Ibuprofen farmalider

Package leaflet: Information for the user

Ibuprofen FARMALIDER,
20 mg/ml, oral suspension
For use in children weighing from 5 kg (6 months of age) to 39 kg (11 years of age)
Ibuprofenum
Please read the entire leaflet carefully before use, as it contains
important information for the patient.
This medicine is available without a prescription. Nevertheless, Ibuprofen FARMALIDER should be used
with caution to achieve the best possible treatment outcomes.

• Keep this leaflet for future reference.
• Consult your pharmacist if you need advice or further information.
• If any of the side effects worsens or if any side effects occur, including those not listed in this leaflet, inform your doctor or pharmacist.
• If there is no improvement after 3 days or if the patient feels worse, consult a doctor.

Table of contents of the leaflet:

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

Ibuprofen FARMALIDER is an analgesic and antipyretic medicine belonging to the group of
non-steroidal anti-inflammatory drugs (NSAIDs).
Ibuprofen FARMALIDER is used for short-term symptomatic treatment of:

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

Ibuprofen FARMALIDER is indicated for use in children weighing from 6 kg (6th month of
life) to 39 kg (11th year of life).

2. Important information before using Ibuprofen FARMALIDER

When not to use 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 previously experienced bronchospasm, asthma attack, nasal mucosal swelling (rhinitis), angioedema, or skin reactions (urticaria) following the intake of acetylsalicylic acid or other non-steroidal anti-inflammatory drugs (NSAIDs).
• If the patient has blood disorders of unknown cause.
• If the patient has previously experienced gastrointestinal bleeding or gastrointestinal perforation associated with prior use of NSAIDs.
• If the patient has active gastric/duodenal ulcer (peptic ulcer) or bleeding from a peptic ulcer, or if the patient has recurrent gastric/duodenal ulcers (peptic ulcers) or recurrent bleeding from peptic ulcers (two or more separate episodes of confirmed peptic ulcer or bleeding from peptic ulcer).
• If the patient has cerebral hemorrhage or any other active bleeding.
• In severe hepatic, renal, or cardiac insufficiency.
• In severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• During the last three months of pregnancy.

Warnings and precautions
The occurrence of adverse effects can be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
The patient should inform the pharmacist or doctor if they have an infection — see below, section titled “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 experiencing adverse effects when using NSAIDs, particularly gastrointestinal bleeding and gastrointestinal perforation, which may be fatal.
Gastrointestinal bleeding, gastrointestinal ulcers, or gastrointestinal perforation:
Cases of gastrointestinal bleeding, gastrointestinal ulcers, or gastrointestinal perforation, which may be fatal, have been reported with the use of all NSAIDs at any time during treatment, with or without warning symptoms or previous serious gastrointestinal events in medical history.
The risk of gastrointestinal bleeding, gastrointestinal ulcers, or gastrointestinal perforation increases with higher NSAID doses and is higher in patients with a history of gastrointestinal ulcers, especially if complicated by bleeding or perforation (see section 2, subsection “When not to use Ibuprofen FARMALIDER”), as well as in elderly patients. Such patients should start treatment with the lowest available dose.
In these patients, and in patients requiring additional concomitant use of low-dose acetylsalicylic acid or other drugs increasing the risk of gastrointestinal disorders, concomitant use of protective agents (e.g., misoprostol or proton pump inhibitors) should be considered.
Patients who have previously experienced gastrointestinal adverse effects, particularly if they are elderly, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially at the beginning of treatment.
Caution is advised in patients concurrently taking medications that may increase the risk of gastrointestinal ulcers or gastrointestinal bleeding, e.g., oral glucocorticoids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors (used in the treatment of various disorders, including depression), and antiplatelet drugs such as acetylsalicylic acid (see section 2, subsection “Other medicines and Ibuprofen FARMALIDER”).
If gastrointestinal bleeding or a gastrointestinal ulcer occurs during treatment with Ibuprofen FARMALIDER, treatment must be discontinued and medical advice should be sought immediately.
NSAIDs should be used with caution in patients with a history of gastrointestinal disease (ulcerative colitis, Crohn’s disease), as these conditions may worsen (see section 4).
Effects on the circulatory system and cerebral vessels
Taking anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of myocardial infarction or stroke, particularly when used at high doses. Do not exceed the recommended dose or duration of treatment.
Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have been reported during treatment.
If any of these symptoms occur, Ibuprofen FARMALIDER must be discontinued immediately and medical help must be sought urgently.
Before using [Brand Name], the patient should discuss treatment with a doctor or pharmacist if:

