IBUPROFEN (ARGININE) FARMALIDER 200 MG ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Ibuprofen (arginine) Farmalider 200 mg granules for oral solution

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

Follow the instructions for administration of the medicine contained in this leaflet or as indicated by your doctor, pharmacist, or nurse.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve, if the fever persists for more than 3 days or the pain for more than 5 days.

Contents of the Package Leaflet

1. What is Ibuprofen (arginine) Farmalider and what is it used for
2. What you need to know before taking Ibuprofen (arginine) Farmalider
3. How to take Ibuprofen (arginine) Farmalider
4. Possible side effects
5. Storage of Ibuprofen (arginine) Farmalider
6. Package Contents and Additional Information

1. What is Ibuprofen (arginine) Farmalider and what is it used for

Ibuprofen, the active ingredient of this medicine, acts by reducing pain and fever.

It is indicated in adults and children over 8 years for the symptomatic relief of mild or moderate occasional pain, such as headaches, dental pain, menstrual pain, muscle pain (cramps) or back pain (lumbago), as well as in febrile states.

2. What you need to know before taking Ibuprofen (arginine) Farmalider

Do not take Ibuprofen (arginine) Farmalider

• If you are allergic (hypersensitive) to ibuprofen, other non-steroidal anti-inflammatory medicines (NSAIDs), aspirin, or any of the other ingredients of Ibuprofen (arginine) Farmalider. Allergic reactions may include: 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 had a stomach or duodenal ulcer or have suffered 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 coagulation 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 coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and Precautions

You should consult your doctor, pharmacist, or nurse 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.
• Inform your doctor if you are receiving treatment with Ibuprofen (arginine) Farmalider, as it may mask fever, which is an important sign of infection, making diagnosis difficult.
• 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.
• If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.

This risk is greater when high doses and prolonged treatments are used, in patients with a history of peptic ulcers, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medicine.

• If your doctor has prescribed an antiplatelet aggregant medication(to prevent the formation of blood clots) that contains acetylsalicylic acid, and you also take Ibuprofen (arginine) Farmalider, you should separate the intake of both medications. To do this, you can follow either of the following guidelines:

• Take the dose of acetylsalicylic acid and wait at least half an hourbefore administering the dose of oral ibuprofen.
• Take the dose of oral ibuprofen at least 8 hours beforeadministering acetylsalicylic acid.

• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet aggregants of the acetylsalicylic acid type. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have 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), as 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 may 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 your 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.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter control if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• If you have an infection; see the "Infections" section below.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofeno (arginina) Farmalider immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Infections

Ibuprofeno (arginina) Farmalider may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofeno (arginina) Farmalider may delay the appropriate treatment of the infection, which can 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.

It is important that you 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 suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofeno (arginina) Farmalider 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 are a smoker.

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

Skin Reactions

Severe skin reactions have been reported with Ibuprofeno (arginina) Farmalider. Stop taking Ibuprofeno (arginina) Farmalider and consult your 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 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno (arginina) Farmalider and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

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 ibuprofen 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.

Interference with Analytical Tests:

If you are going to undergo any diagnostic test (including blood tests, urine tests, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Use of Ibuprofeno (arginina) Farmalider with Other Medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Ibuprofeno (arginina) Farmalider may affect or be affected by other medications. For example:

• Other non-steroidal anti-inflammatory medicines, such as aspirin.
• Antiplatelet aggregants (prevent the formation of blood clots) such as ticlopidine.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Baclofen (used to treat involuntary and persistent muscle contractions)
• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate (to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (inducer of abortions).
• Digoxin and other cardiotonic glycosides (used in the treatment of heart disorders).
• 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.
• Diuretics (medicines used to increase urine production).
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group such as norfloxacin.
• Ion exchange resins such as cholestyramine (used to decrease blood cholesterol levels)
• Sulfinpyrazone (for gout).
• Oral hypoglycemic agents (sulfonylureas) such as tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease)
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (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.
• Herbal extracts: Ginkgo biloba tree.

If your doctor has prescribed an antiplatelet aggregant medication(to prevent the formation of blood clots) that contains acetylsalicylic acid, and you also take Ibuprofeno (arginina) Farmalider, you should separate the intake of both medications (see the section Be especially careful with Ibuprofeno (arginina) Farmalider).

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

Taking Ibuprofeno (arginina) Farmalider with Food, Beverages, and Alcohol:

Ibuprofeno (arginina) Farmalider can be taken alone or with food. In general, it is recommended to take it during meals or with milk to reduce the possibility of stomach upset.

Do not administer ibuprofen with alcohol to avoid damaging the stomach.

The use of ibuprofen in patients who habitually consume alcohol (three or more alcoholic beverages - beer, wine, liquor... per day) may cause stomach bleeding.

Pregnancy, Breastfeeding, and Fertility

Consult your doctor or pharmacist before using any medication.

Do not take ibuprofen if 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 and your baby's ability to bleed and delay or prolong delivery more than expected. Do not take ibuprofen 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 possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of amniotic fluid 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 women should consult their doctor or pharmacist before taking this medication. Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

IMPORTANT FOR WOMEN:

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. The use of medications during pregnancy can be dangerous for the embryo or fetus and should be monitored by your doctor.

Driving and Use of Machines:

Although it is not expected to have effects in this sense, if you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or use hazardous machinery. If you only take one dose of Ibuprofeno (arginina) Farmalider or for a short period, it is not necessary to take special precautions.

