NAPROXEN INFECTOPHARM 50 mg/mL ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Naproxeno Infectopharm 50mg/ml Oral Suspension

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Naproxeno Infectopharm and what is it used for
2. What you need to know before you take Naproxeno Infectopharm
3. How to take Naproxeno Infectopharm
4. Possible side effects
5. Storage of Naproxeno Infectopharm
6. Contents of the pack and other information

1. What is Naproxeno Infectopharm and what is it used for

Naproxeno Infectopharm contains a medicine called naproxen. This is a «non-steroidal anti-inflammatory» or NSAID.

This medicine is used in adults for the symptomatic treatment of:

• pain and inflammation in:

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

• menstrual pain

It can also be used in children from 2 years and adolescents with juvenile idiopathic arthritis.

2. What you need to know before you take Naproxeno Infectopharm

Do not take Naproxeno Infectopharm:

• if you are allergic to naproxen or any of the other ingredients of this medicine (listed in section 6).
• if you have a history of asthma, angioedema, skin reactions or acute rhinitis after taking acetylsalicylic acid or any other NSAID.

• if you have blood formation disorders.
• if you currently have a stomach or intestinal ulcer or bleeding.
• if you have a history of recurrent stomach/duodenal ulcers (peptic ulcers) or bleeding (at least two different episodes of ulcers or bleeding confirmed).
• if you have previously experienced bleeding or perforation of your stomach or intestine while taking NSAIDs.
• if you have severe kidney, liver, or heart failure.
• if you have a cerebral hemorrhage.
• if you are currently suffering from any other form of acute bleeding.
• if you are in the last three months of pregnancy (see «Pregnancy, breast-feeding and fertility»).

Warnings and precautions

Adverse reactions can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.

Medicines like naproxen may be associated with a small increased risk of heart attack («myocardial infarction») or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or treatment duration.

If you have heart problems, have ever had a stroke, or think you may be at increased risk of these conditions (for example: high blood pressure, diabetes, high cholesterol, or if you smoke), discuss this treatment with your doctor or pharmacist.

Consult your doctor or pharmacist before starting to take this medicine:

• if you have asthma, allergies (such as hay fever) or chronic obstructive pulmonary disease or have had facial, lip, eye, or tongue swelling in the past.
• if you have nasal polyps or sneeze a lot or have discharge, obstruction, or itching in the nose (rhinitis).
• if you feel weak (perhaps due to illness) or are an elderly person.
• if you have kidney or liver problems.
• if you have problems with blood coagulation.
• if you are taking medicines such as corticosteroids, anticoagulants, selective serotonin reuptake inhibitors (SSRIs), acetylsalicylic acid, or NSAIDs, including COX-2 inhibitors.
• if you have previously suffered from stomach ulcers or bleeding. You will be asked to inform your doctor about any unusual stomach symptoms.
• if you have an autoimmune disease, such as «systemic lupus erythematosus» (SLE, causes joint pain, skin rashes, and fever) or mixed connective tissue disease and ulcerative colitis or Crohn's disease (diseases that cause intestinal inflammation, abdominal pain, diarrhea, vomiting, and weight loss).

• if you have vision or hearing problems.
• if you have undergone major surgery shortly before starting treatment with naproxen.
• if you have heavy menstrual bleeding.
• if you suffer from a disorder of the biosynthesis of the red pigment that gives color to the blood (porphyria).

Treatment should be discontinued immediately in case of gastrointestinal bleeding, visual disturbances, or hearing impairment.

There have been reports of serious skin reactions, including exfoliative dermatitis, and Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (Lyell's syndrome), and drug reaction with eosinophilia and systemic symptoms (DRESS), in association with Naproxeno Infectopharm. Stop taking Naproxeno Infectopharm and consult your doctor immediately if you notice any of the symptoms related to serious skin reactions described in section 4.

General information

Pain relief and underlying disease

If during treatment with naproxen you do not feel better or if you continue to have pain, fever, fatigue, or other signs of illness, consult your doctor. This is because pain relievers can mask possible warning signs of an underlying disease.

Headache due to pain relievers

Prolonged and high-dose use of pain relievers can cause headaches that should not be treated by taking more pain relievers.

Kidney damage due to pain relievers

Regular use of certain pain relievers for a long period can cause permanent kidney damage with a risk of kidney failure.

If you are in any of the above situations, or if you are not sure, consult your doctor or pharmacist before taking this medicine.