• The patient has heart diseases such as heart failure, angina pectoris (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor blood circulation in the legs due to narrowed or blocked arteries), or has had any stroke (including mini-stroke or transient ischemic attack - TIA).
• The patient has hypertension, diabetes, elevated cholesterol levels, a family history of heart disease or stroke, or if the patient smokes.

Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen use. If the patient experiences any of the symptoms related to these serious skin reactions described in section 4, Ibuprofen FARMALIDER must be discontinued immediately and medical help should be sought.
It is recommended to avoid using Ibuprofen FARMALIDER in patients with chickenpox.
Other information:
Ibuprofen FARMALIDER should be used only after consultation with a doctor:

• In congenital blood disorders (acute intermittent porphyria),
• In certain autoimmune diseases (systemic lupus erythematosus or mixed connective tissue disease).

Particularly careful monitoring by a physician is required in patients:

• With impaired renal function,
• With impaired hepatic function,
• Who are dehydrated,
• Immediately after major surgical procedures,
• With allergies (such as skin reactions to other drugs, bronchial asthma, hay fever), chronic nasal mucosal swelling, or chronic obstructive respiratory diseases — as they are at increased risk of hypersensitivity reactions.

Very rarely, severe acute hypersensitivity reactions (e.g., anaphylactic shock) have been reported. At the first sign of severe hypersensitivity reactions after taking Ibuprofen FARMALIDER, treatment must be discontinued. Depending on symptoms, appropriate medical treatment must be initiated by specialists.
Ibuprofen — the active substance in Ibuprofen FARMALIDER — may cause transient inhibition of platelet function (platelet aggregation). Therefore, patients with coagulation disorders should be closely monitored.
During prolonged use of Ibuprofen FARMALIDER, regular monitoring of liver enzyme activity, renal function parameters, and peripheral blood morphology is necessary.
While 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 analgesics, antipyretics, or antibiotics, they may start taking Ibuprofen FARMALIDER only if recommended by their physician.
If the patient suffers from any serious illness and/or is taking regular medication, they should consult their physician before using Ibuprofen FARMALIDER.
Long-term use of any type of analgesic for headache may worsen the headache. If this 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 analgesics.
Habitual use of analgesics, particularly several analgesics simultaneously, may generally lead to permanent kidney damage and carry a risk of renal failure (analgesic nephropathy).
Ibuprofen FARMALIDER may mask symptoms\4 of infection, such as fever and pain. Therefore, Ibuprofen FARMALIDER may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox.
If the patient takes this medicine during an ongoing infection and symptoms of 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 weighing less than 5 kg.

Ibuprofen FARMALIDER and other medicines
Inform your doctor or pharmacist about all medicines currently taken or recently taken, including those obtained without a prescription.
What to avoid while using this medicine?
Ibuprofen FARMALIDER may affect the action of other medicines or other medicines may affect the action of Ibuprofen FARMALIDER. For example:

• Anticoagulant medicines (i.e., blood thinners/preventing blood clots), such as aspirin/acetylsalicylic acid, warfarin, ticlopidine
• Medicines that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers such as those containing atenolol, angiotensin II receptor antagonists such as losartan)

