Dololibre

1. What is Dololibre and what is it used for

Dololibre contains the active substance naproxen. It is a non-steroidal anti-inflammatory drug, abbreviated as NSAID.
Dololibre is used in adults for the symptomatic treatment of:

• pain and inflammation in the following conditions:
• rheumatoid arthritis, ankylosing spondylitis (pain and stiffness in the neck and back), acute attacks of osteoarthritis and spondyloarthritis
• acute attack of gout
• inflammatory rheumatic diseases of soft tissues
• painful swelling or inflammation after musculoskeletal injury
• menstrual pain

The medicine can also be used in children over 2 years of age and adolescents with juvenile idiopathic arthritis.

2. Important information before taking Dololibre

When not to take Dololibre

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6).
• if you have had asthma, angioedema, skin reactions or acute rhinitis after taking acetylsalicylic acid or any other NSAID.
• if you have blood clotting disorders.
• if you have a current stomach or intestinal ulcer or bleeding.
• if you have had recurrent ulcers (peptic ulcers) or bleeding from the stomach and/or duodenum (at least two separate episodes of confirmed ulcers or bleeding).

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• if you have had bleeding or perforation of the stomach or intestine during treatment with NSAIDs.
• if you have severe kidney, liver or heart failure.
• if you have had bleeding in the brain.
• if you have any other current bleeding.
• for women: if you are in the last three months of pregnancy (see "Pregnancy, breastfeeding and fertility").

Warnings and precautions

Taking the medicine in the smallest effective dose for the shortest duration necessary to control the symptoms reduces the risk of side effects.
Medicines like Dololibre may be associated with a small increased risk of heart attack (myocardial infarction) and stroke. Any risk is increased with higher doses and long-term use. Do not exceed the recommended dose or duration of treatment.
If you have heart disease, have had a stroke or think you may be at increased risk of these conditions (e.g. high blood pressure, diabetes, high cholesterol, smoking), you should discuss this treatment with your doctor or pharmacist.
Before starting treatment with Dololibre, you should discuss with your doctor or pharmacist:

• if you have asthma, allergies (such as hay fever) or chronic obstructive pulmonary disease or have had facial swelling, lip swelling, eye swelling or tongue swelling in the past.
• if you have nasal polyps, frequent sneezing or runny, stuffy or itchy nose (rhinitis).
• if you feel weak (possibly due to some disease) or are elderly.
• if you have kidney or liver disease.
• if you have blood clotting disorders.
• if you are taking certain medications, such as corticosteroids, anticoagulants, selective serotonin reuptake inhibitors, acetylsalicylic acid (aspirin) or other NSAIDs, including COX-2 inhibitors.
• if you have had a stomach ulcer or bleeding. Your doctor will inform you about the need to report any unusual symptoms related to the stomach.
• if you have an autoimmune disease, such as systemic lupus erythematosus (SLE, causing joint pain, skin rashes and fever), mixed connective tissue disease or ulcerative colitis or Crohn's disease (diseases causing inflammation and pain in the intestine, diarrhea, vomiting and weight loss).
• if you have vision or hearing disorders.
• if you have recently undergone major surgery.
• if you have heavy menstrual bleeding.
• if you have a disorder of red blood cell biosynthesis (porphyria).

You should stop taking this medicine immediately if you experience gastrointestinal bleeding, vision disturbances or hearing impairment.
Severe skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)) have been reported with the use of Dololibre. You should stop taking Dololibre and seek medical attention immediately if you experience any symptoms associated with these severe skin reactions, described in section 4.
There are very rare reports of severe skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) associated with the use of NSAIDs. Such reactions are most likely to occur in the first month of treatment. If you experience a rash (including changes in the mucous membranes, e.g. mouth, throat, eyes, genitals) or any other signs of hypersensitivity, you should stop taking Dololibre and contact your doctor.

