Package Insert: Information for the Patient

Solibu 400 mg Solution for Infusion EFG

Ibuprofen

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this package insert. See section 4.

1. What is Solibu and how is it used

2. What you need to know before starting to use Solibu

3. How to use Solibu

4. Possible adverse effects

5. Storage of Solibu

6. Contents of the package and additional information

Ibuprofen belongs to a group of medications known as nonsteroidal anti-inflammatory drugs (NSAIDs). These medications provide relief by changing the body's response to pain and elevated temperature.

This medication is indicated for the symptomatic treatment of moderate pain and fever for a short period, when intravenous administration is clinically justified and other administration routes are not possible.

No use Solibu

• If you have (or have had two or more episodes of) stomach ulcers, perforation, or bleeding in the stomach.
• If you are allergic to ibuprofen or any of the other components of this medication (listed in section 6), acetylsalicylic acid (aspirin), or other anti-inflammatory analgesics.
• If you have a serious liver, kidney, or heart disease.
• If you have ever had bleeding or perforation in the stomach or intestine while taking NSAIDs.
• If you have ever experienced shortness of breath, asthma, skin rashes, itching, nasal or facial inflammation when taking ibuprofen, acetylsalicylic acid (aspirin), or other analgesics (NSAIDs).
• If you suffer from severe dehydration (caused by vomiting, diarrhea, or inadequate fluid intake).
• If you suffer from cerebral hemorrhage or other active hemorrhages.
• If you suffer from disorders of red blood cell production or blood clotting disorders.

If you are in the last three months of pregnancy (see below).

Warnings and Precautions

Consult your doctor or nurse before starting to use this medication:

• If you have, or have had, asthma.
• If you have kidney, heart, liver, or intestinal problems.
• If you have high blood pressure, diabetes, high cholesterol, or are a smoker.
• If you have systemic lupus erythematosus (a disease of the immune system that causes joint pain, skin changes, and other organ disorders).
• If you have a history of gastrointestinal disease (such as ulcerative colitis or Crohn's disease).
• If you are in the first six months of pregnancy.
• If you have chickenpox.
• NSAIDs, such as 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 must discuss your treatment with your doctor or nurse before using Solibu if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, bypass surgery, peripheral artery disease (problems with circulation 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, a family history of heart disease or stroke, or if you are a smoker.
• NSAIDs may mask symptoms of infection.
• If you have an infection; see the heading "Infections" below.

With ibuprofen, signs of allergic reaction to this medication have been reported, such as respiratory problems, swelling of the face and neck region (angioedema), and chest pain. Stop using Solibu immediately and contact your doctor or emergency medical services if you observe any of these signs.

Infections

Solibu may mask the signs of an infection, such as fever and pain. Therefore, it is possible that Solibu may delay the appropriate treatment of the infection, which may increase the risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medication while having an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Skin Reactions

Severe skin reactions associated with Solibu treatment have been reported. Stop taking Solibu and see a doctor immediately if you present any skin rash, membrane lesions, blisters, or other signs of allergy, as these may be the first signs of a very severe skin reaction. See section 4.

Children and Adolescents

The safety ofSolibuin the pediatric population has not been established,Solibushould not be used by children or adolescents (under 18 years of age).

Use of Solibu with Other Medications

Inform your doctor if you are using, have used recently, or may need to use any other medication.

