DALSYDOL 400 MG ORAL SUSPENSION

2. What you need to know before taking Dalsydol

Do not take Dalsydol:

• If you are allergic to ibuprofen or any of the other components of this medicine (listed in section 6) or to other medicines of the non-steroidal anti-inflammatory group (NSAIDs) or to aspirin. Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have had a previous stomach or duodenal ulcer hemorrhage 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 severe liver or kidney disease.
• 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 anticoagulant medicines at the same time, your doctor will perform blood coagulation tests.
• If you are in the third trimester of pregnancy.
• If you have severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Warnings and precautions

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

Tell your doctor:

• If you have edema (fluid retention).
• If you have or have had heart problems or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with this medicine, as it may mask fever, which is an important sign of infection, making diagnosis 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 to 2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure in this case due to dehydration.
• If you have had or developed an ulcer, hemorrhage, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain 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, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach-protecting medicine.
• If you take medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as ibuprofen-type medications may worsen these conditions.
• If you are undergoing treatment with diuretics (medicines to increase urine production), as your doctor should 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.
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter control if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• It is essential to use the smallest dose that relieves/controls the pain and not to take this medicine for longer than necessary to control your symptoms.
• If you have an infection; see the "Infections" section below.
• Ibuprofen has been reported to cause signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Dalsydol immediately and contact your doctor or the medical emergency service immediately if you notice any of these signs.

Infections

Ibuprofen may hide the signs of an infection, such as fever and pain. Consequently, ibuprofen may delay the appropriate treatment of the infection, which can increase 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 the infection symptoms persist or worsen, consult a doctor without delay.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increased risk of having a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration. 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), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems 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, have a family history of heart disease or stroke, or are a smoker.

Similarly, this type of medicine 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Dalsydol treatment and seek medical attention immediately 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 medicines

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

The following medicines may interfere and should not be taken with ibuprofen without consulting your doctor:

• Do not take this medicine if you are taking other non-steroidal anti-inflammatory medicines (NSAIDs) like aspirin, as it may increase the risk of stomach ulcers and bleeding.
• Antiplatelet agents (prevent the formation of blood clots or thrombi in blood vessels) such as ticlopidine.
• Anticoagulant medicines (e.g., to treat blood coagulation problems/prevent blood coagulation, e.g., acetylsalicylic acid, warfarin).
• Medicines that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Baclofen (used to treat involuntary and persistent muscle contractions).
• Lithium (medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (abortion inducer).
• Digoxin (cardiac glycosides) (used in the treatment of heart disorders).
• Hydantoins like phenytoin (used in the treatment of epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Diuretics (medicines used to increase urine production).
• Corticosteroids like cortisone and prednisolone, used in inflammatory processes.
• Selective serotonin reuptake inhibitors (SSRIs), used for depression.
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group like norfloxacin.
• Ion exchange resins like cholestyramine (used to decrease blood cholesterol levels).
• Sulfinpyrazone (for gout).
• Sulfonylureas like tolbutamide (for diabetes).
• Tacrine (used in the treatment of Alzheimer's disease).
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Zidovudine (medicine against the AIDS virus).
• Thrombolytics (medicines that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• CYP2C9 inhibitors (responsible for the metabolism of numerous medicines in the liver), such as voriconazole or fluconazole, used to treat fungal infections.
• Herbal extracts: Ginkgo biloba tree.

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 analytical tests

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

Taking Dalsydol with food, drinks, and alcohol

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

If you drink alcohol while taking this medicine, you may be more prone to side effects.

Pregnancy, breastfeeding, and fertility

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.

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 and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. 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 the 20th week of pregnancy, Dalsydol may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of amniotic fluid surrounding the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional checks.

Precautions during pregnancy and in women of childbearing age

Pregnancy

Due to the administration of medicines of this type being associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy, unless it is considered strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

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

Fertility

For patients of childbearing age, it should be taken into account that medicines like ibuprofen have been associated with a decrease in fertility.

Breastfeeding

Although the levels of the medicine in breast milk are negligible, it is recommended to consult a doctor in cases of long-term treatment or high doses during breastfeeding.

Driving and using machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medicine, you should not drive or operate machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

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

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

Patients on low-sodium diets should note 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 (yellowish skin and eye color) in newborns (up to 4 weeks old).

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

3. How to take Dalsydol

Follow the administration instructions of the medicine contained in this prospectus or as indicated by your doctor or pharmacist. In case of doubt, ask your doctor or pharmacist.

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

The effective lowest 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).

Dosage

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

The recommended dose is one sachet (400 mg of ibuprofen every 4-8 hours), depending on the intensity of the symptoms and the response to treatment. No more than 3 sachets (1200 mg) should be taken within 24 hours.

