DOLOLIBRE 50 mg /Ml Oral Suspension

Зміст інструкції

1. Dololibre 50 mg/ml oral suspension
   1. What is Dololibre and what is it used for
   2. What you need to know before taking Dololibre
   3. How to take Dololibre
   4. Possible side effects
   5. How to store Dololibre
   6. Contents of the pack and other information

Dololibre 50 mg/ml oral suspension

Naproxen
Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What is Dololibre and what is it used for

Dololibre contains a medicine called naproxene, which is a "non-steroidal anti-inflammatory drug" or NSAID.
Dololibre is used in adults for the symptomatic treatment of:

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

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

2. What you need to know before taking Dololibre

Do not take Dololibre:

• 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 attacks, angioedema, skin reactions or acute rhinitis after taking acetylsalicylic acid or any other NSAID.
• if you have blood formation disorders
• if you currently have an ulcer or bleeding in the stomach or intestine
• if you have a history of duodenal/stomach ulcers (peptic ulcers) or recurrent bleeding (at least two distinct episodes of confirmed ulcer or bleeding)
• if you have previously experienced perforation or bleeding in the stomach or intestine while using NSAIDs
• if you have severe kidney, liver or heart failure
• if you experience a cerebral hemorrhage
• if you currently have any other form of acute bleeding
• if you are in the last three months of pregnancy (see “Pregnancy, breastfeeding and fertility”).

Warnings and precautions
Adverse effects can be minimized by using the lowest effective dose for the shortest possible duration necessary to control the symptoms.
Medicines like Dololibre may be associated with a modest increase in the risk of heart attack ("myocardial infarction") or stroke. The risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment.
If you have heart problems, have had a stroke or think you may be at increased risk of these problems (for example, high blood pressure, diabetes, high cholesterol levels or if you smoke), discuss this treatment with your doctor or pharmacist.
Consult your doctor or pharmacist before taking Dololibre:

• if you suffer from asthma, allergies (such as hay fever) or chronic obstructive pulmonary disease, or if you have previously experienced swelling of the face, lips, eyes or tongue
• if you have polyps in the nose or sneeze a lot or have a runny, blocked or itchy nose (rhinitis)
• if you feel weak (possibly due to an illness) or if you are an elderly person
• if you have kidney or liver problems
• if you have blood coagulation problems
• if you are taking medicines such as corticosteroids, anticoagulants, selective serotonin re-uptake inhibitors (selective serotonin re-uptake inhibitors, SSRIs), acetylsalicylic acid or NSAIDs, including cyclooxygenase-2 (COX-2) inhibitors
• if you have previously experienced an ulcer or bleeding in the stomach. You will be asked to report any unusual stomach symptoms to your doctor
• if you suffer from an autoimmune disease, such as systemic lupus erythematosus (SLE; which causes joint pain, skin rashes and fever), or mixed connective tissue disease and ulcerative colitis or Crohn's disease (diseases that cause inflammation and intestinal pain, diarrhea, vomiting and weight loss)
• if you have vision or hearing problems
• if you have undergone major surgery shortly before starting treatment with Dololibre
• if you have heavy menstrual periods
• if you have a disorder of red pigment biosynthesis that gives its color to the blood (porphyria).

Treatment with this medicine should be stopped immediately in case of gastrointestinal bleeding, visual disturbances or hearing impairment.
Severe skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis) have been reported very rarely in association with the administration of NSAIDs. These reactions generally appear early in treatment (within the first month). If you develop a rash (including lesions of the mucous membranes such as mouth, throat, nose, eyes, genitals) or other signs of hypersensitivity, stop using Dololibre immediately and consult your doctor immediately.

General information
Pain relief and underlying disease
If you do not feel better during treatment with naproxen or if you continue to experience pain, fever or other signs of illness, seek medical advice. In fact, painkillers may mask any signs of an underlying disease.
Headache from painkillers
Prolonged use of high doses of painkillers can cause headaches, which should not be treated by taking a larger amount of painkillers.
Kidney damage from painkillers
Regular use of some painkillers for a prolonged period can lead to permanent kidney damage with a risk of kidney failure.

