SOLIBU 600 MG SOLUTION FOR INFUSION

2. What you need to know before you use Solibu

Do not use Solibu

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), to acetylsalicylic acid (aspirin) or other anti-inflammatory painkillers.
• If you have (or have had two or more episodes of) gastrointestinal ulcers, perforation or bleeding.
• If you have severe liver, kidney or heart disease.
• If you have had gastrointestinal bleeding or perforation related to previous treatment with NSAIDs.
• If you have a disease that increases your tendency to bleed.
• If you have dyspnea, asthma, skin rash, pruritus, swelling of the face or nose when you have taken ibuprofen, acetylsalicylic acid (aspirin) or other painkillers (NSAIDs) before.
• If you suffer from severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).
• If you have a cerebrovascular hemorrhage or other active bleeding.
• If you have unclarified blood formation disorders.
• If you are in the last trimester of pregnancy.

Warnings and precautions

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

• 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 intestine problems or if you are an elderly person.
• If you use ibuprofen for a long time, your doctor may need to perform regular check-ups.
• If you experience symptoms of dehydration, e.g. severe diarrhea or vomiting, take sufficient amounts of fluids and inform your doctor immediately, as ibuprofen may cause kidney failure as a result of dehydration.
• Severe skin reactions have been reported with Solibu 600 mg treatment. Stop taking Solibu 600 mg and consult your doctor 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 affect blood coagulation, such as oral anticoagulants, antiplatelet agents like acetylsalicylic acid. You should also inform your doctor if you use other medications that may increase the risk of bleeding, such as corticosteroids and serotonin reuptake inhibitors.
• If you are being treated with diuretics (medicines to urinate) as your doctor should 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 drink alcohol while receiving this medicine, some side effects related to the stomach, intestines and nervous system may increase.
• Anti-inflammatory/analgesic medications 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 medicine if:

• you have heart problems, including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial 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 important that you use the minimum dose that relieves and controls the pain and for the shortest time possible to control the symptoms.
• Allergic reactions may occur with this medicine, mainly at the start of treatment. In this case, treatment should be discontinued.
• If you have seasonal rhinitis/asthma, nasal polyps or chronic obstructive respiratory disorders, you have a higher risk of an allergic reaction. Allergic reactions may present as asthma attacks (so-called analgesic asthma), rapid swelling (Quincke's edema) or rash.
• Concomitant use with NSAIDs, including selective COX-2 inhibitors, should be avoided.
• In general, the habitual use of (various types of) painkillers can cause serious and lasting kidney problems.
• Prolonged use of painkillers can cause headaches that should not be treated with higher doses of the medicine.
• Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported in association with ibuprofen treatment. Discontinue Solibu treatment and seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

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

Infections

Solibu may mask the signs of an infection, such as fever and pain. Consequently, Solibu may delay 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 you have an infection and the symptoms of the infection persist or worsen, consult a doctor without delay.

Other medicines and Solibu

Tell your doctor if you are using, have recently used, or might use any other medicines.

Ibuprofen may affect or be affected by other medicines, e.g.:

• Other non-steroidal anti-inflammatory drugs (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 medicines (e.g. to treat blood clotting problems/prevent clotting such as aspirin/acetylsalicylic acid, warfarin, or ticlopidine).
• Corticosteroids (medicines containing cortisone or similar substances to cortisone), as they may increase the risk of gastrointestinal ulcers or bleeding.
• Lithium (used to treat depression and bipolar disorder), may increase its levels in the blood with the use of ibuprofen.
• Selective serotonin reuptake inhibitors (medicines used for depression), as they may increase the risk of gastrointestinal ulcers or bleeding.
• Methotrexate (used to treat cancer and inflammatory diseases), as its effect may be enhanced by this medicine.
• Zidovudine (a medicine against the AIDS virus), as the use of ibuprofen may increase the risk of bleeding in a joint or cause bleeding that involves inflammation.
• Cyclosporin and tacrolimus (used in organ transplants to prevent rejection), as there is a higher risk of kidney disorders.
• Medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, and angiotensin II receptor antagonists such as losartan) and diuretics, as NSAIDs may reduce the effects of these medicines and may increase the risk to the kidneys (the use of potassium-sparing diuretics with ibuprofen may increase potassium levels in the blood).
• Sulfonylureas (for diabetes), as interactions may occur.
• Phenytoin (used to treat epilepsy), may increase its levels in the blood with ibuprofen.
• Quinolone antibiotics (e.g. ciprofloxacin), as the risk of convulsions may increase.
• Aminoglycoside antibiotics (e.g. gentamicin), as their nephrotoxic effect may be enhanced.
• Voriconazole, fluconazole (CYP2C9 inhibitors) (used for fungal infections), may increase ibuprofen levels in the blood.
• Cardiac glycosides such as digoxin may increase their levels in the blood 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 muscle spasms), as its toxicity may increase.
• Pentoxifylline (used to treat certain blood vessel problems), increases the risk of bleeding.

Other medicines may also affect or be affected by treatment with ibuprofen. Therefore, you should always consult your doctor or nurse before using Solibu 600 mg with other medicines.

The use of ibuprofen may affect the following laboratory tests:

• Coagulation time (may be prolonged for 1 day after treatment is discontinued)
• Blood glucose concentration (may decrease)
• Creatinine clearance (cardiac output)
• Hematocrit or hemoglobin (may decrease)
• Blood urea nitrogen and serum creatinine and potassium levels (may increase).
• In liver function tests: increased transaminase levels.

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.

