PATIENT INFORMATION LEAFLET

Ibufarmalid 400 mg oral suspension

Ibuprofen (D.O.E.)

This leaflet explains:

1. What Ibufarmalid 400 mg oral suspension is and what it is used for
2. Before taking Ibufarmalid 400 mg oral suspension
3. How to take Ibufarmalid 400 mg oral suspension
4. Possible side effects
5. Storage of Ibufarmalid 400 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 alleviate or control pain and not to take Ibufarmalid 400 mg oral suspension for longer than necessary to manage your symptoms.

Do not take Ibufarmalid 400 mg oral suspension if:

• You are allergic (hypersensitive) 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 swelling, 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 (blood thinners).

• You are in the third trimester of pregnancy.

Be cautious with Ibufarmalid 400 mg oral suspension:

• You have had or develop a stomach or duodenal ulcer, hemorrhage, or perforation, which may manifest as severe abdominal pain or persistent and/or black stools, or even without prior warning symptoms.

• This risk is higher when using high doses and prolonged treatment, especially in patients with a history of peptic ulcer disease 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 400 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 coagulation, such as oral anticoagulants, antiplatelet agents like aspirin, or corticosteroids, and antidepressants that inhibit serotonin reuptake. You should also inform your doctor about the use of other medications that may increase the risk of gastrointestinal bleeding, such as diuretics and fluconazole.

• If you have Crohn's disease or ulcerative colitis, as medications like Ibufarmalid 400 mg oral suspension may exacerbate 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 receiving treatment for an infection, as Ibufarmalid 400 mg oral suspension may mask fever, an important sign of infection.
• If you have heart disease, kidney disease, 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 oral suspension may mask the signs of an infection, such as fever and pain. Consequently, Ibufarmalid 400 mg oral suspension 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 varicella. 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 400 mg oral suspension may be associated with a moderate increase in the risk of heart attacks 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

Severe skin reactions associated with Ibufarmalid 400 mg oral suspension treatment have been reported. Stop taking Ibufarmalid 400 mg oral suspension and consult your doctor 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.

Precautions during Pregnancy and in Women of Childbearing Age

Due to the association of ibuprofen medications with an increased risk of congenital anomalies/abortions, the administration of Ibufarmalid 400 mg oral suspension is not recommended during the first and second trimesters of pregnancy, except in cases where 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 Ibufarmalid 400 mg oral suspension is contraindicated.

For women of childbearing age, it is essential to consider that ibuprofen medications have been associated with a decrease in fertility.

Taking Ibufarmalid 400 mg oral suspension with Food and Beverages:

You can take it with or without 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 ibuprofen 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 ibuprofen 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 time possible. From week 20 of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may lead to low amniotic fluid levels (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in your baby's heart. If you need treatment for a period longer than a few days, your doctor may recommend additional checks.

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 8 years old without consulting a doctor.

Driving and Operating Machinery:

If you experience dizziness, vertigo, visual disturbances, or other symptoms while taking this medication, do 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 medications.

Do not 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 must 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.
• Hidantoins like phenytoin (for epilepsy treatment)
• Sulfonamides, 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 (like tolbutamide), tacrolimus, ciclosporin, zidovudine, as they may increase the risk of gastrointestinal ulcers or bleeding.
• Antidepressants that inhibit serotonin reuptake (SSRIs) may also increase the risk of gastrointestinal bleeding.

Information about some components of IBUFARMALID 400 mg oral suspension

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

Each packet contains 58 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).

In adults and young people aged 12 to 18 years, one packet of 400 mg will be taken every 4 to 6 hours, depending on the severity of the condition and response to treatment. In adults, do not take more than 6 packets of 400 mg per day (2400 mg), while in young people aged 12 to 18 years, do not take more than 4 packets of 400 mg per day (1600 mg).

