Leaflet: information for the user

Dalsydol 400 mg film-coated tablets

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 the fever worsens or does not improve after 3 daysor the pain after 5 days (3 days in adolescents)

6. Contents of the pack and additional information

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

This medication is used in adults and adolescents over 12 years(weight above 40 kg)for the symptomatic relief of occasional mild to moderate pains, such as headache, dental, menstrual, muscular (cramps) or back (lumbago) pains, as well as in febrile states.

Do not take Dalsydol:

• 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 could 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 tract.
• 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 more 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 tell you how often these checks should be done.
• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms.

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

• If you are taking anticoagulants (medications used to "thin" the blood) such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that may increase the risk of bleeding such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you have Crohn's disease (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually results in bloody diarrhea) or ulcerative colitis, as Dalsydol-type medications may worsen these conditions.
• If you are taking diuretics (medications to urinate) as your doctor needs to 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 may cause symptoms such as red urine, 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 to experience allergic reactions with this medication.
• Your doctor will perform a more strict control if you receive ibuprofen after undergoing major surgery.
• It is recommended 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 Dalsydol immediately and contact your doctor or emergency medical services 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), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue Dalsydol treatment and seek medical attention immediately if you notice any 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 increased 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 Dalsydol if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including a "mini-stroke" or transient ischemic attack "TIA").
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

Children and adolescents

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

Pregnancy and women of childbearing age

Due to the association of ibuprofen-type medications with an increased risk of congenital anomalies/abortions, it is not recommended to administer Dalsydol during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

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

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

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

Other medications and Dalsydol

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

Dalsydol 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 (medications used to "thin" the blood) such as aspirin, warfarin, ticlopidine.
• Colestiramine (used to treat high cholesterol).
• Inhibitors of serotonin reuptake (used in depression).
• Lithium (used to treat depression). Your doctor may adjust the dose of this medication.
• Metotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (induces abortion).
• Digoxin and cardiac glycosides (used to treat heart problems).
• Hidantoins such as phenytoin (used to treat epilepsy).
• Sulfamides such as sulfamethoxazole and cotrimoxazole (used to treat 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 to treat gout).
• Sulfonilureas such as tolbutamide (used to treat diabetes), as it may cause hypoglycemia.
• Tacrolimus or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (used to treat 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.
• Herbal extracts: 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 Dalsydol treatment. Therefore, always consult your doctor or pharmacist before using Dalsydol with other medications.

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Clearance of creatinine (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Concentrations of urea nitrogen in the 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.

Dalsydol with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

The use of this medication 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 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 more than expected..

This medication should not be taken during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. 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, Dalsydol 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..

Only small amounts of the medication pass into breast milk, but 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, no special precautions are necessary.

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.

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

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.

This medication is administered orally.

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).

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

The tablets should be swallowed whole, with a glass of water, without chewing, breaking, crushing or sucking to avoid mouth discomfort and throat irritation.

The recommended dose is:

• Adults and adolescents over 12 years (over 40 kg of weight):One tablet (400 mg of ibuprofen) every 6-8 hours.

No more than 3 tablets (1,200 mg of ibuprofen) should be taken within 24 hours.

• Over 65 years:The dosage should be established by the doctor, as it may be necessary to reduce the usual dose.
• Patients with kidney, liver or heart diseases:Reduce the dose and consult the doctor.

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 the doctor.

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

If you estimate that the action of this medication is too strong or too weak, inform your doctor or pharmacist.

Use in children and adolescents

This medication is not recommended for use in children (under 12 years) or adolescents with a weight of less than 40 kg.

If you take more Dalsydol than you should

If you have taken more Dalsydol 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 blood-stained mucus), 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, blood in the urine, low potassium levels in the blood, chills and breathing difficulties have been reported. In rare cases, cases of metabolic acidosis, decreased body temperature, kidney function impairment, stomach and intestinal bleeding, coma, transient loss of breathing (apnea), central nervous system and respiratory system depression have been reported. Cases of cardiovascular toxicity (low blood pressure, decreased heart rate and increased heart rate) have also been reported.

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

If you forgot to take Dalsydol

Do not take a double dose to compensate for the missed doses.

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

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

Like all medications, Dalsydol 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:

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

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

• Less frequent side effects(may affect up to 1 in 100 people):

Gastritis, duodenal ulcers, gastric ulcers, skin redness, itching, urticaria, purpura (purple skin patches), light-induced skin reactions, hypersensitivity, paresthesia (numbness, tingling, or prickling sensations, more common in hands, feet, arms, or legs) and drowsiness, insomnia, anxiety,auditory disturbances, visual disturbances,rhinitis (nasal mucosa inflammation), 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 ears), 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, 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, 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), 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 blistering reactions, including Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and lesions with purple color, preferably on the trunk) and toxic epidermal necrolysis (erosions in 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 these worsen during ibuprofen use, it is recommended to see 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 produces diarrhea with blood).

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

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

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

Reporting of side effects:

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance 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.

Do not store at a temperature above25°C.

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 in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of dalsydol 400 mgfilm-coated tablets

• The active ingredient is ibuprofen. Each tablet contains 400 mg of ibuprofen.
• The other components are: Core: microcrystalline cellulose, sodium carmellose, lactose monohydrate, anhydrous colloidal silica, sodium lauryl sulfate, magnesium stearate. Coating: hypromellose, talc, and titanium dioxide (E-171).

Appearance of the product and contents of the packaging

Oval-shaped, white, smooth, unnotched, and uninscribed tablets. They are presented in packs of 30 tablets containing three blisters of aluminum/PVC/PVDC or aluminum/PVC, with 10 tablets in each.

Holder of the marketing authorization and responsible manufacturer

Holder:

Viatris Healthcare Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible manufacturer:

FamarA.V.E. Anthoussa Plant

Anthoussa Avenue, 7

15349 Anthoussa Attiki

Greece

or

Mylan Hungary Kft.

Mylan utca 1

Komárom 2900

Hungary

You can request more information about this medicine 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 medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) https://www.aemps.gob.es/