Ibufarmalid 600 mg oral suspension

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ibufarmalid 600 mg oral suspension

Ibuprofen (D.O.E.)

This leaflet contains:

1. What Ibufarmalid 600 mg oral suspension is and what it is used for
2. Before taking Ibufarmalid 600 mg oral suspension
3. How to take Ibufarmalid 600 mg oral suspension
4. Possible side effects
5. Storage of Ibufarmalid 600 mg oral suspension
6. Further information

1. What Ibufarmalid 600 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 treatment of mild to moderate pain in conditions such as dental pain, post-surgical pain, headache including migraine, and for the symptomatic relief of pain, fever and inflammation associated with 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-related origin), and primary dysmenorrhea (painful menstruation).

2. Before taking Ibufarmalid 600 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 600 mg oral suspension, for longer than necessary to control your symptoms.

Do not take Ibufarmalid 600 mg oral suspension if:

• You are allergic to ibuprofen, to other drugs in the group of non-steroidal anti-inflammatory drugs (NSAIDs), or to any of the excipients of this medicine. Such reactions may include skin rash with itching, swelling of the face, lips, or tongue, runny nose, 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 more than once: a stomach or duodenal ulcer or bleeding.

• You have a severe disease of the liver or kidneys.

• 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 600 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 adding a stomach-protective medicine.

• Signs of allergic reaction to ibuprofen, such as breathing problems, swelling of the face and neck area (angioedema), or chest pain, have been reported. Stop taking Ibufarmalid 600 mg oral suspension immediately and contact your doctor or emergency medical services right away if you notice any of these signs.

Tell your doctor:

• If you are taking medicines that affect blood clotting, 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 have Crohn's disease or ulcerative colitis, as medicines like Ibufarmalid 600 mg oral suspension may worsen these conditions.

• 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 being treated for an infection, as Ibufarmalid 600 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 monitoring. Your doctor will advise you on how often these checks should be done.

• If you have an infection; see the section "Infections" below.

Infections

Ibufarmalid may mask signs of infection, such as fever and pain. Therefore, Ibufarmalid could delay appropriate treatment of the 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 600 mg oral suspension may be associated with a moderate increase in the risk of heart attacks ("myocardial infarction") or strokes. 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 (for example, high blood pressure, diabetes, high cholesterol, or are a smoker), discuss this treatment with your doctor or pharmacist.

Also, 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 600 mg oral suspension. Stop taking Ibufarmalid 600 mg oral suspension and see a doctor immediately if you develop any skin rash, lesions on mucous membranes, blisters, or other signs of allergy, as these may be early signs of a very serious skin reaction. See section 4.

Taking Ibufarmalid 600 mg oral suspension with food and drinks:

You may take it alone or with food. It is generally 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.

You must not take Ibufarmalid 600 mg oral suspension during the last 3 months of pregnancy, as it may harm the fetus or cause problems during childbirth. 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. You should not take this medicine 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, Ibufarmalid 600 mg oral suspension may cause kidney problems in your fetus if taken for more than a few days, which may lead 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.

Because the use of medicines like Ibufarmalid 600 mg oral suspension has been associated with an increased risk of congenital malformations or miscarriage, its use is not recommended during the first and second trimesters of pregnancy unless strictly necessary. In such cases, the dose and duration of treatment should be kept to a minimum.

Fertility:

For women of childbearing age, it should be noted that medicines like Ibufarmalid 600 mg oral suspension have been associated with reduced fertility.

Breastfeeding:

Although drug levels in breast milk are negligible, it is recommended to consult your doctor for long-term treatment or with high doses during breastfeeding.

Use in children:

Do not administer to children under 12 years of age 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 operate machinery. If you take only 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 taking, have recently taken, or might take any other medicines, including those obtained without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one or more medicines.

It is not recommended to take ibuprofen 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 clots, 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 you take methotrexate and ibuprofen simultaneously (within a 24-hour interval), blood levels of methotrexate and the risk of toxicity may increase. Your doctor may advise you not to take ibuprofen if you are receiving high-dose methotrexate treatment.
• 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 inhibitor (SSRI) antidepressants may also increase the risk of gastrointestinal bleeding.

