NAPRITUM 250 mg Tablets

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Napritum, 250 mg, tablets
3. Napritum, 500 mg, tablets
   1. Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of Contents of the Leaflet
4. What is Napritum and what is it used for
5. Important information before taking Napritum
   1. When not to take Napritum:
   2. Warnings and precautions
   3. Napritum and other medicines
   4. Pregnancy, breastfeeding, and fertility
   5. Driving and using machines
6. How to take Napritum
   1. Adult patients
   2. Muscle, joint, or tendon pain, and painful menstruation
   3. Arthritis and ankylosing spondylitis
   4. Gout
   5. Elderly patients, patients with liver or kidney disorders
   6. Children over 5 years old (with a body weight over 25 kg) with juvenile rheumatoid arthritis
   7. Overdose
   8. Missed dose
7. Possible side effects
   1. Important side effects to look out for:
   2. Other possible side effects
   3. Reporting side effects
8. How to store Napritum
9. Contents of the package and other information
   1. What Napritum contains
   2. What Napritum looks like and contents of the pack
   3. Pack sizes:
   4. Marketing authorization holder:
   5. Manufacturer/Importer:
   6. This medicine is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet: 09/2024

Package Leaflet: Information for the User

Napritum, 250 mg, tablets

Napritum, 500 mg, tablets

Naproxen

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for a specific person. 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 side effects, including those not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Napritum and what is it used for

Napritum contains the active substance naproxen. It is a nonsteroidal anti-inflammatory drug (NSAID). Napritum is used to reduce pain, swelling, redness, and inflammation, as well as for adult patients:

• with muscle, joint, and tendon diseases, such as sprains, gout, ankylosing spondylitis (neck and back pain and stiffness), and arthritis.
• with painful menstruation.

The medicine can also be used in children over 5 years old (with a body weight over 25 kg) with juvenile rheumatoid arthritis.

2. Important information before taking Napritum

When not to take Napritum:

If the patient is allergic to naproxen, naproxen sodium, or any of the other ingredients of this medicine (listed in section 6), aspirin, or other NSAIDs (such as ibuprofen or diclofenac).

• if the patient has or has had stomach or intestinal disorders, such as ulcers or bleeding.
• if the patient has had bleeding or perforation of the stomach while taking nonsteroidal anti-inflammatory drugs.
• if the patient has severe liver failure.
• if the patient has severe kidney disease.
• if the patient's heart is not strong enough to pump blood (severe heart failure).
• if the patient is in the last three months of pregnancy.

If any of the above situations apply to the patient, they should not take Napritum. If the patient is unsure, they should consult their doctor before taking Napritum.

Warnings and precautions

In case of heart disease, stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, or high cholesterol, and smoking), the patient should discuss their treatment with their doctor or pharmacist. Before starting Napritum, the patient should discuss it with their doctor or pharmacist:

• if the patient is elderly.
• if the patient has kidney or liver disease.
• if the patient has blood clotting disorders.
• if the patient has blood vessel disorders (arteries) in any part of the body.
• if the patient has too much fat (lipids) in the blood (hyperlipidemia).
• if the patient has colitis or Crohn's disease (causing inflammatory changes in the intestines, abdominal pain, diarrhea, vomiting, and weight loss).
• if the patient has asthma or allergies (such as hay fever) or if they have had facial, lip, tongue, or throat swelling in the past.
• if the patient has nasal polyps or frequent sneezing, runny nose, stuffy nose, or itchy nose (rhinitis).

In patients with heart failure, taking this medicine may cause fluid accumulation (swelling of the ankles, fingers, or mild peripheral edema). Serious skin reactions, including (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS)), have been reported with Napritum. The patient should stop taking Napritum and consult their doctor immediately if they experience any symptoms related to these serious skin reactions, described in section 4. The medicine should not be taken if the patient has chickenpox (varicella). Long-term use of any pain reliever may worsen headaches. If the patient thinks this has happened, they should consult their doctor for advice. ChildrenNapritum is not recommended for children under 5 years old and with a body weight less than 25 kg.