Laboratory test results

If your doctor recommends that you have your blood counts, blood coagulation, liver and kidney function, or any other test (e.g., determination of blood levels of certain medicines), it is essential that you have these tests. This applies particularly to patients with liver failure, heart failure, high blood pressure, or kidney damage.

If you need to have a test of adrenal function, you must stop taking this medicine (temporarily) at least 3 days before the test to avoid interference with the test result.

Children and adolescents

The use of this medicine is not recommended in children under 2 years, as there is not enough experience.

The use of this medicine is not recommended in any disorder other than juvenile idiopathic arthritis in children and adolescents under 18 years.

Other medicines and Naproxeno Infectopharm

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. In particular, tell your doctor or pharmacist if you are taking:

• Other NSAIDs, including salicylates (such as acetylsalicylic acid) and COX-2 inhibitors
• Aspirin/acetylsalicylic acid to prevent blood clot formation
• Corticosteroids (for swelling and inflammation), such as hydrocortisone, prednisolone, and dexamethasone
• Medicines to stop blood coagulation, such as warfarin, heparin, or clopidogrel
• Phenytoin (used to treat epilepsy)
• Sulphonamide medicines, such as hydrochlorothiazide, acetazolamide, or indapamide, including sulphonamide antibiotics (for infections)
• Oral medicines for the treatment of diabetes, such as glimepiride or glipizide
• An «ACE inhibitor» or any other medicine for high blood pressure, such as cilazapril, enalapril, or propranolol
• An angiotensin II receptor antagonist, such as candesartan, eprosartan, or losartan
• A diuretic (water tablet) (for high blood pressure), such as furosemide or triamterene
• A «cardiac glycoside» (for heart problems), such as digoxin
• A «quinolone antibiotic» (for infections), such as ciprofloxacin or moxifloxacin
• Certain medicines for mental health problems, such as lithium or selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine or citalopram
• Probenecid and sulfinpyrazone (for gout)
• Methotrexate (used to treat skin problems, arthritis, or cancer)
• Ciclosporin or tacrolimus (for skin problems or after organ transplantation)
• Zidovudine (used to treat AIDS and HIV infections)
• Mifepristone (used to terminate pregnancy or induce labor if the baby has died)
• «Antacids» (neutralize excess stomach acid)

If you are in any of the above situations, or if you are not sure, consult your doctor or pharmacist before taking this medicine.

Taking Naproxeno Infectopharm with food, drinks, and alcohol

Consuming alcoholic beverages during treatment with this medicine increases the risk of bleeding in the digestive tract (stomach/intestine) and should therefore be avoided.

Pregnancy, breast-feeding, and fertility

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

Pregnancy

Do not take this medicine if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It can cause kidney and heart problems in the fetus. It can affect your tendency to bleed and that of your baby and delay or prolong delivery more than expected. You should not take this medicine during the first 6 months of pregnancy unless it is absolutely necessary and advised by your doctor. If you need treatment during this period or while trying to become pregnant, you should use the minimum dose for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, this medicine may cause kidney problems in the fetus that can reduce the level of amniotic fluid surrounding the baby (oligohydramnios) or cause the narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional monitoring.

Do not take this medicine after delivery, as it may delay the process of uterine contraction to its normal shape and size.

Breast-feeding

Avoid taking this medicine if you are breast-feeding, as it may pass into breast milk in small amounts.

Fertility

This medicine may make it more difficult to become pregnant. Inform your doctor if you are planning to become pregnant or if you are having problems becoming pregnant.

Driving and using machines

This medicine may cause you to feel tired, dizzy, have vision problems, or other central nervous system disorders. Consult your doctor if you experience any of these symptoms and do not drive or use tools or machines.

Naproxeno Infectopharm contains saccharose, sorbitol (E420), sodium, and methyl parahydroxybenzoate (E218)

Saccharose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine. One ml contains 300 mg of saccharose (sugar). This should be taken into account in patients with diabetes. It may be harmful to teeth.

Sorbitol (E 420)

This medicine contains 90 mg of sorbitol (E 420) in each ml. Sorbitol (E 420) is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, consult your doctor before you (or your child) take or receive this medicine.

Sodium

This medicine contains 9.2 mg of sodium (main component of cooking/table salt) in each ml, equivalent to 0.46% of the maximum recommended daily intake of sodium for an adult.

