Anapran

Package Leaflet: Information for the Patient

Anapran, 275 mg, Coated Tablets

Anapran, 550 mg, Coated Tablets

Naproxen Sodium

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medication has been prescribed for a specific person. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Anapran and What is it Used For
• 2. Important Information Before Taking Anapran
• 3. How to Take Anapran
• 4. Possible Side Effects
• 5. How to Store Anapran
• 6. Contents of the Package and Other Information

1. What is Anapran and What is it Used For

Anapran contains naproxen sodium (sodium salt of naproxen). Naproxen is a nonsteroidal anti-inflammatory drug with analgesic and antipyretic effects. The anti-inflammatory effect is based on the inhibition of prostaglandin synthesis; however, other mechanisms are not excluded.

Indications for use:

• rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, degenerative joint disease,
• acute inflammatory conditions of the musculoskeletal system, such as bursitis, tendonitis;
• acute gout attack;
• mild to moderate pain of various origins, acute or chronic, including postoperative, post-traumatic, and other pain, muscle pain, bone pain, joint pain, headache, including migraines, toothache, neuralgia;
• painful menstruation;
• fever of various origins.

2. Important Information Before Taking Anapran

When Not to Take Anapran

• if the patient is allergic to the active substance or any of the other ingredients of this medication (listed in section 6);
• if the patient has hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, which has resulted in symptoms of bronchial asthma, nasal polyps, or urticaria;
• if the patient has experienced gastrointestinal bleeding or perforation after taking nonsteroidal anti-inflammatory drugs;
• if the patient has gastric or duodenal ulcer (active or in history) with bleeding or without bleeding (two or more separate episodes of confirmed ulceration or bleeding);
• if the patient has severe heart, liver, or kidney failure;
• if the patient has bleeding disorders;
• in pregnant women in the third trimester.

Warnings and Precautions

Before starting to take Anapran, the patient should discuss it with their doctor or pharmacist.

Anapran should not be taken simultaneously with medications containing naproxen, as they contain the same active substance.

There is a risk of gastrointestinal bleeding, ulceration, or perforation, which can be fatal and may not be preceded by warning symptoms or may occur in patients who have had such warning symptoms.

In patients with gastrointestinal diseases, such as ulcerative colitis or Crohn's disease, the symptoms may worsen.

The patient should inform their doctor or pharmacist if they are taking medications that may increase the risk of ulcers or bleeding, such as corticosteroids, anticoagulants (e.g., warfarin), or certain antidepressants (selective serotonin reuptake inhibitors).

In case of gastrointestinal bleeding or ulceration, the use of naproxen sodium should be discontinued.

Patient with previously existing gastrointestinal diseases, especially elderly patients, should inform their doctor about any unusual gastrointestinal symptoms (especially bleeding), especially during the initial treatment period.

Such patients should use the smallest effective dose for the shortest possible duration.

Taking medications like Anapran 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 medication.

The patient should not exceed the recommended dose and duration of treatment.

In case of heart disorders, previous stroke, or suspected risk of these disorders (e.g., high blood pressure, diabetes, high cholesterol, smoking), the patient should discuss the treatment with their doctor or pharmacist.

Due to its anti-inflammatory and antipyretic effects, naproxen may mask the symptoms of infection and make it difficult to diagnose the disease.

In patients with bronchial asthma or allergic diseases, bronchospasm may occur.

In patients taking naproxen, very rare abnormalities in laboratory test results may occur (e.g., liver function tests).

Naproxen reduces platelet aggregation and prolongs bleeding time.

The patient should inform their doctor about taking anticoagulant medications or previous bleeding disorders.

In some individuals, hypersensitivity reactions may occur.

Anapran may affect kidney and/or liver function.

If the patient has kidney and/or liver function disorders, they should discuss the treatment with their doctor or pharmacist.

If eye disorders occur during treatment, the patient should immediately consult their doctor.

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders, there may be an increased risk of aseptic meningitis.

Severe skin reactions, some of which are fatal, including exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported very rarely in association with the use of NSAIDs.

The greatest risk of these severe reactions exists at the beginning of treatment, in most cases within the first month of use.

The patient should discontinue the medication at the first sign of a skin rash, mucosal lesions, or other signs of hypersensitivity.

The dose of anti-inflammatory medications should be reduced gradually, especially after long-term treatment.

