FIEDOSIN 20 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Fiedosin 20 mg/ml Oral Suspension

Ibuprofen

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.

This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.

• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet:

1. What is Fiedosin and what is it used for.
2. What you need to know before taking Fiedosin.
3. How to take Fiedosin.
4. Possible side effects.
5. Storage of Fiedosin.
6. Package contents and additional information.

1. What is Fiedosin and what is it used for

Fiedosin contains ibuprofen as the active ingredient. Ibuprofen belongs to a group of medications known as non-steroidal anti-inflammatory drugs (NSAIDs).

This medication is used in children from 3 months of age for the symptomatic relief of mild or moderate pain, as well as in febrile conditions.

2. What you need to know before taking Fiedosin

Do not take Fiedosin

• If you are allergic to the active ingredient, other medications in the NSAID group, aspirin, or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have a 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 (medications 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 (see section "Pregnancy and Breastfeeding").

Warnings and Precautions

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

Ibuprofen has been associated with signs of allergic reactions, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using Fiedosin immediately and contact your doctor or emergency medical services if you experience any of these symptoms.

Consult your doctor or pharmacist before starting to take Fiedosin

• If you have edema (fluid retention).
• If you have or have had heart disorders or high blood pressure.
• If you have asthma or any other respiratory disorder.
• Inform your doctor if you are already receiving treatment with this medication, as it may mask fever, which is an essential sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, drink plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure due to 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 prior warning symptoms. This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcers, and in elderly patients. In these cases, your doctor may consider associating a stomach-protecting medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like aspirin. You should also discuss the use of other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.

• 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-like medications can worsen these conditions.
• If you are being treated with diuretics (medications 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, which are the membranes 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.
• Allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is recommended not to take this medication if you have chickenpox.
• 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. Do not exceed the recommended dose or treatment duration.
• If you have an infection; see the "Infections" section below.

Infections: Fiedosin may mask the signs of an infection, such as fever and pain. Consequently, Fiedosin 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.

You should discuss your treatment with your doctor or pharmacist before taking Fiedosin 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, a family history of heart disease or stroke, or if you are a smoker.
• Additionally, this type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).
• 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 this medication and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Precautions in Elderly Patients

Elderly patients have a higher frequency of adverse reactions to NSAIDs (non-steroidal anti-inflammatory drugs), especially gastrointestinal bleeding and perforation, which can be fatal.

Respiratory Disorders

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

In the third trimester, the administration of this medication is contraindicated. 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 labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as directed 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 may lead to 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 monitoring.

For women of childbearing age, it should be noted that medications like ibuprofen have been associated with a decrease in fertility.

Interference with Laboratory Tests

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

Taking Fiedosin with Other Medications

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

The following medications may interact and should not be taken with ibuprofen without consulting your doctor:

• Aspirin or other anti-inflammatory/analgesic agents: increase the risk of gastrointestinal ulcers and bleeding.
• Antihypertensives (beta-blockers such as atenolol, ACE inhibitors such as captopril, and angiotensin II receptor antagonists such as losartan) and diuretics: NSAIDs may reduce the effect of diuretics and other antihypertensive agents. Concomitant administration of ibuprofen and potassium-sparing diuretics may cause hyperkalemia and increase the risk of renal toxicity.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulants (medications used to "thin" the blood and prevent the formation of clots) such as aspirin, warfarin, and ticlopidine.
• 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 (inducer of abortion).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonylureas such as tolbutamide (used for diabetes).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against the AIDS virus).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluticonazole (used to treat fungal infections).

Taking Fiedosin with Food, Beverages, and Alcohol

You can take it alone or with food. In general, it is recommended to take it with meals or with milk to reduce the possibility of stomach upset.

Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medication.

You should not take ibuprofen during pregnancy, especially during the third trimester (see section "Precautions during Pregnancy and in Women of Childbearing Age").

Ibuprofen and its metabolites are excreted in minimal amounts in breast milk. As no adverse effects are known in the infant, it is not usually necessary to interrupt breastfeeding during short-term use at recommended doses.

Driving and Using Machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate hazardous machinery. If you only take a single dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Fiedosin contains saccharose, yellow-orange colorant (E110), sodium propylparaben (E217), and sodium methylparaben (E219).If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication may cause allergic reactions because it contains yellow-orange colorant (E110). It may cause asthma, especially in patients allergic to aspirin.

It may cause allergic reactions (possibly delayed) because it contains sodium propylparaben (E217) and sodium methylparaben (E219).

3. How to take Fiedosin

The effective lowest dose should be used for the shortest duration 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).

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.

Use in children:

The recommended dose of ibuprofen depends on the age and weight of the child. For children from 6 months to 12 years, the recommended daily dose is 20 to 30 mg per kg of body weight, divided into three or four doses (see table). The interval between doses will depend on the evolution of symptoms, but will never be less than 4 hours.

Ibuprofen is not recommended for children under three months.

As a guide, the following dosing guideline is recommended:

Do not exceed 40 mg/kg/day of ibuprofen.

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

If symptoms worsen in children and adolescents, or if fever persists, consult a doctor.

Patients with kidney and/or liver disease

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

Form of administration

Fiedosin is an oral suspension. It can be administered directly or diluted in water.

For exact dosing, the containers contain a 5 ml oral syringe. The syringe should be cleaned and dried after each use.

1. Shake the container before use.
2. Insert the syringe into the hole in the perforated cap
3. Invert the bottle and withdraw the necessary dose
4. Administer the contents of the syringe directly into the mouth or into a spoon.
5. The syringe should be washed after each intake and can be sterilized by boiling in water or immersing it in the sterilizing solution used for baby bottles.

