DalsyDol Rapid 400 mg soft capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dalsydol Rapid 400mg soft capsules

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 use provided in this leaflet or as directed by your doctor or pharmacist.

• 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 or pharmacist, even if they are effects not listed in this leaflet. See section 4.

• You must consult a doctor if your condition worsens or does not improve, or if fever or pain lasts more than 3 days in adolescents or more than 4 days in adults.

Contents of the leaflet

1. What Dalsydol Rapid is and what it is used for

2. What you need to know before taking Dalsydol Rapid

3. How to take Dalsydol Rapid

4. Possible side effects

   1. How to store Dalsydol Rapid

5. Contents of the pack and other information

1. What Dalsydol Rapid is and what it is used for

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

This medicine is indicated for adults and adolescents weighing 40 kg or more (from 12 years of age) for the short-term symptomatic treatment of mild to moderate pain, such as headache, dental pain, menstrual pain, and fever.

You should consult a doctor if your symptoms worsen or do not improve, or if fever or pain lasts longer than 3 days in adolescents or longer than 4 days in adults.

2. What you need to know before taking Dalsydol Rapid

Do not take Dalsydol Rapid:

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6).

• If you have had allergic reactions such as itchy skin rash, swelling of the face, lips, tongue or throat, runny nose, difficulty breathing, or asthma after taking medicines containing acetylsalicylic acid or other pain and anti-inflammatory drugs (NSAIDs).

• If you have previously experienced gastrointestinal bleeding or perforation related to the use of pain or anti-inflammatory medicines (NSAIDs).

• If you currently have a stomach or small intestine (duodenum) ulcer or gastrointestinal bleeding, or if you have had two or more such episodes in the past.

• If you have severe liver, kidney, or heart disease.

• If you are in the last trimester of pregnancy.

• If you have an illness of unknown origin causing abnormal blood cell formation.

• If you have any active bleeding (including in the brain).

• If you have diseases that increase the tendency to bleed.

• If you have severe dehydration (e.g., caused by vomiting, diarrhoea, or insufficient fluid intake).

Warnings and precautions

Talk to your doctor or pharmacist before starting Dalsydol Rapid:

• If you have had or develop a stomach or duodenal ulcer, bleeding, or perforation, which may present as severe or persistent abdominal pain or black stools, or even without prior warning symptoms. This risk is higher when high-dose or long-term treatments are used, in patients with a history of peptic ulcers, and in elderly patients.
• If you have Crohn’s disease (a chronic condition in which the immune system attacks the intestine, causing inflammation that typically leads to bloody diarrhoea) or ulcerative colitis, as ibuprofen may worsen these conditions.
• If you have oedema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you have or have had heart disease or high blood pressure.
• If you have kidney or liver disease, are over 60 years old, or need to take this medicine on your doctor’s advice for a prolonged period (more than 1–2 weeks), your doctor may need to carry out regular medical check-ups.
• If you experience symptoms of dehydration, such as severe diarrhoea or vomiting, drink plenty of fluids and contact your doctor immediately, as in such cases ibuprofen may cause kidney failure due to dehydration.
• In dehydrated adolescents, there is a risk of impaired kidney function.
• If you are taking medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).
• If you are receiving treatment with diuretics (medicines to increase urine production), as your doctor will need to monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease affecting the immune system that may involve various 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 or liver disease), to assess whether ibuprofen treatment is appropriate.
• If you experience headaches after prolonged treatment, do not take higher doses of this medicine.
• Allergic reactions to this medicine are possible.
• Your doctor will closely monitor your ibuprofen use after major surgery.
• If you have an infection, refer to the section "Infections" below.
• It is not recommended to take this medicine if you have chickenpox.
• It is important to use the lowest dose that relieves or controls your pain and not to take this medicine longer than necessary to control symptoms.
• Signs of allergic reaction to ibuprofen, including breathing difficulties, swelling of the face and neck (angioedema), and chest pain, have been reported. If you notice any of these signs, stop taking this medicine immediately and contact your doctor or emergency services right away.

