IBUPROFEN FARMALIDER 20 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Ibuprofen Farmalider 20 mg/ml Oral Suspension EFG

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

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

Contents of the pack

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

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

Ibuprofen Farmalider contains ibuprofen as the active substance and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used in infants over 3 months and children up to 12 years for the symptomatic relief of mild or moderate occasional pain, as well as in febrile conditions.

2. What you need to know before you take Ibuprofen Farmalider

Do not take Ibuprofen Farmalider

• if you are allergic (hypersensitive) to ibuprofen or any of the other ingredients of this medicine (listed in section 6) or to other medicines of the non-steroidal anti-inflammatory drug group (NSAIDs) or to aspirin. Allergic reactions may be: skin rash with itching, swelling of the face, lips or tongue, nasal discharge, difficulty breathing or asthma,
• if you have severe liver or kidney disease,
• if you have active inflammatory bowel disease,
• if you have had a stomach or duodenal ulcer (peptic ulcer) or have had two or more episodes of stomach or duodenal ulcer or bleeding, or have had a perforation of the digestive tract,
• if you vomit blood,
• if you have black stools or bloody diarrhea,
• if you have bleeding disorders or blood clotting disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood clotting tests,
• if you have severe heart failure,
• if you have significant dehydration (caused by vomiting, diarrhea, or insufficient fluid intake),
• if you are in the third trimester of pregnancy.

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medicine

• if you have edema (fluid retention),
• if you have or have had heart disorders or have high blood pressure,
• if you have asthma or any other respiratory disorder,
• if you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks,
• if you experience symptoms of dehydration, e.g. severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure as a consequence of dehydration in this specific case. There is a risk of kidney failure in dehydrated children and adolescents.
• if you have had or develop an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by severe abdominal pain or persistent abdominal pain and/or black stools, or even without previous warning symptoms, this risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication,
• if you are taking medications that alter blood clotting, such as oral anticoagulants (such as warfarin) or antiplatelet agents of the aspirin type. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids (such as prednisolone) and selective serotonin reuptake inhibitors,
• if you have ulcerative colitis or Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications can worsen these conditions,
• if you are being treated with diuretics (medicines used to increase urine production) because your doctor should monitor your kidney function,
• if you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints) as it can cause aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria),
• if you have acute intermittent porphyria (a metabolic disease that affects the blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen,
• if you experience headaches after prolonged treatment, do not take higher doses of the medication,
• allergic reactions may occur with this medication,
• your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery,
• it is advisable not to take this medication if you have chickenpox.
• Treatment with ibuprofen can mask fever, which is an important sign of infection, making diagnosis difficult.
• If you have an infection; see the "Infections" section below.
• Signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuprofen Farmalider immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Infections

Ibuprofen Farmalider may hide the signs of an infection, such as fever and pain. Consequently, Ibuprofen Farmalider may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Skin reactions

Severe skin reactions have been reported with ibuprofen treatment. Stop taking ibuprofen and go to the doctor immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno Farmalider and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

It is important to use the smallest dose that relieves-controls the pain and do not take this medication for longer than necessary to control your symptoms.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses and in prolonged treatments. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking ibuprofen if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA"),
• you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are a smoker.

Similarly, these types of medications can cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Respiratory disorders

Ibuprofen should be used with caution when administered to patients who have or have a history of bronchial asthma, chronic rhinitis, or allergic diseases, as ibuprofen has been reported to cause bronchospasm, urticaria, or angioedema in such patients.

Children and adolescents

There is a risk of kidney damage in dehydrated children and adolescents.

Precautions during pregnancy and in women of childbearing age

Because the administration of ibuprofen-type medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of this medication is contraindicated.

For women of childbearing age, it should be taken into account that ibuprofen-type medications have been associated with a decrease in fertility.

In case of administration of this medication in adults

Elderly patients

Elderly patients have a higher risk of adverse events when taking NSAIDs, especially of the gastrointestinal and intestinal type. See section 4 'Possible side effects' for more information.

Patient with a history of gastrointestinal toxicity, especially elderly patients, should report any unusual abdominal symptoms (especially gastrointestinal bleeding), especially in the early stages of treatment.

Interference with laboratory tests

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after discontinuing treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values.

