Napritum

Leaflet attached to the packaging: information for the user

Napritum, 250 mg, tablets

Napritum, 500 mg, tablets

Naproxen

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your 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 packaging 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, and in adult patients:

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

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

2. Important information before taking Napritum

When not to take Napritum:

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

If any of the above situations apply to you, do not take Napritum. If you are not sure, you should consult your 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), you should discuss your treatment with your doctor or pharmacist.
Before starting Napritum, you should discuss it with your doctor or pharmacist:

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

In patients with heart function disorders, taking this medicine may cause fluid accumulation (swelling of the ankles, finger swelling, or mild peripheral edema).
Severe 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. You should stop taking Napritum and consult your doctor immediately if you experience any of the symptoms associated with these severe skin reactions, described in section 4.
Do not take this medicine if you have chickenpox (varicella).
Long-term use of any pain reliever may worsen headaches. If you think this has happened to you, you should consult your doctor for advice.
Children
Napritum is not recommended for use in children under 5 years old and with a body weight of less than 25 kg.

Napritum and other medicines

You should tell your doctor or pharmacist about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
This includes medicines available without a prescription and herbal medicines.
In particular, you should inform your doctor or pharmacist if you are taking any of the following medicines:

• 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.
• Cardiac 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 at the end of pregnancy or in case of induced abortion).

If any of the above situations apply to you or if you are in doubt, you should consult your doctor or pharmacist before taking Napritum.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before taking this medicine.
Pregnancy

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

Naproxen may make it more difficult to become pregnant. You should inform your doctor if you plan to become pregnant or are having trouble becoming pregnant.
Breastfeeding
Naproxen passes into breast milk. Therefore, it should not be used in breastfeeding women.
Fertility
This medicine belongs to a group of medicines (NSAIDs) that may negatively affect female fertility during treatment. This effect is reversible upon discontinuation of 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 you experience these effects, you should talk to your doctor and stop driving and operating machinery.
Napritum contains lactose monohydrate. If you have been diagnosed with intolerance to some sugars, you should consult your 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 exactly as directed by your doctor. If you are in doubt, you should ask your 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. You should not exceed the recommended doseor duration of treatment.If you are unsure, you should consult your 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 taken twice a day.

Gout

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

Elderly patients, patients with liver or kidney function disorders

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

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

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

Taking a higher dose of Napritum than recommended

If you have taken too much of the medicine, you should contact your doctor or go to the hospital emergency department immediately. You should take the medicine packaging with you.

Missing a dose of Napritum

If you miss a dose, you should skip it and take the next dose at the usual time. You should not take a double dose to make up for the missed dose.
If you have any further doubts about taking this medicine, you should ask your 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:

You should stop taking Napritum and consult your doctor immediately if you experience any of the following symptoms. You 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 in the form of vomiting blood or coffee grounds;
• bleeding from the anus in the form of black, tarry stools or bloody diarrhea.

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

• ulcers or perforations of the stomach or intestines. Symptoms include indigestion, abdominal pain, fever, nausea, vomiting;
• pancreatitis. Symptoms include severe abdominal pain radiating to the back.

Frequency not known: cannot be estimated from the available data

• worsening of ulcerative colitis or Crohn's disease symptoms, such as 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 (hepatitis), and abnormal laboratory test results (including hepatitis).

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);
• a characteristic skin allergic reaction, called 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 skin swelling, blisters (hives), itching.

Frequency not known: frequency cannot be estimated from the available data

• Widespread rash, high fever, 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 that 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 that 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, abdominal 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 (anaphylactic reaction);
• loss of appetite;
• insomnia;
• mood changes;
• sleep disturbances;
• concentration disorders;
• memory disorders;
• mild depression;
• disorientation;
• a infectious disease characterized by inflammation of the meninges and (or) spinal cord (aseptic meningitis);
• fluid accumulation (angioedema);
• seizures (convulsions);
• eye disorders;
• high blood pressure and impaired heart function (heart failure);
• abnormal blood count results, vasculitis;
• fluid accumulation in the lungs;
• breathlessness attacks caused by muscle spasms and swelling of the mucous membranes of the respiratory tract, often accompanied by coughing and asthma;
• pneumonia;
• esophagitis;
• bloody vomiting;
• pancreatitis;
• dry mouth;
• throat irritation;
• elevated liver enzyme activity;
• liver function disorders;
• hair loss;
• increased skin sensitivity 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, erythema nodosum);
• muscle weakness;
• kidney function 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: frequency cannot be estimated from the available data

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

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. You can also report side effects directly to the Department of Drug Safety Monitoring, 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
You can also report side effects 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 Napritum

The medicine should be stored out of 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.
There are no special storage precautions.
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 packaging 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.
• The 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 beveled edge and the inscription "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 the inscription "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 tablets are 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 Warsaw
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, tablets
Naproxen AB 250 mg/500 mg, capsules
Naproxen AB 250 mg/500 mg, tablets
Finland:
Naproxen Orion 250 mg/500 mg tablets
Luxembourg:
Naproxen AB 250 mg/500 mg, capsules
Naproxen AB 250 mg/500 mg tablets
Netherlands:
Naproxen Aurobindo 250 mg/500 mg, tablets
Norway:
Naproxen Orion 250 mg/500 mg tablets
Poland:
Napritum
Sweden:
Naproxen Orion 250 mg/500 mg tablets

Date of last revision of the leaflet: 09/2024