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.

Consult your doctor or pharmacist before starting ibuprofen if:

• You have heart problems, such as heart failure or angina (chest pain), or if you have had or have had a heart attack, coronary bypass surgery, peripheral artery disease (poor circulation in the legs or feet due to narrowed or blocked arteries), or any type of stroke (such as "mini-stroke" or transient ischaemic attack).
• You have high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.

This type of medicine may also cause fluid retention, especially in patients with heart failure or high blood pressure (hypertension).

Skin reactions

Severe skin reactions have been reported with ibuprofen treatment, including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Stop taking ibuprofen and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Infections

Ibuprofen may mask signs of infection such as fever and pain. As a result, this medicine may delay appropriate treatment for infection, increasing the risk of complications. This has been observed in cases of bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, see a doctor immediately.

Other medicines and Dalsydol Rapid

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Ibuprofen may affect other medicines or vice versa.

For example:

• anticoagulants (i.e., to prevent blood clots, e.g., acetylsalicylic acid, warfarin, ticlopidine);
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan);
• antiplatelet agents (to prevent blood clots in blood vessels), such as ticlopidine or acetylsalicylic acid;
• other NSAIDs, such as acetylsalicylic acid;
• corticosteroids, such as cortisone and prednisone;
• selective serotonin reuptake inhibitors (medicines for depression);
• lithium (used to treat depression);
• methotrexate (used to treat cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• mifepristone (used to induce abortion);
• digoxin and other cardiac glycosides (used for heart disorders);
• hydantoins, such as phenytoin (used to treat epilepsy);
• sulphonamides, such as sulfamethoxazole and cotrimoxazole (used for bacterial infections);
• diuretics (medicines used to increase urine output);
• pentoxifylline (used for circulatory disorders);
• probenecid (used in patients with gout or for infections together with penicillin);
• quinolone antibiotics, such as norfloxacin;
• sulfinpyrazone (used to treat gout);
• insulin and oral hypoglycaemics (used to lower blood glucose);
• cyclosporine and tacrolimus (used to prevent organ transplant rejection);
• thrombolytics (medicines that dissolve or break down blood clots);
• zidovudine (a medicine used against HIV);
• aminoglycoside antibiotics, such as neomycin;
• herbal extracts from Ginkgo biloba;
• baclofen (used to treat involuntary and persistent muscle contractions);
• ion-exchange resins, such as cholestyramine (used to reduce blood cholesterol levels);
• tacrine (used to treat Alzheimer’s disease);
• CYP2C9 inhibitors, such as voriconazole and fluconazole.

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

Interactions with diagnostic tests

If you are undergoing any diagnostic tests (such as blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking or have recently taken this medicine, as it may alter test results.

Taking Dalsydol Rapid with food, drinks and alcohol

Avoid drinking alcohol, as it may worsen the adverse effects of this medicine, especially those affecting the stomach, intestine, or brain.

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 if you are in the last trimester of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may also cause bleeding tendencies in you and your baby and delay or prolong labour. Do not take ibuprofen 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, the lowest possible dose should be used for the shortest possible time. If taken for several days from week 20 of pregnancy onwards, ibuprofen may cause kidney problems in the unborn baby, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby’s heart. If treatment is needed for more than a few days, your doctor may recommend additional monitoring.

This medicine is excreted in breast milk, but it can be taken during breastfeeding if used at the recommended dose for the shortest possible duration.

For women of childbearing age, it should be noted that medicines such as ibuprofen have been associated with reduced fertility. Avoid taking this medicine if you are trying to become pregnant.

Driving and using machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medicine, do not drive or operate dangerous machinery.

This medicine contains sorbitol

This medicine contains 72.4 mg of sorbitol per capsule, equivalent to 1.03 mg/kg.

This medicine contains potassium

This medicine contains potassium, less than 1 mmol (39 mg) per capsule, which is essentially "potassium-free".

