Dololibre

Patient Information Leaflet: Read this leaflet carefully before taking the medicine, as it contains important information for you.

Dololibre, 50 mg/mL, oral suspension
Naproxenum
Read this leaflet carefully before taking the medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not share it with others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents

1. What Dololibre is and what it is used for
2. Important information before taking Dololibre
3. How to take Dololibre
4. Possible side effects
5. How to store Dololibre
6. Contents of the package and other information

1. What Dololibre is and what it is used for

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

• Pain and inflammation in the following conditions:
• Rheumatoid arthritis, ankylosing spondylitis (neck and back pain and stiffness), acute episodes of osteoarthritis, and spondyloarthropathies
• Acute gout attacks
• Inflammatory rheumatic conditions of soft tissues
• Painful swelling or inflammation following musculoskeletal injury
• Dysmenorrhea (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 the patient is allergic to naproxen or any of the other ingredients of this medicine (listed in section 6).
• if the patient has previously experienced asthma attacks, angioedema, skin reactions, or acute rhinitis after taking acetylsalicylic acid or any other NSAID.
• if the patient has blood cell formation disorders.
• if the patient currently has a stomach or intestinal ulcer or gastrointestinal bleeding.
• if the patient has previously had recurrent ulcers (peptic ulcers) or gastrointestinal bleeding from the stomach and/or duodenum (at least two separate episodes of confirmed ulcers or bleeding).

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• if the patient has previously experienced gastrointestinal bleeding or perforation while taking NSAIDs.
• if the patient has severe renal, hepatic, or cardiac insufficiency.
• if the patient has previously experienced intracranial bleeding.
• if the patient currently has any other form of acute bleeding.
• for women: if the patient is in the last three months of pregnancy (see section "Pregnancy, breastfeeding and fertility").

Warnings and precautions
Taking the medicine at the lowest effective dose for the shortest duration necessary to control symptoms reduces the risk of adverse effects.
Medicines such as Dololibre may be associated with a small increased risk of heart attack (myocardial infarction) and stroke. The risk may increase with higher doses and prolonged use. Do not exceed the recommended dose or duration of treatment.
If the patient has heart disease, has ever had a stroke, or believes they may be at increased risk of such conditions (e.g. high blood pressure, diabetes, elevated cholesterol levels, smoking), they should discuss this treatment with their doctor or pharmacist.
Before starting Dololibre, discuss with a doctor or pharmacist:

• if the patient has asthma, allergies (such as hay fever), chronic obstructive pulmonary disease, or has previously experienced facial, lip, eye, or tongue swelling.
• if the patient has nasal polyps, frequently sneezes, or has a runny, blocked, or itchy nose (rhinitis).
• if the patient feels weak (possibly due to an underlying illness) or is elderly.
• if the patient has kidney or liver disease.
• if the patient has blood clotting disorders.
• if the patient is taking certain medicines, such as corticosteroids, anticoagulants, selective serotonin reuptake inhibitors, acetylsalicylic acid (aspirin), or other NSAIDs, including COX-2 inhibitors.
• if the patient has previously had a stomach ulcer or gastrointestinal bleeding. The doctor will advise the patient to report any unusual stomach-related symptoms.
• if the patient has an autoimmune disease such as systemic lupus erythematosus (SLE, causing joint pain, skin rashes, and fever), mixed connective tissue disease, ulcerative colitis, or Crohn's disease (conditions causing intestinal inflammation and pain, diarrhea, vomiting, and weight loss).
• if the patient has vision or hearing disturbances.
• if the patient recently underwent major surgery before starting treatment with Dololibre.
• if the patient has heavy menstrual bleeding.
• if the patient has a disorder of haem biosynthesis (porphyria).

Immediately discontinue use of this medicine in case of gastrointestinal bleeding, visual 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. Discontinue Dololibre and seek immediate medical attention if any of the symptoms associated with these severe skin reactions, described in section 4, occur.
There have been very rare reports of severe skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) associated with the use of NSAIDs. These reactions most commonly occur at the beginning of treatment (within the first month). If the patient develops a rash (including mucosal lesions, e.g. in the mouth, throat, eyes, genital organs) or any other signs of hypersensitivity, Dololibre should be discontinued immediately and the patient should contact their doctor.

