Ibuprofen Farmalider

Leaflet attached to the packaging: information for the user

Ibuprofen FARMALIDER,

20 mg/ml, oral suspension

For use in children with a body weight of 5 kg (6 months of age) to 39 kg (11 years of age)
Ibuprofen
Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
This medicine is available without a prescription. However, Ibuprofen FARMALIDER should be used with caution to achieve the best treatment results.

• Keep this leaflet, you may need to read it again.
• Ask your pharmacist if you need advice or more information.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
• If after 3 days there is no improvement or the patient feels worse, contact a doctor.

Table of contents of the leaflet:

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

1. What is Ibuprofen FARMALIDER and what is it used for

Ibuprofen FARMALIDER is a pain-relieving and antipyretic medicine belonging to the group of nonsteroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen FARMALIDER is used for short-term symptomatic treatment of:

• mild or moderate pain, such as toothache, headache,
• fever.

Ibuprofen FARMALIDER is indicated for use in children with a body weight of 6 kg (6 months of age) to 39 kg (11 years of age).

2. Important information before taking Ibuprofen FARMALIDER

When not to take Ibuprofen FARMALIDER

• If the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever had bronchial asthma, asthmatic attacks, rhinitis, or urticaria after taking acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs.
• If the patient has unexplained blood clotting disorders.
• If the patient has had bleeding or perforation of the gastrointestinal tract in the past when taking NSAIDs.
• If the patient has active stomach or duodenal ulcers (peptic ulcers) or bleeding from peptic ulcers, or has had recurrent peptic ulcers or bleeding from peptic ulcers (two or more separate episodes of proven peptic ulcers or bleeding from peptic ulcers).
• If the patient has cerebral bleeding or other active bleeding.
• In severe liver, kidney, or heart failure.
• In severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• In the last three months of pregnancy.

Warnings and precautions

The risk of side effects can be minimized by using the lowest effective dose for the shortest necessary duration to control symptoms.
Tell your pharmacist or doctor if you have an infection - see below, under "Infections".
Gastrointestinal safety
Concomitant use of Ibuprofen FARMALIDER and other NSAIDs, including so-called COX-2 inhibitors (selective cyclooxygenase-2 inhibitors), should be avoided.
Elderly patients:
Elderly patients are at increased risk of side effects when taking NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal.
Gastrointestinal bleeding, ulcers, or perforation:
There have been reports of gastrointestinal bleeding, ulcers, or perforation, which can be fatal, with all NSAIDs at any time during treatment, with or without warning symptoms or a history of serious gastrointestinal events.
The risk of gastrointestinal bleeding, ulcers, or perforation increases with the dose of NSAIDs and is higher in patients with a history of ulcers, especially if complicated by bleeding or perforation (see section 2, subsection "When not to take Ibuprofen FARMALIDER"), and in elderly patients. Such patients should start treatment with the lowest available dose.
For these patients, as well as for patients who require concomitant use of low-dose acetylsalicylic acid or other drugs that increase the risk of gastrointestinal disorders, consideration should be given to concomitant use of protective agents (e.g., misoprostol or proton pump inhibitors).
Patients who have had gastrointestinal side effects in the past, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the start of treatment.
Caution is advised in patients taking concomitant medications that may increase the risk of gastrointestinal ulcers or bleeding, such as oral corticosteroids, anticoagulants (e.g., warfarin), selective serotonin reuptake inhibitors (used to treat depression), and antiplatelet agents (e.g., acetylsalicylic acid) (see section 2, subsection "Other medicines and Ibuprofen FARMALIDER").
If gastrointestinal bleeding or ulcers occur during treatment with Ibuprofen FARMALIDER, treatment must be discontinued and a doctor consulted.
In patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease), NSAIDs should be used with caution, as these conditions may worsen (see section 4).
Effect on the cardiovascular system and blood vessels
Taking anti-inflammatory/pain-relieving medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose and duration of treatment.
During ibuprofen treatment, allergic reactions to this medicine have occurred, including difficulty breathing, facial and neck edema (angioedema), and chest pain.

In case of any of these symptoms, stop taking Ibuprofen FARMALIDER and contact a doctor or emergency medical services immediately.

