IBUFARMALID 400 mg ORAL SUSPENSION

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibufarmalid 400 mg oral suspension

Ibuprofen (D.O.E.)

This leaflet tells you about:

1. What Ibufarmalid 400 mg oral suspension is and what it is used for
2. Before you take Ibufarmalid 400 mg oral suspension
3. How to take Ibufarmalid 400 mg oral suspension
4. Possible side effects
5. Storing Ibufarmalid 400 mg oral suspension
6. Further information

1. What Ibufarmalid 400 mg oral suspension is and what it is used for

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

This medicine is indicated for the treatment of fever, pain relief of mild to moderate intensity in processes such as dental pain, post-surgical pain, headache including migraine, symptomatic relief of pain, fever, and inflammation that accompanies processes such as pharyngitis (inflammation of the upper throat), tonsillitis (inflammation of the tonsils), and otitis (inflammation of certain structures of the middle ear), among others, 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 inflammatory injuries of traumatic or sports origin), and primary dysmenorrhea (painful menstruation).

2. Before you take Ibufarmalid 400 mg oral suspension

It is important that you use the smallest dose that relieves-controls the pain and do not take this medicine Ibufarmalid 400 mg oral suspension for longer than necessary to control your symptoms.

Do not take Ibufarmalid 400 mg oral suspension if:

• If you are allergic (hypersensitive) to ibuprofen, to other medicines of the group of non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the excipients of this medicine. Such reactions could be: 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 a non-steroidal anti-inflammatory medicine.

• If you currently have or have had more than one occasion: an ulcer or a stomach or duodenal hemorrhage.

• If you have a serious liver or kidney disease.

• If you have severe heart failure.

• If you have bleeding disorders or blood coagulation disorders, or are taking anticoagulants (medicines used to "thin" the blood).

• If you are in the third trimester of pregnancy.

Be careful with Ibufarmalid 400 mg oral suspension:

• If you have had or develop 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 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-protecting medicine.

• With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck (angioedema), and chest pain. Stop using Ibufarmalid 400 mg oral suspension immediately and contact your doctor or the emergency medical service immediately if you observe any of these signs.

Tell your doctor:

• 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 hemorrhages, such as corticosteroids and antidepressants that inhibit the selective reuptake of serotonin.

• If you have Crohn's disease or ulcerative colitis, as medicines of the type of Ibufarmalid 400 mg oral suspension may worsen these pathologies.

• 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 receiving treatment for an infection, as Ibufarmalid 400 mg oral suspension may mask the fever, which is an important sign of infection.
• If you have heart, 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 have an infection; see the "Infections" section below.

Infections

Ibufarmalid oral suspension may hide the signs of an infection, such as fever and pain. Therefore, Ibufarmalid 400 mg oral suspension 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

Medicines like Ibufarmalid 400 mg oral suspension may be associated with a moderate increase in the risk of suffering heart attacks ("myocardial infarctions") or strokes. This risk is more likely to occur when high doses and prolonged treatments are used. 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 pathologies (for example, you have high blood pressure, suffer from diabetes, have high cholesterol, or are a smoker), you should consult your doctor or pharmacist about this treatment.

Similarly, 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 Ibufarmalid 400 mg oral suspension treatment. Stop taking Ibufarmalid 400 mg oral suspension and go to the doctor immediately if you present any skin rash, lesions in the mucous membranes, blisters, or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Precautions during pregnancy and in women of childbearing age

Because the administration of medicines of the type of Ibufarmalid 400 mg oral suspension 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 considered 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 patients of childbearing age, it should be taken into account that medicines of the type of Ibufarmalid 400 mg oral suspension have been associated with a decrease in fertility.

Taking Ibufarmalid 400 mg oral suspension with food and drinks:

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

Pregnancy, breastfeeding, and fertility

Pregnancy:

Consult your doctor or pharmacist before using any medicine.

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 and your baby's tendency 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 possible time. From the 20th week of pregnancy, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low levels of amniotic fluid 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.

Breastfeeding:

Although the levels of the medicine in breast milk are negligible, it is recommended to consult a 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 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, you do not need to take special precautions.

Using other medicines:

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

It is not recommended to take ibuprofen with:

• Other non-steroidal anti-inflammatory drugs (NSAIDs): as it may increase the risk of adverse effects.
• Warfarin, ticlopidine, or other medicines used to "thin" the blood and prevent the formation of clots, as their effect may increase.
• Lithium (a medicine 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 the dose of lithium.
• Methotrexate: if you take methotrexate and ibuprofen at the same time (within a 24-hour interval), it may increase methotrexate levels in the blood and the risk of toxicity from this medicine. 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.

