IBUPROFEN CODRAMOL 200 mg ORAL POWDER

Introduction

Package Leaflet: Information for the User

Ibuprofen Codramol 200 mg Oral Powder

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

• Keep this package leaflet, as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.
• You should consult a doctor if your symptoms worsen or do not improve after 3 days.

Package Leaflet Contents

1. What is Ibuprofen Codramol and what is it used for
2. What you need to know before taking Ibuprofen Codramol
3. How to take Ibuprofen Codramol
4. Possible side effects
5. Storage of Ibuprofeno Codramol
6. Package contents and additional information

1. What is Ibuprofen Codramol and what is it used for

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

This medication is indicated for symptomatic relief in children from 7 years and adults:

• for the symptomatic relief of mild to moderate occasional pain
• for the treatment of fever

You should consult a doctor if your symptoms worsen or do not improve after 3 days.

2. What you need to know before taking Ibuprofen Codramol

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

Do not take Ibuprofen Codramol:

• if you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• if, after taking acetylsalicylic acid or other NSAIDs, you have experienced a 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 hemorrhage or have suffered a perforation of the digestive tract while taking an anti-inflammatory medication.
• if you currently have or have had more than one occasion: a stomach or duodenal ulcer or hemorrhage.
• if you have severe heart failure.
• if you are in the third trimester of pregnancy.
• if you have severe liver or kidney disease.
• if you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medications used to "thin" the blood).
• if you have worsening ulcerative colitis or Crohn's disease.
• severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you have had or developed an ulcer, hemorrhage, or perforation in the stomach or duodenum, which may be manifested by intense or persistent abdominal pain and/or black stools, or even without previous warning symptoms.
• This risk is higher when using high doses and prolonged treatments, 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 have had liver or kidney disease.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you are taking this medication, as ibuprofen can mask fever, which is an important sign of infection, making diagnosis more difficult.
• If you have or have had any heart disorder or have high blood pressure.
• 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), it is possible that your doctor will need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you present symptoms of dehydration, e.g., severe diarrhea or vomiting, take plenty of fluids and contact your doctor immediately, as ibuprofen in this specific case could provoke kidney failure as a consequence of dehydration.
• If you are taking medications that alter blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid. You should also discuss the use of other medications that could increase the risk of such hemorrhages, such as corticosteroids and antidepressants that are selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as medications of this type can worsen these conditions.
• If you are undergoing treatment with diuretics (medications to increase urine production), as your doctor must 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 is more likely that aseptic meningitis (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria) may occur.
• 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 control if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medication if you have chickenpox.
• If you have an infection; see the "Infections" section below.

Cardiovascular precautions

Anti-inflammatory/analgesic medications like ibuprofen can be associated with a small increase in the risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You must discuss your treatment with your doctor or pharmacist before taking Ibuprofen 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 can produce 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 Codramol treatment. Stop taking Ibuprofen Codramol and consult your doctor immediately if you present any skin rash, lesions on the mucous membranes, blisters, or other signs of allergy, as these can be the first signs of a very severe skin reaction. See section 4.

Infections

Ibuprofen Codramol can mask the signs of an infection, such as fever and pain. Consequently, Ibuprofen Codramol 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.

Children and adolescents

There is a risk of kidney damage in dehydrated children and adolescents.

Interference with laboratory tests:

Taking ibuprofen can alter the following laboratory tests:

• 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

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

Consult your doctor or pharmacist before starting to take Ibuprofen Codramol.

Use of Ibuprofen Codramol with other medications

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

Ibuprofen Codramol can affect or be affected by other medications. For example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs): as they may increase the risk of adverse effects.
• Anticoagulant medications (e.g., to treat coagulation problems/prevent coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine). Lithium (a medication used to treat depression): as they may increase blood levels of lithium and the risk of adverse effects. If you need to take lithium and ibuprofen, your doctor may need to adjust your lithium dose.
• Methotrexate: if you take methotrexate and ibuprofen at the same time (within a 24-hour interval), they may increase blood levels of methotrexate and the risk of toxicity from this medication. Your doctor may advise you not to take ibuprofen if you are receiving high-dose methotrexate treatment.
• Hydantoins such as phenytoin (for the treatment of epilepsy).
• Sulfonamides: as they may increase their toxic effects.
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Corticosteroids such as cortisone and prednisolone, as they may increase the risk of stomach ulcers or gastrointestinal bleeding.
• Diuretics (medications used to increase urine production), as they may increase the risk of kidney toxicity.

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

• Fluconazole and voriconazole (used to treat fungal infections), pentoxifylline, probenecid, and sulfinpyrazone (for gout), quinolones (such as norfloxacin), mifepristone, sulfonylureas (such as tolbutamide), tacrolimus and cyclosporin (used to prevent rejection in transplants), zidovudine (kidney risk), and cholestyramine (a medication used to treat high cholesterol).
• Selective serotonin reuptake inhibitor (SSRI) antidepressants can also increase the risk of gastrointestinal bleeding.

Taking Ibuprofen Codramol with food, drinks, and alcohol

For patients with stomach discomfort, it is recommended to take the medication during meals.

Taking alcohol can increase the risk of adverse reactions.

Pregnancy, breastfeeding, and fertility

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

Precautions during pregnancy and in women of childbearing age

Because the administration of this medication has been associated with an increased risk of congenital anomalies/abortions, it is not recommended during the first and second trimester of pregnancy unless strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, administration is contraindicated.

For women of childbearing age, it should be noted that medications of this type have been associated with a decrease in fertility.

