Prospect: Information for the user

Ibuprofen (arginine) Farmalid 600 mg granulated for oral solution EFG

Read the entire prospect carefully before starting to take the medication, because it contains important information for you.

• Keep this prospect, as you may have to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you, and you must not give it to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect. See section 4.
• Consult your doctor if you do not feel better or if you feel worse after 3 days of treatment in adolescents and adults.

Ibuprofeno (arginina) Farmalidbelongs to a group of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is indicated for adults and adolescents over 14 years old for the treatment of pain: headache pain, dental pain, post-operative pain, menstrual pain, symptomatic treatment of headache and febrile states. Ibuprofeno (arginina) Farmalid is also indicated for rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, osteoarthritis and other acute or chronic rheumatic processes, as well as other muscle (sprains and strains) and bone pathologies where pain and inflammation occur.

Do not take Ibuprofeno(arginina) Farmalid

• If you are allergic to the active ingredient or any of the other components of this medication (listed in section 6). Such reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach ulcer or bleeding, or have suffered a perforation of the digestive system.
• 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

Consult your doctor or pharmacist before starting to take Ibuprofeno (arginina) Farmalid.

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 elderly patients. 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 acetylsalicylic acid. Also, inform your doctor about the use of other medications that may increase the risk of these bleeding, such as corticosteroids and selective serotonin reuptake inhibitors antidepressants.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-type medications 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 are receiving treatment for an infection, as Ibuprofeno (arginina) Farmalid may mask fever, which is an important sign of infection.
• 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.
• If you have an infection;see the heading "Infections" below.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain. Stop using Ibuprofeno (arginina) Farmalid immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Infections:Ibuprofeno (Arginina) Farmalid may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno (Arginina) Farmalid 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 of the infection persist or worsen, consult a doctor without delay.

Children and adolescents

There is a risk of renal insufficiency in dehydrated children and adolescents.

Cardiovascular Precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) 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.

Inform your doctor or pharmacist before taking Ibuprofeno (arginina) Farmalid if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation 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 are a smoker.

These types of medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Skin reactions

Severe skin reactions associated with treatment with Ibuprofeno (arginina) Farmalid have been reported. Stop taking Ibuprofeno (arginina) Farmalid and see a doctor immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

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

Taking Ibuprofeno (arginina) Farmalid with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to use any other medication.

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

• Acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs.
• Anticoagulant medications (e.g., for treating coagulation problems/preventing coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers, such as atenolol, and angiotensin II receptor antagonists, such as losartan).
• 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 abortion).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins, such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides, 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).
• Sulfonylureas, such as tolbutamide (used in diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (medication against HIV/AIDS).

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

Children and adolescents

Do not administer to children under 14 years old.

Taking Ibuprofeno (arginina) Farmalid with food, drinks, and alcohol

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, lactation, and fertility

If you are pregnant or breastfeeding, consult your doctor or pharmacist before using this medication.

Do not take Ibuprofeno (arginina) Farmalid if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. 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 delivery more than expected. Do not take Ibuprofeno (arginina) Farmalid during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Ibuprofeno (arginina) Farmalid 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.

Due to the association of ibuprofen-type medication administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer it 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 Ibuprofeno is contraindicated.

For fertile women, it should be noted that ibuprofen-type medications 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 ibuprofen for prolonged periods during lactation.

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

Driving and operating machinery

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.

Ibuprofeno (arginina) Farmalid contains aspartame and saccharose

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

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

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

This medicationis administered orally.

The contents of a packet are dissolved in a glass of water and ingested after preparing the corresponding solution.

If gastrointestinal discomfort is detected after ingesting the medication, it will be administeredconcurrently with milk or during meals.

It is essential to use the smallest dose that relieves/controls pain and should not takethis medicationfor longer than necessary to control symptoms.

The effective dose should be used for the shortest duration necessary to alleviate 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 and adolescents over 14 years:

The recommended dose is 1 packet (600 mg of ibuprofen) every 12 hours.

In rheumatoid arthritis, higher doses may be required, but in any case, it is recommended not to exceed the daily dose of 2,400 mg of ibuprofen (4 packets)in adults and 1,600 mg in adolescentsconsidering that the lower dose considered effective should be administered.

