Nimefort

Package leaflet: Information for the user

Nimefort 100 mg, tablets
(Nimesulidum)
Please read all of this leaflet carefully before taking this medicine because it contains
important information for the patient.

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

Table of contents of the leaflet

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

1. What Nimefort is and what it is used for

Nimefort is a non-steroidal anti-inflammatory drug (NSAID) with analgesic properties.
Nimefort is used in the treatment of acute pain and in the treatment of dysmenorrhoea (menstrual pain).
Before prescribing Nimefort, the doctor will assess whether the benefits the patient may obtain from treatment outweigh the risk of adverse effects.

2. Important information before using Nimefort

When not to use Nimefort

• if the patient has hypersensitivity (allergy) to nimesulide or any of the other components of Nimefort (listed in section 6);
• if the patient has ever experienced allergic reactions to acetylsalicylic acid or other NSAIDs (non-steroidal anti-inflammatory drugs), such as:
• wheezing, tightness in the chest, shortness of breath (asthma);
• inflammation of the nasal mucosa (nasal polyps);
• skin rash or hives;
• sudden swelling of the skin or mucous membranes, such as swelling around the eyes, face, lips, mouth or throat, possibly causing breathing difficulties (angioedema);
• if, after previous treatment with NSAIDs, the patient has experienced in the past:
• gastrointestinal bleeding;
• perforation of the stomach or intestines;
• active or recurrent gastric or intestinal ulcer or bleeding (ulceration or bleeding occurring at least twice);
• cerebral haemorrhage (stroke);
• any other bleeding disorders or any problems related to impaired blood coagulation;
• liver function disorders;
• if the patient is taking other medicines known to have hepatotoxic effects, e.g. paracetamol or other painkillers or NSAIDs;
• if the patient is taking drugs causing dependence or is addicted to drugs or other substances;
• if the patient regularly abuses alcohol;
• if the patient has liver disease or elevated liver enzyme levels;
• if the patient has experienced liver disorders after taking nimesulide;
• if the patient has severe renal insufficiency and is not undergoing dialysis;
• if the patient has severe heart failure;
• if the patient has fever or flu-like symptoms (generalized muscle pain, general malaise, chills or elevated body temperature);
• in women during the last three months of pregnancy;
• in women who are breastfeeding.

Nimefort must not be given to children under 12 years of age.
Warnings and precautions
Before starting to take Nimefort, discuss this with your doctor or pharmacist.
Use of medicines such as Nimefort 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 or duration of treatment. If the patient has heart problems, has had a stroke, or believes they may be at risk of such events (for example, if they have high blood pressure, diabetes, high cholesterol levels or smoke), they should discuss treatment options with their doctor or pharmacist.
In case of serious allergic reactions, immediately discontinue use of Nimefort at the first sign of skin rash, soft tissue damage (mucosal damage), or any other allergic symptoms, and contact a doctor.
Immediately discontinue treatment with Nimefort if the patient notices signs of bleeding (which may cause dark stools) or gastrointestinal ulceration (which may cause abdominal pain).
Exercise particular caution when treating with Nimefort:
If symptoms indicating liver dysfunction occur during treatment with nimesulide, treatment must be discontinued and the doctor must be informed immediately. 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, inform the doctor before taking Nimefort.
If symptoms of fever and/or flu (generalized pain, malaise or chills) occur during treatment with Nimefort, discontinue use of the medicine and inform the doctor.
If the patient has heart disease, high blood pressure, circulatory disorders or kidney disease, inform the doctor before taking Nimefort.
If the patient is elderly, regular visits to the doctor are recommended to ensure that Nimefort is not worsening the condition of the stomach, kidneys, heart or liver.
If the patient is planning pregnancy, consult a doctor, as Nimefort may adversely affect fertility.
Nimefort contains lactose
If the patient has been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Nimefort and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including over-the-counter medicines.

• corticosteroids, e.g. cortisone (anti-inflammatory medicines);
• anticoagulants (blood-thinning medicines such as warfarin, antiplatelet agents, acetylsalicylic acid or other salicylates);
• antihypertensive medicines or diuretics (medicines used to regulate blood pressure or heart function);
• lithium used in the treatment of depression and similar disorders;
• selective serotonin reuptake inhibitors (antidepressants);
• methotrexate (used in the treatment of rheumatoid arthritis and cancer);
• cyclosporine (used after organ transplantation or in the treatment of immune system disorders).

Inform your doctor or pharmacist before starting treatment with Nimefort.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.

• Nimefort must not be used during the last three months of pregnancy, as its action may be harmful to the unborn child and may increase the risk of premature birth.
• Inform the doctor about planned pregnancy, as Nimefort may adversely affect fertility.
• During the first or second trimester of pregnancy, do not exceed the dose or duration of treatment recommended by the doctor.

