IBUPROFEN (ARGININE) FARMALID 600 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the User

Ibuprofen (Arginine) Farmalid 600 mg Granules for Oral Solution EFG

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• Keep this package leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. 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.

Contents of the Package Leaflet

1. What is Ibuprofen (Arginine) Farmalid and what is it used for
2. What you need to know before taking Ibuprofeno (Arginine) Farmalid
3. How to take Ibuprofeno (Arginine) Farmalid
4. Possible side effects
5. Storage of Ibuprofeno (Arginine) Farmalid
6. Contents of the pack and further information

1. What is Ibuprofen (Arginine) Farmalid and what is it used for

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

This medicine is indicated in adults and adolescents over 14 years for the treatment of pain: headaches, dental pain, post-operative pain, menstrual pain, symptomatic treatment of headache and febrile conditions. Ibuprofen (Arginine) Farmalid 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.

2. What you need to know before taking Ibuprofen (Arginine) Farmalid

Do not take Ibuprofen (Arginine) Farmalid

• If you are allergic to the active substance or any of the other components of this medicine (listed in section 6). Such reactions could be: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.
• If you have had a stomach or duodenal ulcer 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 severe liver or kidney disease.

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Ibuprofen (Arginine) Farmalid.

If you have had or developed an ulcer, bleeding, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without prior warning symptoms.

This risk is greater when high doses and prolonged treatments are used, 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 protective medication.

• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the acetylsalicylic acid type. You should also discuss the use of other medications that could increase the risk of such bleeding, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-like medications can worsen these conditions.
• If you have had 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 Ibuprofen (Arginine) Farmalid can 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 "Infections" section below.
• With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibuprofen (Arginine) Farmalid immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Infections: Ibuprofen (Arginine) Farmalid may hide the signs of an infection, such as fever and pain. Consequently, Ibuprofen (Arginine) Farmalid may delay appropriate treatment of the infection, which can increase the risk of complications. This has been observed in bacterial pneumonia and bacterial 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 kidney failure in dehydrated children and adolescents.

Cardiovascular Precautions

Anti-inflammatory/analgesic medications like ibuprofen may be associated with a small increased 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 discuss your treatment with your doctor or pharmacist before taking Ibuprofen (Arginine) Farmalid, if:

• you have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (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, have a family history of heart disease or stroke, or if you are a smoker.

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

Skin Reactions

Severe skin reactions have been reported with Ibuprofen (Arginine) Farmalid treatment. Stop taking Ibuprofen (Arginine) Farmalid and see a doctor immediately if you experience any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a 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), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Ibuprofen (Arginine) Farmalid and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Taking Ibuprofen (Arginine) Farmalid with Other Medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications.

Ibuprofen (Arginine) Farmalid may affect or be affected by other medications. For example:

• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medications that lower blood pressure (ACE inhibitors, such as captopril, beta-blockers like atenolol, and angiotensin-II receptor antagonists like losartan).
• Lithium (a medication used to treat depression). Your doctor may adjust the dose of this medication.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite medication (slows down the growth of certain cells produced by the body).
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins like phenytoin (used in the treatment of epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Diuretics (medications used to increase urine production).
• Fluconazole (for the treatment of fungal infections).
• Pentoxifylline (for intermittent claudication).
• Probenecid (used in patients with gout or with penicillin in infections).
• Antibiotics of the quinolone group like norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas like tolbutamide (for diabetes).
• Tacrolimus (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).

Other medications may also affect or be affected by treatment with Ibuprofen (Arginine) Farmalid. Therefore, you should always consult your doctor or pharmacist before using Ibuprofen (Arginine) Farmalid with other medications.

Children and Adolescents

Do not administer to children under 14 years of age.

Taking Ibuprofen (Arginine) 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, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Do not take Ibuprofen (Arginine) 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 and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take Ibuprofen (Arginine) 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 the 20th week of pregnancy, Ibuprofen (Arginine) Farmalid may cause kidney problems in your fetus if taken for more than a few days, which can cause low levels of the fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for more than a few days, your doctor may recommend additional checks.

