Package Insert: Information for the User

Algidrin 600 mg Powder for Oral Suspension

Ibuprofen (lysine)

Read this package insert carefully before starting to take the medication, as it contains important information for you

• Keep this package insert, as you may need to read it again.
  If you have any questions, consult your doctor or pharmacist.
• This medication 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 package insert. See section 4.

1. What Algidrin is and for what it is used

2. What you need to know before starting to take Algidrin

3. How to take Algidrin

4. Possible adverse effects

5. Storage of Algidrin

6. Contents of the package and additional information

Algidrin belongs to a group of medications called analgesics. The active ingredient of this medication, ibuprofen,is an analgesic, antipyretic, and nonsteroidal anti-inflammatory agent that is presented in the form of a soluble salt (Ibuprofen lysine).

This medication is used for the symptomatic treatment of pain, of mild to moderate intensity and of non-chronic inflammatory processes, such as headache, dental pain, postoperative pain, musculoskeletal pain, and menstrual pain.

Do not take Algidrin 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.

Warnings and precautions

Signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported with ibuprofen. Stop using Algidrin immediately and contact your doctor or emergency services if you observe any of these signs.

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

Gastrointestinal precautions

Precautions with other medications

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.

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 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 are a smoker.

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

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer this medication during the first and second trimesters of pregnancy, except in cases where 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 fertile women, it should be taken into account that ibuprofen has been associated with a decrease in the ability to conceive.

Other disorders and considerations

If you have 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, a tendency to bleeding, systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), or mixed connective tissue disease, as it may cause aseptic meningitis (inflammation of the meninges, which are the membranes that protect the brain and spinal cord, not caused by bacteria).

Severe skin reactions

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with this medication and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

• If you have an infection, see the "Infections" heading below.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Therefore, it is possible that ibuprofen 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 bacterial skin infections related to varicella. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Other medications and Algidrin

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 potentiate gastrointestinal lesions, 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 treatment with this medication. Therefore, always consult your doctor or pharmacist before using it with other medications.

Taking Algidrin with food, drinks, and alcohol

This medication can be taken regardless of meals.

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

Pregnancy, lactation, and fertility

Consult your doctor or pharmacist before using any medication.

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

It is recommended to avoid using this medication during lactation, as it passes into breast milk. Therefore, if you are breastfeeding, consult your doctor.

Use in elderly patients

Generally, no modification of the dosage is required, although in some cases, a reduction in the dosage may be necessary.

Use in children

This medication is not recommended for children under 12 years due to the dose of active principle it contains.

Driving and operating machines

Ibuprofen may cause, as a low-incidence adverse reaction, drowsiness or vertigo, which may interfere with the ability to drive or operate machines.

Algidrin contains ciclodextrina (betadex E-459), tartrazina (E-102), sacarosa, and sodium.

- This medication contains 3 g of ciclodextrina in each sachet.

- This medication may cause allergic reactions because it contains tartrazina (E-102). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

- This medication contains sacarosa. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication. It may cause caries.

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

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

The effective dose should be used for the shortest time necessary to alleviate 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 14 years and older, it is recommended to take one packet (600 mg of ibuprofen) every 6-8 hours, according to the intensity of thesymptomatology and the evolution of treatment.

The recommended daily dose is 1,200 mg of ibuprofen, divided into 3 or 4 doses. In some treatments, higher doses may be needed, 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 12 to 18 years old.

Children:

This medication is not recommended for use in children and adolescents under 14 years old, as the dose of ibuprofen contained is not suitable for the recommended dosage in this group of patients.

Older adults:

Your doctor may prescribe a lower dose than usual.If so, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

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.

Empty the contents of a packet into a half glass of water, shake and take afterwards.

Patients with stomach discomfort should take the medication during meals.

Your doctor will indicate the duration of your treatment with this medication. Do not discontinue treatment before the indicated time.

If you take more Algidrin than you should

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

The symptoms of overdose may includenausea, stomach pain, vomiting (which may contain blood-stained mucus), 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.

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

If you forgot to take Algidrin

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

If you forget to take your 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 your usual time.

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

Like all medicines, this medicine can have side effects, although not everyone will experience them.All people may not suffer them.

The observed side effects 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 may occur are gastrointestinal: nausea, vomiting, diarrhea, and indigestion. With low frequency, peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Also, flatulence, constipation, heartburn, abdominal pain, gastritis, blood in stools, mouth ulcers, worsening of ulcerative colitis, and Crohn's disease have been observed (unknown frequency).

Cardiovascular:

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

Rarely, edema (fluid retention), hypertension, and heart failure (unknown frequency) have been observed in association with treatment with this medicine.

Unknown frequency: Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Cutaneous

Of the immune system:

It may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (clinical picture that affects the skin, mucous membranes, and other internal organs) and Toxic Epidermal Necrolysis (skin disease that manifests with the appearance of blisters and exfoliative lesions on the skin).

Rarely, hypersensitivity reactions (exaggerated immune system reaction) may be observed, manifesting as 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. 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 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 Algidrin 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 be observed. 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 appear.

Visual:

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

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 a deficiency in its formation), and hemolytic anemia (decreased red blood cell production due to premature destruction) may occur.

Hepatic:

Ibuprofen may be associated, in rare cases, with liver damage.

If any of the side effects listed below appear, discontinue treatment and seek immediate medical attention::

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 prospectus. You can also report them directly through the Spanish System for the 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. By doing so, you will help protect the environment.

Composition of Algidrin

• The active ingredient 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 aroma (contains tartrazine (E-102), cornstarch and corn maltodextrin), sodium saccharin, sodium cyclamate, sodium citrate, and sucrose.

Appearance of Algidrin and content of the packaging

It is presented in the form of a powder, white in color, packaged in sachets.

Each package contains 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 2024

The detailed information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/