Leaflet: information for the user

Ibufarmalid 200 mg oral suspension

Ibuprofen

Read this leaflet carefully before starting to take the medicine.

- Keep this leaflet as you may need to read it again.

- If you have any questions, consult your doctor or pharmacist.

- This medicine has been prescribed for you and should not be given to others even if they have the same symptoms, as it may harm them.

- If you consider that any of the side effects you are experiencing are serious or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist (see section 4).

1. What is Ibufarmalid 200 mg oral suspension and what it is used for

2. What you need to know before starting to take Ibufarmalid 200 mg oral suspension

3. How to take Ibufarmalid 200 mg oral suspension

4. Possible side effects

5. Storage of Ibufarmalid 200 mg oral suspension

6. Contents of the pack and additional information

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

This medicine is indicated for the treatment of fever, the treatment of mild to moderate pain, the symptomatic relief of pain, fever, and inflammation that accompanies processes such as pharyngitis (inflammation of the upper throat region), tonsillitis (inflammation of the tonsils), and otitis (inflammation of certain structures of the middle ear), among others, the treatment of juvenile rheumatoid arthritis and primary dysmenorrhea (painful menstruation).

It is essential to use the smallest effective dose to relieve/control pain and not to take this

medication Ibufarmalid 200 mg oral suspension for longer than necessary to control your symptoms.

Do not take Ibufarmalid 200 mg if:

- 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.

- If you have had a previous stomach or duodenal hemorrhage or have suffered a perforation of the digestive tract while taking an NSAID.

- If you currently have or have had more than one episode of: stomach or duodenal ulcer or hemorrhage.

- If you have a severe liver or kidney disease.

- If you have severe heart failure.

- If you have bleeding or coagulation disorders, or are taking anticoagulants (blood thinners).

- If you are in the third trimester of pregnancy.

Warnings and precautions:

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

• This risk is higher with 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 allergic reaction to ibuprofen, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. Stop using Ibufarmalid 200 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.

You should also inform your doctor about the use of 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 medications like Ibufarmalid 200 mg oral suspension may worsen these conditions.

- If you have kidney or liver disease.

- If you have edema (fluid retention).

- If you have heart failure, high blood pressure.

- If you have asthma or any other respiratory disorder.

- If you are being treated for an infection, as Ibufarmalid 200 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 200 mg oral suspension may mask the signs of an infection, such as fever and pain. Therefore, it 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

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 inform your doctor or pharmacist before taking Ibufarmalid 200 mg if:

• You have heart problems, including heart failure, angina (chest pain), or have had a heart attack, coronary artery bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowed or blocked 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.

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

Skin Reactions

Severe skin reactions associated with Ibufarmalid 200 mg oral suspension treatment have been reported. Stop taking Ibufarmalid 200 mg oral suspension immediately and consult a doctor 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.

Precautions during pregnancy and in fertile women

Due to the association of ibuprofen administration with an increased risk of congenital anomalies/abortions, it is not recommended to administer Ibufarmalid 200 mg oral suspension during the first and second trimesters of pregnancy, except in cases where it is strictly necessary. In these cases, the dose and duration should be limited to the minimum possible.

In the third trimester, the administration of Ibufarmalid 200 mg oral suspension is contraindicated.

For fertile women, it should be noted that medications like Ibufarmalid 200 mg oral suspension have been associated with a decrease in fertility.

Taking Ibufarmalid 200 mg with food and beverages:

You can take Ibufarmalid 200 mg directly from the package or dissolved in water. You can take it alone or with food. In general, it is recommended to take it before meals to reduce the possibility of stomach discomfort.

Pregnancy, lactation, and fertility

Pregnancy:

Consult your doctor or pharmacist before using any medication.

You should 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 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, ibuprofen may cause kidney problems in your fetus if taken for more than a few days, which may cause low amniotic fluid levels (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.

Lactation:

Although the levels of medication in breast milk are negligible, it is recommended to consult a doctor in cases of long-term treatment or high doses during lactation.

Use in children:

Do not administer to children under 6 months 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 Ibufarmalid with other medications:

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

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

• Anticoagulants (e.g., for treating coagulation problems/preventing coagulation, e.g., aspirin, warfarin, ticlopidine)
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan)

Do not take ibuprofen with:

• Other nonsteroidal anti-inflammatory drugs (NSAIDs): as it may increase the risk of adverse effects
• 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.
• Hidantoins like phenytoin (for treating epilepsy)
• Sulfonamides: as they may increase their toxic effects.