3. How to take Dalsydol Rapid

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

The recommended dose is:

• Adults and adolescents weighing 40 kg or more (from 12 years of age):

The recommended dose is 1 capsule (400 mg), which may be taken up to 3 times daily, if necessary. The interval between doses should be at least 6 hours.

The maximum daily dose is 3 capsules (1200 mg of ibuprofen), which must not be exceeded within a 24-hour period.

• Patients with renal, hepatic, or cardiac disease: consult your doctor, as dose reduction may be required.
• Patients over 65 years of age: your doctor should determine the appropriate dose, as a reduction from the usual dose may be necessary.

Use the lowest effective dose for the shortest duration required to relieve symptoms. If you have an infection, see a doctor immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

Children under 12 years of age and adolescents weighing less than 40 kg

This medicine is not intended for children under 12 years of age or adolescents weighing less than 40 kg due to the 400 mg dose of ibuprofen. Other formulations more suitable for this age and body weight group are available.

How to take it

This medicine is taken orally.

Take the medicine with a glass of water. Do not chew it.

Take the medicine with food, especially if you have digestive problems.

Duration of treatment

This medicine should only be taken while pain or fever persists. Once the pain or fever has resolved, you should stop taking the medicine.

If use of this medicine is required in adolescents aged 12 to 18 years for more than 3 days, or if symptoms worsen, consult a doctor.

In adults, if symptoms worsen, if fever lasts more than 3 days, or if pain persists for more than 4 days, consult a doctor.

If you take more Dalsydol Rapid than you should

If you take more medicine than you should, or if a child accidentally ingests the medicine, consult a doctor immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount ingested, or go to the nearest hospital to obtain information about the risk and advice on the measures to take. It is recommended that you provide your healthcare professional with the medicine's packaging and patient information leaflet.

Symptoms of overdose may include stomach pain, nausea, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see also section 4 below), diarrhoea, headache, confusion, involuntary eye movements, and tinnitus. Agitation, drowsiness, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, hypotension, metabolic acidosis, coma, drowsiness, chest pain, palpitations, loss of consciousness, seizures (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and difficulty breathing may be reported. In addition, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute renal failure and liver damage may occur. In asthmatic patients, asthma may be exacerbated. Low blood pressure and reduced breathing may also be observed.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Adverse effects are more common in people over 65 years of age. The occurrence of adverse effects is lower with short-term treatment and when the daily dose is below the recommended maximum dose.

STOP TAKING this medicine and seek medical help immediately if you experience:

• signs of gastrointestinal bleeding, such as severe abdominal pain, black or tar-like stools, and blood or dark particles resembling coffee grounds in vomit;
• signs of a rare but serious allergic reaction, such as worsening of asthma, wheezing or unexplained breathing difficulties, swelling of the face, tongue or throat, difficulty breathing, strong or rapid heartbeat, low blood pressure leading to shock. These signs may occur even the first time this medicine is used;
• serious skin reactions, such as rashes covering the entire body, skin exfoliation, blisters or peeling of the skin;
• flat, red, target-shaped or circular spots on the trunk, often with central blisters, skin peeling, and ulcers in the mouth, throat, nose, genitals, and eyes. These serious skin reactions may be preceded by fever and flu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis);
• widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome);
• widespread 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).

Consult your doctor if you experience the following adverse effects:

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

• stomach problems such as heartburn, stomach pain, nausea, indigestion, diarrhea, vomiting, flatulence (gas), constipation, and mild bleeding in the stomach or intestine which may exceptionally lead to anemia.

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

• gastrointestinal ulcers, perforation or gastrointestinal bleeding, inflammation of the mouth mucosa with ulceration, worsening of existing bowel disease (ulcerative colitis or Crohn's disease), gastritis;
• vision disturbances;
• various skin rashes;
• hypersensitivity reactions with hives and itching.

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

• tinnitus (ringing in the ears);
• increased blood urea concentration, pain in the sides or abdomen, blood in the urine, and fever, which may indicate kidney damage (papillary necrosis);
• decreased hemoglobin levels.

