Solibu 400 mg solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Solibu 400 mg infusion solution EFG

Ibuprofen

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Contents of the leaflet

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

1. What Solibu is and what it is used for

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

Do not use Solibu

• if you have (or have had two or more episodes of) stomach ulcer, stomach perforation, or gastrointestinal bleeding.
• if you are allergic to ibuprofen or to any of the other components of this medicine (listed in section 6), acetylsalicylic acid (aspirin), or other anti-inflammatory painkillers.
• if you suffer from severe liver, kidney, or heart disease.
• if you have ever experienced bleeding or perforation of the stomach or intestine while taking NSAIDs.
• if you previously developed dyspnea, asthma, skin rash, pruritus, nasal congestion, or facial swelling after 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 have a cerebral hemorrhage or other active bleeding.
• if you have disorders affecting 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 medicine:

• 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 (an autoimmune disease causing 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/painkillers such as ibuprofen may be associated with a small increased risk of heart attack or stroke, especially when used at high doses. Do not exceed the recommended dose or duration of treatment.

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, coronary bypass surgery, peripheral arterial disease (circulation problems in legs or feet due to narrowed or blocked 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 section "Infections" below.

Signs of allergic reaction to this medicine, such as breathing difficulties, swelling of the face and neck area (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 signs of infection such as fever and pain. Therefore, Solibu may 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 without delay.

Skin reactions

Serious skin reactions have been reported with Solibu treatment. Stop taking Solibu and contact your doctor immediately if you develop any skin rash, mucosal lesions, blisters, or other signs of allergy, as these may be early signs of a severe skin reaction. See section 4.

Children and adolescents

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

Using Solibu with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

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

• anticoagulant medicines (e.g., to treat or prevent clotting problems, e.g., acetylsalicylic acid, warfarin, ticlopidine).
• glucocorticoids (medicines containing cortisone or cortisone-like substances), aspirin, or other NSAIDs (anti-inflammatory and painkillers), as these may increase the risk of gastrointestinal ulcers or bleeding.
• lithium (used for bipolar disorder and depression), as its effect may be enhanced.
• selective serotonin reuptake inhibitors (medicines used for depression), as these may increase the risk of gastrointestinal ulcers or bleeding.
• methotrexate (used for cancer or rheumatism), as its effect may be enhanced.
• zidovudine (used to treat HIV infection), as ibuprofen use may increase the risk of bleeding into a joint or cause bleeding leading to inflammation.
• cyclosporine and tacrolimus (used to prevent transplant rejection), as there may be an increased risk of kidney problems.
• medicines that lower high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol-containing medicines, and angiotensin II receptor antagonists such as losartan) and diuretics, as NSAIDs may reduce the effectiveness of these medicines and increase kidney risk (using potassium-sparing diuretics with ibuprofen may increase blood potassium levels).
• sulfonylureas (antidiabetic medicines), as interactions may occur.
• 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 enhanced.
• cardiac glycosides such as digoxin, as their effect may be enhanced.
• mifepristone (used to terminate pregnancies), as its effect may be reduced.
• probenecid and sulfinpyrazone (medicines for gout), as ibuprofen may be metabolized more slowly by the body.
• baclofen (used to relieve severe muscle spasms), as its toxicity may be increased.
• pentoxifylline (used to treat high blood pressure), increasing the risk of hypotension.
• tacrine (an antidementia medicine), as its toxicity may be increased.

Other medicines may also affect or be affected by Solibu treatment. 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 urea nitrogen levels and serum creatinine and potassium concentrations (may increase)
• Liver function tests: increased transaminase values.

Inform your doctor if you are scheduled for clinical testing and are currently 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 become pregnant, consult your doctor before using 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 your baby's tendency to bleed and may delay or prolong labor longer than expected. You should not take ibuprofen during the first six months of pregnancy unless clearly necessary and as directed by your doctor. If treatment is needed during this period or while trying to conceive, you should take the lowest possible 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 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.

Talk to your doctor or nurse before taking this medicine 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 duration.

Ibuprofen belongs to a group of medicines that may affect fertility in women. This effect is reversible upon discontinuation of the medicine. It is unlikely that occasional use will affect your chances of becoming pregnant. However, consult your doctor before starting this medicine if you have difficulty 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; therefore, 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 on a sodium-controlled 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), up to a maximum of 3 days.

The recommended daily dose is 1200 mg of ibuprofen.

The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen (see section 2).

Ibuprofen solution must be administered as an intravenous infusion over 30 minutes.

