Napritum

Package leaflet: Information for the user

Napritum, 250 mg, tablets
Napritum, 500 mg, tablets
Naproxenum
Please read this leaflet carefully before using the medicine, as 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 other people, even if their symptoms are the same.
• If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Napritum is and what it is 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 pack and other information

1. What Napritum is and what it is used for

Napritum contains a substance called naproxen. It is a non-steroidal anti-inflammatory drug (NSAID).
Napritum is used to reduce pain, swelling, redness and inflammation in adult patients:

• in conditions affecting muscles, joints and tendons, such as strains, gout, ankylosing spondylitis (neck and back pain and stiffness), and arthritis.
• for painful menstruation.

The medicine may also be used in children above 5 years of age (with body weight above 25 kg) with juvenile rheumatoid arthritis.

2. Important information before using Napritum

When not to use Napritum:
Do not use 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 ever had stomach or intestinal problems, such as ulcer or bleeding.
• if the patient has previously experienced bleeding or perforation of the stomach while taking non-steroidal anti-inflammatory drugs.
• if the patient has severe liver failure.
• if the patient has severe kidney disease.
• if heart function is insufficient to pump blood (severe heart failure).
• if the patient is in the last three months of pregnancy.

If any of the situations described above apply to the patient, Napritum should not be used.
If the patient is unsure whether they can take this medicine, they should contact their doctor before using Napritum.
Warnings and precautions
In case of heart disease, history of stroke, or suspicion of risk of these conditions (e.g. high blood pressure, diabetes, elevated cholesterol levels, or smoking), discuss treatment approach with a doctor or pharmacist.
Before starting treatment with Napritum, discuss the following with a 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 (artery) disorders anywhere in the body.
• If the patient has high levels of fat (lipids) in the blood (hyperlipidemia).
• If the patient has ulcerative colitis or Crohn's disease (causing intestinal inflammation, abdominal pain, diarrhea, vomiting, and weight loss).
• If the patient has asthma or allergies (such as hay fever), or if they previously experienced swelling of the face, lips, eyes, or tongue.
• If the patient has nasal polyps or frequent sneezing, nasal discharge, stuffy nose, or nasal itching (rhinitis).

In patients with impaired heart function, use of this medicine may lead to fluid accumulation (ankle swelling, finger swelling, mild peripheral edema).
Serious skin reactions have been reported with the use of Napritum, including (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)). Treatment with Napritum should be discontinued immediately and medical advice sought if any of the symptoms associated with these serious skin reactions, described in section 4, occur.
This medicine should not be used if the patient has chickenpox (varicella).
Long-term use of any painkiller may worsen headache (medication-overuse headache). If the patient suspects this has occurred, they should contact their doctor for advice.
Children
Napritum is not recommended for use in children under 5 years of age and weighing less than 25 kg.
Napritum 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 use.
This includes medicines available without prescription and herbal medicines.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• Other painkillers, such as: ibuprofen, diclofenac, and paracetamol.
• Acetylsalicylic acid used to prevent blood clots,
• Medicines used to prevent blood clotting, such as: warfarin, heparin, ticlopidine, or clopidogrel.
• Hydantoins (used to treat epilepsy), such as phenytoin.
• Sulfonamide medicines, such as hydrochlorothiazide, acetazolamide, indapamide, and sulfonamide antibiotics (used to treat infections).
• Sulfonylureas (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 conditions), such as digoxin.
• Corticosteroids (used to treat swelling and inflammatory conditions), such as hydrocortisone, prednisolone, and dexamethasone.
• Quinolone antibiotics (used to treat infections), such as: ciprofloxacin or moxifloxacin.
• Certain medicines used to treat psychiatric disorders, 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 to induce delivery of a dead fetus).

If any of the above situations apply to the patient, or if there is any uncertainty, contact a doctor or pharmacist before using Napritum.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy

• Do 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 tendency to bleeding in both mother and child and may delay or prolong labor. Napritum should not be used during the first 6 months of pregnancy unless a doctor considers it 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. From week 20 of pregnancy, Napritum may cause kidney function disturbances in the unborn child if taken for longer than a few days. This may lead to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.

