Ibufarmalid 400 mg oral suspension

Patient Information Leaflet

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibufarmalid 400 mg oral suspension

Ibuprofen (D.O.E.)

In this leaflet:

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. 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 and the relief of mild to moderate pain associated with conditions such as dental pain, postoperative pain, headache including migraine, and for the symptomatic relief of pain, fever, and inflammation accompanying conditions such as pharyngitis (inflammation of the upper part of the throat), tonsillitis (inflammation of the tonsils), and otitis (inflammation of certain structures of the middle ear), among others. It is also indicated for the treatment of arthritis or joint inflammation (rheumatoid, psoriatic, gouty, etc.), osteoarthritis (inflammation of the joint cartilage), ankylosing spondylitis (inflammation affecting 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 taking Ibufarmalid 400 mg oral suspension

It is important that you use the lowest dose that relieves/controls your pain and that you 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:

• You are allergic (hypersensitive) to ibuprofen, to other medicines in the group of non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the excipients of this medicine. Such reactions could include: itchy skin rash, swelling of the face, lips, or tongue, nasal discharge, breathing difficulties, or asthma.

• You have previously experienced stomach or duodenal bleeding or have suffered a perforation of the gastrointestinal tract while taking a non-steroidal anti-inflammatory drug.

• You currently have or have had on more than one occasion: a stomach or duodenal ulcer or bleeding.

• You suffer from severe liver or kidney disease.

• You have severe heart failure.

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

• You are in the third trimester of pregnancy.

Take special care with Ibufarmalid 400 mg oral suspension:

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

• This risk is higher when high doses are used or treatment is prolonged, in patients with a history of peptic ulcer, and in elderly patients. In such cases, your doctor may consider prescribing a stomach-protective medicine.

• Signs of an allergic reaction to this medicine, such as breathing problems, swelling of the face and neck area (angioedema), or chest pain, have been reported with ibuprofen. Stop taking Ibufarmalid 400 mg oral suspension immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Inform your doctor:

• If you are simultaneously taking medicines that affect blood coagulation, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also mention the use of other medicines that could increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitor (SSRI) antidepressants.

• If you suffer from Crohn's disease or ulcerative colitis, as medicines like Ibufarmalid 400 mg oral suspension may worsen these conditions.

• If you have previously suffered from kidney or liver disease.

• If you experience edema (fluid retention).

• If you suffer from 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, kidney, or liver disease, are over 60 years old, or need to take the medicine for a prolonged period (more than 1–2 weeks), your doctor may need to perform regular check-ups. Your doctor will advise you on how often these checks should occur.

• If you have an infection; see the section titled «Infections» below.

Infections

Ibufarmalid oral suspension may mask signs of infection, such as fever and pain. Therefore, Ibufarmalid 400 mg oral suspension could delay appropriate treatment of an infection, increasing the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine while having an infection and infection symptoms persist or worsen, consult a doctor immediately.

Cardiovascular Precautions

Medicines such as Ibufarmalid 400 mg oral suspension may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke. This risk is more likely when high doses are used or treatment is prolonged. Do not exceed the recommended dose or duration of treatment.

If you have heart problems, a history of stroke, or think you may be at risk for these conditions (e.g., high blood pressure, diabetes, high cholesterol, or if you smoke), you should discuss this treatment with your doctor or pharmacist.

In addition, this type of medicine may cause fluid retention, especially in patients with heart failure and/or high blood pressure (hypertension).

Skin Reactions

Serious skin reactions have been reported with treatment using Ibufarmalid 400 mg oral suspension. Stop taking Ibufarmalid 400 mg oral suspension and contact your doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.

Precautions during pregnancy and in women of childbearing potential

Because the use of medicines like Ibufarmalid 400 mg oral suspension has been associated with an increased risk of congenital abnormalities or miscarriage, administration during the first and second trimesters of pregnancy is not recommended unless strictly necessary. In such cases, the dose and duration should be limited to the minimum possible.

Administration of Ibufarmalid 400 mg oral suspension is contraindicated during the third trimester of pregnancy.

For women of childbearing potential, it should be noted that medicines like Ibufarmalid 400 mg oral suspension have been associated with reduced fertility.

Taking Ibufarmalid 400 mg oral suspension with food and drinks:

You may take it alone or with food. In general, 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 medicine.

Do not take ibuprofen if you are in the last 3 months of pregnancy, as it could harm the fetus or cause problems during delivery. It may cause kidney and heart problems in your unborn baby. It may affect your and your baby's tendency to bleed and may delay or prolong labor beyond the expected time. You should not take ibuprofen during the first 6 months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to become pregnant, you should take the lowest possible 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, leading to low levels of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment for longer than a few days is needed, your doctor may recommend additional monitoring.

Breastfeeding:

Although levels of the medicine in breast milk are negligible, it is recommended to consult your doctor during long-term treatment or when using high doses while breastfeeding.

Use in children:

Do not administer to children under 8 years of age without consulting a doctor.

Driving and use of machines:

If you experience dizziness, vertigo, vision disturbances, or other symptoms while taking this medicine, you should not drive or operate machinery. If you only take a single dose of ibuprofen or use it for a short period, no special precautions are usually necessary.

Use of other medicines:

Inform your doctor or pharmacist if you are currently taking, or have recently taken, any other medicines, including those obtained without a prescription, as it may be necessary to stop treatment or adjust the dose of one of them.

