Package Insert: Information for the User

Ibuprofen Codramol 200 mg Oral Powder

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

Follow exactly the administration instructions contained in this package insert or those indicated by your doctor or pharmacist.

• Keep this package insert, as you may need to refer to it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.
• You should consult a doctor if your condition worsens or does not improve after 3 days.

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

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

• forthesymptomaticreliefofoccasionalmild to moderate pain
• for the treatment of fever

He should consult a doctor if it worsens or does not improve after 3 days.

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

Do not take Ibuprofeno Codramol:

• if you are allergic to ibuprofen or any of the other components of this medication (listed in section 6).
• ifaftertakingaspirinorotherNSAIDsyouhaveexperiencedskineruptionwithitching,swellingoftheface,
• lipsortongue,nasalsecretion,difficultybreathingorasthma.
• if you have had a stomach or duodenal ulcer bleeding or have suffered a perforation of the digestive tract while taking an anti-inflammatory medication.
• if you currently have or have had more than once: a stomach or duodenal ulcer or bleeding.
• if you have severe heart failure.
• if you are in the third trimester of pregnancy.
• if you have a severe liver or kidney disease.
• if you have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood).
• if you have ulcerative colitis or Crohn's disease.
• severe dehydration(causedbyvomiting,diarrheaorinsufficientliquidintake).

Warnings and precautions

Consultyourdoctororpharmacistbeforestartingtotakethismedication:

• If you have had or develop 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 treatments, in patients with a history of peptic ulcer disease, and in elderly patients. In these cases, your doctor will consider the possibility of associating a stomach protector medication.
• If you have had kidney or liver disease.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you are taking this medication, as ibuprofen may mask fever, which is an important sign of infection, making its diagnosis more difficult.
• Ifyouhaveorhavehadanyheartdisorderorhavehighbloodpressure.
• 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), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• Ifyoupresentsymptomsofdrought, e.g. severe diarrhea or vomiting, takeabundantliquidandcontactyourdoctorimmediately,asibuprofeninthiscasemaycauserenalinsufficiencyduetodrought.
• If you are takingsimultaneouslymedicationsthatalterbloodcoagulationlikeoralanticoagulants,antiplateletagentslikeaspirin,alsocommenttheuseofothermedicationsthatmayincreasetheriskofbleedinglikecorticosteroidsandSSRIs(selectiveserotoninreuptakeinhibitors).
• If you have Crohn's disease or ulcerative colitis, as these medications may worsen these conditions.
• If you are takingdiuretics(medicationsusedtoincreaseurineproduction),asyourdoctormustmonitoryourkidneyfunction.
• If you have systemic lupus erythematosus(a chronic disease that affects the immune system and can affectdifferent vital organs, the nervous system, blood vessels, skin, andjoints),asitismorelikelytocauseasepticmeningitis(inflammationofthemeningesthatarethemembranesthatprotectthebrainandspinalcord,notcausedbybacteria).
• If you have porphyria(a metabolic disease that affects your blood and can cause symptoms such asredurinecoloration,bloodinurineorliverdisease),soyourdoctorcanevaluatethenecessityoftreatmentwithibuprofen.
• If you have headaches after aprolongedtreatment,donottakehigherdosesofthemedication.
• It is possible that you may experienceallergicreactionswiththismedication.
• Your doctor will perform a morestrictcheckifyouaretakingibuprofenaftersurgery.
• It is recommended that you do not take thismedicationifyouhavechickenpox.
• If you have an infection; see the heading "Infections" below.

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 consult your doctor or pharmacist before taking Ibuprofeno Codramol if:

- you have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (problems with circulation 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, a family history of heart disease or stroke, or are a smoker.

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

Severe Skin Reactions

Severe skin reactions have been reported associated with Ibuprofeno Codramol treatment. Stop taking Ibuprofeno Codramol and see your doctor immediately if you experience any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Infections

Ibuprofeno Codramol may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibuprofeno Codramol may delay the appropriate treatment of the infection, increasing 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 having an infection and the infection symptoms persist or worsen, consult a doctor without delay.

