Prospect: Information for the Patient

Solibu 600 mg Infusion Solution

Ibuprofen

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

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

1.What is Solibu and what is it used for

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 medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).

This medicine is used in adults forthe short-term symptomatic treatment of moderate acute pain, when intravenous administration is clinically justified and other administration routes are not possible.

No use Solibu

• If you are allergic to ibuprofen, or to any of the other components of this medication (listed in section 6), to acetylsalicylic acid (aspirin) or other nonsteroidal anti-inflammatory drugs (NSAIDs).
• If you have (or have had two or more episodes of) gastrointestinal ulcers, perforation, or bleeding.
• If you have a severe liver, kidney, or heart disease.
• If you have had gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
• If you have a condition that increases your tendency to bleed.
• If you have dyspnea, asthma, skin rash, pruritus, facial or nasal swelling when you have taken ibuprofen, acetylsalicylic acid (aspirin) or other NSAIDs previously.
• 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 blood clotting disorders without clarification.
• If you are in the last trimester of pregnancy.

Warnings and Precautions

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

• If you have undergone major surgery.
• If you have edema (fluid retention).
• If you have or have had asthma.
• If you have kidney, heart, liver, or intestinal problems, or if you are an elderly person.
• If you use ibuprofen for a long time, your doctor may need to perform regular checks.
• If you have symptoms of dehydration, such as severe diarrhea or vomiting, take enough fluids and immediately inform your doctor, as ibuprofen may cause renal failure due to dehydration in this case.
• Severe skin reactions associated with Solibu 600 mg treatment have been reported. Stop taking Solibu 600 mg and seek medical attention immediately 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. See section 4.
• If you have systemic lupus erythematosus (a disease of the immune system that causes joint pain, skin changes, and other organ disorders) and related connective tissue diseases.
• If you have a history of gastrointestinal disease (such as ulcerative colitis or Crohn's disease).
• If you use medications that alter blood clotting, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid, or other medications that may increase the risk of bleeding, such as corticosteroids and serotonin reuptake inhibitors.
• If you are taking diuretics (medications to urinate) as your doctor must monitor your kidney function.
• If you are in the first 6 months of pregnancy.
• If you have chickenpox.
• If you have a hereditary disorder of porphyrin metabolism (e.g., acute intermittent porphyria).
• If you consume alcohol while taking this medication, some side effects related to the stomach, intestines, and nervous system may be increased.
• NSAIDs like ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or treatment duration.

You should discuss your treatment with your doctor or nurse before using this medication if:

• You have heart problems, including heart failure, angina (chest pain), or if you have had a heart attack, coronary bypass surgery, peripheral artery disease (circulation problems in the legs or feet due to narrowing or blockage of the arteries), or any type of stroke (including "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 "Infections" heading below.
• It is essential to use the minimum dose that relieves and controls pain and for the shortest time possible to control symptoms.
• Allergic reactions may occur with this medication, mainly at the beginning of treatment. In this case, treatment should be interrupted.
• If you have seasonal allergic rhinitis, nasal polyps, or chronic obstructive respiratory disorders, you are at higher risk of an allergic reaction. Allergic reactions may present as asthma attacks (known as analgesic asthma), rapid swelling (Quincke's edema), or hives.
• Concomitant use with NSAIDs, including COX-2 inhibitors, should be avoided.
• Long-term use of analgesics may cause severe and lasting kidney problems.
• Prolonged use of analgesics may cause headaches that should not be treated with higher doses of the medication.
• Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), generalized acute pustular psoriasis (PEGA), have been reported in association with ibuprofen treatment. Stop taking Solibu and seek medical attention immediately if you notice any symptoms related to these severe skin reactions described in section 4.

Signs of allergic reaction to ibuprofen, such as respiratory problems, facial and neck swelling (angioedema), and chest pain, have been reported. 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.

Other Medications and Solibu

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

Ibuprofen may affect or be affected by other medications, for example:

• Other NSAIDs, including COX-2 inhibitors (e.g., celecoxib), may increase the risk of gastrointestinal ulcers and bleeding due to an additive effect. Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the possibility of increased adverse effects.
• Anticoagulant medications (e.g., for treating coagulation problems or preventing coagulation, such as aspirin, warfarin, or ticlodipine).
• Glucocorticoids (medications containing cortisone or similar substances), as they may increase the risk of gastrointestinal ulcers or bleeding.
• Lithium (used to treat depression and bipolar disorder), which may increase your blood levels when taking ibuprofen.
• Selective serotonin reuptake inhibitors (medications used to treat depression), as they may increase the risk of gastrointestinal ulcers or bleeding.
• Methotrexate (used to treat cancer and inflammatory diseases), as it may potentiate the effect of this medication.
• Zidovudine (medication against HIV), as the use of ibuprofen may increase the risk of bleeding in a joint or cause bleeding that leads to inflammation.
• Ciclosporin and tacrolimus (used in organ transplants to prevent rejection), as there is a higher risk of kidney problems.
• Medications that lower high blood pressure (ACE inhibitors like captopril, beta-blockers like atenolol, and angiotensin II receptor antagonists like losartan) and diuretics, as NSAIDs may reduce the effects of these medications and may increase the risk to the kidneys (the use of potassium-sparing diuretics with ibuprofen may increase blood potassium levels).
• Sulfonilureas (for diabetes), as interactions may occur.
• Phenytoin (used to treat epilepsy), which may increase your blood levels when taking ibuprofen.
• Quinolone antibiotics (e.g., ciprofloxacin), as the risk of seizures may increase.
• Aminoglycoside antibiotics (e.g., gentamicin), as their nephrotoxic effect may be potentiated.
• Voriconazole, fluconazole (CYP2C9 inhibitors) (used to treat fungal infections), which may increase ibuprofen blood levels.
• Digoxin (cardiotonic glycosides), which may increase your blood levels when taken with ibuprofen.
• Mifepristone (used to interrupt pregnancy), as its effect may be reduced.
• Probenecid and sulfinpyrazone (used to treat gout), as ibuprofen metabolism may be reduced.
• Baclofen (used to relieve severe involuntary muscle contractions), as its toxicity may be increased.
• Pentoxifylline (used to treat certain blood vessel problems), which may increase the risk of bleeding.

