Nimesil

Leaflet accompanying the packaging: patient information

NIMESIL 100 mg, Granules for oral suspension

( Nimesulide)

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• 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 only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Nimesil and what is it used for

Nimesil is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties.
Nimesil is indicated for the treatment of acute pain and primary dysmenorrhea.
Before prescribing Nimesil, the doctor will consider whether the benefits of taking the medicine outweigh the risk of side effects.

2. Important information before taking Nimesil

When not to take Nimesil:

• if you are allergic (hypersensitive) to nimesulide or any of the other ingredients of this medicine (listed in section 6);
• if you have had an allergic reaction (e.g. wheezing, nasal discharge or nasal congestion, hives) after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (NSAIDs);
• if you have had a liver reaction to nimesulide in the past;
• if you are taking other medicines that are known to affect the liver, such as paracetamol, other painkillers or NSAIDs;
• if you are taking addictive medicines, are addicted to medicines or other substances;
• if you abuse alcohol;
• if you have liver disease or elevated liver enzyme activity;
• if you have been diagnosed with a stomach ulcer (gastric or duodenal ulcer) currently or in the past;
• if you have had gastrointestinal bleeding;
• if you have had a brain hemorrhage (stroke);
• if you have had other bleeding disorders or insufficient blood clotting;
• if you have heart failure, kidney disease (kidney failure) or any liver disease;
• if you currently have a fever or flu-like symptoms (generalized muscle pain, malaise, chills or fever);
• in the last 3 months of pregnancy;
• in breastfeeding women.

Do not take Nimesil in children under 12 years of age.

Warnings and precautions

Do not take this medicine or inform your doctor before taking Nimesil if you have ever had a persistent rash (circular or oval patches of redness and swelling of the skin, blisters, hives and itching) after taking nimesulide.
If you are taking any of the following medicines that may interfere with the action of Nimesil:

• blood thinners (anticoagulants, acetylsalicylic acid or other salicylates);
• diuretics used in heart failure or high blood pressure;
• lithium, which is used to treat depression and similar disorders;
• methotrexate;
• cyclosporine; should inform your doctor or pharmacist before starting Nimesil.
• If you experience symptoms indicating liver disorders while taking Nimesil, you should stop taking it immediately and inform your doctor. Symptoms indicating liver disorders are: loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue or dark urine. If you have had ulcers, gastrointestinal bleeding, ulcerative colitis or Crohn's disease, you should tell your doctor before starting Nimesil.
• If you develop a fever and/or flu-like symptoms (generalized muscle pain, malaise, chills) while taking Nimesil, you should stop taking it and inform your doctor.
• If you have been diagnosed with heart or kidney disease, you should inform your doctor before starting Nimesil. Nimesil may worsen kidney function.
• During treatment, elderly patients may require periodic visits to exclude side effects of Nimesil on the stomach, kidneys, heart or liver.
• If you are planning to become pregnant, you should inform your doctor, as Nimesil may adversely affect fertility.

Taking medicines like Nimesil may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. This risk increases with long-term use of high doses. Do not exceed the recommended dose and duration of treatment.
In case of heart disorders, previous stroke or suspected risk of these disorders (e.g. high blood pressure, diabetes, high cholesterol, smoking) you should discuss the treatment with your doctor or pharmacist.
Nimesil contains sucrose: this should be taken into account when administering the medicine to patients with diabetes and patients on a low-calorie diet.
If you have previously been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine. The medicine may have a harmful effect on teeth.

Nimesil and other medicines

If you are taking any of the following medicines that may interfere with the action of Nimesil:

• corticosteroids, e.g. cortisone (anti-inflammatory medicine);
• blood thinners, e.g. warfarin (anticoagulants, acetylsalicylic acid);
• serotonin reuptake inhibitors (antidepressants);
• lithium, used to treat depression and similar disorders;
• methotrexate (used to treat rheumatoid arthritis and cancer);
• cyclosporine, a medicine used after transplantation or to treat immune system disorders; should inform your doctor or pharmacist before starting Nimesil.

You should tell your doctor about all medicines you have taken recently, including those available without a prescription.
Patients taking Nimesil who are also treated with other medicines that irritate the gastrointestinal tract should be monitored more closely.
Concomitant administration of Nimesil and anticoagulant medicines enhances their effect.
Due to the strong binding of nimesulide to plasma proteins, patients treated with hydantoin and sulfonamides should be under constant control (enhancement of hydantoin and sulfonamide action due to displacement from protein binding).
Nonsteroidal anti-inflammatory drugs may increase the plasma concentration of: digoxin, lithium, methotrexate and cyclosporine, increasing the toxicity of these medicines. Concomitant administration of nimesulide with other NSAIDs, antiplatelet agents, selective serotonin reuptake inhibitors or corticosteroids increases the risk of gastrointestinal side effects.
Concomitant administration of nimesulide with potassium-sparing diuretics may cause an increase in potassium plasma levels.