Naproxen should not be taken simultaneously with other nonsteroidal anti-inflammatory drugs and glucocorticosteroids due to the increased risk of severe side effects.

The patient should discuss with their doctor, even if the above warnings refer to past situations.

Children and Adolescents

The safety of naproxen in children under 5 years of age has not been established.

In children and adolescents under 16 years of age, naproxen can be used only for the treatment of juvenile rheumatoid arthritis.

Use of Anapran in Elderly Patients

Anapran should be used with caution, as the risk of side effects is higher than in younger individuals.

Anapran and Other Medications

The patient should tell their doctor or pharmacist about all medications they are currently taking or have recently taken, as well as any medications they plan to take.

Antacids, cholestyramine:

Taking antacids or cholestyramine may delay the absorption of naproxen.

Hydantoin, anticoagulants, sulfonamides

Naproxen taken simultaneously with hydantoin, anticoagulants, or sulfonamides increases their effect.

Warfarin, heparin

Concomitant use of NSAIDs and warfarin or heparin should be monitored closely by the doctor.

Furosemide

Nonsteroidal anti-inflammatory drugs reduce the diuretic effect of furosemide.

Lithium

Naproxen reduces lithium excretion, leading to increased lithium levels in the blood.

Blood Pressure-Lowering Medications

NSAIDs may reduce the effectiveness of blood pressure-lowering medications (e.g., propranolol and other beta-adrenergic blockers) and may increase the risk of kidney failure associated with the use of ACE inhibitors.

Probenecid

Probenecid increases the plasma concentration of naproxen.

Methotrexate

Naproxen and other anti-inflammatory medications may reduce the excretion of methotrexate, leading to increased toxicity.

Cardiac Glycosides

Naproxen may increase the symptoms of heart failure and increase the levels of cardiac glycosides in the blood.

Cyclosporine

Concomitant use of nonsteroidal anti-inflammatory drugs and cyclosporine increases the risk of kidney damage.

Mifepristone

Nonsteroidal anti-inflammatory drugs taken within 8-12 days after mifepristone administration may reduce its effectiveness.

Corticosteroids

Concomitant administration of nonsteroidal anti-inflammatory drugs and corticosteroids may increase the risk of gastrointestinal bleeding.

Other NSAIDs

The patient should avoid concomitant use of two or more nonsteroidal anti-inflammatory drugs due to the risk of side effects.

Quinolone Antibiotics

In patients taking nonsteroidal anti-inflammatory drugs and quinolone antibiotics, there is an increased risk of seizures.

Acetylsalicylic Acid

Concomitant administration of naproxen and acetylsalicylic acid may reduce the plasma concentration of naproxen.

Concomitant (on the same day) intake of naproxen for a period longer than one day may weaken the effect of low-dose acetylsalicylic acid used to prevent blood clots on platelet activity.

Antiplatelet Agents and Selective Serotonin Reuptake Inhibitors

Antiplatelet agents and selective serotonin reuptake inhibitors taken simultaneously with naproxen may increase the risk of gastrointestinal bleeding.

Tacrolimus, used to prevent organ transplant rejection, may increase the toxic effect of Anapran on the kidneys when taken concomitantly.

Zidovudine, used to treat HIV infections, may increase the risk of bleeding.

Anapran with Food and Drink

The medication should be taken during or after meals.

Pregnancy, Breastfeeding, and Fertility

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

Pregnancy

Naproxen should not be taken during the last 3 months of pregnancy, as it may harm the unborn child or cause complications during delivery.

It may cause kidney and heart problems in the unborn child.

It may increase the risk of bleeding in the mother and child and cause prolongation of labor.

During the first 6 months of pregnancy, naproxen should not be taken unless the doctor considers it absolutely necessary.

If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible duration.

From the 20th week of pregnancy, Anapran may cause kidney problems in the unborn child if taken for more than a few days, which may lead to a decrease in the amount of amniotic fluid surrounding the child (oligohydramnios) or narrowing of the ductus arteriosus in the child's heart.

If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Naproxen passes into breast milk.

The medication should not be taken during breastfeeding.

Fertility

The use of naproxen may have a negative effect on female fertility and is not recommended for women who are trying to conceive.

Naproxen may make it difficult to conceive.

If the patient plans to conceive or is having difficulty conceiving, they should inform their doctor.