Before taking the medicine [Brand Name], the patient should discuss treatment with a doctor or pharmacist if:

• the patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, has peripheral arterial disease (poor circulation in the legs due to narrowing or blockage of blood vessels), or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• the patient has high blood pressure, diabetes, high cholesterol, has a family history of heart disease or stroke, or smokes.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported with ibuprofen use. If the patient experiences any symptoms associated with these severe skin reactions, stop taking Ibuprofen FARMALIDER and seek medical attention.
It is recommended to avoid taking Ibuprofen FARMALIDER in patients with chickenpox.
Other information:
Ibuprofen FARMALIDER should only be used after consulting a doctor:

• in congenital blood clotting disorders (intermittent porphyria),
• in certain immune system diseases (systemic lupus erythematosus or mixed connective tissue disease).

Particular caution is required in patients with:

• renal impairment,
• hepatic impairment,
• dehydration,
• immediately after major surgery,
• allergies (such as skin reactions to other medicines, asthma, hay fever), chronic rhinitis, or chronic respiratory diseases of an obstructive type - they are at increased risk of hypersensitivity reactions.

Very rare cases of severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been reported. If the first symptoms of severe hypersensitivity reactions occur after taking Ibuprofen FARMALIDER, treatment must be discontinued. Depending on the symptoms, any necessary treatment must be initiated by specialists.
Ibuprofen, the active substance of Ibuprofen FARMALIDER, may cause transient inhibition of platelet aggregation. Therefore, patients with coagulation disorders should be closely monitored.
During long-term use of Ibuprofen FARMALIDER, regular monitoring of liver enzyme activity, kidney function parameters, and peripheral blood morphology is necessary.
When taking Ibuprofen FARMALIDER, the patient should consult a doctor or dentist and inform them before undergoing any surgical procedure.
If the patient is already taking other pain-relieving or antipyretic medicines or antibiotics, they may start taking Ibuprofen FARMALIDER only if advised by their doctor.
If the patient has a serious illness and/or is taking regular medication, they should consult their doctor before taking Ibuprofen FARMALIDER.
Long-term use of any type of pain-relieving medicine for headache may worsen it. If this situation occurs or is suspected, the patient should consult a doctor for advice and discontinue treatment. Medication-overuse headache should be suspected in patients who experience frequent or daily headaches despite (or because of) regular use of pain-relieving medicines.
Habitual use of pain-relieving medicines, especially several pain-relieving medicines at the same time, can generally lead to permanent kidney damage and increase the risk of kidney failure (analgesic nephropathy).
Ibuprofen FARMALIDER may mask the symptoms of infection, such as fever and pain. Therefore, Ibuprofen FARMALIDER may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox.
If the patient takes this medicine while an infection is present and the symptoms of the infection persist or worsen, they should consult a doctor immediately.

Children

Ibuprofen FARMALIDER is not recommended for use in children under 6 months of age or with a body weight below 5 kg.

Ibuprofen FARMALIDER and other medicines

Tell your doctor or pharmacist about all medicines you are taking or have recently taken, including those available without a prescription.
What to avoid while taking this medicine?
Ibuprofen FARMALIDER may affect the action of other medicines or other medicines may affect the action of Ibuprofen FARMALIDER. For example:

• blood-thinning medicines (e.g., aspirin/acetylsalicylic acid, warfarin, ticlopidine),
• blood pressure-lowering medicines (e.g., ACE inhibitors, such as captopril, beta-blockers, such as atenolol, angiotensin II receptor antagonists, such as losartan),

