Leaflet: information for the user

Dalsydol 400 mg oral suspension

ibuprofen

Read this leaflet carefully before you start taking this medicine, as it contains important information for you

Follow exactly the administration instructions for the medicine contained in this leaflet or those indicated by your doctor, pharmacist or nurse.

• Keep this leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.
• You should consult a doctor if the fever worsens or does not improve after 3 days or the pain after 5 days (3 days in adolescents).

1. What is Dalsydol and what it is used for

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

3. How to take Dalsydol

4. Possible side effects

5. Storage of Dalsydol

6. Contents of the pack and additional information

Ibuprofen, the active ingredient of this medication, acts by reducing pain and fever.

This medication is used in adults and adolescents 12 years of age and older and weighing more than 40 kg for the symptomatic relief of occasional mild to moderate pain, such as headaches, toothaches, menstrual cramps, muscle spasms, or back pain (lumbago), as well as in febrile states.

Do not take Dalsydol:

• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6)or to other nonsteroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Allergic reactions may include:skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have had a history of stomach or duodenal ulcers or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have severe heart failure.
• If you have a severe liver or kidney disease.
• If you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood). If necessary, your doctor will perform blood clotting tests.
• If you are in the third trimester of pregnancy.
• If you have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).

Warnings and precautions

Consult your doctor or pharmacist before starting this medication.

Inform your doctor:

• If you have edema (fluid retention).
• If you have or have had any heart problems or high blood pressure.
• If you have asthma or any other respiratory problems.
• If you are receiving treatment with this medication, as it may mask fever, an important sign of infection, making its diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for an extended period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will tell you how often these checks should be done.
• If you experience symptoms of dehydration, such as severe diarrhea or vomiting, take plenty of fluids and immediately contact your doctor, as ibuprofen in this case may cause kidney failure due to dehydration.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent pain and/or black stools, or even without previous warning symptoms. This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcers and in elderly patients. In these cases, your doctor may consider adding a stomach protector medication.
• If you are taking anticoagulants (oral anticoagulants, antiplatelet agents such as aspirin), or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that typically results in bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are receiving diuretic treatment, as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic condition that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis.
• If you have intermittent acute porphyria (a metabolic disorder that affects your blood and may cause symptoms such as urine discoloration, bloody urine, or liver disease), so your doctor can assess the advisability of ibuprofen treatment.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible to experience allergic reactions with this medication.
• Your doctor will perform a more stringent check if you receive ibuprofen after undergoing major surgery.
• It is not recommended to take this medication if you have chickenpox.
• It is recommended to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.
• If you have an infection; see the "Infections" section below.
• Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Dalsydol immediately and contact your doctor or emergency medical services if you observe any of these signs.

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, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Cardiovascular Precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increased 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 (problems with circulation in the legs or feet due to narrowing or blockage of the 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.

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

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), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Stop using Dalsydol immediately and seek medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

Children and Adolescents

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

Taking Dalsydol with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

The following medications may interact and should not be taken with ibuprofen without consulting your doctor:

• Do not take this medication if you are taking other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulants (e.g., for treating blood clotting problems or preventing clotting, e.g., aspirin, warfarin).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin (cardiotonic glucosides) (used to treat heart problems).
• Hidantoins such as phenytoin (used to treat epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Diuretics (used to increase urine production).
• Corticosteroids such as cortisone and prednisolone, used in inflammatory processes.
• Selective serotonin reuptake inhibitors (SSRIs), used to treat depression.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Ion exchange resins such as cholestyramine (used to lower blood cholesterol levels).
• Sulfinpyrazone (used to treat gout).
• Sulfonureas such as tolbutamide (used to treat diabetes).
• Tacrine (used to treat Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat HIV/AIDS).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• CYP2C9 inhibitors (responsible for metabolizing numerous medications in the liver), such as voriconazole or fluconazole, used to treat fungal infections.
• Herbal extracts: from the Ginkgo biloba tree.

Other medications may also affect or be affected by ibuprofen treatment. Therefore, always consult your doctor or pharmacist before using ibuprofen with other medications.

Interference with diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

Taking Dalsydol with food, drinks, and alcohol

You can take it alone or with food. Generally, it is recommended to take it with meals to reduce the possibility of stomach discomfort.

If you consume alcohol while taking this medication, you may be more prone to experiencing adverse effects.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as your doctor indicates. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Dalsydol may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios). If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Precautions during pregnancy and in fertile women

Pregnancy

Due to the association of administering medications of this type 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 should be limited to the minimum possible.

In the third trimester, administration of this medication is contraindicated.

Fertility

For fertile women, it should be noted that medications like ibuprofen have been associated with a decrease in the ability to conceive.

Breastfeeding

Although the levels of medication in breast milk are negligible, it is recommended to consult your doctor in cases of prolonged treatment or high doses during breastfeeding.

Driving and operating machinery

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, you should not drive or operate machinery. If you only take a single dose of ibuprofen or for a short period, you do not need to take special precautions.

Dalsydol contains sodium, sodium benzoate (E-211), and maltitol liquid (E-965)

This medication contains 57.94 mg of sodium (main component of table salt/for cooking) in each sachet. This is equivalent to 2.9% of the recommended daily maximum sodium intake for an adult.

Patients with low-sodium diets should note that this medication contains 57.94 mg (2.5 mmol) of sodium per sachet.

This medication contains 10 mg of sodium benzoate (E-211) per sachet.Sodium benzoatemay increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

This medication contains maltitol liquid (E-965). If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

Follow exactly the medication administration instructions contained in this prospectus or those indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.It is essential to take the smallest dose that relieves the pain and not to take the medication for longer than necessary to control your symptoms.

