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

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

Read the entire leaflet carefully before starting to take this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only; do not give it to others, even if they have the same symptoms as you, as it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if the effects are 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.

Leaflet contents

1. What Ibuprofeno (arginina) Farmalid is and what it is used for
2. What you need to know before taking Ibuprofeno (arginina) Farmalid
3. How to take Ibuprofeno (arginina) Farmalid
4. Possible adverse effects
5. How to store Ibuprofeno (arginina) Farmalid
6. Contents of the pack and other information

1. What Ibuprofeno (arginina) Farmalid is and what it is used for

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

This medicine is indicated for adults and adolescents over 14 years of age for the treatment of pain: headaches, dental pain, postoperative pain, menstrual pain, symptomatic treatment of headache and febrile conditions. Ibuprofeno (arginina) Farmalid is also indicated in rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, osteoarthritis, and other acute or chronic rheumatic conditions, as well as in other muscle (sprains and strains) and bone disorders 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 to any of the other ingredients of this medicine (listed in section 6). Such reactions could include skin rash with itching, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• If you have had a stomach or duodenal ulcer, gastrointestinal bleeding, or have experienced 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 Ibuprofeno (arginina) Farmalid.

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 and prolonged treatments are used, in patients with a history of peptic ulcer, and in elderly patients. In these cases, your doctor may consider the possibility of adding a stomach-protective medication.

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

• If you suffer from Crohn's disease or ulcerative colitis, as ibuprofen-type medications can worsen these conditions.

• If you have previously suffered from kidney or liver disease.

• If you experience edema (fluid retention).

• If you suffer from 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 long-term (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on the frequency of these checks.

• If you have an infection; see the section «Infections» below.

• Allergic reactions to ibuprofen have been reported, including respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop taking Ibuprofeno (arginina) Farmalid immediately and contact your doctor or emergency medical services without delay if you notice any of these signs.

Infections: Ibuprofeno (Arginina) Farmalid may mask signs of infection, such as fever and pain. Therefore, Ibuprofeno (Arginina) Farmalid 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 medication while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Children and adolescents

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

Cardiovascular precautions

Anti-inflammatory/analgesic medications 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 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 arterial disease (circulation problems in the 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.

Furthermore, these types of medications 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 Ibuprofeno (arginina) Farmalid. Stop taking Ibuprofeno (arginina) Farmalid and contact your 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.

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 in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno (arginina) Farmalid and seek immediate medical attention if you notice any symptoms related to these severe skin reactions described in section 4.

Taking Ibuprofeno (arginina) Farmalid with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

• Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs).
• Anticoagulant medicines (e.g., for treating or preventing blood clotting problems, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that lower blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin-II receptor antagonists such as losartan).
• 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 (abortion-inducing agent).
• 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 (medicines used to increase urine elimination).
• Fluconazole (for the treatment of fungal infections).
• Pentoxifylline (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 transplantation to prevent rejection).
• Zidovudine (an anti-HIV medicine).

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

Children and adolescents

Do not administer to children under 14 years of age.

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

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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Do not take Ibuprofeno (arginina) Farmalid during 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 may delay or prolong labor more than expected. Do not take Ibuprofeno (arginina) Farmalid during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, the lowest effective dose should be used for the shortest possible time. From week 20 of pregnancy, Ibuprofeno (arginina) Farmalid may cause kidney problems in the 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.

Because the use of ibuprofen-type medicines has been associated with an increased risk of congenital malformations and miscarriage, their 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.

Ibuprofen is contraindicated during the third trimester of pregnancy.

For women of childbearing age, it should be noted that ibuprofen-type medicines such as Ibuprofeno (arginina) Farmalid have been associated with a reversible reduction in fertility.

Breastfeeding

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

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

Driving and use of machines

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

Ibuprofeno (arginina) Farmalid contains aspartame and sucrose

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

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

3. How to take Ibuprofen (arginine) Farmalid

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

This medicine is administered orally.

Dissolve the contents of one sachet in a glass of water and take after preparing the corresponding solution.

If gastric discomfort occurs after taking the medicine, it should be taken together with milk or during meals.

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

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

Adults and adolescents over 14 years of age:

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

In rheumatoid arthritis, higher doses may be required; however, it is recommended not to exceed a daily dose of 2,400 mg of ibuprofen (4 sachets) in adults and 1,600 mg in adolescents, bearing in mind that the lowest effective dose should be administered.

Special populations:

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.

Children and adolescents:

The use of this medicine 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 dosing in these patients.

Consult your doctor if, in adolescents, treatment lasts longer than 3 days or if 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 container, consult your doctor or pharmacist or the Toxicology Information Service immediately, 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, convulsions (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) Farmalid

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

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.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

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

The frequencies are defined according to the following classification: very common (in more than 1 out of every 10 patients); common (seen in up to 1 out of every 10 patients); uncommon (seen in up to 1 out of every 100 patients); rare (seen in up to 1 out of every 1,000 patients); very rare (seen in up to 1 out of every 10,000 patients); frequency not known (cannot be estimated from available data).

The following adverse effects have been observed:

Gastrointestinal:

The most common adverse effects associated with medicines such as ibuprofen 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, and 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 difficulties.

Rare: severe allergic reactions (anaphylactic shock).

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

Medicines such as ibuprofen 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 as nausea, vomiting, swelling of the face, tongue, and throat, breathing difficulties, asthma, palpitations, hypotension, or shock.

Frequency not known: 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).

Generalized red, scaly rash with bumps under the skin and blisters, mainly affecting 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 help immediately. See also section 2. The skin may become sensitive to light.

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 difficulties.

Very rare: aseptic meningitis.

Blood:

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

Cardiovascular:

Medicines such as ibuprofen 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 of the ibuprofen type.

Kidney:

Kidney disease.

Liver:

Rare: hepatitis (liver inflammation) and jaundice (yellowing of the skin). Medicines such as Ibuprofen (arginina) Farmalid may, in rare cases, be associated with liver injury.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via 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 Ibuprofen (Arginine) Farmalid

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

Keep out of the sight and reach of children.

Expiry

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

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused containers and medicines at the SIGRE Point located at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ibuprofeno (Arginina) Farmalid

The active substance is ibuprofen. Each sachet contains 600 mg of ibuprofen in the form of ibuprofen (arginine).

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, contains maize starch), purified water.

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

White granules with a characteristic mint odour. It is presented as single-dose paper/aluminium/polyethylene sachets containing granules for oral solution.

It is available in packs containing 20 or 40 sachets.

Marketing Authorisation 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 most recent review of this leaflet: September 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/