Other medications may also affect or be affected by ibuprofen treatment. Therefore, you should always consult your doctor or nurse before using Solibu 600 mg 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 (heart function)
• Hematocrit or hemoglobin (may decrease)
• Serum urea nitrogen concentrations and serum creatinine and potassium concentrations (may increase)
• In liver function tests: increased levels of transaminases.

Therefore, if you are to undergo a clinical analysis, inform your doctor or pharmacist if you are taking or have taken ibuprofen recently.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, or if you think you may be 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 and your baby's tendency to bleed and delay or prolong delivery. Do not take ibuprofen 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 time possible. 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 more than a few days, your doctor may recommend additional monitoring. Inform your doctor or nurse before starting to use the medication if you are in the first six months of pregnancy or breastfeeding.

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

Ibuprofen belongs to a group of medications that may affect female fertility. This effect is reversible if the medication is discontinued. It is unlikely to affect conception if used occasionally. However, consult your doctor before starting to use this medication if you have difficulty conceiving.

Driving and Using Machines

The influence of this medication on the ability to drive and use machines is minimal.

Individually, some patients may experience fatigue and dizziness, which may impair the ability to drive vehicles and/or use machines.This applies to a greater extent in combination with alcohol.

Solibu contains sodium

This medication contains 19.4 mmol (454.5 mg) of sodium per 150 mL of solution, which should be taken into account in patients with low-sodium diets.

Follow exactly the administration instructions for this medication as indicated by your doctor. If you have any doubts, consult your doctor.

Dosage

AdultsThe recommended dose is 600 mg of ibuprofen. If clinically justified, another dose of 600 mg may be administered every 6-8 hours depending on the intensity and response to treatment. The maximum daily dose is 1200 mg.

Your doctor will use the most effective dose and for the shortest time possible to avoid side effects. Your doctor will also ensure that you have taken enough liquids to minimize the risk of side effects on the kidneys.

Use should be limited to situations where oral administration is inappropriate. Patients should switch to oral treatment as soon as possible.

This medication is indicated for short-term acute treatment and should not be used for more than 3 days.

Use the most effective dose 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).

Administration Form

Intravenous route.

This medication should be administered as an intravenous infusion over 30 minutes.

Use in Children and Adolescents

This medication should not be used in children and adolescents. The use of Solibu has not been studied in children and adolescents. Therefore, its safety and efficacy have not been established.

If You Take More Solibu Than You Should

Consult your 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), headache, ringing in the ears, confusion, and involuntary eye movement. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness, blood in the urine, chills, and breathing difficulties have been reported.

If you have any other doubts 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 most effective dose for the shortest time possible to treat symptoms. You may experience one or more known side effects of NSAIDs (see below).

If you experience one of these side effects, you should stop using this medicine and consult a doctor as soon as possible. Patients over 65 years old who take this medicine are at a higher risk of developing problems associated with side effects.

The most commonly observed side effects are gastrointestinal (stomach and intestinal problems). You may develop peptic ulcers (stomach or intestinal ulcers), perforation (punctured stomach or intestinal wall) or stomach or intestinal bleeding, sometimes fatal, particularly in older adults. Nausea, vomiting, diarrhea, flatulence, constipation, indigestion, abdominal pain, dark stools, vomiting with blood, ulcerative stomatitis (inflammation of the oral mucosa with ulceration) exacerbation of colitis (inflammation of the large intestine) and Crohn's disease. Less frequently, gastritis (inflammation of the stomach) has been observed. In particular, the risk of stomach and intestinal bleeding depends on the dose range and duration of use.

Edema (fluid accumulation in tissues), high blood pressure and heart failure associated with NSAID treatment have been reported. Medications such as ibuprofen may be associated with a mild increase in heart attack (“myocardial infarction”) or stroke.

In rare cases, severe allergic reactions (including reactions at the injection site, anaphylactic shock) and serious skin adverse effects such as bullous eruptions (formation of blisters) reactions that include Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell syndrome), multiform erythema, alopecia (hair loss), light sensitivity and allergic vasculitis (inflammation of blood vessels) have been reported.

