IBUPROFEN CODRAMOL 20 mg/ml ORAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Ibuprofen Codramol 20 mg/ml Oral Suspension.

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, 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, do not pass it on to others. It may harm them, even if their symptoms 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 Codramol and what is it used for
2. What you need to know before you take Ibuprofen Codramol
3. How to take Ibuprofen Codramol
4. Possible side effects
5. Storing Ibuprofeno Codramol
6. Further information

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

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

Ibuprofen is indicated for the treatment of fever and pain of mild to moderate intensity.

2. Before taking Ibuprofen Codramol

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

Do not take Ibuprofen Codramol

• If you are allergic (hypersensitive) to ibuprofen, to other medicines of the NSAID group (e.g. acetylsalicylic acid, naproxen, etc.) or to any of the other ingredients of this medicine. Allergic reactions may include: skin rash with itching, swelling of the face, lips or tongue, runny nose, difficulty breathing or asthma.
• If you have had 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 severe liver or kidney disease.
• If you have bleeding disorders or blood coagulation disorders or are taking anticoagulants (medicines used to "thin" the blood). If it is necessary to use anticoagulant medicines 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

Be careful with Ibuprofen Codramol

Tell your doctor:

• 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 previous warning symptoms.
• This risk is greater when high doses and prolonged treatments are used, 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 protective medicine.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you 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 medicine 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 as a consequence of dehydration.
• If you are taking medicines that alter blood coagulation, such as oral anticoagulants, antiplatelet agents of the type of acetylsalicylic acid. You should also discuss the use of other medicines that may increase the risk of such bleeding, such as corticosteroids and antidepressants, selective serotonin reuptake inhibitors.
• If you have Crohn's disease or ulcerative colitis, as ibuprofen-type medications can worsen these conditions.
• If you are being treated with diuretics (medicines 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.
• 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 are receiving treatment with ibuprofen, as it may mask fever, which is an important sign of infection, making its diagnosis difficult.
• If you experience headaches after prolonged treatment, do not take higher doses of the medicine.
• It is possible that allergic reactions may occur with this medicine.
• Your doctor will perform stricter monitoring if you receive ibuprofen after undergoing major surgery.
• It is advisable not to take this medicine if you have chickenpox.
• It is important that you use the smallest dose that relieves/controls the pain and do not take this medicine for longer than necessary to control your symptoms.
• If you have an infection: see the "Infections" section below.

Infections

Ibuprofen Codramol may hide the signs of an infection, such as fever and pain. Consequently, Ibuprofen 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 take this medicine while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Cardiovascular Precautions

Anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increased risk of 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 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 if you are a smoker.
• Ibuprofen has been reported to cause signs of allergic reaction to this medicine, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using Ibuprofen Codramol immediately and contact your doctor or the emergency medical service if you notice any of these signs.

Additionally, this type of medicine 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 Codramol. Stop taking Ibuprofen Codramol 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.

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 Codramol and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

Precautions during Pregnancy and in Women of Childbearing Age

Because the administration of ibuprofen-type medicines 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 is contraindicated

For women of childbearing age, it should be taken into account that ibuprofen-type medicines have been associated with a decrease in fertility.

Interference with Laboratory 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)
• With liver function tests: increased transaminase values

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

Using Ibuprofen Codramol with Other Medicines

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Do not take ibuprofen with other painkillers without consulting your doctor.

Ibuprofen Codramol may affect or be affected by other medicines. For example:

• Corticosteroids such as cortisone and prednisolone.
• Selective serotonin reuptake inhibitors (used in depression).
• Other NSAIDs such as aspirin.
• Lithium (a medicine used to treat depression). Your doctor may adjust the dose of this medicine.
• Anticoagulant medicines (e.g. to treat coagulation problems/prevent coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin-II receptor antagonists such as losartan).
• Methotrexate (for cancer and inflammatory diseases). Your doctor may adjust the dose of this medicine.
• Mifepristone (abortion inducer).
• Digoxin and other cardiac glycosides (used in the treatment of heart disorders).
• Hydantoins such as phenytoin (used in the treatment of epilepsy).
• Sulfonamides such as sulfamethoxazole and cotrimoxazole (used in the treatment of certain bacterial infections).