Also, some other medicines may be affected by or may affect treatment with Ibuprofen FARMALIDER. Therefore, always consult a doctor or pharmacist before using [Brand Name] with other medicines.
Concomitant use of Ibuprofen FARMALIDER with digoxin (a medicine used to strengthen the heart), phenytoin (a medicine used in epilepsy treatment), or lithium salts (used in the treatment of certain psychiatric disorders) may lead to increased blood concentrations of these medicines. If the medicine is used correctly (for up to 3 days maximum), serum monitoring of lithium, digoxin, and phenytoin levels is usually not necessary.
Ibuprofen FARMALIDER may reduce the effectiveness of diuretics (water tablets) and antihypertensive medicines (medicines for high blood pressure); there may also be an increased risk to the kidneys.
Ibuprofen FARMALIDER may reduce the effectiveness of angiotensin-converting enzyme (ACE) inhibitors (medicines used in heart failure and hypertension treatment). In addition, 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 elevated blood potassium levels.
The risk of developing gastrointestinal ulcers or gastrointestinal bleeding is increased when Ibuprofen FARMALIDER is used concomitantly with glucocorticoids and other anti-inflammatory and analgesic medicines belonging to NSAIDs.
Antiplatelet agents 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 blood methotrexate levels and increased adverse effects of this medicine.
In the case of cyclosporine (a medicine used to prevent transplant rejection and in rheumatic disease treatment), there is a higher probability of kidney damage if certain non-steroidal anti-inflammatory drugs are used concomitantly. The possibility of this effect cannot be excluded when cyclosporine and ibuprofen are used together.
Medicines containing probenecid or sulfinpyrazone (medicines used in gout treatment) may delay the elimination of ibuprofen from the body. This may cause ibuprofen to accumulate in the body and intensify its adverse effects.
NSAIDs may enhance the effects of anticoagulants such as warfarin. When these medicines are used together, blood coagulation parameters should be monitored.
Clinical studies have shown interactions between NSAIDs and sulfonylurea derivatives (used to lower blood glucose levels). Although interactions between ibuprofen and sulfonylurea derivatives have not been described so far, blood glucose levels should be monitored when they are used concomitantly.
Tacrolimus: concomitant use of tacrolimus and ibuprofen increases the risk of kidney damage.
Zidovudine: HIV-infected hemophilia patients are at increased risk of joint hemorrhages and hematomas when zidovudine and ibuprofen are taken 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 systemic exposure to ibuprofen (a CYP2C9 substrate). In a study using voriconazole and fluconazole (CYP2C9 inhibitors), exposure to S(+)-ibuprofen increased by approximately 80–100%. When strong CYP2C9 inhibitors are co-administered, consideration should be given to reducing the ibuprofen dose, especially if high ibuprofen doses are administered concomitantly with voriconazole or fluconazole.
If the patient is taking any of the medicines listed above, they should consult their doctor before using Ibuprofen FARMALIDER.

Ibuprofen FARMALIDER with food, drink, and alcohol
Alcohol consumption should be avoided during treatment with Ibuprofen FARMALIDER.

Pregnancy, breastfeeding, and fertility
Pregnancy
If the patient becomes pregnant while using Ibuprofen FARMALIDER, she should inform her 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 disorders in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labor. During the first 6 months of pregnancy, Ibuprofen FARMALIDER should not be used unless the doctor considers its use absolutely necessary. If treatment is required 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 function disorders in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios). If treatment longer than a few days is required, the doctor may recommend additional monitoring.

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

Fertility
This medicine belongs to a group of medicines (NSAIDs) that may impair female fertility. This effect is reversible upon discontinuation of the medicine.

Driving and operating machinery
During treatment with Ibuprofen FARMALIDER, adverse effects such as fatigue or dizziness may occur. As a result, some individuals may experience impaired reaction ability, ability to actively participate in road traffic, and ability to operate machinery. This is particularly relevant in combination with alcohol. The patient may lose the ability to react quickly and appropriately to unexpected or sudden situations. In such cases, driving a car or any vehicle, operating machinery, or performing any dangerous tasks should be avoided.

Ibuprofen FARMALIDER contains maltitol liquid and sodium
This medicinal product contains up to 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 controlling sodium intake in their diet.
This medicine contains liquid maltitol. If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.

3. How to use Ibuprofen FARMALIDER

This medicine should always be used according to the information in the patient leaflet. If in doubt,
consult a doctor or pharmacist.
Unless otherwise directed by a doctor, the recommended doses of Ibuprofen FARMALIDER 20 mg/ml are
as follows:

