Package Insert: Information for the Patient

Ibuprofen (arginine) Codramol 600 mg Granule for Oral Solution EFG

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

- Keep this package insert, as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Ibuprofen (arginine) Codramol

3. How to take Ibuprofen (arginine) Codramol

4. Possible adverse effects

5. Storage of Ibuprofen (arginine) Codramol

6. Contents of the package and additional information

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

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

Do not take Ibuprofeno (arginina) Codramol:

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (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 bleeding, or have suffered a perforation of the digestive system.
• if you have severe heart failure
• if you are in the third trimester of pregnancy
• if you have a serious liver or kidney disease.

Warnings and precautions

• You have had or are developing a stomach or duodenal ulcer, bleeding or perforation, which may manifest as severe abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatment, in patients with a history of peptic ulcer and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector.
• If you take simultaneously medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also inform your doctor about the use of other medications that may increase the risk of these bleeding, such as corticosteroids and selective serotonin reuptake inhibitors antidepressants.
• If you have Crohn's disease or ulcerative colitis, as Ibuprofeno (arginina) Codramol may worsen these conditions.
• If you have kidney or liver disease.
• If you have edema (fluid retention)
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment for an infection, as Ibuprofeno (arginina) 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 heading "Infections" later.
• Signs of allergic reaction to this medication, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain, have been reported with ibuprofen. Stop using Ibuprofeno (arginina) Codramol immediately and contact your doctor or emergency medical services immediately if you observe any of these signs.

Infections: Ibuprofeno (Arginina) Codramol may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno (Arginina) Codramol may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and skin infections related to chickenpox. If you take this medication while you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Cardiovascular Precautions

Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may be associated with a small increase in the risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should inform your doctor or pharmacist before taking Ibuprofeno (arginina) Codramol if:

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

Skin Reactions

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

Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Discontinue treatment with Ibuprofeno (arginina) 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 diagnostic tests

If you are to undergo any diagnostic test (including blood, urine, 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)
• Serum concentrations of urea nitrogen and creatinine and potassium (may increase)
• With liver function tests: increase in 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.

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

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

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

Children and adolescents

Do not administer to children under 14 years

Taking Ibuprofeno (arginina) 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 discomfort.

Pregnancy, breastfeeding and fertility

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

Do not take Ibuprofeno (arginina) 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 predisposition and that of your baby to bleeding and delay or prolong delivery more than expected. You should not take Ibuprofeno (arginina) Codramol during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Ibuprofeno (arginina) Codramol may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Pregnancy and fertility precautions

Due to the administration of medications of the type Ibuprofeno (arginina) Codramol being associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer the same during the first and second trimesters of pregnancy unless strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of Ibuprofeno (arginina) Codramol is contraindicated

For women of childbearing age, it should be noted that medications of the type Ibuprofeno (arginina) Codramol have been associated with a decrease in the ability to conceive.

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 operating machinery

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.

Ibuprofeno (arginina) Codramol contains aspartame and saccharose

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

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

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

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

The recommended average dosage for adults is 1 granule every 12 hours.

In rheumatoid arthritis, higher doses may be required, but in any case, it is recommended not to exceed a daily dose of 2,400 mg of ibuprofen (4 packets), taking into account that the smallest effective dose should be administered.

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

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

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

This medication is administered orally.

Empty the contents of a packet into a half glass of water, shake until dissolved, and then take.

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

If you take more Ibuprofeno (arginina) 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 immediately or the Toxicological 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.

The symptoms of an overdose may include nausea, stomach pain, vomiting (which may contain blood-tinged mucus), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported. At high doses, blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have also been reported.

If you forgot to take Ibuprofeno (arginina) Codramol

Do not take a double dose to compensate for the missed doses.

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

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

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

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

- Flat, red spots, in the shape of a target or circles on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, and eye ulcers. These severe skin eruptions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, eritema poliforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

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

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

The observed side 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 1000 people); Very rare (may affect up to 1 in 10,000 people).

The following side effects have been observed:

Gastrointestinal

The most common side effects that occur with ibuprofen (arginine) Codramol are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Skin and allergic reactions

Common:skin eruption.

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

Rare:severe allergic reactions (anaphylactic shock)

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

The 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.

Asymptomatic meningitis, in most cases in patients with some autoimmune disease such as systemic lupus erythematosus.

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

Frequency "unknown":

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

Generalized, red, scaly eruption, with bumps under the skin and blisters, located mainly in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular psoriasis). Stop taking ibuprofen (arginina) Codramol if you experience these symptoms and seek medical attention immediately. See section 2

The skin becomes sensitive to light.

Central nervous system

Common:headache, feeling unsteady, and nervousness.

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

Rare:disorientation or confusion, depression, abnormal or blurred vision, and auditory disturbances.

Very rare:asymptomatic 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

The medicines like ibuprofen (arginina) Codramol may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or cerebral.

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medicines of the type ibuprofen (arginina) Codramol.

Kidney

Kidney disease.

Liver

Rare:hepatitis (liver inflammation) and jaundice (yellow skin discoloration) The medicines like ibuprofen (arginina) Codramol may be associated, in rare cases, with liver damage

Reporting of side effects

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

Keep this medication 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 medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash.Deposit empty containers and unused medications at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist how to dispose of empty containers and unused medications.This will help protect the environment.

Composition of Ibuprofeno (arginina) Codramol

• The active ingredient is ibuprofen. Each sachet contains 600 mg of ibuprofen provided by 1.155 mg of ibuprofen (arginina).
• The other components are: Arginina, aspartamo (E-951), sacarosa, hidrogenocarbonato de sodio, sacarina sódica, laurilsulfato de sodio, aroma de menta compuesto por componentes aromáticos (preparaciones aromatizantes naturales, sustancias aromatizantes naturales y sustancias aromatizantes idénticas a las naturales), componentes no aromáticos (que (contienen almidón de maíz modificado (E-1450), maltodextrina, triacetina (E-1518)) y sustancias activas (pulegona) and purified water.

Appearance of Ibuprofeno (arginina) Codramol and contents of the packaging

White granulated powder with a characteristic minty odor packaged in paper/aluminum/polyethylene sachets.

Presented in packaging with 20 sachets.

Holder of the marketing authorization:

FARMALIDER S.A.,

C/ La Granja, 1

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Toll Manufacturing Services S.L.,

c/ Aragoneses, 2.

28108 Alcobendas (Madrid)

Spain

Date of the last review of this prospectus: September 2024

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/ .