Ibufarmalid 600 mg suspension oral

PATIENT INFORMATION LEAFLET

Ibufarmalid 600 mg oral suspension

Ibuprofen (D.O.E.)

This leaflet explains:

1. What Ibufarmalid 600 mg oral suspension is and what it is used for
2. Before taking Ibufarmalid 600 mg oral suspension
3. How to take Ibufarmalid 600 mg oral suspension
4. Possible side effects
5. How to store Ibufarmalid 600 mg oral suspension
6. Additional information

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

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain in processes such as dental pain, postoperative pain, headache including migraine, symptomatic relief of pain, fever, and inflammation that accompanies processes such as pharyngitis (inflammation of the upper region of the throat), tonsillitis (inflammation of the tonsils), and otitis (inflammation of certain structures of the middle ear), among others, the treatment of arthritis or joint inflammation (rheumatoid, psoriatic, gouty, etc), osteoarthritis (inflammation of the cartilage of the joints), ankylosing spondylitis (inflammation that affects the joints of the spine), non-rheumatic inflammation (bursitis, synovitis, capsulitis, or other types of traumatic or sports-related inflammatory injuries), and primary dysmenorrhea (painful menstruation).

It is essential to use the smallest effective dose to relieve or control pain and not to take Ibufarmalid 600 mg oral suspension for longer than necessary to control your symptoms.

Do not take Ibufarmalid 600 mg oral suspension if:

• You are allergic to ibuprofen, other nonsteroidal anti-inflammatory drugs (NSAIDs), or any of the excipients in this medication. Such reactions may include: skin rash with itching, facial, lip, or tongue swelling, nasal discharge, difficulty breathing, or asthma.

• You have had a previous stomach or duodenal hemorrhage or have experienced a perforation of the digestive tract while taking an NSAID.

• You currently have or have had more than one episode of stomach or duodenal ulcer or hemorrhage.

• You have a severe liver or kidney disease.

• You have severe heart failure.

• You have bleeding or clotting disorders, or are taking anticoagulants (medications used to "thin" the blood).

• You are in the third trimester of pregnancy.

Be especially careful with Ibufarmalid 600 mg oral suspension:

• You have had or develop a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as 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 treatment, especially in patients with a history of peptic ulcer and the elderly. In these cases, your doctor may consider associating a stomach protector medication.

• Signs of severe allergic reactions to ibuprofen, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibufarmalid 600 mg oral suspension immediately and contact your doctor or emergency medical services if you observe any of these signs.

Inform your doctor:

• If you are taking medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like aspirin, or other medications that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors (SSRIs).

• If you have Crohn's disease or ulcerative colitis, as ibuprofen-like medications may worsen these conditions.

• If you have kidney or liver disease.
• If you have edema (fluid retention).
• If you have asthma or any other respiratory disorder.
• If you are being treated for an infection, as ibuprofen 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 medication for an extended period (more than 1-2 weeks), your doctor may need to perform regular checks. Your doctor will indicate the frequency of these checks.
• If you have an infection; see the "Infections" section below.

Infections

Ibufarmalid may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Ibufarmalid 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.

Cardiovascular Precautions

Medications like Ibufarmalid 600 mg oral suspension may be associated with a moderate increase in the risk of heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when using high doses and prolonged treatment. Do not exceed the recommended dose or treatment duration.

If you have heart problems, a history of strokes, or think you may be at risk for these conditions (e.g., you have high blood pressure, diabetes, high cholesterol, or are a smoker), consult this treatment with your doctor or pharmacist.

These types of medications may also cause fluid retention, especially in patients with heart failure and/or high blood pressure.

Severe skin reactions have been reported associated with the treatment of Ibufarmalid 600 mg oral suspension. Stop taking Ibufarmalid 600 mg oral suspension and seek medical attention immediately if you experience any skin rash, mucous membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

Taking Ibufarmalid 600 mg oral suspension with food and beverages:

You can take it alone or with food. Generally, it is recommended to take it before meals to reduce the possibility of stomach discomfort.

Pregnancy, breastfeeding, and fertility:

Pregnancy:

Consult your doctor or pharmacist before using any medication.

Do not take Ibufarmalid 600 mg oral suspension if you are in the last 3 months of pregnancy, as it may harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your fetus. It may affect your predisposition and that of your baby to bleed and delay or prolong delivery more than expected. Do not take this medication during the first 6 months of pregnancy unless it is clearly necessary and as indicated by your doctor. If you need treatment during this period or while trying to become pregnant, you should take the minimum dose for the shortest possible time. From week 20 of pregnancy, Ibufarmalid 600 mg oral suspension may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

Due to the association of administering medications like Ibufarmalid 600 mg oral suspension with an increased risk of congenital anomalies/abortions, it is not recommended to administer the same during the first and second trimesters of pregnancy unless strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

Fertility:

For fertile women, it is essential to consider that medications like Ibufarmalid 600 mg oral suspension have 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 cases of long-term treatment or high doses during breastfeeding.

Use in children:

Do not administer to children under 12 years old without consulting a doctor.

Driving and operating machinery:

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 a single dose of ibuprofen or for a short period, no special precautions are necessary.

Use of other medications:

Inform your doctor or pharmacist if you are using, or have recently used, any other medication, including those acquired without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.

It is not recommended to take ibuprofen with:

• Other nonsteroidal anti-inflammatory drugs (NSAIDs): as it may increase the risk of adverse effects.
• Warfarin, ticlopidine, or other medications used to "thin" the blood and prevent clotting, as their effect may increase.
• Lithium (a medication used to treat depression): as it may increase lithium levels in the blood 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 levels in the blood and the risk of toxicity. Your doctor may advise you not to take ibuprofen if you receive high-dose metotrexate treatment.

