PROSPECTO: INFORMATION FOR THE USER

Algidrin pediatric 20 mg/ml oral suspension

Ibuprofen (lysine)

Read this prospectus carefully before starting to take this medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only to you, and you must not give it to other people even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Algidrin pediatric belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). The active ingredient of this medication, ibuprofen, which is presented in the form of a soluble salt, ibuprofen (lysine), reduces fever and relieves pain and inflammation.

It is used in children from 3 months of age for the symptomatic treatment of fever and mild to moderate pain.

Do not take Algidrin pediátrico:

• If you are allergic (hypersensitive) to ibuprofen, any other nonsteroidal anti-inflammatory drug, acetylsalicylic acid, or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, 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 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 bleeding or clotting disorders or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported with ibuprofen. Stop using Algidrin pediátrico immediately and contact your doctor or emergency services if you observe any of these signs.

Consult your doctor or pharmacist before starting to take this medication.

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication 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 have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent 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 ulcer disease, and in elderly patients. In these cases, your doctor may consider associating a stomach protector medication.
• If you are taking anticoagulants (medications used to "thin" the blood) such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, or other medications that may increase the risk of bleeding such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that produces, usually, bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are taking diuretics (medications to urinate) because your doctor needs to 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 intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as red urine, bloody urine, or liver disease), so your doctor can assess the advisability or not of treatment with ibuprofen.
• 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.
• If you have an infection, see the "infections" heading below.

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.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, ibuprofen 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/analgesic medications 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 discuss your treatment with your doctor or pharmacist before taking this medication if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, 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 "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.

Additionally, 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, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofen treatment. Stop using Algidrin pediátrico immediately and seek medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children and Adolescents

Do not administer this medication to children under 3 months.

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

Pregnancy, Breastfeeding, and Fertility

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, unless strictly necessary. In these cases, the dose and duration will be limited to the minimum possible (see pregnancy, breastfeeding, and fertility section).

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

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

Other Medications and Algidrin pediátrico:

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

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

• Other nonsteroidal anti-inflammatory drugs like aspirin, which may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent the formation of blood clots in blood vessels) like ticlopidine.
• Anticoagulants, e.g., to treat blood clotting problems or prevent clotting (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Colestiramine (used to lower high cholesterol levels).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (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 cardiac glycosides (used in heart disease treatment).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids like cortisone and prednisolone (anti-inflammatory and immunosuppressive medications).
• Diuretics (used to increase urine production), which may increase the risk of kidney toxicity.
• 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), which may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplantation to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• 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).
• Aminoglycoside antibiotics like neomycin.
• Extracts of Ginkgo biloba.
• Inhibitors of CYP2C9 (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for up to a day after stopping treatment).
• Glucose levels in blood (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease)
• Urea nitrogen levels and serum creatinine and potassium levels (may increase).
• With liver function tests: increased values of transaminases.

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

Taking Algidrin pediátrico with food, drinks, and alcohol:

It is recommended to take the medication with milk or with food, or immediately after eating, to reduce the possibility of stomach discomfort. Do not take alcohol, as it may increase gastrointestinal adverse reactions.

Pregnancy, Breastfeeding, and Fertility

The use of this medication is not recommended in women trying to conceive. If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before taking this medication.

Do not take ibuprofen during the third trimester as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in the fetus. It may affect your tendency and that of your baby and make labor longer or later than expected. Do not take ibuprofen during the first 6 months of pregnancy unless absolutely necessary and indicated by your doctor. If you need treatment during this period or while trying to conceive, use the lowest dose for the shortest possible time. If taken for more than a few days after 20 weeks of pregnancy, ibuprofen may cause kidney problems in the fetus that may lead to 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 monitoring.

During breastfeeding, it is recommended not to take this medication for prolonged periods as small amounts of ibuprofen may pass into breast milk.

Driving and Operating Machinery:

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do not drive or operate hazardous machinery. If you only take a single dose of the medication or for a short period, no special precautions are necessary.

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require increased vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

Algidrin pediátrico contains the colorant Red Allura AC (E-129)which may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

Algidrin pediátrico contains Maltitol (E-965).If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Algidrin pediátrico contains 25 mg of Sorbitol (E-420)per ml. Sorbitol is a source of fructose. If your doctor has indicated that you (or your child) have an intolerance to certain sugars, or have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disease in which the patient cannot break down fructose, consult with your doctor (or your child) before taking this medication.

Algidrin pediátrico contains parahydroxybenzoates (E-218), parahydroxybenzoic acid ethyl ester (E-214), and parahydroxybenzoic acid propyl ester (E-216)which may cause allergic reactions (possibly delayed).

Follow exactly the administration instructions of this medication as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will indicate the duration of treatment with this medication. Do not discontinue treatment before the indicated time as it may not have the expected effect.

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

This medication is an oral suspension intended for children aged 3 months and older. It can be administered directly or diluted in water.

