Label: information for the user

Dolorac 600 mg powder for oral suspension

Ibuprofen (lysine)

Read this label carefully before starting to take this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

1. What is Dolorac and how is it used

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

3. How to take Dolorac

4. Possible adverse effects

5. Storage of Dolorac

6. Contents of the package and additional information

Dolorac belongs to the group of medicationsknown as analgesics. The active ingredient of this specialty, Ibuprofen, is an analgesic,antipyretic, and nonsteroidal anti-inflammatory agent that is presented in the form of a soluble salt (Ibuprofen lysine).

This medication is used for the symptomatic treatment of pain, of mild to moderate intensity and ofnon-chronic inflammatory processes, such as headache, toothache, post-operative pain, musculoskeletal pain, and menstrual pain.

Do not takeDolorac if:

- You are allergic (hypersensitive) to ibuprofen, any other nonsteroidal anti-inflammatory drug, acetylsalicylic acid, or any of the excipients of this medication.

- You have had a stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking a nonsteroidal anti-inflammatory drug.

- You have an aggravation of an inflammatory bowel disease (ulcerative colitis).

- You have severe liver or kidney disease.

- You have severe heart failure.

- You are in the third trimester of pregnancy.

Warnings and precautions

Signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported with ibuprofen. Stop using Dolorac immediately and contact your doctor or emergency services if you observe any of these signs.

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

Gastrointestinal precautions

• If you have had or developed a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as 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 treatment, 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 protector medication.
• If you have Crohn's disease or ulcerative colitis, this medication may worsen these conditions.

Precautions with other medications

Inform your doctor if you are taking anticoagulant medications, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, corticosteroids, and selective serotonin reuptake inhibitors (SSRIs), as they may increase the risk of bleeding.

Cardiovascular precautions

Nonsteroidal anti-inflammatory drugs like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should consult your doctor or pharmacist before taking this medication if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked 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 if you are a smoker.

This type of medication may cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Precautions during pregnancy and in fertile women

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

In the third trimester, the administration of ibuprofen is contraindicated.

For fertile women, it should be noted that ibuprofen has been associated with a decrease in fertility.

Other conditions and considerations

If you have kidney or liver disease.

If you have asthma or any respiratory disorder.

In other conditions that predispose to fluid retention, ibuprofen should be administered with caution and under medical supervision. In elderly patients, patients with blood disorders, a tendency to bleeding, 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), or mixed connective tissue disease, 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).

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 exanthema (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with this medication and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

• If you have an infection, see the "infections" heading below.

Infections

Ibuprofen may mask the signs of an infection, such as fever and pain. Consequently, this medication may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and in skin infections related to varicella. If you take this medication while having an infection and the symptoms persist or worsen, consult a doctor without delay.

Other medications and Dolorac

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medication, including over-the-counter medications, especially furosemide, thiazide diuretics, digoxin, phenytoin, lithium, methotrexate, oral hypoglycemic agents, insulin, zidovudine, corticosteroids, bisphosphonates, or oxipentifilina. The use of this medication with salicylates, phenylbutazone, indomethacin, or other nonsteroidal anti-inflammatory drugs may potentiate gastrointestinal lesions, so concomitant therapy is not recommended.

This medication may affect or be affected by other medications. For example:

• Anticoagulant medications (e.g., for treating coagulation problems/preventing coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine)
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan)

Other medications may also affect or be affected by the treatment with this medication. Therefore, you should always consult your doctor or pharmacist before using it with other medications.

Taking Dolorac with food, drinks, and alcohol

This medication can be taken regardless of meals.

Consuming alcohol during treatment may increase the risk of gastrointestinal adverse reactions.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using any medication.

Ibuprofen should not be taken during the third trimester (see section on precautions during pregnancy and fertile women).

It is recommended to avoid using this medication during breastfeeding.

Therefore, if you become pregnant or are breastfeeding, consult your doctor.

Use in elderly patients

Generally, no modification of the dosage is required, although in some cases, a reduction of the dosage may be necessary.

Use in children

This medication is not recommended for children under 12 years due to the active ingredient dose it contains.

Driving and operating machinery

Ibuprofen may cause, as a low-incidence adverse reaction, drowsiness or vertigo, which may interfere with the ability to drive or operate machinery.

Dolorac contains cyclodextrin (betadex) (E-459), tartrazine (E-102), sucrose, and sodium.

- This medication contains 3 g of cyclodextrin in each sachet.

- This medication may cause allergic reactions because it contains tartrazine (E-102). It may cause asthma, especially in patients allergic to acetylsalicylic acid.

- This medication contains sucrose. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause tooth decay.

