Package Leaflet: Information for the User

Dalsy 40 mg/ml Oral Suspension

ibuprofen

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

Follow exactly the administration instructions contained in this leaflet or those given 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 your symptoms worsen or do not improve after 3 days in case of fever or 5 days (3 days in children from 6 months) in case of pain. In the case of children from 3 to 5 months, you should consult a doctor if symptoms worsen or persist after 24 hours.

1. What Dalsy is and what it is used for

2. What you need to know before taking Dalsy

3. How to take Dalsy

4. Possible side effects

5. Storage of Dalsy

6. Contents of the pack and additional informationl

Dalsy contains ibuprofen as the active ingredient and belongs to a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medication is used inchildren from 3 months of age, adolescents, and adultsfor the symptomatic relief of occasional mild to moderate pain, as well as in febrile states.

Do not take Dalsy:

• If you are allergic (hypersensitive) to ibuprofen or any of the other components of this medication (listed in section 6) or to other medications in the group of nonsteroidal anti-inflammatory drugs (NSAIDs) or to aspirin. The reactions that indicate allergy may be: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have a severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have suffered a perforation of the digestive system.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• 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 have severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.

Warnings and precautions

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 difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medication for a prolonged period (more than 1 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without previous warning symptoms.

This risk is higher when using high doses and prolonged treatments, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.

• If you take this medication simultaneously with medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of these bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs) antidepressants.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that produces, usually, bloody diarrhea) or ulcerative colitis, as Dalsy-type medications may worsen these pathologies.
• If you are being treated with diuretics (medications to urinate) because your doctor must monitor your kidney function.
• If you have 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), 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).
• If you have intermittent acute porphyria (a metabolic disease that affects your blood and can cause symptoms such as urine discoloration, bloody urine, or liver disease), so your doctor can assess the advisability or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medication.
• It is possible that you may experience allergic reactions with this medication.
• Your doctor will perform a more strict check if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• If you have an infection: see the "Infections" heading later.

It is essential to use the smallest dose that relieves or controls pain and not to take this medication for longer than necessary to control your symptoms.

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

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

CARDIOVASCULAR PRECAUTIONS

Nonsteroidal anti-inflammatory drugs (NSAIDs) like 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.

You should inform your doctor or pharmacist before taking Dalsy if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, 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 if you are a smoker.

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

Children and adolescents

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

Pregnancy and lactation

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, unless 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 this medication is contraindicated.

For women of childbearing age, it should be noted that ibuprofen-type medications have been associated with a decrease in the ability to conceive.

Infections

Dalsy may mask the signs of an infection, such as fever and pain. Consequently, it is possible that Dalsy may delay the appropriate treatment of the infection, increasing the risk of complications. This has been observed in pneumonia caused by bacteria and in bacterial skin infections related to chickenpox. If you take this medication while having an infection and the infection symptoms persist or worsen, consult your doctor without delay.

Other medications and Dalsy

Inform your doctor or pharmacist if you are using or have used recently any other medication, including those purchased without a prescription.

Dalsy may affect or be affected by other medications. For example:

• Other nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as it may increase the risk of stomach ulcers and bleeding.

• Antiplatelet agents (prevent the formation of blood clots in blood vessels) such as ticlopidine.
• Anticoagulants, e.g., to treat blood clotting problems or prevent coagulation (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Colestiramine (medication used to treat high cholesterol).
• Inhibitors of serotonin reuptake (used in depression).
• Lithium (medication 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 and cardiac glycosides (used in the treatment of heart problems).
• Hidantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine production), as it may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used for gout).
• Sulfonilureas such as tolbutamide (used for diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (medication against HIV/AIDS).
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Trombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Extracts of the Ginkgo biloba tree.
• Inhibitors of CYP2C9 (responsible for the metabolism of numerous medications in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

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

The use of ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment).
• Glucose concentration in blood (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Concentrations of urea nitrogen in blood and serum concentrations of creatinine and potassium (may increase).
• With liver function tests: increase in transaminase values.

Inform your doctor if you are to undergo a clinical analysis and are taking or have recently taken ibuprofen.