Children and Adolescents

There is a risk ofkidneydamageinchildrenandadolescentswhoaredroughted.

Interference with Laboratory Tests:

The taking of ibuprofenmayalterthefollowinglaboratorytests:

• Bleeding time (maybeprolongedfor1dayafterstoppingtreatment)
• Blood glucose concentration (maydecrease)
• Creatinine clearance (maydecrease)
• Hematocrit or hemoglobin (maydecrease)
• Blood concentrations of urea nitrogen and serum concentrations of creatinine and potassium (mayincrease)

With liver function tests: increased values of transaminases

Informyourdoctorifyouareabouttoundergoaclinicaltestandaretakingorhaverecentlytakenibuprofen.

ConsultyourdoctororpharmacistbeforestartingtotakeIbuprofenoCodramol.

Use of Ibuprofeno Codramol with Other Medications

Informyourdoctororpharmacistifyouaretakingorhavetakenrecentlyormayneedtotakeanyothermedication.

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

• Other nonsteroidal anti-inflammatory drugs (NSAIDs): as it may increase the risk of adverse effects.
• Anticoagulant medications (e.g. for treating bleeding or coagulation problems, e.g. aspirin, warfarin, ticlopidine).Lithium (medication used to treat depression): as it may increase lithium blood levels and the risk of adverse effects. If you need to take lithium and ibuprofen, your doctor may need to adjust your lithium dose.
• Metotrexate: if you take metotrexate and ibuprofen at the same time (within a 24-hour interval), they may increase metotrexate blood levels and the risk of toxicity. Your doctor may advise you not to take ibuprofen if you receive high-dose metotrexate treatment.
• Hidantoins like phenytoin (for treating epilepsy).
• Sulfamides: as they may increase their toxic effects.
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan).
• Corticosteroids like prednisone and prednisolone, as they may increase the risk of stomach or intestinal bleeding.
• Diuretics (medications used to increase urine production), as they may increase the risk of kidney toxicity.

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

• Fluconazoleandvoriconazole(usedtotreatfungusinfections),pentoxifylline,probencid,sulfinpyrazone(forgout),quinolones(suchasnorfloxacin),mifepristone,sulfonylureas(suchastolbutamide),tacrolimusandciclosporin(usedtopreventtransplantrejection),zidovudine(kidneyrisk),colestiramine(usedtotreathighcholesterol).
• SSRIs may also increase the risk of gastrointestinal bleeding.

Taking Ibuprofeno Codramol with Food, Drinks, and Alcohol

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

Theconsumptionofalcoholmayincreasetheriskofadversereactions.

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

Due to the administration of this medication being associated with an increased risk of congenital anomalies/abortions, it is not recommended to administer it during the first and second trimesters 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, administration is contraindicated.

For women of childbearing age, it should be taken into account that this type of medication has been associated with a decrease in the ability to conceive.

Breastfeeding

Although the levels of medication in breast milk are negligible, it is recommended to consult your doctor in long-term or high-dose treatments during breastfeeding.

Driving and Operating Machines

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, you should not drive or operate machinery. If you only take ibuprofen or for a short period, no special precautions are necessary.

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

Ibuprofeno Codramol contains glucose and sorbitol E420

Ifyourdoctorhastoldyouthatyouhaveatolerancetocertainsugars,consultwithhimbeforetakingthismedication.

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

You should use the most effective dose for the shortest time necessary to relieve symptoms. If you have an infection, consult a doctor as soon as possible if 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)

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

Orientatively, the following recommendations can be followed:

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

To minimize the appearance of adverse reactions, use the lowest effective doses for the shortest time possible to control symptoms (see section 4.4).

This medication is used in short-term treatments.

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

The administration of this medication is subject to the appearance of pain or fever. As soon as these symptoms disappear, discontinue the medication.