Some other medicines may also be affected or have an effect on Ibuprofen FARMALIDER treatment. Therefore, before taking the medicine [Brand Name] with other medicines, always consult a doctor or pharmacist.
Taking Ibuprofen FARMALIDER with digoxin (a medicine used to strengthen the heart), phenytoin (a medicine used to treat epilepsy), or lithium salts (used to treat certain mental illnesses) may increase the levels of these medicines in the blood. If the medicine is used correctly (for a maximum of 3 days), it is usually not necessary to determine the levels of lithium, digoxin, and phenytoin in the serum.
Ibuprofen FARMALIDER may weaken the effect of diuretics and blood pressure-lowering medicines; it may also increase the risk to the kidneys.
Ibuprofen FARMALIDER may weaken the effect of ACE inhibitors (medicines used to treat heart failure and high blood pressure). Additionally, concomitant use of these medicines is associated with an increased risk of kidney function disorders.
Concomitant use of Ibuprofen FARMALIDER with potassium-sparing diuretics (a type of diuretic) may lead to increased potassium levels in the blood.
The risk of gastrointestinal ulcers or bleeding is increased when Ibuprofen FARMALIDER is used concomitantly with corticosteroids and other anti-inflammatory and pain-relieving medicines belonging to NSAIDs.
Platelet aggregation inhibitors and certain antidepressants (selective serotonin reuptake inhibitors, SSRIs) may increase the risk of gastrointestinal bleeding.
Using Ibuprofen FARMALIDER within 24 hours before or after methotrexate administration may lead to increased methotrexate levels in the blood and increased side effects of this medicine.
In the case of cyclosporine (a medicine used to prevent transplant rejection and treat rheumatic diseases), there is a higher risk of kidney damage if certain nonsteroidal anti-inflammatory drugs are used concomitantly. It cannot be excluded that this effect may occur with concomitant use of cyclosporine and ibuprofen.
Taking medicines containing probenecid or sulfinpyrazone (medicines used to treat gout) may delay the elimination of ibuprofen from the body. This may cause ibuprofen to accumulate in the body and increase its side effects.
NSAIDs may enhance the effects of anticoagulant medicines, such as warfarin. When these medicines are used concomitantly, it is recommended to monitor blood coagulation parameters.
Clinical studies have shown interactions between NSAIDs and sulfonylurea derivatives (used to lower blood sugar levels). Although interactions between ibuprofen and sulfonylurea derivatives have not been reported to date, when used concomitantly, it is recommended to monitor blood sugar levels.
Tacrolimus: concomitant use of tacrolimus and ibuprofen may increase the risk of kidney damage.
Zidovudine: individuals with HIV infection and hemophilia are at increased risk of bleeding into the joints and hematomas when taking zidovudine and ibuprofen concomitantly.
Quinolone antibiotics: when these medicines are used concomitantly with ibuprofen, the risk of seizures may increase.
CYP2C9 inhibitors: concomitant use of ibuprofen and CYP2C9 inhibitors may increase exposure to ibuprofen (a CYP2C9 substrate). In a study using voriconazole and fluconazole (CYP2C9 inhibitors), an increase in exposure to S(+)-ibuprofen of approximately 80-100% was observed. When concomitantly administering strong CYP2C9 inhibitors, consideration should be given to reducing the ibuprofen dose, especially if high doses of ibuprofen are administered concomitantly with voriconazole or fluconazole.
If the patient is taking any of the above medicines, they should consult a doctor before taking Ibuprofen FARMALIDER.

Ibuprofen FARMALIDER with food, drink, and alcohol

When taking Ibuprofen FARMALIDER, it is recommended to avoid drinking alcohol.

Pregnancy, breastfeeding, and fertility

Pregnancy

If the patient becomes pregnant while taking Ibuprofen FARMALIDER, they should inform their doctor.
Do not take Ibuprofen FARMALIDER if you are in the last three months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart problems in the unborn child.
It may increase the risk of bleeding in the mother and child and cause prolongation or prolongation of labor. During the first six months of pregnancy, Ibuprofen FARMALIDER should not be used unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the lowest possible dose should be used for the shortest possible time. From the 20th week of pregnancy, Ibuprofen FARMALIDER may cause kidney problems in the unborn child if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios). If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

Breastfeeding

Only small amounts of ibuprofen and its breakdown products pass into breast milk.
Since no harmful effects have been found in infants to date, it is usually not necessary to stop breastfeeding during short-term use of ibuprofen at recommended doses.

Fertility

The medicine belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible by stopping the medicine.

Driving and using machines

When taking Ibuprofen FARMALIDER, side effects such as fatigue or dizziness may occur. As a result, some individuals may experience impaired reaction ability, ability to participate in traffic, and ability to operate machines. This is especially true for interactions with alcohol. The patient may then lose the ability to react quickly and appropriately to unexpected or sudden situations. In this case, do not drive a car or any vehicle, do not operate machines, or perform any hazardous tasks.

Ibuprofen FARMALIDER contains maltitol liquid and sodium

This medicinal product contains a maximum of 1.23 mmol (i.e., 28.17 mg) of sodium per maximum single dose of 10 ml. This should be taken into account by patients on a controlled sodium diet.
The medicine contains maltitol liquid. If the patient has previously been diagnosed with intolerance to some sugars, they should consult a doctor before taking the medicine.