If you use more Solibu than you should

Contact a doctor immediately. If you have taken more Solibu than you should, or if a child has accidentally ingested the medicine, contact a doctor immediately or go to the nearest hospital to assess the risk and obtain advice on the measures to be taken.

Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood-stained sputum), gastrointestinal bleeding (see also section 4), diarrhea, headache, tinnitus, confusion, and involuntary eye movements. Agitation, somnolence, disorientation, or coma may also occur. Occasionally, patients may develop seizures. At high doses, symptoms such as somnolence, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in the urine, low blood potassium levels, chills, and breathing difficulties have been reported. In addition, prothrombin time/INR may be prolonged, likely due to interference with the actions of circulating coagulation factors. Acute renal failure and hepatic damage may occur. Asthma may be exacerbated in asthmatic patients. In addition, hypotension and decreased respiration may occur.

If you have any further questions about 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 everyone will experience them.

Adverse effects can be minimized by using the lowest effective dose for the shortest time necessary to relieve symptoms. If you experience any side effect, or have concerns about possible adverse effects, stop taking this medicine and speak to your doctor as soon as possible. Elderly patients aged 65 years and older who use this product are at increased risk of developing problems related to adverse effects.

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

• Symptoms of gastrointestinal bleeding such as: severe abdominal pain, vomiting blood or black particles resembling coffee grounds.
• Very rare but serious symptoms of allergic reactions: worsening of asthma, wheezing or unexplained shortness of breath, swelling of the face, tongue or throat, difficulty breathing, palpitations, drop in blood pressure and shock. These symptoms may occur even the first time you use this medicine.
• Severe skin reactions such as rashes covering the whole body, skin peeling, blisters or skin shedding.

Talk to your doctor if you experience any of the following adverse effects, if they worsen, or if you notice any effects not listed below.

Frequent: may affect up to 1 in 10 people

• Heartburn, abdominal pain, dizziness and indigestion.

Uncommon: may affect up to 1 in 100 people

• Inflammation of the stomach, worsening of colitis or Crohn's disease.
• Headache, dizziness, insomnia, restlessness, irritability or fatigue.
• Flatulence (gas), diarrhoea, constipation and vomiting.
• Allergic reactions such as skin rashes, itching, or 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 oesophagus or pancreas, intestinal obstruction.
• Severe skin infections, which may occur during chickenpox.
• Kidney disorders that may be observed as increased or decreased urination: cloudy urine, blood in the urine, back pain and/or swelling (especially in the legs). In general, regular use of various types of painkillers may lead to rare cases of serious and long-lasting kidney problems.
• Blood disorders that may cause bruising, 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, heart attack.
• Liver dysfunction or inflammation of the liver. Liver damage or failure, especially during long-term treatment, characterized by yellowing of the skin and eyes, pale stools and dark urine.
• With the use of ibuprofen, symptoms of aseptic meningitis with neck stiffness have been observed: headache, nausea, vomiting, fever or confusion. Patients with autoimmune disorders (lupus, mixed connective tissue disease) may have a higher risk of experiencing these symptoms. If such symptoms occur, contact a doctor immediately.
• Swelling of skin tissues such as hands, feet or face.
• Medicines such as ibuprofen may be associated with a moderately increased risk of heart attack ("myocardial infarction") or stroke.

Frequency not known:

• Drug reaction with eosinophilia and systemic symptoms (DRESS): a severe 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 cell).
• Skin becomes sensitive to light.
• 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). Stop taking Solibu if you experience these symptoms and seek immediate medical attention. See also section 2.
• Chest pain, which may be a sign of a potentially serious allergic reaction called Kounis syndrome.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Solibu

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

No special storage conditions are required.

The product should be inspected visually before administration. Do not use this medicine if you notice any particles or if the solution has changed colour.

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

6. Contents of the pack and other information

Composition of Solibu

The active substance is ibuprofen.

Each ml of solution contains 4 mg of ibuprofen.

Each 100 ml bag contains 400 mg of ibuprofen.

The other components are tromethamine, sodium chloride, hydrochloric acid, sodium hydroxide, and water for injections.

Appearance of the product and contents of the pack

Solibu is a clear, colourless solution contained in 100 ml polyolefin bags with an aluminium laminate overwrap.

Solibu 400 mg solution for infusion is available in:

Cartons containing 20 and 50 bags of 100 ml.

Marketing Authorisation Holder

Altan Pharmaceuticals, S.A.
C/ Cólquide 6, Portal 2, 1st Floor, office 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 most recent revision of this leaflet: December 2024