Administration of Dalsy with food, drinks, and alcohol

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

Pregnancy, lactation, and fertility

The use of this medication is not recommended for women trying to become pregnant.

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.This medication should not be taken during pregnancy, especially during the third trimester (see section on precautions during pregnancy and in women of childbearing age), 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.

This medication should not be taken during the first 6 months of pregnancy unless it is absolutely necessary and your doctor advises you to do so. If you need treatment during this period or while trying to become pregnant, you should use the lowest dose for the shortest time necessary. From week 20 of pregnancy onwards, Dalsy may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (oligohydramnios) or narrowing of the blood vessels (ductus arteriosus) in your baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Althoughonly small amountsof the medication pass into breast milk, it is recommended not to take ibuprofen for prolonged periods during breastfeeding.

Driving and operating machinery

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

Ibuprofen may delay your reaction time, which should be taken into account before performing activities that require increased vigilance, such as driving and operating machinery.

This applies to a greater extent when combined with alcohol.

This medication contains maltitol liquid.If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

This medicationmay cause allergic reactions because it contains azorubine. It may cause asthma, especially in patients allergic to acetylsalicylic acid.

This medicationcontains less than 23 mg of sodium (1 mmol) per milliliter; it is essentially "sodium-free."

Follow exactly the administration instructions of this medication contained in this leaflet or those indicated by your doctor, pharmacist or nurse. In case of doubt, ask your doctor, pharmacist or nurse.

Only for occasional use and for limited periods.

The 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).

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

Adults and adolescents over 12 years (≥40 kg):

The recommended dose is 5-10 ml (200-400 mg of ibuprofen) at intervals not less than 4 hours, if necessary and while symptoms persist, without exceeding 1200 mg of ibuprofen in 24 hours.

The maximum dose per dose should not exceed 400 mg of ibuprofen. More than 400 mg in a single dose does not provide better analgesic effect.

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

In adults and adolescents, consult a doctor if this medication needs to be used for more than 3 days in case of fever or 4 days in case of pain or if symptoms worsen.

Children from 3 months to 12 years:

The recommended dose of ibuprofen depends on the age and weight of the child.Generally, for children from 3 months to 12 years, the recommended daily dose is 20 to 30 mg per kg of body weight depending on the intensity of symptoms and is divided into three doses.

The use of this medication in children under 2 years will always be by medical prescription.

As a guide, the following doses can be followed:

The suspension can also be dosed following a regimen of 4 daily doses. In this case, the maximum daily doses should not be exceeded (see the last column of the table above). The dose to be administered in each dose every 6 hours will be recalculated/reduced proportionally.

This medication should not be used in children under 3 months or weighing less than 5 kg.

• Over 65 years?the dosage should be established by the doctor, as there is a possibility that a reduction in the usual dose may be needed.
• Patients with kidney, liver or heart diseases: they should reduce the dose and consult a doctor. Ibuprofen should not be used in patients with severe heart, renal and hepatic failure.

Adults and adolescents should consult a doctor if symptoms worsen or do not improve after 3 days in case of fever or 5 days in case of pain.

Children from 6 months to 12 years should consult a doctor if symptoms worsen or do not improve after 3 days.

Children from 3 to 5 months should consult a doctor if symptoms worsen or persist after 24 hours.

Administration Form

Dalsy is a suspension for oral administration. It can be administered directly or diluted in water.

1. Shake the container before use.
2. Insert the syringe into the perforated cap.
3. Invert the bottle and remove the necessary dose.
4. Administer the syringe contents directly into the mouth or on a spoon.
5. The syringe should be washed after each dose and can be sterilized by boiling it in water or immersing it in the sterilizing solution used for bottles.

A burning sensation in the mouth or throat may occur with ibuprofen oral suspension; make sure to shake the bottle well before administering the medication.

Patients with stomach discomfort should take the medication with milk and/or during meals.

If you take more Dalsy than you should

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

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

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, involuntary eye movement, and muscle coordination loss. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. In rare cases, cases of increased plasma acidity (metabolic acidosis), decreased body temperature, kidney function alteration, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), depression of the central nervous system and respiratory system have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) have also been reported.

