IBUPROFEN (ARGININE) CODEINE FARMALIDER 200 mg/mL + 10 mg/mL ORAL SOLUTION

Introduction

Package Leaflet: Information for the User

Ibuprofen (Arginine) Codeine Farmalider 200 mg/ml+10 mg/ml Oral Solution

Ibuprofen (arginine) / codeine, phosphate hemihydrate

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.

Contents of the Package Leaflet

1. What is Ibuprofen (Arginine) Codeine Farmalider and what is it used for
2. What you need to know before you start taking Ibuprofen (Arginine) Codeine Farmalider
3. How to take Ibuprofen (Arginine) Codeine Farmalider
4. Possible side effects
5. Storing Ibuprofen (Arginine) Codeine Farmalider
6. Package Contents and Additional Information

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

This medication contains ibuprofen and codeine as active substances. Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs)

Codeine belongs to a group of medicines called opioid analgesics that work by relieving pain. It can be used alone or in combination with other analgesics such as paracetamol or ibuprofen.

This medication is used in adults and adolescents from 12 years of age for the short-term treatment of moderate intensity pain that is not relieved by other analgesics such as paracetamol or ibuprofen alone.

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

Do not take Ibuprofen (Arginine) Codeine Farmalider:

• If you are allergic to ibuprofen, codeine, other non-steroidal anti-inflammatory drugs (NSAIDs), or any of the other components of this medication (listed in section 6). Allergic reactions may include: skin rash with itching, swelling of the face, lips, or tongue, nasal discharge, difficulty breathing, or asthma.

• If you have a severe liver or kidney disease.
• If you have had or have a stomach or duodenal ulcer or have suffered a perforation of the digestive tract.
• If you vomit blood.
• If you have black stools or bloody diarrhea.
• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood). If it is necessary to use anticoagulant medications at the same time, your doctor will perform blood coagulation tests.
• If you have severe heart failure.
• If you are in the third trimester of pregnancy.
• If you are breastfeeding.
• If you have asthma or chronic obstructive pulmonary disease.
• If you have respiratory depression or chronic constipation.
• To relieve pain in children and adolescents (0-18 years old) after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.
• If you know you metabolize codeine to morphine very quickly.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to take this medication.

Tell your doctor

• If you have edema (fluid retention).
• If you have or have had any heart disorder or have high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment with Ibuprofen (Arginine) Codeine Farmalider, as it may mask fever, which is an important sign of infection, making diagnosis more difficult.
• If you have 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 experience symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen may cause kidney failure in this case due to dehydration.
• 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 higher when high doses are used and treatments are prolonged, in patients with a history of peptic ulcer, and in the elderly. In these cases, your doctor will consider the possibility of associating a stomach-protecting medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like aspirin. You should also discuss 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 (a chronic disease in which the immune system attacks the intestine, causing inflammation that usually produces bloody diarrhea) or ulcerative colitis, as medications like Ibuprofen (Arginine) Codeine Farmalider may worsen these conditions.
• If you are being treated with diuretics (medications to increase urine production), as your doctor should monitor your kidney function.
• If you have systemic lupus erythematosus (a chronic disease that affects the immune system and can affect various vital organs, the nervous system, blood vessels, skin, and joints), as it may cause aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria).
• If you have acute intermittent porphyria (a metabolic disease that affects your blood and can cause symptoms such as reddish urine color, blood in urine, or liver disease), so that your doctor can assess the convenience or not of treatment with ibuprofen.
• If you experience headaches after prolonged treatment, you should not take higher doses of the medication.
• It is possible that allergic reactions may occur with this medication.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• In cases of intracranial injuries, codeine can cause respiratory depression. Similarly, codeine's adverse reactions can mask the clinical course of patients with head trauma.
• Due to its codeine content, prolonged treatments, as well as potential abuse of the medication, may lead to tolerance and dependence, both psychological and physical.
• Codeine can also cause chronic constipation, as although some tolerance to the effects of opioids on gastrointestinal motility develops, patients who take opioids chronically continue to suffer from constipation.
• Codeine is converted to morphine in the liver by an enzyme. Morphine is the substance that provides pain relief. Some people have a variation of this enzyme that can affect people in different ways. In some people, morphine is not produced or is produced in very low quantities, and it will not provide sufficient pain relief. Other people are more likely to suffer from severe adverse reactions because they produce a very high amount of morphine. If you experience any of the following adverse effects, you should stop taking this medication and seek medical help immediately: slow or shallow breathing, confusion, drowsiness, constricted pupils, nausea or vomiting, constipation, loss of appetite.
• If you have an infection; see the "Infections" section below.