Do not use Nimefort during breastfeeding.
Driving and operating machinery
Do not drive or operate machinery if Nimefort causes dizziness or drowsiness in the patient.
Nimefort contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult a doctor before taking this medicine.
Nimefort contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e. is essentially "sodium-free".

3. How to use Nimefort

This medicine should always be taken exactly as directed by a doctor or pharmacist. In case of doubt,
consult a doctor or pharmacist.
Undesirable effects can be minimized by using the lowest effective dose for the shortest duration
necessary to control disease symptoms.
The recommended dose of Nimefort is one tablet (100 mg) twice daily, taken after meals.
Nimefort should be used for the shortest possible duration and not longer than 15 days in a single
treatment cycle.
The division line on the tablet is not intended for breaking the tablet.
Use of a higher than recommended dose of Nimefort
In case of overdose or suspected overdose of Nimefort, contact a doctor or hospital emergency
department immediately. Bring any unused medicine with you. In case of overdose, one or more of
the following symptoms may occur: insomnia, vomiting, abdominal pain, stomach bleeding, or
difficulty breathing.
Missed dose of Nimefort
Do not take a double dose to make up for a missed dose.

4. Possible adverse reactions

Like any medicine, Nimefort may cause adverse reactions, although not everyone will experience them.
If any of the symptoms listed below occur, stop taking the medicine and contact your doctor immediately, as they may indicate rare, serious adverse reactions requiring urgent medical intervention:

• indigestion or stomach pain, loss of appetite, nausea (malaise), vomiting, or bleeding from the stomach or intestines, or black stools
• skin disorders such as rash or redness of the skin
• wheezing or shortness of breath
• yellowing of the skin or whites of the eyes (jaundice)
• unexpected change in the amount or colour of urine
• swelling of the face, feet or legs
• persistent feeling of fatigue

General adverse reactions associated with non-steroidal anti-inflammatory drugs (NSAIDs):
The use of certain non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thromboembolic events (arterial thrombotic events), e.g. heart attack (myocardial infarction) or stroke (apoplexy), particularly with high doses and prolonged treatment.
Fluid retention (oedema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID therapy.
Most commonly observed gastrointestinal adverse reactions (gastrointestinal disorders):

• ulceration of the stomach and upper part of the small intestine (gastric and/or duodenal ulceration)
• intestinal perforation or gastrointestinal bleeding (sometimes fatal, particularly in elderly patients).

Adverse reactions that may occur during treatment with Nimefort:

• Common (may affect more than 1 in 100 people): diarrhoea, nausea, vomiting, slight changes in laboratory test results of liver function.
• Uncommon (may affect less than 1 in 100 people): dyspnoea, dizziness, elevated blood pressure, constipation, flatulence, gastritis, pruritus, skin rash, excessive sweating, oedema, gastrointestinal bleeding, ulceration and perforation of the duodenum and/or stomach.
• Rare (may affect less than 1 in 1000 people): anaemia, decreased white blood cell count, increased white blood cell count (eosinophilia), changes in blood pressure, bleeding, difficulty or pain during urination or urinary retention, haematuria, increased blood potassium concentration, restlessness or nervousness, nightmares, blurred vision, tachycardia, redness of the skin, erythema, dermatitis, malaise and weakness (fatigue).
• Very rare (may affect less than 1 in 10,000 people): severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), which may cause blistering and discomfort; kidney failure or kidney inflammation (nephritis), brain function disorders (encephalopathy), decreased platelet count leading to subcutaneous bleeding or bleeding in other parts of the body; black stools due to gastrointestinal bleeding, hepatitis, sometimes very severe, causing jaundice and cholestasis; allergies, including severe allergic reactions with collapse and dyspnoea, asthma, hypothermia, vertigo, headache, somnolence; abdominal pain, dyspepsia; stomatitis; itchy skin rash (urticaria); facial and periorbital oedema; visual disturbances.

Taking medicines such as Nimefort may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist.
Adverse reactions can be reported directly to the Department of Monitoring 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. Storage of Nimefort
Keep the medicine in its original packaging to protect it from light. Store the medicine out of the 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.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Nimefort contains
The active substance is nimesulide.
The other ingredients are: sodium docusate, hydroxypropylcellulose, lactose monohydrate,
sodium carboxymethyl starch (type A), microcrystalline cellulose, magnesium stearate and
hydrogenated vegetable oil (type I).

What Nimefort looks like and contents of the pack
Light yellow, round tablets with a score line on one side, packed in blisters made of PVC/Aluminium.
Pack sizes: 10, 20 or 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Solinea Sp. z o.o.
Ul. Szafranowa 6, Elizówka
21-003 Ciecierzyn
Poland

Manufacturer
Bluepharma - Indústria Farmacêutica, S.A.
S. Martinho do Bispo
3045-016 Coimbra
Portugal

The medicinal product described is authorised for marketing in EEA Member States under the following names:
Poland - NIMEFORT
Portugal - Nimesulid Oara
08-12-2023