Dalsy 40 mg/ml oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dalsy 40 mg/ml oral suspension

ibuprofen

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

Follow exactly the instructions for administration of 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 adverse effects, consult your doctor, pharmacist or nurse, even if these are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if you worsen or do not improve after 3 days in case of fever or 5 days (3 days in children from 6 months of age) in case of pain. In the case of children aged 3 to 5 months, you should consult a doctor if symptoms worsen or persist after 24 hours.

Leaflet contents:

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 adverse effects
5. Storage of Dalsy
6. Package contents and additional information

1. What Dalsy is and what it is used for

Dalsy contains ibuprofen as the active substance and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is used in children from 3 months of age, adolescents and adults for the symptomatic relief of mild to moderate occasional pain, as well as for febrile conditions.

2. What you need to know before taking Dalsy

Do not take Dalsy:

• If you are allergic (hypersensitive) to ibuprofen or to any of the other components of this medicine (listed in section 6), or to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs) or to aspirin. Signs of allergy may include skin rash with itching, swelling of the face, lips or tongue, nasal discharge, breathing difficulties or asthma.
• If you have severe liver or kidney disease.
• If you have had a stomach or duodenal ulcer or bleeding, or have experienced a perforation of the gastrointestinal tract.
• If you are vomiting blood.
• If you have black stools or bloody diarrhoea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulants simultaneously, your doctor will perform blood coagulation tests.
• If you have severe dehydration (caused by vomiting, diarrhoea or insufficient 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 oedema (fluid retention).
• If you have or have had heart disorders or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are being treated with this medicine, as it may mask fever, an important sign of infection, making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to carry out regular monitoring. Your doctor will advise you on how often these checks should be performed.
• 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 such cases, your doctor may consider adding a stomach-protective medicine.

• If you are taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of such 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 usually leads to bloody diarrhoea) or ulcerative colitis, as medicines like Dalsy may worsen these conditions.
• If you are being treated with diuretics (medicines to increase urination), as your doctor needs to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that can affect vital organs, the nervous system, blood vessels, skin and joints), as aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria) may occur.
• If you have acute intermittent porphyria (a metabolic disorder affecting the blood that may cause symptoms such as reddish urine, blood in urine, or liver disease), so your doctor can assess whether treatment with ibuprofen is appropriate.
• If you suffer headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions may occur with this medicine.
• Your doctor will perform closer monitoring if you receive ibuprofen after major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• If you have an infection: see the “Infections” section below.

It is important to use the lowest dose that relieves/controls your pain and not to take this medicine longer than necessary to control your symptoms.

Signs of 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. Stop using Dalsy immediately and contact your doctor or emergency medical services immediately if you notice any of these signs.

Skin reactions

Serious skin reactions have been reported with ibuprofen, including 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 Dalsy and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Cardiovascular 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 Dalsy if:

• You have heart problems, including heart failure, angina (chest pain), have had a heart attack, 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 ischaemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you are a smoker.

In addition, these medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Children and adolescents

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

Pregnancy and fertility precautions

Because administration of medicines like Dalsy has been associated with an increased risk of congenital abnormalities or miscarriage, their 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 this medicine is contraindicated during the third trimester.

For women of childbearing potential, it should be noted that medicines like Dalsy have been associated with reduced fertility.

Infections

Dalsy may mask signs of infection such as fever and pain. Therefore, Dalsy may delay appropriate treatment of 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 your doctor immediately.

Other medicines and Dalsy

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.

Dalsy may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs such as aspirin, as this may increase the risk of gastrointestinal ulceration and bleeding.
• Antiplatelet agents (to prevent blood clots or thrombi in blood vessels), such as ticlopidine.
• Anticoagulant medicines, e.g., to treat or prevent coagulation disorders (e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Cholestyramine (a medicine used to treat high cholesterol).
• Selective serotonin reuptake inhibitors (used in depression).
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (an abortion-inducing agent).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medicines used to increase urine output), as they may increase the risk of kidney toxicity.
• Pentoxifylline (used to treat intermittent claudication).
• Probenecid (used in gout patients or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes), which may cause hypoglycaemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts: Ginkgo biloba.
• CYP2C9 inhibitors (responsible for the metabolism of many drugs in the liver), such as voriconazole and fluconazole (used to treat fungal infections).

