Ibuprofen Altan

Leaflet accompanying the packaging: patient information

Ibuprofen Altan

400 mg, solution for infusion

Ibuprofen

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 their symptoms are the same.
• If the patient experiences any side effects, including any 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, 400 mg solution for infusion and what is it used for
• 2. Important information before using Ibuprofen Altan, 400 mg solution for infusion
• 3. How to use Ibuprofen Altan, 400 mg solution for infusion
• 4. Possible side effects
• 5. How to store Ibuprofen Altan, 400 mg solution for infusion
• 6. Contents of the packaging and other information
• 1.

What is Ibuprofen Altan, 400 mg solution for infusion and what is it used for

Ibuprofen belongs to a group of medicines called nonsteroidal 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 routes of administration are not possible.

2. Important information before using Ibuprofen Altan, 400 mg solution for infusion

When not to use Ibuprofen Altan, 400 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 disorders.
• If the patient is in the third trimester of pregnancy.

Warnings and precautions

Before using this medicine, consult your 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 monitor them.
• 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.
• Severe skin reactions have been reported with the use of Ibuprofen Altan 400 mg, including exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis (AGEP). If the patient experiences any skin rash, mucosal lesions, blisters or other signs of allergy, they should discontinue Ibuprofen Altan 400 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), they should also inform their doctor if they are taking other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• 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 (such as acute intermittent porphyria).
• Drinking alcohol and taking this medicine at the same time may increase the risk of gastrointestinal and nervous system side effects. Taking anti-inflammatory and analgesic medicines, such as ibuprofen, may be associated with a small increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment. Before using Ibuprofen Altan 400 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 narrowed or blocked 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 important that the patient receives the smallest dose that relieves and controls the pain and does not take the medicine for longer than necessary to control the 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 greater risk of allergic reactions. Allergic reactions may occur as asthma attacks (so-called analgesic asthma), sudden swelling (Quincke's edema) or rash.
• Avoid taking NSAIDs, including selective cyclooxygenase-2 inhibitors, at the same time.
• Generally, habitual use (of various types) of painkillers can lead to long-term severe kidney damage.
• With long-term use of painkillers, headache may occur, which cannot be treated with increased doses of the medicine.
• With the use of ibuprofen, severe skin reactions have been reported, including exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis (AGEP). Discontinue Ibuprofen Altan 400 mg and seek medical attention immediately if any of the symptoms associated with severe skin reactions described in section 4 occur.

During treatment with ibuprofen, symptoms of an allergic reaction to this medicine have been reported, including
difficulty breathing, swelling in the face and neck (angioedema), chest pain. If any of these symptoms are observed, the patient should immediately discontinue Ibuprofen Altan 400 mg and contact their doctor or emergency medical services.
Infections
Ibuprofen Altan 400 mg may mask the signs of infection, such as fever and pain. Therefore, Ibuprofen Altan 400 mg 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 symptoms of the infection persist or worsen, they should consult their doctor immediately.

Ibuprofen Altan 400 mg and other medicines

Tell your doctor about all the medicines you are taking now or have taken recently, as well as any medicines you plan to take.
Ibuprofen may affect other medicines or other medicines may affect ibuprofen, for example:

• other nonsteroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (such as 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 side effects.
• anticoagulant medicines (such as blood thinners or anticoagulants, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine).
• glucocorticoids (medicines containing cortisone or substances similar to cortisone), as they may increase the risk of stomach ulcers or bleeding in the gastrointestinal tract.
• lithium (used to treat depression and bipolar disorder), may increase its concentration in the blood when taken with ibuprofen.
• selective serotonin reuptake inhibitors (medicines used for depression), as they may increase the risk of stomach ulcers or bleeding in the gastrointestinal tract.
• methotrexate (used to treat cancer and inflammatory diseases), as its effect may be increased.
• zidovudine (a medicine against AIDS), as taking ibuprofen may increase the risk of intramuscular bleeding or cause bleeding that leads to inflammation.
• cyclosporine and tacrolimus (used in organ transplants to prevent rejection), as there is a greater 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 effect of these medicines and there may be a greater risk of kidney function disorder (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), may increase its concentration in the blood when taken with ibuprofen.
• antibiotics called quinolones (such as ciprofloxacin) due to increased risk of seizures.
• antibiotics called aminoglycosides (such as gentamicin), as they may promote their nephrotoxic effect.
• voriconazole, fluconazole (CYP2C9 inhibitors) (used in fungal infections) may increase the concentration of ibuprofen in the blood.
• cardiac glycosides, such as digoxin, may increase its concentration in the blood when taken with ibuprofen.
• mifepristone (a medicine with abortive effects), as its effect may be reduced.
• probenecid and sulfinpyrazone (used in gout), as the metabolism of ibuprofen may be reduced.
• baclofen (used to relieve severe involuntary muscle spasms), as its toxicity may be increased.
• pentoxifylline (used to treat certain blood vessel diseases) increases the risk of bleeding.

Some other medicines may also affect or be affected by Ibuprofen Altan 400 mg treatment. Therefore, before using Ibuprofen Altan 400 mg with other medicines, the patient should always consult their doctor or nurse.
The use of ibuprofen may affect the following analytical tests:

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

Tell your doctor if you are taking ibuprofen now or have taken it recently, if you are going to have a clinical analysis test.

