Nimesil

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, the information on the immediate packaging is in a foreign language!

Nimesil

100 mg, granules for oral suspension preparation
Nimesulidum

You should carefully read the contents of the leaflet before taking 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 specifically for you. Do not pass it on 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 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 packaging and other information

1. What is Nimesil and what is it used for

Nimesil is a non-steroidal 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 the patient has been diagnosed with an allergy (hypersensitivity) to nimesulid 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 drugs (NSAIDs);
• if the patient has had a liver reaction to nimesulid 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 experienced gastrointestinal bleeding;
• if the patient has experienced cerebral bleeding (stroke);
• if the patient has experienced other bleeding disorders or insufficient blood clotting;
• if the patient has been diagnosed with 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 taken in children under 12 years of age.

Warnings and precautions

Do not take this medicine or inform your doctor 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 nimesulid.
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 their 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 experienced ulcers, gastrointestinal bleeding, ulcerative colitis or Crohn's disease, they should tell their doctor before starting Nimesil.
• If the patient experiences 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 their doctor to rule out side effects of Nimesil on 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. Do not take higher doses or longer treatment than recommended.
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 certain sugars, they should consult 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 who are also treated with other medicines that irritate the gastrointestinal tract should be monitored more closely.
Concomitant administration of Nimesil and anticoagulant medicines may enhance their effect.
Due to the strong binding of nimesulid 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 drugs may increase the plasma concentration of: digoxin, lithium, methotrexate and cyclosporine, increasing the toxicity of these medicines. Concomitant administration of nimesulid with other NSAIDs, platelet inhibitors, selective serotonin reuptake inhibitors or glucocorticoids may increase the risk of gastrointestinal side effects.
Concomitant administration of nimesulid with potassium-sparing diuretics may cause an increase in plasma potassium 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 taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest 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 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, the doctor may recommend additional monitoring.
Since it is not known whether nimesulid passes into breast milk, its use during breastfeeding is contraindicated.

Driving and operating machinery

Like other non-steroidal anti-inflammatory drugs, Nimesil may cause drowsiness and dizziness. If these occur, the patient should refrain from activities that require mental and physical ability.
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 the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
The recommended dose of Nimesil is 100 mg twice a day (2 sachets) 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: 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

The patient should 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 have been observed, including gastrointestinal disorders such as: heartburn, nausea, vomiting, diarrhea, bloating. 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: dyspepsia, abdominal pain, oral inflammation. These symptoms usually do not require discontinuation of the medicine.
Skin allergic reactions, such as: rash, itching, urticaria, skin inflammation, exacerbation of edema and hives, have been reported.
Persistent rash (which may look like circular or oval patchy redness and swelling of the skin), blisters (hives), itching have been reported with unknown frequency.
Central nervous system side effects, such as: headache, dizziness and drowsiness, have been reported very rarely.
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); petechiae and purpura, especially on the lower limbs, exceptionally associated with thrombocytopenia.
Very rarely, liver damage may occur, which is usually reversible after discontinuation of therapy.
Non-steroidal 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 non-steroidal anti-inflammatory drugs, nimesulid 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 any side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. 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 will help to gather more information on the safety of the medicine.

5. How to store Nimesil

The medicine should be stored in a place inaccessible and invisible to children.
The medicine should not be taken after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
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 needed. This will help protect the environment.

6. Contents of the packaging and other information

What Nimesil contains

• The active substance of the medicine is nimesulid.
• The other ingredients are: cetostearyl ether of macrogol, sucrose, maltodextrin, citric acid, orange flavor and aroma enhancer.

What Nimesil looks like and what the packaging contains

Nimesulid is a granulate for oral suspension preparation packaged in sachets and a cardboard box.
The packaging contains 9 sachets of 2 g each.
1 sachet contains 100 mg of nimesulid.
For more detailed information, the patient should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in the Czech Republic, 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 Berlino, 39
Zingonia-Verdellino (Bergamo)
Italy
Laboratorios Menarini S.A.
Alfonso XII, 587
08918 Badalona Barcelona
Spain

Parallel importer:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź

Repackaged by:

Medezin Sp. z o.o.
ul. Zbąszyńska 3
91-342 Łódź
Laboratorium Galenowe Olsztyn Sp. z o.o.
ul. Spółdzielcza 25A
11-001 Dywity
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
CEFEA Sp. z o.o. Sp. komandytowa
ul. Działkowa 56
02-234 Warsaw
Marketing authorization number in the Czech Republic, the country of export: 29/118/02-C
Parallel import authorization number: 207/19

Date of leaflet approval: 16.05.2024

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