Ibuprofen is not recommended to be taken together with:

• Other non-steroidal anti-inflammatory drugs (NSAIDs): as this may increase the risk of adverse effects.
• Warfarin, ticlopidine, or other medicines used to "thin" the blood and prevent clot formation: as their effect may be increased.
• Lithium (a medicine used to treat depression): as blood levels of lithium and the risk of adverse effects may increase. If you must take both lithium and ibuprofen, your doctor may need to adjust your lithium dose.
• Methotrexate: if methotrexate and ibuprofen are taken together (within a 24-hour interval), blood levels of methotrexate and the risk of toxicity may increase. Your doctor may advise against taking ibuprofen if you are receiving high-dose methotrexate therapy.
• Hydantoins such as phenytoin (used to treat epilepsy).
• Sulphonamides: as they may increase their toxic effects.

Other interactions requiring 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.
• Selective serotonin reuptake inhibitors (SSRIs) may also increase the risk of gastrointestinal bleeding.

Information about some of the components of IBUFARMALID 400 mg oral suspension

Due to the presence of azorubine as an excipient, it may cause allergic-type 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 on low-sodium diets.

3. How to take Ibufarmalid 400 mg oral suspension

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

This medicine is administered orally.

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

In adults and adolescents aged 12 to 18 years, one 400 mg sachet should be taken every 4 to 6 hours, depending on the severity of symptoms and response to treatment. In adults, do not take more than 6 sachets of 400 mg per day (2400 mg), whereas in adolescents aged 12 to 18 years, do not take more than 4 sachets of 400 mg per day (1600 mg).

In children aged 8 to 12 years, the dose administered depends on the child's age and weight. Generally, the recommended daily dose is 20 to 30 mg/kg body weight, divided into three or four individual doses. However, the following dosing schedule is recommended: a dose of 200 mg (5 ml of suspension) every 4 to 6 hours, depending on the severity of symptoms 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 sachets of 400 mg per day (2400 mg).

Do not administer Ibufarmalid 400 mg oral suspension to children under 8 years of age without consulting a doctor.

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

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

Always take the lowest dose that is effective. The duration of treatment will be determined by your doctor and should not be stopped prematurely.

This product is a suspension. It must be homogenized before use by pressing several times with your fingers on the upper and lower parts of the sachet. It can be taken directly from the sachet or diluted in water. For accurate dosing, the packaging contains a double-ended spoon.

If gastrointestinal discomfort occurs, it is recommended to take the medicine with food.

Remember to take your medicine as prescribed. If you feel that the effect of Ibufarmalid 400 mg oral suspension is too strong or too weak, inform your doctor or pharmacist.

If you have taken more Ibufarmalid 400 mg oral suspension than you should:

If you have taken more Ibufarmalid 400 mg oral suspension than prescribed or have accidentally ingested the contents of the package, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 5620420, indicating the medicine and the amount ingested. It is recommended to bring the packaging and the package leaflet to the healthcare professional.

If you have taken more Ibufarmalid than you should, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

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

If you forget to take Ibufarmalid 400 mg oral suspension:

Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, 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 occurring with medicines such as Ibufarmalid 400 mg oral suspension are gastrointestinal: peptic ulcers, gastrointestinal bleeding, perforations (in some cases fatal), especially in the elderly. Nausea, vomiting, diarrhea, flatulence, constipation, heartburn, abdominal pain, blood in stools, mouth ulcers, and 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, heartburn, flatulence, and constipation.

Uncommon (at least 1 in 1,000 people but less than 1 in 100): gastrointestinal bleeding, stomach or duodenal ulcers.

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

Skin and allergic reactions:

Frequent: skin rash.

Uncommon: redness of the skin, itching or swelling of the skin, swelling of the lips, face or tongue, increased nasal discharge, and breathing difficulty.

Rare: severe allergic reactions (anaphylactic shock).

Very rare (less than 1 in 10,000 people): sudden onset of intense skin itching or blisters on the skin, joint pain and fever (systemic lupus erythematosus), hair loss, photosensitivity reactions (skin reactions due to light exposure), aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), mostly in patients with autoimmune disorders such as systemic lupus erythematosus.

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

Medicines such as Ibufarmalid 400 mg oral suspension may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and allergic vasculitis.

A serious skin reaction known as DRESS syndrome may occur. Symptoms of DRESS syndrome include: skin rash, swollen lymph nodes, and elevated eosinophils (a type of white blood cell).

Frequency not known: widespread red scaly rash with lumps under the skin and blisters mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). Stop taking Ibufarmalid 400 mg oral suspension if you experience these symptoms and seek immediate medical attention. See also section 2. The skin becomes sensitive to light.

Central nervous system:

Frequent: headache, dizziness, and nervousness.

Uncommon: fatigue or drowsiness, insomnia, anxiety, visual disturbances, tinnitus (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, blood cell abnormalities (early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds, and skin bleeding).

Cardiovascular:

Medicines such as Ibufarmalid 400 mg oral suspension may be associated with a moderate increase in the risk of heart attack ("myocardial infarction") or stroke.

Edema (fluid retention), high blood pressure, and heart failure have also been observed in association with treatment using medicines of the type Ibufarmalid 400 mg oral suspension.

Kidney:

Kidney disease.

Liver:

Rare: hepatitis (inflammation of the liver) and jaundice (yellowing of the skin). Medicines such as Ibufarmalid 400 mg oral suspension may, on rare occasions, be associated with liver injury.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. Storage of Ibufarmalid 400 mg oral suspension

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

Keep in the original packaging.

Expiry date:

Do not use Ibufarmalid 400 mg oral suspension after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Additional Information

Composition

The active substance 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, cochineal red A (E-122), glycerol, and purified water.

Nature of the product and contents of the container

Ibufarmalid 400 mg oral suspension is presented as an oral suspension to be taken directly from the sachet or dissolved in water. Each pack 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 most recent revision of this package leaflet: November 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/