Ibuprofen Altan

Leaflet accompanying the packaging: patient information

Ibuprofen Altan

600 mg, solution for infusion

Ibuprofen

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of the disease are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Ibuprofen Altan solution for infusion, 600 mg and what is it used for
• 2. Important information before using Ibuprofen Altan solution for infusion, 600 mg
• 3. How to use Ibuprofen Altan solution for infusion, 600 mg
• 4. Possible side effects
• 5. How to store Ibuprofen Altan solution for infusion, 600 mg
• 6. Contents of the packaging and other information
• 1.

What is Ibuprofen Altan solution for infusion, 600 mg and what is it used for

Ibuprofen belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
This medicine is used in adults for the short-term symptomatic treatment of moderate acute pain, when intravenous administration is clinically justified and other administration routes are not possible.

2. Important information before using Ibuprofen Altan solution for infusion, 600 mg

When not to use Ibuprofen Altan, 600 mg

• If the patient is allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), to acetylsalicylic acid (aspirin) or other anti-inflammatory and analgesic medicines.
• If the patient has (or has had two or more episodes of) stomach or intestinal ulcers, perforation or bleeding.
• If the patient has severe liver, kidney or heart disease.
• If the patient has had perforation or bleeding in the stomach or intestine while taking NSAIDs.
• If the patient has a condition that increases their tendency to bleed or has active bleeding.
• If the patient has: shortness of breath, asthma, skin rash, itching, swelling of the face or nose when taking ibuprofen, acetylsalicylic acid (aspirin) or other painkillers (NSAIDs).
• If the patient is severely dehydrated (due to vomiting, diarrhea or insufficient fluid intake).
• If the patient has cerebral or other active bleeding.
• If the patient has unexplained blood clotting disorders.
• If the patient is in the third trimester of pregnancy.

Warnings and precautions

Before using this medicine, consult a doctor or nurse:

• If the patient has recently undergone major surgery.
• If the patient has edema (fluid retention).
• If the patient has asthma.
• If the patient has kidney, heart, liver or intestinal disorders or is elderly.
• If the patient has been taking ibuprofen for a long time, the doctor may regularly check their condition.
• If the patient shows signs of dehydration, such as severe diarrhea or vomiting, they should take appropriate fluids and contact their doctor immediately, as dehydration may lead to kidney failure when taking ibuprofen.
• Severe skin reactions have been reported with the use of Ibuprofen Altan 600 mg, including exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis (AGEP). If skin rash, mucosal lesions, blisters or other signs of allergy occur, discontinue Ibuprofen Altan 600 mg and seek medical attention immediately, as these may be the first signs of a severe skin reaction. See section 4.
• If the patient has systemic lupus erythematosus (an autoimmune disease that causes joint pain, skin changes and other organ disorders) and related connective tissue diseases.
• If the patient has had gastrointestinal diseases (such as ulcerative colitis or Crohn's disease) in the past.
• If the patient is taking anticoagulant medicines (such as blood thinners or anticoagulants, e.g. aspirin, warfarin, ticlopidine).
• If the patient is taking diuretics, as the doctor should monitor kidney function.
• If the patient is in the first six months of pregnancy.
• If the patient has been diagnosed with chickenpox.
• If the patient has a hereditary disorder of porphyrin metabolism (e.g. acute intermittent porphyria).
• Drinking alcohol and taking this medicine at the same time may increase the risk of adverse effects related to the stomach, intestines and nervous system. Taking painkillers and anti-inflammatory medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when taken in high doses. Do not exceed the recommended dose or duration of treatment. Before using Ibuprofen Altan, 600 mg, the patient should discuss their treatment with their doctor or nurse if:
• The patient has heart disease, such as heart failure, angina pectoris (chest pain), has had a heart attack, coronary artery bypass grafting, or has peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of arteries) or has had any stroke (including "mini-stroke" or transient ischemic attack "TIA").
• The patient has high blood pressure, diabetes, high cholesterol, or has a family history of heart disease or stroke, or smokes.
• NSAIDs may mask the signs of infection.
• The patient has an infection - see below, section entitled "Infections".
• It is essential to use the smallest effective dose to relieve and control pain and not to use the medicine for longer than necessary to control symptoms.
• Reactions may occur, mainly at the beginning of treatment. In such cases, treatment should be discontinued.
• If the patient has hay fever, nasal polyps or chronic obstructive pulmonary disease, there is a higher risk of allergic reactions. Allergic reactions may occur as asthma attacks (so-called analgesic asthma), severe swelling (Quincke's edema) or rash.
• Avoid taking NSAIDs, including selective cyclooxygenase-2 inhibitors, at the same time.
• Chronic use of (various) painkillers can lead to long-term severe kidney disease.
• With long-term use of painkillers, headache may occur that cannot be treated with increased doses of the medicine.
• Severe skin reactions have been reported with ibuprofen, including exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis (AGEP). Discontinue Ibuprofen Altan and seek medical attention immediately if any symptoms of severe skin reactions occur, as described in section 4.

