IBUFARMALID 200 mg ORAL SUSPENSION

2. What you need to know before taking Ibufarmalid 200 mg Oral Suspension

It is important to use the smallest dose that relieves/control the pain and do not take this medicine 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, to other medicines of the non-steroidal anti-inflammatory drug (NSAID) group, 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 previously 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 once: 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).

Warnings and Precautions:

• 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, 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 protective medicine.

• With ibuprofen, signs of allergic reaction to this medicine have been reported, such as respiratory problems, swelling of the face and neck area (angioedema), and chest pain. Stop using Ibufarmalid 200 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 aspirin type. You should also comment on the use of other medicines that may increase the risk of such hemorrhages, such as corticosteroids and selective serotonin reuptake inhibitor antidepressants.

If you have Crohn's disease or ulcerative colitis, as medicines of the Ibufarmalid 200 mg Oral Suspension type may worsen these conditions.

• If you have had kidney or liver disease.
• If you have edema (fluid retention).
• If you have heart failure or high blood pressure.
• If you have asthma or any other respiratory disorder.
• If you are receiving treatment for an infection, as Ibufarmalid 200 mg 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.

Infections

Ibufarmalid 200 mg Oral Suspension may hide the signs of an infection, such as fever and pain. Consequently, Ibufarmalid 200 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

Anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or pharmacist before taking Ibufarmalid 200 mg if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral arteriopathy (circulation problems 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, have a family history of heart disease or stroke, or are a smoker.

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 200 mg Oral Suspension treatment. Stop taking Ibufarmalid 200 mg Oral Suspension and see a doctor immediately if you experience any skin rash, lesions on the mucous membranes, 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

Since the administration of medicines of the Ibufarmalid 200 mg Oral Suspension type 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 strictly necessary. In these cases, the dose and duration will be limited to the minimum possible.

In the third trimester, the administration of Ibufarmalid 200 mg Oral Suspension is contraindicated.

For women of childbearing age, it should be taken into account that medicines of the Ibufarmalid 200 mg Oral Suspension type have been associated with a decrease in fertility.

Taking Ibufarmalid 200 mg with Food and Drinks:

You can take Ibufarmalid 200 mg directly from the sachet 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 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 this medicine 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 more 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 6 months without consulting a doctor.

Driving and Using Machines:

If you experience dizziness, vertigo, vision changes, 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 Ibufarmalid with Other Medicines:

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

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

• Anticoagulant medicines (e.g., to treat coagulation problems/prevent coagulation, e.g., aspirin, warfarin, ticlopidine).
• Medicines that lower high blood pressure (e.g., ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin-II receptor antagonists like losartan).

It is not recommended to take ibuprofen with:

• Other non-steroidal anti-inflammatory drugs (NSAIDs): as it may increase the risk of adverse effects.
• 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 your lithium dose.
• 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 like phenytoin (for the treatment of epilepsy).
• Sulfonamides: as they may increase their toxic effects.

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

• Corticosteroids like cortisone and prednisolone, diuretics, fluconazole, pentoxifylline, probenecid, quinolones (like norfloxacin), sulfinpyrazone, sulfonylureas (like tolbutamide), tacrolimus, cyclosporine, zidovudine, as they may increase the risk of gastrointestinal ulcer or bleeding.
• Selective serotonin reuptake inhibitor antidepressants may also increase the risk of gastrointestinal bleeding.

Information about some of the components of Ibufarmalid 200 mg

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

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

3. How to take Ibufarmalid 200 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 time to relieve symptoms. If you have an infection, consult a doctor without delay if the 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. In general, the recommended daily dose is 20 to 30 mg/kg of weight, divided into three or four individual doses.

However, the following dosage guideline is recommended:

• Children under 25 kg of weight: 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 from 25 to 40 kg of weight: 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 over 40 kg of weight: The recommended daily dose is 1200-1600 mg of ibuprofen, divided into 3 or 4 doses (2 sachets 3 or 4 times a day), with a maximum recommended daily dose of 1600 mg.

For the treatment of juvenile rheumatoid arthritis, higher doses may be necessary, although 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. It is not recommended to use ibuprofen in children under 6 months.

Adults:

The recommended daily dose is 1200-1800 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 2400 mg.

Elderly:

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

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

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

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 with measures of 1.25 ml, 2.5 ml, and 5 ml.

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 200 mg Oral Suspension is too strong or too weak, tell 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 medicine, consult a doctor immediately or contact the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested, or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken. It is recommended to take the package and package leaflet of the medicine to the healthcare professional.

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.

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, and sometimes low blood pressure and fainting.

If you forget to take Ibufarmalid 200 mg:

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

4. Possible Adverse Effects

Like all medicines, Ibufarmalid 200 mg can have adverse effects.

Chest pain, which can 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 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, heartburn, abdominal pain, blood in stool, oral thrush, worsening of ulcerative colitis and Crohn's disease have also been observed. Gastritis has been observed less frequently.

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

Infrequent:bleeding, stomach or duodenal ulcers.

Rare: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:intense itching of the skin with sudden onset 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 covering the brain and spinal cord), in most cases in patients with some autoimmune disease such as systemic lupus erythematosus.

Severe allergic reaction that can manifest with nausea, vomiting, swelling of the face, tongue, and throat, difficulty breathing, 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 "not known":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). A generalized red scaly rash, with bumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis), may also occur. Stop taking Ibufarmalid 200 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, nasal and skin bleeding)

Cardiovascular:

Medicines like Ibufarmalid 200 mg oral suspension may be associated with a moderate increased 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 (inflammation of the liver) and jaundice (yellowing of the skin). Medicines like Ibufarmalid 200 mg oral suspension may be associated, in rare cases, with liver damage.

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Ibufarmalid 200 mg Oral Suspension

Keep Ibufarmalid 200 mg out of the reach and sight of children.

Keep it in its original container.

Expiry:

Do not use Ibufarmalid 200 mg after the expiry date indicated on the container.

The expiry date is the last day of the month indicated.

Medicines should not be thrown away through the sewage system or in the trash. Deposit the containers and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. This way, you will help protect the environment.

6. Additional Information

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, hypromellose, xanthan gum, liquid maltitol, strawberry flavor, azorubine (E-122), glycerol, and purified water.

Appearance of the Product and Container Content

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

Marketing Authorization Holder

Laboratorios Farmalider, S.A.

C/Aragoneses, nº 15

28108 Alcobendas (Madrid)

Spain

Manufacturer

Industrial Farmacéutica Cantabria, S.A.

Carretera Cazoña/Adarzo s/n

39011 Santander

Spain

This prospectus was approved inOctober 2024

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