Tell your doctor if you are going to have a clinical analysis and are taking or have recently taken ibuprofen.

Other medications and Ibuprofen Farmalider

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication, including those obtained without a prescription.

Ibuprofen may affect or be affected by other medications. For example:

• other non-steroidal anti-inflammatory drugs such as aspirin, and other NSAID-type medications (including Cox-2 inhibitors such as celecoxib or etoricoxib), as the risk of stomach ulcers and gastrointestinal bleeding may increase,
• antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine,
• anticoagulant medications, e.g. to treat coagulation problems/prevent coagulation, (e.g. aspirin, warfarin, ticlopidine),
• cholestyramine (a medication used to treat high cholesterol), as the administration of NSAIDs with cholestyramine may delay and reduce the absorption of NSAIDs,
• selective serotonin reuptake inhibitors (used in depression),
• lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication,
• methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication,
• mifepristone (an abortion inducer): NSAIDs should not be taken in the 8-12 days following the use of mifepristone,
• digoxin and cardiac glycosides (used in the treatment of heart disorders): ibuprofen may increase the plasma concentrations of these medications,
• hydantoins such as phenytoin (used in the treatment of epilepsy),
• sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections),
• corticosteroids (such as cortisone and prednisolone), as they may increase the risk of gastrointestinal bleeding or ulcers,
• diuretics (medicines used to increase urine production), as they may increase the risk of kidney toxicity,
• pentoxifylline (used to treat intermittent claudication),
• probenecid (used in patients with gout or with penicillin in infections) and sulfinpyrazone (for gout),
• quinolone antibiotics such as norfloxacin,
• sulfinpyrazone (for gout),
• sulfonylureas such as tolbutamide (for diabetes), as it may cause hypoglycemia,
• tacrolimus or cyclosporin (used in organ transplants to prevent rejection),
• zidovudine (a medication against the AIDS virus),
• medications that lower high blood pressure (ACE inhibitors such as captopril, beta blockers such as atenolol, and angiotensin II receptor antagonists such as losartan),
• thrombolytics (medications that dissolve blood clots),
• aminoglycoside antibiotics such as neomycin,
• Ginkgo biloba tree extracts,
• baclofen (used to treat involuntary and persistent muscle contractions),
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluticonazole (used to treat fungal infections), as these medications may increase the exposure to NSAIDs,
• tacrine (a medication for Alzheimer's disease).

Other medications may also affect or be affected by treatment with ibuprofen. Therefore, you should always consult your doctor or pharmacist before using ibuprofen with other medications.

Taking Ibuprofen Farmalider with food, drinks, and alcohol

It is recommended to take this medication with milk or with food, or immediately after eating, to reduce the possibility of stomach upset.

It is not recommended to drink alcohol during treatment, as it increases the risk of gastrointestinal side effects.

Pregnancy, breastfeeding, and fertility

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

Pregnancy

Ibuprofen should not be taken during pregnancy, especially during the third trimester (see section precautions during pregnancy and in women of childbearing age).

Breastfeeding

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding. Normally, it is not necessary to interrupt breastfeeding during short-term treatment with the recommended dose for pain and fever.

Female fertility

Ibuprofen belongs to a group of medications (NSAIDs) that may affect female fertility. This effect is reversible upon discontinuation of the medication. Avoid taking this medication if you are trying to get pregnant.

Driving and using machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, do not drive or use hazardous machinery.

If you only take one dose of the medication or take it for a short period, it is not necessary to take special precautions.

Ibuprofen Farmalider contains maltitol liquid (E965) and sodium

This medication contains maltitol liquid. If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medication.

Patients on low-sodium diets should note that this medication contains 3.58 mg (0.16 mmol) of sodium per milliliter.

3. How to take Ibuprofeno Farmalider

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

Your doctor will indicate the duration of treatment with this medication. Do not stop treatment before, as the expected results will not be obtained. Similarly, do not use this medication for longer than indicated by your doctor.

It is essential to use the smallest dose that relieves/controls the pain and should not take this medication for longer than necessary to control symptoms.

The effective lowest dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Use in children

The recommended dose of ibuprofen depends on the child's age and weight. As a general rule, the recommended daily dose is 20 to 30 mg of ibuprofen per kg of the child's weight, divided into three or four individual doses every 6-8 hours. It is recommended not to exceed the maximum daily dose of 40 mg of ibuprofeno per kg of weight. The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours.