If any of the above cases apply to your situation or if you have any doubts, consult your doctor or pharmacist before taking Dololibre.
Laboratory test results
If your doctor recommends monitoring your blood count, blood coagulation tests and/or kidney and liver function and/or other tests (for example, the determination of certain drug levels in the blood), it is essential that you undergo them. This is particularly important for patients with liver impairment, heart failure, high blood pressure or kidney damage.
If you are to undergo a test of adrenal function, you must suspend (temporarily) the intake of Dololibre at least 3 days before the test, to avoid interference with the test results.

Children and adolescents
Dololibre is not recommended in children under 2 years of age due to lack of adequate experience.
Dololibre is not recommended for use in conditions other than juvenile idiopathic arthritis in children and adolescents under 18 years of age.

Other medicines and Dololibre
Tell your doctor or pharmacist if you are taking, have recently taken or may take any other medicines, including those you buy without a prescription or 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 for the prevention of blood clots
• Glucocorticoids (for swelling and inflammation), such as hydrocortisone, prednisolone and dexamethasone
• Medicines to prevent blood clotting, such as warfarin, heparin or clopidogrel
• Phenytoin (used to treat epilepsy)
• Sulfonamide medicines, such as hydrochlorothiazide, acetazolamide, indapamide and including sulfonamide 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 (medicine to increase urine output) (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
• Some medicines for mental health problems, such as lithium or selective serotonin re-uptake inhibitors (SSRIs), such as fluoxetine or citalopram
• Probenecid and sulfinpyrazone (for gout)
• Methotrexate (used in the treatment of skin problems, arthritis or cancer)
• Cyclosporine or tacrolimus (for skin problems or after organ transplantation)
• Zidovudine (used in the treatment of AIDS and HIV infections)
• Mifepristone (used to terminate a pregnancy or induce labor in case of fetal death in

utero)

• Antacids (to neutralize excess acidity in the stomach)

If any of the above cases apply to your situation or if you have any doubts, consult your doctor or pharmacist before taking Dololibre.

Dololibre with food, drinks and alcohol
Drinking alcohol during treatment with Dololibre increases the risk of bleeding in the gastrointestinal tract (stomach and intestine) and, therefore, should be avoided.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
The use of Dololibre should be avoided during the first 6 months of pregnancy unless your doctor has explicitly prescribed it.
Do not take Dololibre if you are in the last trimester of pregnancy, as it may have harmful effects on you and your baby.
Do not take Dololibre after childbirth, as it may delay the process of reducing the volume of the uterus to its normal shape and size.
Breastfeeding
You should avoid taking Dololibre during breastfeeding, as the medicine may be excreted in breast milk in small amounts.
Fertility
Dololibre may make it more difficult to conceive. You should inform your doctor if you are planning a pregnancy or have difficulty conceiving.

Driving and operating machinery
Dololibre can cause fatigue, dizziness, visual disturbances or other central nervous system disorders. If you experience any of these problems, consult your doctor and do not drive vehicles or operate machinery.

Dololibre contains sucrose, sorbitol (E 420), sodium and methyl parahydroxybenzoate (E 218)
Sucrose
If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine. 1 ml contains 300 mg of sucrose (sugar). This should be taken into consideration in people with diabetes mellitus. It may be harmful to teeth.
Sorbitol (E 420)
This medicine contains 90 mg of sorbitol (E 420) per ml. Sorbitol (E 420) is a source of fructose. If your doctor has told you that you (or your child) are intolerant to certain sugars, or if you have a diagnosis of hereditary fructose intolerance (HFI), a rare genetic disease in which patients cannot convert fructose, talk to your doctor before you (or your child) take this medicine.
Sodium
This medicine contains 9.2 mg of sodium (the main component of table salt) per ml. This is equivalent to 0.46% of the recommended daily intake with the diet of an adult.
Methyl parahydroxybenzoate (E 218)
This medicine contains methyl parahydroxybenzoate (E 218) as a preservative. It may cause allergic reactions (including delayed reactions).

