PATIENT INFORMATION LEAFLET

Ibuprofen (arginine) Combix 600 mg oral granule suspension EFG

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

This medicine is indicated for the treatment of pain: headache pain, dental pain, post-operative pain, menstrual pain, symptomatic treatment of headache and febrile states. Ibuprofeno (Arginina) is also indicated in rheumatoid arthritis (including juvenile rheumatoid arthritis) ankylosing spondylitis, osteoarthritis and other acute or chronic rheumatic processes, as well as in other muscle (sprains and strains) and bone pathologies where pain and inflammation occur.

Do not take Ibuprofeno (arginina) Combix

• If you are allergic to Ibuprofeno or other medications such as acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs. Such reactions may include: skin rash with itching, facial swelling, lip or tongue swelling, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach ulcer or bleeding, or have suffered a perforation of the digestive tract.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.
• If you have a serious liver or kidney disease.

Warnings and precautions:

Be especially careful with Ibuprofeno (arginina) Combix:

• If you have had or develop a stomach ulcer, bleeding, or perforation in the stomach or duodenum, 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 disease, and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach protector medication.

• If you take simultaneously medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as Ibuprofeno (arginina) Combix 600 mg may worsen these conditions.
• If you have kidney or liver disease.
• If you have edema (fluid retention).

• If you have asthma or any other respiratory disorder.
• If you have heart, 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 indicate the frequency of these checks.
• See the "Infections" section later.

Infections: Ibuprofeno (arginina) Combix may mask the signs of an infection, such as fever and pain. Consequently, it 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 skin infections related to chickenpox. If you take this medication while having an infection and the symptoms persist or worsen, consult a doctor without delay, which is an important sign of infection.

Signs of allergic reaction to this medication, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibuprofeno (arginina) Combix immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), generalized acute pustular exanthema (PEGA), have been reported in association with ibuprofeno treatment. Interrupt treatment with Ibuprofeno (arginina) Combix and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Cardiovascular Precautions

Nonsteroidal anti-inflammatory drugs like ibuprofeno may be associated with a small increase in the risk of suffering a 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 Ibuprofeno (arginina) Combix 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 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 if you are a smoker.

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

Skin Reactions

Severe skin reactions associated with Ibuprofeno (arginina) Combix treatment have been reported. Stop taking Ibuprofeno (arginina) Combix immediately and seek medical attention immediately if you notice any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Use of Ibuprofeno (arginina) Combix with other medications:

Inform your doctor or pharmacist if you are using, or have recently used, any other medication, including those purchased without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one of them.

Ibuprofeno (arginina) Combix may affect or be affected by other medications. For example:

• Other nonsteroidal anti-inflammatory drugs.

• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).

• Lithium (medication used to treat depression). Your doctor may adjust the dose of this medication.
• Metotrexate. Your doctor may adjust the dose of this antimetabolite (slows down the growth of certain cells produced by the body).
• Mifepristone (inducer of abortions).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hidantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids such as cortisone and prednisolone.
• Diuretics (medications used to increase urine elimination).
• Fluconazole (used in the treatment of fungal infections).
• Pentoxifylline (used in the treatment of intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Quinolone antibiotics such as norfloxacin.
• Sulfinpyrazone (used in gout).
• Sulfonilureas such as tolbutamide (used in diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against 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).

Other medications may also affect or be affected by Ibuprofeno (arginina) Combix treatment. Therefore, always consult your doctor or pharmacist before using Ibuprofeno (arginina) Combix with other medications.

Taking Ibuprofeno (arginina) Combix with food and drinks:

You can take it alone or with food. In general, it is recommended to take it before meals to reduce the possibility of stomach discomfort.

Pregnancy and breastfeeding

Precautions during pregnancy and in fertile women

Due to the association of administering medications of the type Ibuprofeno (arginina) Combix with an increased risk of congenital anomalies/abortions, it is not recommended to administer the same during the first and second trimesters of pregnancy, except in cases where it is strictly necessary and your doctor recommends it. In these cases, the dose and duration will be limited to the minimum possible.From week 20 of pregnancy, Ibuprofeno (arginina) Combix may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

In the third trimester, the administration of Ibuprofeno (arginina) Combix is contraindicated. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong labor more than expected.

For fertile women, it should be taken into account that medications of the type Ibuprofeno (arginina) Combix have been associated with a decrease in the ability to conceive.