General information

Pain relief and underlying disease
If you do not feel better or still experience pain, fever, fatigue or other symptoms of the disease while taking naproxen, you should consult your doctor for advice. This is because painkillers may mask possible warning signs of the underlying disease.
Headache caused by taking painkillers
Long-term use of painkillers in high doses may cause headaches, which should not be treated by taking more painkillers.
Kidney damage caused by taking painkillers
Frequent use of certain painkillers for a long time may lead to permanent kidney damage with a risk of kidney failure.

If any of the above points apply to you or you are not sure, you should talk to your doctor or pharmacist before taking Dololibre.

Laboratory test results
If your doctor prescribes a blood count, blood clotting and/or liver and kidney function tests, or any other tests (e.g. measurement of certain drug levels in the blood), it is very important that these tests are performed. This is especially true for patients with liver dysfunction, heart failure, high blood pressure or kidney damage.
If a test of adrenal function is necessary, the patient must (temporarily) stop taking Dololibre at least 3 days before the test to avoid interfering with the test result.

Children and adolescents

Due to the lack of sufficient experience, Dololibre is not recommended for use in children under 2 years of age.
Dololibre is not recommended for use in children and adolescents under 18 years of age in any other disease except juvenile idiopathic arthritis.

Dololibre and other medicines

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

• Other NSAIDs, including salicylates (such as acetylsalicylic acid) and COX-2 inhibitors
• Acetylsalicylic acid (aspirin) used to prevent blood clots
• Glycocorticosteroids (used in case of swelling and inflammation), such as hydrocortisone, prednisolone or dexamethasone
• Medicines to prevent blood clots, such as warfarin, heparin or clopidogrel
• Phenytoin (a medicine used to treat epilepsy)
• Sulfonamide medicines, such as hydrochlorothiazide, acetazolamide, indapamide and sulfonamide antibacterials (used to treat infections)
• Oral antidiabetic medicines, such as glimepiride or glipizide
• ACE inhibitor or any other antihypertensive medicine, such as cilazapril, enalapril or propranolol

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• Angiotensin II receptor antagonist, such as candesartan, eprosartan or losartan
• Diuretic (used to treat high blood pressure), such as furosemide or triamterene
• Cardiac glycoside (used to treat heart disease), such as digoxin
• Quinolone antibiotic (used to treat infections), such as ciprofloxacin or moxifloxacin
• Certain medicines used to treat mental health, such as lithium or selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine or citalopram
• Probenecid and sulfinpyrazone (used to treat gout)
• Methotrexate (used to treat skin disorders, arthritis or cancer)
• Cyclosporin or tacrolimus (used to treat skin disorders or after organ transplantation)
• Zidovudine (a medicine used to treat AIDS and HIV infection)
• Mifepristone (a medicine used to terminate pregnancy or induce labor in case of fetal death)
• Medicines that neutralize excess stomach acid.

If any of the above points apply to you or you are not sure, you should talk to your doctor or pharmacist before taking Dololibre.

Taking Dololibre with food, drink and alcohol

Consuming alcoholic beverages during treatment with Dololibre increases the risk of gastrointestinal bleeding (stomach or intestinal), and should be avoided.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, you should ask your doctor for advice before taking this medicine.
Pregnancy
You should not take Dololibre if you are in the last three months of pregnancy, as it may harm the unborn baby or cause complications during delivery. It may cause kidney and heart problems in the unborn baby. It may affect your and your baby's ability to clot and cause prolonged or delayed delivery. You should not take Dololibre during the first six months of pregnancy, unless it is absolutely necessary and recommended by your doctor. If treatment is necessary during this period or when trying to conceive, you should use the smallest dose for the shortest possible time.
If you take Dololibre for more than a few days from the 20th week of pregnancy, it may cause kidney problems in the unborn baby, which may lead to a low amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, your doctor may recommend additional monitoring.
You should not take Dololibre after delivery, as it may delay the process of the uterus returning to its normal shape and size.
Breastfeeding
You should avoid taking Dololibre while breastfeeding, as it may pass into breast milk in small amounts.
Fertility
Dololibre may make it more difficult to become pregnant. If you are planning to become pregnant or are having trouble becoming pregnant, you should tell your doctor.