Other interactions that require caution:

• Corticosteroids such as cortisone and prednisolone, diuretics, fluconazole, pentoxifylline, probenecid, quinolones (such as norfloxacin), sulfinpyrazone, sulfonylureas (such as tolbutamide), tacrolimus, cyclosporine, zidovudine, as they may increase the risk of gastrointestinal ulcer or bleeding.
• Antidepressants that inhibit the selective reuptake of serotonin (SSRIs) may also increase the risk of gastrointestinal bleeding.

Information about some of the 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 acetylsalicylic acid.

Each sachet contains 58 mg of sodium, which should be taken into account in patients with low-sodium diets.

3. How to take Ibufarmalid 400 mg oral suspension

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

This medicine is administered orally.

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

In adults and young people from 12 to 18 years old, take one sachet of 400 mg every 4 to 6 hours, depending on the intensity of the condition and the response to treatment. In adults, do not take more than 6 sachets of 400 mg per day (2400 mg), while in young people from 12 to 18 years old, do not take more than 4 sachets of 400 mg per day (1600 mg).

In children from 8 to 12 years old, the administered dose depends on the child's age and weight. As a general rule, the recommended daily dose is 20 to 30 mg/kg of body weight, divided into three or four individual doses. However, the following dosage guideline is recommended: take a dose of 200 mg (5 ml of suspension) every 4 to 6 hours, depending on the intensity of the condition and the 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 sachets 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 should only be increased once your doctor has checked that you tolerate the medicine well.

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

Always take the lowest effective dose. The duration of treatment will be decided by your doctor and should not be suspended beforehand.

This product is a suspension. It should be homogenized before taking by pressing the top and bottom of the sachet with your fingers several times. It can be taken directly from the sachet or diluted in water. For exact dosing, the packages contain a double-spouted spoon.

In case of gastrointestinal upset, it is recommended to take the medicine with meals.

Remember to take your medicine, and if you think the effect of Ibufarmalid 400 mg oral suspension is too strong or too weak, tell 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 Toxicology Information Service, phone: 91 5620420, indicating the medicine and the amount ingested. It is recommended to take the package and the leaflet of the medicine to the healthcare professional.

If you have taken more Ibufarmalid than you should, or if a child has accidentally ingested the medicine, consult a doctor immediately or go to the nearest hospital to find out 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), 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 Ibufarmalid 400 mg oral suspension:

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 very close, skip the forgotten dose and take the next dose at the usual time.

4. Possible Adverse Effects

Like all medications, Ibufarmalid 400 mg oral suspension may have adverse effects.

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

The following adverse effects have been observed:

Gastrointestinal:

The most frequent adverse effects that occur with medications 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, heartburn, abdominal pain, blood in stool, oral thrush, worsening of ulcerative colitis, and Crohn's disease have also been observed. Less frequently, the appearance of gastritis has been observed.

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

Infrequent (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 1000):gastric or intestinal perforation, esophageal inflammation, and ulcers or inflammation of the intestine.

Skin and Allergic Reactions:

Frequent:skin rash.

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

Rare:severe allergic reactions (anaphylactic shock)

Very Rare(less than 1 in 10,000 people): intense itching on the skin that appears suddenly or blisters on the skin, joint pain, and fever (systemic lupus erythematosus), hair loss, skin reactions due to light influence, aseptic meningitis (inflammation of the membranes that cover the brain and spinal cord), in most cases in patients with some autoimmune disease such as systemic lupus erythematosus.

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

Medications 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. The symptoms of DRESS syndrome include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).

Frequency "not known":generalized red scaly rash, with bumps under the skin and blisters mainly located on skin folds, trunk, and upper limbs, which is accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). 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.

Infrequent:fatigue or drowsiness, insomnia, anxiety, vision changes, ringing or buzzing 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, flu-like symptoms, excessive fatigue, nosebleeds, and skin bleeding)

Cardiovascular:

Medications like Ibufarmalid 400 mg oral suspension may be associated with a moderate increased 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 type Ibufarmalid 400 mg oral suspension

Kidney:

Kidney disease.

Liver:

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

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

5. Conservation of Ibufarmalid 400 mg Oral Suspension

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

Keep it in its original packaging.

Expiration Date:

Do not use Ibufarmalid 400 mg oral suspension after the expiration date indicated on the packaging. The expiration date is the last day of the month indicated

Medications should not be thrown away through the sewers or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. This way, you will help protect the environment.

6. Additional Information

Composition

The active ingredient 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, hypromellose, xanthan gum, liquid maltitol, thaumatin (E-957), strawberry flavor, azorubine (E-122), glycerol, and purified water.

Appearance of the Product and Packaging Content

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.

Marketing Authorization Holder

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

Manufacturer

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

Date of the Last Revision of this Prospectus:November 2024

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