Special groups of patients

Patients with kidney, liver, or heart diseases:

Reduce the dose and consult a doctor. Do not use ibuprofen 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 does not adapt to its posology.

Form of administration

For oral use.

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

If you take more Ibuprofeno Codramol than you should

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

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

The symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained 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. Blood in the urine, low potassium levels in the blood, chills, and breathing difficulties have also been reported.

If you forgot to take Ibuprofeno Codramol

Do not take a double dose to compensate for the missed 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 missed dose and take the next dose at your usual time.

If you have any other doubts 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.

Frequencies have been defined as follows:

Very common:can affect more than 1 in 10 patients

Common:can affect up to 1 in 10 patients

Uncommon:can affect up to 1 in 100 patients

Rare:can affect up to 1 in 1,000 patients

Very rare:can affect up to 1 in 10,000 patients

Frequency not known:cannot be estimated from available data

The following side effects have been observed:

Gastrointestinal disorders

The most common side effects that occur with medicines containing this active ingredient are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in elderly patients. Nausea, vomiting, diarrhea, flatulence, constipation, stomach pain, bloody stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, the appearance of gastritis has been observed.

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

Uncommon:bleeding, stomach or duodenal ulcers.

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

Skin and subcutaneous tissue disorders

Common:skin rash.

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 skin blisters, joint pain, and fever (systemic lupus erythematosus), hair loss, skin reactions caused by light exposure. Medicines 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, facial, tongue, and throat swelling, breathing difficulty, asthma, palpitations, hypotension, or shock.

Frequency not known::A severe skin reaction known as DRESS syndrome may occur. DRESS syndrome symptoms include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). Generalized red scaly rash, with blisters under the skin and localized blisters mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular exanthema). Stop taking Ibuprofeno Codramol if you experience these symptoms and seek medical attention immediately. See also section 2. The skin becomes sensitive to light.

Nervous system disorders

Common:headache.

Uncommon: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

Common:feeling of instability and nervousness.

Uncommon:anxiety.

Rare:disorientation or confusion, depression.

Vestibular disorders

Uncommon:tinnitus or buzzing in the ears.

Rare:hearing difficulty.

Eye disorders

Uncommon:vision alteration.

Rare:abnormal or blurred vision.

Blood and lymphatic system disorders

Very rare:prolongation of bleeding time, alterations in blood cells (the first symptoms may be: fever, sore throat, mouth ulcers, symptoms similar to the flu, excessive fatigue, nasal and skin bleeding).

Cardiovascular disorders

These medicinesmay be associated with a moderate increase in the risk of suffering a heart attack (“myocardial infarction”) or cerebral Also, edema (fluid retention), hypertension, and heart failure have been observed in association with treatments with medicines of this type.

Renal and urinary disorders

Kidney disease.

Hepatobiliary disorders

Rare:hepatitis (liver inflammation) and jaundice (yellow skin discoloration). These medicines 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 Vigilance 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

Do not use this medication after the expiration date that appearson the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medications at the SIGRE pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Composition of Ibuprofeno Codramol

• The active ingredient is ibuprofen. Each blister pack 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 diestearate (type I) and lemon aroma(natural flavorings, maltodextrin and alpha tocopherol (E-307).

Appearance of the product and content of the container

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

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

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization

FARMALIDER, S.A.

C/ La Granja 1

28108- Alcobendas- Madrid

Spain

Phone: 91.661.23.35

email:[email protected]

Responsible for manufacturing

BIOFABRI, S.L.

A Relva, s/n, O Porriño

36400 Pontevedra

Spain

Ó

EDEFARM, S.L

Polígono Industrial Enchilagar del Rullo, 117

46191 Villamarchante

Valencia

Spain

ó

FARMALIDER, S.A.

C/Aragoneses, 2

28108 Alcobendas (Madrid)

Spain

Dateofthelastreviewofthisleaflet:November2024

“Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”