During ibuprofen treatment, symptoms of allergic reactions to this medicine have been reported, including
difficulty breathing, swelling around the face and neck (angioedema), chest pain. If any of these symptoms occur, discontinue Ibuprofen Altan immediately and contact a doctor or emergency medical services.
Infections
Ibuprofen Altan may mask the signs of infection, such as fever and pain. Therefore, Ibuprofen Altan may delay the use of appropriate infection treatment and consequently lead to increased risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If the patient is taking this medicine during an infection and the infection symptoms persist or worsen, they should consult their doctor immediately.

Ibuprofen Altan, 600 mg and other medicines

Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Ibuprofen may affect other medicines or other medicines may affect ibuprofen, e.g.:

• other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 (e.g. celecoxib), may increase the risk of stomach ulcers and bleeding due to potentiation of action. Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended due to the possibility of increased adverse effects.
• anticoagulant medicines (e.g. blood thinners or anticoagulants, such as aspirin, warfarin, ticlopidine).
• glucocorticoids (medicines containing cortisone or cortisone-like substances), as they may increase the risk of stomach ulcers or bleeding.
• lithium (used to treat depression and bipolar disorder), as its blood levels may increase when taken with ibuprofen.
• selective serotonin reuptake inhibitors (medicines used for depression), as they may increase the risk of stomach ulcers or bleeding.
• methotrexate (used to treat cancer and inflammatory diseases), as its effects may increase.
• zidovudine (a medicine against AIDS), as ibuprofen may increase the risk of bleeding or cause bleeding that leads to inflammation.
• cyclosporine and tacrolimus (used in organ transplants to prevent rejection), as there is a higher risk of kidney damage.
• medicines that lower high blood pressure (ACE inhibitors, such as captopril, beta-adrenergic 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 higher risk of kidney function disorders (using potassium-sparing diuretics with ibuprofen may increase potassium levels in the blood).
• sulfonylureas (for diabetes), as interactions may occur.
• phenytoin (used to treat epilepsy), as its blood levels may increase when taken with ibuprofen.
• quinolone antibiotics (e.g. ciprofloxacin) due to increased risk of seizures.
• aminoglycoside antibiotics (e.g. gentamicin), as they may promote their nephrotoxic effects.
• voriconazole, fluconazole (CYP2C9 inhibitors) (used for fungal infections) may increase ibuprofen blood levels.
• digitalis glycosides, such as digoxin, as their blood levels may increase when taken with ibuprofen.
• mifepristone (a medicine with abortifacient effects), as its effects may be reduced.
• probenecid and sulfinpyrazone (used for 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 diseases) increases the risk of bleeding.

Other medicines may also interact with or affect Ibuprofen Altan treatment,,600 mg. Therefore, before using Ibuprofen Altan, 600 mg with other medicines, always consult a doctor or nurse.
Taking ibuprofen may affect the following laboratory tests:

• Bleeding time (may be prolonged on the first day after discontinuation of the medicine).
• Blood glucose levels (may decrease).
• Creatinine clearance (may decrease)
• Hematocrit or hemoglobin (may decrease)
• Blood levels of urea, creatinine, and potassium (may increase).
• In liver function tests: increased aminotransferase values.

Tell the doctor about taking ibuprofen currently or recently if the patient is going to have clinical analysis tests.