Very rare (may affect more than 1 in 10,000 people):

• esophagitis, pancreatitis, and development of diaphragm-like intestinal stenosis;
• heart failure, heart attack, and swelling of the face and hands (edema);
• reduced urine output, swelling (edema), and cloudy urine (nephrotic syndrome), inflammatory kidney disease (interstitial nephritis), which may lead to acute renal failure. If you experience any of the above symptoms, stop taking Dalsydol Rapid and consult your doctor immediately, as these could be early signs of kidney damage or failure;
• psychotic reactions, depression;
• high blood pressure, vasculitis;
• palpitations;
• liver dysfunction (the first symptom may be a change in skin color), liver damage especially with prolonged treatment, liver failure, acute liver inflammation (acute hepatitis);
• problems with blood cell production. Initial symptoms include fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nosebleeds, skin bleeding, and unexplained bruising. In such cases, treatment must be stopped immediately and medical advice sought. Do not self-medicate with painkillers or fever-reducing medicines (antipyretics);
• skin infections and severe soft tissue complications during chickenpox;
• worsening of infection-related inflammation (e.g., necrotizing fasciitis) has been reported with the use of certain painkillers (NSAIDs). If signs of infection appear or worsen, seek immediate medical attention. The need for antibiotic treatment should be evaluated;
• symptoms of aseptic meningitis, including neck stiffness, headache, nausea, vomiting, fever, or confusion, have been observed during treatment with ibuprofen. This is more likely to occur in patients with autoimmune disorders (e.g., SLE, mixed connective tissue disease). If this occurs, contact your doctor immediately;
• severe forms of skin reactions, such as skin rashes with redness and blisters (e.g., Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lyell syndrome), and hair loss (alopecia).

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

• respiratory tract reactivity, including asthma, bronchospasm, or dyspnea;
• a serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, swollen lymph nodes, and increased neutrophil count (a type of white blood cell);
• widespread red, scaly rash with bumps under the skin and blisters, mainly affecting skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis, AGEP). If you experience these symptoms, stop taking Dalsydol Rapid and seek medical attention immediately (see also section 2);
• skin becomes sensitive to light;
• headache, dizziness, insomnia, restlessness, irritability, or fatigue;
• chest pain, which may be a sign of a potentially serious condition known as Kounis syndrome.

Medicines of this type may be associated with a slightly increased risk of heart attack or stroke (myocardial infarction or cerebrovascular accident). Prolonged bleeding time, edema (fluid retention), high blood pressure, and heart failure have also been reported in association with treatments using medicines such as ibuprofen.

Based on experience with NSAIDs, cases of interstitial nephritis (kidney disorders), nephrotic syndrome (a disorder characterized by protein in the urine and body swelling), and renal failure (sudden loss of kidney function) cannot be ruled out.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines, www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dalsydol Rapid

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

Store below 30 °C.

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

Do not use this medicine if you notice any deterioration of the capsules.

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 dispose of medicines and containers you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

Composition of Dalsydol Rapid

• The active substance is ibuprofen. Each soft capsule contains 400 mg of ibuprofen.
• The other components are:

Core: macrogol 600, potassium hydroxide (E525), purified water.

Capsule shell: gelatin (E441), partially dehydrated liquid sorbitol (E420), and purified water.

Appearance of the product and contents of the pack

Dalsydol Rapid is a soft gelatin capsule, oval in shape (approximately 16 mm × 10 mm), colourless or slightly yellowish, filled with a clear solution.

Dalsydol Rapid is available in packs containing 10, 12, 15, 20 or 30 soft capsules, packaged in PVC/PVDC/Al blisters. Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Viatris Healthcare Limited
Damastown Industrial Park
Mulhuddart, Dublin 15
Dublin
Ireland

Manufacturer

Laboratorios Liconsa S.A.
Pol. Ind. Miralcampo, Avenida Miralcampo nº7
19200, Azuqueca de Henares (Guadalajara),
Spain

For further information about this medicinal product, please contact 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: August 2025.

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