Breastfeeding

Although the levels of the medication in breast milk are negligible, it is recommended to consult a doctor in cases of prolonged treatment or high doses during breastfeeding.

Driving and using machines

If you experience dizziness, vertigo, vision changes, or other symptoms while taking this medication, you should not drive or operate machinery. If you only take one dose of ibuprofen or for a short period, it is not necessary to take special precautions.

Ibuprofen can delay your reaction time, which should be taken into account before performing activities that require greater vigilance, such as driving and operating machinery.

Ibuprofen Codramol contains glucose and sorbitol E420

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Ibuprofen Codramol

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

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

Dosage

Adults and adolescents (>40 kg):

The recommended dose is 1 or 2 sachets 3-4 times a day, every 6-8 hours.

Do not exceed 1200 mg of ibuprofen (6 sachets) in 24 hours.

Children (under 12 years) (<40 kg):

The recommended dose of ibuprofen depends on the child's age and weight. For children from 6 months to 12 years, the recommended daily dose is 7 to 10 mg/kg as a single dose, up to a maximum daily dose of 30 mg per kg of body weight.

Guidelines can be followed based on the table below:

The interval between doses should be chosen according to the symptoms and the maximum daily dose and may be 6 or 8 hours. Do not exceed the maximum recommended daily dose in the last column.

The appearance of adverse reactions can be minimized by using the lowest effective doses for the shortest possible time to control symptoms (see section 4.4).

This medication is used for short-term treatments.

If your symptoms worsen, if the fever persists for more than 3 days, or the pain for more than 5 days (3 days in children and adolescents), you should consult a doctor.

The administration of this medication is subject to the appearance of pain or fever. As these symptoms disappear, the medication should be discontinued.

Special patient groups

Patients with kidney, liver, or heart disease:

Reduce the dose and consult your doctor. Ibuprofen should not be used in patients with severe renal or hepatic insufficiency.

Pediatric population:

This medication should not be administered to children under 7 years or with a body weight less than 21 kg, as the dose is not suitable for their posology.

Method of administration

For oral use.

Empty the contents of the sachet directly into the mouth. In patients with stomach discomfort, it is recommended to take the medication during meals.

If you take more Ibuprofen Codramol than you should

If you have taken more Ibuprofen Codramol than you should, or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested. It is recommended to bring the package and the package leaflet of the medication to the healthcare professional.

If you have taken more Ibuprofen Codramol than you should, or if a child has accidentally ingested the medication, consult a doctor or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

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 such as 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 Codramol

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 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.

Frequencies have been defined as follows:

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

Frequency not known:cannot be estimated from the available data

The following adverse effects have been observed:

Gastrointestinal disorders

The most frequent adverse effects that occur with medications containing this active ingredient are gastrointestinal: peptic ulcers, digestive hemorrhages, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Gastritis has been observed less frequently.

Frequent:nausea, vomiting, abdominal pain, heartburn, flatulence, and constipation.

Infrequent:hemorrhage, stomach or duodenal ulcers.

Rare:gastric or intestinal perforation, esophageal inflammation, and ulcers or inflammation of the intestine.

Disorders of the skin and subcutaneous tissue

Frequent:skin rash.

Infrequent: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. Medications containing this active ingredient may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

Severe allergic reaction that may 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, 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 Codramol if you experience these symptoms and seek medical attention immediately. See also section 2. The skin becomes sensitive to light.

Disorders of the nervous system

Frequent:headache.

Infrequent:fatigue or drowsiness.

Very rare: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.

Psychiatric disorders

Frequent:feeling of instability and nervousness.

Infrequent:anxiety.

Rare:disorientation or confusion, depression.

Disorders of the ear and labyrinth

Infrequent:ringing or buzzing in the ears.

Rare:hearing difficulty.

Eye disorders

Infrequent:vision alteration.

Rare:abnormal or blurred vision.

Disorders of the blood and lymphatic system

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 disorders

These medications may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke. Edema (fluid retention), arterial hypertension, and heart failure have also been observed in association with treatments with medications of this type.

Renal and urinary disorders

Kidney disease.

Hepatobiliary disorders

Rare:hepatitis (inflammation of the liver) and jaundice (yellowing of the skin). These medications 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 does not appear 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 Ibuprofeno Codramol

Keep this medicine out of sight and reach of children.

No special storage conditions are required.

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 thrown away through wastewater or household waste. Deposit the packaging and unused medicines in the SIGRE collection point at the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and unused medicines. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Ibuprofeno Codramol

• The active ingredient is ibuprofen. Each sachet contains 200 mg of ibuprofen.
• The other components (excipients) are: Isomalt 720 (contains glucose and sorbitol E420), anhydrous citric acid, potassium acesulfame (E-950), glycerol distearate (type I), and lemon flavor (natural flavorings, maltodextrin, and alpha-tocopherol (E-307).

Appearance of the Product and Package Contents

Ibuprofeno Codramol is presented in the form of a white or almost white oral powder with a marked lemon odor and in monodose sachets of polyester/aluminum/polyethylene.

There are two presentations: packages of 12 units and 24 units.

Only some package sizes may be marketed.

Marketing Authorization Holder

FARMALIDER, S.A.

C/ La Granja 1

28108 - Alcobendas - Madrid

Spain

Tel: 91.661.23.35

email: [email protected]

Manufacturer

BIOFABRI, S.L.

A Relva, s/n, O Porriño

36400 Pontevedra

Spain

or

EDEFARM, S.L.

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante

Valencia

Spain

or

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Date of the last revision of this prospectus:November 2024

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