Driving and using machines

Dololibre may cause fatigue, dizziness, vision disturbances or other central nervous system disorders. If you experience such symptoms, you should tell your doctor and not drive or operate any tools or machines.

Dololibre contains sucrose, liquid sorbitol, crystallizing (E 420), sodium and methyl parahydroxybenzoate (E 218)

Sucrose
If you have been diagnosed with intolerance to some sugars, you should contact your doctor before taking this medicine. One mL of the medicine contains 300 mg of sucrose (sugar). This should be taken into account in patients with diabetes. Sucrose may have a harmful effect on teeth.
Sorbitol (E 420)
This medicine contains 90 mg of sorbitol (E 420) in 1 mL. Sorbitol is a source of fructose. If you have been diagnosed with intolerance to some sugars or have been diagnosed with hereditary fructose intolerance, a rare genetic disorder in which the body does not break down fructose, you should discuss this with your doctor before taking the medicine or giving it to a child.
Sodium
The medicine contains 9.2 mg of sodium (the main component of common salt) in each mL. This corresponds to 0.46% of the recommended maximum daily intake of sodium in the diet for adults.
Methyl parahydroxybenzoate (E 218)
This medicine contains methyl parahydroxybenzoate (E 218) as a preservative. It may cause allergic reactions (which may be delayed).

3. How to take Dololibre

This medicine should always be taken as directed by your doctor. If you are unsure, you should ask your doctor or pharmacist.
Before use, the bottle should be shaken vigorously. Dololibre should be taken with a sufficient amount of liquid. Dololibre starts working faster if taken on an empty stomach. It is recommended that patients with sensitive stomachs take Dololibre during meals.
Dololibre - like all NSAIDs - should be taken in the smallest dose that provides pain relief and for the shortest possible duration. This precaution helps minimize possible side effects.
The packaging contains an 8 mL oral syringe with a scale every 0.1 mL, which should be used when administering the medicine.
Using the syringe:

• Insert the syringe tip into the medicine.
• Holding the syringe in place, gently pull the plunger back, drawing the medicine into the syringe to the correct mark on the scale.
• If air bubbles appear, push the medicine back into the bottle and draw it back into the syringe to the correct mark on the scale.
• Remove the syringe from the bottle.
• Place the syringe tip in the patient's mouth and gently press the plunger to slowly administer the medicine.
• Immediately after use, replace the cap on the bottle. Wash the syringe with water. Disassemble the syringe into two parts and let it air dry. Store it out of the reach of children.

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If your doctor does not recommend otherwise, the usual dose is:

Adults under 65 years of age

The recommended dose range is 10-20 mL of Dololibre (500 mg to 1000 mg of naproxen) per day. The daily dose should not exceed 20 mL of Dololibre (1000 mg of naproxen).
The dose should be adjusted individually according to the clinical condition.
Symptomatic treatment of painful swelling or inflammation after musculoskeletal injury
The recommended initial dose is 10 mL of Dololibre (500 mg of naproxen); if necessary, an additional dose of 5 mL of the medicine (250 mg of naproxen) can be taken every 6 to 8 hours. The daily dose should not exceed 20 mL of Dololibre (1000 mg of naproxen).
Symptomatic treatment of pain and inflammation in rheumatoid arthritis, ankylosing spondylitis and acute attacks of osteoarthritis and spondyloarthritis, as well as in inflammatory rheumatic diseases of soft tissues
The daily dose is usually 10-15 mL of Dololibre (500-750 mg of naproxen). At the beginning of treatment, in the acute phase of inflammation or when switching from another NSAID at a high dose to Dololibre, the recommended daily dose is 15 mL of Dololibre (750 mg of naproxen), divided into two doses per day (10 mL of Dololibre in the morning and 5 mL in the evening or vice versa) or as a single dose (in the morning or evening).
In individual cases, your doctor may increase the daily dose to 20 mL of Dololibre (1000 mg of naproxen).
The maintenance dose is 10 mL of Dololibre (500 mg of naproxen) per day, which can be taken in two divided doses (5 mL in the morning and 5 mL in the evening) or as a single dose (in the morning or evening).
Symptomatic treatment of pain and inflammation in acute gout attack
The recommended initial dose is 15 mL of Dololibre (750 mg of naproxen); then 5 mL of Dololibre (250 mg of naproxen) should be taken every 8 hours until the attack is over.
In the case of acute gout attacks, the patient may exceed the maximum daily dose of 20 mL (1000 mg of naproxen) (for a short period).
Symptomatic treatment of menstrual pain
The usual initial dose is 10 mL of Dololibre (500 mg of naproxen); then 5 mL of Dololibre (250 mg of naproxen) can be taken every 6-8 hours. The daily dose should not exceed 20 mL of Dololibre (1000 mg of naproxen).