General information
Pain relief and underlying disease
If, during treatment with naproxen, the patient does not feel better or continues to experience pain, fever, fatigue, or other symptoms of illness, medical advice should be sought. This is because pain-relieving medicines may mask possible warning signs of an underlying condition.
Headache caused by pain-relieving medicines
Long-term use of pain-relieving medicines in high doses may cause headaches, which should not be treated by taking additional pain-relieving medicines.
Kidney damage caused by pain-relieving medicines
Frequent, long-term use of certain pain-relieving medicines may lead to permanent kidney damage with a risk of renal failure.

If any of the above points apply to the patient or the patient is unsure, consult a doctor or pharmacist before starting Dololibre.

Laboratory test results
If the doctor orders blood count, blood coagulation, and/or liver and kidney function tests, or any other tests (e.g. measuring blood levels of certain medicines), it is very important that these tests are performed. This particularly applies to patients with liver dysfunction, heart failure, high blood pressure, or kidney damage.
If an adrenal function test is required, the patient must (temporarily) stop taking Dololibre at least 3 days before the test to avoid interference with test results.

Children and adolescents
Due to insufficient 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 for any condition other than juvenile idiopathic arthritis.

Dololibre and other medicines
Inform the doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take. This includes medicines available without a prescription, including herbal medicines. In particular, inform the doctor or pharmacist if the patient is taking:

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

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• An angiotensin II receptor antagonist, such as candesartan, eprosartan, or losartan
• A diuretic (water tablet) used to treat high blood pressure, such as furosemide or triamterene
• A cardiac glycoside (used in heart disease), such as digoxin
• A quinolone antibiotic (used to treat infections), such as ciprofloxacin or moxifloxacin
• Certain medicines used to treat mental health conditions, 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)
• Cyclosporine 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 pharmacologically or to induce delivery in case of fetal death)
• Medicines that neutralize excess hydrochloric acid in the stomach.

If any of the above points apply to the patient or the patient is unsure, consult a doctor or pharmacist before starting Dololibre.

Taking Dololibre with food, drink, and alcohol
Consuming alcoholic beverages during treatment with Dololibre increases the risk of gastrointestinal bleeding (from the stomach or intestines), and should therefore be avoided.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor before using this medicine.

Pregnancy
Do not take Dololibre if the patient is in the last three 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 affect the tendency of the patient and her child to bleed and may delay or prolong labour. Do not take Dololibre during the first 6 months of pregnancy unless absolutely necessary and prescribed by a doctor. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time.
If Dololibre is taken for longer than a few days from week 20 of pregnancy, it may cause kidney problems in the unborn child, leading to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the child's heart. If treatment is required for longer than a few days, the doctor may recommend additional monitoring.
Do not take Dololibre after childbirth, as it may delay the process of the uterus returning to its normal size and shape.

Breastfeeding
The patient should avoid taking Dololibre during breastfeeding, as it may pass into breast milk in small amounts.

Fertility
Dololibre may make it more difficult to become pregnant. If the patient is planning to conceive or has difficulty becoming pregnant, she should inform her doctor.

Driving and using machines
Dololibre may cause fatigue, dizziness, visual disturbances, or other central nervous system effects. If such symptoms occur, the patient should inform their doctor and should not drive or operate tools or machinery.

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

Sucrose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their 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 be harmful to teeth.

Sorbitol (E 420)
This medicine contains 90 mg of sorbitol (E 420) per 1 mL. Sorbitol is a source of fructose. If the patient (including children) has previously been diagnosed with intolerance to certain sugars or hereditary fructose intolerance, a rare genetic disorder in which the body cannot break down fructose, discuss with the doctor before taking the medicine or giving it to a child.

Sodium
The medicine contains 9.2 mg of sodium (the main component of table salt) in each mL. This corresponds to 0.46% of the recommended maximum daily dietary sodium intake for adults.

Methyl parahydroxybenzoate (E 218)
This medicine contains methyl parahydroxybenzoate (E 218) as a preservative. It may cause allergic reactions (including delayed-type reactions).