Ibuprofeno (arginina) Farmalider contains aspartame, phenylalanine, and sodium

Patients on low-sodium diets should note that this medication contains 5.81 mg of sodium per dose.

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

This medication contains sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Ibuprofen (arginine) Farmalider

Follow the administration instructions for this medication exactly, unless your doctor has indicated otherwise. Consult your doctor or pharmacist if you have any doubts.

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

The normal dose is:

• Adults and adolescents from 12 years: take a dose of 200 mg every 4 or 6 hours, if necessary. If pain or fever does not respond to a dose of 200 mg, doses of 400 mg every 6 or 8 hours can be used (in adolescents with a weight over 40 kg).

Do not take more than 1200 mg in 24 hours.

• Patients with kidney, liver, or heart disease: reduce the dose and consult a doctor.

Always use the lowest effective dose.

Use in children

• Children from 8 to 12 years: 1 sachet (200 mg of ibuprofen) every 6 or 8 hours if necessary. Do not take more than 4 sachets (800 mg of ibuprofen) in 24 hours.

Do not administer to children under 8 years without consulting a doctor.

Use in people over 65 years

• People over 65 years: the amount to take should be established by the doctor, as it may be necessary to reduce the usual dose.

Elderly people are more likely to experience adverse effects, so the dose may need to be reduced. Consult your doctor.

Method of administration:

This medication is administered orally.

Take the medication with meals or with milk, especially if you notice digestive discomfort.

Dissolve the granulate from the sachet in a glass of water and stir until it dissolves.

Administration of this preparation is subject to the appearance of pain or fever. As these disappear, the medication should be suspended.

If symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days, consult a doctor.

If you take more Ibuprofen (arginine) Farmalider than you should:

If you have taken more Ibuprofen than you should, consult your doctor or pharmacist immediately, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medication and the amount ingested. It is recommended to take the packaging and the prospectus of the medication to the healthcare professional.

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), 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 a severe poisoning has occurred, the doctor will take the necessary measures.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric lavage will be considered if significant amounts have been ingested and within 60 minutes after ingestion.

If you forget to take Ibuprofen (arginine) Farmalider

Do not take a double dose to make up for the forgotten dose.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

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

4. Possible adverse effects

Like all medications, Ibuprofen (arginine) Farmalider can have adverse effects, although not all people experience them.

Adverse effects of medications like Ibuprofeno (arginina) Farmalider are more common in people over 65 years.

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

Stop treatment with ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Reddish spots, not raised, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, 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, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Frequent (may affect up to 1 in 10 patients): fatigue, headache, stomach and intestine disorders (heartburn, diarrhea, nausea, vomiting), skin disorders (rash, itching), and ringing in the ears.

Uncommon (may affect up to 1 in 100 patients): allergic reactions, asthma, rhinitis, and hives, gastrointestinal bleeding and ulcers, sleep disturbances and mild restlessness, blurred vision, decreased visual acuity, or changes in color perception, and hearing disturbances.

Rare (may affect up to 1 in 1,000 patients): edema (swelling due to fluid retention), blood disorders (leukopenia), stomach and intestine perforation, liver disorders (including jaundice), kidney disorders consisting of acute interstitial nephritis with hematuria (blood in urine), proteinuria (protein elimination in urine), and occasionally nephrotic syndrome; depression, vision disorders (vision loss), neck stiffness, and bronchospasm (sudden feeling of suffocation), dyspnea (difficulty breathing), and angioedema (inflammation of the deep layers of the skin, which can cause swelling of the face, lips, tongue, or throat, potentially causing difficulty swallowing or breathing).

Very rare (observed in up to 1 in 10,000 patients): aseptic meningitis (inflammation of the meninges not caused by bacteria), blood and coagulation disorders (aplastic anemia and hemolytic anemia), hypertension, and heart failure, severe skin, eye, and mucous membrane disorders (erythema cutaneum), such as Stevens-Johnson syndrome (severe erythema multiforme) and toxic epidermal necrolysis (skin and mucous membrane lesions that cause skin detachment) and erythema multiforme.

Frequency "not known": a severe skin reaction known as DRESS syndrome can occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized 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 Ibuprofeno (arginina) farmalider if you experience these symptoms and seek medical attention immediately. See also section 2.

The skin becomes sensitive to light.

Reporting adverse effects

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

5. Conservation of Ibuprofen (arginine) farmalider

No special storage conditions are required.

Keep this medication out of sight and reach of children.

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

6. Package contents and additional information

Composition of Ibuprofen (arginine) Farmalider

• The active ingredient is ibuprofen. Each sachet contains 200 mg of ibuprofen as 369 mg of ibuprofen (arginine).
• The other components are: arginine, aspartame (E-951), sucrose, sodium hydrogen carbonate, sodium saccharin, sodium lauryl sulfate, mint flavor composed of flavoring components (natural flavoring preparations, natural flavoring substances, and natural-identical flavoring substances), non-flavoring components (which contain modified cornstarch (E-1450), maltodextrin, triacetin (E-1518)), and active substances (pulegone) and purified water.

Appearance of the product and package contents

Sachets with granulate for oral solution. It is presented in the form of white granulate with a characteristic mint odor, packaged in paper/aluminum/polyethylene sachets.

It is presented in packages with 20 sachets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

FARMALIDER S.A.,

c/ Aragoneses 15,

28108 Alcobendas (Madrid)

Spain

Manufacturer

Toll Manufacturing Services S.L.,

c/ Aragoneses, 2.

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this prospectus: November 2024

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