Naproxen may make it more difficult to become pregnant. Inform the doctor if the patient plans to become pregnant or has difficulty conceiving.
Breastfeeding
Naproxen passes into the breast milk. Therefore, it should not be used in women who are breastfeeding.
Fertility
This medicine belongs to a group of medicines (NSAIDs) that may negatively affect female fertility during use. This effect is reversible upon discontinuation of the medicine.
Driving and operating machinery
Naproxen may cause side effects such as drowsiness or dizziness. It may also cause fatigue, visual disturbances, loss of balance, depression, or sleep disturbances. If the patient experiences any of these effects, they should consult their doctor and refrain from driving or operating machinery.
Napritum contains lactose monohydrate. If the patient has previously been diagnosed with intolerance to certain 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, meaning the medicine is considered "sodium-free".

3. How to use Napritum

This medicine should always be used exactly as directed by the physician. If in doubt, consult your doctor or pharmacist.
The use of medicines such as Napritum may be associated with a small risk of heart attack (myocardial infarction) or stroke. This risk is more likely when higher doses are used and with long-term treatment. Do not exceed the recommended dose or duration of treatment. If the patient is unsure, they should consult their doctor.

The recommended daily dose is:

Adult patients

Muscle, joint, or tendon pain and painful menstruation

• Recommended initial dose is 500 mg, followed by 250 mg every 6 to 8 hours, as needed.

Arthritis and ankylosing spondylitis

• Recommended dose is 500 mg to 1000 mg.
• The dose may be taken as a single dose or divided into two doses taken twice daily.

Acute gout
Initial dose is 750 mg, then 500 mg after 8 hours, followed by 250 mg every 8 hours until the attack subsides.

Elderly patients, patients with impaired liver or kidney function
The physician will decide the appropriate dose, which will usually be lower than for other adults.

Children above 5 years of age (weighing more than 25 kg) with juvenile rheumatoid arthritis
Recommended dose is 10 mg/kg body weight taken daily.
The dose should be divided into two doses administered every 12 hours.

Method of administration:
Oral use. Tablets should be swallowed whole with a glass of water, during or after a meal.
The tablet may be divided into equal doses.

The patient should ensure adequate fluid intake (stay well-hydrated) while taking Napritum. This is particularly important for patients who have kidney problems.

While taking Napritum, the doctor may wish to monitor whether the patient is receiving the correct dose and whether any adverse effects occur. This is especially important for elderly patients.

Overdose of Napritum
If an excessive dose is taken, contact a doctor immediately or go to the nearest hospital emergency department. Take the medicine packaging with you.

Missed dose of Napritum
If a dose is missed, skip the missed dose and take the next dose at the usual time. Do not take a double dose to make up for a missed dose.

If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Important side effects to be aware of:
You should stop taking Napritum and immediately consult a doctor if any of the symptoms listed below occur.
Immediate treatment may be necessary:

Severe stomach or intestinal problems, symptoms include:
Uncommon: may occur in 1 in 100 people

• Bleeding from the stomach, presenting as vomiting blood or material resembling coffee grounds;
• Bleeding from the rectum, presenting as tarry, sticky stools or bloody diarrhoea.

Rare: may occur in 1 in 1,000 people

• Ulceration or defects in the mucous lining of the stomach or intestines. Symptoms include indigestion, abdominal pain, fever, nausea, vomiting;
• Pancreatic dysfunction. Symptoms include severe abdominal pain radiating to the back.

Frequency not known: cannot be estimated based on available data

• Worsening of symptoms of ulcerative colitis or Crohn's disease such as: abdominal pain, diarrhoea, vomiting, and weight loss.

Allergic reactions, symptoms include:
Rare: may occur in 1 in 1,000 people

• Difficulty breathing, tightness in the chest.

Frequency not known: cannot be estimated based on available data

• Sudden swelling of the throat, face, hands, or feet.

Liver disorders, symptoms include:
Rare: may occur in 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 rashes, symptoms include:
Rare: may occur in 1 in 1,000 people

• Severe, rapidly spreading rash with blisters and peeling of the outer layer of skin, possibly including blisters in the mouth, throat, and eyes. Fever, headache, cough, and body aches may also occur simultaneously;
• Skin blisters after exposure to sunlight, occurring mainly on the hands, face, and palms (late cutaneous porphyria);
• Characteristic allergic skin reaction called fixed drug eruption, which typically recurs in the same location(s) upon re-administration of the medicine and may appear as round or oval red patches, swelling of the skin, blisters (urticaria), and itching.