Pregnancy, breastfeeding and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor before using this medicine.
Do not take Ibuprofen Altan, 600 mg if the patient is in the last 3 months of pregnancy, as it may harm the unborn child or cause problems during delivery. It may cause kidney and heart disorders in the unborn child. It may increase the patient's and child's tendency to bleed and cause delayed or prolonged labor. During the first 6 months of pregnancy, do not use Ibuprofen Altan, 600 mg unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, use the smallest dose for the shortest possible time. From

• the 20th week of pregnancy, Ibuprofen Altan, 600 mg may cause kidney function disorders in the unborn child if taken for more than a few days. This may lead to decreased amniotic fluid around the child (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the child's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

Before using this medicine, inform the doctor or nurse if the patient is breastfeeding or is in the first six months of pregnancy.
This medicine passes into breast milk, but it can be used during breastfeeding in recommended doses and for the shortest possible time.
Ibuprofen belongs to a group of medicines that may affect female fertility. This effect is reversible after discontinuation of the medicine. It is unlikely to affect the ability to conceive if this medicine is used occasionally. However, before starting treatment with this medicine, consult a doctor if the patient is having trouble conceiving.

Driving and using machines

The effect of Ibuprofen Altan, 600 mg on the ability to drive and use machines is minor.
Some patients may experience dizziness and fatigue, which may affect the ability to drive and/or operate machines. This is more likely when the medicine is taken with alcohol.

Ibuprofen Altan, 600 mg contains sodium

This medicine contains 13 mmol (303 mg) of sodium per 100 ml of solution. This should be taken into account for patients on a low-sodium diet.

3. How to use the solution for infusion Ibuprofen Altan, 600 mg

This medicine should always be used as directed by the doctor. In case of doubts, consult a doctor.
Recommended dose
Adults
The recommended dose is 600 mg of ibuprofen. If clinically justified, a second dose of 600 mg can be administered after 6 to 8 hours, depending on the intensity and response to treatment.
The maximum total daily dose is 1200 mg.
The doctor will prescribe the smallest effective dose for the shortest possible time to avoid side effects. The doctor will also ensure that the patient has sufficient fluids to minimize the risk of side effects related to the kidneys.
Use should be limited to situations where oral administration is not appropriate. Patients should switch to oral treatment as soon as possible.
This medicine is indicated only for short-term treatment of acute symptoms and should not be used for more than 3 days.
Use the smallest effective dose for the shortest possible time to relieve symptoms. If the symptoms of infection (such as fever and pain) persist or worsen, consult a doctor immediately (see section 2).
Method of administration
Intravenous administration.
This medicine should be administered by intravenous infusion over 30 minutes.

Use in children and adolescents

This medicine should not be used in children and adolescents. The use of Ibuprofen Altan, 600 mg in children and adolescents has not been studied. Therefore, the safety and efficacy of its use have not been established.

Using a higher dose of Ibuprofen Altan, 600 mg than recommended

Consult a doctor immediately. If the patient has taken a higher dose of Ibuprofen Altan, 600 mg than recommended or if a child has accidentally taken the medicine, they should always consult a doctor or go to the nearest hospital to get an opinion on the possible risk to their health and advice on what to do in such a case.
Symptoms of overdose may include nausea, stomach pain, vomiting (which may contain blood), gastrointestinal bleeding (see section 4), diarrhea, headache, ringing in the ears, disorientation, and nystagmus. Additionally, there may be agitation, drowsiness, disorientation, or coma. Sometimes, patients experience seizures. After taking a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, and dizziness have been reported, as well as blood in the urine, low potassium levels in the blood, feeling cold, and breathing difficulties. Furthermore, prothrombin time/INR may be prolonged, probably due to disruption of circulating clotting factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. Additionally, low blood pressure and slow breathing may occur.
In case of any further doubts about using this medicine, consult a 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 smallest effective dose for the shortest possible time to relieve symptoms. It is possible that one or more of the known side effects of NSAIDs may occur (see below).
The most common side effects are related to the gastrointestinal tract (stomach and intestines). Stomach ulcers (stomach or intestinal ulcers), perforation (hole in the stomach or intestinal wall) or gastrointestinal bleeding, sometimes fatal, especially in the elderly, may occur. Nausea, vomiting, diarrhea, bloating, constipation, indigestion, abdominal pain, and minor gastrointestinal bleeding, which can occasionally cause anemia, may also occur. Ulcerative stomatitis (inflammation of the mucous membrane of the mouth with ulcers), exacerbation of colitis (inflammation of the colon) and Crohn's disease may occur. Less commonly, gastritis (inflammation of the stomach) has been reported. The risk of gastrointestinal bleeding is dose- and duration-dependent.