Lactation:

Although only small amounts of the medication pass into breast milk, it is recommended not to take ibuprofeno for prolonged periods during lactation.

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

Use in children

Do not administer to children under 14 years old.

Driving and operating machines:

Although this effect occurs rarely, this medication should be used with caution in patients whose activity requires attention and who have observed drowsiness, dizziness, or depression during treatment.

Important information about some of the componentsIbuprofeno (arginina) Combix:

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

This medication contains saccharose. If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

Ibuprofeno (arginina) Combix is administered orally.

The most effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor promptly if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended average dosage is 1 tablet of Ibuprofeno (arginina) Combix every 12 hours. If gastrointestinal discomfort is detected after taking the medication, it should be taken with milk or during meals. In rheumatoid arthritis, higher doses may be required, but in any case, it is recommended not to exceed a daily dose of 2,400 mg of ibuprofen (4 tablets), taking into account that the lowest effective dose should be administered.

In elderly patients, the dosage should be established by the doctor, as it may be necessary to reduce the usual dose. In cases of kidney disorders, doses should be adjusted since the medication is primarily eliminated through this route.

This medication is not recommended for children under 14 years old, as the ibuprofen dose contained is not suitable for the recommended dosage in these children.

If you take more doses ofIbuprofeno (arginina) Combixthan you should:

If you have taken more Ibuprofeno (arginina) Combix than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken.

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

In case of overdose or accidental ingestion, you can also call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

The symptoms of an overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged 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, low potassium levels in the blood, chills, and breathing difficulties have also been reported.

If you forget to takeIbuprofeno (arginina) Combix:

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

Like all medicines, Ibuprofeno (arginina) Combixcan cause side effects.

The side effects observed are described below according to the frequency of presentation:

Very common (in at least 1 in 10 patients); Common (in at least 1 in 100 patients); Uncommon (in at least 1 in 1000 patients); Rare (in at least 1 in 10,000 patients); Very rare (less than 1 in 10,000 patients).

The following side effects have been observed:

Gastrointestinal:

The most common side effects that occur with Ibuprofeno (arginina) Combix 600 mg are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

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 secretion and difficulty breathing.

Rare:severe allergic reactions (anaphylactic shock).

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

Ibuprofeno (arginina) Combix 600 mg may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

Asymptomatic meningitis (inflammation of the membranes covering the brain and spinal cord), in most cases in patients with some autoimmune disease such as systemic lupus erythematosus.

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

Unknown frequency:generalized red scaly rash, with bumps under the skin and localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular exanthema), the skin becomes sensitive to light. Stop taking Ibuprofeno (arginina) Combix if you experience these symptoms and seek medical attention immediately. See section 2.

Central nervous system:

Common:headache, feeling of instability, and nervousness.

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

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

Very rare:asymptomatic meningitis.

Blood:

Very rare:prolongation of bleeding time, alterations in blood cells (the first symptoms may be: fever, sore throat, mouth ulcers, symptoms similar to the flu, excessive fatigue, nasal and skin bleeding).

Cardiovascular:

Ibuprofeno (arginina) Combix may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or cerebral.

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with Ibuprofeno (arginina) Combix.

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

Kidney:

Kidney disease.

Liver:

Rare:hepatitis (inflammation of the liver) and jaundice (yellowing of the skin).Ibuprofeno (arginina) Combix may be associated, in rare cases, with liver damage.

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).

If you consider that any of the side effects you are experiencing is severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Stop taking ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

• Flat, red spots, in the shape of a target or circles 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 symptoms similar to the flu [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. The symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does 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.

KeepIbuprofen (arginina) Combixout of the reach and sight of children.

No special storage conditions are required. Store in the original packaging to protect from light and moisture.

Expiration Date:

This medication should not be used after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medicines. By doing so, you will help protect the environment.

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

The active ingredient 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, peppermint aroma (10.86.4580), spearmint aroma (506041 TP0504) contains cornstarch without gluten, purified water.

Appearance of the product and contents of the packaging

Sachets with oral solution granules.It is presented in the form of a white granulated product with a characteristic peppermint odor.

It is presented in packaging with 20 or 40 sachets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Combix, S.L.U. Laboratories

C/ Badajoz 2, Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

Biocentury Pharmaceutical Laboratory. Ctra. N-II, Km. 71417242 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

Last review date of this leaflet: November 2024

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