Frequency not known: frequency cannot be estimated based on available data

• Widespread rash, high fever, elevated liver enzymes, blood disorders (eosinophilia), swollen lymph nodes, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2.

Heart attack, symptoms include:
Rare: may occur in 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 occur in 1 in 1,000 people

• Muscle weakness and numbness, which may occur on one side of the body;
• Sudden disturbance of the sense of smell, taste, hearing, or vision, dizziness (confusion).

Meningitis, symptoms include:
Rare: may occur in 1 in 1,000 people

• Fever, nausea, vomiting, neck stiffness, headache, sensitivity to bright light, and confusion (most likely in patients with autoimmune disorders such as systemic lupus erythematosus).

Other possible side effects
Common: may occur in 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 (oedema);
• Shortness of breath.

Uncommon: may occur in 1 in 100 people

• Blurred vision;
• Dizziness or sensation of "spinning";
• Paresthesia;
• Hearing disturbances;
• Palpitations;
• Vomiting;
• Inflammation of the mucous membrane of the mouth;
• Digestive disturbances;
• Thirst;
• Indigestion;
• Diarrhoea;
• Tarry stools;
• Abnormal results in liver function tests;
• Bruising;
• Purpura;
• Excessive sweating.

Rare: may occur in 1 in 1,000 people

• Blood disorders such as anaemia or changes in white blood cell count;
• Severe hypersensitivity reactions to certain substances (anaphylactic reaction);
• Loss of appetite;
• Insomnia;
• Mood changes;
• Difficulty falling asleep or sleep disturbances;
• Reduced concentration;
• Memory disturbances;
• Mild depression;
• Disorientation;
• Infectious disease characterized by inflammation of the meninges and/or spinal cord (aseptic meningitis);
• Accumulation of fluid (oedema) in mucous membranes (angioedema);
• Seizures (convulsions);
• Eye abnormalities;
• Increased blood pressure and impaired heart function (heart failure);
• Abnormal blood count results, vasculitis;
• Fluid accumulation in the lungs;
• Breathing attacks caused by muscle spasms and swelling of the mucous membranes of the respiratory tract, often including cough and asthma;
• Pneumonia;
• Inflammation of the oesophageal mucosa;
• Vomiting blood;
• Pancreatitis;
• Dryness of the mouth;
• Throat irritation;
• Increased liver enzyme activity;
• Liver function disorders;
• Hair loss;
• Increased skin sensitivity to sunlight;
• Severe skin reactions or mucosal changes with peeling or blisters (e.g. Stevens-Johnson syndrome), erythema multiforme, exacerbation of skin diseases (e.g. lichen planus, nodular erythema);
• Muscle weakness;
• Kidney function disorders;
• Increased frequency of urination (pollakiuria);
• Blood in the urine;
• Increased serum creatinine concentration;
• Increased potassium levels in blood laboratory tests;
• Fatigue;
• Decreased body temperature;
• Fever.

Frequency not known: frequency cannot be estimated based on available data

• Allergic reactions;
• Gastritis;
• Obstruction;
• Muscle pain;
• Systemic lupus erythematosus (SLE). Symptoms include fever, rash, kidney dysfunction, and joint pain;
• Fertility disorders in women;
• General malaise.

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

5. How to store Napritum

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label, carton, and bottle:
EXP. The expiry date refers to the last day of the stated month.
No special storage conditions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. Such measures 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 monohydrate lactose, corn starch, sodium carboxymethyl starch, 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 tablets (10.5 mm in diameter), uncoated, with bevelled edges, marked with "T" and "18" on both sides of the break line 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, marked with "T" and "20" on both sides of the break line 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/Aluminium blisters and in HDPE containers with PP caps, sealing liner and tamper-evident ring, packed in a cardboard box.
Pack sizes:
Blister packs: 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 Authorisation Holder:
Aurovitas Pharma Polska Sp. z o.o.
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 medicinal product is authorised in the European Economic Area countries 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