Children over 2 years of age and adolescents in the treatment of juvenile idiopathic arthritis

The recommended dose is 10 mg of naproxen per kilogram of body weight per day, which corresponds to a daily dose of 0.2 mL of Dololibre per kilogram of body weight, given in two divided doses (single dose 0.1 mL of Dololibre (5 mg of naproxen) per kilogram of body weight). The daily dose in adolescents should not exceed 20 mL (1000 mg of naproxen).
Dololibre is not recommended for use in children under 2 years of age (see "Warnings and precautions", "Children and adolescents").

Special patient groups

Elderly patients (over 65 years of age)
Close medical supervision is required. In elderly patients, it is especially important to choose the smallest effective dose of Dololibre for the shortest possible duration (see section 2 "Important information before taking Dololibre").
Patients with liver dysfunction
Patients with liver dysfunction are at risk of overdose when taking Dololibre. Therefore, the smallest effective dose of Dololibre should be chosen.
Close medical supervision is required.
In case of severe liver failure, Dololibre should not be taken (see section 2 "Important information before taking Dololibre").
Patients with kidney dysfunction
If you have kidney dysfunction, your doctor may decide to reduce the dose of Dololibre.
In case of severe kidney failure, Dololibre should not be taken (see section 2 "Important information before taking Dololibre").

Duration of treatment

The duration of treatment is determined by your doctor.
In the case of rheumatic diseases, it may be necessary to administer Dololibre for a longer period.
In dysmenorrhea, the duration of treatment depends on the symptoms. However, treatment with Dololibre should not last longer than a few days.

Taking a higher dose of Dololibre than recommended

If you take a higher dose of Dololibre than recommended, you should talk to your doctor or go to the hospital immediately. You should take the packaging with you.
Information for healthcare professionals: Information on overdose management is provided at the end of the leaflet.

Missing a dose of Dololibre

You should not take a double dose to make up for a missed dose. You should continue taking Dololibre as usual.
If you have any further questions about taking this medicine, you should ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Medicines like Dololibre may be associated with a small increased risk of heart attack (myocardial infarction) and stroke.

Important side effects to look out for:

If you experience any of the following side effects, you should stop taking Dololibre and contact your doctor immediately:

Severe allergic reactions(may occur in up to 1 in 10,000 patients), their symptoms include:

• Shortness of breath
• Significant drop in blood pressure
• Swelling of the face or throat, difficulty swallowing
• (Itchy) rash, redness, small blisters on the skin

Severe skin reactions(frequency cannot be estimated from the available data), such as:

• Widespread rash, high fever, elevated liver enzyme activity, blood disorders (eosinophilia), lymph node enlargement and involvement of other organs

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(drug reaction with eosinophilia and systemic symptoms, also known as DRESS). See also section 2.

