mylan Generics, fever and/or flu-like symptoms (general feeling of malaise, discomfort, chills or shaking) appear. You should stop taking the medicine and inform your doctor;
• during treatment with Nimesulide Mylan Generics, you experience problems with your stomach or intestines (bleeding or peptic ulcer). You should stop taking the medicine and inform your doctor;
• you have suffered from a peptic ulcer, gastric or intestinal bleeding, ulcerative colitis or Crohn's disease. You should inform your doctor before taking Nimesulide Mylan Generics;
• you are elderly. Your doctor may subject you to regular checks to ensure that Nimesulide Mylan Generics does not cause problems with your stomach, kidneys, heart or liver;
• you have kidney problems. You should inform your doctor before taking Nimesulide Mylan Generics as kidney function may worsen with treatment with Nimesulide Mylan Generics;
• you have heart problems, blood circulation 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 if you smoke). Medicines like 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 treatments. Do not exceed the recommended dose or duration of treatment.

Stop treatment with Nimesulide Mylan Generics immediately if bleeding occurs (with
black stools) or ulceration of the digestive tract (causing abdominal pain).

Children
Nimesulide Mylan Generics is not recommended in children under the age of 12 years.

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, tell your doctor because these 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)
• medicines for high blood pressure or diuretics (for controlling blood pressure or heart disorders)
• lithium, used to treat depression or similar disorders
• medicines used to treat depression, known as selective serotonin reuptake inhibitors (SSRIs)
• methotrexate (medicine used to treat rheumatoid arthritis and cancer)
• cyclosporine (medicine used after a transplant or to treat disorders of the immune system).

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Nimesulide Mylan Generics in the last 3 months of pregnancy as it may harm
the fetus or cause problems during childbirth. It may cause problems with the kidneys and heart of the fetus. It may affect
your and your baby's tendency to bleed and delay or prolong labour more than expected. You should not take Nimesulide Mylan Generics in the first 6 months of pregnancy unless absolutely
necessary and under the advice of your doctor. If treatment is needed during this period or during attempts
to conceive, the minimum dose should be used for the shortest possible time. From the 20th week
of pregnancy, Nimesulide Mylan Generics can cause kidney problems in the fetus if taken for more than a few
days, thus reducing the levels of amniotic fluid surrounding the baby (oligohydramnios) or causing
the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is needed for more than a few
days, your doctor may advise additional monitoring
Breastfeeding
Do not take Nimesulide Mylan Generics while breastfeeding.
Fertility
Nimesulide Mylan Generics can cause fertility problems in women. Therefore, if you are planning to start a
pregnancy, you should inform your doctor because Nimesulide Mylan Generics may reduce fertility.

Driving and using machines
Nimesulide Mylan Generics can cause dizziness or drowsiness. If this happens to you, do not drive vehicles
or use machines.

Nimesulide Mylan Generics 100 mg tablets contains lactose, sodium and hydrogenated castor oil

Lactose
If you have been diagnosed with intolerance to some sugars, contact your doctor 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 stomach upset and diarrhoea.

Nimesulide Mylan Generics 100 mg granules for oral suspension contains sucrose.
If you have been diagnosed with intolerance to some sugars, contact your doctor before taking this
medicine.

3. How to take Nimesulide Mylan Generics

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 tablet or sachet of 100 mg 2 times a day, after meals.
Take Nimesulide Mylan Generics for the shortest possible period and for no more 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 swallowed an excessive dose of Nimesulide Mylan Generics, or if you think a
child has swallowed an excessive dose, consult a doctor immediately.
The symptoms of an overdose are as follows: drowsiness, lethargy, nausea, vomiting, stomach problems
(pain, gastric ulcer, gastrointestinal bleeding), high blood pressure, kidney problems, difficulty
breathing and coma.
In case of accidental intake/ingestion of an excessive dose of this medicine, inform
your doctor immediately or go to the Emergency Room of the nearest hospital.
Bring this leaflet, the remaining medicine and its container to the hospital or doctor so
they know which medicine was 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 to take
the next dose. 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 everybody gets them.
If you experience any of the following symptoms, stop taking the medicine and immediately inform your
doctor as it may indicate a rare but serious side effect that requires urgent medical attention:

• stomach or abdominal discomfort or pain, loss of appetite, nausea (feeling sick), 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 color of urine;
• swelling of the face, feet or legs;
• persistent fatigue.

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 (of the liver).

Uncommon(may affect up to 1 in 100 people)
Dizziness, high blood pressure, shortness of breath, constipation, presence of gas in the intestine, bleeding
from the stomach or intestine, duodenal or stomach ulcer and perforated ulcers, itching, skin rash, increased sweating, fluid retention in the body.

Rare(may affect up to 1 in 1,000 people)
Decreased red blood cells, increased type of white blood cells (eosinophilia), hypersensitivity reactions,
increased potassium levels in the blood, anxiety, nervousness, nightmares, blurred vision, fast
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 of all blood cells (pancytopenia), purpura (diseases
characterized by reddish skin spots), sudden, potentially life-threatening allergic reaction
(anaphylaxis), headache, drowsiness, Reye's syndrome (a brain disease), visual disturbances, asthma,
difficulty breathing (bronchospasm), inflammation of the stomach, abdominal pain, indigestion,
inflammation of the mouth (stomatitis), blood in the stool, 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), facial swelling, 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), impaired kidney function (renal failure), decreased urine output, interstitial nephritis
(a kidney disease), lowered body temperature.

Not known(frequency cannot be estimated from available data)
Bleeding from the stomach, esophagus or duodenum with vomiting (hematemesis), worsening
of inflammation of the colon and Crohn's disease (a chronic inflammatory bowel disease).
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.
With the use of non-steroidal anti-inflammatory drugs (NSAIDs), the following side effects may also occur:

• a modest increase in the risk of myocardial infarction or stroke (cerebrovascular accident), especially with high doses and for prolonged treatments
• reduced heart function (heart failure).

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

• gastric and duodenal ulcers
• perforation of the intestinal walls or gastric or intestinal bleeding (sometimes fatal, especially in elderly patients).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell 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 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 any medicine in waste water or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Nimesulide Mylan Generics contains
Nimesulide Mylan Generics 100 mg tablets
The active ingredient is nimesulide.
Each tablet contains 100 mg of nimesulide.
The other ingredients are: sodium dioctylsulfosuccinate, hydroxypropylcellulose, lactose, sodium starch
glycolate, microcrystalline cellulose, hydrogenated castor oil, magnesium stearate.

Nimesulide Mylan Generics 100 mg granules for oral suspension
The active ingredient is nimesulide.
Each sachet contains 100 mg of nimesulide.
The other ingredients are: cetomacrogol 1000, sucrose, maltodextrins, citric acid, orange flavour.

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

Marketing Authorisation 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)