• Hidantoínas like phenytoin (for epilepsy treatment)
• Sulfamidas: as they may increase their toxic effects.

Other interactions requiring caution:

• Corticosteroids like cortisone and prednisolone, diuretics, fluconazole, pentoxifylline, probenecid, quinolones (such as norfloxacin), sulfinpyrazone, sulfonylureas (such as tolbutamide), tacrolimus, ciclosporin, zidovudine, as they may increase the risk of stomach ulcers or bleeding.
• SSRIs may also increase the risk of stomach bleeding.

Information about some components of IBUFARMALID 600 mg oral suspension

Containing azorubine as an excipient may cause allergic reactions. It may cause asthma, especially in patients allergic to aspirin.

Each sachet contains 87 mg of sodium, which should be taken into account in patients with low-sodium diets.

Follow these instructions unless your doctor has given you different instructions.

This medication is administered orally.

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

The recommended doses in adults and young people aged 12 to 18 years is one packet (600 mg) every 6 to 8 hours, depending on the severity of the condition and response to treatment. In adults, the maximum daily recommended dose is 2400 mg, while in young people aged 12 to 18 years, it is 1800 mg.

Do not administer Ibufarmalid 600 mg oral suspension to children under 12 years of age without consulting a doctor.

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

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

Always take the smallest effective dose. The duration of treatment will be decided by your doctor and should not be stopped prematurely.

This product is a suspension. It should be homogenized before taking by pressing the top and bottom of the packet several times with your fingers. It can be taken directly from the packet or diluted in water.

It is recommended to take the medication with meals if you experience gastrointestinal discomfort.

Remember to take your medication and inform your doctor or pharmacist if you estimate that the action of Ibufarmalid 600 mg oral suspension is too strong or too weak.

If you take more Ibufarmalid 600 mg oral suspension than you should:

If you have taken more Ibufarmalid 600 mg oral suspension than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or contact the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. or go to the nearest hospital to inform yourself about the risk and ask for advice on the measures to be taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

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

The most common symptoms in case of overdose are: nausea, vomiting, abdominal pain, headache, dizziness, drowsiness, involuntary eye movements, blurred vision, ringing in the ears, sometimes low blood pressure, and fainting.

If you forget to take Ibufarmalid 600 mg oral suspension:

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

If you forget to take your dose, take it as soon as you remember. However, if the time for the next dose is almost due, skip the missed dose and take the next dose at your usual time.

Like all medications, Ibufarmalid 600 mg oral suspension may have adverse effects.

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

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects that occur with medications such as Ibufarmalid 600 mg oral suspension are gastrointestinal: peptic ulcers, digestive bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, stomach burning, abdominal pain, blood in stool, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

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

Infrequent:bleeding, stomach or duodenal ulcers.

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

Skin and allergic reactions:

Frequent:skin rash.

Infrequent: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 sudden appearance of blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, light-sensitive skin reactions,

Medications like Ibufarmalid 600 mg oral suspension may be associated, in very rare cases, with severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

Asymptomatic meningitis (inflammation of the membranes covering the brain and spinal cord), in most cases in patients with autoimmune diseases such as systemic lupus erythematosus.

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

Frequency "unknown"»:A severe skin reaction known as DRESS syndrome may occur. DRESS syndrome symptoms include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell). A generalized red, scaly rash with localized blisters, mainly on the skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized pustular exanthema). Stop taking Ibufarmalid 600 mg oral suspension if you experience these symptoms and seek medical attention immediately. See section 2.The skin becomes sensitive to light.

Central nervous system:

Frequent:headache, feeling of instability, and nervousness.

Infrequent:fatigue or somnolence, insomnia, anxiety, visual disturbances, buzzing or ringing in the ears.

Rare:disorientation or confusion, depression, abnormal or blurred vision, and hearing difficulty.

Very rare:asymptomatic meningitis.

Blood:

Very rare:prolonged bleeding time, alterations in blood cells (initial symptoms may be: fever, sore throat, mouth ulcers, flu-like symptoms, excessive fatigue, nasal and skin bleeding)

Cardiovascular:

Medications like Ibufarmalid 600 mg oral suspension may be associated with a moderate increase in the risk of suffering a heart attack ("myocardial infarction") or stroke

Edema (fluid retention), hypertension, and heart failure have also been observed in association with treatments with medications of the type Ibufarmalid 600 mg oral suspension

Kidney::

Kidney disease.

Liver::

Rare:hepatitis (liver inflammation) and jaundice (yellow skin discoloration) Medications like Ibufarmalid 600 mg oral suspension may be associated, in rare cases, with liver damage

If you observe these adverse effects or any other not described in this prospectus, consult your doctor or pharmacist

Keep Ibufarmalid 600 mg Oral Suspension out of the reach and sight of children.

Store in its original container.

Expiration Date:

Do not use Ibufarmalid 600 mg Oral Suspension after the expiration date indicated on the container.

The expiration date is the last day of the month indicated

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.

Composition

The active ingredient is Ibuprofen. Each sachet contains 600 mg of ibuprofen.

The other components (excipients) are: Sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, hypromellose, xanthan gum, liquid maltitol, thiomersal (E-957), strawberry flavor, azorubine (E-122), glycerol, and purified water.

Appearance of the product and contents of the package

Ibufarmalid 600 mg oral suspension is presented in the form of an oral suspension to be taken directly from the sachet or dissolved in water. Each package contains 20 or 40 sachets.

Holder of the marketing authorization

Farmalider Laboratories, S.A. C/Aragoneses, nº 2 28108 Alcobendas (Madrid) Spain

Responsible for manufacturing

Industrial Pharmaceutical Cantabria, S.A. Carretera Cazoña/Adarzo s/n 39011 Santander Spain

Date of the last review of this leaflet:November 2024

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