The recommended dose in case of pain and fever is:

*The use of this medication in children under 2 years will always be by medical prescription

It is not recommended to use in children under 3 months or with a weight less than 5 kg.

In infants between 3 and 5 months with more than 5 kg of weight

In infants from 3 to 5 months, medical attention should be sought if symptoms worsen or within a period not exceeding 24 hours if symptoms persist.

In children between 6 months and 12 years and in adolescents (under 18 years)

In children from 6 months and in adolescents, a doctor should be consulted if it is necessary to administer the medication for more than 3 days or if symptoms worsen.

Adults and adolescents (over 12 years)

A dose of 20 ml (equivalent to 400 mg of ibuprofen) will be taken every 4 or 6 hours, if necessary. The maximum daily dose for adolescents should not exceed 1,200 mg of ibuprofen in 24 hours.

Due to the amount of ibuprofen contained in this medication, the use of other more suitable presentations for treatment in adults and adolescents over 12 years is recommended.

Patients with kidney and/or liver disease

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose that has been prescribed.

Consult your doctor if during the treatment period symptoms persist or worsen.

If you think the action of this medication is too strong or weak, inform your doctor or pharmacist.

For oral administration.

Administration method with the syringe

1. Shake the bottle well.
2. Remove the cap from the bottle by pressing it down and turning it counterclockwise.
3. Insert the syringe firmly into the port (hole) located on the neck of the bottle.
4. To fill the syringe, invert the bottle. While holding the syringe, gently pull the plunger down until the suspension reaches the appropriate mark on the syringe.
5. Return the bottle to its normal position and remove the syringe from the port by gently turning it.
6. Place the end of the syringe in the child's mouth. Press the plunger slowly to release the suspension gently. Replace the cap after use. Wash the syringe with warm water and let it dry. Keep it out of sight and reach of children.

In patients with stomach discomfort, it is recommended to administer the medication during meals.

If you take more Ibuprofeno Farmalider than you should

If you accidentally take or administer a dose of ibuprofen higher than recommended, consult your doctor or pharmacist immediately or call the toxicology information service, phone 91 562 04 20, indicating the medication and the amount used. It is recommended to take the package and the prospectus of the medication to the healthcare professional.

If you have taken more Ibuprofeno Farmalider than you should, or if a child has accidentally ingested the medication, consult immediately with a doctor or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

The symptoms of overdose include nausea, vomiting, abdominal pain, (which may contain bloody stools), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

If you forget to takeor give to your childIbuprofeno Farmalider

Do not take or administer a double dose to make up for forgotten doses. If you forget to take or administer a dose, do so as soon as you remember and then take the next dose according to the previously indicated administration interval.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them.

Adverse effects can be minimized by taking the lowest dose for the shortest time necessary to relieve symptoms. You or your child may experience one of the known adverse effects of NSAIDs. In such a case, or if you have any concerns about it, stop administering/taking this medication and consult your doctor as soon as possible. Elderly patients who use this product are at a higher risk of developing problems associated with adverse effects.

The incidence of adverse effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

STOP administering or taking this medication and seek medical help immediately if you or your child experience:

• signs of intestinal bleeding, such as: severe abdominal pain, black or tarry stools, vomiting blood or dark particles that resemble ground coffee.
• signs of a very rare but severe allergic reaction, such as worsening of asthma, wheezing or unexplained breathing difficulties, swelling of the face, tongue, or throat, difficulty breathing, rapid heartbeat, decreased blood pressure that causes shock. These can occur even with the first use of this medication.
• severe skin reactionssuch as rashes that cover the entire body, peeling, blisters, or skin exfoliation.
• Red spots not elevated, in the shape of a target or circular on the trunk, often with blisters in the center, skin exfoliation, mouth, throat, nose, genital, and eye ulcers. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Inform your doctor if you experience the following adverse effects:

Common adverse effects(may affect up to 1 in 10 patients)

• Stomach problems, such as heartburn, stomach pain, and nausea, indigestion, vomiting, diarrhea, flatulence (gas), and constipation, and mild blood loss in the stomach and/or intestine that can cause anemia in exceptional cases.