Children: The dose of ibuprofen to be administered depends on the child's age and weight. Generally, for children aged 3 months to 12 years, the recommended daily dose is 20 to 30 mg of ibuprofen per kilogram of body weight, divided into three or four doses.

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

This medication is not recommended for children under 3 months or with a weight less than 5 kg.

The following dosing schedule is recommended:

Adolescents (12 years and older):

The recommended dose is 10-20 ml (equivalent to 200-400 mg of ibuprofen), every 4 or 6 hours, if necessary, without exceeding 1200 mg of ibuprofen in a 24-hour period.

Patients with kidney and/or liver diseases:

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

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

If you estimate that the effect of this medication is too strong or too weak, inform your doctor or pharmacist.

Administration form

For an exact dosage, the containers contain an oral syringe for use.

1. Shake the container before use.
2. Remove the cap from the container and insert the tip of the syringe into the perforated cap.
3. Invert the container, pull the syringe plunger until the liquid reaches the ml mark indicating the dose to be administered. Place the container in its initial position and remove the syringe.
4. Administer directly with the syringe.
5. The syringe must be washed and dried well after each dose.

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

Adults:

Consult your doctor or pharmacist about other presentations of the medication suitable for use in adults.

If you take more Algidrin pediatric than you should:

If you have taken more Algidrin pediatric than you should, or if a child has accidentally ingested the medication, consult a doctor or pharmacist immediately or call 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.

Normally, symptoms of overdose occur 4 to 6 hours after taking ibuprofen.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain bloody mucus), gastrointestinal bleeding, diarrhea, headache, ringing in the ears, confusion, and involuntary eye movement and muscle coordination. Agitation, drowsiness, disorientation, or coma may also occur. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Additionally, there may be low blood pressure and reduced breathing.

If you forget to take Algidrin pediatric:

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

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

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects of the medicine are more common in people over 65 years old.

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

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1,200 mg of oral ibuprofen:

• Common side effects(may affect up to 1 in 10 people): Gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, heartburn, abdominal pain, bloody stools, vomiting with blood, headache, dizziness or feeling of instability, fatigue.

• Rare side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple patches on the skin), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, or prickling sensations, more common in hands, feet, arms, or legs), somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), and acute renal failure, acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

• Very rare side effects(may affect up to 1 in 1,000 people):

Disorientation or confusion, depression, vertigo, tinnitus (ringing or buzzing in the ears), auditory disturbances, reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include facial swelling, tongue swelling, laryngeal swelling, dyspnea, 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). In most cases where aseptic meningitis has been reported with ibuprofen, the patient had 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. Other side effects include thrombocytopenia, leukopenia (decreased white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (which may manifest as difficulty breathing and pale skin), neutropenia, and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), and 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, unexplained bleeding, and hematomas.

• Extremely rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, severe skin reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purple lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and skin detachment), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during varicella. Liver failure, heart failure, myocardial infarction, hypertension. Exacerbation of inflammation related to infections coinciding with the use of NSAIDs has been observed. If signs of infection or worsening of these symptoms occur during ibuprofen use, it is recommended to see a doctor as soon as possible.

Exacerbation of colitis and Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood).

Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

A severe skin reaction known as DRESS syndrome (by its English acronym) may 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 localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Algidrin pediatric if you experience these symptoms and seek medical attention immediately. See section 2.

If any of the following side effects appear, discontinue treatment and seek medical attention immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Significant blisters or peeling of the skin.
• Severe headache or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this same section).
• Swelling of the limbs or accumulation of fluid in the arms or legs.
• Flat, red patches, often with blisters in the center, on the trunk, which may be accompanied by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Store below 30°C.

Once the container is opened, it must be used within the 12 months following its opening.

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.

Medications should not be disposed of through drains or in the trash. Dispose of containers and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and unused medications. By doing so, you will help protect the environment.

Composition of Algidrin pediatric

• The active ingredient is Ibuprofen (lysine). Each ml of oral suspension contains 20 mg of ibuprofen (provided by 34 mg of ibuprofen lysine).
• The other components are: purified water, microcrystalline cellulose, sodium carboxymethylcellulose, sorbitol (E-420), maltitol (E-965), beta-cyclodextrin, sodium saccharin, sucralose (E-955), berry fruit aroma, red Allura AC dye (E-129), methyl parahydroxybenzoate (E-218), ethyl parahydroxybenzoate (E-214), propyl parahydroxybenzoate (E-216).

Appearance of the product and contents of the packaging

Red oral suspension with aroma and berry fruit flavor.

The packaging contains a 100 ml, 120 ml, or 200 ml amber-colored polyethylene terephthalate (PET) bottle with a white polyethylene cap, provided with a child-resistant closure, and a transparent polyethylene stopper with a 5 ml graduated syringe for oral dosing.

Only some packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Laboratorio de Aplicaciones Farmacodinámicas, S.A.

Grassot, 16, 08025-BARCELONA

Last review date of this leaflet: October 2024

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