Pregnancy, breastfeeding and fertility

Before taking any medicine, consult your doctor or pharmacist.
Do not take Nimesil if you are in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child. It may increase the risk of bleeding in the mother and child and cause prolongation or prolongation of labor. During the first 6 months of pregnancy, do not take Nimesil unless your doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest possible dose for the shortest possible time.
If taken for more than a few days from the 20th week of pregnancy, Nimesil may cause narrowing of the blood vessel (ductus arteriosus) in the baby's heart or kidney function disorders in the unborn child, which may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios). If treatment is necessary for a longer period, your doctor may recommend additional monitoring.
Because it is not known whether nimesulide passes into breast milk, its use during breastfeeding is contraindicated.

Driving and using machines

Like other nonsteroidal anti-inflammatory drugs, Nimesil may cause drowsiness and dizziness.
In case of their occurrence, you should refrain from activities that require psychophysical fitness.
Patients whose professional activity requires constant concentration should immediately inform their doctor if they experience drowsiness or dizziness during treatment.

3. How to take Nimesil

This medicine should always be taken as directed by your doctor. If you are unsure, consult your doctor or pharmacist.
The recommended dose of Nimesil is 100 mg twice a day (2 times 1 sachet) after meals. The contents of the sachet should be dissolved in a suitable amount of water (e.g. 1 glass).
Nimesil should be taken for the shortest possible period and no longer than 15 days in one treatment cycle.
Taking the medicine for the shortest possible period necessary to alleviate symptoms reduces the risk of side effects.
Elderly patients: there is no need to reduce the daily dose.

Use in children and adolescents

Children over 12 years of age: no dose adjustment is necessary.

Taking a higher dose of Nimesil than recommended

In case of suspected overdose, consult your doctor immediately. Symptomatic treatment is recommended. Gastric lavage and administration of activated charcoal may be considered if the overdose occurred no more than 4 hours earlier. Monitoring of liver and kidney function is required.

Missing a dose of Nimesil

Do not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Nimesil can cause side effects, although not everybody gets them.
Mild and transient side effects related to the gastrointestinal system, such as: heartburn, nausea, vomiting, diarrhea, bloating, have been observed. Less frequently, gastrointestinal bleeding, ulcers and perforation of the duodenum or stomach, gastritis and enteritis have been reported. Very rarely, the following have been reported: indigestion, abdominal pain, oral inflammation. These symptoms usually did not require withdrawal of the medicine.
Skin allergic reactions, such as: rash, itching, urticaria, dermatitis, exacerbation of edema and hives, have been reported.
Persistent rash (may appear as circular or oval patches of redness and swelling of the skin), blisters (hives), itching have been reported with unknown frequency.
Very rarely, central nervous system side effects, such as: headache, dizziness and drowsiness, have been observed.
Other very rare side effects include: oliguria with or without fluid retention and local or generalized edema; hematemesis (probably related to gastrointestinal bleeding and ulcers); purpura and ecchymosis, especially of the lower limbs, exceptionally associated with thrombocytopenia.
Very rarely, liver damage, mostly transient after discontinuation of therapy, may occur.
Nonsteroidal anti-inflammatory drugs have been associated with reports of edema, hypertension and heart failure.
Taking medicines like Nimesil may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Like other nonsteroidal anti-inflammatory drugs, nimesulide may very rarely cause severe hypersensitivity reactions (such as Stevens-Johnson syndrome, Lyell's syndrome).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please tell your doctor or pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
By reporting side effects, you can help provide more information on the safety of this medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store Nimesil

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
There are no special precautions for storage of the medicinal product.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Nimesil contains

• The active substance is nimesulide.
• The other ingredients are: sucrose, orange flavor and aroma, anhydrous citric acid, maltodextrin, cetostearyl ether of macrogol.

What Nimesil looks like and contents of the pack

Nimesulide is a granulate for oral suspension packaged in sachets and a cardboard box.
The pack contains 9, 15 or 30 sachets
1 sachet contains 100 mg of nimesulide.

Marketing authorization holder

Laboratori Guidotti S.p.A.
Via Livornese 897
56122 Pisa
Italy

Manufacturer

Fine Foods and Pharmaceuticals N.T.M. S.P.A.
Via Grignano 43
24041, Brembate (Bergamo)
Italy
or
Laboratorios Menarini S.A.
Alfonso XII 587
E-08918 Badalona, Barcelona
Spain
To obtain more detailed information, please contact the representative of the marketing authorization holder:
Berlin-Chemie/Menarini Polska Sp. z o.o.
tel. (22) 566 21 00
fax (22) 566 21 01
Date of last revision of the leaflet: 02/2023