3. How to take Ibuprofen FARMALIDER

Always take this medicine exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist.
Unless your doctor has told you otherwise, the recommended dose of Ibuprofen FARMALIDER 20 mg/ml is as follows:

Use the lowest effective dose for the shortest duration necessary to relieve symptoms. If the symptoms of infection (such as fever and pain) persist or worsen, consult a doctor (see section 2).
The dosage of Ibuprofen FARMALIDER is based on body weight (bw), with a single dose usually being 7-10 mg/kg bw, and the maximum daily dose being 30 mg/kg bw.
The interval between consecutive doses should be at least 6 hours.
Do not exceed the recommended dose.
The medicine is not recommended for use in children under 6 months of age or with a body weight below 5 kg.
Oral administration.
A 5 ml oral syringe is included with the packaging (with a scale every 0.25 ml).
Before use, the bottle should be shaken vigorously.
The oral suspension can be taken with or without food. Patients with sensitive stomachs are advised to take the medicine with food.
If the patient feels that Ibuprofen FARMALIDER is too strong or too weak, they should talk to a doctor or pharmacist.
Duration of treatment
The medicine is intended for short-term use only.
If symptoms worsen or persist for more than 3 days, consult a doctor.

Overdose of Ibuprofen FARMALIDER

Stop taking ibuprofen and consult a doctor if symptoms of overdose occur, such as headache, dizziness, feeling of impending fainting, loss of consciousness (in children, also seizures), abdominal pain, nausea, vomiting, gastrointestinal bleeding, liver or kidney function disorders, decreased blood pressure, decreased respiratory rate (respiratory depression), or cyanosis (blue discoloration of the lips or skin).
If the patient has taken more than the recommended dose of Ibuprofen FARMALIDER or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to assess the risk to their health and for advice on what to do.

Missed dose of Ibuprofen FARMALIDER

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

Stopping Ibuprofen FARMALIDER treatment

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

If the patient experiences any of the following symptoms, they should stop taking ibuprofen and seek medical attention:

• Red, non-raised, target-like, or circular patches on the torso, often with blisters in the center, peeling of the skin, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever, and enlarged lymph nodes (DRESS syndrome).
• Red, scaly rash with bumps under the skin and blisters, with fever, usually occurring at the start of treatment (acute generalized exanthematous pustulosis).

The following side effects have been reported with ibuprofen, including those reported during long-term use of ibuprofen in high doses in patients with rheumatic diseases.
Side effects more frequent than very rare are those that occur during short-term use at daily doses not exceeding the maximum dose of 1200 mg (= 60 ml Ibuprofen FARMALIDER oral suspension, maximum daily dose for adults and adolescents from 12 years of age) in the case of oral preparations and a maximum dose of 1800 mg in the case of suppositories.
Regarding the following side effects, it should be taken into account that they mostly show a dose-dependent effect and have a high interindividual variability.
The most common side effects are related to the gastrointestinal tract.
Side effects may include gastrointestinal ulcers, perforation, or bleeding, which can be fatal, especially in elderly patients (see section 2, subsection "Warnings and precautions").

Frequent side effects (occurring in 1 to 10 in 100 patients)

• Gastrointestinal symptoms, such as heartburn, abdominal pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal bleeding, which may rarely lead to anemia.

Uncommon side effects (occurring in 1 to 10 in 1,000 patients)

• Stomach or intestinal ulcers, sometimes with bleeding and perforation. Mouth ulcers, worsening of ulcerative colitis and Crohn's disease, gastritis. If the patient experiences severe abdominal pain, vomiting blood, blood in the stool, or black stool, they should stop taking Ibuprofen FARMALIDER and immediately inform their doctor.
• Central nervous system disorders, such as headache, dizziness, insomnia, restlessness, irritability, and fatigue.
• Vision disorders. In this case, the patient should inform their doctor and stop taking Ibuprofen FARMALIDER.
• Hypersensitivity reactions with skin rashes and itching, as well as asthma attacks (with possible decreased blood pressure). In this case, the patient should immediately consult a doctor and stop taking Ibuprofen FARMALIDER.
• Various skin rashes.

Rare side effects (occurring in 1 to 10 in 10,000 patients)

• Kidney tissue damage (renal papillary necrosis), especially with long-term use of the medicine, increased uric acid levels in the blood.
• Ringing in the ears (tinnitus).