Uncommon adverse effects(may affect up to 1 in 100 patients)

• It has been observed the appearance of gastritis, peptic ulcers, inflammation of the oral mucosa with ulcer formation, gastrointestinal perforations, worsening of existing intestinal disease (ulcerative colitis or Crohn's disease),
• skin redness, itching, or skin swelling, purpura (purple spots on the skin), skin reactions due to light influence,
• hypersensitivity, paresthesia (sensation of numbness, tingling, etc. more frequent in hands, feet, arms, or legs), headache, dizziness, drowsiness, insomnia, anxiety, agitation, irritability, and fatigue,
• hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa),
• hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes).

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

• Tinnitus (ringing in the ears)
• increased urea concentrations in the blood, pain in the sides and/or abdomen, blood in the urine, and fever may be signs of kidney damage (papillary necrosis),
• decrease in hemoglobin levels,
• disorientation or confusion, depression, vertigo, reversible toxic amblyopia,
• liver damage, edema (swelling caused by fluid accumulation in tissues),
• optic neuritis.

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

• esophagitis, pancreatitis, and formation of intestinal stenosis of the diaphragm type,
• very severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions that affect the skin and two or more mucous membranes and purple-colored lesions, preferably on the trunk) and toxic epidermal necrolysis/Lyell syndrome (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis), erythema multiforme (skin lesion), hair loss (alopecia),
• psychotic reactions, depression,
• high blood pressure, vasculitis,
• palpitations,
• in case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria),
• symptoms of aseptic meningitis have been observed during treatment with ibuprofen. In most cases, the patient suffered from some form of autoimmune disease (such as systemic lupus erythematosus and other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation,
• problems in the production of blood cells: decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and paleness of the skin), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. In these cases, treatment should be stopped immediately and a doctor consulted. Do not self-medicate with pain relievers or medications to reduce fever (antipyretic medications),
• severe skin infections and soft tissue complications during chickenpox infection,
• Liver failure (severe liver damage), liver damage (the first signs may be skin discoloration), especially during long-term treatment, liver failure, acute liver inflammation (hepatitis),
• heart failure, heart attack, and swelling of the face and hands (edema),
• decreased urine output and inflammation (especially in patients with hypertension or reduced kidney function), interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), acute kidney failure, and papillary necrosis (especially with prolonged use) associated with an increase in urea. If you experience any of the above symptoms or if you feel sad, stop taking this medication and consult your doctor immediately, as it may be the first signs of kidney damage or failure,
• It has been observed that the use of NSAIDs coincides with the exacerbation of inflammation-related infections. If there are signs of infection or if they worsen during the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

Frequency not known(cannot be estimated from available data)

• Respiratory tract reactivity including asthma, bronchospasm, or dyspnea
• A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).
• Widespread, red, scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking ibuprofen if you experience these symptoms and seek medical attention immediately. See also section 2.
• The skin becomes sensitive to light.
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines, ww.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Ibuprofeno Farmalider

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Once the package is opened, store below 25°C for a maximum of 6 months.

Do not use this medication after the expiration date that appears on the package after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE point of the pharmacy. Ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno Farmalider

• The active ingredient is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other components are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin (E-954), sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), glycerol (E-422), strawberry flavor, and purified water.

Appearance of the product and package contents

Ibuprofeno Farmalider is an oral suspension, viscous, white or almost white in color, and with a strawberry flavor. It is presented in 200 ml PET containers, with a child safety cap.

It contains a 5 ml graduated syringe

Marketing authorization holder and manufacturer

Marketing authorization holder

Farmalider, S.A.

C/ La Granja 1,

28108 Alcobendas

Madrid, Spain

Manufacturer

DELPHARM BLADEL BVIndustrieweg 1

5531 AD Bladel

Netherlands

or

ZINEREO PHARMA, S.L.UA Relva - Torneiros, s/n, O Porriño,

36410 Pontevedra

Spain

or

FARMALIDER, S.A.

c/ Aragoneses 15- Polígono Industrial Alcobendas

28108- Alcobendas

Madrid

Spain

or

FARMASIERRA MANUFACTURING S.L

Ctra de Irun Km 26,200

28700 (San Sebastian de los Reyes)

Madrid

Spain

Or

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117,

Villamarchante, 46191

Valencia

Spain

Date of the last revision of this prospectus:November2024

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