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If, during an infection, its symptoms (such as fever and pain) persist or worsen, medical advice should be sought immediately (see section 2).
The dosage of Ibuprofen FARMALIDER in children depends on body weight (b.w.), with a single dose typically being 7–10 mg/kg b.w. and the maximum daily dose being 30 mg/kg b.w. The interval between doses should be at least 6 hours.
Do not exceed the recommended dose.
This medicine is not recommended for children under 6 months of age or weighing less than 5 kg.
Oral administration.
An oral syringe with a capacity of 5 ml (graduated every 0.25 ml) is supplied with the package.
Shake the bottle vigorously before use.
The oral suspension can be taken independently of meals. For patients with a sensitive stomach, it is recommended to take Ibuprofen FARMALIDER during meals.
If the patient feels that Ibuprofen FARMALIDER is having too strong or too weak an effect, they should discuss this with their doctor or pharmacist.
Duration of treatment
This medicine is intended for short-term use only.
If symptoms worsen or persist for more than 3 days, medical advice should be sought.
Overdose of Ibuprofen FARMALIDER
Discontinue ibuprofen and consult a doctor if symptoms of overdose occur, such as headache, dizziness, feeling faint, loss of consciousness (seizures in children), abdominal pain, nausea and vomiting, gastrointestinal bleeding, liver or kidney dysfunction, low blood pressure, reduced respiratory rate (respiratory depression), or cyanosis (bluish discoloration of lips or skin).
If a patient has taken more than the recommended dose of Ibuprofen FARMALIDER or if a child has accidentally ingested the medicine, medical advice should always be sought from a doctor or the nearest hospital to assess potential health risks and receive guidance on appropriate actions.
Symptoms may include nausea, stomach pain, vomiting (possibly with blood), headache, tinnitus, disorientation, and nystagmus. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, feeling cold, and breathing difficulties have been reported.
Missed dose of Ibuprofen FARMALIDER
Do not take a double dose to make up for a missed dose.
Discontinuation of Ibuprofen FARMALIDER
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.
If the patient experiences any of the following symptoms, ibuprofen use must be stopped immediately and medical help should be sought:

• Red, flat, non-raised, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital or eye lesions. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome).
• Red, scaly rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

The adverse reactions listed below include all adverse reactions reported during ibuprofen use, including those reported during long-term treatment with high doses in patients with rheumatic diseases.
Adverse reactions more frequent than very rare are those occurring during short-term use at daily doses not exceeding the maximum daily dose of 1200 mg (= 60 ml of Ibuprofen FARMALIDER oral suspension, the maximum daily dose for adults and adolescents aged 12 years and older) for oral formulations, and a maximum dose of 1800 mg for suppositories.
Regarding the adverse reactions listed below, it should be noted that in most cases they are dose-dependent and show considerable inter-individual variability.
The most commonly observed adverse reactions involve the gastrointestinal tract.
Gastric/duodenal ulcers (peptic ulcers), gastrointestinal perforation, or gastrointestinal bleeding may occur, sometimes leading to death, particularly in elderly patients (see section 2, subsection titled "Warnings and precautions").
After administration of ibuprofen, cases of nausea, vomiting, diarrhoea, bloating, constipation, indigestion, abdominal pain, tarry stools, bloody vomiting, ulcerative stomatitis, exacerbation of ulcerative colitis and Crohn's disease have been described (see section 2, subsection "Warnings and precautions").
Gastritis has been reported less frequently.
Use of medicines such as Ibuprofen FARMALIDER may be associated with a slightly increased risk of myocardial infarction (heart attack) or stroke.
Cases of oedema, hypertension, and heart failure have been reported with the use of NSAIDs.

Common adverse reactions (occurring in 1 to 10 out of 100 patients)

• Gastrointestinal disorders, e.g. heartburn, abdominal pain, nausea, vomiting, bloating, diarrhoea, constipation, and minor gastrointestinal blood loss, which may exceptionally lead to anaemia.

Uncommon adverse reactions (occurring in 1 to 10 out of 1,000 patients)

• Gastric or intestinal ulcers, sometimes with bleeding and perforation. Oral mucosal inflammation with ulcer formation, exacerbation of ulcerative colitis and Crohn's disease, gastritis. If the patient develops severe upper abdominal pain, vomiting blood, blood in the stool or tarry stools, treatment with Ibuprofen FARMALIDER must be discontinued immediately and the physician must be informed without delay.
• Central nervous system disorders, e.g. headache, dizziness, insomnia, psychomotor agitation, irritability, and fatigue.
• Visual disturbances. In such cases, the physician should be informed and use of Ibuprofen FARMALIDER should be discontinued.
• Hypersensitivity reactions with skin rash and itching, as well as bronchial asthma attacks (possibly with a drop in blood pressure). In such cases, immediate medical consultation is required and use of/ingestion of Ibuprofen FARMALIDER must be discontinued.
• Various skin rashes.