Very rare side effects (occurring less frequently than 1 in 10,000 patients)

• Palpitations, heart failure, heart attack (myocardial infarction).
• Esophageal inflammation, pancreatitis, narrowing of the small and large intestine resembling membranes.
• Decreased urine production and fluid accumulation in the body (edema), especially in patients with high blood pressure or kidney problems. Nephrotic syndrome [fluid accumulation in the body (edema) and excretion of large amounts of protein in the urine], interstitial nephritis (inflammation of the kidney tissue), which may be accompanied by acute kidney failure. If these symptoms occur or worsen, the patient must stop taking Ibuprofen FARMALIDER and immediately consult a doctor.
• Liver function disorders, liver damage, especially with long-term use, liver failure, acute hepatitis.
• Blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Early symptoms may include fever, sore throat, mouth ulcers, flu-like symptoms, increased fatigue, nosebleeds, and bruising. If any of these symptoms occur, the patient should immediately stop taking the medicine and consult a doctor. Do not take any pain-relieving or antipyretic medicines on your own.
• Severe skin reactions with rash, redness, and blistering [e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome)], hair loss (alopecia). In rare cases, during chickenpox, severe skin infections and subcutaneous tissue complications may occur (compare "Infections and infestations").
• Increased risk of infection (e.g., development of necrotizing fasciitis) has been reported with the use of some anti-inflammatory medicines (nonsteroidal anti-inflammatory drugs, including Ibuprofen FARMALIDER). If symptoms of infection occur or worsen during Ibuprofen FARMALIDER treatment (e.g., redness, swelling, overheating, pain, fever), the patient should immediately consult a doctor for advice.
• Hypertension.
• Symptoms of aseptic meningitis, such as severe headache, nausea, vomiting, fever, stiff neck, and clouding of consciousness. Patients with certain immune system diseases (systemic lupus erythematosus or mixed connective tissue disease) appear to be at increased risk.
• Severe generalized hypersensitivity reactions. Symptoms may include facial, tongue, and laryngeal edema associated with respiratory tract constriction, dyspnea, tachycardia, decreased blood pressure to life-threatening shock. If the patient experiences any of these symptoms, which may occur even after the first use of the medicine, they will require immediate medical attention.
• Psychotic reactions, depression.

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

• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, lymph node swelling, and increased eosinophil count (a type of white blood cell). Red, scaly rash with bumps under the skin and blisters, usually occurring at the start of treatment, located mainly in skin folds, on the torso, and upper limbs, with fever.

If these symptoms occur, stop taking Ibuprofen FARMALIDER and seek medical attention immediately. See also section 2.

• Skin becomes sensitive to light
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome

If any side effects worsen or any side effects not listed in this leaflet occur, the patient should tell their doctor or pharmacist.

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the
Department for Monitoring of Adverse Reactions to Medicinal Products
Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
e-mail: ndl@urpl.gov.pl
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ibuprofen FARMALIDER

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the bottle. The expiry date refers to the last day of the month.
The medicinal product does not require special storage conditions.
After opening, the medicine remains stable at room temperature for 6 months.

6. Contents of the pack and other information

What Ibuprofen FARMALIDER contains
The active substance of the medicine is ibuprofen.
1 ml of oral suspension contains 20 mg of ibuprofen.
The other ingredients are:
sodium benzoate (E211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose 15 cP, xanthan gum, liquid maltitol, glycerol (E422), strawberry flavor [contains substances identical to natural flavors, natural flavors, maltodextrin, triethyl citrate (E1505), propylene glycol (E1520), and benzyl alcohol], purified water.

What Ibuprofen FARMALIDER looks like and contents of the pack

Ibuprofen FARMALIDER oral suspension is a viscous suspension with a white to creamy color.
Ibuprofen FARMALIDER 20 mg/ml oral suspension is available in plastic bottles of 100 ml, 150 ml, and 200 ml with child-resistant closures.
Not all pack sizes may be marketed.
To facilitate accurate dosing, a 5 ml oral syringe made of polypropylene with a scale every 0.25 ml up to 5 ml is included with the packaging.

Marketing authorization holder and manufacturer

Marketing authorization holder
Farmalider S.A., Calle La Granja, 1, 28108 Alcobendas (Madrid), SPAIN

Manufacturer

Farmasierra Manufacturing S.L.
Carretera de Irún, Km. 26,200
28700 San Sebastian de los Reyes (Madrid)
Spain
Farmalider, S.A
C/Aragoneses, 2
28108 Alcobendas (Madrid)
Spain
Delpharm Bladel B.V.
Industrieweg 1
5531 AD Bladel
Netherlands
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Hungary
Ibuprofen FARMALIDER 20 mg/ml oral suspension
Poland
Ibuprofen FARMALIDER
Portugal
Ibuprofen Farmalider 20 mg/ml oral suspension
Slovenia
Ibuprofen FARMALIDER 20 mg/ml oral suspension
Date of last revision of the leaflet: 02/2024