Leaflet: information for the user

Ibuprofen Farmalid 20 mg/ml oral suspension.

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you consider that any of the side effects you experience are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist (see section 4).

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

2. What you need to know before starting to take Ibuprofen Farmalid

3. How to take Ibuprofen Farmalid

4. Possible side effects

5. Storage of Ibuprofen Farmalid

6. Contents of the pack and additional information

Ibuprofeno belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

Ibuprofeno is indicated for the treatment of fever and mild to moderate pain.

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

Do not take Ibuprofeno Farmalid

• If you are allergic (hypersensitive) to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, naproxen, etc., or any of the other components of this medication. Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach ulcer or bleeding, or have suffered a perforation of the digestive tract.

• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have a severe liver or kidney disease.
• If you have bleeding disorders or coagulation problems or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

Inform your doctor:

• If you have had or develop a stomach ulcer, bleeding, or perforation in the stomach or duodenum, which may manifest as intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcers, and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have a heart condition or high blood pressure.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for an extended 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 present symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluid and immediately contact your doctor, as ibuprofen in this case may cause kidney failure as a consequence of dehydration.
• If you are taking medications that alter blood clotting, such as anticoagulants, antiplatelet agents like aspirin, or corticosteroids and antidepressants that inhibit serotonin reuptake.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are being treated with diuretics (medications to increase urine production), as your doctor must 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 may cause aseptic meningitis.
• If you have intermittent acute porphyria (a metabolic disorder that affects your blood and can cause symptoms such as reddish urine, blood in urine, or liver disease), for your doctor to evaluate the convenience or not of treatment with ibuprofen.
• If you are receiving ibuprofen treatment, as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after undergoing major surgery.
• It is not recommended to take this medication if you have chickenpox.
• It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.
• If you have an infection; see the "Infections" section below.

Infections

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

Cardiovascular Precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibuprofeno Farmalid if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary bypass surgery, peripheral artery disease (problems with circulation 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, a family history of heart disease or stroke, or are a smoker.
• Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibuprofeno Farmalid immediately and contact your doctor or emergency medical services if you observe any of these signs.

Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Severe Skin Reactions

Severe skin reactions associated with Ibuprofeno Farmalid treatment have been reported. Stop taking Ibuprofeno Farmalid and seek medical attention immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a 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), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue Ibuprofeno Farmalid treatment and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Pregnancy and Fertility Precautions

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, administration of Ibuprofeno is contraindicated.

For women of childbearing age, it is essential to consider that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Interference with Laboratory Tests

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Serum concentrations of urea nitrogen, creatinine, and potassium (may increase)
• With liver function tests: increased values of transaminases

Inform your doctor if you are about to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Use of Ibuprofeno Farmalid with Other Medications

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including those purchased without a prescription.

Do not take ibuprofen with other analgesics without consulting your doctor.

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

• Anticoagulant medications (e.g., for treating coagulation problems/preventing coagulation, e.g., aspirin, warfarin, ticlopidine)
• Antiplatelet agents (prevent blood clot formation in blood vessels) such as ticlopidine.
• Corticosteroids like cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (used in depression).
• Other NSAIDs like aspirin.
• Lithium (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 (induces abortion).
• Digoxin and other cardiac glycosides (used to treat heart conditions).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Diuretics (medications used to increase urine production).
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics like norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas like tolbutamide (used for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan)
• Thrombolytics (medications that dissolve blood clots).
• Zidovudine (medication against HIV/AIDS).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts (from the Ginkgo biloba tree).

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

Taking Ibuprofeno Farmalid with Food and Drinks

It is recommended to take Ibuprofeno with milk or with food, or immediately after eating, to reduce the likelihood of stomach discomfort.

Pregnancy, Breastfeeding, and Fertility

Pregnancy

Consult your doctor or pharmacist before using any medication.

Do not takeIbuprofeno Farmalidif you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do not take Ibuprofeno Farmalid during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest time possible. From week 20 of pregnancy, Ibuprofeno Farmalid may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Breastfeeding

Ibuprofen passes into breast milk, but it is not necessary to stop breastfeeding during a short treatment with the recommended dose for pain and fever.

