Algidrin Pediatric 40 mg/ml oral suspension

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Algidrin pediatric 40 mg/ml oral suspension

Ibuprofen (lysine)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should 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 effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

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

Algidrin pediatric belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). The active ingredient in this medicine, ibuprofen, is presented in the form of a soluble salt, ibuprofen (lysine), which 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.

2. What you need to know before taking Algidrin paediatric

Do not take Algidrin paediatric:

• 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). Signs of allergy may include itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties, or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
• If you are vomiting blood.
• If you have black stools or diarrhoea with blood.
• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If anticoagulants must be used simultaneously, your doctor will perform blood coagulation tests.
• If you have severe dehydration (caused by vomiting, diarrhoea, or insufficient fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions:

Allergic reactions to ibuprofen, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain, have been reported. Stop using Algidrin paediatric immediately and contact your doctor or emergency services right away if you notice any of these symptoms.

Consult your doctor or pharmacist before starting this medicine if:

• You have oedema (fluid retention).

• You have or have had heart problems or high blood pressure.

• You have asthma or any other respiratory disorder.

• You have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks). In such cases, your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be done.

• You have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

• This risk is higher with high doses and long-term treatment, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider adding a stomach-protective medicine.

• You are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicilic acid. You should also mention the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.

• You have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhoea) or ulcerative colitis, as ibuprofen-type medicines may worsen these conditions.

• You are taking diuretics (medicines to increase urine production), as your doctor needs to monitor kidney function.

• You have systemic lupus erythematosus (a chronic disease affecting the immune system that can involve vital organs, the nervous system, blood vessels, skin, and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.

• You have acute intermittent porphyria (a metabolic disorder affecting the blood, which may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether ibuprofen treatment is appropriate.

• You have headaches after prolonged treatment and should not take higher doses of the medicine.

• Allergic reactions may occur with this medicine.

• Your doctor will monitor you more closely if you receive ibuprofen after major surgery.

• It is advisable not to take this medicine if you have chickenpox.

• If you have an infection, see the section “Infections” below.

Infections

Ibuprofen may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin bacterial infections associated with chickenpox. If you take this medicine during an infection and infection symptoms persist or worsen, consult a doctor immediately.

Cardiovascular precautions:

Anti-inflammatory/analgesic medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

Discuss your treatment with your doctor or pharmacist before taking this medicine if:

• You have heart problems, including heart failure, angina (chest pain), a history of heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked arteries), or any type of stroke (including "mini-stroke" or transient ischaemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

In addition, these medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Serious skin reactions have been reported with ibuprofen, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP). Stop treatment with this medicine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Children and adolescents

Do not give this medicine to children under 3 months of age.

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

Precautions during pregnancy and in women of childbearing age

Because the use of ibuprofen-type medicines has been associated with an increased risk of congenital malformations or miscarriage, their use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should be kept to a minimum (see section on pregnancy, breastfeeding, and fertility).

In the third trimester, the use of this medicine is contraindicated.

For women of childbearing age, it should be noted that ibuprofen-type medicines may reduce fertility.

Other medicines and Algidrin paediatric

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Algidrin paediatric may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulcer and bleeding.
• Antiplatelet agents (which prevent blood clot formation in blood vessels), such as ticlopidine.
• Anticoagulant medicines, e.g., for treating coagulation disorders or preventing blood clots (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Cholestyramine (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 need to adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may need to adjust the dose of this medicine.
• Mifepristone (an abortion-inducing agent).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone (anti-inflammatory and immunosuppressive medicines).
• Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in gout patients or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycaemia.
• Tacrolimus or cyclosporine (used in organ transplantation to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medicines may also interact with or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using Algidrin paediatric with other medicines.

Taking ibuprofen may alter the following laboratory tests:

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

Inform your doctor if you are scheduled for clinical testing and are currently taking or have recently taken ibuprofen.

Taking Algidrin paediatric with food, drinks, and alcohol:

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

Pregnancy, breastfeeding, and fertility

The use of this medicine is not recommended in women 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 delivery complications. It may cause kidney and heart problems in the fetus. It may affect your labour and your baby’s, causing it to start later or last longer than expected. You should not take ibuprofen during the first 6 months of pregnancy unless absolutely necessary and prescribed by your doctor. If treatment is needed during this period or while trying to conceive, the lowest effective dose should be used 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, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

During breastfeeding, prolonged use of this medicine is not recommended, as small amounts of ibuprofen may pass into breast milk.

Driving and use of machines:

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, do not drive or operate dangerous machinery. If you take only a single dose or use the medicine for a short period, special precautions are generally not required.

Ibuprofen may slow your reaction time, which should be considered before engaging in activities requiring high alertness, such as driving or operating machinery.

This is especially relevant when combined with alcohol.

