Nimesil

Leaflet accompanying the packaging: patient information

Warning! Keep the leaflet! Information on the immediate packaging in a foreign language.

Nimesil, 100 mg, granules for oral suspension preparation
Nimesulidum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. 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 packaging and other information

1. What is Nimesil and what is it used for

Nimesil is a non-steroidal anti-inflammatory medicine (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 using the medicine outweigh the risk of side effects.

2. Important information before taking Nimesil

When not to use Nimesil:

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

Nimesil should not be used in children under 12 years of age.

Warnings and precautions

Nimesil should not be used or the doctor should be informed before taking Nimesil if the patient has ever experienced a persistent rash (circular or oval patchy redness and swelling of the skin, blisters, hives, and itching) after taking nimesulide.
If the patient is taking the following medicines that may interfere with the action of Nimesil:

• blood-thinning medicines (anticoagulants, acetylsalicylic acid, or other salicylates);
• diuretics used in heart failure or hypertension;
• lithium, which is used to treat depression and similar disorders;
• methotrexate;
• cyclosporine; the patient should inform the doctor or pharmacist before starting Nimesil.
• If the patient experiences symptoms indicating liver disorders while taking Nimesil, they should stop taking the medicine immediately and inform their doctor without delay. Symptoms indicating liver disorders include: loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue, or dark urine. If the patient has ever had ulcers, gastrointestinal bleeding, ulcerative colitis, or Crohn's disease, they should tell their doctor before starting Nimesil.
• If the patient develops a fever and/or flu-like symptoms (generalized muscle pain, malaise, chills) while taking Nimesil, they should stop taking the medicine and inform their doctor.
• If the patient has been diagnosed with heart or kidney disease, they should inform their doctor before starting Nimesil. Nimesil may worsen kidney function.
• During treatment, elderly patients may require periodic visits to allow the doctor to rule out side effects of Nimesil related to the stomach, kidneys, heart, or liver.
• If the patient plans to become pregnant, they should inform their doctor, as Nimesil may have a negative effect on 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 of the medicine. Higher doses and longer treatment periods than recommended should not be used.
In case of heart disorders, previous stroke, or suspected risk of these disorders (e.g. high blood pressure, diabetes, high cholesterol, smoking), the patient should discuss the treatment with their 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 the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine. The medicine may have a harmful effect on teeth.

Nimesil and other medicines

If the patient is taking any of the following medicines that may interfere with the action of Nimesil:

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

The patient should tell their doctor about all medicines taken recently, including those available without a prescription.
Patients taking Nimesil and 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 (enhanced effect of hydantoin and sulfonamides due to displacement from protein binding).
Non-steroidal anti-inflammatory medicines may increase the plasma concentration of: digoxin, lithium, methotrexate, and cyclosporine, increasing the toxicity of these medicines. Concomitant administration of nimesulide with other NSAIDs, platelet inhibitors, selective serotonin reuptake inhibitors, or corticosteroids increases the risk of gastrointestinal side effects.
Concomitant administration of nimesulide with potassium-sparing diuretics may lead to an increase in potassium plasma concentration.

Pregnancy, breastfeeding, and fertility

Before taking any medicine, the patient should consult their doctor or pharmacist.
Nimesil should not be taken if the patient is 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 disorders in the unborn child. It may increase the risk of bleeding in the patient and child and cause delayed or prolonged delivery. During the first 6 months of pregnancy, Nimesil should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used 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 child's heart or kidney function disorders in the unborn child, which may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios). If treatment is necessary for a longer period, the 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 non-steroidal anti-inflammatory medicines, Nimesil may cause drowsiness and dizziness. If these occur, the patient should refrain from activities that require mental and physical ability.
Patients whose professional activities require constant concentration should immediately inform their doctor if they experience drowsiness or dizziness during treatment.

Nimesil contains sucrose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Nimesil

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult their 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 an appropriate amount of water (e.g. 1 glass).
Nimesil should be taken for the shortest possible period and not 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: there is no need to modify the dosage.

Using a higher dose of Nimesil than recommended

In case of suspected overdose, the patient should immediately consult their doctor. Symptomatic treatment is recommended. Gastric lavage and administration of activated charcoal may be considered if it has not been more than 4 hours since the overdose. Monitoring of liver and kidney function is required.

Missing a dose of Nimesil

A double dose should not be taken 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 colitis have occurred. Very rarely, the following have occurred: dyspepsia, abdominal pain, oral inflammation. These symptoms usually did not require discontinuation of the medicine.
Skin allergic reactions, such as rash, itching, urticaria, skin inflammation, and angioedema, have been reported.
Persistent rash (may appear as circular or oval patchy 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.
Non-steroidal anti-inflammatory medicines 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 non-steroidal anti-inflammatory medicines, nimesulide may very rarely cause severe hypersensitivity reactions (such as Stevens-Johnson syndrome, Lyell's syndrome).
If any of the side effects worsen or any side effects not listed in this leaflet occur, the patient should inform their doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor, 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, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Nimesil

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
There are no special precautions for storage.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the packaging and other information

What Nimesil contains

• The active substance of Nimesil is nimesulide. 1 sachet (2 g granules) contains 100 mg nimesulide.
• The other ingredients are: sucrose, orange flavor, citric acid, maltodextrin, macrogol ether cetostearyl.

What Nimesil looks like and contents of the packaging

Nimesil is a granule for oral suspension preparation packaged in sachets and a cardboard box.
The packaging contains 9, 15, or 30 sachets.
For more detailed information, the patient should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Latvia, the country of export:

Laboratori Guidotti S.p.A.
Via Livornese, 897 – 56122 Pisa – La Vettola, Italy

Manufacturer:

Fine Foods & Pharmaceuticals N.T.M. S.p.A.
Via Grignano, 43
24041 Brembate, Bergamo, Italy
Laboratorios Menarini S.A.
Alfonso XII, 587
08918 Badalona – Barcelona, Spain

Parallel importer:

InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw

Repackaged by:

InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorization number in Latvia, the country of export:00-0460

Parallel import authorization number: 94/25

Date of leaflet approval: 13.03.2025

[Information about the trademark]