Because the administration of ibuprofen-like medications has been associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimester of pregnancy unless 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 women of childbearing age, it should be taken into account that ibuprofen-like medications have been associated with a decrease in fertility.

Breastfeeding

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

Therefore, if you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before taking any medication.

Driving and Using Machines

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

Ibuprofen (Arginine) Farmalid Contains Aspartame and Sucrose

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

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

3. How to Take Ibuprofen (Arginine) Farmalid

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

This medication is administered orally.

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

If stomach discomfort is detected after taking the medication, it should be administered together with milk or during meals.

It is important that you use the smallest dose that relieves/controls the pain and do not take this medication for longer than necessary to control your symptoms.

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

Adults and Adolescents Over 14 Years:

The recommended dose is 1 sachet (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 sachets) in adults and 1,600 mg in adolescents, taking into account that the lowest effective dose should be administered.

Special Populations:

In elderly patients, the dosage should be established by the doctor, as there may be a need to reduce the usual dose. In case of kidney disorders, the doses should be adjusted since the medication is eliminated mainly through this route.

Children and Adolescents:

The use of this medication is not recommended in children or adolescents under 14 years of age, as the dose of ibuprofen it contains is not suitable for the recommended dosage in these patients.

You should consult your doctor if, in adolescents, the treatment lasts more than 3 days or if the symptoms worsen.

If You Take More Ibuprofen (Arginine) Farmalid Than 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 or the Toxicology 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), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness, and dizziness, blood in the urine, low potassium levels in the blood, chills, and breathing problems have been reported.

If You Forget to Take Ibuprofen (Arginine) Farmalid

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time for the next dose is near, skip the forgotten dose and take the next dose at the usual time.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

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

• Chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.
• Red, non-raised, target-shaped or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread rash, high body temperature, and swollen lymph nodes (DRESS syndrome).
• Widespread, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Frequencies are established according to the following classification: very frequent (in more than 1 in 10 patients); frequent (observed in up to 1 in 10 patients); infrequent (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 adverse effects have been observed:

Gastrointestinal:

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

Skin and allergic reactions:

Frequent:skin rash.

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

Rare:severe allergic reactions (anaphylactic shock).

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

Medicines like ibuprofen may be associated, in very rare cases, 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), in most cases in patients with some autoimmune disease such as systemic lupus erythematosus.

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

Frequency unknown: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).

Widespread, red, scaly rash, with bumps under the skin and blisters, mainly in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Ibuprofeno (arginina) Farmalid if you experience these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.

Central Nervous System:

Frequent:headache, feeling of instability, and nervousness.

Infrequent:fatigue or drowsiness, insomnia, anxiety, vision changes, 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, alterations in blood cells (the first symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nasal and skin bleeding).

Cardiovascular:

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

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatments with medicines of the ibuprofen type.

Kidney:

Kidney disease.

Liver:

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

Reporting of Adverse Effects

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

5. Conservation of Ibuprofeno (arginina) Farmalid

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

Keep out of sight and reach of children.

Expiration Date

Do not use this medicine after the expiration date that appears on the package, after CAD. The expiration date is the last day of the month indicated.

Medicines should not be thrown away through the sewers or in the trash. Deposit the packages and medicines you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibuprofeno (Arginina) Farmalid

The active ingredient is ibuprofen. Each sachet contains 600 mg of ibuprofen in the form of ibuprofeno (arginina).

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

Appearance of Ibuprofeno (Arginina) Farmalid and Package Contents

White granulate with characteristic mint odor. It is presented in the form of single-dose paper/aluminum/polyethylene sachets with granulate for oral solution.

It is presented in packages with 20 or 40 sachets.

Marketing Authorization Holder

Farmalider S.A.

C/ La Granja, 1

28108 – Alcobendas, Madrid

Spain

Manufacturer

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

Date of the Last Revision of this Prospectus:September 2024

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/