Ibuprofen (arginine) Combix 600 mg granules for oral solution EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibuprofen (arginine) Combix 600 mg granules for oral solution EFG

Read the entire leaflet carefully before you start taking this medicine.

• 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 personally and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you think any of the side effects you experience is severe or if you notice any side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Ibuprofen (arginine) Combix is and what it is used for
2. Before you take Ibuprofen (arginine) Combix
3. How to take Ibuprofen (arginine) Combix
4. Possible side effects
5. How to store Ibuprofen (arginine) Combix
6. Further information

1. What Ibuprofen (arginine) Combix is and what it is used for

Ibuprofen (arginine) belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for the treatment of pain: headaches, dental pain, postoperative pain, menstrual pain, symptomatic treatment of headache and febrile conditions. Ibuprofen (arginine) is also indicated in rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, osteoarthritis, and other acute or chronic rheumatic disorders, as well as in other muscular (sprains and strains) and bone conditions where pain and inflammation occur.

2. Before taking Ibuprofen (arginine) Combix

Do not take Ibuprofen (arginine) Combix

• If you are allergic to ibuprofen or other medicines such as acetylsalicylic acid or other non-steroidal anti-inflammatory drugs. Such reactions may include itchy skin rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have had a stomach or duodenal ulcer or gastrointestinal bleeding or have experienced a perforation of the digestive tract.
• If you suffer from severe heart failure.
• If you are in the third trimester of pregnancy.
• If you have severe liver or kidney disease.

Warnings and precautions:

Take special care with Ibuprofen (arginine) Combix:

• 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 greater 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 adding a stomach-protective medicine.

• If you are taking concomitant 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 may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you have Crohn's disease or ulcerative colitis, as medicines like Ibuprofen (arginine) Combix 600 mg may worsen these conditions.
• If you have previously had kidney or liver disease.
• If you have edema (fluid retention).
• If you suffer from asthma or any other respiratory disorder.
• If you have heart, kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on the frequency of such checks.
• See the section "Infections" below.

Infections: Ibuprofen (arginine) Combix may mask signs of infection such as fever and pain. Therefore, Ibuprofen (arginine) Combix 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 symptoms persist or worsen, consult a doctor immediately, as this may be a sign of a serious infection.

Allergic reactions to ibuprofen have been reported, including respiratory problems, facial and neck swelling (angioedema), and chest pain. Stop taking Ibuprofen (arginine) Combix immediately and contact your doctor or emergency medical services without delay if you experience any of these symptoms.

Serious skin reactions such as 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) have been reported with ibuprofen treatment. Discontinue treatment with Ibuprofen (arginine) Combix and seek immediate medical attention if you notice any of the symptoms related to these serious skin reactions described in section 4.

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.

You should discuss your treatment with your doctor or pharmacist before taking Ibuprofen (arginine) Combix if:

• You have heart problems, including heart failure, angina (chest pain), have had a heart attack, coronary artery 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.

Also, this type of medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Serious skin reactions have been reported with Ibuprofen (arginine) Combix. Stop taking Ibuprofen (arginine) Combix and see a doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.

Use of Ibuprofen (arginine) Combix with other medicines:

Inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including those obtained without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.

Ibuprofen (arginine) Combix may affect or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs.

• Anticoagulant medicines (e.g., to treat or prevent blood clotting problems, e.g., acetylsalicylic acid, warfarin, ticlopidine).

• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.

• Methotrexate. Your doctor may adjust the dose of this antimetabolite medicine (which slows the growth of certain body cells).

• Mifepristone (used to induce abortion).

• Digoxin and cardiac glycosides (used to treat heart disorders).

• Hydantoins such as phenytoin (used to treat epilepsy).

• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).

• Corticosteroids such as cortisone and prednisolone.

• Diuretics (medicines used to increase urine elimination).

• Fluconazole (used to treat fungal infections).

• Pentoxifylline (used for intermittent claudication).

• Probenecid (used in patients with gout or together with penicillin for infections).

• Quinolone antibiotics such as norfloxacin.

• Sulfinpyrazone (for gout).

• Sulfonylureas such as tolbutamide (for diabetes).

• Tacrolimus (used in organ transplants to prevent rejection).

• Zidovudine (an anti-HIV medicine).

• 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 Ibuprofen (arginine) Combix. Therefore, always consult your doctor or pharmacist before using Ibuprofen (arginine) Combix with other medicines.

Taking Ibuprofen (arginine) Combix with food and drink:

You may take it alone or with food. It is generally recommended to take it before meals to reduce the possibility of stomach discomfort.

Pregnancy and breastfeeding

Precautions during pregnancy and in women of childbearing age

Because administration of medicines such as Ibuprofen (arginine) Combix has been associated with an increased risk of congenital malformations and miscarriage, administration is not recommended during the first and second trimesters of pregnancy unless strictly necessary and specifically advised by your doctor. In such cases, the dose and duration will be limited to the minimum possible. From week 20 of pregnancy, Ibuprofen (arginine) Combix may cause kidney problems in your fetus if taken for more than a few days, which may lead 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 for longer than a few days is needed, your doctor may recommend additional monitoring.

In the third trimester, administration of Ibuprofen (arginine) Combix is contraindicated. It may cause kidney and heart problems in your fetus. It may affect your tendency and your baby's tendency to bleed and may delay or prolong labor beyond expected duration.

For women of childbearing age, it should be noted that medicines such as Ibuprofen (arginine) Combix have been associated with reduced fertility.

Breastfeeding:

Although only small amounts of the medicine pass into breast milk, ibuprofen is not recommended for prolonged use during breastfeeding.

