Nimefort

Package Leaflet: Information for the User

Nimefort 100 mg, tablets

(Nimesulide)

Read the package leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Nimefort and what is it 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 is Nimefort and what is it used for

Nimefort is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic properties.
Nimefort is used to treat acute pain and menstrual pain.
Before prescribing Nimefort, your doctor will assess whether the benefits of treatment outweigh the risk of side effects.

2. Important information before taking Nimefort

When not to take Nimefort

• wheezing, chest tightness, shortness of breath (asthma);
• nasal polyps;
• skin rash or urticaria;
• sudden skin or mucous membrane swelling, such as swelling around the eyes, face, lips, mouth, or throat, which may cause difficulty breathing (angioedema);
• after previous NSAID therapy and a history of:
• stomach or intestinal bleeding;
• perforation of the stomach or intestine;
• active or recurrent stomach or intestinal ulcers or bleeding (ulceration or bleeding that has occurred at least twice);
• cerebral bleeding (stroke);
• any other bleeding disorders or problems with blood clotting;
• liver dysfunction;
• during breastfeeding.

Nimefort should not be given to children under 12 years of age.

Warnings and precautions

Before taking Nimefort, discuss it with your doctor or pharmacist.
Taking medicines like 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
of the medicine. Do not exceed the recommended dose or duration of treatment. If you have heart problems, have had a stroke, or think you may be at risk of these (for example, if you have high blood pressure, diabetes, high cholesterol, or smoke), you should discuss your treatment with your doctor or pharmacist.
In case of serious allergic reactions, at the first sign of skin rash, soft tissue damage (mucosal damage), or
any other signs of allergy, you should stop taking Nimefort and contact your doctor.
You should immediately stop taking Nimefort if you notice signs of bleeding (which causes dark stools) or gastrointestinal ulceration (which causes abdominal pain).
You should be particularly careful when taking Nimefort:
If symptoms occur that indicate liver damage, you should stop taking nimesulide and immediately inform your doctor. Symptoms indicating liver damage include loss of appetite, nausea, vomiting, abdominal pain, persistent fatigue, or dark urine.
If you have ever had stomach ulcers, stomach or intestinal bleeding, ulcerative colitis, or Crohn's disease, you should tell your doctor before taking Nimefort.
If you experience symptoms of fever and/or flu (generalized pain, malaise, or chills) while taking Nimefort, you should stop taking the medicine and inform your doctor.
If you have heart disease, high blood pressure, circulatory disorders, or kidney disease, you should tell your doctor before taking Nimefort.
If you are elderly, you should have regular check-ups with your doctor to ensure that Nimefort does not worsen your stomach, kidney, heart, or liver condition.
If you are planning a pregnancy, you should contact your doctor, as Nimefort may adversely affect fertility.

Nimefort contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Nimefort and other medicines

You should tell your doctor or pharmacist about all medicines you are taking now or recently, as well as any medicines you plan to take, including those available without a prescription.

• corticosteroids, such as cortisone (an anti-inflammatory medicine);
• blood thinners (anticoagulants, such as warfarin, antiplatelet agents, acetylsalicylic acid, or other salicylates);
• antihypertensive or diuretic medicines (used to regulate blood pressure or heart function),
• lithium used to treat depression and similar disorders;
• selective serotonin reuptake inhibitors (antidepressants);
• methotrexate (used to treat rheumatoid arthritis and cancer);
• cyclosporin (used after transplantation or to treat immune system disorders);

You should inform your doctor or pharmacist about this before starting to take Nimefort.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor or pharmacist for advice before taking this medicine.

• Nimefort should not be used in the last 3 months of pregnancy, as it may harm the baby and increase the risk of premature birth.
• You should tell your doctor about planned pregnancy, as Nimefort may adversely affect fertility.
• In the first or second trimester of pregnancy, do not exceed the recommended dose and duration of treatment.

Nimefort should not be used during breastfeeding.

Driving and using machines

You should not drive or operate machinery if Nimefort causes dizziness or drowsiness.

Nimefort contains lactose

If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking the medicine.

Nimefort contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet, which is essentially "sodium-free".