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

This medicine contains maltitol (E-965). If your doctor has diagnosed you with intolerance to certain sugars, consult 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 diagnosed you (or your child) with intolerance to certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic condition in which fructose cannot be broken down, consult your doctor before taking this medicine.

This medicine contains methylparahydroxybenzoate (E-218), ethylparahydroxybenzoate (E-214), and propylparahydroxybenzoate (E-216), which may cause allergic reactions (possibly delayed).

This medicine contains sodium. This medicine contains less than 1 mmol of sodium per millilitre, i.e., 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 specifically advised by your doctor.

3. How to take Algidrin Pediatric

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will advise you on how long to take this medicine. Do not stop treatment earlier than indicated, as it may not have the intended effect.

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

This medicine 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 body weight. Generally, for children from 3 months up to 12 years of age, the recommended daily dose is 20 to 30 mg of ibuprofen per kg of body weight, divided into three or four doses.

The interval between doses will depend on the progression of symptoms, but must never be less than 4 hours.

Use of this medicine is not recommended in children under 3 months of age or weighing less than 5 kg.

The recommended dose for pain and fever is:

Adolescents (from 12 years of age):

The recommended dose is 10–20 ml (equivalent to 200–400 mg of ibuprofen), every 4 or 6 hours as needed, 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 than usual dose. If so, take exactly the dose prescribed by your doctor.

Consult your doctor if symptoms persist or worsen during treatment.

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

Method of administration

For accurate dosing, the packaging contains an oral graduated syringe.

1. Shake the bottle before use.
2. Unscrew the cap and insert the tip of the syringe into the hole in the pierced stopper.
3. Invert the bottle, pull the plunger of the syringe until the liquid reaches the mark indicating the required number of ml. Return the bottle to its upright position and remove the syringe.
4. Administer directly using the syringe.
5. The syringe should be washed and thoroughly dried after each use.

In patients experiencing stomach discomfort, it is recommended to administer the medicine during meals.

Adults:

Consult your doctor or pharmacist about other presentations of this medicine suitable for adult use.

If you take more Algidrin pediatric than you should:

If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to learn about the risks and receive advice on the measures to be taken.

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, involuntary eye movements, and muscle incoordination. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, 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 missed doses.

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects of this medicine are more common in people over 65 years of age.

The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

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

• Common adverse 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 stools, vomiting blood, headache, dizziness or feeling unsteady, fatigue.

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

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

Disorientation or confusion, depression, dizziness, tinnitus (ringing or noises in the ear), hearing disturbances, reversible toxic amblyopia, liver injury, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include swelling of the face, tongue and larynx, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema or severe shock), aseptic meningitis (inflammation of the meninges, the membranes protecting 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 represented a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other adverse effects include 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 pale skin), neutropenia (decreased neutrophils), agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow failure to produce various types of blood cells), hemolytic anemia (premature destruction of red blood cells). Initial symptoms are: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding and bruising.

• Very rare adverse effects (may affect up to 1 in 10,000 people): Pancreatitis, very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions in mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during chickenpox. Hepatic failure (severe liver impairment), heart failure, myocardial infarction, hypertension. Exacerbation of inflammation related to infections has been observed during use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, 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 condition in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhea).

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

A serious skin reaction known as DRESS syndrome (Drug Reaction with Eosinophilia and Systemic Symptoms) may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes and elevated eosinophils (a type of white blood cell). Generalized red, scaly rash with bumps under the skin and blisters mainly in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Algidrin pediatric if you experience these symptoms and seek immediate medical attention. See also section 2.

The skin becomes sensitive to light.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

• Allergic reactions such as skin rashes, facial swelling, wheezing or breathing difficulties.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blisters or extensive skin peeling.
• 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 arms or legs.
• Flat, non-elevated red spots, target-shaped or circular, on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, high 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 (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is an effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Algidrin pediatric

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

After opening, the container should be used within 12 months of opening.

Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Algidrin pediatric

• The active substance 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 red AC coloring agent (E-129), methylparahydroxybenzoate (E-218), ethylparahydroxybenzoate (E-214), propylparahydroxybenzoate (E-216). See section 2 Warnings and precautions.

Appearance of Algidrin pediatric and contents of the pack

Red-colored oral suspension with forest fruit flavor and aroma.

The pack contains a bottle of 100, 150 or 200 ml made of amber-colored polyethylene terephthalate (PET), with a white polyethylene cap equipped with child-resistant closure, and a translucent polyethylene seal, together with a 5 ml graduated oral dosing syringe.

It is possible that only certain pack sizes are marketed.

Marketing Authorization Holder and Manufacturer

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A.

Grassot, 16, 08025-Barcelona (Spain)

Date of the most recent revision of this leaflet: January 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/