Information about some of the components of Ibufarmalid 600 mg oral suspension

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

Each sachet contains 87 mg of sodium, which should be considered in patients on low-sodium diets.

3. How to take Ibufarmalid 600 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 immediately if symptoms (such as fever and pain) persist or worsen (see section 2).

The recommended dose for adults and adolescents aged 12 to 18 years is one sachet (600 mg) every 6 to 8 hours, depending on the severity of symptoms and response to treatment. In adults, the maximum recommended daily dose is 2400 mg, whereas in adolescents aged 12 to 18 years it is 1800 mg.

Do not administer Ibufarmalid 600 mg oral suspension to children under 12 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 case, the dose may only be increased once your doctor has confirmed that you tolerate the medicine well.

If you suffer from kidney and/or liver disease, your doctor may prescribe a lower than usual dose. In such 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 discontinued 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.

In case of gastrointestinal discomfort, it is recommended to take the medicine with food.

Remember to take your medicine as prescribed. If you feel that the effect of Ibufarmalid 600 mg oral suspension is too strong or too weak, inform your doctor or pharmacist.

If you take more Ibufarmalid 600 mg oral suspension than you should:

If you have taken more Ibufarmalid 600 mg oral suspension than you should, or if a child has accidentally ingested the medicine, contact a doctor or the Toxicology Information Service immediately, telephone: 91 562 04 20, stating the medicine and the amount ingested, or go to the nearest hospital to obtain information about the risk and advice on the measures to be taken. It is recommended to bring the medicine's packaging and leaflet to the healthcare professional.

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 (particularly in children), weakness, dizziness, blood in the urine, low blood potassium levels, 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, tinnitus, sometimes low blood pressure, and fainting.

If you forget to take Ibufarmalid 600 mg oral suspension:

Do not take a double dose to make up for forgotten 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 your usual time.

4. Possible adverse effects

Like all medicines, Ibufarmalid 600 mg oral suspension can 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 600 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, worsening of ulcerative colitis and Crohn's disease have also been observed. Less frequently, gastritis has been reported.

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

Uncommon: gastrointestinal bleeding, gastric or duodenal ulcers.

Rare: gastric or intestinal perforation, inflammation of the esophagus, and ulcers or inflammation of the intestine.

Skin and allergic reactions:

Common: skin rash.

Uncommon: skin redness, 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: sudden onset of intense skin itching or skin blisters, joint pain and fever (systemic lupus erythematosus), hair loss, skin reactions due to light exposure.

Medicines such as Ibufarmalid 600 mg oral suspension may, very rarely, be associated with severe blistering reactions such as Stevens-Johnson syndrome, Toxic Epidermal Necrolysis, and allergic vasculitis.

Aseptic meningitis (inflammation of the membranes covering the brain and spinal cord), mostly occurring in patients with autoimmune disorders such as systemic lupus erythematosus.

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

Frequency not known: 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 cells). 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 beginning of treatment (acute generalized exanthematous pustulosis) may also occur. Stop taking Ibufarmalid 600 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:

Common: headache, dizziness, and restlessness.

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 disorders (early symptoms may include: fever, sore throat, mouth ulcers, flu-like symptoms, excessive tiredness, nosebleeds, and skin bleeding).

Cardiovascular:

Medicines such as Ibufarmalid 600 mg oral suspension may be associated with a moderately increased 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 600 mg oral suspension.

Kidney:

Kidney disease.

Liver:

Rare: hepatitis (inflammation of the liver) and jaundice (yellowing of the skin). Medicines such as Ibufarmalid 600 mg oral suspension may, on rare occasions, be associated with liver injury.

If you experience any of these adverse effects or any others not described in this leaflet, consult your doctor or pharmacist.

5. Storage of Ibufarmalid 600 mg oral suspension

Keep Ibufarmalid 600 mg oral suspension out of the reach and sight of children.

Keep it in its original container.

Expiry:

Do not use Ibufarmalid 600 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 you no longer need. This will help protect the environment.

6. Additional Information

Composition

The active substance is Ibuprofen. Each sachet contains 600 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 medicinal product and contents of the pack

Ibufarmalid 600 mg oral suspension is presented as an oral suspension to be taken directly from the sachet or dissolved in water. Each package contains 20 or 40 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 review of this 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/