Napritum and other medicines

The patient should tell their doctor or pharmacist about all medicines they are taking, have recently taken, or might take, including those obtained without a prescription and herbal medicines. In particular, the patient should inform their doctor or pharmacist if they are taking:

• other pain relievers, such as ibuprofen, diclofenac, and paracetamol.
• aspirin, used to prevent blood clots.
• medicines used to prevent blood clots, such as warfarin, heparin, ticlopidine, or clopidogrel.
• hydantoin (used to treat epilepsy), such as phenytoin.
• sulfonamide medicines, such as hydrochlorothiazide, acetazolamide, indapamide, and sulfonamide antibiotics (used to treat infections).
• sulfonylurea (used to treat diabetes), such as glimepiride, glipizide.
• angiotensin-converting enzyme (ACE) inhibitors or other medicines used to treat high blood pressure, such as cilazapril, enalapril, or propranolol.
• angiotensin II receptor antagonists, such as candesartan, eprosartan, or losartan.
• diuretics (used to treat high blood pressure) such as furosemide.
• digitalis glycosides (used to treat heart disease) such as digoxin.
• corticosteroids (used to treat swelling and inflammation), such as hydrocortisone, prednisone, and dexamethasone.
• quinolone antibiotics (used to treat infections), such as ciprofloxacin or moxifloxacin.
• certain medicines used to treat mental illness, such as lithium or selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine or citalopram.
• probenecid (used to treat gout).
• methotrexate (used to treat skin diseases, arthritis, or cancer).
• cyclosporine or tacrolimus (used to treat skin diseases or after organ transplantation).
• zidovudine (used to treat AIDS and HIV infection).
• mifepristone (used to terminate pregnancy or induce labor in case of a dead fetus).

If any of the above situations apply to the patient or if they are unsure, they should consult their doctor or pharmacist before taking Napritum.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, thinks they may be pregnant, or plans to have a baby, they should consult their doctor or pharmacist before taking this medicine. Pregnancy

• Napritum should not be taken during the last three months of pregnancy, as it may harm the unborn baby or cause problems during delivery. Napritum may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in the mother and baby and prolong labor. During the first six months of pregnancy, Napritum should not be taken unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Napritum may cause kidney problems in the unborn baby if taken for more than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for a longer period, the doctor may recommend additional monitoring.

Naproxen may make it harder to get pregnant. The patient should tell their doctor if they plan to get pregnant or are having trouble getting pregnant. BreastfeedingNaproxen passes into breast milk. Therefore, it should not be taken by breastfeeding women. FertilityThis medicine belongs to a group of medicines (NSAIDs) that may negatively affect female fertility during treatment. This effect is reversible upon stopping the medicine.

Driving and using machines

Naproxen may cause side effects such as drowsiness or dizziness. It may cause fatigue, vision disturbances, balance disorders, depression, or sleep disturbances. If the patient experiences these effects, they should talk to their doctor and stop driving and using machines. Napritum contains lactose monohydrate. If the patient has been diagnosed with intolerance to some sugars, they should consult their doctor before taking this medicine. Napritum contains sodium. This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means it is essentially "sodium-free".

3. How to take Napritum

This medicine should always be taken as directed by the doctor. If the patient is unsure, they should ask their doctor or pharmacist. Taking medicines like Napritum may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. This risk is more likely with higher doses and long-term treatment. The patient should not exceed the recommended dose or duration of treatment. If they are unsure, they should consult their doctor. The recommended daily dose is:

Adult patients

Muscle, joint, or tendon pain, and painful menstruation

• The recommended initial dose is 500 mg, then 250 mg every 6 to 8 hours as needed.

Arthritis and ankylosing spondylitis

• The recommended dose is 500 mg to 1000 mg.
• The dose can be taken once or divided into two doses per day.

Gout

The initial dose is 750 mg, then 500 mg after 8 hours, and 250 mg every 8 hours until the attack subsides.

Elderly patients, patients with liver or kidney disorders

The doctor will decide on the dose and usually, it will be lower than for other adults.

Children over 5 years old (with a body weight over 25 kg) with juvenile rheumatoid arthritis

The recommended dose is 10 mg/kg body weight per day, divided into two doses every 12 hours. Administration: Oral. The tablets should be swallowed whole with a glass of water, during or after meals. The tablet can be divided into equal doses. The patient should ensure they drink enough fluids (are well-hydrated) while taking Napritum, especially if they have kidney problems. During Napritum treatment, the doctor will want to check that the patient is taking the correct dose and not experiencing side effects. This is especially important for elderly patients.