3. How to take Dololibre

Take this medicine following exactly the instructions of your doctor. If you have doubts, consult your
doctor or pharmacist.
Shake the bottle vigorously before use. Take Dololibre with a sufficient amount of liquid.
Dololibre starts to work more quickly if taken on an empty stomach. It is recommended that patients who
have a sensitive stomach take Dololibre during meals.
As with all NSAIDs, you should take the lowest possible dose of Dololibre needed to relieve the
pain and for the shortest possible time. This precaution helps to minimize
any undesirable effects.
The package contains an 8 ml graduated oral syringe, with increments of
0.1 ml, which must be used to administer this medicine.
Use of the oral syringe:

• Immerse the tip of the oral syringe into the medicine.
• Holding the syringe in position, gently pull back the plunger to aspirate the medicine up to the correct graduation on the syringe.
• If bubbles form, reintroduce the medicine into the bottle, then aspirate the medicine again up to the correct graduation on the syringe.
• Remove the syringe from the bottle.
• Insert the end of the syringe into the patient's mouth and push the plunger gently and slowly to release the medicine.
• After use, close the bottle with the screw cap. Wash the syringe with water. Disassemble the two parts of the syringe and let it dry. Keep out of reach of children.

Unless otherwise prescribed by your doctor: the recommended dose is:

Adults up to 65 years of age
The recommended dose is between 10 and 20 ml of Dololibre (500 mg to 1,000 mg of naproxen) per
day. Do not exceed a daily dose of 20 ml of Dololibre (1,000 mg of naproxen).
The dosage should be adjusted based on the clinical condition of the individual.
Symptomatic treatment of painful or inflammatory swelling following musculoskeletal
injuries
The initial dose is usually 10 ml of Dololibre (500 mg of naproxen). If necessary, you can take
an additional dose of 5 ml (250 mg of naproxen) every 6-8 hours. The daily dose should not
exceed 20 ml of Dololibre (1,000 mg of naproxen).
Symptomatic treatment of pain and inflammation in rheumatoid arthritis, ankylosing spondylitis
and acute attacks of osteoarthritis and spondyloarthrosis, as well as in inflammatory rheumatic diseases of the
soft tissues
The daily dose is usually 10-15 ml of Dololibre (500-750 mg of naproxen). At the beginning of
therapy, during the acute phases of inflammation, or when switching from another high-dose NSAID to
Dololibre, the recommended dose is 15 ml of Dololibre (750 mg of naproxen), taken as two
divided 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 (1,000 mg of
naproxen).
The maintenance dose is 10 ml of Dololibre (500 mg of naproxen) per day, which can 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 in acute gout
The initial dose is usually 15 ml of Dololibre (750 mg of naproxen); subsequently take 5 ml
of Dololibre (250 mg of naproxen) every 8 hours until the attack resolves. During attacks
of acute gout, you may exceed the maximum daily dose of 20 ml (1,000 mg of naproxen) (for a
short period of time).
Symptomatic treatment of menstrual pain
The initial dose is usually 10 ml of Dololibre (500 mg of naproxen); subsequently you can take
5 ml of Dololibre (250 mg of naproxen) every 6-8 hours. Do not exceed a daily dose of
20 ml of Dololibre (1,000 mg of naproxen).

Children from 2 years of age and adolescents for the treatment of idiopathic juvenile
arthritis
The recommended dose is 10 mg/kg of body weight of naproxen per day, which corresponds to
a daily dose of 0.2 ml of Dololibre per kilogram of body weight, administered as two
divided doses (single dose of 0.1 ml of Dololibre (5 mg of naproxen) per kilogram of body
weight). In adolescents, the daily dose should not exceed 20 ml (1,000 mg of naproxen).
Dololibre is not recommended for children under 2 years of age (see section “Warnings and
precautions”, paragraph “Children and adolescents”).

Special populations of patients
Elderly (over 65 years of age)
Careful monitoring by the doctor is necessary. In elderly patients, it is particularly
important to select the minimum effective dose of Dololibre for the shortest possible duration of treatment
(see section 2 "What you need to know before taking Dololibre").
Patients with impaired liver function
Patients with impaired liver function are at risk of overdose when taking
Dololibre. Therefore, the minimum dose of Dololibre that is still effective must be selected. Careful monitoring by the doctor is necessary.
If your liver function is severely impaired, you should not take Dololibre (see
section 2 "What you need to know before taking Dololibre").
Patients with impaired kidney function
If your kidney function is impaired, your doctor may decide to reduce the dose of Dololibre.
If your kidney function is severely impaired, you should not take Dololibre (see
section 2 "What you need to know before taking Dololibre").

