Algidrin Infantil 200 mg powder for oral suspension
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Algidrin Infantil 200 mg powder for oral suspension
Ibuprofen (lysine)
Read the entire 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, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it could 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.
Leaflet Contents
- What Algidrin Infantil is and what it is used for
- What you need to know before taking Algidrin Infantil
- How to take Algidrin Infantil
- Possible adverse effects
- How to store Algidrin Infantil
- Contents of the pack and other information
1. What Algidrin Infantil is and what it is used for
Algidrin Infantil belongs to a group of medicines called analgesics. Ibuprofen lysine, the active substance in this medicine, is a soluble salt of ibuprofen with analgesic, antipyretic, and anti-inflammatory properties.
This medicine is used for the symptomatic treatment of fever and mild to moderate pain, such as headache, dental pain, postoperative pain, and musculoskeletal pain, as well as in inflammatory conditions and forms of arthritis affecting the pediatric population.
2. What you need to know before taking Algidrin Infantil
Do not take Algidrin Infantil if
- You are allergic (hypersensitive) to ibuprofen, to any other non-steroidal anti-inflammatory drug (NSAID), to acetylsalicylic acid, or to any of the other components of this medicine.
- You have previously had a stomach or duodenal bleed or a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
- You suffer from 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.
- Use of this medicine is not recommended in children under 6 years of age 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 medicine.
Gastrointestinal precautions
- If 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 when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider prescribing a stomach-protecting medicine.
- Inform your doctor if you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that usually leads to bloody diarrhea) or ulcerative colitis, as this medicine may worsen these conditions.
- Use with caution if you have a history of gastrointestinal disturbances due to the use of non-steroidal anti-inflammatory drugs.
Precautions with other medicines
Inform your doctor if you are simultaneously taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
Cardiovascular and cerebrovascular precautions
Medicines such as NSAIDs/analgesics like 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.
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 have had a heart attack, bypass surgery, peripheral arterial disease (circulation problems in the legs or feet due to narrowing or blockage of arteries), or any 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.
Also, this type of medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).
If you have bleeding disorders, coagulation disorders, or are on anticoagulant therapy.
Precautions during pregnancy and in women of childbearing age
Because administration of ibuprofen has been associated with an increased risk of congenital abnormalities/abortion, its use is not recommended during the first and second trimesters of pregnancy unless
it is considered strictly necessary. In such cases, the dose and duration will be limited to the minimum possible.
Administration of ibuprofen is contraindicated during the third trimester.
For women of childbearing age, it should be noted that ibuprofen has been associated with a reduced ability to conceive.
Other disorders and considerations
Use with caution if you have had kidney or liver disease. If you suffer from bronchial asthma.
Skin reactions
Serious skin reactions have been reported with ibuprofen treatment.
Stop taking this medicine and seek medical advice immediately if you develop any skin rash, lesions of 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 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 bacterial skin infections related to chickenpox. If you take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.
Other medicines and Algidrin Infantil
Inform your doctor or pharmacist if you are currently using, or have recently used, any other medicines, including 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 increase the risk of gastrointestinal injury, and therefore combined therapy is not recommended.
This medicine may affect or be affected by other medicines. For example:
- Anticoagulant medicines (e.g., medicines to treat or prevent blood clotting, such as acetylsalicylic acid, warfarin, ticlopidine)
- Medicines 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, always consult your doctor or pharmacist before using it with other medicines.
Taking Algidrin Infantil with food, drinks, and alcohol
This medicine can be taken regardless of meals; however, it is better absorbed when taken on an empty stomach or before meals. To reduce possible gastrointestinal discomfort, it may be taken during meals.
Consumption of alcohol during treatment may increase the risk of gastrointestinal adverse reactions.
Use in elderly patients
This medicine is recommended for pediatric use. In the case of use in elderly patients, dosage adjustment is generally not required, although in some cases a dosage 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 considerations should be taken into account:
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, prolonged use of this medicine is not recommended, as small amounts of ibuprofen may pass into breast milk.
Driving and use of machines
This medicine is recommended for pediatric use. In the case of use in adults, the following considerations should be taken into account:
Some patients, especially those sensitive to ibuprofen, may experience rare adverse reactions such as drowsiness or dizziness, which may impair the ability to drive or operate dangerous machinery. In such cases, avoid driving vehicles and/or operating machinery.
Algidrin Infantil contains cyclodextrin (betadex) (E-459), Allura Red AC (E-129), sucrose, and sodium.
