Dolorac 600 mg powder for oral suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Dolorac 600 mg powder for oral suspension

Ibuprofen (lysine)

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, talk to your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Dolorac is and what it is used for

Dolorac belongs to a group of medicines known as analgesics. Ibuprofen, the active ingredient in this medicinal product, is a non-steroidal analgesic, antipyretic, and anti-inflammatory agent presented in the form of a soluble salt (ibuprofen lysine).

This medicine is used for the symptomatic treatment of mild to moderate pain and non-chronic inflammatory conditions, such as headache, dental pain, postoperative pain, musculoskeletal pain, and menstrual pain.

2. What you need to know before taking Dolorac

Do not take Dolorac if:

• You are allergic (hypersensitive) to ibuprofen, to any other non-steroidal anti-inflammatory drug (NSAID), to acetylsalicylic acid, or to any of the excipients of this medicine.
• You have previously had a stomach or duodenal bleed or experienced a perforation of the digestive tract while taking a non-steroidal anti-inflammatory drug.
• You suffer from worsening 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

Allergic reactions to ibuprofen, such as breathing difficulties, swelling of the face and neck area (angioedema), and chest pain, have been reported. Immediately stop using Dolorac and contact your doctor or emergency services if you notice any of these symptoms.

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

Gastrointestinal precautions

• 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 medication.
• If you suffer from Crohn's disease or ulcerative colitis, as this medicine may worsen these conditions.

Precautions with other medicines

Inform your doctor if you are simultaneously taking medications that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.

Cardiovascular precautions

Non-steroidal 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), a history of heart attack, coronary 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 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.

In addition, these medicines may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Precautions during pregnancy and in women of childbearing age

Because ibuprofen administration has been associated with an increased risk of congenital malformations or miscarriage, 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 ibuprofen is contraindicated during the third trimester.

For women of childbearing age, it should be noted that ibuprofen has been associated with reduced fertility.

Other disorders and considerations

If you have previously suffered from kidney or liver disease.

If you suffer from 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 affecting the immune system that can involve various vital organs, the nervous system, blood vessels, skin, and joints), or mixed connective tissue disease, ibuprofen may cause aseptic meningitis (inflammation of the meninges—the membranes protecting the brain and spinal cord—not caused by bacteria).

Skin reactions

Serious skin reactions have been reported with ibuprofen, including 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). Discontinue treatment with this medicine and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

• If you have an infection, see the “Infections” section below.

Infections

Ibuprofen may mask signs of infection, such as fever and pain. Therefore, this medicine may delay appropriate treatment of the infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial 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.

Other medicines and Dolorac

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription, especially furosemide, thiazide diuretics, digoxin, phenytoin, lithium, methotrexate, oral hypoglycemics, insulin, zidovudine, corticosteroids, bisphosphonates, or oxypentifylline. The use of this medicine together with salicylates, phenylbutazone, indomethacin, or other non-steroidal anti-inflammatory drugs may increase gastrointestinal damage, so combination therapy is not recommended.

This medicine may affect or be affected by other medicines. For example:

• Anticoagulant medicines (e.g., those used to treat or prevent blood clotting problems, such as 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)

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

Taking Dolorac with food, drinks, and alcohol

This medicine 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 medicine.

Ibuprofen should not be taken during the third trimester (see section “Precautions during pregnancy and in women of childbearing age”).

It is recommended to avoid using this medicine during breastfeeding.

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

Use in elderly patients

Dosage adjustment is generally not required, although in some cases a reduction may be necessary.

Use in children

Administration is not recommended in children under 12 years of age due to the active ingredient dose contained.

Driving and use of machines

Ibuprofen may cause drowsiness or dizziness as a low-incidence adverse reaction, which could impair your ability to drive or operate machinery.

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

• This medicine contains 3 g of cyclodextrin per sachet.
• This medicine contains sucrose. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine. It may cause tooth decay.
• This medicine contains less than 1 mmol (23 mg) of sodium per sachet, i.e., essentially “sodium-free”.

3. How to take Dolorac

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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).

