Nimesil

Package leaflet: information for the patient

Warning! Keep the leaflet – information on the immediate packaging is in a foreign language!
Nimesil
100 mg, granules for oral suspension
Nimesulidum
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Nimesil is and what it is 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 Nimesil is and what it is 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 dysmenorrhoea.
Before prescribing Nimesil, the doctor will assess whether the benefits of treatment outweigh the risks of adverse effects.

2. Important information before using Nimesil

When not to use Nimesil:

• if the patient has a known hypersensitivity (allergy) to nimesulide or any of the other ingredients of this medicine (listed in section 6);
• if the patient has previously experienced an allergic reaction (e.g. wheezing, runny nose, nasal congestion, urticaria) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has previously experienced liver-related adverse reactions to nimesulide;
• if the patient is taking other medicines known to affect the liver, e.g. paracetamol, other painkillers or NSAIDs;
• if the patient is taking drugs that may cause dependence, is drug-dependent or addicted to other substances;
• if the patient abuses alcohol;
• if the patient has been diagnosed with liver disease or elevated liver enzyme activity;
• if the patient has a current or past history of peptic ulcer (gastric or duodenal ulcer);
• if the patient has experienced gastrointestinal bleeding;
• if the patient has experienced intracranial bleeding (stroke);
• if the patient has other bleeding disorders or impaired blood coagulation;
• if the patient has heart failure, kidney disease (renal failure), or any liver disease;
• if the patient currently has fever or flu-like symptoms (generalized muscle pain, malaise, chills or fever);
• in pregnant women during the last three months of pregnancy;
• in breastfeeding women.

Do not use Nimesil in children under 12 years of age.
Warnings and precautions
Do not use this medicine or inform your doctor before taking Nimesil if the patient has ever experienced a persistent skin rash (circular or oval patches of redness and swelling of the skin, blisters, urticaria, and itching) after taking nimesulide.
If the patient is taking any of the following medicines, which may interfere with the action of Nimesil:

• anticoagulants (blood thinners), acetylsalicylic acid or other salicylates;
• diuretics used in heart failure or hypertension;
• lithium, used in the treatment of depression and similar disorders;
• methotrexate;
• cyclosporine; the patient should inform the doctor or pharmacist before starting Nimesil.

If symptoms indicating liver dysfunction occur during treatment with Nimesil, treatment must be stopped immediately and the doctor must be informed without delay. Symptoms indicating liver dysfunction include: loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue, or dark urine. If the patient has ever had peptic ulcers, gastrointestinal bleeding, ulcerative colitis or Crohn's disease, this should be reported to the doctor before starting Nimesil.

If fever and/or flu-like symptoms (generalized muscle pain, malaise, chills) occur during treatment with Nimesil, treatment should be discontinued and the doctor informed.

If the patient has been diagnosed with heart or kidney disease, this should be reported to the doctor before starting Nimesil. Nimesil may impair kidney function.

During treatment of elderly patients, periodic check-ups may be necessary so that the doctor can rule out any adverse effects of Nimesil on the stomach, kidneys, heart or liver.

If a woman is planning pregnancy, she should inform the doctor, as Nimesil may adversely affect fertility.

Taking medicines such as 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 use higher doses or longer treatment duration than recommended.

In case of heart disorders, previous stroke, or suspicion of risk factors for these conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), the treatment approach should be discussed with the doctor or pharmacist.

Nimesil contains sucrose: this should be taken into account when administering the medicine to patients with diabetes or those on a low-calorie diet.

If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult the doctor before taking the medicine. The medicine may have harmful effects on teeth.

Interaction of Nimesil with other medicines
If the patient is taking any of the following medicines, which may interfere with the action of Nimesil:

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

Inform the doctor about all medicines recently taken, including those available without a prescription.

Patients taking Nimesil and receiving additional treatment with other medicines that irritate the gastrointestinal tract should be monitored more closely.

Concomitant administration of Nimesil and anticoagulants enhances their effect.

Due to the strong binding of nimesulide to plasma proteins, patients receiving concomitant treatment with hydantoins and sulfonamides should remain under constant monitoring (increased effect of hydantoins and sulfonamides due to displacement from protein binding sites).

Non-steroidal anti-inflammatory drugs may increase plasma concentrations of digoxin, lithium, methotrexate, and cyclosporine, thereby increasing the toxicity of these drugs. Concomitant use of nimesulide with other NSAIDs, platelet function inhibitors, selective serotonin reuptake inhibitors, or glucocorticosteroids increases the risk of gastrointestinal adverse effects.

Concomitant administration of nimesulide with potassium-sparing diuretics may lead to increased serum potassium levels.