• Characteristic skin allergic reaction, known as fixed drug eruption, which usually recurs in the same place (places) after re-administration of the medicine and may take the form of round or oval red patches and skin swelling, blisters (hives), itching

Gastrointestinal symptoms(may occur in up to 1 in 10 patients), their symptoms include:

• Severe abdominal pain (stomach), especially with a sudden onset
• Vomiting blood or coffee grounds
• Bloody or black stools
• Ulcers, perforations (holes) and bleeding in the stomach or intestines, which can lead to death, especially in the elderly

Heart attack, its symptoms include:

• Chest pain, which may radiate to the neck and shoulders and down the left arm

Liver symptoms(may occur in up to 1 in 10,000 patients), their symptoms include:

• Severe fatigue with loss of appetite, combined with yellowing of the skin and whites of the eyes, or without
• Nausea or vomiting, or pale stools

Sensory organ disorders, such as:

• Sudden vision disturbances (may occur in up to 1 in 10,000 patients) or hearing impairment (may occur in up to 1 in 10 patients)

Aseptic meningitis(may occur in up to 1 in 10,000 patients), its symptoms include:

• Severe headache, especially with a sudden onset
• Stiff neck, fever, nausea or vomiting
• Confusion, hypersensitivity to light

Patients with autoimmune diseases (systemic lupus erythematosus, mixed connective tissue disease) are at increased risk of developing meningitis.
Blood and lymphatic system disorders(may occur in up to 1 in 10,000 patients), their symptoms include:

• Flu-like symptoms, mouth ulcers, sore throat and nosebleeds

Dololibre may cause the following side effects:

Very common side effects (may occur in more than 1 in 10 patients):

• Nausea
• Vomiting
• Heartburn
• Stomach pain
• Feeling of fullness
• Constipation or diarrhea and minor gastrointestinal bleeding, which can rarely cause anemia

Common side effects (may occur in up to 1 in 10 patients):

• Bleeding from the skin and mucous membranes
• Depression

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• Abnormal dreams
• Sleep disorders or insomnia
• Headache
• Dizziness
• Agitation
• Irritability
• Sleep disorders
• Fatigue
• Perception and cognitive function disorders
• Ringing in the ears
• Dizziness
• Excessive sweating
• Fluid retention in the body (edema), especially in patients with high blood pressure
• Increased thirst

Uncommon side effects (may occur in up to 1 in 100 patients):

• Changes in blood count
• Increased number of a certain type of white blood cell (eosinophilia)
• Asthma attacks (with or without a drop in blood pressure)
• Pulmonary inflammation (eosinophilic pneumonia)
• Symptoms in the lower abdomen (e.g. colitis, exacerbation of Crohn's disease/ulcerative colitis)
• Mouth ulcers
• Esophageal damage
• Liver function changes with elevated transaminase activity
• Hair loss (usually temporary)
• Skin inflammation caused by light (sunlight), which may include blistering
• Muscle pain
• Muscle weakness
• Acute kidney failure
• Kidney function disorder (nephrotic syndrome)
• Kidney inflammation (interstitial nephritis)
• Fever and chills, malaise
• Stomach inflammation
• Gas

Rare side effects (may occur in up to 1 in 1,000 patients):

• Skin disorders with blistering (reactions similar to pemphigus)

Very rare side effects (may occur in up to 1 in 10,000 patients):

• Decreased number of red blood cells and/or white blood cells and/or platelets (aplastic anemia or hemolytic anemia, thrombocytopenia, leukopenia, pancytopenia, agranulocytosis)
• Seizures
• Nerve inflammation (neuritis)
• High blood pressure
• Increased heart rate
• Palpitations (feeling of strong heartbeat)
• Heart failure
• Vasculitis

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• Worsening of inflammatory conditions (e.g. occurrence of necrotizing fasciitis, i.e. acute inflammation and necrosis of fatty tissue under the skin and muscles)
• Generalized anaphylactic or anaphylactoid reactions
• Liver inflammation, liver damage, especially with long-term treatment
• Allergic reactions, such as skin rash, polymorphic erythema, in single cases manifesting as severe skin reactions (including Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Kidney damage (renal papillary necrosis), especially with long-term treatment
• Increased blood uric acid levels