Duration of treatment
The duration of treatment is decided by the attending physician.
For rheumatic diseases, it may be necessary to take Dololibre for a prolonged period of time.
In menstrual pain, the duration of treatment depends on the respective symptoms. Treatment
with Dololibre should not, however, exceed a few days.

If you take more Dololibre than you should
If you take more Dololibre than you should, seek immediate medical attention or go immediately
to the hospital. Bring the package of the medicine with you.

For healthcare professionals: information regarding the management of naproxen poisoning
If you forget to take Dololibre
Do not take a double dose to make up for a missed dose. Continue to take
Dololibre as usual.
If you have any doubts about the use of this medicine, 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 modest increase in the risk
of heart attack ("myocardial infarction") or stroke.

Important side effects to watch out for:
If you experience any of the following symptoms or combinations of symptoms, stop taking
this medicine and seek medical attention immediately. You may need
urgent medical treatment.
Severe allergic reactions(may affect up to 1 in 10,000 people), the signs include:

• Shortness of breath
• Severe drop in blood pressure
• Swelling of the face or throat, difficulty swallowing
• Skin rash (itchy), redness, small blisters

Serious problems of the stomach and intestines(may affect up to 1 in 10 people), the signs
include:

• Abdominal pain (in the stomach) relatively severe, especially if it appears suddenly
• Vomiting blood or vomit that looks like coffee grounds
• Black or bloody stools
• Ulcers, perforations (holes) and bleeding in the stomach or intestine, sometimes fatal particularly in the elderly Heart attack, the signs include:
• Chest pain that may spread to the neck and shoulders and down the left arm

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

• Extreme fatigue associated with loss of appetite, with or without yellowish discoloration of the skin and whites of the eyes
• Nausea or vomiting or pale stools

Impairment of the sensory organs, for example:

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

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

• Severe headache, especially if sudden
• Stiff neck, fever, nausea or vomiting
• Confusion, sensitivity to bright light

Patients with autoimmune diseases (SLE, mixed connective tissue disease) are at greater
risk of developing meningitis.

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

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

Dololibre may cause the following side effects:

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

• Feeling unwell
• Vomiting
• Heartburn
• Stomach pain
• Fullness
• Constipation or diarrhea and minor blood loss in the gastrointestinal tract which, in rare cases, can lead to anemia

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

• Skin and mucous membrane bleeding
• Depression
• Changes in dream activity
• Difficulty falling asleep or staying asleep (insomnia)
• Headache
• Dizziness
• Agitation
• Irritability
• Sleep disturbances
• Fatigue
• Disturbances of perception and cognitive dysfunction
• Tinnitus (ringing in the ears)
• Vertigo (dizziness)
• Sweating
• Fluid retention in the tissues (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 number of certain types of white blood cells (eosinophilia)
• Asthma attacks (with or without a drop in blood pressure)
• Inflammation of the lungs (eosinophilic pneumonia)
• Symptoms in the lower abdomen (for example, inflammation of the large intestine with bleeding or worsening of Crohn's disease/ulcerative colitis)
• Inflammation of the inner lining of the oral cavity (mouth)
• Injury to the digestive tract
• Changes in liver function with increased transaminases
• Hair loss (usually temporary)
• Skin inflammation caused by light (sun) (which may include rash with blisters)
• Muscle pain
• Muscle weakness
• Acute kidney failure
• Impaired kidney function (nephrotic syndrome)
• Inflammation of one or both kidneys (interstitial nephritis)
• Fever and chills, malaise
• Inflammation of the inner lining of the stomach
• Gas

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

• Skin rash with blisters (reactions similar to bullous epidermolysis)