Other medicines may also interact with or be affected by Dalsy treatment. Therefore, always consult your doctor or pharmacist before using Dalsy with other medicines.

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for up to 1 day after stopping treatment).
• Blood glucose concentration (may decrease).
• Creatinine clearance (may decrease).
• Hematocrit or hemoglobin (may decrease).
• Blood urea nitrogen levels and serum creatinine and potassium concentrations (may increase).
• Liver function tests: increased transaminase levels.

Inform your doctor if you are scheduled for clinical testing and are currently taking or have recently taken ibuprofen.

Taking Dalsy with food, drinks and alcohol

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

Pregnancy, breastfeeding and fertility

The use of this medicine is not recommended in women trying to become pregnant.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine. Dalsy should not be taken during pregnancy, especially during the third trimester (see section on pregnancy and fertility precautions), as it may harm the fetus or cause complications during delivery. It may cause kidney and heart problems in your unborn child. It may affect your and your baby's tendency to bleed and may delay or prolong labour more than expected.

You should not take Dalsy during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If treatment is needed during this period or while trying to conceive, use the lowest possible dose for the shortest time necessary. From week 20 of pregnancy onwards, Dalsy may cause kidney problems in your unborn child if taken for more than a few days, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of blood vessels (ductus arteriosus) in the baby's heart. If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Although only small amounts of the medicine pass into breast milk, prolonged use of ibuprofen during breastfeeding is not recommended.

Driving and using machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, you should not drive or operate machinery. If you take only a single dose of ibuprofen or use it for a short period, special precautions are generally not required.

Ibuprofen may delay your reaction time, which should be considered before engaging in activities requiring heightened alertness, such as driving or operating machinery.

This is particularly relevant when combined with alcohol.

This medicine contains liquid maltitol. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

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

This medicine contains less than 23 mg of sodium (1 mmol) per millilitre; hence, it is essentially "sodium-free".

3. How to take Dalsy

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

For occasional use only and for limited periods.

The lowest effective dose should be used for the shortest time 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).

Administration of the medicine depends on the presence of pain or fever. As these symptoms subside, the medication should be discontinued.

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

The recommended dose is 5–10 ml (200–400 mg of ibuprofen) at intervals of no less than 4 hours, if necessary and while symptoms persist, without exceeding 1200 mg of ibuprofen in a 24-hour period.

The maximum dose per administration must not exceed 400 mg of ibuprofen. Taking more than 400 mg in a single dose does not provide better analgesic effect.

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

In adults and adolescents, consult a doctor if use of this medicine is required for more than 3 days for fever or more than 4 days for pain, or if symptoms worsen.

Children from 3 months to 12 years of age:

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

Use of this medicine in children under 2 years of age must always be under medical prescription.

As a guide, the following dosage table may be followed:

The suspension can also be dosed according to a schedule of 4 doses per day. In this case, the maximum daily doses (see last column of the table above) must not be exceeded within 24 hours. The dose to be administered every 6 hours will be recalculated/reduced proportionally.

The use of this medicine is not recommended in children under 3 months of age or weighing less than 5 kg.

• Patients over 65 years of age: dosage must be established by the physician, as dose reduction from the usual dose may be necessary.
• Patients with kidney, liver, or heart disease: dose reduction is required; consult a physician. Ibuprofen must not be used in patients with severe heart, renal, or hepatic failure.

Adults and adolescents should consult a physician if their condition worsens or does not improve after 3 days in case of fever, or after 5 days in case of pain.

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

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

Method of administration

Dalsy is an oral suspension. It may be administered directly or diluted in water.

1. Shake the container before use.
2. Insert the syringe into the hole in the pierced cap.
3. Invert the bottle and withdraw the required dose.
4. Administer the contents of the syringe directly into the mouth or onto a spoon.
5. The syringe should be washed after each use and may be sterilized by boiling in water or by immersion in the sterilizing solution used for baby bottles.

A burning sensation in the mouth or throat may occur with oral ibuprofen suspension; ensure that the bottle has been shaken well before administering the medicine.

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

If you take more Dalsy than you should

If you have taken more Dalsy than prescribed, or if a child has accidentally ingested the medicine, immediately contact your physician or pharmacist, call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and amount ingested, or go to the nearest hospital to assess the risk and obtain advice on necessary measures.

