ALGIDRIN INFANTIL 200 mg POWDER FOR ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Algidrin Infant 200 mg Powder for Oral Suspension

Ibuprofen (Lysine)

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Algidrin Infant and what is it used for
2. What you need to know before taking Algidrin Infant
3. How to take Algidrin Infant
4. Possible side effects
5. Storage of Algidrin Infant
6. Contents of the pack and further information

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

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

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

2. What you need to know before taking Algidrin Infant

Do not take Algidrin Infant 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.
• You have had a stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• You have worsening of an inflammatory disease of the intestines (ulcerative colitis).
• You have severe liver or kidney disease.
• You have severe heart failure.
• You are in the third trimester of pregnancy.
• This medicine is not recommended for use in children under 6 years of age or weighing less than 20 kg, due to the amount of active ingredient it contains.

Warnings and precautions

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

Gastrointestinal precautions

• If you have had or developed an ulcer, hemorrhage, 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 higher 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-protecting 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 medicine may worsen these conditions.
• It should be taken with caution if you have a history of gastrointestinal disorders due to the use of non-steroidal anti-inflammatory drugs.

Precautions with other medicines

Inform your doctor 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 hemorrhages, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.

Cardiovascular and cerebrovascular 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 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.

Similarly, this type of medication may produce fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

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

Precautions during pregnancy and in women of childbearing age

Because the administration of ibuprofen has been associated with an increased risk of congenital anomalies/abortions, its administration is not recommended 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.

In the third trimester, the administration of ibuprofen is contraindicated.

For patients of childbearing age, it should be taken into account that ibuprofen has been associated with a decrease in fertility.

Other disorders and considerations

It should be taken with caution if you have had kidney or liver disease. If you have bronchial asthma.

Skin Reactions

Severe skin reactions have been reported in association with ibuprofen treatment.

Stop taking this medicine and consult a doctor immediately if you present any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

• 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 may 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.

Other medicines and Algidrin Infant

Inform your doctor or pharmacist if you are using or have recently used any other medicine, even those obtained without a prescription, especially furosemide, thiazide diuretics, digoxin, phenytoin, lithium, methotrexate, oral hypoglycemics, insulin, zidovudine, corticosteroids, bisphosphonates, or oxypentifylline.

The use of this medicine together with salicylates, phenylbutazone, indomethacin, or other non-steroidal anti-inflammatory drugs may cause a risk of gastrointestinal lesions, so concomitant therapy is not recommended.

This medicine may affect or be affected by other medicines. For example:

• Anticoagulant medications (e.g., medications to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).

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

Taking Algidrin Infant with food, drinks, and alcohol

This medicine can be administered independently of meals; however, it is better absorbed if administered on an empty stomach or before meals. To reduce possible gastrointestinal discomfort, it can be administered during meals.

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

Use in elderly patients

This medicine is recommended for pediatric use. In the case of use in elderly patients, the dosage usually does not need to be modified, although in some cases, a reduction may be necessary.

Pregnancy, breastfeeding, and fertility

This medicine is recommended for pediatric use. In the case of use in adults during pregnancy or breastfeeding, the following aspects should be considered:

Consult your doctor or pharmacist before using any medicine.

Ibuprofen should not be taken during the third trimester (see section on precautions during pregnancy and in women of childbearing age).

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

This medicine is recommended for pediatric use. In the case of use in adults, the following aspects should be considered:

Some patients, especially those sensitive to ibuprofen, may experience drowsiness or dizziness as an adverse reaction, which may interfere with the ability to drive or operate hazardous machinery. In this case, avoid driving vehicles and/or machines.

Algidrin Infant contains cyclodextrin (betadex) (E-459), Allura Red AC (E-129), sucrose, and sodium.

-This medicine contains 1 g of cyclodextrin in each sachet.

• This medicine contains Allura Red AC (E-129), which may cause allergic reactions. It can cause asthma, especially in patients allergic to acetylsalicylic acid.