Rare adverse reactions (occurring in 1 to 10 out of 10,000 patients)

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

Very rare adverse reactions (occurring in fewer than 1 out of 10,000 patients)

• Palpitations, heart failure, myocardial infarction (heart attack).
• Oesophagitis, pancreatitis, small and large intestinal strictures resembling membranes.
• Reduced urine output by the kidneys and fluid accumulation in the body (oedema), particularly in patients with hypertension or impaired kidney function. Nephrotic syndrome [fluid accumulation in the body (oedema) and excretion of large amounts of protein in the urine], kidney inflammation (interstitial nephritis), which may be accompanied by acute kidney failure. If the above symptoms appear or worsen, the patient must discontinue use of Ibuprofen FARMALIDER and contact a physician immediately.
• Liver function disorders, liver damage, particularly during prolonged use, liver failure, acute hepatitis.
• Blood disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Early symptoms may include: fever, sore throat, superficial mouth sores, flu-like symptoms, severe fatigue, nosebleeds, and subcutaneous bleeding. If any of these symptoms occur, the medicine must be discontinued immediately and the patient should consult a physician. At this point, no analgesic or antipyretic medicines should be taken without medical advice.
• Severe skin reactions presenting with rash, redness and blister formation [e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome)], hair loss (alopecia). In exceptional cases during varicella infection, severe skin infections and complications involving subcutaneous tissue may occur (see "Infections and parasitic diseases").
• Cases of worsening inflammation associated with infection (e.g. development of necrotizing fasciitis) have been reported in temporal association with the use of certain anti-inflammatory medicines (non-steroidal anti-inflammatory drugs, including Ibuprofen FARMALIDER). If signs of infection (e.g. redness, swelling, warmth, pain, fever) appear or worsen during treatment with Ibuprofen FARMALIDER, the patient should seek immediate medical advice.
• Hypertension.
• Symptoms of aseptic meningitis, e.g. severe headache, nausea, vomiting, fever, neck stiffness and altered consciousness. Patients with certain immune system disorders (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 swelling associated with airway narrowing, dyspnoea, tachycardia, and drop in blood pressure to life-threatening shock levels. If any of these symptoms occur, even after the first dose of the medicine, immediate medical attention is required.
• Psychotic reactions, depression.

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

• Severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell), red scaly rash with subcutaneous nodules and blisters, predominantly located in skin folds, on the trunk and upper limbs, with fever occurring at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, Ibuprofen FARMALIDER must be discontinued and immediate medical help sought. See also section 2.

• Skin becomes sensitive to light

• Chest pain, which may be a symptom of a potentially serious allergic reaction known as Kounis syndrome

If any adverse reaction worsens or if any adverse reaction occurs, including those not listed in this leaflet, inform a doctor or pharmacist.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to:
Department of Monitoring Adverse Drug Reactions
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
e-mail: mailto: [email protected]
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Ibuprofen FARMALIDER

Keep the medicine in a place inaccessible and out of sight 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 specified month.
This 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 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 flavour [containing
substances identical to natural flavours, natural flavours, 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, white to creamy in colour.
Ibuprofen FARMALIDER 20 mg/ml oral suspension is available in plastic bottles of 100 ml, 150 ml, and 200 ml capacity, with a child-resistant closure.
Not all pack sizes may be marketed.
An oral syringe made of polypropylene, graduated in 0.25 ml increments up to 5 ml, is supplied with the pack to facilitate accurate dose measurement.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Farmalider S.A., Calle La Granja, 1, 28108 Alcobendas (Madrid), SPAIN
Manufacturers
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
The Netherlands
This medicinal product is authorised for marketing in the European Economic Area under the following names:
Hungary Ibuprofen FARMALIDER 20 mg/ml belsőleges szuszpenzió
Poland Ibuprofen FARMALIDER
Portugal Ibuprofeno Farmalider 20 mg/ml suspensão oral
Slovenia Ibuprofen FARMALIDER 20 mg/ml peroralna suspenzija