It is essential 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.

Infections: Ibuprofen (Arginine) Codeine Farmalider may mask the signs of an infection, such as fever and pain. Consequently, Ibuprofen (Arginine) Codeine Farmalider may delay the 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.

Cardiovascular precautions

Anti-inflammatory/pain-relieving 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) Codeine Farmalider 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, 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) Codeine Farmalider. Stop taking Ibuprofen (Arginine) Codeine Farmalider and see a doctor immediately if you experience any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Precautions during pregnancy and in women of childbearing age

Since the administration of medications like Ibuprofen (Arginine) Codeine Farmalider 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 (Arginine) Codeine Farmalider is contraindicated.

For women of childbearing age, it should be noted that medications like Ibuprofen (Arginine) Codeine Farmalider have been associated with a decrease in fertility.

Interference with diagnostic tests

Taking ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values

If you are going to have a diagnostic test, inform your doctor that you are being treated with Ibuprofen (Arginine) Codeine Farmalider, as it may alter the results.

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

Children and adolescents

This medication is only for administration to adults and children over 12 years old.

Use in children and adolescents after surgery

Codeine should not be used for pain relief in children and adolescents after tonsillectomy or adenoidectomy due to obstructive sleep apnea syndrome.

Use in children with respiratory problems

Codeine is not recommended for use in children with respiratory problems, as the symptoms of morphine toxicity may be worse in these children.

Use of Ibuprofen (Arginine) Codeine Farmalider with other medications

Tell your doctor or pharmacist that you are using, have recently used, or may need to use any other medication.

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

Related to ibuprofen

• Other non-steroidal anti-inflammatory drugs like aspirin.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., aspirin, warfarin, ticlopidine).
• Medications that lower high blood pressure (ACE inhibitors like 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 (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medication.
• Mifepristone (abortion inducer).
• Digoxin and cardiac glycosides (used to treat heart disorders).
• Hydantoins like phenytoin (used to treat epilepsy).
• Sulfonamides like sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections).
• Corticosteroids like cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (used to treat depression).
• Diuretics (medications used to increase urine production).
• 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 or cyclosporine (used in organ transplants to prevent rejection).
• Zidovudine (a medication against the AIDS virus).
• Thrombolytics (medications that dissolve blood clots).
• Aminoglycoside antibiotics like neomycin.
• Herbal extracts: Ginkgo biloba tree.

Related to codeine

• Morphine-derived medications like nalbuphine, buprenorphine, or pentazocine (used to treat moderate or severe pain).
• Central nervous system depressants (antidepressants, sedatives, antihistamines H1, anxiolytics, and hypnotics, neuroleptics, barbiturates, benzodiazepines, clonidine, and related, talidomide).

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

Tell your doctor if you are going to have a clinical analysis and are taking or have recently taken ibuprofen.

Taking Ibuprofen (Arginine) Codeine Farmalider with food, drinks, and alcohol

It is generally recommended to take the medication with meals to reduce the possibility of stomach upset.

Alcohol enhances the sedative effect of this medication, so you should avoid taking alcoholic beverages and medications that contain alcohol.

Pregnancy, breastfeeding, and fertility

Do not take this medication during pregnancy, especially during the third trimester (see "Precautions during pregnancy and in women of childbearing age" section).

Do not take codeine if you are breastfeeding. Codeine and morphine pass into breast milk.