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

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

3. How to take Algidrin Infant

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

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

Children

This medicine is intended for children from 7 years of age.

The recommended dose is:

• Children weighing 20 to 28 kg (7 to 9 years): 1 sachet every 6-8 hours, with a maximum recommended dose of 3 sachets per day.
• Children weighing 29 to 40 kg (10 to 12 years): 1 sachet every 6-8 hours, with a maximum recommended dose of 4 sachets per day.
• Children and adolescents weighing more than 40 kg: 2 sachets every 6-8 hours, not exceeding the maximum daily dose of 8 sachets.

In children up to 12 years of age, the maximum daily dose is 800 mg of ibuprofen, and in adolescents from 12 years of age, 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 the dose of 40 mg of ibuprofen per kg of body weight per day.

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.

Method of administration

For oral administration.

To take this medicine, dissolve the contents of the sachet in a glass with a little water, stir, and take immediately.

Patients with stomach discomfort should take the medicine during meals.

If you take more Algidrin Infant than you should

If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, consult a doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested, to find out 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 such as drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in urine, chills, and breathing problems have been reported.

In cases of ingestion of significant amounts, activated charcoal should be administered. Gastric lavage will be considered if large amounts have been ingested and within 60 minutes following ingestion.

If you forget to take Algidrin Infant

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

If you forget a dose, take it as soon as you remember. However, if the time for the next dose is near, skip the missed dose and take the next dose at the usual time.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects observed are described below according to their frequency of presentation: very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency not known (cannot be estimated from the available data).

Gastrointestinal:

The most frequent side effects that occur with this medicine are gastrointestinal: nausea, vomiting, diarrhea, and dyspepsia. Uncommonly, peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly. Also, flatulence, constipation, heartburn, abdominal pain, gastritis, blood in stools, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have been observed (frequency not known).

Cardiovascular:

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

Rarely, edema (fluid retention), high blood pressure, and heart failure (frequency not known) have been observed in association with treatments with ibuprofen-like medications.

Skin:

Immune system:

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

Rarely, hypersensitivity reactions (exaggerated immune system reaction) may be observed, which manifest 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).

Frequency not known: a severe skin reaction known as DRESS syndrome 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 blisters located mainly in skin folds, trunk, and upper limbs, which is accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking this medicine if you present these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.

Central nervous system:

Rarely, a sensation of headache and drowsiness may be observed. Neurological reactions such as depression, confusion, and dizziness.

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

Auditory:

Rarely, ringing in the ears may appear.

Ocular:

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

Blood:

Rarely, it may lead to hematological disorders such as thrombocytopenia (decrease in platelet count), agranulocytosis (decrease in neutrophil count, a type of white blood cell), aplastic anemia (decrease in red blood cells produced by a deficit in their formation), and hemolytic anemia (decrease in red blood cells produced by premature destruction).

Hepatic:

This medicine may be associated, in rare cases, with liver damage.

Reporting 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 leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Algidrin Infantil

It does not require special storage conditions.

Once the envelope is opened, the suspension should be prepared immediately according to the instructions for use.

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

Do not use this medicine after the expiration date that appears on the packaging after (EXP). The expiration date is the last day of the month indicated.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need at the pharmacy's Sigre Point. Ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Algidrin Infantil

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

The other components (excipients) are betadex (E-459), forest fruit flavor, red allura colorant (E-129), sodium saccharin, sodium cyclamate, sodium citrate, and sucrose.

Appearance of Algidrin Infantil and Package Contents

It is presented in the form of a white powder, packaged in envelopes. When dissolved in water, the solution becomes red.

Each package contains 20 single-dose envelopes.

Marketing Authorization Holder and Manufacturer:

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A. - FARDI

Grassot, 16 - 08025-Barcelona (Spain).

Date of the Last Revision of this Prospectus:January 2021

Detailed and updated information about this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/