Therefore, if you become pregnant or are breastfeeding, consult your doctor or pharmacist before using any medicine.

Use in children:

Do not administer to children under 14 years of age.

Driving and use of machines:

Although this effect is rare, this medicine should be used with caution in patients whose activities require alertness and who experience drowsiness, dizziness, or depression during treatment.

Important information about some of the components of Ibuprofen (arginine) Combix:

This medicine may be harmful to people with phenylketonuria because it contains aspartame, a source of phenylalanine.

This medicine contains sucrose. If your doctor has told you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Ibuprofen (arginine) Combix

Ibuprofen (arginine) Combix is administered orally.

The lowest effective dose for the shortest duration necessary to relieve symptoms should be used. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended average dosage is 1 sachet of Ibuprofen (arginine) Combix every 12 hours. If gastric discomfort occurs after taking the medicine, it should be taken together with milk or during meals. In rheumatoid arthritis, higher doses may be required; however, in any case, it is recommended not to exceed the daily dose of 2,400 mg of ibuprofen (4 sachets), bearing in mind that the lowest effective dose should be administered.

In elderly patients, dosage should be determined by the physician, as a reduction of the usual dose may be necessary. In case of kidney disorders, doses should be adjusted, since the drug is primarily eliminated through this route.

Use of this medicine is not recommended in children under 14 years of age, as the ibuprofen dose it contains is not suitable for the recommended pediatric dosage.

If you take more Ibuprofen (arginine) Combix than you should:

If you have taken more Ibuprofen (arginine) Combix than you should, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

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

In case of overdose or accidental ingestion, you may also call the Toxicology Information Service at telephone: 91 562 04 20, indicating the medicine and the amount ingested.

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, low blood potassium levels, chills, and breathing difficulties have been reported.

If you forget to take Ibuprofen (arginine) Combix:

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

4. Possible adverse effects

Like all medicines, Ibuprofen (arginine) Combix can cause adverse effects.

The adverse effects observed are described below according to their frequency of occurrence:

Very common (at least 1 in 10 patients); Common (at least 1 in 100 patients); Uncommon (at least 1 in 1,000 patients); Rare (at least 1 in 10,000 patients); Very rare (less than 1 in 10,000 patients).

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects occurring with medicines such as Ibuprofen (arginine) Combix 600 mg 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 stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Skin and allergic reactions:

Common: skin rash.

Uncommon: skin redness, itching or swelling of the skin, swelling of the lips, face or tongue, increased nasal discharge, and breathing difficulty.

Rare: severe allergic reactions (anaphylactic shock).

Very rare: sudden onset of intense skin itching or skin blisters, joint pain and fever (systemic lupus erythematosus), hair loss, skin reactions due to light exposure.

Medicines such as Ibuprofen (arginine) Combix 600 mg may very rarely be associated with severe blistering reactions such as Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis, and allergic vasculitis.

Aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), mostly occurring in patients with autoimmune disorders such as systemic lupus erythematosus.

Severe allergic reaction that may present with nausea, vomiting, swelling of the face, tongue and throat, breathing difficulty, asthma, palpitations, hypotension or shock.

Frequency not known: widespread 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), skin becoming sensitive to light. Stop taking Ibuprofen (arginine) Combix if you experience these symptoms and seek immediate medical attention. See also section 2.

Central nervous system:

Common: headache, dizziness, nervousness.

Uncommon: fatigue or drowsiness, insomnia, anxiety, visual disturbances, tinnitus (ringing or buzzing in the ears).

Rare: disorientation or confusion, depression, abnormal or blurred vision, and hearing difficulty.

Very rare: aseptic meningitis.

Blood:

Very rare: prolonged bleeding time, blood cell disorders (initial symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds, and skin bleeding).

Cardiovascular:

Medicines such as Ibuprofen (arginine) Combix 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 medicines like Ibuprofen (arginine) Combix.

Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Kidney:

Kidney disease.

Liver:

Rare: hepatitis (liver inflammation) and jaundice (yellowing of the skin). Medicines such as Ibuprofen (arginine) Combix may rarely be associated with liver damage.

A severe 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 cells).

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Discontinue treatment with ibuprofen and seek immediate medical attention if you notice any of the following symptoms:

• Flat, non-elevated red spots, target-like or circular rashes on the trunk, often with blisters in the center, skin peeling, mouth, throat, nose, genital or 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].
• Widespread skin rash, high 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 (acute generalized exanthematous pustulosis).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ibuprofen (arginine) Combix

Keep Ibuprofen (arginine) Combix out of the reach and sight of children.

Special storage conditions are not required. Store in the original container to protect from light and moisture.

Expiry:

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

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. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Additional Information

Composition of ibuprofen (arginine) Combix 600 mg granules for oral solution

The active substance is Ibuprofen. Each sachet contains 600 mg of Ibuprofen.

The other components (excipients) are: Arginine, Aspartame (E-951), Compressing sugar (sucrose), sodium bicarbonate, sodium saccharin, sodium lauryl sulfate, menthol flavour (10.86.4580), mint flavour (506041 TP0504) containing gluten-free corn starch, purified water.

Appearance of the product and contents of the pack

Sachets containing granules for oral solution. It is presented as white granules with a characteristic mint odour.

It is available in packs containing 20 or 40 sachets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Laboratorio Farmacéutico Biocentury. Ctra. N-II, Km. 714 17242 Quart (Girona) Spain

or

Lamp S. Prospero S.p.A., Via de la Pace, 25 – 41030 San Prospero (MO). Italy

or

Toll Manufacturing Services S.L., C/Aragoneses, 2. 28108 Alcobendas (Madrid) Spain

Date of the most recent revision of this leaflet: November 2024

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