Elderly patients:

The dosage should be established by the doctor, as it may be necessary to reduce the usual dose. Elderly people are often more prone to adverse effects.

Patients with kidney, liver, or heart disease:

Reduce the dose and consult a 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 should consult a doctor.

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

Use in children and adolescents:

The use of this medicine is not recommended in children or adolescents with a weight of less than 40 kg.

Method of administration

This medicine is a suspension, administered orally.

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

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

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

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

In case of digestive discomfort, it is recommended to take the medicine 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 or the Toxicology Information Service, phone: 91 5620420, indicating the medicine and the amount ingested. It is recommended to bring the package and the prospectus of the medicine to the healthcare professional.

If you have taken more Dalsydol than you should, or if a child has accidentally ingested the medicine, consult a doctor or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

Overdose symptoms may include nausea, stomach pain, vomiting (which may contain bloody sputum), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have been reported.

It is rare for more severe symptoms to appear, such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, convulsions, altered kidney function, coma, adult respiratory distress, and transient respiratory arrest in children (after ingesting large amounts).

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

If you forget to take Dalsydol

Do not take a double dose to make up for forgotten doses.

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time of the next dose is very close, skip the forgotten dose and take the next dose at the usual time.

If you have any other doubts 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 all people suffer from them.

The incidence of adverse effects is lower in short 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 adverse effects(may affect up to 1 in 10 people): gastrointestinal bleeding, especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, dyspepsia (disorder of gastrointestinal secretion or motility), constipation, heartburn, abdominal pain, blood in stools, vomiting with blood, 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 spots on the skin), skin reactions due to light influence, hypersensitivity, paresthesia (sensation of numbness, tingling, or prickling, more frequent in hands, feet, arms, or legs), headache and drowsiness, insomnia, anxiety, hearing disorders, vision changes, rhinitis (inflammation of the nasal mucosa), inflammation of the oral mucosa with ulcer formation (mouth sores), gastrointestinal perforations, hepatitis (inflammation of the liver), liver function anomalies, 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 buzzing in the ears), reversible toxic amblyopia, liver damage, edema (swelling caused by fluid accumulation in tissues), optic neuritis.

• Very rare adverse effects(may affect up to 1 in 10,000 people): pancreatitis, severe blistering reactions including Stevens-Johnson syndrome (widespread skin and mucous membrane lesions) and toxic epidermal necrolysis (skin and mucous membrane lesions with necrosis and detachment of the epidermis), erythema multiforme (skin lesion). In the event of a severe generalized hypersensitivity reaction, signs may include swelling of the face, tongue, and larynx, 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 adverse effects are decreased platelets, decreased white blood cells (which may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which may manifest as difficulty breathing and pale skin), neutropenia (decrease in neutrophils), and agranulocytosis (very large decrease in neutrophils), aplastic anemia (bone marrow failure 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, pseudoinfluenza symptoms, extreme fatigue, bleeding, and bruises of unknown cause. Severe liver failure, heart failure, myocardial infarction, hypertension. Tubulointerstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the 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-related infections has been observed coinciding with the use of NSAIDs. If signs of infection or worsening of symptoms occur during the use of ibuprofen, it is recommended to consult a doctor as soon as possible.

• Unknown frequency(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 that usually produces bloody diarrhea).

A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). Generalized red scaly rash, with bumps under the skin and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).

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

The skin becomes sensitive to light.

If any of the following adverse effects occur, discontinue treatment and consult your doctor immediately:

• Red, non-elevated, target-like or circular spots on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital, and 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).
• Generalized skin rash, elevated body temperature, and hypertrophic lymph nodes (DRESS syndrome).
• Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).
• Allergic reactions such as skin rashes, facial swelling, chest tightness, or difficulty breathing.
• Vomiting blood or coffee-ground-like material.
• Blood in stools or bloody diarrhea.
• 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 the arms or legs.
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report it directly through the Spanish Pharmacovigilance System for Human Use Medicines, www.notificaRAM.es.

5. Conservation of Dalsydol

Keep this medicine out of sight and reach of children.

Store below 30°C.

Do not use this medicine after the expiration date shown on the package after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE collection point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

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), maltitol liquid (E-965), xanthan gum, sodium saccharin (E-954), anhydrous citric acid, sodium citrate (E-331), sodium chloride, thaumatin, 15% hypromellose, strawberry flavor, and purified water.

Appearance of the product and package contents

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

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Manufacturer

ALCALA FARMA, S.L.

Avenida de Madrid, 82

28802 Alcalá de Henares (Madrid)

“or”

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)

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

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

Date of the last revision of this prospectus: October 2024

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