DalsyDol 400 mg oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dalsydol 400 mg oral suspension

ibuprofen

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

Follow exactly the instructions for administering this medicine provided 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
• You should consult a doctor if fever worsens or does not improve after 3 days, or if pain does not improve after 5 days (3 days in adolescents).

Contents of this leaflet

1. What Dalsydol is and what it is used for
2. What you need to know before taking Dalsydol
3. How to take Dalsydol
4. Possible side effects
5. How to store Dalsydol
6. Contents of the pack and other information

1. What Dalsydol is and what it is used for

Ibuprofen, the active substance in this medicine, works by reducing pain and fever.

This medicine is used in adults and adolescents aged 12 years and older weighing over 40 kg, for the symptomatic relief of mild to moderate occasional pain, such as headaches, dental pain, menstrual pain, muscle pain (strains), or back pain (lumbago), as well as for feverish conditions.

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

Do not take Dalsydol:

• If you are allergic 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 itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have previously 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 diarrhoea with blood.
• If you have severe heart failure.
• If you suffer from serious liver or kidney disease.
• If you have bleeding or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood). If concomitant use of anticoagulant medicines is necessary, your doctor will perform blood coagulation tests.
• If you are in the third trimester of pregnancy.
• If you suffer from severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take this medicine.

Inform your doctor:

• If you have oedema (fluid retention).
• If you suffer from or have suffered from heart disorders or have 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, thereby making diagnosis more difficult.
• If you have kidney or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (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 experience symptoms of dehydration, e.g. severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as in such cases ibuprofen could lead to renal failure as a consequence of dehydration.
• 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 prescribing 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 mention 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 diarrhoea with blood) or ulcerative colitis, as ibuprofen-type medicines may worsen these conditions.
• If you are being treated with diuretics (medicines to increase urination), because 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 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 from headaches after prolonged treatment, do not take higher doses of the medicine.
• Allergic reactions to this medicine may occur.
• 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.
• It is important to use the lowest dose that relieves/controls pain and not to take this medicine longer than necessary to control your symptoms.
• If you have an infection; see the section «Infections» below.
• Allergic reactions to ibuprofen have been reported, including respiratory problems, swelling of the face and neck region (angioedema), and chest pain. Stop using Dalsydol immediately and contact your doctor or medical emergency services immediately if you notice any of these signs.

Infections

Ibuprofen may mask signs of infection, such as fever and pain. Therefore, ibuprofen may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor without delay.

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 this medicine if:

• You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary artery 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).

Skin reactions

Serious skin reactions such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP) have been reported with ibuprofen treatment. Stop treatment with Dalsydol and seek immediate medical attention if you notice any symptoms related to these serious 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 medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

The following medicines may interact and therefore should not be taken together with ibuprofen without first consulting your doctor:

• Do not take this medicine if you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, as this may increase the risk of gastrointestinal ulcer and bleeding.
• Antiplatelet agents (prevent blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g. to treat coagulation disorders/prevent clotting, e.g. acetylsalicylic acid, warfarin).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor antagonists such as losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• 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 (abortion-inducing agent).
• Digoxin (cardiac glycosides) (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Diuretics (medicines used to increase urine elimination).
• Corticosteroids such as cortisone and prednisolone, used in inflammatory conditions.
• Selective serotonin reuptake inhibitors (SSRIs), used for depression.
• Pentoxifylline (to treat intermittent claudication).
• Probenecid (used in patients with gout or together with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Ion-exchange resins such as cholestyramine (used to lower blood cholesterol levels).
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (an anti-HIV medicine).
• Thrombolytics (medicines that dissolve clots).
• Aminoglycoside antibiotics such as neomycin.
• CYP2C9 inhibitors (responsible for the metabolism of numerous drugs in the liver), such as voriconazole or fluconazole, used to treat fungal infections.
• Herbal extracts: Ginkgo biloba.

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

Interference with laboratory tests

If you are scheduled for any diagnostic tests (including blood and urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medicine, as it may alter test results.

Taking Dalsydol with food, drinks and alcohol

You may take it alone or with food. It is generally recommended to take it with meals to reduce the possibility of stomach discomfort.

If you consume alcohol while taking this medicine, you may be more likely to experience adverse effects.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take ibuprofen during 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 and your baby's tendency to bleed and delay or prolong labour more than expected. Do not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible 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 lead to low levels of amniotic fluid surrounding the baby (oligohydramnios). If treatment is needed for longer than a few days, your doctor may recommend additional monitoring.

Precautions during pregnancy and in women of childbearing age

Pregnancy

Because administration of this type of medicine has been associated with an increased risk of congenital malformations/abortion, its use is not recommended during the first and second trimesters of pregnancy, unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of this medicine is contraindicated during the third trimester.

Fertility

For women of childbearing age, it should be noted that medicines such as ibuprofen have been associated with a reduced ability to conceive.

Breastfeeding

Although drug levels in breast milk are negligible, it is recommended to consult your doctor during long-term treatment or with high doses while breastfeeding.

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, no special precautions are necessary.

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

This medicine contains 57.94 mg of sodium (main component of table/cooking salt) per sachet. This corresponds to 2.9% of the maximum daily recommended sodium intake for an adult.

Patients on low-sodium diets should be aware that this medicine contains 57.94 mg (2.5 mmol) of sodium per sachet.

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

This medicine contains maltitol liquid (E-965). If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Dalsydol

Follow exactly the instructions for administering this medicine as described in this leaflet or as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

It is important to always take the smallest dose that relieves pain, and you should not take the medicine for longer than necessary to control your symptoms.