Methyl parahydroxybenzoate (E 218)

This medicine contains methyl parahydroxybenzoate (E 218) as a preservative. It may cause allergic reactions (possibly delayed).

3. How to take Naproxeno Infectopharm

Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Shake the bottle well before use. Take this medication with a sufficient amount of liquid. This medication starts to work faster when taken on an empty stomach. It is recommended that patients with sensitive stomachs take this medication during meals.

This medication, like all NSAIDs, should be taken at the lowest necessary dose to relieve pain for the shortest possible time. This precaution helps minimize potential adverse effects.

The packaging contains an 8 ml oral graduated syringe with 0.1 ml graduations that must be used to administer this medication.

Using the oral syringe:

• Submerge the tip of the oral syringe in the medication.
• While holding the syringe in place, gently pull the plunger up and extract the medication to the correct mark on the syringe.
• If bubbles form, pour the medication back into the bottle and extract the medication again to the correct mark on the syringe.
• Remove the syringe from the bottle.
• Place the end of the syringe in the patient's mouth and gently press the plunger down to release the medication slowly and smoothly.
• After use, replace the bottle cap. Wash the syringe with water. Disassemble the two parts of the syringe and let them dry. Store out of the reach of children.

Unless your doctor indicates otherwise, the recommended dose is:

Adults up to 65 years

The recommended dosage interval is 10 to 20 ml of oral suspension (500 mg to 1000 mg of naproxen) per day. A daily dose of 20 ml (1000 mg of naproxen) should not be exceeded.

The dose should be adjusted individually according to the clinical picture.

Symptomatic treatment of swelling or painful inflammation after musculoskeletal injuries

The usual initial dose is 10 ml of oral suspension (500 mg of naproxen). If necessary, an additional dose of 5 ml (250 mg of naproxen) can be taken every 6 to 8 hours. The daily dose should not exceed 20 ml (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 to 15 ml of oral suspension (500 to 750 mg of naproxen). At the start of treatment, during phases of acute inflammation or when switching from another high-dose NSAID to this medication, the recommended dose is 15 ml of oral suspension (750 mg of naproxen), divided into two doses per day (10 ml in the morning and 5 ml in the evening, or vice versa) or as a single dose (either in the morning or evening).

In individual cases, your doctor may increase the daily dose to 20 ml (1000 mg of naproxen).

The maintenance dose is 10 ml of oral suspension (500 mg of naproxen) per day, which can be taken divided into two 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

The usual initial dose is 15 ml of oral suspension (750 mg of naproxen); thereafter, take 5 ml of oral suspension (250 mg of naproxen) every 8 hours until the attack ends. During acute gout attacks, the maximum daily dose of 20 ml (1000 mg of naproxen) may be exceeded (for a short period).

Symptomatic treatment of menstrual pain

The usual initial dose is 10 ml of oral suspension (500 mg of naproxen); thereafter, 5 ml of oral suspension (250 mg of naproxen) can be taken every 6 to 8 hours. A daily dose of 20 ml (1000 mg of naproxen) should not be exceeded.

Children from 2 years and adolescents for 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 oral suspension per kilogram of body weight, administered in two doses (single dose of 0.1 ml (5 mg of naproxen) per kilogram of body weight). The daily dose for adolescents should not exceed 20 ml (1000 mg of naproxen).

The use of this medication is not recommended in children under 2 years (see section "Warnings and precautions", subsection "Children and adolescents").

Special patient populations

Elderly patients (over 65 years)

Close monitoring by your doctor is required. In elderly patients, it is especially important to select the effective lowest dose of this medication for the shortest possible time (see section 2 "What you need to know before taking Naproxeno Infectopharm").

Patients with hepatic impairment

Patients with hepatic impairment are at risk of overdose when taking this medication. Therefore, the lowest effective dose of this medication should be selected. Close monitoring by your doctor is required.

If your liver function is severely impaired, you should not take this medication (see section 2 "What you need to know before taking Naproxeno Infectopharm").

Patients with renal impairment

If your kidney function is affected, your doctor may want to reduce your medicinal dose.

If your kidney function is severely impaired, you should not take this medication (see section 2 "What you need to know before taking Naproxeno Infectopharm").

Duration of treatment

The duration of treatment will be decided by your doctor.

For rheumatic diseases, it may be necessary to take this medication for a prolonged period.

