ALGIDRIN PEDIATRIC 40 mg/mL ORAL SUSPENSION

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

Do not take Algidrin pediatric:

• If you are allergic (hypersensitive) to ibuprofen, to any other non-steroidal anti-inflammatory drug, to acetylsalicylic acid, or to any of the other components of this medicine (listed in section 6). The reactions that indicate allergy could 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 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 dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

Ibuprofen has been reported to cause signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using Algidrin pediatric immediately and contact your doctor or emergency services immediately if you notice any of these signs.

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

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have 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 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 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 ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protective medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such 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 produces, usually, bloody diarrhea) or ulcerative colitis, since medications of the ibuprofen type can worsen these conditions.
• If you are being treated with diuretics (medicines to urinate) because your doctor must monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it can 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 suffer from headaches after prolonged treatment, do not take higher doses of the medication.

• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter control if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection, see the "infections" heading later.

Infections

Ibuprofen may hide the signs of an infection, such as fever and pain. Consequently, this medicine 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 medicine while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

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 this medicine 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 "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 if you 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, 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 medicine 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 give this medicine to children under 3 months.

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

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 (see section pregnancy, lactation, and fertility).

In the third trimester, the administration of this medicine 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.

Other medicines and Algidrin pediatric

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

Algidrin pediatric may affect or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs, such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medications, e.g., to treat coagulation problems/prevent coagulation (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Colestyramine (a medicine used to lower high cholesterol levels).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (inductor of abortions).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoinas 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 (anti-inflammatory and immunosuppressive medications).
• Diuretics (medicines used to increase urine elimination), as they may increase the risk of kidney toxicity.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout)
• Sulfonylureas such as tolbutamide (for diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporin (used in organ transplantation to prevent rejection).
• Zidovudine (a medicine against the AIDS virus).
• Medicines that lower high blood pressure, such as ACE inhibitors (e.g., captopril), beta-blockers (e.g., atenolol), and angiotensin II receptor antagonists (e.g., losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Ginkgo biloba tree extracts.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole and fluticonazole (used to treat fungal infections).

Other medicines may also affect or be affected by treatment with ibuprofen. Therefore, you should always consult your doctor or pharmacist before using Algidrin pediatric with other medicines.

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for a day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen and serum creatinine and potassium concentrations (may increase).
• Liver function tests: increased transaminase values.

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

Taking Algidrin pediatric with food, drinks, and alcohol:

It is recommended to take the medicine with milk or with food, or immediately after eating, to reduce the possibility of stomach upset. Do not drink alcohol, as it may increase gastrointestinal side effects.

Pregnancy, lactation, and fertility

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

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 ability and that of your baby to make labor later or longer than expected. Do not take ibuprofen during the first 6 months of pregnancy unless it is absolutely necessary and your doctor indicates it. If you need treatment during this period or while trying to become pregnant, the lowest dose should be used for the shortest possible time. If you take it for more than a few days from the 20th week of pregnancy, ibuprofen may cause kidney problems in the fetus, which can 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.

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

Driving and using machines:

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, do not drive or use hazardous machinery. If you only take one dose of the medicine or for a short period, it is not necessary to take special precautions.

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

This applies to a greater extent to the combination with alcohol.

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

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

This medicine contains 25 mg of sorbitol (E-420)per ml. Sorbitol is a source of fructose. If your doctor has told you 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 before taking this medicine.

This medicine contains methylparaben (E-218), ethylparaben (E-214), and propylparaben (E-216)and may cause allergic reactions (possibly delayed).

This medicine contains sodium,this medicine contains less than 1 mmol of sodium per milliliter, i.e., it is essentially sodium-free.

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

3. How to take Algidrin pediatric

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

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

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

This medication is an oral suspension intended for children from 3 months of age. 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. As a general rule, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg of ibuprofeno per kilogram of body weight, divided into three or four doses.

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

The use of this medication is not recommended in children under 3 months or with a weight of less than 5 kg.

The recommended dose in case of 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 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.

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

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

Method of administration

For exact dosing, the containers contain an oral graduated syringe.

1. Shake the container before use.
2. Open the bottle and insert the end of the syringe into the hole in the perforated cap.
3. Invert the bottle, pull the syringe plunger until the liquid reaches the signal of the ml to be administered. Place the bottle in its initial position and remove the syringe.
4. Administer directly with the syringe.
5. The syringe should 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 Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount ingested, or go to the nearest hospital to find out 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.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), 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, convulsions (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing difficulties have been reported.

If you forget to take Algidrin pediatric:

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

If you forget to take a dose, take it as soon as possible. However, if the time of the next dose is near, skip the forgotten dose and take the next dose at the usual time.

If you have any other questions 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 this medication 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.

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1200 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 (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stool, vomiting blood, headache, dizziness or feeling of instability, fatigue.

• Uncommon side effects(may affect up to 1 in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, hives, purpura (purple spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, etc., more frequent in hands, feet, arms or legs), drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth sores), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities, and jaundice (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and swelling of the body), and renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with an increase in urea.

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

Disorientation or confusion, depression, vertigo, tinnitus (beats or sounds in the ear), hearing impairment, 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, and larynx, 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 are 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 paleness of the skin), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (insufficiency of the bone marrow to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, bleeding, and bruising of unknown cause.

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

• Frequency not known(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 usually produces bloody diarrhea).

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

A serious skin reaction known as DRESS syndrome (by its English acronym) 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, accompanied by fever. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Algidrin pediatric if you experience these symptoms and seek medical attention immediately. See also section 2.

The skin becomes sensitive to light.

If any of the following side effects occur, discontinue treatment and consult your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-like vomit.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Red, non-elevated, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (exfoliative dermatitis, 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. The symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Algidrin pediatric

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

Do not store above 30°C.

Once the container is opened, it must be used within the next 12 months.

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

Medications should not be disposed of through wastewater or household waste. Deposit the containers and medications you no longer need in the SIGRE Point of the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

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), betadex (E-459), sodium saccharin, sucralose (E-955), forest fruit flavor, Allura AC red colorant (E-129), methyl parahydroxybenzoate (E-218), ethyl parahydroxybenzoate (E-214), propyl parahydroxybenzoate (E-216). See section 2 Warnings and precautions.

Appearance of Algidrin pediatric and package contents

Red oral suspension with forest fruit aroma and flavor.

The container contains a 100, 150, or 200 ml bottle, made of amber-colored polyethylene terephthalate (PET), with a white polyethylene cap, provided with a child safety lock, and a translucent polyethylene plug, with a 5 ml graduated oral syringe for dosing.

It is possible that only some package sizes are marketed.

Marketing authorization holder and manufacturer

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A.

Grassot, 16, 08025-Barcelona (Spain)

Date of the last revision of this leaflet: January 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/