SOLIBU 400 MG SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Solibu400 mg solution for infusion EFG

Ibuprofen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Solibu and what is it used for
2. What you need to know before you use Solibu
3. How to use Solibu
4. Possible side effects
5. Storing Solibu
6. Contents of the pack and other information

1. What is Solibu and what is it used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). These medicines provide relief by changing the body's response to pain and high temperature.

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

2. What you need to know before you use Solibu

Do not 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 ingredients of this medicine (listed in section 6), to acetylsalicylic acid (aspirin) or other anti-inflammatory painkillers.
• if you have severe liver, kidney or heart disease.
• if you have ever had bleeding or perforation in the stomach or intestine when taking NSAIDs.
• if you have ever suffered from dyspnea, asthma, skin rash, pruritus, nasal or facial inflammation when taking ibuprofen, acetylsalicylic acid (aspirin) or other painkillers (NSAIDs).
• if you suffer from severe dehydration (caused by vomiting, diarrhea or insufficient fluid intake).
• if you suffer from cerebral hemorrhage or other active bleeding.
• if you suffer from red blood cell production disorders or blood coagulation 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 medicine:

• if you have, or have had, asthma.
• if you have kidney, heart, liver or intestine 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.
• anti-inflammatory/analgesic medicines like ibuprofen may be associated with a small increased risk of suffering a heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or treatment duration.

You should 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 arteriopathy (circulation problems 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, have a family history of heart disease or stroke, or are a smoker.
• NSAIDs can mask symptoms of infection.
• if you have an infection; see the "Infections" heading below.

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 medical emergency service immediately if you notice any of these signs.

Infections

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

Skin reactions

Serious skin reactions have been reported with Solibu treatment. Stop taking Solibu and go to the doctor immediately if you present any skin rash, lesions on the mucous membranes, blisters or other signs of allergy, as these may be the first signs of a very serious skin reaction. See section 4.

Children and adolescents

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

Using Solibu with other medicines

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

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

• anticoagulant medicines (e.g. to treat coagulation problems/prevent coagulation, e.g. acetylsalicylic acid, warfarin, ticlopidine).
• glucocorticoids (medicines that contain cortisone or similar substances to cortisone), aspirin or other NSAIDs (anti-inflammatory and analgesic) as they may increase the risk of suffering from stomach ulcers or gastrointestinal bleeding.
• lithium (medicine for bipolar disorder and depression) as its effect may be enhanced.
• selective serotonin reuptake inhibitors (medicine used for depression) as they may increase the risk of suffering from stomach ulcers or gastrointestinal bleeding.
• methotrexate (medicine for cancer or rheumatism) as its effect may be enhanced.
• zidovudine (medicine for HIV infection treatment) as the use of ibuprofen may increase the risk of bleeding in a joint or lead to bleeding with inflammation.
• cyclosporin and tacrolimus (to prevent rejection in transplants) as there may be a greater 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 there may be a greater risk to the kidney (the use of potassium-sparing diuretics with ibuprofen may increase potassium levels in the blood).
• sulfonylureas (antidiabetic medicine) as there may be interactions.
• phenytoin (for epilepsy) as its effect may be increased.
• quinolone antibiotics (e.g. ciprofloxacin) as the risk of suffering from convulsions may be increased.
• aminoglycoside antibiotics (e.g. gentamicin) as their nephrotoxic effect may be enhanced.
• cardiac glycosides such as digoxin, as their effect may be enhanced.
• mifepristone (used to interrupt pregnancies) as its effect may be reduced.
• probenecid and sulfinpyrazone (medicines 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 (medicine for dementia) as its toxicity may be increased.

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

Taking 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 levels of urea nitrogen and serum creatinine and potassium (may increase)
• With liver function tests: increase in transaminase values.

Tell your doctor if you are going to have a clinical analysis and are using or have recently used 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 you and your baby's tendency to bleed and delay or prolong labor more than expected. You should not take ibuprofen during the first six 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 possible time. 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 checks.

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

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

Ibuprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible if the medicine is stopped. It is unlikely to affect your chances of becoming pregnant if used occasionally. However, consult your doctor before starting to take this medicine if you have problems becoming pregnant.

