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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ibuprofeno (arginina) Codramol 600 mg effervescent granules for oral solution EFG

Read the entire 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

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

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

2. What you need to know before taking Ibuprofeno (arginina) Codramol

Do not take Ibuprofeno (arginina) Codramol:

• if you are allergic to ibuprofen or any of the other components of this medicine (listed in section 6). Such reactions could include itchy rash, swelling of the face, lips or tongue, runny nose, breathing difficulties or asthma.
• if you have had a stomach or duodenal ulcer or gastrointestinal bleeding or perforation.
• 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 develop a stomach or duodenal ulcer, bleeding or perforation, which may present as severe or persistent abdominal pain and/or black stools, even without prior warning symptoms.
• This risk is greater when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider adding a stomach-protective medicine.
• If you are taking concomitant medicines that affect blood clotting, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor about the use of other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.
• If you suffer from Crohn's disease or ulcerative colitis, as medicines like Ibuprofeno (arginina) Codramol may worsen these conditions.
• If you have previously had kidney or liver disease.
• If you experience edema (fluid retention).
• If you suffer from asthma or any other respiratory disorder.
• If you are being treated for an infection, as Ibuprofeno (arginina) Codramol may mask fever, an important sign of infection.
• If you have heart, kidney or liver disease, are over 60 years old, or need to take the medicine long-term (more than 1–2 weeks), your doctor may need to perform regular monitoring. Your doctor will advise you on how often these checks should be done.
• 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 region (angioedema), and chest pain. Stop using Ibuprofeno (arginina) Codramol immediately and contact your doctor or emergency medical services without delay if you notice any of these signs.

Infections: Ibuprofeno (arginina) Codramol may mask signs of infection such as fever and pain. Therefore, treatment with Ibuprofeno (arginina) Codramol 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 medicine during an infection and infection symptoms persist or worsen, consult a doctor immediately.

Cardiovascular precautions

Anti-inflammatory/analgesic medicines 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) Codramol if:

• you have heart problems, including heart failure, angina (chest pain), a history of heart attack, coronary bypass surgery, peripheral arterial disease (circulation problems in 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 smoke.

In addition, this type of medicine may cause fluid retention, particularly in patients with heart failure and/or high blood pressure (hypertension).

Skin reactions

Serious skin reactions have been reported with Ibuprofeno (arginina) Codramol. Stop taking Ibuprofeno (arginina) Codramol and see a doctor immediately if you develop any skin rash, mucosal lesions, blisters or other signs of allergy, as these may be early signs of a serious 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) Codramol and seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Interference with diagnostic tests

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

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

Use of ibuprofen with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines, including those obtained without a prescription.

Ibuprofeno (arginina) Codramol may interact with or be affected by other medicines. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs)
• Anticoagulant medicines (e.g., those used to treat or prevent blood clotting, such as acetylsalicylic acid, warfarin, ticlopidine)
• Medicines that lower high 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 your dose.
• Methotrexate. Your doctor may adjust the dose of this antimetabolite medicine (which slows the growth of certain body cells).
• Mifepristone (an abortion-inducing agent)
• Digoxin and cardiac glycosides (used to treat heart disorders)
• Hydantoins such as phenytoin (used to treat epilepsy)
• Sulphonamides such as sulfamethoxazole and cotrimoxazole (used to treat certain bacterial infections)
• Corticosteroids such as cortisone and prednisolone
• Diuretics (medicines used to increase urine elimination)
• Fluconazole (used to treat fungal infections)
• Pentoxifylline (used for intermittent claudication)
• Probenecid (used in gout patients 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 (an anti-HIV medicine)

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

Children and adolescents

Do not administer to children under 14 years of age.

Taking Ibuprofeno (arginina) Codramol with food and drinks

You may take it with or without 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 are planning to become pregnant, consult your doctor before using this medicine.

Do not take Ibuprofeno (arginina) Codramol 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 unborn baby. 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) Codramol 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, use the lowest effective 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, leading 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 is needed for longer than a few days, your doctor may recommend additional monitoring.

Precautions during pregnancy and in women of childbearing potential

Because the use of medicines like Ibuprofeno (arginina) Codramol has been associated with an increased risk of congenital malformations or 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 kept to a minimum.

During the third trimester, Ibuprofeno (arginina) Codramol is contraindicated.

For women of childbearing potential, it should be noted that medicines like Ibuprofeno (arginina) Codramol have been associated with a temporary 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 using 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 occur during treatment.

Ibuprofeno (arginina) Codramol contains aspartame and sucrose

This medicine may be harmful to people 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 use Ibuprofen (arginine) Codramol

Follow exactly the administration instructions for this medicine as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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.

In adults, the recommended average dosage is 1 sachet every 12 hours.

In rheumatoid arthritis, higher doses may be required; however, the daily dose of ibuprofen should not exceed 2,400 mg (4 sachets), keeping in mind that the lowest effective dose should be administered.

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

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 medicine is primarily eliminated through the kidneys.

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

This medicine is administered orally.

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

If gastric discomfort occurs after taking the medicine, it should be taken together 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 immediately, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

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

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, seizures (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) Codramol

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

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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, mouth, throat, nose, genital, and eye ulcers. 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 adverse effects observed are described below according to their frequency of occurrence:

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 frequent adverse effects with medicines such as 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, 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, skin itching or swelling, swelling of the lips, face, or tongue, increased nasal discharge, and breathing difficulty.

Rare: severe allergic reactions (anaphylactic shock).

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

Medicines such as Ibuprofen (arginine) Codramol may, very rarely, be associated with very serious 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 in patients with autoimmune disorders such as systemic lupus erythematosus.

Severe allergic reaction that may present with nausea, vomiting, facial, tongue, and throat swelling, breathing difficulty, 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 located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning 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.

Skin becomes sensitive to light.

Central nervous system

Common: headache, dizziness, and nervousness.

Uncommon: fatigue or drowsiness, insomnia, anxiety, vision disturbances, tinnitus (ringing or buzzing in the ears).

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

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 (arginine) Codramol may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatment using medicines like Ibuprofen (arginine) Codramol.

Kidney

Kidney disease.

Liver

Rare: hepatitis (liver inflammation) and jaundice (yellowing of the skin). Medicines such as Ibuprofen (arginine) Codramol may, rarely, be associated with liver injury.

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 not listed in this leaflet. You may 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) 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 expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE point located at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the container and other information

Composition of Ibuprofeno (arginina) Codramol

• The active substance 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 flavour composed of flavouring components (natural flavouring preparations, natural flavouring substances and nature-identical flavouring substances), non-flavouring components (containing modified corn starch (E-1450), maltodextrin, triacetin (E-1518)), active substances (pulegone) and purified water.

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

White granules with a characteristic mint odour, packed in paper/aluminium/polyethylene sachets.

Packaged in containers containing 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 most recent revision of this leaflet: September 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/