- This medicine contains 1 g of cyclodextrin per sachet.
- This medicine contains Allura Red AC (E-129), which may cause allergic reactions. It may provoke asthma, especially in patients allergic to acetylsalicylic acid.
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This medicine contains sucrose. If your doctor has informed you of an intolerance to certain sugars, consult him before taking this medicine. It may cause dental caries.
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This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., it is essentially "sodium-free".
3. How to take Algidrin infantil
Follow exactly the instructions for using this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The lowest effective dose should be used for the shortest possible duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).
Children
This medicine is intended for children aged 7 years and older.
Recommended dosage:
- 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 a 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 required, 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 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.
Method of administration
For oral use.
To take this medicine, dissolve the contents of the sachet in a glass of water, stir, and take immediately.
Patients experiencing stomach discomfort should take the medicine during meals.
If you take more Algidrin infantil 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, go to the nearest hospital, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested, to obtain information about the risk and advice on the measures to be taken.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in urine, chills, and breathing difficulties have been reported.
In cases of ingestion of large amounts, activated charcoal should be administered. Gastric lavage should be considered if large amounts have been ingested and within 60 minutes of ingestion.
If you forget to take Algidrin infantil
Do not take a double dose to make up for missed doses.
If you forget a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at your usual time.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may have adverse effects, although not everyone experiences them.
The adverse effects observed are described below according to frequency of occurrence: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from the available data).
Gastrointestinal:
The most common adverse effects with this medicine are gastrointestinal: nausea, vomiting, diarrhoea, and dyspepsia. Peptic ulcers, gastrointestinal haemorrhages, and perforations (in some cases fatal), especially in the elderly, have occurred uncommonly. Also observed (frequency not known) are flatulence, constipation, heartburn, abdominal pain, gastritis, blood in stools, mouth ulcers, and worsening of ulcerative colitis and Crohn's disease.
Cardiovascular:
This medicine may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.
Oedema (fluid retention), hypertension, and heart failure (frequency not known) have rarely been observed in association with treatments using medicines of the ibuprofen type.
Dermatological:
Immune system:
This medicine may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson Syndrome (a clinical condition affecting the skin, mucous membranes, and internal organs) and toxic epidermal necrolysis (a skin disease characterized by the appearance of blisters and exfoliative skin lesions).
Hypersensitivity reactions (exaggerated immune system response), manifesting as skin rash with or without itching, and anaphylactic reaction, have rarely been observed.
Very rarely, and in any case only in predisposed patients, it may cause bronchospasm (contraction of the bronchi).
Frequency not known: a serious skin reaction known as DRESS syndrome 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 nodules under the skin and blisters located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking this medicine if you experience these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.
Central nervous system:
Headache and drowsiness may rarely occur. Neurological-type reactions such as depression, confusion, and dizziness may also be observed.
Very rarely, aseptic meningitis (inflammation of the meninges not caused by bacteria) has been reported.
Auditory:
Tinnitus (ringing in the ears) may rarely occur.
Ocular:
Visual disturbances such as blurred vision, decreased visual acuity, or changes in color perception that resolve spontaneously may very rarely be observed.
Blood-related:
Rarely, haematological disorders such as thrombocytopenia (decreased platelet count), agranulocytosis (decreased neutrophil count, a type of white blood cell), aplastic anaemia (decreased red blood cells due to impaired production), and haemolytic anaemia (decreased red blood cells due to premature destruction) may occur.
Hepatic:
This medicine may, rarely, be associated with liver injury.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Algidrin infantil
No special storage conditions are required.
Once the sachet has been opened, the suspension must 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 expiry date stated on the packaging after (EXP). The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the Sigre Point located at the pharmacy. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Algidrin infantil
The active substance is Ibuprofen (lysine). Each sachet contains 200 mg of Ibuprofen (provided by 341.67 mg of Ibuprofen lysine).
The other components (excipients) are betadex (E-459), forest fruit flavour, Allura red dye (E-129), sodium saccharin, sodium cyclamate, sodium citrate and sucrose.
Appearance of Algidrin infantil and contents of the pack
It is presented as a white powder, packed in sachets. When dissolved in water, the solution becomes red.
Each pack contains 20 single-dose sachets.
Marketing Authorization Holder and Manufacturer:
LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A. - FARDI
Grassot, 16 - 08025-Barcelona (Spain).
Date of the most recent review of this leaflet: January 2021
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/