Algidrin 600 powder for oral suspension
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Algidrin 600 mg powder for 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 must not be given to other people, even if they have the same symptoms as you, because 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.
Contents of the leaflet
- What Algidrin is and what it is used for
- What you need to know before taking Algidrin
- How to take Algidrin
- Possible adverse effects
- How to store Algidrin
- Contents of the pack and other information
1. What Algidrin is and what it is used for
Algidrin belongs to a group of medicines called analgesics. Ibuprofen, the active substance in this medicine, is a non-steroidal analgesic, antipyretic, and anti-inflammatory agent presented in the form of a soluble salt (ibuprofen lysine).
This medicine is used for the symptomatic treatment of mild to moderate pain and non-chronic inflammatory conditions, such as headache, dental pain, postoperative pain, musculoskeletal pain, and menstrual pain.
2. What you need to know before taking Algidrin
Do not take Algidrin 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 previously had a stomach or duodenal bleed or have experienced a gastrointestinal perforation 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.
Warnings and precautions
Signs of an allergic reaction to this medicine, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported with ibuprofen. Immediately stop using Algidrin and contact your doctor or emergency services immediately if you notice any of these symptoms.
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 and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider adding a stomach-protective 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 results in bloody diarrhea) or ulcerative colitis, as this medicine may worsen these conditions.
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
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.
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), have had a 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 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).
Precautions during pregnancy and in women of childbearing age
Because administration of ibuprofen has been associated with an increased risk of congenital abnormalities or miscarriage, its use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration should 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
If you have previously suffered from kidney or liver disease.
If you have asthma or any other respiratory disorder.
In other conditions that predispose to fluid retention, ibuprofen should be administered with caution and under medical supervision. In elderly patients, patients with blood disorders, tendency to bleeding, systemic lupus erythematosus (a chronic disease affecting the immune system that can affect vital organs, the nervous system, blood vessels, skin, and joints), or mixed connective tissue disease, aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
Skin reactions
Serious skin reactions have been reported with ibuprofen, such as 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). Discontinue treatment with this medicine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in 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, ibuprofen 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 infection symptoms persist or worsen, consult a doctor without delay.
Other medicines and Algidrin
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 gastrointestinal damage, so combined therapy is not recommended.
This medicine may affect or be affected by other medicines. For example:
- Anticoagulant medicines (e.g., to treat or prevent clotting problems, e.g., acetylsalicylic acid, warfarin, ticlopidine)
- Medicines that lower 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 with food, drinks, and alcohol
This medicine can be taken regardless of meals.
Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.
Pregnancy, breastfeeding, and fertility
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).
Use of this medicine during breastfeeding is not recommended, as it passes into breast milk. Therefore, if you are breastfeeding, consult your doctor.
Use in elderly patients
Generally, dosage adjustment is not required, although in some cases a reduction may be necessary.
Use in children
Administration is not recommended for children under 12 years of age due to the dose of active ingredient it contains.
Driving and using machines
Ibuprofen may cause drowsiness or dizziness as a low-incidence adverse reaction, which could impair the ability to drive or operate machinery.
Algidrin contains cyclodextrin (betadex E-459), sucrose, and sodium.
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This medicine contains 3 g of cyclodextrin per sachet.
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This medicine contains sucrose. If your doctor has diagnosed you with 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
Follow exactly the administration instructions for this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.
The lowest effective dose should be used for the shortest time 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).
Adults
In adults and adolescents aged 14 years and older, it is recommended to take one sachet (600 mg of ibuprofen) every 6–8 hours, depending on the severity of symptoms and the course of treatment.
Generally, the recommended daily dose is 1,200 mg of ibuprofen, divided into 3 or 4 doses. In some treatments, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2,400 mg of ibuprofen in adults and 1,600 mg in adolescents aged 12 to 18 years.
Children:
This medicine is not recommended for use in children and adolescents under 14 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosage in this patient group.
Elderly patients:
Your doctor may prescribe you a lower than usual dose. If so, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.
Patients with kidney and/or liver disease:
If you have kidney and/or liver disease, your doctor may prescribe you a lower than usual dose. If so, take exactly the dose prescribed by your doctor.
Method of administration
For oral use.
Pour the contents of one sachet into half a glass of water, shake and take immediately.
Patients experiencing stomach discomfort should take the medicine during meals.
Your doctor will determine the duration of your treatment with this medicine. Do not stop treatment earlier than advised.
If you take more Algidrin than you should
If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, contact 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 obtain information about the risk and advice on the measures to take.
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 (particularly in children), weakness and dizziness, blood in the urine, chills, and breathing difficulties have been reported.
In cases of ingestion of large amounts, activated charcoal should be administered. Gastric emptying should be considered if large amounts have been ingested and within 60 minutes of ingestion.
If you forget to take Algidrin
Do not take a double dose to make up for forgotten doses.
If you forget to take your scheduled dose, take it as soon as you remember. However, if the time for your next dose is approaching, skip the missed dose and take the next dose at your 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 may have adverse effects, although not everyone experiences them.
The adverse effects observed are described below according to their 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 available data).
Gastrointestinal:
The most common adverse effects are gastrointestinal: nausea, vomiting, diarrhoea, and dyspepsia. Peptic ulcers, gastrointestinal bleeding, and perforations (in some cases fatal) have occurred uncommonly, especially in elderly patients. 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.
Rarely, oedema (fluid retention), hypertension, and heart failure (frequency not known) have been observed during treatment with this medicine.
Frequency not known: Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.
Skin
Immune system:
Very rarely, this medicine may be associated with severe blistering reactions such as Stevens-Johnson syndrome (a clinical condition affecting the skin, mucous membranes, and other internal organs) and toxic epidermal necrolysis (a skin disease characterized by the appearance of blisters and exfoliative lesions).
Hypersensitivity reactions (exaggerated immune system response), manifesting as skin rash with or without itching, and anaphylactic reaction, may occur rarely.
Bronchospasm (bronchial constriction) may very rarely occur, particularly in predisposed patients.
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 bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Algidrin 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 occur rarely. Neurological-type reactions such as depression, confusion, and dizziness may also occur.
Very rarely, aseptic meningitis (inflammation of the meninges not caused by bacteria) has been reported.
Auditory:
Tinnitus (ringing in the ears) may occur rarely.
Ocular:
Very rarely, visual disturbances such as blurred vision, decreased visual acuity, or changes in color perception may occur, which resolve spontaneously.
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:
Ibuprofen may rarely be associated with liver injury.
If any of the following adverse effects occur, stop treatment and consult your doctor immediately:
- Flat, red, target-shaped or circular spots on the trunk, often with blisters in the center, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. 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 enlarged 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, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can 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
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 (CAD). The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the Sigre Collection Point in your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Algidrin
- The active substance is Ibuprofen (lysine). Each sachet contains 600 mg of Ibuprofen (provided by 1025 mg of Ibuprofen lysine).
- The other components (excipients) are betadex (E-459), lemon flavour (containing gum arabic (E-414), ascorbic acid (E-300) and corn maltodextrin), sodium saccharin, sodium cyclamate, sodium citrate and sucrose.
Appearance of Algidrin and contents of the pack
It is presented as a white powder, packed in sachets.
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 2024
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/