3. How to take Dololibre

This medicine should always be taken as directed by the physician. In case of doubt, consult a doctor or pharmacist.
Before use, shake the bottle vigorously. Dololibre should be taken with an adequate amount of liquid. Dololibre acts faster when taken on an empty stomach. Patients with sensitive stomachs are advised to take Dololibre during meals.
Like all NSAIDs, Dololibre should be taken at the lowest effective dose that relieves pain, and for the shortest possible duration. This precaution helps minimize potential adverse effects.
The medicine package contains an 8 mL oral syringe with 0.1 mL graduations, which should be used when administering the medicine.

Using the syringe:

• Immerse the tip of the syringe into the medicine.
• While keeping the syringe in place, gently pull back the plunger to draw the medicine up to the appropriate mark on the syringe scale.
• If air bubbles appear, expel the medicine back into the bottle and draw it again up to the correct mark on the syringe scale.
• Remove the syringe from the bottle.
• Place the tip of the syringe into 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 leave to dry. Store out of reach of children.

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Unless otherwise directed by a physician, the usual dosage is:
Adults up to 65 years of age
The recommended dose range is 10–20 mL of Dololibre (500 mg to 1000 mg naproxen) per day. The daily dose should not exceed 20 mL of Dololibre (1000 mg naproxen).
The dose should be individually adjusted according to the clinical condition.

Symptomatic treatment of painful swelling or inflammatory condition following musculoskeletal injury
The recommended initial dose is 10 mL of Dololibre (500 mg naproxen). If needed, an additional dose of 5 mL of the medicine (250 mg naproxen) may be taken every 6 to 8 hours. The daily dose should not exceed 20 mL of Dololibre (1000 mg naproxen).

Symptomatic treatment of pain and inflammation in rheumatoid arthritis, ankylosing spondylitis, acute episodes of osteoarthritis and spondyloarthropathy, as well as inflammatory rheumatic diseases of soft tissues
The usual daily dose is 10–15 mL of Dololibre (500–750 mg naproxen). At the beginning of treatment, during the acute phase of inflammation, or when switching from another NSAID used at a high dose to Dololibre, the recommended daily dose is 15 mL of Dololibre (750 mg naproxen), divided into two daily doses (10 mL of Dololibre in the morning and 5 mL in the evening, or vice versa) or as a single daily dose (in the morning or evening).
In individual cases, the physician may increase the daily dose up to 20 mL of Dololibre (1000 mg naproxen).
The maintenance dose is 10 mL of Dololibre (500 mg naproxen) per day, which may be taken as 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 during acute gout attack
The recommended initial dose is 15 mL of Dololibre (750 mg naproxen); thereafter, 5 mL of Dololibre (250 mg naproxen) should be taken every 8 hours until the attack resolves.
Therefore, during acute gout attacks, the patient may temporarily exceed the maximum daily dose of 20 mL (1000 mg naproxen) for a short period.

Symptomatic treatment of menstrual pain
The usual initial dose is 10 mL of Dololibre (500 mg naproxen); thereafter, 5 mL of Dololibre (250 mg naproxen) may be taken every 6–8 hours. The daily dose should not exceed 20 mL of Dololibre (1000 mg naproxen).

Children over 2 years of age and adolescents for the treatment of juvenile idiopathic arthritis
The recommended dose is 10 mg naproxen per kilogram of body weight per day, corresponding to a daily dose of 0.2 mL of Dololibre per kg body weight, given in two divided doses (single dose: 0.1 mL of Dololibre (5 mg naproxen) per kg body weight). The daily dose in adolescents should not exceed 20 mL (1000 mg naproxen).
Dololibre is not recommended for use in children under 2 years of age (see section "Warnings and precautions", subsection "Children and adolescents").

Special patient groups
Elderly patients (over 65 years of age)
Close medical supervision is required. In elderly patients, it is particularly important to select the lowest effective dose of Dololibre for the shortest possible duration (see section 2 "Important information before taking Dololibre").

Patients with hepatic impairment
Patients with impaired liver function are at risk of overdosage when taking Dololibre. Therefore, the lowest effective dose of Dololibre should be selected.
Close medical supervision is required.
Dololibre must not be used in cases of severe hepatic insufficiency (see section 2 "Important information before taking Dololibre").