Overdose

If the patient takes too much Napritum, they should contact their doctor or go to the hospital emergency department immediately. They should take the medicine packaging with them.

Missed dose

If the patient misses a dose, they should skip it and take the next dose at the usual time. They should not take a double dose to make up for the missed dose. If the patient has any further questions about taking this medicine, they should ask their doctor or pharmacist.

4. Possible side effects

Like all medicines, Napritum can cause side effects, although not everybody gets them.

Important side effects to look out for:

The patient should stop taking Napritum and consult their doctor immediately if they experience any of the following symptoms. They may need urgent medical attention:

Severe stomach or intestinal disorders, symptoms include:

• Uncommon: may affect up to 1 in 100 people: bleeding from the stomach, visible as vomiting blood or black, tarry stools.
• Rare: may affect up to 1 in 1,000 people: ulcers or perforation of the stomach or intestines. Symptoms include indigestion, stomach pain, fever, nausea, vomiting.

Frequency not known: cannot be estimated from the available data

• worsening of ulcerative colitis or Crohn's disease, such as abdominal pain, diarrhea, vomiting, and weight loss.

Allergic reactions, symptoms include:

• Rare: may affect up to 1 in 1,000 people: difficulty breathing, chest tightness.

Frequency not known: cannot be estimated from the available data

• sudden swelling of the throat, face, hands, and feet.

Liver disorders, symptoms include:

• Rare: may affect up to 1 in 1,000 people: yellowing of the skin or whites of the eyes (jaundice); feeling tired, loss of appetite, nausea, vomiting, pale stools (liver inflammation), and abnormal laboratory test results.

Severe skin reactions, symptoms include:

• Rare: may affect up to 1 in 1,000 people: severe, rapidly spreading rash, with blisters and peeling of the skin, as well as possible blisters in the mouth, throat, and eyes. Fever, headache, cough, body aches may occur at the same time; blisters on the skin after exposure to sunlight, mainly on the hands, face, and fingers (porphyria cutanea tarda); characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same place (places) after re-exposure to the medicine and may take the form of round or oval red patches and swelling of the skin, blisters (hives), itching.

Frequency not known: cannot be estimated from the available data

• widespread rash, high body temperature, elevated liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.

Heart attack, symptoms include:

• Rare: may affect up to 1 in 1,000 people: chest pain, which may radiate to the neck and arms and down the left arm.

Stroke, symptoms include:

• Rare: may affect up to 1 in 1,000 people: weakness and numbness, which may occur on one side of the body; sudden disturbance of smell, taste, hearing, or vision, confusion (disorientation).

Meningitis, symptoms include:

• Rare: may affect up to 1 in 1,000 people: fever, nausea, vomiting, stiff neck, headache, sensitivity to light, and confusion (most likely in people with autoimmune disorders, such as systemic lupus erythematosus).

Other possible side effects

Common: may affect up to 1 in 10 people

• prolonged bleeding time;
• headache, dizziness, daytime sleepiness, feeling of emptiness in the head;
• ringing in the ears;
• vision disturbances;
• heartburn, constipation, stomach pain, nausea;
• bloating;
• fluid retention (edema);
• shortness of breath.

Uncommon: may affect up to 1 in 100 people

• blurred vision;
• dizziness or feeling of "spinning";
• paresthesia;
• hearing disturbances;
• palpitations;
• vomiting;
• mouth ulcers;
• digestive disorders;
• thirst;
• indigestion;
• diarrhea;
• black stools;
• abnormal liver function test results;
• bruises;
• petechiae;
• excessive sweating.