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 labor more than expected. You should not take ibuprofen during the first 6 months of pregnancy unless 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 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 monitoring. Inform your doctor or nurse before starting to use the medicine if you are in the first six months of pregnancy or breastfeeding.

This medicine passes into breast milk, but it can be used during breastfeeding in the recommended dosage and for the shortest time possible.

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

Driving and using machines

The influence of this medicine on the ability to drive and use machines is minor.

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 medicine contains 19.4 mmol (454.5 mg) of sodium per 150 mL of solution, which should be taken into account in patients on a low-sodium diet.

3. How to use Solibu

Follow exactly the administration instructions of this medicine indicated by your doctor. If you have any doubts, consult your doctor.

Dosage

Adults The 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 lowest effective dose and for the shortest time possible in order to avoid side effects. Likewise, your doctor will ensure that you have taken sufficient fluids to minimize the risk of side effects on the kidneys.

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

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

The lowest effective dose should be used for the shortest time necessary to relieve the 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).

Method of administration

Intravenous route.

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

Use in children and adolescents

This medicine 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 use 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 medicine, consult a doctor immediately or go to the nearest hospital to find out about the risk and ask for advice on the measures to be taken.

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, chills, and breathing problems have been reported.

If you have any further questions on the use of this medicine, ask your doctor or nurse.

4. Possible Adverse Effects

Like all medicines, this medicine can cause adverse effects, although not all people suffer from them.

Adverse effects can be minimized by using the effective lowest dose for the shortest possible time to treat symptoms. You may experience one or more known effects of NSAIDs (see below).

If you experience one of these adverse effects, you should discontinue use of this medicine and consult a doctor as soon as possible. Elderly patients taking this medicine are at greater risk of developing problems associated with adverse effects.

The most commonly observed adverse effects are gastrointestinal effects (stomach and intestinal disorders). Peptic ulcers (stomach or intestinal ulcers), perforation (perforated stomach or intestinal wall), or stomach or intestinal bleeding, sometimes fatal, particularly in elderly adults, may occur. 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. Medicines like ibuprofen may be associated with a slight increase in heart attack ("myocardial infarction") or stroke.

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

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

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

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

• Fatigue or drowsiness, headache, and dizziness.
• Heartburn, abdominal pain, nausea, vomiting, flatulence, diarrhea, constipation, and blood in stools, and mild bleeding in the stomach and intestines that can cause anemia in exceptional cases.
• Gastrointestinal ulcers with bleeding and potential perforation. Ulcerative stomatitis, exacerbation of colitis, and Crohn's disease.

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

• Dizziness.
• Skin rashes.
• Pain and burning sensation at the administration site.

Uncommon adverse 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).
• Reduced urine production, and particularly in patients with high blood pressure or kidney problems, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney 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 adverse effects (may affect 1 in 1,000 people):

• Toxic amblyopia (reversible double vision).
• Hearing difficulty.
• Esophageal stricture (esophageal blood vessels), complications of diverticula in the large intestine, hemorrhagic colitis. If stomach or intestinal bleeding occurs, it can cause anemia.
• Kidney tissue damage (papillary necrosis), particularly in long-term therapy, increased plasma concentration of uric acid in the blood.
• Yellowing of the skin or whites of the eyes, liver damage, particularly in long-term treatment of acute hepatitis (liver inflammation).
• Psychotic reactions, nervousness, irritability, confusion, or disorientation, and depression.
• Stiff neck.

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

• Disorders of blood cell formation (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial ulcers in the mouth, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding.
• Palpitations (rapid heartbeats), heart failure, myocardial infarction.
• Hypertension.
• Aseptic meningitis (stiff neck, headache, vomiting, fever, or confusion). Patients with autoimmune disorders (SLE, mixed connective tissue disease) seem to be predisposed.
• Inflammation of the esophagus or pancreas, intestinal stricture.
• Asthma, breathing difficulties (bronchospasm), shortness of breath, and wheezing.
• Systemic lupus erythematosus (autoimmune disease), severe allergic reactions (facial edema, tongue inflammation, throat inflammation with constriction of the airways, difficulty breathing, rapid heartbeats, decreased blood pressure, and potentially fatal shock).

Unknown frequency adverse effects (cannot be determined from available data):

• Kidney failure.
• Reactions at the injection site, such as inflammation, bruising, or bleeding.
• Severe skin reactions associated with Solibu 600 mg treatment have been reported. Stop taking Solibu 600 mg and consult a doctor 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 very severe skin reaction. See section 4.
• Skin becomes sensitive to light.
• Drug reaction with eosinophilia and systemic symptoms: a severe skin reaction known as DRESS syndrome can 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 can be a sign of a potentially severe allergic reaction called Kounis syndrome.

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

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

•

• Generalized skin rash, elevated body temperature, and hypertrophic lymph nodes (DRESS syndrome). • Generalized, red, and scaly rash, with bumps under the skin and blisters, accompanied by fever. The symptoms usually appear at the start of treatment (acute generalized exanthematous pustulosis).

Reporting Adverse Effects

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

5. Storage of Solibu

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiration date shown on the box after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Inspect the solution visually before administration. Do not use this medicine if you observe any particles or if the solution has changed color.

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

6. Package Contents and Additional Information

Solibu Contents

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

Each 150 ml bag contains 600 mg of ibuprofen.

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

Appearance of Solibu and Package Contents

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

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

Marketing Authorization Holder

Altan Pharmaceuticals S.A.

C/ Cólquide, Nº 6, Portal 2, 1ª Planta, Oficina F. Edificio Prisma

28230 Las Rozas (Madrid)

Spain

Manufacturer

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 revision of this prospectus:October 2024.