Patients with renal impairment
If a patient has impaired renal function, the physician may decide to reduce the dose of Dololibre.
Dololibre must not be used in cases of severe renal insufficiency (see section 2 "Important information before taking Dololibre").

Duration of treatment
The duration of treatment is determined by the treating physician.
In rheumatic diseases, prolonged administration of Dololibre may be necessary.
In dysmenorrhea, treatment duration depends on symptoms. However, treatment with Dololibre should not last longer than a few days.

Overdose of Dololibre
If more Dololibre has been taken than recommended, the patient should immediately contact a doctor or go to a hospital. Bring the medicine packaging along.
Information for healthcare professionals: Information on management of naproxen poisoning is provided at the end of the leaflet.

Missed dose of Dololibre
Do not take a double dose to make up for a missed dose. Continue taking Dololibre as usual.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Medicines such as Dololibre may be associated with a small increased risk of heart attack (myocardial infarction) and stroke.
Important adverse reactions to watch for:
If any of the following adverse reactions occur, stop using Dololibre immediately and contact your doctor without delay:

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

• Shortness of breath
• Severe 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 determined from available data), for example:

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

• Characteristic skin allergic reaction called fixed drug eruption, which typically recurs in the same location(s) upon re-exposure to the drug and may present as round or oval red patches, swelling of the skin, blisters (urticaria), and itching

Symptoms related to stomach and intestinal disorders (may occur in up to 1 in 10 patients), symptoms include:

• Relatively severe abdominal (stomach) pain, especially sudden in onset
• Vomiting blood or material resembling coffee grounds
• Bloody or black stools
• Ulcers, perforations (holes), and bleeding in the stomach or intestines, which may be fatal, especially in elderly patients

Heart attack, symptoms include:

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

Symptoms related to liver disorders (may occur in up to 1 in 10,000 patients), symptoms include:

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

Sensory organ disorders, for example:

• Sudden onset of visual 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), symptoms include:

• Severe headache, especially sudden in onset
• Neck stiffness, fever, nausea, or vomiting
• Confusion, sensitivity to bright light

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

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

Dololibre may cause the following adverse reactions:
Very common adverse reactions (may occur in more than 1 in 10 patients):

• Nausea
• Vomiting
• Heartburn
• Stomach pain
• Feeling of fullness
• Constipation or diarrhoea, and minor gastrointestinal bleeding, which in rare cases may lead to anaemia

Common adverse reactions (may occur in up to 1 in 10 patients):

• Bleeding from the skin and mucous membranes
• Depression
• Abnormal dreams
• Difficulty falling or staying asleep (insomnia)
• Headache
• Dizziness
• Restlessness
• Irritability
• Sleep disturbances
• Fatigue
• Disturbances in perception and cognitive function
• Ringing in the ears
• Dizziness
• Excessive sweating
• Fluid retention (oedema), especially in patients with high blood pressure
• Increased thirst

Uncommon adverse reactions (may occur in up to 1 in 100 patients):

• Changes in blood count
• Increase in a certain type of white blood cells (eosinophilia)
• Asthma attacks (with or without drop in blood pressure)
• Lung inflammation (eosinophilic pneumonia)
• Symptoms in the lower abdomen (e.g. colitis with bleeding or exacerbation of Crohn’s disease/ulcerative colitis)
• Inflammation of the oral mucosa
• Oesophageal damage
• Changes in liver function with increased aminotransferase activity
• Hair loss (usually temporary)
• Skin inflammation caused by light (sunlight), which may include blister formation
• Muscle pain
• Muscle weakness
• Acute kidney failure
• Kidney dysfunction (nephrotic syndrome)
• Kidney (renal) inflammation (interstitial nephritis)
• Fever and chills, general malaise
• Inflammation of the stomach lining
• Gas

Rare adverse reactions (may occur in up to 1 in 1,000 patients):

• Skin disorders with blister formation (reactions resembling blistering detachment of the epidermis)

Very rare adverse reactions (may occur in up to 1 in 10,000 patients):