Driving and Using Machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, you should not drive or operate machinery. If you only take a single dose of ibuprofen or for a short period, you do not need to take special precautions.

Important Information about Some Components of Ibuprofeno Farmalid

This medication may cause headaches, stomach discomfort, and diarrhea because it contains glycerol (E-422).

This medication contains maltitol syrup (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

It may cause a mild laxative effect because it contains 0.25 g of maltitol syrup per ml.

Caloric value: 2.3 kcal/g of maltitol/isomaltase

Follow exactly the administration instructions for ibuprofen Farmalid indicated by your doctor.

Consult your doctor or pharmacist if you have doubts.

Remember to take your medication.

The effective dose should be the lowest dose necessary to relieve symptoms. If you have an infection, consult a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Ibuprofeno Farmalid is an oral suspension for administration.

The containers contain an oral dosing device. First, you must shake the solution, then the dosing device is inserted into the perforated cap, the bottle is inverted, the plunger is pulled until the liquid reaches the prescribed amount by the doctor, the bottle is returned to its initial position, and the dosing device is removed. The dosing device must be disassembled, washed, and dried.

Patients with stomach discomfort should take the medication with milk and/or during meals.

Children:

The dose of ibuprofen to be administered depends on the child's age and weight. Generally, the recommended daily dose is 20 to 30 mg/kg of body weight, divided into three or four individual doses (see table). It is recommended not to exceed the maximum daily dose of 40 mg/kg of body weight of ibuprofen.

It is not recommended to use this medication in children under 3 months.

The interval between doses will depend on the evolution of symptoms, but it will never be less than 4 hours.

However, as a guideline, the following dosing schedule is recommended:

Adults and adolescents:

Due to the amount of ibuprofen contained in Ibuprofeno Farmalid, it is recommended to use other presentations more suitable for ibuprofen treatment in adults and adolescents (over 12 years). The recommended dose is 20 ml 3 to 4 times a day (equivalent to 1200-1600 mg of ibuprofen/day), as long as symptoms persist.

Senior patients:

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, you can only increase the dose once your doctor has confirmed that you tolerate the medication well.

Patients with renal or hepatic insufficiency:

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

Your doctor will indicate the duration of treatment with Ibuprofeno. Do not stop treatment before, as this will not achieve the expected results.

Similarly, do not use Ibuprofeno for longer than indicated by your doctor.

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

If you take more Ibuprofeno Farmalid than you should

If you have taken more Ibuprofeno Farmalid than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

Mild symptoms of an overdose are: abdominal pain, nausea, vomiting, indifference, sleepiness, headache, rapid involuntary eye movements, ringing in the ears, and muscle coordination problems.

It is rare for more severe symptoms to appear, such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, seizures, kidney function impairment, coma, adult respiratory distress, and transient cessation of breathing in children (after ingesting large amounts).

If a severe intoxication has occurred, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered.

Stomach emptying will be considered if significant amounts have been ingested and within 60 minutes of ingestion.

If you forget to take Ibuprofeno Farmalid

Do not take a double dose to compensate for the missed dose.

If you forget to take your dose, take it as soon as you remember. However, if the next dose is due soon, skip the missed dose and take the next dose at its usual time.

Like all medications, Ibuprofen may have side effects, although not everyone will experience them.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

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

Side effects of medications such as ibuprofen are more common in people over 65 years old.

Frequencies are established according to the following classification: very common (in more than 1 in 10 patients); common (between 1 and 10 in 100 patients); uncommon (between 1 and 10 in 1,000 patients); rare (between 1 and 10 in 10,000 patients); very rare (in less than 1 in 10,000 patients); frequency unknown (cannot be estimated from available data).

The following side effects have been observed related to the use of Ibuprofen.

Gastrointestinal:

The most common side effects that occur with medications such as Ibuprofen are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other side effects are: Uncommon: inflammation of the buccal mucosa with the formation of ulcers.

Rare: esophageal inflammation, esophageal stricture (esophageal stenosis), exacerbation of intestinal diverticulum disease, non-specific hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: pancreatitis

Cardiovascular:

Medications such as Ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or cerebral stroke. Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medications of the type Ibuprofen. Unknown frequency: chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Cutaneous:

Medications such as ibuprofen may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and epidermal detachment).