• Fatigue or insomnia, headache, and dizziness.
• Heartburn, stomach pain, nausea, vomiting, bloating, diarrhea, constipation, and minor gastrointestinal bleeding, which can occasionally cause anemia.
• Stomach and intestinal ulcers, sometimes with bleeding and perforation. Ulcerative stomatitis, exacerbation of colitis and Crohn's disease.

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

• Dizziness.
• Rash.
• Pain and burning at the injection site.

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

• Insomnia (sleep disorders), restlessness, irritability or fatigue, anxiety and unease.
• Visual disturbances.
• Tinnitus (ringing or buzzing in the ears).
• Decreased urine output, especially in patients with hypertension or kidney disorders, nephrotic syndrome, interstitial nephritis, which may be accompanied by acute kidney failure.
• Urticaria, itching, purpura (including allergic purpura), skin rash.
• Allergic reactions with skin rash and itching, as well as asthma attacks (possibly with decreased blood pressure).

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

• Transient blurred vision (double vision).
• Hearing impairment.
• Constriction of the esophagus (narrowing of the esophagus), complications of diverticulitis, non-specific bleeding colitis. Gastrointestinal bleeding, which can cause anemia.
• Kidney damage (renal papillary necrosis), especially with long-term therapy, increased blood uric acid levels.
• Jaundice or liver dysfunction, liver damage, especially with long-term therapy, acute hepatitis (liver inflammation).
• Psychotic reactions, nervousness, irritability, disorientation, and depression.
• Stiffness of the neck.

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

• Blood disorders (anemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, superficial oral ulcers, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding.
• Palpitations (rapid heartbeat), heart failure, myocardial infarction.
• Hypertension.
• Aseptic meningitis (stiffness of the neck, headache, nausea, vomiting, fever, or disorientation). Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) seem to be predisposed.
• Esophagitis or pancreatitis, intestinal stricture.
• Asthma, breathing difficulties (bronchospasm), shortness of breath, and wheezing.
• Systemic lupus erythematosus (an autoimmune disease), severe allergic reaction (face, tongue, or throat swelling with narrowing of the airways, difficulty breathing, rapid heartbeat, and low blood pressure, as well as life-threatening shock).

Frequency not known (frequency cannot be estimated from the available data):

• Liver failure.
• At the injection site, symptoms such as swelling, bruising, or bleeding may occur.
• A red, scaly, generalized rash with bumps under the skin and accompanying fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, discontinue Ibuprofen Altan 600 mg and seek medical attention immediately. See also section 2.
• The skin becomes sensitive to light.
• Drug reaction with eosinophilia and systemic symptoms: severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, swollen lymph nodes, and increased eosinophil count (a type of white blood cell).
• Chest pain, which may be a sign of a potentially severe allergic reaction called Kounis syndrome.

Discontinue the medicine and seek medical attention immediately if the patient experiences:

• red, non-raised, plate-like or round patches on the torso, often with blisters in the center, peeling of the skin, oral, throat, nose, genital, and eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, and toxic epidermal necrolysis]
• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome)
• red, scaly, generalized rash with bumps under the skin and accompanying fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis)

Reporting side effects

If side effects occur, including any side effects not listed in this leaflet, tell the doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, e-mail: [email protected] .
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of this medicine.

5. How to store the solution for infusion Ibuprofen Altan 600 mg

Store out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Expiry date". The expiry date refers to the last day of the month.
There are no special precautions for storage.

6. Contents of the packaging and other information

What Ibuprofen Altan contains

The active substance of the medicine 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, sodium hydroxide, hydrochloric acid, water for injections.

What Ibuprofen Altan looks like and contents of the pack

Ibuprofen Altan, 600 mg is a clear and colorless solution in 150 ml polyolefin bags in an outer aluminum packaging.
The solution for infusion Ibuprofen Altan, 600 mg is available in cardboard boxes containing 20 and 50 bags of 150 ml each.

Marketing authorization holder

Altan Pharma Ltd.
The Lennox Building, 50 South Richmond street
Dublin 2, D02FK02
Ireland

Manufacturer

Altan Pharmaceuticals S.A.
Polígono Industrial de Bernedo s/n
01118 Bernedo (Álava)
Spain

This medicinal product is authorized in the Member States of the EEA under the following names:

Portugal
Solibu 600 mg Solution for infusion
Spain
Solibu 600 mg Solution for infusion
Germany
Solibu 600 mg Infusion solution

Date of last revision of the leaflet: 09.2024