Symptoms of overdose usually occur 4 to 6 hours after taking ibuprofen.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, involuntary eye movements, and lack of muscle coordination. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. Rarely, cases of increased blood plasma acidity (metabolic acidosis), decreased body temperature, impaired kidney function, gastrointestinal bleeding, coma, temporary cessation of breathing (apnea), central nervous system depression, and respiratory depression have occurred. Cardiovascular toxicity (low blood pressure, decreased heart rate, and increased heart rate) has also been reported.

In cases of severe poisoning, renal failure and liver damage may occur. In such cases, the physician will take the necessary measures.

If you forget to take Dalsy

Do not take a double dose to make up for missed 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 the regular time.

If you have any further questions about the use of this medicine, ask your physician, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, Dalsy can cause adverse effects, although not everyone will experience them. The incidence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

The frequencies shown below refer to short-term use of maximum daily oral doses of up to 1,200 mg of ibuprofen:

• Frequent adverse 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, heartburn, abdominal pain, blood in stools, vomiting blood, headache, dizziness or feeling of instability, fatigue.

• Uncommon adverse effects (may affect up to 1 in 100 people):

Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching or tingling of the skin, urticaria, purpura (purple skin spots), photosensitivity reactions (skin reactions due to light exposure), hypersensitivity, paresthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms, or legs), somnolence, insomnia, anxiety, auditory disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), 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 (disorder characterized by protein in urine and body swelling), renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use), associated with increased urea levels.

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

Disorientation or confusion, depression, dizziness, tinnitus (ringing or noises in the ear), hearing disturbances, reversible toxic amblyopia, liver injury, edema (swelling due to fluid accumulation in tissues), optic neuritis, anaphylactic reaction (in case of severe generalized hypersensitivity reaction, signs may include facial, tongue, and laryngeal swelling, dyspnea (shortness of breath), tachycardia, hypotension (anaphylaxis, angioedema, or severe shock), aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria). In most reported cases of aseptic meningitis with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which constituted a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever, or disorientation. Other adverse effects include decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as shortness of breath and pale skin), neutropenia (decreased neutrophils), agranulocytosis (severe decrease in neutrophils), aplastic anemia (bone marrow failure to produce various types of blood cells), hemolytic anemia (premature destruction of red blood cells). Initial symptoms include: fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding and bruising.

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

Pancreatitis, severe blistering skin reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes, and purplish lesions, primarily on the trunk) and toxic epidermal necrolysis (erosions of mucous membranes and painful lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). Rarely, severe skin infections and soft tissue complications may occur during chickenpox. Hepatic failure (severe liver deterioration), heart failure, myocardial infarction, hypertension.

Exacerbation of inflammation associated with infections has been observed during concomitant use of NSAIDs. If signs of infection appear or worsen during ibuprofen use, it is recommended to seek medical advice promptly.

• Frequency not known (cannot be estimated from available data):

Exacerbation of colitis and Crohn's disease (chronic condition in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea).

A serious skin reaction known as DRESS syndrome (an acronym from English) 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, primarily located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Dalsy immediately if you experience these symptoms and seek medical attention immediately. See also section 2.

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

A characteristic drug-induced skin allergic reaction known as fixed drug eruption, which typically recurs in the same area upon re-exposure to the drug and usually appears as round or oval-shaped spots of redness and swelling of the skin, blisters (urticaria), and itching.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

• Flat, non-elevated red spots, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, or eye ulcers. These severe skin reactions 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).
• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or material resembling coffee grounds.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in arms or legs.

Reporting of adverse effects:

If you experience any adverse effect, consult your doctor or pharmacist, 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 Dalsy

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

No special storage conditions are required.

This medicine should be used within 12 months after opening.

Do not use this medicine after the expiry date stated on the packaging after "CAD" or "EXP". The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dalsy 40 mg/ml oral suspension

• The active substance 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, maltitol liquid (E-965), glycerol (E-422), strawberry flavour, thaumatin, colour azorubine (E-122) and purified water.

Appearance of the product and contents of the pack

Viscous oral suspension, pink in colour, with a strawberry odour and taste. It is available in 30 ml and 150 ml containers. Includes an oral dosing syringe graduated in millilitres.

Marketing Authorisation Holder and Manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

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

Further information about this medicinal product can be obtained by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.

C/ General Aranaz, 86

28027 Madrid

Spain

Date of the most recent review of this leaflet: January 2026.

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/