Do not take Ibuprofen (Arginine) Codeine Farmalider 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 delivery more than expected. You should not take Ibuprofen (Arginine) Codeine Farmalider 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) Codeine Farmalider may cause kidney problems in your fetus if taken for more than a few days, which can 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 you need treatment for more than a few days, your doctor may recommend additional monitoring.

Driving and using machines

If you experience drowsiness, dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate hazardous machinery.

Ibuprofen (Arginine) Codeine Farmalider contains liquid maltitol and sucrose

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

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) Codeine Farmalider

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

Your doctor will indicate the duration of treatment with this medication. Do not suspend treatment beforehand, as the expected results will not be obtained. Similarly, do not use Ibuprofeno (Arginina) Codeína Farmalider for longer than indicated by your doctor.

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

This medication should not be taken for more than 3 days. If the pain does not improve after 3 days, consult your doctor.

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

Use in adults

Take 2-3 ml every 6 to 8 hours (1,200/60 mg - 1,800/90 mg per day), depending on the intensity of the condition and response to treatment.

In some processes, higher doses may be required, but in any case, the maximum daily dose of 12 ml (2,400/120 mg per day) should not be exceeded.

Use in children over 12 years old

Children 12 to 15 years old, weighing more than 40 kg

Take 2 ml every 8 hours (1,200/60 mg per day), as needed.

Children 16 to 18 years old

Take 2 ml every 6 to 8 hours (1,200/60 mg - 1,600/80 mg per day), depending on the intensity of the condition and response to treatment.

Do not exceed the maximum daily dose of 8 ml (1,600/80 mg per day).

Use in children under 12 years old

Children under 12 years old should not take this medication due to the risk of severe respiratory problems.

Children weighing less than 40 kg should not take this medication due to the lack of safety and efficacy data for the combination.

Use in elderly patients

If you are over 60 years old, your doctor may prescribe a lower dose than usual. If so, the dose can only be increased once your doctor has checked that you tolerate the medication well.

Use in patients with kidney and/or liver disease

If you have kidney and/or liver disease, your doctor may prescribe a lower dose than usual. If so, take the exact dose prescribed by your doctor.

Do not take this medication if you have severe kidney and/or liver disease.

Method of administration

This medication is administered orally.

The dose will be administered after diluting the solution in water. Take the medication with meals or with some food. If you experience digestive discomfort, consult your doctor before taking the medication.

If you think the effect of Ibuprofeno (Arginina) Codeína Farmalider is too strong or weak, inform your doctor or pharmacist.

If you take more Ibuprofeno (Arginina) Codeína Farmalider than you should

If you have taken more medication than you should, or if a child has accidentally ingested the contents of the package, consult your doctor or pharmacist immediately, or call the Toxicology Information Service at 91 562 04 20, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken, indicating the medication and the amount ingested. It is recommended to bring the package and the medication leaflet to the healthcare professional.

Symptoms of overdose may include: stomach pain, nausea, vomiting (which may contain bloody sputum), indifference, sleepiness, headache, involuntary eye movements, ringing in the ears, confusion, and lack of muscle coordination.

It is rare for more severe symptoms to appear, such as intestinal bleeding, low blood pressure, low body temperature, metabolic acidosis, seizures, altered kidney function, coma, dyspnea/acute adult respiratory distress syndrome, and transient respiratory arrest in children (after ingesting large amounts).

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

Symptoms reported with codeine overdose include drowsiness, skin rash, pinpoint pupils (miosis), vomiting, tingling, lack of muscle coordination, and skin swelling. Cases of respiratory failure and some deaths have also been reported. Other symptoms observed are initial excitement, anxiety, insomnia, and later, in certain cases, headache, changes in blood pressure, changes in heart rhythm, dry mouth, allergic reactions, increased heart rate, seizures, gastrointestinal disorders, nausea, vomiting, and respiratory depression.

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

In case of ingestion of significant amounts, activated charcoal should be administered. Stomach emptying will be considered if significant amounts have been ingested and within 60 minutes after ingestion.