In menstrual pain, the duration of treatment depends on the respective symptoms. However, treatment with this medication should not be prolonged for more than a few days.

If you take more Naproxeno Infectopharm than you should

If you take more medication than you should, consult your doctor or go immediately to the nearest hospital or call the Toxicology Information Service, phone: 91 5620420, indicating the medication and the amount ingested. Bring the medication packaging with you.

For healthcare professionals: information on how to treat naproxen overdose can be found at the end of this prospectus.

If you forget to take Naproxeno Infectopharm

Do not take a double dose to make up for forgotten doses. Continue taking this medication as usual.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them. Medications like Naproxeno Infectopharm may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.

Important side effects to pay attention to:

If you notice the appearance of the following side effects, stop taking Naproxeno Infectopharm and consult your doctor immediately:

Severe allergic reactions(may affect up to 1 in 10,000 people), signs include:

• Difficulty breathing
• Significant decrease in blood pressure
• Swelling of the face or throat, difficulty swallowing
• Skin rash (with itching), redness, small blisters

Severe skin reactions(cannot be estimated from available data), for example:

• Widespread skin rash, elevated body temperature, high levels of liver enzymes, blood abnormalities (eosinophilia), lymph node enlargement, and involvement of other body organs (Drug Reaction with Eosinophilia and Systemic Symptoms, also known as DRESS). See also section 2.
• A characteristic allergic skin reaction known as fixed drug eruption, which usually recurs in the same location when re-exposed to the medication and may appear as red, round, or oval patches and skin swelling, blisters (urticaria), and itching.

Severe stomach and intestine problems(may affect up to 1 in 10 people), signs include:

• Severe abdominal pain (stomach pain), especially if sudden onset
• Vomiting blood or vomit resembling coffee grounds
• Black stools
• Ulcers, perforations (holes), and bleeding in the stomach or intestine, sometimes fatal, especially in elderly people

Heart attack, signs include:

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

Liver problems(may affect up to 1 in 10,000 people), signs include:

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

Deterioration of sensory organs, for example:

• Sudden visual disturbances (may affect up to 1 in 10,000 people) or hearing impairment (may affect up to 1 in 10 people)

Aseptic meningitis(may affect up to 1 in 10,000 people), signs include:

• Severe headache, especially if sudden onset

• Stiff neck, fever, nausea, or vomiting

• Confusion, sensitivity to bright light

Patients with autoimmune diseases (SLE, mixed connective tissue diseases) have a higher risk of developing meningitis.

Blood and lymphatic disorders(may affect up to 1 in 10,000 people), signs include:

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

Naproxeno Infectopharm may cause the following side effects:

Very common side effects (may affect more than 1 in 10 people):

• Nausea
• Vomiting
• Heartburn
• Stomach pain
• Bloating
• Constipation or diarrhea and mild bleeding in the digestive tract that, in exceptional cases, can cause anemia

Common side effects (may affect up to 1 in 10 people):

• Bleeding from the skin and mucous membranes
• Depression
• Sleep disturbances
• Difficulty falling asleep or staying asleep (insomnia)
• Headache
• Dizziness
• Agitation
• Irritability
• Sleep disturbances
• Fatigue
• Disorders of perception and cognitive dysfunction
• Ringing in the ears
• Dizziness (vertigo)
• Sweating
• Fluid deposits in the body (edema), especially in patients with high blood pressure
• Thirst

Uncommon side effects (may affect up to 1 in 100 people):

• Changes in blood counts
• Increased count of certain types of white blood cells (eosinophilia)
• Asthma attacks (with or without decreased blood pressure)
• Lung inflammation (eosinophilic pneumonia)
• Symptoms in the lower abdomen (e.g., inflammation of the large intestine with bleeding or worsening of Crohn's disease/ulcerative colitis)
• Inflammation of the lining of the mouth (buccal mucosa)
• Esophageal injury
• Changes in liver function with elevated transaminases
• Hair loss (usually temporary)
• Skin inflammation caused by light (sunlight) (which may include blisters)
• Muscle pain
• Muscle weakness
• Acute kidney failure
• Renal function impairment (nephrotic syndrome)
• Kidney inflammation (interstitial nephritis)
• Fever and chills, general malaise
• Inflammation of the stomach lining
• Gas

Rare side effects (may affect up to 1 in 1,000 people):

• Blistering skin conditions (epidermolysis bullosa-like reactions)