• Diuretics (medicines 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 such as norfloxacin.
• Sulfinpyrazone (for gout).
• Sulfonylureas such as tolbutamide (for diabetes).
• Tacrolimus or cyclosporin (used in organ transplants to prevent rejection).
• Anti-hypertensives (to lower high blood pressure).
• Thrombolytics (medicines that dissolve blood clots).
• Zidovudine (a medicine against the AIDS virus).
• Aminoglycoside antibiotics such as neomycin.
• Herbal extracts (from the Ginkgo biloba tree).

Other medicines may 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 medicines.

Taking Ibuprofen Codramol with Food and Drinks

It is recommended to take Ibuprofen with milk or with food, or immediately after eating, to reduce the possibility of stomach upset.

Pregnancy, Breast-feeding, and Fertility

Pregnancy

Consult your doctor or pharmacist before taking any medicine.

Do not take Ibuprofen 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 ability to bleed and prolong or delay delivery more than expected. You should not take this medicine 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 possible time. From the 20th week of pregnancy, Ibuprofen Codramol may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of the fluid that surrounds 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.

Breast-feeding

Ibuprofen passes into breast milk, but it is not necessary to interrupt breast-feeding during short-term treatment with the recommended dose for pain and fever.

Driving and Using Machines

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

Important Information about Some of the Ingredients of Ibuprofen Codramol

This medicine may cause headache, stomach upset, and diarrhea because it contains glycerol (E-422).

This medicine contains maltitol syrup (E-965). If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

It may have a slight laxative effect because it contains 0.25 g of maltitol syrup per ml.

Caloric value: 2.3 kcal/g of maltitol/isomaltase

3. How to take Ibuprofen Codramol

Follow the administration instructions for ibuprofen Codramol exactly as indicated by your doctor.

Consult your doctor or pharmacist if you have any doubts.

Remember to take your medication.

Ibuprofen Codramol is an oral suspension for administration.

The lowest effective dose should be used for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

For exact dosing, the containers contain a graduated oral doser. First, you must shake the solution, then the doser is inserted into the perforated cap, the bottle is inverted, the plunger is pulled until the liquid reaches the amount prescribed by the doctor, the bottle is returned to its initial position, and the doser is removed. The doser must be disassembled, washed, and dried.

Patients with stomach discomfort should take the medication with milk and/or during meals.

Children

The dose of ibuprofen to be administered depends on the child's age and weight. As a general rule, the recommended daily dose is 20 to 30 mg/kg of weight, divided into three or four individual doses (see table). It is recommended not to exceed the maximum daily dose of 40 mg per kg of weight per day of ibuprofen.

This medication is not recommended for children under 3 months.

The interval between doses will depend on the evolution of symptoms, but it will never be less than 4 hours.

However, as a guideline, the following dosage regimen is recommended:

Adults and adolescents:

Due to the amount of ibuprofen contained in Ibuprofen Codramol, it is recommended to use other more suitable presentations for ibuprofen treatment in adults and adolescents (over 12 years). The recommended dose is 20 ml 3 to 4 times a day (equivalent to 1200-1600 mg of ibuprofen/day), while symptoms persist.

Elderly patients:

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

Patients with renal or hepatic insufficiency:

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

Your doctor will indicate the duration of treatment with Ibuprofen. Do not stop treatment before, as the expected results will not be obtained.

Similarly, do not use Ibuprofen for longer than indicated by your doctor.

Consult your doctor if symptoms persist or worsen during the treatment period.

If you take more Ibuprofen Codramol than you should

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

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain bloody sputum), 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 difficulties have been reported.

Mild symptoms of an overdose are: abdominal pain, nausea, vomiting, indifference, sleep, headache, rapid involuntary eye movements, ringing in the ears, and lack of muscle coordination.

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

If a 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 Ibuprofen Codramol

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

If you forget to take your corresponding dose, take it as soon as you remember. However, if the time for the next dose is very close, skip the forgotten dose and take the next dose at your usual time.

4. Possible adverse effects

Like all medications, Ibuprofen can have adverse effects, although not everyone will experience them.

If you consider that any of the adverse effects you suffer from is serious or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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

Adverse effects of medications like ibuprofen are more common in people over 65 years old.

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

The following adverse effects related to the use of Ibuprofen have been observed.