A burning sensation in the mouth or throat may occur with ibuprofen oral suspension; make sure you have shaken the bottle well before use.

Patients with stomach upset should take the medication during meals.

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

If you take more Fiedosin than you should

If you have taken more ibuprofen than you should or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to take the container and the prospectus of the medication to the healthcare professional.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients develop seizures. 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. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute kidney failure and liver damage may occur. Exacerbation of asthma in asthmatics is possible. Additionally, drops in blood pressure and respiratory alterations may occur.

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 Fiedosin

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

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 interrupt treatment with Fiedosin

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

4. Possible side effects

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

The side effects of medications like ibuprofen are more common in people over 65 years old.

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

Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

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

• Reddish spots, not raised, in a target or circular shape on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat ulcers, nose ulcers, genital ulcers, and eye ulcers. These serious skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, polymorphic erythema, 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. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Frequencies are established according to the following classification: very frequent (may affect more than 1 in 10 patients); frequent (may affect up to 1 in 10 patients); infrequent (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from available data).

The following side effects have been observed:

Infections and infestations:

Very rare: Exacerbation of inflammation-related infections (e.g., development of necrotizing fasciitis), coinciding with the use of non-steroidal anti-inflammatory drugs*

*Note: If signs of infection or worsening occur during treatment with ibuprofen, it is recommended to go to the doctor immediately, in case antibiotic therapy needs to be initiated.

Gastrointestinal disorders

The most frequent side effects that occur with medications like ibuprofen are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Gastrointestinal discomfort such as heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and mild gastrointestinal bleeding that can cause anemia in exceptional cases have also been observed. Infrequent: gastrointestinal ulcers, potentially with bleeding and perforation, ulcerative stomatitis, exacerbation of colitis and Crohn's disease, gastritis.

Other side effects are: Infrequent: inflammation of the oral mucosa with ulcer formation.

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

Cardiac and vascular disorders

Medications like ibuprofen may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatments with medications of the ibuprofen type.

Disorders of the skin and subcutaneous tissue

Medications like ibuprofen may be associated, in very rare cases, with 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 (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis).

Other side effects are: Frequent: skin rash. Infrequent: skin redness, itching or skin swelling, purpura (purple spots on the skin). Very rare: hair loss, polymorphic erythema (skin lesion), skin reactions due to light influence, inflammation of skin blood vessels. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox. Frequency not known: skin becomes sensitive to light.

Disorders of the immune system

Infrequent: hypersensitivity reactions with skin rash and itching, as well as asthma attacks (possibly along with a drop in blood pressure). Very rare: severe hypersensitivity reactions (these are usually characterized by swelling of the face, tongue, and larynx with bronchospasm, dyspnea, tachycardia, and hypotension that can include a potentially fatal shock).

Note: In the appearance of these symptoms, which can occur in the first use, immediate medical attention is required.

Disorders of the nervous system

Frequent: fatigue or drowsiness, headache, and dizziness or feeling of instability. Infrequent: headache, dizziness. Rare: paresthesia (sensation of numbness, tingling, prickling, etc., most frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, 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.

Psychiatric disorders

Infrequent: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability. Very rare: psychotic reactions, depression.

Disorders of the ear and labyrinth

Frequent: vertigo. Infrequent: ringing or buzzing in the ears. Rare: hearing difficulty.

Eye disorders

Infrequent: vision changes. Rare: abnormal or blurred vision.

Disorders of the blood and lymphatic system

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 can predispose to infections), pancytopenia (deficiency of red, white blood cells, and platelets in the blood), agranulocytosis (very significant 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). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

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).

Renal and urinary disorders

Very rare: edema (signs that may indicate kidney disease, which can sometimes include kidney failure); kidney tissue damage (papillary necrosis), increased serum uric acid concentration.

Hepatobiliary disorders

Medications like 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). Very rare: liver dysfunction, liver damage (particularly with long-term treatment), liver failure, acute hepatitis. Frequency not known: liver failure (severe deterioration of the liver).

General

Worsening of inflammation during infectious processes.

To date, no serious allergic reactions have been reported with ibuprofen, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

If any of the following side effects occur, stop treatment and go immediately to your doctor

• Allergic reactions such as skin rashes, swelling of the face, wheezing in the chest, or difficulty breathing.
• Vomiting blood or coffee grounds-like vomit.
• Blood in the stool or bloody diarrhea.
• Severe stomach pain.
• Blistering or significant skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Reporting of side effects

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

5. Conservation of Fiedosin

Keep this medication out of sight and reach of children.

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

No special storage conditions are required. This medication should be used within 18 months after opening.

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

6. Container content and additional information

Composition of Fiedosin

• The active ingredient is ibuprofen. Each ml of suspension contains 20 mg of ibuprofen.
• The other components are anhydrous citric acid, microcrystalline cellulose, sodium carmellose, polysorbate 80, sucrose, orange flavor, orange yellow S (E110), peach flavor, sodium propyl parahydroxybenzoate (E217), sodium methyl parahydroxybenzoate (E219), and glycerol (E422).

Appearance of the product and container content

Homogeneous suspension of orange color, sweet taste, and fruity smell.

It is presented in a 200 ml container. It includes a standard 5 ml dosing syringe (graduated in milliliters) made of polyethylene and polystyrene.

Marketing authorization holder and manufacturer

Marketing authorization holder

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Manufacturer

Laboratorios Reig Jofré, S.A.

Avda. Gran Capitá, 10.

08970 Sant Joan Despí (Barcelona)

Spain

Or

Industria Química y Farmacéutica VIR, S.A.

C/ Laguna 66-70, Polígono Industrial Urtinsa II

28923 Alcorcón (Madrid)

Spain

Date of the last revision of this prospectus: February 2025

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/