Adults

In adults and adolescents aged 14 years and older, one sachet (600 mg of ibuprofen) every 6–8 hours is recommended, depending on the severity of symptoms and the course of treatment.

Generally, 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 2,400 mg of ibuprofen in adults and 1,600 mg in adolescents aged 12 to 18 years.

Children

The use of this medicine is not recommended in children and adolescents under 14 years of age due to the amount of active substance it contains.

Elderly patients

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

Patients with kidney and/or liver disease

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

Method of administration

For oral use.

Empty the contents of one sachet into half a glass of water, shake and take immediately.

Patients experiencing stomach discomfort should take the medicine during meals.

If you take more Dolorac than you should

If you have taken more medicine than you should, or if a child has accidentally ingested the medicine, contact a doctor or pharmacist immediately, go to the nearest hospital, or call the Toxicology Information Service (telephone 91 562 04 20), indicating the medicine and the amount ingested, to obtain information about the risk and advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), headache, tinnitus, confusion, and involuntary eye movements. At high doses, symptoms such as drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness and dizziness, blood in the urine, chills, and breathing difficulties have been reported.

In case of ingestion of large amounts, activated charcoal should be administered. Gastric emptying should be considered if large amounts have been ingested and within 60 minutes following ingestion.

If you forget to take Dolorac

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 the time for your next dose is approaching, 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 may cause adverse effects, although not everyone experiences them.

The adverse effects observed are described below according to their frequency of occurrence: very common (may affect more than 1 in 10 people); common (may affect up to 1 in 10 people); uncommon (may affect up to 1 in 100 people); rare (may affect up to 1 in 1,000 people); very rare (may affect up to 1 in 10,000 people); frequency not known (cannot be estimated from the available data).

Gastrointestinal:

The most common adverse effects are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stool, oral ulcers, and worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Skin and subcutaneous tissue:

Very rarely, this medicine may be associated with severe blistering reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.

Hypersensitivity reactions, manifesting as skin rash with or without itching, may rarely occur.

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 cell).

Frequency not known: 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 beginning of treatment (acute generalized exanthematous pustulosis). Stop taking this medicine if you experience these symptoms and seek immediate medical attention. See also section 2. The skin may become sensitive to light.

Cardiac and vascular:

This medicine may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment using this medicine.

Frequency not known: Chest pain, which may be a symptom of a potentially serious allergic reaction called Kounis syndrome.

Hepatobiliary:

Liver injury may occur, although rarely.

Immune system:

Cases of aseptic meningitis (inflammation of the membranes covering the brain and spinal cord) have been reported, mostly in patients with autoimmune disorders such as systemic lupus erythematosus.

Nervous system:

Headache and drowsiness may rarely occur. Aseptic meningitis (see Immune system).

Psychiatric:

Neurological-type reactions such as depression, confusion, and dizziness.

Ear and labyrinth:

Tinnitus (ringing in the ears) may rarely occur.

Eye:

Visual disturbances.

Blood and lymphatic system:

Prolonged use and high doses may cause changes in blood cells.

Respiratory, thoracic, and mediastinal:

Bronchospasm (bronchial constriction) may occur infrequently and, in any case, mainly in predisposed patients.

If any of the following adverse effects occur, stop treatment immediately and consult your doctor without delay:

• Flat, red, target-shaped or circular spots on the trunk, often with blisters in the center, 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).
• Generalized skin rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Generalized, 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).

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Dolorac

No special storage conditions are required.

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

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 or household waste. Dispose of unused containers and medicines at the SIGRE Point at your pharmacy. Ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Dolorac

• The active substance 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 flavour (containing gum arabic (E-414), ascorbic acid (E-300) and corn maltodextrin), sodium saccharin, sodium cyclamate, sodium citrate and sucrose.

Appearance of Dolorac and contents of the pack

It is presented as a white powder, packed in sachets.

Each pack contains 20 or 40 unit-dose sachets.

Marketing Authorisation Holder and Manufacturer

LABORATORIO DE APLICACIONES FARMACODINÁMICAS, S.A.

Grassot, 16 - 08025- Barcelona (Spain)

Date of the most recent review of this leaflet: January 2024

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/