Driving and using machines

Solibu may have a minor influence on the ability to drive and use machines. Some isolated cases may experience dizziness and fatigue, so driving ability may be affected.

Solibu contains sodium

This medicine 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.

3. How to use Solibu

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 (provided the disease does not progress and the patient continues to tolerate the treatment) for a maximum of 3 days.

The recommended daily dose is 1200 mg of ibuprofen.

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

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 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 clots), gastrointestinal bleeding (see also section 4), diarrhea, headache, ringing in the ears, confusion and involuntary eye movement. Agitation, drowsiness, disorientation or coma may also occur. Occasionally, patients develop convulsions. At high doses, symptoms of drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in the urine, low potassium levels in the blood, chills and breathing problems have been reported. Additionally, the prothrombin time/INR may be prolonged, probably due to interference with the actions of circulating coagulation factors. Acute kidney 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 further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

• Symptoms of intestinal bleeding such as: severe abdominal pain, vomiting blood or black particles with a coffee grounds appearance.
• Very rare but serious symptoms of allergic reactions: worsening of asthma, wheezing or shortness of breath for unknown reasons, swelling of the face, tongue or throat, difficulty breathing, palpitations, low blood pressure and shock. All these symptoms may occur even the first time you use this medicine.
• Serious skin reactions such as rashes that cover the whole body, exfoliation, blisters or skin peeling.

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

Common: may affect up to 1 in 10 people

• Acidity, abdominal pain, dizziness and indigestion.

Uncommon: may affect up to 1 in 100 people

• Gastritis, worsening of colitis and Crohn's disease.
• Headache, dizziness, insomnia, agitation, 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: may affect up to 1 in 1,000 people

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

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

• Inflammation of the esophagus or pancreas, obstruction in the intestine.
• Severe skin infections, which may occur during chickenpox.
• Kidney disorders that may be observed by urinating more or less than usual: cloudy urine, blood in the urine, back pain and/or inflammation (especially of the legs). In general, the habitual use of several types of painkillers may lead to exceptional cases of serious and lasting kidney problems.
• Blood disorders that may lead to bruising, unexplained or unusual bleeding, fever, sore throat, mouth ulcers, pseudo-flu syndromes and extreme exhaustion.
• Psychotic reactions and depression.
• Worsening of inflammation due to infections.
• Hypertension, high blood pressure, palpitations, heart failure, heart attack.
• Liver dysfunction or liver inflammation. Liver damage or failure, especially during long-term treatment, characterized by yellowing of the skin and eyes or pale stools and dark urine.
• Ibuprofen use has been associated with symptoms of aseptic meningitis with cervical stiffness: headache, nausea, vomiting, fever or confusion. Patients with autoimmune disorders (Lupus, mixed connective tissue disease) may have a higher probability of suffering from these symptoms. If they appear, contact a doctor immediately.
• Inflammation of the skin tissues such as the hands, feet or face.
• Medicines like ibuprofen may be associated with a moderate increase in the risk of suffering from heart attacks ("myocardial infarction") or strokes.

Frequency not known:

• Drug reaction with eosinophilia and systemic symptoms: a serious skin reaction known as DRESS syndrome may occur. The symptoms of DRESS syndrome 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 in skin folds, trunk and upper limbs, which is accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis). Stop taking Solibu if you present these symptoms and seek medical attention immediately. See also section 2.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Solibu

Keep this medication out of 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 should be visually inspected. Do not use this medication if you observe any particles or if the solution has changed color.

For single use. Once the product is opened, it should be used immediately. The remaining solution should not be used and should be discarded.

6. Package Contents and Additional Information

Composition of Solibu

The active ingredient is ibuprofen.

Each ml 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 Package Contents

Solibu is a clear and colorless solution packaged in 100 ml polyolefin bags with an aluminum foil wrapper.

Solibu 400 mg solution for infusion is available in:

Cases containing 20 and 50 bags of 100 ml.

Marketing Authorization Holder

Altan Pharmaceuticals, S.A.

C/ Cólquide 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

Date of the Last Revision of this Prospectus: December 2024