Other side effects are: Common: skin rash. Uncommon: skin redness, itching, or swelling, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesion), light-sensitive skin reactions, inflammation of skin blood vessels. Exceptionally, severe skin infections and complications in soft tissue during chickenpox may occur. Unknown frequency: a severe skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). A generalized red scaly rash, with bumps under the skin and localized blisters, mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular exanthema). Stop taking Ibuprofen Farmalid if you experience these symptoms and seek medical attention immediately. See section 2

The skin becomes sensitive to light.

Immune system:

Uncommon: transient edema in areas of the skin, mucous membranes, or sometimes in internal organs (angioedema), nasal mucosa inflammation, bronchospasm (bronchi constriction that prevents air from reaching the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue, and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may occur. Very rare: joint pain and fever (lupus erythematosus).

Central nervous system:

Common: fatigue or drowsiness, headache, dizziness, or feeling unsteady. Rare: paresthesia (numbness, tingling, or prickling sensation, more common in hands, feet, arms, or legs). Very rare: aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. Symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Uncommon: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Common: vertigo. Uncommon: ringing or buzzing in the ears. Rare: hearing difficulty.

Ocular:

Uncommon: vision disturbances. Rare: abnormal or blurred vision.

Hematologic:

Rare: 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 pale skin), decreased granulocytes (a type of white blood cell that may predispose to infections), pancytopenia (deficiency of red and white blood cells and platelets in the blood), agranulocytosis (very large decrease in granulocytes), aplastic anemia (insufficiency of the bone marrow to produce different types of cells) or hemolytic anemia (premature destruction of red blood cells).

Initial symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, nasal and cutaneous hemorrhage. Very rare: prolonged bleeding time.

Renal:

Based on the experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (characterized by protein in the urine and body swelling), and renal insufficiency (sudden loss of kidney function) cannot be ruled out.

Hepatic:

Medications such as ibuprofen may be associated, in rare cases, with liver damage. Other rare side effects are: hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes). Unknown frequency: liver insufficiency (severe deterioration of the liver).

General:

Worsening of inflammation during infectious processes.

Until the present date, no severe allergic reactions have been reported with Ibuprofen, although they cannot be ruled out. Manifestations of this type of reaction may include fever, skin rash, abdominal pain, severe headache, nausea, vomiting, facial swelling, tongue, and larynx swelling, difficulty breathing, asthma, palpitations, hypotension, or shock.

If any of the following side effects appear, interrupt treatment and seek immediate medical attention:

- Allergic reactions such as skin rash, facial swelling, chest tightness, or difficulty breathing.

- Vomiting blood or coffee ground-like vomit.

- Blood in stools or bloody diarrhea.

- Severe stomach pain.

- Severe blistering or peeling of the skin.

- Severe headache or persistent headache.

- Yellowing of the skin (jaundice).

- Signs of severe hypersensitivity (see above in this same section).

- Swelling of the limbs or accumulation of fluid in the arms or legs.

- Reddish spots not elevated, in the form of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and symptoms similar to the flu [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

- Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

- Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not mentioned in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use this medication after the expiration date that appears on the packaging after

CAD. The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at your local SIGRE collection point at your usual pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications.

By doing so, you will help protect the environment..

Composition of Farmalid Ibuprofen.

• The active ingredient is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other components (excipients) are: glycerol (E-422), maltitol syrup (E-965), microcrystalline cellulose, xanthan gum, anhydrous citric acid, sodium citrate, sodium benzoate (E-211), polisorbate 80, sodium saccharin, orange essence, and purified water

Appearance of the product and contents of the package

The medicine, after being shaken, will result in a white suspension with an orange odor.

It is presented in a 200 ml bottle and includes a 5 ml dosing syringe.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Farmalider, S.A

c/Aragoneses 15

28108- Alcobendas- Madrid.

Spain

Responsible for manufacturing:

Laboratorio Aldo-Unión, S.A.

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA – SPAIN

Or

Farmalider S.A.

C/ Aragoneses 2

28108 – Alcobendas, Madrid

Spain

This leaflet has been reviewed andupdated in October 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/