Special populations:

In elderly patients, the dosage should be established by the doctor, as there is a possibility that a reduction in the usual dose may be necessary. In cases of kidney disorders, doses should be adjusted since the medication is eliminated primarily by this route.

Children and adolescents:

This medication is not recommended for use in children or adolescents under 14 years, as the dose of ibuprofen contained is not suitable for the recommended dosage in these patients.

Consult a doctor in the case of adolescents if treatment lasts more than 3 days or if symptoms worsen.

If you take more doses ofIbuprofeno (arginina) Farmalidthan you should

If you have taken more ibuprofen than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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The symptoms of 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, as well as blood in the urine, low potassium levels in the blood, chills, and breathing difficulties.

If you forgot to takeIbuprofeno (arginina) Farmalid

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 time for the next dose is near, skip the missed dose and take the next dose at your usual time.

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

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

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

- 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 eruptions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, eritema poliforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

- Generalized skin eruption, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

- Generalized, red, scaly eruption, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Frequencies are established according to the following classification: very common (in more than 1 in 10 patients); common (observed in up to 1 in 10 patients); uncommon (observed in up to 1 in 100 patients); rare (observed in up to 1 in 1,000 patients); very rare (observed in up to 1 in 10,000 patients); frequency unknown (cannot be estimated from available data).

The following side effects have been observed:

Gastrointestinal:

The most common side effects that occur with ibuprofen medications are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in older people. 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 eruption.

Uncommon:skin redness, itching, or swelling, lip, face, or tongue swelling, increased nasal secretion, and breathing difficulty.

Rare:severe allergic reactions (anaphylactic shock).

Very rare:intense skin itching or blisters, joint pain, and fever (systemic lupus erythematosus), hair loss, light-sensitive skin reactions.

Ibuprofen medications 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 autoimmune diseases such as systemic lupus erythematosus.

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

Unknown frequency:A severe skin reaction known as DRESS syndrome may occur. DRESS syndrome symptoms include: skin eruption, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Generalized, red, scaly eruption, with bumps under the skin and blisters, located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofen (arginine) Farmalid if you experience these symptoms and seek medical attention immediately. See section 2. The skin becomes sensitive to light.

Central nervous system:

Common:headache, feeling unsteady, and nervousness.

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

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

Very rare:asymptomatic meningitis.

Blood:

Very rare:prolonged bleeding time, blood cell abnormalities (initial symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nasal and skin bleeding).

Cardiovascular:

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

Edema (fluid retention), hypertension, and heart failure have also been observed in association with ibuprofen medication treatments.

Kidney:

Kidney disease.

Liver:

Rare:hepatitis (liver inflammation) and jaundice (yellow skin discoloration)Ibuprofen medications may be associated, in rare cases, with liver damage.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in the prospectus. 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 in its original packaging to protect it from light and moisture.

Keep out of sight and reach of children.

Expiration Date

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.

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

Composition of Ibuprofeno (Arginina) Farmalid

The active ingredient is ibuprofen. Each blister pack contains 600 mg of ibuprofen in the form of ibuprofen (arginine).

The other components (excipients) are: arginine, aspartame (E-951), compression sugar (sucrose), sodium bicarbonate, sodium saccharin, sodium lauryl sulfate, peppermint aroma (10.86.4580), spearmint aroma (506041 TP0504, contains cornstarch), purified water.

Appearance of Ibuprofeno (Arginina) Farmalid and contents of the packaging

White granule with characteristic peppermint odor. It is presented in the form ofsingle-dose paper/aluminum/polyethylene blisters with oral solution granule.

It is presented in packaging with 20 or 40 blisters.

Holder of the marketing authorization

Farmalider S.A.

C/ La Granja,1

28108 – Alcobendas, Madrid

Spain

Responsible for manufacturing

Toll Manufacturing Services S.L., C/Aragoneses, 2.28108 Alcobendas (Madrid) Spain

or

Lamp S. Prospero S.P.A.

Via Della Pace 25 (San Prospero (MO)) 41030 Italy

Revision date of this leaflet:September2024

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/