If you forgot to take Ibuprofeno (Arginina) Codeína Farmalider

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.

If you interrupt treatment with Ibuprofeno (Arginina) Codeína Farmalider

There is a risk of possible withdrawal effects when stopping treatment with this medication.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medications, Ibuprofeno (Arginina) Codeína Farmalider can cause adverse effects, although not everyone will experience them. Inform your doctor or pharmacist if you experience any of the following adverse effects.

Adverse effects of medications like Ibuprofeno (Arginina) Codeína Farmalider are more common in people over 65 years old.

The incidence of adverse effects is lower in short treatments and if the daily dose is below the maximum recommended dose.

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

Ibuprofeno (Arginina) Codeína Farmalider, especially when taken in doses higher than recommended or for a prolonged period, may cause kidney damage, making them unable to effectively eliminate acid from the blood (renal tubular acidosis). It may also significantly reduce potassium levels in the blood (see section 2). This is a very serious disorder that requires immediate treatment. The signs and symptoms include muscle weakness and dizziness.

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

The following adverse effects have been observed:

Related to ibuprofen

Gastrointestinal:

The most frequent adverse effects that occur with medications like Ibuprofeno (Arginina) Codeína Farmalider are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stool, vomiting blood, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other adverse effects are: Infrequent: inflammation of the oral mucosa with ulcer formation. Rare: esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of diverticular disease, non-specific hemorrhagic colitis (gastroenteritis with bloody diarrhea). Very rare: pancreatitis.

Cardiovascular:

Medications like Ibuprofeno (Arginina) Codeína Farmalider 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 medications like Ibuprofeno (Arginina) Codeína Farmalider.

Skin:

Medications like Ibuprofeno (Arginina) Codeína Farmalider may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome (widespread erosions affecting the skin and two or more mucous membranes and purplish lesions, preferably on the trunk) and toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis).

Unknown frequency:

Drug reaction with eosinophilia and systemic symptoms: A severe skin reaction known as DRESS syndrome can occur. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

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

Other adverse effects are: Frequent: skin rash. Infrequent: skin redness, itching or skin swelling, purpura (purple spots on the skin). Very rare: hair loss, erythema multiforme (skin lesion), skin reactions due to light influence, inflammation of blood vessels in the skin. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox.

Immune system:

Infrequent: transient edema in areas of the skin, mucous membranes, or sometimes in viscera (angioedema), nasal mucosa inflammation, bronchospasm (bronchial spasm that prevents air from passing into the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of severe generalized hypersensitivity reaction, facial swelling, tongue and larynx swelling, bronchospasm, asthma, tachycardia, hypotension, and shock may appear.

Very rare: joint pain and fever (lupus erythematosus).

Central nervous system:

Frequent: fatigue or drowsiness, headache, and dizziness or instability. Rare: paresthesia (sensation of numbness, tingling, prickling, etc., more frequent in hands, feet, arms, or legs). Very rare: aseptic meningitis. In most cases where aseptic meningitis has been reported with ibuprofen, the patient had some form of autoimmune disease (such as systemic lupus erythematosus or other collagen diseases), which was a risk factor. The symptoms of aseptic meningitis observed were neck stiffness, headache, nausea, vomiting, fever, or disorientation.

Psychiatric:

Infrequent: insomnia, anxiety, restlessness. Rare: disorientation or confusion, nervousness, irritability, depression, psychotic reaction.

Auditory:

Frequent: vertigo. Infrequent: ringing or buzzing in the ears. Rare: hearing difficulty.

Ocular:

Infrequent: vision changes. Rare: abnormal or blurred vision.