Pregnancy, breastfeeding and fertility

Before taking any medicine, consult a doctor or pharmacist.

Do not take Nimesil if the patient is in the last three months of pregnancy, as it may harm the unborn child or cause complications during delivery. It may cause kidney and heart problems in the unborn child. It may increase the tendency to bleeding in both the mother and the child and may delay or prolong labor.

During the first six months of pregnancy, Nimesil should not be used unless the doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, the lowest possible dose for the shortest possible time should be used.

If used for longer than a few days beyond the 20th week of pregnancy, Nimesil may cause narrowing of the blood vessel (ductus arteriosus) in the child's heart or kidney dysfunction in the unborn child, which may lead to reduced amniotic fluid volume surrounding the child (oligohydramnios). If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Since it is not known whether nimesulide 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, activities requiring mental and physical alertness should be avoided.

Patients whose occupation requires constant concentration should immediately inform their doctor if drowsiness or dizziness occurs during treatment.

3. How to take Nimesil

This medicine should always be taken according to the doctor's instructions. If in doubt, consult your
doctor or pharmacist.
The recommended dose of Nimesil is 100 mg twice daily (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 duration possible and no longer than 15 days in
one treatment cycle.
Taking the medicine for the shortest period necessary to relieve symptoms reduces the risk of
adverse effects.
Elderly patients: there is no need to reduce the daily dose.
Use in children and adolescents
Children above 12 years of age: there is no need to modify the dosage.
Taking a higher than recommended dose of Nimesil
In case of suspected overdose, seek immediate medical attention. Symptomatic treatment is
recommended. Gastric lavage and administration of activated charcoal may be considered if
less than 4 hours have passed since the overdose. Monitoring of liver and kidney function is required.
Missed dose of Nimesil
Do not take a double dose to make up for a missed dose.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everybody will experience them.
Mild and transient gastrointestinal disorders have been observed, such as: heartburn, nausea, vomiting, diarrhoea, flatulence. Gastrointestinal bleeding, or intestinal bleeding, ulceration and perforation of the stomach or duodenum, gastritis and enteritis occurred less frequently. Very rarely: dyspepsia, abdominal pain, stomatitis. These symptoms most often did not require discontinuation of the medicine.
Skin allergic reactions have been reported, such as: erythema, pruritus, rash, dermatitis, exacerbation of oedema and urticaria.
Persistent erythema (may appear as circular or oval macular redness and swelling of the skin), blisters (urticaria), pruritus have been reported with unknown frequency.
Much less frequently, adverse effects from the central nervous system have been observed, such as: headache, dizziness and drowsiness.
Other very rare adverse effects include: oliguria with or without fluid retention and with local or generalized oedema; haematemesis (probably associated with gastrointestinal bleeding and ulceration); petechiae and purpura, particularly of the lower limbs, exceptionally associated with thrombocytopenia.
Very rarely, liver damage may occur, in most cases reversible after discontinuation of therapy.
Treatment with NSAIDs has been associated with the occurrence of oedema, hypertension and heart failure.
Use of medicines such as Nimesil may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.
As with other non-steroidal anti-inflammatory drugs, nimesulide may very rarely cause severe hypersensitivity reactions (such as Stevens-Johnson syndrome, Lyell's syndrome).
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, consult a doctor or pharmacist.
Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration 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
By reporting adverse effects, additional information on the safety of the medicine can be collected.

5. How to store the medicine Nimesil

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Medicines must 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 packaging and other information

What Nimesil contains

• The active substance is nimesulid.
• The other ingredients are: macrogol cetostearyl ether, sucrose, maltodextrin, citric acid, orange-flavoured substance for improving taste and smell.

What Nimesil looks like and contents of the pack
Nimesulid is a granulate for oral suspension, packed in sachets and placed in a cardboard box.
The pack contains 9 sachets of 2 g each.
Each sachet contains 100 mg of nimesulid.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation 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.
Zbąszyńska 3 Street
91-342 Łódź
Poland

Repackaged in:
Medezin Sp. z o.o.
Zbąszyńska 3 Street
91-342 Łódź
Poland
Laboratorium Galenowe Olsztyn Sp. z o.o.
Spółdzielcza 25A Street
11-001 Dywity
Poland
Pharma Innovations Sp. z o.o.
Jagiellońska 76 Street
03-301 Warszawa
Poland
CEFEA Sp. z o.o. Sp. komandytowa
Działkowa 56 Street
02-234 Warszawa
Poland

Marketing authorisation number in the Czech Republic, the country of export: 29/118/02-C
Parallel import authorisation number: 207/19