Very rarely, exacerbation of inflammation related to infections (e.g., development of necrotizing fasciitis) has been reported, coinciding with the use of NSAIDs.

In exceptional cases, severe skin infections and tissue cell complications produced during varicella infections have been reported.

Very common side effects (may affect more than 1 in 10 people):

• Fatigue or drowsiness, headache and dizziness.

• Stomach burning, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation and blood in stools and mild bleeding in the stomach and intestines that may cause anemia in exceptional cases.

• Gastrointestinal ulcers with bleeding and potential perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease.

Common side effects (may affect up to 1 in 10 people):

• Dizziness.

• Skin rashes.

• Pain and burning sensation at the injection site.

Uncommon side effects (may affect 1 in 100 people):

• Insomnia (sleep problems), agitation, irritability or fatigue, anxiety and excitement.

• Visual disturbances.

• Tinnitus (ringing or buzzing in the ears).

• Reduction in urine production and, particularly in patients with high blood pressure or kidney problems, nephrotic syndrome, interstitial nephritis that may be accompanied by acute renal failure.

• Urticaria, pruritus, purpura (including allergic purpura), skin rash.

• Allergic reactions with skin rashes and pruritus, as well as asthma attacks (possibly with a drop in blood pressure).

Rare side effects (may affect 1 in 1,000 people):

• Reversible toxic amblyopia (double vision).

• Hearing difficulty.

• Esophageal stricture (esophageal blood vessels), complications of diverticula in the large intestine, non-specific colitis. If stomach or intestinal bleeding occurs, it may cause anemia.

• Renal tissue damage (papillary necrosis), particularly in long-term therapy, increased plasma uric acid concentration in the blood.

• Yellow discoloration of the skin or white of the eyes, liver damage, particularly in long-term treatment of acute hepatitis (inflammation of the liver).

• Psychotic reactions, nervousness, irritability, confusion or disorientation and depression.

• Neck stiffness.

Very rare side effects: (may affect 1 in 10,000 people):

• Disorders in the formation of blood cells (anemia, leukopenia, thrombocytopenia, pancitopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, symptoms similar to the flu, severe fatigue, nasal and cutaneous bleeding.

• Palpitations (rapid heartbeats), heart failure, myocardial infarction.

• Hypertension.

• Aseptic meningitis (neck stiffness, headache, vomiting, fever or confusion). Patients with autoimmune disorders (LES, mixed connective tissue disease) appear to be predisposed.

• Inflammation of the esophagus or pancreas, intestinal stricture.

• Asthma, respiratory difficulty (bronchospasm) shortness of breath and wheezing.

• Systemic lupus erythematosus (autoimmune disease), severe allergic reactions (facial edema, inflammation of the tongue, inflammation of the throat with constriction of the airways, difficulty breathing, rapid heartbeats, decreased blood pressure and potentially fatal shock).

Unknown side effects (cannot be determined from available data):

• Renal insufficiency.

• Reactions at the injection site, such as inflammation, bruising or bleeding.

• Severe skin reactions associated with the treatment ofSolibu 600 mghave been reported. Stop takingSolibu 600 mgand see a doctor immediately if you experience any skin rash, membrane lesions, blisters or other signs of allergy, as these may be the first signs of a severe skin reaction. See section 4.

• The skin becomes sensitive to light.

• Drug reaction with eosinophilia and systemic symptoms: a severe skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node inflammation and elevated eosinophils (a type of white blood cell).

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

Stop treatment with ibuprofen and seek medical attention immediately if you notice any of the following symptoms:

• Flat, red, circular or target-shaped patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital and eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms [dermatitis exfoliativa, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].

•

• Generalized skin rash, elevated body temperature and swollen lymph nodes (DRESS syndrome).• Generalized, red and scaly rash, with protuberances under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Reporting of side effects

If you experience any side effect, consult your doctor 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: 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 box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Visually inspect the solution before administration. Do not use this medication if you observe any particles or if the solution has changed color.

For single use only. Once opened, the medication must be used immediately. The remaining solution should not be used, it must be discarded.

Contents of Solibu

The active principle is ibuprofen. Each ml of solution contains 4 mg of ibuprofen.

Each 150 ml bag contains 600 mg of ibuprofen.

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

Appearance of Solibu and contents of the packaging

This medicine is a transparent and colorless solution packaged in 150 ml polyolefin bags with an aluminum overwrap.

Solibu is available in cases containing 20 and 50 bags of 150 ml.

Holder of the marketing authorization

Altan Pharmaceuticals S.A.

C/ Cólquide, Nº 6, Portal 2, 1st Floor, Office F. Edificio Prisma

28230 Las Rozas (Madrid)

Spain

Responsible for manufacturing

Altan Pharmaceuticals S.A.

Polígono Industrial de Bernedo s/n

01118 Bernedo (Álava)

Spain

This medicine is authorized in the Member States of the EEA, with the following names:

Germany: Solibu 600 mg Infusionslösung

Poland: Ibuprofen Altan

Portugal: Solibu 600 mg Solução para perfusão

Date of the last review of this leaflet:October 2024.