Blood:

Rare: decreased platelets, decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (may manifest as difficulty breathing and pale skin), decreased granulocytes (a type of white blood cell that can predispose to infections), pancytopenia (deficiency of red, white blood cells, and platelets in the blood), agranulocytosis (very significant decrease in granulocytes), aplastic anemia (bone marrow failure to produce different types of cells), or hemolytic anemia (premature destruction of red blood cells). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, pseudogripal symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Kidney:

Based on experience with NSAIDs in general, cases of interstitial nephritis (kidney disorder), nephrotic syndrome (disorder characterized by protein in the urine and body swelling), and kidney failure (sudden loss of kidney function) cannot be ruled out.

Liver:

Medications like Ibuprofeno (Arginina) Codeína Farmalider may be associated, in rare cases, with liver damage. Other rare adverse effects are: hepatitis (liver inflammation), abnormal liver function, and jaundice (yellowing of the skin and eyes). Unknown frequency: liver failure (severe liver deterioration).

General:

Very rare: worsening of inflammation during infectious processes.

To date, no severe allergic reactions have been reported with Ibuprofeno (Arginina) Codeína Farmalider, although they cannot be ruled out. The manifestations of this type of reaction could be fever, skin rash, abdominal pain, severe and persistent headache, nausea, vomiting, facial swelling, tongue and throat swelling, difficulty breathing, asthma, palpitations, hypotension (lower than usual blood pressure), or shock.

If any of the following adverse effects appear, stop treatment and go to your doctor immediately:

• Allergic reactions such as skin rashes, facial swelling, wheezing, or difficulty breathing.
• Vomiting blood or coffee grounds-like vomit.
• Blood in stool or bloody diarrhea.
• Severe stomach pain.
• Severe skin peeling or blistering.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (allergy) (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.

Related to codeine

Gastrointestinal:

Rare: constipation, nausea. Very rare: jaundice (yellowing of the skin and eyes).

Blood:

Very rare: decreased platelets, agranulocytosis (very significant decrease in granulocytes, a type of white blood cell), decreased white blood cells (may manifest as frequent infections with fever, chills, or sore throat), decreased neutrophils (a type of white blood cell that can predispose to infections), hemolytic anemia (premature destruction of red blood cells).

General:

Rare: discomfort, drowsiness. Very rare: fever, allergic reactions ranging from a simple skin rash or urticaria to severe allergic reactions like anaphylactic shock.

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. 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 medication.

5. Conservation of Ibuprofeno (Arginina) Codeína Farmalider

Keep this medication out of sight and reach of children.

Do not store at a temperature above 25°C.

Keep in the original packaging.

Do not use this medication after the expiration date shown on the package after "CAD". The expiration date is the last day of the month indicated.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofeno (arginine) Codeína Farmalider

The active ingredients are ibuprofen (arginine) and codeine phosphate hemihydrate. Each ml of solution contains 200 mg of ibuprofen, provided by 370 mg of ibuprofeno arginina, and 7.4 mg of codeine equivalent to 10 mg of codeine phosphate hemihydrate.

The other components are: L-arginine, domiphen bromide, maltitol liquid (E-965), sodium saccharin, peppermint flavor (compound of natural flavoring preparations, natural flavoring substances, natural-identical flavoring substances, maltodextrin, modified corn starch (E-1450), glycerol triacetate (E-1518), and pulegone), thaumatin (E-957), purified water.

Appearance of Ibuprofen (arginine) Codeine Farmaliderand package contents

Transparent solution, brown in color, free of foreign substances and with a marked mint odor, in a topaz glass bottle containing 30 and 60 ml of solution along with a graduated dosing cup marked in ½, 1, 2, 3, and 4 ml.

Marketing authorization holder:

Farmalider S.A.

C/ La Granja 1

28108 Alcobendas, (Madrid)

Spain

Manufacturer:

Farmasierra Manufacturing S.L.

Ctra. de Irún, km 26,200

28700 San Sebastián de los Reyes (Madrid)

Spain

or

Farmalider, S.A.

Aragoneses, 15

28108 Alcobendas (Madrid)

Spain

or

Edefarm, S.L.

Pol. Industrial Enchilagar del Rullo 117

46191 Villamarchante, Valencia

Spain

Date of the last revision of this leaflet:September 2024

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