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

• Increased potassium levels
• Decreased white blood cell count (neutropenia)
• Swelling of the lens of the eye and the end of the optic nerve
• Corneal clouding
• Inflammation of the end of the optic nerve
• Feeling of tingling and numbness or numbness of hands and feet
• Pulmonary edema
• Pancreatitis (inflammation of the pancreas, a large gland located behind the stomach)
• Erythema nodosum (inflammation of the skin, including red, painful nodules)
• Lichen planus (a non-infectious, itchy rash that can occur on many areas of the body)
• Systemic lupus erythematosus (SLE, an autoimmune disease that can cause inflammation in various parts of the body)
• Pustular reaction
• Blood in the urine (hematuria)
• Inflammation of certain parts of the kidneys (glomerulonephritis)
• Infertility in women
• Edema

Naproxen may interfere with the results of certain laboratory tests; therefore, you should inform all your doctors (if applicable) that you are taking Dololibre (see section 2 "Important information before taking Dololibre").
Methyl parahydroxybenzoate (E 218) may cause allergic reactions (which may be delayed).

Additional side effects in children and adolescents

The frequency, type and severity of side effects in children and adolescents are similar to those observed in adults.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Monitoring of the 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 authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dololibre

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Store in the original packaging to protect from light.
After first opening, this medicine is stable for 3 months. Store in the original packaging to protect from light.
There are no special storage temperature recommendations for the medicinal product.
Medicines should be kept out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month stated.
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 required. This will help protect the environment.

6. Contents of the packaging and other information

What Dololibre contains

• The active substance of the medicine is naproxen. 1 mL of Dololibre contains 50 mg of naproxen.
• The other ingredients are sucrose (sugar), sodium cyclamate (E 952), sodium chloride, methyl parahydroxybenzoate (E 218), potassium sorbate (E 202), tragacanth, citric acid, liquid sorbitol, crystallizing (E 420), purified water.

What Dololibre looks like and contents of the pack

Dololibre is an oral suspension with a white to yellowish-white color.
A brown glass bottle with a child-resistant closure.
An 8 mL oral syringe with a scale every 0.1 mL
Pack size: 100 mL

Marketing authorization holder and manufacturer

INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany
Email: [email protected]

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

Austria:
Naproxen Infectopharm 50 mg/mL Suspension zum Einnehmen
Spain:
Naproxeno Infectopharm
Poland:
Dololibre
Portugal:
Naprosumo
Italy:
Dololibre

Date of last revision of the leaflet: 14.10.2024 -------------------------------------------------------------------------------------------------------------------- Information intended for healthcare professionals only:

In case of naproxen overdose:

Symptoms of overdose
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Symptoms of overdose may include central nervous system disorders, such as headache, dizziness or drowsiness, abdominal pain and discomfort, nausea, vomiting, changes in liver function, hypoprothrombinemia, kidney function disorders, metabolic acidosis, respiratory depression and disorientation. Naproxen may be rapidly absorbed. High blood levels can be expected. In a few patients, seizures have occurred, but it is not known whether they were caused by naproxen treatment. Gastrointestinal bleeding may also occur. Hypertension, acute kidney failure, respiratory failure and coma may occur, but this is rare. Anaphylactic reactions have been described after treatment with non-steroidal anti-inflammatory drugs and such reactions may also occur after overdose.
Treatment of overdose
Patients should be treated symptomatically. There is no specific antidote. Measures to prevent further absorption (e.g. administration of activated charcoal) may be indicated if not more than four hours have passed since ingestion or in case of large overdose. Forced diuresis, alkalization of urine, hemodialysis and hemoperfusion are likely to be ineffective due to the high binding of naproxen to plasma proteins.