Anapran

Package Leaflet: Information for the Patient

Anapran, 275 mg, Film-Coated Tablets

Anapran, 550 mg, Film-Coated Tablets

Naproxen Sodium

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. 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 inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package 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 pack 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 attack of gout;
• 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 migraine, toothache, neuralgia;
• menstrual pain;
• fever of various origins.

2. Important information before taking Anapran

When not to take Anapran

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• if you have hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs, which has manifested with symptoms of bronchial asthma, rhinitis, nasal polyps, or urticaria;
• if you have had gastrointestinal bleeding or perforation after taking nonsteroidal anti-inflammatory drugs;
• if you have stomach or duodenal ulcer (active or in history) with bleeding or without bleeding (two or more separate episodes of confirmed ulceration or bleeding);
• if you have severe heart, liver, and/or kidney failure;
• if you have bleeding disorders;
• in the third trimester of pregnancy.

Warnings and precautions

Before starting to take Anapran, discuss it with your doctor or pharmacist.

Anapran should not be taken simultaneously with other medicines 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, Crohn's disease, the symptoms may worsen.

Please inform your doctor or pharmacist if you are taking medicines 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, naproxen sodium should be discontinued.

Patients with pre-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 such medicines as 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 medicine.

Do 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), consult your 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.

Please inform your doctor about taking anticoagulant medications or previous bleeding disorders.

Some people may experience hypersensitivity reactions.

Anapran may affect kidney and/or liver function.

If you have had kidney and/or liver function disorders, consult your doctor or pharmacist.

If you experience eye disorders during treatment, contact your doctor immediately.

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 them 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.

Stop taking the medicine at the first sign of a skin rash, mucosal lesions, or any other sign of hypersensitivity.

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

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

Please consult your doctor, even if the above warnings refer to situations that have occurred in the past.

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 patients.

Anapran and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, as well as any medicines you 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 under close medical supervision.

Furosemide

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

Lithium

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

Antihypertensive drugs

NSAIDs may reduce the effectiveness of antihypertensive drugs (e.g., propranolol and other beta-adrenergic blockers) and may increase the risk of renal failure associated with the use of ACE inhibitors.

Probenecid

Probenecid increases the plasma concentration of naproxen.

Methotrexate

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

Cardiac glycosides

Naproxen may increase the symptoms of heart failure and increase the plasma concentration of cardiac glycosides.

Cyclosporin

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

Mifepristone

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

Corticosteroids

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

Other NSAIDs

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 more 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 rejection of transplanted organs, when taken simultaneously with Anapran, may increase its toxic effect on the kidneys.

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

Anapran with food and drink

The medicine should be taken during or after meals.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Do not take naproxen in 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 her child and cause prolongation of labor.

In 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 lowest possible dose should be used for the shortest possible time.

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 baby (oligohydramnios) or narrowing of the arterial duct in the baby's heart.

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

Breastfeeding

Naproxen passes into breast milk.

The medicine 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 planning to conceive.

Naproxen may make it difficult to conceive.

If you are planning to conceive or are having trouble conceiving, inform your doctor.

Driving and using machines

During treatment, the ability to react to external stimuli may decrease, and coordination disorders (drowsiness, vision disturbances, dizziness) may occur.

Consult your doctor about the possibility of driving vehicles and operating machinery while taking naproxen.

Effect on laboratory tests

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

The medicine contains lactose and sodium

Lactose

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

Sodium

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

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

3. How to take Anapran

Always take this medicine exactly as your doctor or pharmacist has told you.

If you are not sure, ask your doctor or pharmacist.

Do not divide the tablets.

The maximum daily dose is 1375 mg.

Adults

Rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, degenerative joint disease

Usually, 550 mg to 1100 mg per day is taken in two divided doses, every 12 hours.

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

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

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

Acute inflammatory conditions of the musculoskeletal system, mild to moderate pain of various origins, menstrual pain, 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 of treatment.

Acute attack of gout

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

Migraine headaches

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

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

Kidney and/or liver function disorders

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

In patients taking the medicine for a long time, 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 medicine is not recommended for children under 16 years of age for other indications.

Taking the medicine in the lowest effective dose for the shortest possible duration reduces the risk of side effects.

If you feel that the effect of Anapran is too strong or too weak, consult your 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 medicine should be removed from the stomach and a doctor should be consulted immediately.

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

In case of overdose, consult your doctor or pharmacist immediately.

Missed dose of Anapran

Take the missed dose as soon as possible.

Do not take a double dose to make up for the missed dose.

4. Possible side effects

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

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

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

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

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

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

• -gastrointestinal bleeding, stomach 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 anaphylactic shock leading to death;
• seizures, sleep disorders, depression, disorientation, 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 received; taking such medicines as 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, drug reaction with eosinophilia and systemic symptoms (DRESS), fixed drug eruption, which usually recurs in the same location (locations) after re-administration of the drug and may take the form of round or oval red patches and skin edema, blisters (urticaria), itching;
• 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 you experience any of the following side effects, stop taking Anapran and contact your doctor immediately:

• widespread rash, high fever, elevated liver enzyme activity, blood disorders (eosinophilia), lymphadenopathy, and involvement of other organs (drug reaction with eosinophilia and systemic symptoms, also known as DRESS syndrome). See also section 2.
• a characteristic skin allergic reaction called fixed drug eruption, which usually recurs in the same location (locations) after re-administration of the drug and may take the form of round or oval red patches and skin edema, blisters (urticaria), itching;

Some people may experience other side effects not listed in this leaflet.

If you experience any other side effects, not mentioned in this leaflet, inform your doctor.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please inform your 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:

Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 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, you can help provide more information on the safety of this medicine.

5. How to store Anapran

Keep this medicine out of the sight and reach of children.

Store in a temperature below 25°C.

Store in the original package to protect from light.

Do not use this medicine after the expiry date stated on the carton.

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

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

Ask your pharmacist how to dispose of medicines no longer required.

This will help protect the environment.

6. Contents of the pack and other information

What Anapran contains

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

What Anapran looks like and contents of the pack

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

Anapran 550 mg: blue, round, biconvex tablets with a score line, smooth on one side.

Anapran, film-coated tablets 275 mg

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, film-coated tablets 550 mg

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

phone: +48 22 732 77 00

Manufacturer

Adamed Pharma S.A.

Pieńków, ul. M. Adamkiewicza 6A

05-152 Czosnów

Date of last revision of the package leaflet