- This medication contains less than 1 mmol (23 mg) per sachet, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Adults

For adults and adolescents 14 years and older, it is recommended to take one packet (600 mg of ibuprofen) every 6-8 hours, according to the intensity of the symptoms and the evolution of the treatment.

The recommended daily dose is 1200 mg of ibuprofen, divided into 3 or 4 doses. In some treatments, higher doses may be required, but in any case, it is recommended not to exceed the maximum daily dose of 2400 mg of ibuprofen in adults and 1600 mg in adolescents 12 to 18 years old.

Children

This medication is not recommended for use in children and adolescents under 14 years old, due to the active ingredient dose it contains.

Senior patients

Your doctor may prescribe a lower dose than usual.If so, the dose can only be increased once your doctor has confirmed that you tolerate the medication well.

Patients with kidney and/or liver diseases

If you have a kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

Method of use

For oral administration.

Empty the contents of one packet into a glass of water, shake and take afterwards.

Patients with stomach discomfort should take the medication during meals.

If you take more Dolorac than you should

If you have taken more medication than you should, or if a child has ingested the medication by accident, consult a doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicological Information Service (phone 91 562 04 20) indicating the medication and the amount ingested, to inform yourself about the risk and ask for advice on the measures to be taken.

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. Blood in the urine, chills, and breathing difficulties have also been reported.

In case of ingestion of significant amounts, activated charcoal should be administered. Gastric lavage will be considered if significant amounts have been ingested and within 60 minutes of ingestion.

If you forgot to takeDolorac

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 questions about the use of the medication, ask your doctor or pharmacist.

Like all medicines, this medicine canhave side effects, although not everyone will experience them.

The side effects observed are described below according to the frequency of presentation: very common (may affect more than 1 in 10 patients); common (may affect up to 1 in 10 patients); uncommon (may affect up to 1 in 100 patients); rare (may affect up to 1 in 1,000 patients); very rare (may affect up to 1 in 10,000 patients); frequency unknown (cannot be estimated from available data.

Gastrointestinal:

The most common side effects that may occur are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Alsonausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have been observed. Less frequently, the appearance of gastritis has been observed.

Skin and subcutaneous tissue:

May be associated, invery rare occasions with severe blistering reactions such as Stevens-Johnson Syndromeand Toxic Epidermal Necrolysis.

Rarely, hypersensitivity reactions may be observed, which manifest as skin rash with more or less itching.

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).

Frequency "unknown": Generalized red scaly rash, with bumps under the skin and localized blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking this medicine if you experience these symptoms and seek medical attention immediately. See also section 2. The skin becomes sensitive to light.

Cardiac and vascular:

May be associated witha moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke.

Also, edema (fluid retention), hypertension, and heart failure have been observed in association with treatment with this medicine.

Frequency unknown: Chest pain, which may be a symptom of a potentially severe allergic reaction called Kounis syndrome.

Hepatobiliary:

May be associated, inrare occasions, with liver damage.

Immune system:

Cases of aseptic meningitis (inflammation of the membranes covering thebrain and spinal cord) have been reported, in most cases in patients with some autoimmune disease such as systemic lupus erythematosus.

Nervous system:

Rarely, headache and drowsiness may be observed.Aseptic meningitis (see immune system).

Psychiatric:

Neurological reactions such as depression, confusion, and drowsiness

Ear and labyrinth:

Rarely, tinnitus may be observed.

Eye:

Visual disturbances.

Blood and lymphatic system:

After prolonged administration and at high doses, it may cause alterations in blood cells.

Respiratory, thoracic, and mediastinal:

With low incidence, and in any case in predisposed patients, it may lead tobronchospasm (contraction of the bronchi).

If any of the side effects mentioned below appear, interrupt the treatment and seek immediate medical attention:

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, including possible side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

No special storage conditions are required.

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

Do not use this medication after the expiration date that appears on the packaging after (CAD).The expiration date is the last day of the month indicated.

Do not dispose of medications through drains or trash.Deposit the packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Dolorac

• The active ingredient is ibuprofen. Each sachet contains 600 mg of Ibuprofen (provided by 1025 mg of Ibuprofen lysine).
• The other components (excipients) are betadex (E-459), lemon aroma (contains tartrazine (E-102), cornstarch and corn maltodextrin), sodium saccharin, sodium cyclamate, sodium citrate and sucrose.

Appearance of Doloracand contents of the packaging

It is presented in the form of a powder, white in color, packaged in sachets.

Each package contains20 or 40 single-dose sachets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorio de Aplicaciones Farmacodinámicas, S.A.

Grassot, 16 - 08025- Barcelona (Spain)

Date of the last review of this leaflet:January 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/