Driving and Operating Machinery

During treatment with Anapran, the patient's ability to react to external stimuli may be reduced, and coordination disorders (drowsiness, vision disturbances, dizziness) may occur.

The patient should consult their doctor about the possibility of driving vehicles and operating machinery while taking naproxen.

Effect on Laboratory Tests

It is recommended to perform tests of adrenal cortex function at least 48 hours after the last dose of naproxen, as naproxen may interfere with laboratory test results.

The Medication Contains Lactose and Sodium

Lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should consult their doctor before taking the medication.

Sodium

The medication contains 25.1 mg (for 275 mg tablets) or 50.2 mg (for 550 mg tablets) of sodium (the main component of common salt) per dose.

This corresponds to 1.26% (for 275 mg tablets) or 2.51% (for 550 mg tablets) of the maximum recommended daily intake of sodium in the diet for adults.

3. How to Take Anapran

This medication should always be taken as directed by the doctor or pharmacist.

In case of doubts, the patient should consult their doctor or pharmacist.

Tablets should not be divided.

The maximum daily dose is 1375 mg.

Adults

Rheumatoid Arthritis, Ankylosing Spondylitis, Osteoarthritis, Degenerative Joint Disease

The usual dose is 550 mg to 1100 mg per day in two divided doses, every 12 hours.

If a dose of 1100 mg is necessary, the patient can take one 550 mg tablet twice a day or two 550 mg tablets as a single dose (in the morning or evening).

In the following cases, a loading dose of 825 mg or 1100 mg per day should be administered:

• in patients reporting increased pain at night or morning stiffness;
• in patients who have changed their treatment from a high dose of another anti-rheumatic medication to naproxen;
• in osteoarthritis, when the main symptom is pain.

Acute Inflammatory Conditions of the Musculoskeletal System, Mild to Moderate Pain of Various Origins, Painful Menstruation, Fever of Various Origins

The initial dose is 550 mg, followed by 275 mg every 6 to 8 hours as needed, not exceeding 1375 mg on the first day and 1100 mg on subsequent days.

Acute Gout Attack

The recommended initial dose is 825 mg, followed by 275 mg every 8 hours until the pain subsides.

Migraine Headaches

The recommended dose is 825 mg at the first symptoms of an impending attack.

Additionally, a dose of 275 mg to 550 mg can be taken during the day if necessary, but not earlier than 30 minutes after the first dose.

Kidney and/or Liver Function Disorders

The medication should be used with caution in patients with kidney and/or liver function disorders.

In patients taking the medication long-term, kidney and liver function should be monitored.

Children and Adolescents

Children over 5 years of age:

Juvenile Rheumatoid Arthritis

The recommended dose is 10 mg of naproxen per kilogram of body weight per day in 2 divided doses.

The medication is not recommended for children under 16 years of age for other indications.

Taking the medication in the smallest effective dose for the shortest possible duration reduces the risk of side effects.

If the patient feels that the effect of Anapran is too strong or too weak, they should consult their doctor.

Overdose of Anapran

Symptoms include headache, heartburn, nausea, vomiting, abdominal pain, gastrointestinal bleeding, diarrhea, disorientation, excitement, drowsiness, dizziness, tinnitus, fainting.

In case of significant overdose, acute kidney failure and liver damage are possible.

Respiratory depression and coma may occur after taking NSAIDs, but are rare.

Seizures may also occur.

In case of accidental or intentional overdose of large amounts of naproxen, the medication should be removed from the stomach, and the patient should immediately consult their doctor.

Due to the significant binding of the medication to proteins, hemodialysis is ineffective.

In case of overdose, the patient should immediately consult their doctor or pharmacist.

Missed Dose of Anapran

The patient should take the missed dose as soon as possible.

The patient should not take a double dose to make up for the missed dose.

4. Possible Side Effects

Like all medications, Anapran can cause side effects, although not everybody gets them.

