PATIENT INFORMATION LEAFLET

Algidrin pediatric40 mg/ml oral suspension

Ibuprofen (lysine)

Read this leaflet carefully before you start taking this medicine, as 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 it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What Algidrin pediatric is and for what it is used

2.What you need to know before starting to take Algidrin pediatric

3.How to take Algidrin pediatric

4.Possible side effects

5Storage of Algidrin pediatric

6.Contents of the pack and additional information

Algidrin pediatricbelongs to a group of medications callednonsteroidal anti-inflammatory drugs (NSAIDs).Ibuprofen, the active ingredient of this medication, which is presented in the form of soluble ibuprofen (lisinate), reduces fever and relieves pain and inflammation.

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

Do not take Algidrin pediátrico:

• If you are allergic (hypersensitive) to ibuprofen, to any other nonsteroidal anti-inflammatory drug, to acetylsalicylic acid, or to any of the other components of this medication (listed in section 6). The reactions that indicate an allergy may be: 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 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 an allergic reaction to this medication, such as respiratory problems, swelling of the face and neck (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 disease or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you have kidney or liver disease, are over 60 years old, or need to take the 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 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 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. You should also inform your doctor about the use of 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 condition 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 being treated with diuretics (medications to urinate) because your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition 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 disorder that affects your blood and can cause symptoms such as urine discoloration, blood in urine, or liver disease), so your doctor can assess the advisability of ibuprofen treatment.
• 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" section below.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication 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 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 this medication if:

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

Furthermore, 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 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.

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, lactation, and fertility

Due to the association of ibuprofen administration 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, lactation, 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 such as aspirin, as the risk of stomach ulcers and bleeding may increase.
• Antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants, e.g., to treat blood clotting problems (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.
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart conditions).
• 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 (anti-inflammatory and immunosuppressive medications).
• Diuretics (used to increase urine production), as they may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonureas such as tolbutamide (used for diabetes), as it 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 such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Fibrinolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: from the Ginkgo biloba tree.
• CYP2C9 inhibitors (responsible for the metabolism of many medications in the liver), such as voriconazole and flucanozole (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.

This medication 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 in blood 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, lactation, and fertility

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 time possible. 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 lactation, 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.

This medication contains the azo dye Allura AC (E-129)and may cause allergic reactions.

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

This medication 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 disorder in which the patient cannot break down fructose, consult with your doctor (or your child) before taking this medication.

This medication contains parahydroxybenzoates (E-218, E-214, and E-216)and may cause allergic reactions (possibly delayed).

This medication contains sodium,this medication contains less than 1 mmol of sodium per milliliter, which is essentially sodium-free.

This medication contains 205.2 mg of betadex (E-459, a type of cyclodextrin). Do not use in children under 2 years unless recommended by your doctor..

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

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 kg 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 of less than 5 kg.

The recommended dose for pain and fever is:

Adolescents(from 12 years old):

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 during the treatment period the symptoms persist or worsen.

If you estimate that the action 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 medication than you should, or if a child has accidentally ingested the medication, consult your 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 blood), headache, ringing in the ears, confusion, and involuntary movement of the eyes and lack of muscle coordination. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing problems have been reported.

If you forget to take Algidrin pediatric:

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

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 can 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 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, stomach 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 spots on the skin), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, or prickling sensations, more common in hands, feet, arms, or legs), drowsiness, 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 (yellowing 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 (sudden loss of kidney function), 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 (decreased red blood cells, which may manifest as difficulty breathing and pale skin), neutropenia (decreased neutrophils), 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 on 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 (severe deterioration of the liver), heart failure, myocardial infarction, hypertension. Exaggerated inflammation related to infections has been observed coinciding with the use of NSAIDs. If signs of infection or worsening of these symptoms occur during ibuprofen use, it is recommended to see a doctor as soon as possible.

- Unknown frequency(cannot be estimated from available data):

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

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

A severe skin reaction known as DRESS (by its English acronym) may occur. The symptoms of DRESS 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.

The skin becomes sensitive to light.

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

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 Medicines 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.

Do not store at a temperature above 30°C.

Once the packaging 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 packaging 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.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. 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 40 mg of ibuprofen (provided by 68 mg of ibuprofen lysine).

The other components are: purified water, microcrystalline cellulose, sodium carboxymethylcellulose, sorbitol (E-420), maltitol (E-965), beta-dex (E-459), sodium saccharin, sucralose (E-955), berry flavor, red Allura AC dye (E-129), methyl parahydroxybenzoate (E-218), ethyl parahydroxybenzoate (E-214), propyl parahydroxybenzoate (E-216). See section 2Warnings and precautions.

Appearance of Algidrin pediatric and contents of the packaging

Red oral suspension with flavor and taste of berries.

The packaging contains a 100, 150, or 200 ml amber-colored PET bottle with a white polyethylene cap, provided with a child-resistant closure, and a translucent polyethylene stopper with a 5 ml graduated syringe for oral dosing.

Only some sizes of packaging may be commercially available.

Marketing authorization holder and responsible manufacturer

Laboratorio de Aplicaciones Farmacodinámicas, S.A.

Grassot, 16, 08025-Barcelona (Spain)

Last review date of this leaflet: January 2024

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