If a severe intoxication has occurred, renal insufficiency and liver damage may occur. In these cases, the doctor will take the necessary measures.

If you forget to take Dalsy

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 next dose is due soon, skip the missed dose and take the next dose at its usual time.

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

Like all medications, Dalsy may cause side effects, although not everyone will experience them. The incidence of side effects is lower in short-term treatments and when 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 1,200 mg of oral ibuprofen:

• Common side effects(may affect up to 1 in 10 people):

Gastrointestinal bleeding, especially in older patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (gastrointestinal secretion or motility disorder), constipation, stomach pain, bloody stools, vomiting with blood, headache, dizziness, or feeling unsteady, fatigue.

• Uncommon side effects(may affect up to 1 in 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, or prickling sensations, more common in hands, feet, arms, or legs), drowsiness, insomnia, anxiety,auditory disturbances, 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 (yellowing of the skin and eyes), asthma, bronchospasm, dyspnea (difficulty breathing). Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (characterized by proteinuria and body swelling), and acute renal failure (sudden loss of kidney function), acute renal failure, and papillary necrosis (especially with prolonged use) associated with increased urea.

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

Disorientation or confusion, depression,vertigo, tinnitus (ringing or buzzing in the ear), auditory disturbances, reversible toxic amblyopia,hepatic lesions, edema (swelling caused by fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include facial swelling, tongue swelling, laryngeal swelling, dyspnea, 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 side effects include thrombocytopenia,leukopenia (decreased white blood cells, which may manifest as frequent infections with fever, chills, or sore throat), anemia (may manifest as difficulty breathing and pale skin),neutropenia (decreased neutrophils) and agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow insufficiency to produce different types of cells), and hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, unexplained bleeding, and hematomas.

• Very rare side effects(may affect up to 1 in 10,000 people):

Pancreatitis,severe skin reactions, including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions of purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and epidermal detachment), erythema multiforme (skin lesion). Exceptionally, severe skin infections and soft tissue complications may occur during varicella. Liver failure (severe deterioration of the liver), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation related to infections coinciding with the use of NSAIDs has been observed. If signs of infection or worsening of these symptoms occur during ibuprofen use, it is recommended to see a doctor as soon as possible.

• Frequency unknown(cannot be estimated from available data):

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).

A severe skin reaction known as DRESS syndrome (by its English acronym) may occur. DRESS syndrome symptoms 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 localized blisters, mainly located in skin folds, the trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Dalsy if you experience these symptoms and seek medical attention immediately. See section 2.

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

• Flat, non-elevated red patches, in the shape of a target or circles 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 symptoms similar to the flu (dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalized skin rash, elevated body temperature, and hypertrophied lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with protuberances 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 grounds-like material.
• Bloody stools or diarrhea with blood.
• Severe stomach pain.
• Intense or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this same section).
• Swelling of the limbs or accumulation of fluid 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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

No special storage conditions are required.

This medication should be used within 12 months after opening.

Do not use this medication after the expiration date that appears on the packaging after “CAD or EXP”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash.Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy.Ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Dalsy 40 mg/ml oral suspension

• The active ingredient is ibuprofen. Each 1 ml of suspension contains 40 mg of ibuprofen.
• The other components are: sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol (E-965), glycerol (E-422), strawberry flavor, taumatine, azorubine colorant (E-122) and purified water.

Appearance of the product and contents of the packaging

Oral suspension with a viscous appearance, pink color and strawberry flavor and smell. It is presented in 30 and 150 ml containers. It includes a graduated oral dosifier in milliliters.

Holder of the marketing authorization and responsible for manufacturing

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible for manufacturing

AbbVie S.R.L. S.R. 148 Pontina Km 52 snc (Campoverde di Aprilia (LT))-04011-Italy

FARMASIERRA MANUFACTURING S.L.

Ctra. Irún, km. 26,200. (San Sebastián de los Reyes (Madrid))-28700-Spain

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

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Last review date of this leaflet: October 2024.

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