Nimesil

Package leaflet: Information for the patient

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

• Keep this leaflet for future reference.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

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 package 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 risk of adverse effects.

2. Important information before using Nimesil

When not to use Nimesil:

• if the patient has hypersensitivity (allergy) to nimesulide or to 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 or stuffy nose, urticaria) after taking acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs);
• if the patient has previously experienced a liver-related reaction 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 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 current or past peptic ulcer (gastric or duodenal ulcer);
• if the patient has experienced gastrointestinal bleeding;
• if the patient has experienced intracerebral 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 disorder;
• if the patient currently has fever or flu-like symptoms (generalised muscle pain, malaise, chills or fever);
• in 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 consult a doctor before taking Nimesil if the patient has ever experienced a persistent skin redness (erythema) after taking nimesulide (circular or oval patches of redness and swelling of the skin, blisters, urticaria, and itching).
If the patient is taking any of the following medicines, which may interfere with the action of Nimesil:

• anticoagulant drugs (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 during treatment with Nimesil the patient develops symptoms suggesting liver disorders, treatment must be stopped immediately and the doctor must be informed 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 peptic ulcers, gastrointestinal bleeding, ulcerative colitis or Crohn's disease, this should be reported to the doctor before starting Nimesil.

If during treatment with Nimesil the patient develops fever and/or flu-like symptoms (generalised muscle pain, malaise, chills), 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 cause worsening of kidney function.

During treatment of elderly patients, periodic visits 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 for these conditions (e.g. high blood pressure, diabetes, elevated cholesterol, smoking), discuss the treatment approach 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 a doctor before taking the medicine. The medicine may have harmful effects on teeth.

Nimesil and 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 drugs);
• 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 transplantation or in the treatment of immune system disorders; the patient should inform the doctor or pharmacist before starting Nimesil.

Tell the doctor about all medicines taken recently, 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 treated simultaneously 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, increasing the toxicity of these drugs. Concurrent use of nimesulide with other NSAIDs, platelet inhibitors, selective serotonin reuptake inhibitors or glucocorticosteroids increases the risk of gastrointestinal adverse effects.

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

Pregnancy, breastfeeding and effects on 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 problems during delivery. It may cause kidney and heart disorders in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour.

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

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

As 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, avoid performing activities requiring mental and physical alertness.

Patients whose professional activities require constant concentration should immediately inform their doctor if drowsiness or dizziness occurs during treatment.

Nimesil contains sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

3. How to use Nimesil

This medicine should always be used according to the doctor's instructions. In case of doubt, consult
your doctor or pharmacist.
The recommended dose of Nimesil is 0.1 g 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 used for the shortest duration possible and no longer than 15 days in
one treatment cycle.
Taking the medicine for the shortest necessary period 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.
Use of 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. Liver and kidney function must be monitored.
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 everyone experiences them.
Mild and transient gastrointestinal disorders have been observed, such as: heartburn, nausea, vomiting, diarrhoea, flatulence. Gastrointestinal bleeding, gastric or duodenal ulceration and perforation, gastritis and enteritis occurred less frequently. Very rarely: dyspepsia, abdominal pain, stomatitis. These symptoms most often did not necessitate 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.
Central nervous system adverse effects such as headache, dizziness and somnolence have been observed much less frequently.
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, which in most cases is transient after discontinuation of therapy.
Treatment with NSAIDs has been associated with the occurrence of oedema, hypertension and heart failure.
The use of medicines such as Nimesil may be associated with a small increased risk of myocardial infarction (heart attack) 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, inform your doctor or pharmacist.
Reporting of adverse effects
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions, 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.
Reporting adverse effects allows the collection of further information on the safety of the medicine.

5. How to store Nimesil

Keep this medicine out of sight and reach 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 apply.
Medicines must not be disposed of via wastewater 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 packaging and other information

What Nimesil contains

• The active substance is nimesulide. One sachet (2 g of granules) contains 100 mg of nimesulide.
• Other ingredients are: sucrose, orange flavouring agent, citric acid, maltodextrin, cetostearyl polyether.

What Nimesil looks like and contents of the pack
Nimesil is a granulate for oral suspension, packed in sachets and placed in a cardboard box.
The pack contains 9, 15 or 30 sachets.
For more detailed information, please contact the marketing authorisation holder or the parallel importer.

Marketing authorisation holder in the Czech Republic, 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.
Alfons XII, 587
08918 Badalona, Barcelona
Spain

Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland
Pharma Innovations Sp. z o.o.
ul. Jagiellońska 76
03-301 Warsaw
Poland

Marketing authorisation number in the Czech Republic, country of export: 29/118/02-C
Parallel import authorisation number: 157/19