Leaflet: information for the user

Algidrin infantil 200 mg powder for oral suspension

Ibuprofen (lysine)

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

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, 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 leaflet. See section 4.

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

2. What you need to know before taking Algidrin Infantil

3. How to take Algidrin Infantil

4.Possible adverse effects

5. Storage of Algidrin Infantil

6. Contents of the pack and additional information

Algidrin Infantil belongs to a group of medicines called analgesics. Ibuprofen lysine, the active ingredient of this medicine, is a soluble salt of ibuprofenwith analgesic, antipyretic, and anti-inflammatory action.

This medicine is used for the symptomatic treatment of fever and mild to moderate pain such as headache, toothache, post-operative pain, and musculoskeletal pain, as well as in inflammatory processes and forms of arthritis that affect pediatric populations.

Do not take Algidrin Infantil if

• You are allergic (hypersensitive) to ibuprofen, any other nonsteroidal anti-inflammatory drug, acetylsalicylic acid, or any of the other components of this medication.
• You have had a previous stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.
• You have a worsening of an inflammatory bowel disease (ulcerative colitis).
• You have severe liver or kidney disease.
• You have severe heart failure.
• You are in the third trimester of pregnancy.
• This medication is not recommended for children under 6 years old or weighing less than 20 kg, due to the dose of active ingredient it contains.

Warnings and precautions

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

Gastrointestinal precautions

• If you have had or develop a stomach or duodenal ulcer, hemorrhage, 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 and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• Inform your doctor if you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces diarrhea with blood) or ulcerative colitis, as this medication may worsen these conditions.
• You should take it with caution if you have a history of gastrointestinal alterations due to the use of nonsteroidal anti-inflammatory drugs.

Precautions with other medications

Inform your doctor if you are taking anticoagulant medications, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.

Cardiovascular and cerebrovascular precautions

Nonsteroidal anti-inflammatory medications, such as 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 (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any other 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.

This type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

If you have bleeding disorders, coagulation problems, or are being treated with anticoagulants.

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen administration with an increased risk of congenital anomalies/abortions, this medication is not recommended during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

This medication is contraindicated in the third trimester of pregnancy.

For fertile women, consider that ibuprofen has been associated with a decrease in the ability to conceive.

Other disorders and considerations

You should take it with caution if you have kidney or liver disease.If you have asthma.

Skin Reactions

Severe skin reactions associated with ibuprofen treatment have been reported.

Stop taking this medication and see your doctor immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

• 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 in skin infections related to varicella. If you take this medication while having an infection and the symptoms persist or worsen, consult a doctor without delay.

Other medications and Algidrin Infantil

Inform your doctor or pharmacist if you are using, or have recently used, any other medication, including those purchased without a prescription, especially furosemide, thiazide diuretics, digoxin, phenytoin, lithium, methotrexate, oral hypoglycemic agents, insulin, zidovudine, corticosteroids, bisphosphonates, or oxipentifilina.

The use of this medication with salicylates, phenylbutazone, indomethacin, or other nonsteroidal anti-inflammatory drugs may increase the risk of gastrointestinal damage, so concomitant therapy is not recommended.

This medication may affect or be affected by other medications. For example:

Other medications may also affect or be affected by the treatment with this medication. Therefore, always consult your doctor or pharmacist before using it with other medications.

Taking Algidrin Infantil with food, drinks, and alcohol

This medication can be taken regardless of meals, but it is better absorbed if taken on an empty stomach or before meals. To reduce possible gastrointestinal discomfort, it can be taken during meals.

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

Use in elderly patients

This medication is recommended for use in children, in cases of use in elderly patients, the usual dosage is generally not required to be modified, although in some cases it may be necessary to reduce it.

Pregnancy, breastfeeding, and fertility

This medication is recommended for use in children, in cases of use in adults during pregnancy or breastfeeding, the following aspects should be considered:

Consult your doctor or pharmacist before using any medication.

Do not take ibuprofen during the third trimester (see section on precautions during pregnancy and in fertile women).

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

This medication is recommended for use in children, in cases of use in adults, the following aspects should be considered:

Some patients, especially those sensitive to ibuprofen, may experience as a low-incidence adverse reaction, drowsiness or vertigo, which may interfere with the ability to drive or operate hazardous machinery. In this case, avoid driving vehicles and/or operating machinery.

Algidrin Infantil contains cyclodextrin (betadex) (E-459), red allura AC (E-129), sucrose, and sodium.

This medication contains 1 g of cyclodextrin in each sachet.

This medication contains red allura AC (E-129), which may cause allergic reactions. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medication contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

This medication contains less than 1 mmol (23 mg) per sachet, which is essentially "sodium-free".

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.

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

Children

This medication is intended for children aged 7 years and above.