3. How to take Nimefort

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, you should ask your doctor or pharmacist.
Side effects can be minimized by using the smallest effective dose for the shortest possible duration necessary to control the symptoms of the disease.
The recommended dose of Nimefort is one tablet (100 mg) twice a day, after meals.
Nimefort should be taken for the shortest possible duration, not exceeding 15 days in one treatment cycle.
The dividing line on the tablet is not intended for breaking the tablet.

Overdose of Nimefort

In case of overdose or suspected overdose of Nimefort, you should immediately contact your doctor or hospital emergency department. You should take any remaining 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

You should not take a double dose to make up for a missed dose.

4. Possible side effects

Like all medicines, Nimefort can cause side effects, although not everybody gets them.
If you experience any of the following symptoms, you should stop taking the medicine and immediately contact your doctor, as they may indicate rare, serious side effects that require urgent medical attention:

• indigestion or abdominal pain, loss of appetite, nausea (malaise), vomiting, or stomach or intestinal bleeding or dark stools
• skin diseases, such as rash or skin redness
• wheezing or shortness of breath
• yellowing of the skin or whites of the eyes (jaundice)
• unusual changes in urine quantity or color
• swelling of the face, feet, or ankles
• persistent feeling of fatigue

General side effects caused by nonsteroidal anti-inflammatory drugs (NSAIDs):
Taking some nonsteroidal anti-inflammatory drugs (NSAIDs) may be associated with a small increased risk of arterial thrombotic events (arterial thrombotic events), such as heart attack (myocardial infarction) or stroke (apoplexy), especially with high doses and long-term treatment.
Fluid retention (edema), high blood pressure (hypertension), and heart failure have been reported in association with NSAID treatment.
The most commonly observed side effects related to the gastrointestinal tract (gastrointestinal disorders):

• stomach and duodenal ulcers (stomach and (or) duodenal ulcers)
• intestinal perforation or gastrointestinal bleeding (sometimes fatal, especially in the elderly).

Side effects that may occur when taking Nimefort:

• Often (may affect more than 1 in 100 people): diarrhea, nausea, vomiting, minor changes in liver function test results.
• Uncommon (may affect less than 1 in 100 people): shortness of breath, dizziness, elevated blood pressure, constipation, gas, gastritis, itching, skin rash, excessive sweating, edema, stomach or intestinal bleeding, ulcers, and perforation of the duodenum and (or) stomach.
• Rare (may affect less than 1 in 1,000 people): anemia, decreased white blood cell count, increased white blood cell count (eosinophilia), changes in blood pressure, bleeding, difficulty or pain when urinating, or urinary retention, hematuria, elevated potassium levels in the blood, anxiety or nervousness, nightmares, blurred vision, rapid heartbeat, skin redness, flushing, skin inflammation, 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 can cause blistering and discomfort; kidney failure or kidney inflammation (nephritis), brain disorders (encephalopathy), decreased platelet count causing subcutaneous or other bleeding; dark stools due to

bleeding, liver inflammation, sometimes very severe, causing jaundice and bile flow obstruction; allergies, including severe allergic reactions with shock and shortness of breath, asthma, decreased body temperature, vertigo of labyrinthine origin, headache, drowsiness; abdominal pain, indigestion; oral inflammation; skin rash with itching (urticaria); facial and periorbital edema; vision disorders.
Taking medicines like Nimefort may be associated with a small increased risk of heart attack (myocardial infarction) or stroke.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist.
Side effects can be reported directly to the Department of Post-Marketing Surveillance of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl".
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Nimefort

The medicine should be stored in the original packaging to protect it from light. The medicine should be stored 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 month.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will 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 docuzate, hydroxypropylcellulose, lactose monohydrate, sodium carboxymethylcellulose (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 dividing line on one side, packaged in PVC/Aluminum blisters.
Pack sizes: 10, 20, or 30 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer:

Marketing authorization holder

Solinea Sp. z o.o.
Szafranowa 6, Elizówka
21-003 Ciecierzyn
Poland

Manufacturer

Bluepharma - Indústria Farmacêutica, S.A.

• S. Martinho do Bispo 3045-016 Coimbra Portugal

This medicinal product is authorized in the Member States of the EEA under the following names:
Poland - NIMEFORT
Portugal - Nimesulid Oara

Date of last revision of the leaflet:

08-12-2023