Rare: may affect up to 1 in 1,000 people

• blood disorders, such as anemia or changes in white blood cell count;
• severe allergic reactions to certain substances (anaphylactic reaction);
• loss of appetite;
• insomnia;
• mood changes;
• sleep disturbances;
• concentration problems;
• memory disorders;
• mild depression;
• disorientation;
• aseptic meningitis (a disease characterized by inflammation of the meninges and spinal cord);
• fluid accumulation (angioedema);
• seizures (convulsions);
• eye disorders;
• high blood pressure and impaired heart function (heart failure);
• abnormal blood test results, vasculitis;
• fluid accumulation in the lungs;
• asthma attacks caused by bronchospasm and swelling of the mucous membranes of the respiratory tract, often including cough and asthma;
• pneumonia;
• esophagitis;
• bloody vomiting;
• pancreatitis;
• dry mouth;
• throat irritation;
• elevated liver enzyme activity;
• liver disorders;
• hair loss;
• increased sensitivity of the skin to sunlight;
• severe skin reactions or changes in the mucous membranes with peeling or blisters (e.g., Stevens-Johnson syndrome, erythema multiforme), exacerbation of skin diseases (e.g., psoriasis, pemphigus);
• muscle weakness;
• kidney disorders;
• increased urination (pollakiuria);
• blood in the urine;
• increased creatinine levels in the blood;
• increased potassium levels in the blood;
• fatigue;
• decreased body temperature;
• fever.

Frequency not known: cannot be estimated from the available data

• allergic reactions;
• gastritis;
• intestinal obstruction;
• muscle pain;
• systemic lupus erythematosus (SLE). Symptoms include fever, rash, kidney disorders, and joint pain;
• female fertility disorders;
• general feeling of being unwell.

Reporting side effects

If the patient experiences any side effects, including those not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych, Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: +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, the patient can help provide more information on the safety of the medicine.

5. How to store Napritum

The medicine should be kept out of the sight and reach of children. Do not use this medicine after the expiry date stated on the label, carton, and bottle after EXP. The expiry date refers to the last day of the month stated. There are no special storage instructions. Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines they no longer use. This will help protect the environment.

6. Contents of the package and other information

What Napritum contains

• The active substance is naproxen. Each tablet contains 250 mg of naproxen. Each tablet contains 500 mg of naproxen.
• Other ingredients are lactose monohydrate, cornstarch, sodium carboxymethylcellulose, povidone (K-29/32), yellow iron oxide (E 172), magnesium stearate (E 470b)

What Napritum looks like and contents of the pack

Tablet Napritum, 250 mg, tablets:Yellow, speckled, biconvex, round (10.5 mm in diameter), uncoated tablets with a broken line and "T" and "18" on both sides of the break line and on one side of the tablet, and smooth on the other side. The tablet can be divided into equal doses. Napritum, 500 mg, tablets:Yellow, speckled, biconvex, capsule-shaped, uncoated tablets with "T" and "20" on both sides of the break line and on one side of the tablet, and smooth on the other side. The tablet can be divided into equal doses. Napritum is available in PVC/PE/PVDC/Aluminum blisters and HDPE containers with a PP cap and a sealing ring, in a cardboard box.

Pack sizes:

Blisters: 7, 10, 12, 15, 16, 20, 24, 25, 28, 30, 40, 50, 56, 60, 90, 98, 100, 250, and 500 tablets. HDPE containers: Napritum, 250 mg, tablets:30, 100, 250, and 1000 tablets. Napritum, 500 mg, tablets:30, 100, and 500 tablets. Not all pack sizes may be marketed.

Marketing authorization holder:

Aurovitas Pharma Polska Sp. z o.o. ul. Sokratesa 13D lok. 27 01-909 Warszawa e-mail: [email protected]

Manufacturer/Importer:

APL Swift Services (Malta) Limited HF26, Hal Far Industrial Estate, Hal Far Birzebbugia, BBG 3000 Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Naproxen AB 250 mg/500 mg, Tabletten Naproxen AB 250 mg/500 mg, comprimes Naproxen AB 250 mg/500 mg, tabletten Finland: Naproxen Orion 250 mg/500 mg tabletit Luxembourg: Naproxen AB 250 mg/500 mg, comprimes Naproxen AB 250 mg/500 mg Tabletten Netherlands: Naproxen Aurobindo 250 mg/500 mg, tabletten Norway: Naproxen Orion 250 mg/500 mg tabletter Poland: Napritum Sweden: Naproxen Orion 250 mg/500 mg tabletter

Date of last revision of the leaflet: 09/2024