The recommended dose is:

• Children weighing 20 to 28 kg (7 to 9 years): 1 tablet every 6-8 hours, with a maximum recommended daily dose of 3 tablets.
• Children weighing 29 to 40 kg (10 to 12 years): 1 tablet every 6-8 hours, with a maximum recommended daily dose of 4 tablets.
• Children and adolescents weighing more than 40 kg: 2 tablets every 6-8 hours, without exceeding the maximum daily dose of 8 tablets.

In children up to 12 years, the maximum daily dose is 800 mg of ibuprofen, and in adolescents 12 years and above, it is 1,200 mg of ibuprofen, divided into 3 or 4 doses.

In the treatment of juvenile arthritis, higher doses may be necessary, although it is recommended not to exceed a dose of 40 mg of ibuprofen per kg of body weight per day.

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.

Method of use

For oral administration.

To take this medication, dissolve the contents of the tablet in a glass with a little water, shake and take afterwards.

Patients with stomach discomfort should take the medication during meals.

If you take more Algidrin infantil than you should

If you have taken more medication than you should, or if a child has ingested the medication accidentally, consult a doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicological Information Service (phone 91 562 04 20) indicating the medication and the amount ingested, to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Blood in the urine, chills, and breathing difficulties have also been reported.

In cases of significant ingestion, activated charcoal should be administered. Gastric lavage may be considered if a significant amount has been ingested and within 60 minutes of ingestion.

If you forgot to take Algidrin infantil

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

If you forgot a dose, take it as soon as you remember. 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 doubts 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.Although not everyone will experience them.

The side effects observed are described below according to the frequency of presentation: 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); unknown frequency (cannot be estimated from available data).

Gastrointestinal:

The most frequent side effects that occur with this medicine are gastrointestinal: nausea, vomiting, diarrhea, and dyspepsia. With infrequent frequencypeptic ulcers, digestive bleeding, perforations (in some cases fatal),especially in the elderly. Also, flatulence, constipation, heartburn, abdominal pain, gastritis, blood in stools, mouth ulcers,exacerbation of ulcerative colitis and Crohn's disease have been observed (unknown frequency).

Cardiovascular

This medicine may be associated with a moderate increaseof the risk of suffering a heart attack ("myocardial infarction") or cerebral.

Rarely, edema (fluid retention), hypertension, and heart failure (unknown frequency) have been observed in association with treatments with ibuprofen-type medicines.

Cutaneous

Of the immune system:

This medicine may be associated, in very rare cases tosevere blistering reactions such as Stevens-Johnson syndrome (clinical condition that affects the skin, mucous membranes, and internal organs) and toxic epidermal necrolysis (cutaneous disease that manifests with the appearance of blisters and exfoliative lesions on the skin).

Rarely, hypersensitivity reactions (exaggerated immune system reaction) may occur, manifesting as a skin rash with more or less itching, and anaphylactic reaction.

Very rarely, and in any case in predisposed patients, it may lead to bronchospasm(contraction of the bronchi).

Unknown frequency: a severe skin reaction known as DRESS syndrome may occur. 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 (acute generalized pustular exanthema). Stop taking this medicine if you experience these symptoms and seek medical attention immediately. See section 2. The skin becomes sensitive to light.

Of the central nervous system:

Rarely, headache and drowsiness may occur. Neurological reactions such as depression, confusion, and drowsiness.

Very rarely, aseptic meningitis (inflammation of the meninges not caused by bacteria) has been described.

Auditory:

Rarely, tinnitus may occur.

Visual:

Very rarely, visual disturbances such as blurred vision, decreased visual acuity, or changes in color perception that resolve spontaneously may occur.

Blood:

Rarely, hematological disorders such as thrombocytopenia (decreased platelet count), agranulocytosis (decreased neutrophil count, a type of white blood cell), aplastic anemia (decreased red blood cell production due to deficiency of its formation), and hemolytic anemia (decreased red blood cell production due to premature destruction) may occur.

Hepatic:

This medicine may be associated, in rare cases toliver damage.

Communication of side effects

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

No special storage conditions are required.

Once the package is opened, prepare the suspension immediately according to the usage instructions.

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

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.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the Pharmacy Take-Back Point. Ask your pharmacist how to dispose of unused packaging and medications. This will help protect the environment.

Composition of Algidrin infantil

The active ingredient is Ibuprofen (lysine). Each sachet contains 200 mg of Ibuprofen (provided by 341.67 mg of Ibuprofen lysine).

The other components (excipients) are beta-dex (E-459), berry flavor, red allura dye (E-129), sodium saccharin, sodium cyclamate, sodium citrate, and sucrose.

Appearance of Algidrin infantil and contents of the packaging

It is presented in the form of a powder, white in color, packaged in sachets. When dissolved in water, the solution turns red.

Each packagecontains 20 single-dose sachets.

Holder of the marketing authorization and responsible for manufacturing:

Laboratorio de Aplicaciones Farmacodinámicas, S.A. - Fardi

Grassot, 16 - 08025-Barcelona (Spain).

Date of the last review of this leaflet:January 2021

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