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

• Corticosteroids like 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 stomach ulcers or bleeding
• SSRIs may also increase the risk of stomach ulcers or bleeding.

Information about some components of Ibufarmalid 200 mg

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

Each package contains 36 mg of sodium, which should be considered in patients with low-sodium diets.

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

This medication is administered orally.

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

Children:

The dose of ibuprofen to be administered depends on the child's age and weight. Generally, the recommended daily dose is 20 to 30 mg/kg of body weight, divided into three or four individual doses.

However, the following dosage regimen is recommended:

• Children weighing less than 25 kg: The recommended daily dose is 150 – 600 mg of ibuprofen, divided into 3 or 4 doses, with a maximum recommended daily dose of 800 mg.
• Children weighing 25 to 40 kg: The recommended daily dose is 600 – 800 mg of ibuprofen, divided into 3 or 4 doses (1 sachet 3 or 4 times a day), with a maximum recommended daily dose of 1200 mg.
• Children weighing more than 40 kg: The recommended daily dose is 1.200 – 1.600 mg of ibuprofen, divided into 3 or 4 doses (2 sachets 3 or 4 times a day), with a maximum recommended daily dose of 1.600 mg.

For the treatment of juvenile rheumatoid arthritis, higher doses may be necessary, but it is recommended not to exceed 40 mg/kg/day of ibuprofen.

The interval between doses will depend on the evolution of symptoms, but it will never be less than 4 hours. Ibuprofen should not be used in children under six months.

Adults:

The recommended daily dose is 1.200 – 1.800 mg of ibuprofen, divided into 3 or 4 doses (2 or 3 sachets 3 or 4 times a day), with a maximum recommended daily dose of 2.400 mg.

Seniors:

Ibuprofen pharmacokinetics is not altered in elderly patients, so it is not necessary to modify the dose or administration frequency. However, in these patients, precautions should be taken, as they are generally more prone to side effects and have a higher probability of presenting renal, cardiovascular, or hepatic dysfunction and receiving concomitant medication.

In cases of renal, hepatic, or cardiac insufficiency, the dose should be reduced (See warnings).

Always take the smallest effective dose. The duration of treatment will be decided by the 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 sachet several times with your fingers. It can be taken directly from the sachet or diluted in water.

For an exact dosage, the containers contain a double-spoon scoop with measurements of 1.25 ml, 2.5 ml, and 5 ml.

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 200 mg oral suspension is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibufarmalid 200 mg than you should:

If you have taken more Ibufarmalid 200 mg than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or the Toxicological 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 container and the medication package to the healthcare professional.

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 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 frequent 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 200 mg:

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 near, skip the missed dose and take the next dose at your usual time.

Like all medicines, Ibufarmalid 200 mg may cause side effects.

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

The following side effects have been observed:

Gastrointestinal:

The most frequent side effects that occur with medicines like Ibufarmalid 200 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, joint pain, and fever (systemic lupus erythematosus), hair loss, light-sensitive skin reactions, Aspergillus meningitis (inflammation of the membranes covering the brain and spinal cord), mostly in patients with autoimmune diseases such as systemic lupus erythematosus.

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

Medicines like Ibufarmalid 200 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.

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 200 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 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, flu-like symptoms, excessive fatigue, nasal and skin bleeding)

Cardiovascular:

Medicines like Ibufarmalid 200 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 200 mg oral suspension.

Kidney:

Kidney disease.

Liver:

Rare:hepatitis (liver inflammation) and jaundice (yellowing of the skin) The

medicines like Ibufarmalid 200 mg oral suspension 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 Pharmacovigilance 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 Ibufarmalid 200 mg out of the reach and sight of children.

Store in its original packaging.

Expiration Date:

Do not use Ibufarmalid 200 mg after the expiration date indicated on the packaging.

The expiration date is the last day of the month indicated

Do not dispose of medications through drains or trash. Dispose of the containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

Composition

The active ingredient is Ibuprofen. Each sachet contains 200 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, strawberry flavor, azorubine (E-122), glycerol, and purified water.

Appearance of the product and contents of the package

Ibufarmalid 200 mg is presented in the form of an oral suspension to be taken directly from the sachet or diluted in water. Each package contains 20 sachets.

Holder of the marketing authorization

Laboratorios Farmalider, S.A.

C/Aragoneses, nº 15

28108 Alcobendas (Madrid)

Spain

Responsible for manufacturing

Industrial Farmacéutica Cantabria, S.A.

Carretera Cazoña/Adarzo s/n

39011 Santander

Spain

This leaflet has been approved inOctober 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/