• Decrease in red blood cells and/or white blood cells and/or platelets (aplastic or haemolytic anaemia, thrombocytopenia, leukopenia, pancytopenia, agranulocytosis)
• Seizures
• Nerve (neuropathy) inflammation
• High blood pressure
• Rapid heartbeat
• Palpitations (sensation of strong heartbeats)
• Heart failure
• Vasculitis (inflammation of blood vessels)
• Worsening of inflammatory conditions associated with infection (e.g. necrotising fasciitis, i.e. severe inflammation and tissue necrosis of subcutaneous fat and muscle tissue)
• Generalised anaphylactic or pseudo-anaphylactic reactions
• Liver inflammation, liver damage, especially after long-term treatment
• Hypersensitivity reactions such as skin rash, erythema multiforme, in isolated cases manifesting as severe skin reactions (including Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Kidney damage (papillary necrosis), especially during long-term treatment
• Increased blood uric acid levels

Frequency unknown (frequency cannot be determined from available data):

• Increased potassium levels
• Decreased number of white blood cells in blood (neutropenia)
• Lens and optic nerve head swelling
• Corneal opacity
• Optic neuritis
• Pricking, tingling, or numbness of hands and feet
• Pulmonary oedema
• Pancreatitis (a large gland located behind the stomach)
• Nodular erythema (skin inflammation presenting as red, painful nodules)
• Lichen planus (non-infectious itchy rash that may appear on multiple body areas)
• Systemic lupus erythematosus (SLE, an autoimmune disease causing inflammatory process that may affect various body areas)
• Acneiform eruption
• Presence of blood in urine (haematuria)
• Inflammation of certain parts of the kidneys (glomerulonephritis)
• Infertility in women
• Oedema

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

Additional adverse reactions in children and adolescents
The frequency, type, and severity of adverse reactions in children and adolescents are similar to those observed in adults.

Reporting of adverse reactions
If any adverse symptoms occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the 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.
No special requirements for storage temperature of the medicinal product.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and on the carton after
"EXP". The expiry date refers to the last day of the stated month.
Medicines must 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 Dololibre contains

• The active substance is naproxen. 1 mL of Dololibre contains 50 mg of naproxen.
• Other ingredients are sucrose (sugar), sodium saccharin (E 954), sodium cyclamate (E 952), sodium chloride, methyl 4-hydroxybenzoate (E 218), potassium sorbate (E 202), tragacanth, citric acid, sorbitol liquid, crystallizing (E 420), purified water.

What Dololibre looks like and contents of the pack
Dololibre is an oral suspension, white to yellowish-white in colour.
Orange glass bottle with child-resistant closure.
Oral syringe with a capacity of 8 mL, graduated in 0.1 mL increments.
Pack size: 100 mL

Marketing Authorisation Holder and Manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Str. 1
64646 Heppenheim
Germany
E-mail: [email protected]

This medicinal product is authorised in the European Economic Area member states under the following names:
Austria: Naproxen Infectopharm 50 mg/mL Suspension zum Einnehmen
Spain: Naproxxeno Infectopharm
Poland: Dololibre
Portugal: Naprosumo
Italy: Dololibre

Information intended exclusively for medical professionals:

In case of naproxen overdose:
Symptoms of overdose
pal-naproxen-dcp2-pl-5-0
Symptoms of overdose may include central nervous system disturbances such as headache, dizziness, or feeling of faintness, epigastric pain and abdominal discomfort, dyspepsia, nausea, vomiting, transient changes in liver function, hypoprothrombinemia, disturbances in kidney function, metabolic acidosis, respiratory depression, and disorientation. Naproxen may be rapidly absorbed. A rapid achievement of high blood concentrations should be expected. Seizures have occurred in a few patients, but it is unknown whether they were caused by naproxen treatment. Gastrointestinal bleeding may also occur. Hypertension, acute renal failure, respiratory failure, and coma may occur, although these are rare. Anaphylactic reactions have been reported with nonsteroidal anti-inflammatory drugs, and such reactions may also occur following overdose.

Management 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 less than four hours have elapsed since ingestion or in cases of large overdose. Forced diuresis, urinary alkalization, hemodialysis, and hemoperfusion are likely ineffective due to the high protein binding of naproxen.