In children aged 8 to 12 years, the administered dose depends on the child's age and weight, generally, the recommended daily dose is 20 to 30 mg/Kg of weight divided into three or four individual doses, however, the following dosage regimen is recommended: one dose of 200 mg (5 ml of suspension) every 4 to 6 hours, depending on the severity of the condition and response to treatment. In cases of juvenile rheumatoid arthritis, the usual daily dose is 30-50 mg/Kg/day in three or four divided doses.

Do not take more than 6 packets of 400 mg per day (2400 mg).

Do not administer Ibufarmalid 400 mg oral suspension to children under 8 years old 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 a 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 lowest effective dose. The duration of treatment will be decided by your doctor and should not be discontinued 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. For an exact dosage, the containers contain a double-spoon scoop.

In case of gastrointestinal discomfort, it is recommended to take the medication with meals.

Remember to take your medication and if you estimate that the action of Ibufarmalid 400 mg oral suspension is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibufarmalid 400 mg oral suspension than you should:

If you have taken more oral suspension of Ibufarmalid 400 mg than you should or have accidentally ingested the contents of the package, consult your doctor or pharmacist immediately or the Toxicological Information Service, phone: 91 5620420, indicating the medication and the amount ingested. It is recommended to bring the package and the medication's leaflet to the healthcare professional.

If you have taken more Ibufarmalid than you should, or if a child has accidentally ingested the medication, consult a doctor immediately 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-tinged 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 Ibufarmalid 400 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 medicines, Ibufarmalid 400 mg oral suspension may have side effects.

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

The following side effects have been observed:

Gastrointestinal:

The most common side effects that occur with medicines like Ibufarmalid 400 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 stools, mouth ulcers, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been observed.

Frequent (at least 1 in 100 people but less than 1 in 10):nausea, vomiting, abdominal pain, burning, flatulence, and constipation.

Occasional (at least 1 in 1000 people but less than 1 in 100):bleeding, stomach or duodenal ulcers.

Rare (at least 1 in 10,000 people but less than 1 in 1,000):gastric or intestinal perforation, esophageal inflammation, and intestinal ulcers or inflammation.

Skin and allergic reactions:

Frequent:skin rash.

Occasional:skin redness, itching, or swelling, lip, face, or tongue swelling, increased nasal secretion, and breathing difficulty.

Rare:serious allergic reactions (anaphylactic shock)

Very rare(less than 1 in 10,000 people): intense skin itching or sudden appearance of blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, light-sensitive skin reactions, aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), in most cases in patients with some autoimmune diseases such as systemic lupus erythematosus.

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

Medicines like Ibufarmalid 400 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.

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).

Frequency "unknown":generalized red scaly rash, with bumps under the skin and 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 400 mg oral suspension if you experience these symptoms and seek medical attention immediately. See also section 2. The skin becomes sensitive to light.

Central nervous system:

Frequent:headache, feeling of instability, and nervousness.

Occasional:fatigue or drowsiness, insomnia, anxiety, visual disturbances, buzzing or ringing in the ears.

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

Very rare:aseptic meningitis.

Blood::

Very rare:prolonged 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::

Medicines like Ibufarmalid 400 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 medicines of the type Ibufarmalid 400 mg oral suspension.

Kidney::

Kidney disease.

Liver::

Rare:hepatitis (liver inflammation) and jaundice (yellowing of the skin) Medicines like Ibufarmalid 400 mg oral suspension may be associated, in rare cases, with liver damage.

If you consider that any of the side effects you are experiencing is serious or if you think any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep Ibufarmalid 400 mg oral suspension out of the reach and sight of children.

Store in its original container.

Expiration:

Do not use Ibufarmalid 400 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 that you no longer need. This will help protect the environment.

Composition

The active principle is Ibuprofen. Each sachet contains 400 mg of ibuprofen.

The other components (excipients) are: Sodium benzoate (E-211), anhydrous citric acid, sodium citrate, sodium saccharin, sodium chloride, 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 400 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 30 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/