It is necessary to use the most effective dose at the lowest level 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).

Dosage

Adults and adolescents (over 40 kg in weight) from 12 years old:

The recommended dose isone packet (400 mg of ibuprofen every 4-8 hours), depending on the intensity of symptoms and response to treatment. Do not take more than 3 packets (1200 mg) in 24 hours.

Older patients:

The dosage should be established by the doctor, as there is a possibility that a reduction in the usual dose may be needed. Older people are more prone to presenting adverse effects.

Patients with kidney, liver, or heart diseases:

Reduce the dose and consult the doctor. Ibuprofen should not be used in patients with severe renal, hepatic, or cardiac insufficiency.

If symptoms worsen, if fever persists for more than 3 days or pain for more than 5 days (3 days in adolescents), you must consult the doctor.

The administration of this medication is subject to the appearance of pain or fever. As these disappear, the medication should be discontinued.

Use in children and adolescents:

This medication is not recommended for use in children or adolescents with a weight of less than 40 kg.

Administration form

This medication is a suspension, administered orally.

It is necessary to homogenize the suspension immediately before taking it, as indicated in the following figure:

1 – Press with your fingers the top and bottom of the packet several times.

2 – Press from the top and bottom and vice versa for at least 30 seconds.

You can take it directly from the packet or diluted in water.

In case of digestive discomfort, it is recommended to take the medication with meals.

If you take more Dalsydol than you should

If you have taken more oral suspension than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to bring the package and the prospectus of the medication to the healthcare professional.

If you have taken more Dalsydol than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital to inform yourself 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-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. It is rare for more severe symptoms to appear, such as intestinal hemorrhage, low blood pressure, low body temperature, metabolic acidosis, seizures, kidney function impairment, coma, adult respiratory distress, and transient cessation of breathing in children (after ingesting large amounts).

If a severe intoxication has occurred, the doctor will take the necessary measures.

If you forgot to take Dalsydol

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 this medication, ask your doctor or pharmacist.

Like all medications, this medication may cause side effects, although not everyone will experience them.

The incidence of side effects is lower in short-term treatments and if the daily dose is below the maximum recommended dose.

The frequencies shown below refer to the short-term use of maximum daily doses of up to 1200 mg of oral ibuprofen:

• Frequent side effects(may affect up to 1 in 10 people):gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach burning, abdominal pain, blood in stool, vomiting with blood, dizziness or feeling of instability, fatigue.

• Less frequent side effects(may affect up to 1in 100 people): Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling, urticaria, purpura (purple patches on the skin), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, aching, etc., more common in hands, feet, arms, or legs), headache, and drowsiness, insomnia, anxiety, auditory disorders, visual disturbances, rhinitis (inflammation of the nasal mucosa), oral mucosa inflammation with ulcer formation (oral aphthae), gastrointestinal perforations, hepatitis (liver inflammation), liver function abnormalities, and jaundice (yellow discoloration of the skin and eyes), asthma, bronchospasm (difficulty breathing).

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

disorientation or confusion, depression, vertigo, tinnitus (ringing in the ears), reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis.

• Very rare side effects(may affect up to 1 in 10,000 people): Pancreatitis, severe blistering reactions including Stevens-Johnson syndrome (widespread skin and mucous membrane erosions) and toxic epidermal necrolysis (skin erosions and painful detachment of the epidermis), erythema multiforme (skin lesions). In cases of severe generalized hypersensitivity reactions, signs may include facial swelling, tongue swelling, laryngeal swelling, shortness of breath, tachycardia, hypotension (anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges, which are the membranes that protect 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 was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other very rare side effects are thrombocytopenia, leukopenia (decreased white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (decreased red blood cells, which may manifest as difficulty breathing and pale skin), neutropenia (decreased neutrophils), agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), hemolytic anemia (premature destruction of red blood cells). The first symptoms are fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, extreme fatigue, unexplained bleeding, and hematomas. Liver failure (severe deterioration of the liver), heart failure, myocardial infarction, hypertension. Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), and renal insufficiency (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

Exacerbation of colitis and Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that produces diarrhea with blood) has been observed. 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).

A generalized red scaly rash, with bumps under the skin and blisters, located mainly in skin folds, the trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema).

Stop taking Dalsydol if you experience these symptoms and seek medical attention immediately. See section 2.

The skin becomes sensitive to light.

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

• Flat, circular, or target-like red patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (generalized acute pustular exanthema).
• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Blood in stool or diarrhea with blood.
• Severe stomach pain.
• Intense or persistent headache.
• Yellow discoloration of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use,www.notificaRAM.es.

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

Store below 30°C.

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.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dalsydol

• The active ingredient is ibuprofen. Each sachet contains 400 mg of ibuprofen.
• The other components (excipients) are: sodium benzoate (E-211), 99.5% glycerol (E-422), liquid maltitol (E-965), xanthan gum, sodium saccharin (E-954), anhydrous citric acid, sodium citrate (E-331), sodium chloride, taumatina, 15% hypromellose, strawberry flavor, and purified water.

Appearance of the product and contents of the packaging

Dalsydol is a white oral suspension with a strawberry flavor contained in elongated single-dose sachets (sticks) of 10 ml, formed by a complex of polyester, aluminum, polyester, and polyethylene.

It is presented in packaging of 12 or 20 units (sticks).

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

ALCALA FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

“ó”

ZINEREO PHARMA, S.L.U.

A Relva, s/n, O Porriño,

36410 Pontevedra

“ó”

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

“ó”

EDEFARM S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante (Valencia)

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Last review date of this leaflet: October 2024

“Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/”