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

Dosage

Adults and adolescents (weighing over 40 kg) aged 12 years and above:

The recommended dose is one sachet (400 mg of ibuprofen) every 4–8 hours, depending on the severity of symptoms and response to treatment. Do not take more than 3 sachets (1200 mg) within 24 hours.

Elderly patients:

Dosage should be determined by the doctor, as a reduction from the usual dose may be necessary. Elderly individuals are generally more likely to experience adverse effects.

Patients with kidney, liver, or heart disease:

Reduce the dose and consult your 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 if pain lasts longer than 5 days (3 days in adolescents), you must consult a doctor.

This medicine should only be administered when pain or fever occurs. As these symptoms subside, treatment should be discontinued.

Use in children and adolescents:

This medicine is not recommended for use in children or adolescents weighing less than 40 kg.

Instructions for administration

This medicine is a suspension intended for oral administration.

The suspension must be homogenized immediately before use, as shown in the following figure:

1 – Press repeatedly with your fingers on the top and bottom parts of the sachet.

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

The suspension can be taken directly from the sachet or diluted in water.

If gastrointestinal discomfort occurs, it is recommended to take the medicine with food.

If you take more Dalsydol than you should

If you have taken more oral suspension than prescribed or have accidentally ingested the contents of the container, contact your doctor or pharmacist immediately, or call the Toxicology Information Service at telephone number: 91 5620420, stating the name of the medicine and the amount ingested. It is recommended to bring the medicine’s packaging and leaflet to the healthcare professional.

If you have taken more Dalsydol than recommended, or if a child has accidentally ingested the medicine, consult a doctor or go to the nearest hospital to assess the risk and receive advice on necessary measures.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), headache, tinnitus, confusion, and involuntary eye movements. At higher doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, chills, and breathing difficulties may occur.

More severe symptoms are rare but may include gastrointestinal bleeding, low blood pressure, decreased body temperature, metabolic acidosis, seizures, impaired kidney function, coma, adult respiratory distress syndrome, and transient respiratory arrest in children (after ingestion of large amounts).

In cases of severe poisoning, the doctor will take the necessary measures.

If you forget to take Dalsydol

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

If you forget to take your scheduled dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take the next dose at the usual time.

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

4. Possible adverse effects

Like all medicines, this medicine 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 1200 mg of ibuprofen:

• Frequent adverse effects (may affect up to 1 in 10 people): gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhoea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting blood, dizziness or feeling unsteady, fatigue have also been observed.

• 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 spots on the skin), skin reactions due to light exposure, hypersensitivity, paraesthesia (numbness, tingling, "pins and needles" sensation, more frequent in hands, feet, arms or legs), headache and drowsiness, insomnia, anxiety, hearing disturbances, visual disturbances, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth ulcers), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function abnormalities and jaundice (yellowing of the skin and eyes), asthma, bronchospasm (difficulty breathing).

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

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

• Very rare adverse effects (may affect up to 1 in 10,000 people): pancreatitis, very severe blistering reactions including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purpuric lesions, predominantly 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). In case of severe generalized hypersensitivity reaction, signs may include swelling of the face, tongue and larynx, dyspnoea (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 and other collagen diseases), which represented a risk factor. Symptoms observed in aseptic meningitis included neck stiffness, headache, nausea, vomiting, fever or disorientation. Other very rare 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 difficulty breathing and pale skin), neutropenia (decreased neutrophils) and agranulocytosis (severe decrease in neutrophils), aplastic anaemia (bone marrow failure to produce different types of cells), haemolytic anaemia (premature destruction of red blood cells). Initial symptoms include fever, sore throat, superficial mouth ulcers, flu-like symptoms, extreme fatigue, unexplained bleeding and bruising. Hepatic failure (severe liver impairment), heart failure, myocardial infarction, hypertension. Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterised by protein in urine and body swelling) and renal failure (sudden loss of kidney function), acute renal failure and papillary necrosis (especially with prolonged use) associated with increased urea.

Exacerbation of inflammation associated with infections has been observed during use of NSAIDs. If signs of infection are present 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 disease in which the immune system attacks the intestine causing inflammation, usually resulting in bloody diarrhoea).

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes and elevated eosinophils (a type of white blood cells).

Generalised red scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis).

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

The skin becomes sensitive to light.

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

A characteristic drug-related skin allergic reaction known as drug-induced fixed eruption, which usually reappears in the same area upon re-exposure to the medicine and typically presents as round or oval-shaped patches 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:

• Non-elevated reddish spots, target-shaped or circular on the trunk, often with blisters in the centre, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Generalised skin rash, high body temperature and enlarged lymph nodes (DRESS syndrome).
• Generalised, red and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalised 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 diarrhoea with blood.
• Severe stomach pain.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (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 effects, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, www.notificaRAM.es.

5. Storage of Dalsydol

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Dalsydol

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

Appearance of the product and contents of the pack

Dalsydol is a white, strawberry-flavoured oral suspension contained in single-dose, elongated sachets (sticks) of 10 ml, made from a laminate of polyester, aluminium, polyester and polyethylene.

It is available in packs of 12 or 20 units (sticks).

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

ZINEREO PHARMA, S.L.U.

A Relva, s/n, O Porriño,

36410 Pontevedra

“or”

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

“or”

EDEFARM S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante (Valencia)

For further information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

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

“Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/”