IBUPROFEN (ARGININE) CODRAMOL 600 mg ORAL SOLUTION GRANULES

Introduction

Package Leaflet: Information for the Patient

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

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

• Keep this package leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

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

Ibuprofen (Arginine) Codramol belongs to the group of medications called non-steroidal anti-inflammatory drugs (NSAIDs).

This medication is indicated for the treatment of fever, treatment of mild or moderate pain, including migraine, treatment of arthritis (inflammation of the joints, including hands and feet, leading to swelling and pain), juvenile rheumatoid arthritis, osteoarthritis (a chronic disorder that causes cartilage damage), ankylosing spondylitis (inflammation that affects the joints of the spine), non-rheumatic inflammation, and primary dysmenorrhea (painful menstruation).

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

Do not take Ibuprofeno (Arginine) Codramol:

• if you are allergic to ibuprofen 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 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

• 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 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-protecting medication.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the aspirin type. You should also discuss the use of other medications that may 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 medications like Ibuprofen (Arginine) Codramol may 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) Codramol 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 "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) Codramol immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Infections: Ibuprofen (Arginine) Codramol may hide the signs of an infection, such as fever and pain. Therefore, Ibuprofen (Arginine) Codramol may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections related to chickenpox. If you are taking this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

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) Codramol 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 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 in association with Ibuprofen (Arginine) Codramol treatment. Stop taking Ibuprofen (Arginine) Codramol and see a doctor immediately if you present 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.

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Ibuprofen (Arginine) Codramol and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Interference with Laboratory Tests

If you are going to undergo any diagnostic test (including blood tests, urine tests, skin tests using allergens, etc.), inform your doctor that you are taking this medication, as it may alter the results.

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

Use of Ibuprofen with Other Medications

Inform your doctor or pharmacist if you are using or have recently used any other medication, including those purchased without a prescription.

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

• Other non-steroidal anti-inflammatory drugs
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., aspirin, warfarin, ticlopidine)
• Medications that lower high blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin-II receptor antagonists like losartan).
• Lithium (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 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.
• 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 (medication against the AIDS virus).

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

Children and Adolescents

Do not administer to children under 14 years of age.

Taking Ibuprofen (Arginine) Codramol with Food and Drinks

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

Pregnancy, Breastfeeding, and Fertility

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

Do not take Ibuprofen (Arginine) Codramol 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) Codramol during the first 6 months of pregnancy unless it is clearly necessary and as directed 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 time necessary. From the 20th week of pregnancy, Ibuprofen (Arginine) Codramol may cause kidney problems in your fetus if taken for more than a few days, which may cause 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 checks.

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of medications like Ibuprofen (Arginine) Codramol has been associated with an increased risk of congenital anomalies/abortions, it is not recommended 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) Codramol is contraindicated.

For women of childbearing age, it should be noted that medications like Ibuprofen (Arginine) Codramol 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 become pregnant or are breastfeeding, consult your doctor or pharmacist before using 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) Codramol contains Aspartame and Sucrose

This medication may be harmful to people with phenylketonuria because 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 Use Ibuprofen (Arginine) Codramol

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

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.

In adults, the average recommended dose is 1 sachet of granules 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), taking into account that the effective dose should be administered.

The effective dose should be used for the shortest time 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).

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

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.

This medication is administered orally.

Pour the contents of a sachet into a half glass of water, stir until dissolved, and take immediately.

If stomach upset occurs after taking the medication, it should be administered with milk or during meals.

If you take more Ibuprofen (Arginine) Codramol 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.

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

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) Codramol

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

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

4. Possible Adverse Effects

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

Discontinue 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 eruptions can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Widespread skin 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).

The observed adverse effects are described below according to their frequency of presentation:

Very common (may affect more than 1 in 10 people); Common (may affect up to 1 in 10 people); Uncommon (may affect up to 1 in 100 people); Rare (may affect up to 1 in 1,000 people); Very rare (may affect up to 1 in 10,000 people).

The following adverse effects have been observed:

Gastrointestinal

The most common adverse effects that occur with medicines like Ibuprofen (arginine) Codramol 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, 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 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 (arginine) Codramol 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, swelling of the face, tongue, and throat, difficulty breathing, asthma, palpitations, hypotension, or shock.

Frequency "not known":

A severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, inflammation of the lymph nodes, and elevated eosinophils (a type of white blood cell).

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

The skin becomes sensitive to light.

Central nervous system

Common:headache, feeling of instability, and nervousness.

Uncommon:fatigue or drowsiness, insomnia, anxiety, vision changes, ringing or buzzing in the ears.

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

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 tiredness, nasal and skin bleeding)

Cardiovascular

Medicines like Ibuprofen (arginine) Codramol 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 type Ibuprofen (arginine) Codramol

Kidney

Kidney disease.

Liver

Rare:hepatitis (inflammation of the liver) and jaundice (yellowing of the skin) Medicines like Ibuprofen (arginine) Codramol may be associated, in rare cases, with liver damage

Reporting of 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 is not listed in this 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 Ibuprofen (arginine) Codramol

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Store in the original packaging to protect from light and moisture. Do not use this medicine 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 wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ibuprofen (arginine) Codramol

• The active ingredient is ibuprofen. Each sachet contains 600 mg of ibuprofen provided by 1.155 mg of ibuprofen (arginine).
• The other components are: Arginine, aspartame (E-951), sucrose, sodium hydrogen carbonate, sodium saccharin, sodium lauryl sulfate, mint flavor composed of flavoring components (natural flavoring preparations, natural flavoring substances, and natural-identical flavoring substances), non-flavoring components (which contain modified corn starch (E-1450), maltodextrin, triacetin (E-1518)) and active substances (pulegone) and purified water.

Appearance of Ibuprofen (arginine) Codramol and package contents

White-colored granulate with a characteristic mint smell, packaged in paper/aluminum/polyethylene sachets.

It is presented in packages with 20 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

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/.