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

• Anticoagulant medications(e.g., to treat coagulation problems/avoid coagulation, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• Glucocorticoids (medications containing cortisone or similar substances to cortisone), aspirin, or other NSAIDs (anti-inflammatory and analgesic) as it may increase the risk of stomach ulcers or gastrointestinal bleeding.
• Lithium (medication for bipolar disorder and depression) as it may potentiate the effect of this medication.
• Selective serotonin reuptake inhibitors (medication used for depression) as it may increase the risk of stomach ulcers or gastrointestinal bleeding.
• Methotrexate (medication for cancer or rheumatism) as its effect may be potentiated.
• Zidovudine (medication for HIV infection) as the use of ibuprofen may increase the risk of bleeding in a joint or cause inflammation.
• Ciclosporin and tacrolimus (to prevent rejection in transplants) as there may be a higher risk of kidney disorders.
• Medications that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as medications with atenolol, and angiotensin II receptor antagonists such as losartan) and diuretics, as NSAIDs may reduce the effects of these medications and there may be a higher risk for the kidneys (the use of potassium-sparing diuretics with ibuprofen may increase blood potassium levels).
• Sulfonilureas (antidiabetic medication) as there may be interactions.
• Phenytoin (for epilepsy) as its effect may be increased.
• Quinolone antibiotics (e.g., ciprofloxacin) as the risk of seizures may be increased.
• Aminoglycoside antibiotics (e.g., gentamicin), as their nephrotoxic effect may be potentiated.
• Digoxin (cardiotonic glucosides) as its effect may be potentiated.
• Mifepristone (used to interrupt pregnancies) as its effect may be reduced.
• Probenecid and sulfinpyrazone (medications for gout): ibuprofen may take longer to be metabolized by the body.
• Baclofen (used to relieve intense muscle spasms) as its toxicity may be increased.
• Pentoxifylline (used to treat high blood pressure) increases the risk of hypotension.
• Tacrine (antidementia medication) as its toxicity may be increased.

Other medications may also affect or be affected by Solibu treatment. Therefore, you must always consult your doctor or nurse before using Solibu with other medications.

Ibuprofen may alter the following laboratory tests:

• Bleeding time (may be prolonged for 1 day after stopping treatment)
• Blood glucose concentration (may decrease)
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen concentrations and serum creatinine and potassium concentrations (may increase)
• With liver function tests: increased values of transaminases.

Inform your doctor if you are to undergo a clinical analysis and are using or have used ibuprofen recently.

Pregnancy, Lactation, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Ibuprofen is contraindicated during the third trimester 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 tendency and that of your baby to bleed and delay or prolong delivery. Do not take ibuprofen during the first six months of pregnancy unless it is clearly necessary and as your doctor indicates. 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 surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If you need treatment for a period exceeding a few days, your doctor may recommend additional checks.

Speak with your doctor or nurse before taking this product if you are in the first six months of pregnancy or are breastfeeding.

This medication passes into breast milk, but it may be used during lactation at the recommended dose and for the shortest possible time.

Ibuprofen belongs to a group of medications that may alter fertility in women. This effect is reversible if the medication is discontinued. It is unlikely that occasional use may affect your chances of becoming pregnant. However, consult your doctor before starting to take this medication if you have difficulty becoming pregnant.

Driving and Operating Machines

Solibumay have a minor influence on the ability to drive and operate machines. Some isolated cases may experience dizziness and fatigue, therefore, the ability to drive may be affected.

Solibu contains sodium

This medication contains 13 mmol (303 mg) of sodium per 100 ml of solution, which should be taken into account in patients with a controlled sodium diet.

For the treatment of moderate pain and for the treatment of fever. Administer 400 mg of ibuprofen (100 ml of solution) intravenously every 6 hours as needed (as long as the disease does not progress and the patient continues to tolerate the treatment) up to a maximum of 3 days.

The recommended daily dose is 1200 mg of ibuprofen.

The effective dose should be used for the shortest time 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 ibuprofen solution should be administered as an intravenous infusion over 30 minutes.

If you use more Solibu than you should

Consult a doctor immediately.If you have taken more Solibu than you should, or if a child has accidentally ingested the medication, consult a doctor immediately or go to the nearest hospital to inform yourself 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-stained mucus),gastrointestinal bleeding (see also section 4), diarrhea,headache, ringing in the ears, confusion, and involuntary eye movement.Agitation, drowsiness, disorientation, or coma may also appear. Occasionally, patients develop seizures.At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported.Blood in the urine,low potassium levels in the blood,chills, and breathing difficulties have also been reported.Furthermore, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating clotting factors. Acute renal failure and liver damage may occur. Exacerbation of asthma in asthmatics is also possible. Additionally, hypotension and decreased respiration may occur.

If you have any other questions about the use of this medication, ask your doctor or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Side effects can be minimized by using the lowest dose for the shortest time necessary to relieve symptoms. If you have any side effects, or you think you may be experiencing a side effect, stop taking this medicine and talk to your doctor as soon as possible. People over 65 years old who use this product are at a higher risk of developing problems related to side effects.