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

• Decrease in the number of red blood cells and/or white blood cells and/or platelets in the blood, (aplastic or hemolytic anemia, thrombocytopenia, leukopenia, pancytopenia, agranulocytosis)
• Convulsions (seizures)
• Inflammation of the nerves
• High blood pressure
• Increased heart rate
• Feeling of a racing heartbeat
• Heart failure
• Inflammation of blood vessels
• Worsening of infection-related inflammation (for example, development of necrotizing fasciitis, i.e., acute inflammation and necrosis [tissue death] of the fatty tissues under the skin and muscles)
• Systemic anaphylactic or anaphylactoid reactions
• Liver inflammation (hepatitis), liver damage particularly after long-term therapy
• Hypersensitivity reactions such as skin rashes, erythema multiforme; in isolated cases they manifest as severe skin reactions (including Stevens-Johnson syndrome or toxic epidermal necrolysis)
• Kidney damage (renal papillary necrosis) (particularly after long-term therapy)
• Increased uric acid levels in the blood

Not known (frequency cannot be estimated based on available data):

• Increased potassium levels
• Decreased number of white blood cells (neutropenia)
• Swelling of the crystalline lens and head of the optic nerve
• Corneal opacity
• Inflammation of the head of the optic nerve
• Tingling or numbness of hands and feet
• Pulmonary edema
• Inflammation of the pancreas (a large gland behind the stomach)
• Erythema nodosum (a skin inflammation that involves the formation of painful reddish bumps)
• Lichen planus (an itchy, non-infectious rash that can appear in many areas of the body)
• Systemic lupus erythematosus (SLE, an autoimmune disease that leads to an inflammatory process that can affect various parts of the body)
• Pustular reaction
• Fixed drug eruption (FDE, an allergic skin rash that appears in the same location each time the drug is taken)
• Blood in the urine (hematuria)
• Inflammation of certain parts of the kidneys (glomerulonephritis)
• Female infertility
• Edema

Naproxen may interfere with laboratory test results; you should therefore inform the doctors
treating you (if relevant) that you are taking Dololibre (see section 2 "What you need to know before
taking Dololibre").
Methyl parahydroxybenzoate (E 218) may cause allergic reactions (even delayed ones).

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

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse .
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Dololibre

Store in the original package to protect the medicine from light.
After first opening, this medicine is stable for 3 months. Store in the original package
to protect the medicine from light.
This medicine does not require any particular storage temperature.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and the package after
“Expiry”. The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to eliminate medicines that
you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Dololibre contains

• The active ingredient is naproxen 1 ml of Dololibre contains 50 mg of naproxen.
• The other ingredients are: sucrose (sugar), sodium saccharin (E 954), sodium cyclamate (E 952), sodium chloride, methyl parahydroxybenzoate (E 218), potassium sorbate (E 202), tragacanth gum (E 413), citric acid (E 330), liquid sorbitol (crystallizable) (E 420), water.

Description of the appearance of Dololibre and contents of the pack
Dololibre is an oral suspension of white or whitish-yellow color.
Amber-colored glass bottle fitted with a child-resistant screw cap.
8 ml graduated syringe for oral administration, with 0.1 ml increments.
Pack size: 100 ml

Marketing authorisation holder and manufacturer
INFECTOPHARM Arzneimittel und Consilium GmbH
Von-Humboldt-Strasse 1
64646 Heppenheim
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Naproxen Infectopharm 50 mg/ml Suspension zum Einnehmen
Italy: Dololibre
Poland: Dololibre
Portugal: Dololibre
Spain: Naproxeno Infectopharm, 50 mg/ml suspensión oral
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The following information is intended exclusively for doctors or healthcare professionals:
In case of naproxen overdose:
Symptoms of overdose
Symptoms of overdose may include CNS disturbances, including headache, dizziness and
mental confusion, and epigastric pain and abdominal discomfort, indigestion, nausea, vomiting,
transient alteration of liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis,
apnea and disorientation. Naproxen may be rapidly absorbed. High and early blood drug concentrations should be anticipated. Some patients have experienced
seizures, but it was not clear whether these were caused by treatment with
naproxen. Gastrointestinal bleeding may also occur. Hypertension, acute renal failure, respiratory depression and coma may occur, although rarely. Anaphylactic reactions have been reported following treatment with non-steroidal anti-inflammatory drugs and may also occur following overdose.
Overdose management
Patients should be treated symptomatically. There are no specific antidotes. Preventive measures
to avoid further absorption (for example, administration of activated charcoal) may be
indicated in patients within four hours of ingestion or due to a massive overdose. Forced diuresis, alkalinization of the urine, hemodialysis or hemoperfusion are unlikely to be indicated
given the strong protein binding of naproxen.