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 400 mg if you are in the last 3 months of pregnancy, as it may harm the unborn baby or cause problems during delivery. It may cause kidney and heart problems in the unborn baby. It may increase the risk of bleeding in the mother and baby and cause delayed or prolonged labor. During the first 6 months of pregnancy, do not use Ibuprofen Altan 400 mg unless the doctor considers it absolutely necessary. If treatment is necessary during this period or when trying to conceive, the smallest dose should be used for the shortest possible time. From

• the 20th week of pregnancy, Ibuprofen Altan 400 mg may cause kidney problems in the unborn baby if taken for more than a few days. This may lead to a decrease in the amount of amniotic fluid surrounding the baby (oligohydramnios) or narrowing of the arterial duct (ductus arteriosus) in the baby's heart. If treatment is necessary for a longer period, the doctor may recommend additional monitoring.

Before using this medicine, the patient should inform their doctor or nurse if they are breastfeeding or are 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 as short a period as possible.
Ibuprofen belongs to a group of medicines that may affect fertility in women. 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, the patient should consult their doctor if they are having trouble conceiving.

Driving and using machines

The effect of Ibuprofen Altan 400 mg on the ability to drive and use machines is minor.
Some patients may experience dizziness and fatigue, which may affect their ability to drive and (or) use machines. This is more likely when the medicine is used with alcohol.

Ibuprofen Altan 400 mg contains sodium

This medicine contains 13 mmol (303 mg) of sodium per 100 ml of solution. This should be taken into account in patients controlling their sodium intake.

3. How to use the solution for infusion Ibuprofen Altan, 400 mg

This medicine should always be used as directed by the doctor. If you have any doubts, consult your doctor.
Recommended dose
Adults
The recommended dose is 400 mg of ibuprofen every 6 to 8 hours as needed, not exceeding the maximum total daily dose of 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 must 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.
The smallest effective dose should be used for the shortest possible time to relieve symptoms. If the symptoms of the infection (such as fever and pain) persist or worsen, the patient should consult their 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 400 mg in children and adolescents has not been studied. Therefore, the safety and efficacy of its use have not been established.

Using more than the recommended dose of Ibuprofen Altan 400 mg

Consult a doctor immediately. If the patient has taken more than the recommended dose of Ibuprofen Altan 400 mg 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.

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 problems. Furthermore, the prothrombin time/INR may be prolonged, probably due to the 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.
If you have any further doubts about the use of this medicine, consult 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 smallest effective dose for the shortest possible time to treat symptoms. It is possible that one or more of the known side effects of NSAIDs (see below) may occur.
If any of these side effects occur, treatment should be discontinued and the doctor should be consulted. Elderly patients who use this medicine are at greater risk of complications related to side effects.
The most commonly observed side effects affect 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, stomach pain, and minor gastrointestinal bleeding, which can occasionally lead to 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 observed. The risk of gastrointestinal bleeding, in particular, depends on the dose and duration of treatment.
During treatment with NSAIDs, fluid retention (edema), high blood pressure, and heart failure have been reported. Medicines like ibuprofen may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke.
Very rarely, severe allergic reactions (including reactions at the infusion site, anaphylactic shock) and skin reactions, such as blistering reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), have been reported. Exacerbation of infections (e.g., necrotizing fasciitis) developing in association with NSAID use has been reported very rarely.
In rare cases, severe skin and soft tissue infections may occur during chickenpox.
Very common side effects (may affect more than 1 in 10 people):

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

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

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

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

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

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

• Transient visual disturbances (double vision).
• Hearing impairment.
• Constriction of the esophagus (narrowing of the blood vessels in the esophagus), complications of diverticulitis, hemorrhagic colitis. Gastrointestinal bleeding, which can lead to anemia.
• Kidney damage (renal papillary necrosis), especially with long-term therapy, increased blood urea concentration.
• Jaundice or liver dysfunction, liver damage, especially with long-term therapy, acute hepatitis (hepatitis).
• Psychotic reactions, nervousness, irritability, disorientation, and depression.
• Stiffness of the neck.

Very rare side effects (may affect up to 1 in 10,000 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 (angioedema, anaphylactic 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 rash with nodules under the skin and blisters, usually located in skin folds, on the torso, and upper limbs, with fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, the patient should discontinue Ibuprofen Altan 400 mg and seek medical attention immediately. See also section 2.
• The skin becomes sensitive to light.
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome): severe skin reactions known as DRESS syndrome may occur. The symptoms of DRESS syndrome include: skin rash, fever, lymph node swelling, and an increased number of eosinophils (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 acute generalized exanthematous pustulosis (AGEP)].

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

• widespread rash, high fever, and swollen lymph nodes (DRESS syndrome)
• red, scaly, generalized rash with nodules 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 not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal 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.
By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store the solution for infusion Ibuprofen Altan, 400 mg

Keep out of sight and reach of children.
Do not use this medicine after the expiration date stated on the carton after "Expiration date". The expiration date refers to the last day of the month.
There are no special precautions for storing the medicine.
Before administration, the medicine should be inspected. Do not use this medicine if you notice any contamination or if the solution has changed color.
For single use only. After opening, the medicine should be used immediately. Do not use the remaining solution; discard it.

6. Contents of the packaging and other information

What Ibuprofen Altan 400 mg contains

The active substance of the medicine is ibuprofen. Each ml of solution contains 4 mg of ibuprofen.
Each 100 ml bag contains 400 mg of ibuprofen.
The other ingredients are: trometamol, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

What Ibuprofen Altan 400 mg looks like and what the pack contains

Ibuprofen Altan 400 mg is a clear and colorless solution in 100 ml polyolefin bags in an outer aluminum packaging.
The solution for infusion Ibuprofen Altan 400 mg is available in cardboard boxes containing 20 and 50 bags of 100 ml.

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 400 mg Solution for infusion
Spain
Peribu 400 mg Solution for infusion
Germany
Solibu 400 mg Infusion solution

Date of last revision of the leaflet: 09.2024