Side effects are listed by frequency of occurrence: common (may affect up to 1 in 10 people):

• -dizziness, headache, feeling of emptiness in the head;
• nausea, indigestion, heartburn, abdominal pain.

uncommon (may affect up to 1 in 100 people):

• fatigue, insomnia, drowsiness;
• -vomiting, constipation, diarrhea, abdominal discomfort;
• skin rash, itching, urticaria.

rare (may affect up to 1 in 1,000 people):

• -gastrointestinal bleeding, gastric or duodenal ulcer (with bleeding and perforation or without);
• angioedema;
• kidney failure;
• peripheral edema, fever.

very rare (may affect up to 1 in 10,000 people):

• blood disorders (thrombocytopenia, granulocytopenia, agranulocytosis, eosinophilia, leukopenia), aplastic anemia, hemolytic anemia;
• hypersensitivity to light, anaphylactic reactions, including fatal anaphylactic shock;
• seizures, sleep disorders, depression, aseptic meningitis, concentration and cognitive function disorders;
• vision disorders, corneal clouding, optic neuritis, papillitis, optic disc edema;
• tinnitus, hearing disorders, including hearing loss;
• dyspnea, edema, palpitations, heart failure, hypertension; in association with NSAID treatment, reports of edema, hypertension, and heart failure have been made; taking medications like Anapran, especially in high doses, may be associated with a small increased risk of heart attack (myocardial infarction) or stroke;
• -vasculitis, hypertension;
• dyspnea, bronchial asthma, eosinophilic pneumonia, pulmonary edema;
• -pancreatitis, gastric or intestinal mucosal inflammation;
• jaundice, hepatitis;
• alopecia, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema nodosum, lichen planus, systemic lupus erythematosus, reactions resembling pemphigus, bullous exfoliation, purpura, petechiae, hemorrhagic diathesis, excessive sweating;
• muscle pain or weakness;
• glomerulonephritis, interstitial nephritis, nephrotic syndrome, hematuria, increased serum creatinine, renal papillary necrosis;
• excessive thirst, fatigue, oral mucosal inflammation with ulcers, esophagitis;
• increased creatinine, abnormal liver function test results, hyperkalemia (elevated potassium levels in the blood).

frequency not known (frequency cannot be estimated from the available data):

• increased potassium levels in the blood;
• insomnia, sleep disorders, depression, disorientation, and hallucinations;
• female fertility disorders.

If any of the following side effects occur, the patient should stop taking Anapran and immediately consult their doctor:

• 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 syndrome). See also section 2.
• characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same location (locations) after re-administration of the medication and may take the form of round or oval red patches and skin edema, blisters (urticaria), itching;

In some individuals, other side effects may occur.

If other side effects occur that are not listed in this leaflet, the patient should inform their doctor.

Reporting Side Effects

If any side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse.

Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:

Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 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, more information can be collected on the safety of the medication.

5. How to Store Anapran

The medication should be stored out of sight and reach of children.

Store in a temperature below 25°C.

Store in the original packaging to protect from light.

Do not use this medication after the expiration date stated on the packaging.

The expiration date refers to the last day of the month stated.

Medications should not be disposed of via wastewater or household waste.

The patient should ask their pharmacist how to dispose of medications that are no longer needed.

This will help protect the environment.

6. Contents of the Package and Other Information

What Anapran Contains

• The active substance of the medication is naproxen sodium.
• One tablet contains 275 mg or 550 mg of naproxen sodium.
• Other ingredients are: microcrystalline cellulose, povidone, talc, magnesium stearate, hydroxypropyl cellulose (low-substituted), lactose monohydrate, stearic acid, hypromellose, macrogol 8000, Opaspray K-1R-4210A coating containing: indigo carmine (E132), aluminum hydroxide, titanium dioxide, hydroxypropyl cellulose.

What Anapran Looks Like and What the Package Contains

Anapran 275 mg: blue, round, biconvex tablets, smooth on both sides.

Anapran 550 mg: blue, round, biconvex tablets with a "-" sign embossed on one side, smooth on the other side.

Anapran, 275 mg coated tablets

Polyethylene container in a cardboard box:

20 tablets (1 container of 20 tablets) or

40 tablets (1 container of 40 tablets)

PVC/Aluminum blisters in a cardboard box:

20 tablets (2 blisters of 10 tablets) or

40 tablets (4 blisters of 10 tablets) or

60 tablets (6 blisters of 10 tablets)

Anapran, 550 mg coated tablets

Polyethylene container in a cardboard box:

20 tablets (1 container of 20 tablets)

PVC/Aluminum blisters in a cardboard box:

20 tablets (2 blisters of 10 tablets) or

60 tablets (6 blisters of 10 tablets)

Marketing Authorization Holder

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

tel. +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Date of Last Revision of the Leaflet