Stop using this medicine and seek medical help immediately if you develop:

• Intestinal bleeding symptoms such as: severe abdominal pain, vomiting with blood or black particles resembling coffee grounds.
• Very rare but serious allergic reactions: worsening of asthma, wheezing or difficulty breathing for unknown reasons, facial, tongue, or throat inflammation, difficulty breathing, palpitations, low blood pressure, and shock. All these symptoms could appear even the first time you use this medicine.
• Severe skin reactions such as widespread rashes, exfoliation, blisters, or skin peeling.

Talk to your doctor if you have any of the following side effects, if they worsen, or if you notice other side effects not listed.

Frequent: can affect up to 1 in 10 people

• Heartburn, abdominal pain, dizziness, and indigestion.

Occasional: can affect up to 1 in 100 people

• Stomach inflammation, worsening of colitis, and Crohn's disease.
• Headache, dizziness, insomnia, restlessness, irritability, or fatigue.
• Flatulence (gas), diarrhea, constipation, and vomiting.
• Allergic reactions, such as skin rashes, itching, and asthma attacks.
• Pain and irritation at the infusion site.

Rare: can affect up to 1 in 1,000 people

• Tinnitus (ringing in the ears).
• Renal damage and gout development.

Very rare: can affect up to 1 in 10,000 people

• Esophageal or pancreatic inflammation, intestinal obstruction.
• Severe skin infections, which can occur during chickenpox.
• Renal disorders that can be observed by urinating more or less than normal: cloudy urine, blood in the urine, back pain, and/or inflammation (especially in the legs). In general, long-term use of various types of analgesics can lead to rare cases of severe and lasting renal problems.
• Blood disorders that can cause bruises, unexplained or unusual bleeding, fever, sore throat, mouth ulcers, flu-like symptoms, and extreme exhaustion.
• Psychotic reactions and depression.
• Worsening of inflammation due to infections.
• Hypertension, high blood pressure, palpitations, heart failure, and myocardial infarction.
• Liver dysfunction or inflammation. Liver damage or failure, especially during long-term treatment, characterized by yellowing of the skin and eyes or pale stools and dark urine.
• With the use of ibuprofen, symptoms of aseptic meningitis with cervical stiffness have been observed: headache, nausea, vomiting, fever, or confusion. Patients with autoimmune disorders (Lupus, mixed connective tissue disease) may be more likely to experience these symptoms. If they appear, contact a doctor immediately.
• Inflammation of skin tissues such as hands, feet, or face.
• Medicines like ibuprofen can be associated with a moderate increase in the risk of suffering heart or brain attacks.

Unknown frequency:

• Drug reaction with eosinophilia and systemic symptoms: a severe skin reaction known as DRESS syndrome can occur. DRESS syndrome symptoms include: skin rash, lymph node inflammation, and elevated eosinophils (a type of white blood cell).
• The skin becomes sensitive to light.
• Generalized red scaly rash, with bumps under the skin and blisters located mainly on skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (generalized acute pustular exanthema). Stop taking Solibu if you experience these symptoms and seek medical attention immediately. See section 2.
• Chest pain, which can be a sign of a potentially severe allergic reaction called Kounis syndrome.

Reporting of side effects

If you experience any type of side effect, consult your doctor or nurse, even if it's a possible side effect not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Before administration, the product must be visually inspected. Do not use this medication if any particles are observed or if the solution has changed color.

For single use only. Once opened, the product must be used immediately. The remaining solution must not be used and must be discarded.

Composition of Solibu

The active principle is ibuprofen.

Each milliliter of solution contains 4 mg of ibuprofen.

Each 100 ml bag contains 400 mg of ibuprofen.

The other components are trometamol, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Appearance of the product and content of the packaging

Solibuis a transparent and colorless solution conditioned in 100 ml polyolefin bags with aluminum foil wrapping.

Solibu 400 mgintravenous solutionis available in:

Boxes containing 20 and 50 bags of 100 ml.

Holder of the marketing authorization

Altan Pharmaceuticals, S.A.

C/ Cólquide 6, Portal 2, 1st Floor, Office F. Prisma Building

28230 Las Rozas (Madrid) Spain

Responsible for manufacturing

Altan Pharmaceuticals, S.A.

Industrial Park of Bernedo s/n

01118 Bernedo (Álava) Spain

Last review date of this leaflet: December 2024