Gastrointestinal:

The most frequent adverse effects that occur with medications like Ibuprofen 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 stools, oral ulcers, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Other adverse effects are: Uncommon: inflammation of the oral mucosa with ulcer formation.

Rare: esophageal inflammation, esophageal narrowing (esophageal stenosis), exacerbation of diverticular disease, hemorrhagic colitis. Very rare: pancreatitis

Cardiovascular:

Medications like Ibuprofen 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 of the ibuprofen type. Unknown frequency: chest pain, which can be a sign of a potentially serious allergic reaction called Kounis syndrome.

Dermatological:

Medications like ibuprofen 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 toxic epidermal necrolysis (erosions on mucous membranes and painful lesions with necrosis and shedding of the epidermis).

Other adverse effects are: Frequent: skin rash. Uncommon: 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 the blood vessels of the skin. Exceptionally, severe skin infections and soft tissue complications can occur during chickenpox. Unknown frequency: 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). Also, a 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) can occur. Stop taking Ibuprofen Codramol if you present these symptoms and seek medical attention immediately. See also section 2.

The skin becomes sensitive to light.

Immune system:

Uncommon: 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 to the lungs). Rare: severe allergic reactions (anaphylactic shock). In case of generalized severe 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 (inflammation of the meninges that protect the brain and spinal cord, not caused by bacteria). In most cases where aseptic meningitis has been reported with ibuprofen, the patient suffered from 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:

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

Auditory:

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

Ocular:

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

Blood:

Rare: decreased platelets, decreased white blood cells (which can manifest as frequent infections with fever, chills, or sore throat), decreased red blood cells (which can 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 large 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, pseudo-flu symptoms, extreme fatigue, nosebleeds, and skin bleeding. Very rare: prolonged bleeding time.

Renal:

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 renal failure (sudden loss of kidney function) cannot be ruled out.

Hepatic:

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

General:

Worsening of inflammation during infectious processes.

To date, no serious allergic reactions have been reported with Ibuprofen, 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 occur, stop treatment and go to your doctor immediately:

• Allergic reactions such as skin rash, facial swelling, wheezing in the chest, or difficulty breathing.
• Vomiting blood or coffee grounds-like vomit.
• Blood in stools or bloody diarrhea.
• Severe stomach pain.
• Blistering or significant skin peeling.
• Severe or persistent headache.
• Yellowing of the skin (jaundice).
• Signs of severe hypersensitivity (see above in this section).
• Swelling of the limbs or fluid accumulation in the arms or legs.
• Red, non-raised, target-like or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genitals, and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• Generalized rash, elevated body temperature, and swollen lymph nodes (DRESS syndrome).

A generalized, red, scaly rash, with bumps under the skin and blisters, accompanied by fever, usually appears at the start of treatment (acute generalized exanthematous pustulosis).

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 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 medication.

5. Conservation of Ibuprofen Codramol

Keep out of the reach and sight of children.

Do not use this medication after the expiration date that appears on the package after

EXP. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be thrown down the drain or into the trash. Deposit the packages and medications you no longer need in the SIGRE Point of your usual pharmacy. If in doubt, ask your pharmacist how to dispose of the packages and medications you no longer need.

In this way, you will help protect the environment.

6. Additional information

Composition of Ibuprofen Codramol.

• The active ingredient is ibuprofen. Each ml of oral suspension contains 20 mg of ibuprofen.
• The other components (excipients) are: glycerol (E-422), maltitol syrup (E-965), microcrystalline cellulose, xanthan gum, anhydrous citric acid, sodium citrate, sodium benzoate (E-211), polysorbate 80, sodium saccharin, orange essence, and purified water

Appearance of the product and package content

The medication, after being shaken, will result in a white-colored suspension with an orange odor.

It is presented in a 200 ml bottle and includes a 5 ml dosing syringe.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Farmalider, S.A.

c/Aragoneses 15

28108 - Alcobendas - Madrid.

Spain

Manufacturer:

Laboratorio Aldo-Unión, S.A.

Calle Baronesa de Maldá, 73

08950 Esplugues de Llobregat

BARCELONA - SPAIN

Or

Farmalider S.A.

C/ Aragoneses 2

28108 - Alcobendas, Madrid

Spain

This prospectus was revised in October 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/