Very rare side effects (may affect up to 1 in 10,000 people):

• Decreased count of red blood cells, white blood cells, or platelets (aplastic or hemolytic anemia, thrombocytopenia, leucopenia, pancytopenia, agranulocytosis)
• Seizures (attacks)
• Nerve inflammation
• High blood pressure
• Increased heart rate
• Heart palpitations
• Heart failure
• Inflammation of blood vessels
• Worsening of inflammation related to infection (e.g., development of necrotizing fasciitis, i.e., acute and necrotic inflammation of the fatty tissue under the skin and muscles)
• Anaphylactic or anaphylactoid systemic reactions
• Liver inflammation (hepatitis), liver damage, especially after prolonged treatment
• Hypersensitivity reactions such as skin rash, erythema multiforme, in isolated cases manifesting as severe cutaneous adverse reactions (including Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Kidney damage (papillary renal necrosis) (especially during long-term treatment)
• Increased uric acid concentration in blood

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

• Increased potassium concentration
• Decreased white blood cell count (neutropenia)
• Swelling of the lens and head of the optic nerve
• Corneal opacity
• Inflammation of the head of the optic nerve
• Numbness or tingling of hands and feet
• Pulmonary edema
• Pancreatitis (inflammation of the pancreas, a large gland behind the stomach)
• Erythema nodosum (a skin inflammation that produces painful red lumps)
• Lichen planus (a non-infectious itchy rash that can affect many areas of the body)
• Systemic lupus erythematosus (SLE, an autoimmune condition that causes an inflammatory process that can affect several parts of the body)
• Pustular reaction
• Blood in the urine (hematuria)
• Inflammation of certain parts of the kidneys (glomerulonephritis)
• Female infertility
• Edema

Naproxen may interfere with laboratory test results; therefore, you should inform all your doctors (if applicable) that you are taking this medication (see section 2 "What you need to know before taking Naproxeno Infectopharm").

Methyl parahydroxybenzoate (E 218) may cause allergic reactions (possibly delayed).

Other side effects in children and adolescents

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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Conservation of Naproxeno Infectopharm

Keep in the original packaging to protect from light.

After the first opening, this medication remains stable for 3 months. Keep in the original packaging to protect from light.

This medication does not require special temperature storage conditions.

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

Do not use this medication after the expiration date shown on the label and carton after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the Sigre Collection Point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Container contents and additional information

Composition of Naproxeno Infectopharm

• The active ingredient is naproxen

1 ml of oral suspension contains 50 mg of naproxen.

• The other components are: sucrose (sugar), sodium saccharin (E 954), sodium cyclamate (E 952), sodium chloride, methyl parahydroxybenzoate (E 218), potassium sorbate (E 202), tragacanth (E 413), citric acid (E 330), liquid sorbitol (crystallizing) (E 420), and water.

Appearance of Naproxeno Infectopharmand container contents

White to yellowish-white oral suspension.

Brown glass bottle with child-resistant screw cap

8 ml graduated oral syringe with 0.1 ml graduations

Container size: 100 ml

Marketing authorization holder and manufacturer

INFECTOPHARM Arzneimittel und Consilium GmbH

Von-Humboldt-Str. 1

64646 Heppenheim

Germany

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 50 mg/ml oral suspension

Italy: Dololibre

Poland: Dololibre

Portugal: Dololibre

Date of the last revision of this leaflet:10/2024.

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/.

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This information is intended exclusively for healthcare professionals:

In the event of an overdose of naproxen:

Overdose symptoms

Overdose symptoms include, among others, CNS alterations such as headache, dizziness or drowsiness, epigastric pain and abdominal discomfort, indigestion, nausea, vomiting, transient changes in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, and disorientation. Naproxen is rapidly absorbed. High and early concentrations of the drug in the blood should be expected. Some patients have experienced seizures, but it was not clear whether they were caused by naproxen treatment. Gastrointestinal bleeding may also occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactic reactions have been described after treatment with non-steroidal anti-inflammatory drugs and may also occur after an overdose.

Treatment of an overdose

Patients should be treated according to symptoms. There is no specific antidote. Preventive measures to avoid further absorption (e.g., administration of activated charcoal) may be indicated in patients within four hours of ingestion or as a result of a significant overdose. Forced diuresis, urine alkalinization, hemodialysis, or hemoperfusion are likely to be ineffective due to naproxen's high protein binding.