Ibuprofen altan

Package leaflet: Information for the patient

Ibuprofen Altan
400 mg, infusion solution
Ibuprofenum
Please read all of this leaflet carefully before receiving this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of the leaflet

1. What Ibuprofen Altan 400 mg infusion solution is and what it is used for
2. Important information before using Ibuprofen Altan 400 mg infusion solution
3. How to use Ibuprofen Altan 400 mg infusion solution
4. Possible side effects
5. How to store Ibuprofen Altan 400 mg infusion solution
6. Contents of the pack and other information

1. What Ibuprofen Altan 400 mg infusion solution is and what it is 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 routes of administration are not possible.

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

When not to use Ibuprofen Altan 400 mg

• If you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), to acetylsalicylic acid (aspirin), or to other anti-inflammatory and analgesic medicines.
• If you have (or have had two or more episodes of) peptic ulcer, gastrointestinal perforation, or gastrointestinal bleeding.
• If you have severe liver, kidney, or heart disease.
• If you have experienced gastrointestinal perforation or bleeding while taking NSAIDs.
• If you have a condition that increases your tendency to bleed or have active bleeding.
• If you have experienced asthma, skin rash, itching, facial or nasal swelling after previous intake of ibuprofen, acetylsalicylic acid (aspirin), or other painkillers (NSAIDs).
• If you are severely dehydrated (due to vomiting, diarrhoea, or insufficient fluid intake).
• If you have cerebral haemorrhage or any other active bleeding.
• If you have unexplained blood formation disorders.
• If you are in the third trimester of pregnancy.

Warnings and precautions
Before using this medicine, consult your doctor or nurse:

• If you have recently undergone major surgery.
• If you have oedema (fluid retention).
• If you have asthma or have had it in the past.
• If you have kidney, heart, liver, or intestinal disorders, or if you are elderly.
• If you have been taking ibuprofen long-term, your doctor may perform regular check-ups.
• If you experience symptoms of dehydration, such as severe diarrhoea or vomiting, you should take appropriate fluids and contact your doctor immediately, as dehydration may lead to kidney failure when taking ibuprofen.
• Severe skin reactions have been reported with Ibuprofen Altan 400 mg. If you develop any skin rash, mucosal changes, blisters, or other signs of allergy, stop taking Ibuprofen Altan 400 mg immediately and seek medical help without delay, as these may be early signs of a very serious skin reaction. See section 4.
• If you have systemic lupus erythematosus (an autoimmune disease causing joint pain, skin changes, and other organ disorders) or related connective tissue diseases.
• If you have had gastrointestinal disorders in the past (such as ulcerative colitis or Crohn's disease).
• If you are taking anticoagulant medicines, such as oral anticoagulants or antiplatelet agents like acetylsalicylic acid. You should also inform your doctor if you are taking other medicines that may increase the risk of bleeding, such as corticosteroids and selective serotonin reuptake inhibitors.
• If you are taking diuretics, as your doctor should monitor kidney function.
• If you are in the first 6 months of pregnancy.
• If you have been diagnosed with chickenpox.
• If you have a hereditary disorder of porphyrin metabolism (e.g. acute intermittent porphyria).
• Alcohol consumption together with this medicine may increase adverse effects related to the stomach, intestines, and nervous system. Taking anti-inflammatory and pain-relieving 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, discuss treatment with your doctor or nurse if:
• You have heart conditions such as heart failure, angina (chest pain), history of heart attack, coronary artery bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrowed or blocked arteries), or if you have had any stroke (including "mini-stroke" or transient ischaemic attack "TIA").
• You have hypertension, diabetes, high cholesterol levels, a family history of heart disease or stroke, or if you smoke.
• NSAIDs may mask signs of infection.
• You have an infection – see below under the heading “Infections”.
• It is important that you receive the lowest effective dose that relieves and controls pain and that you do not use this medicine longer than necessary to control symptoms.
• Allergic reactions may occur with this medicine, mainly at the beginning of treatment. In such cases, treatment should be discontinued.
• If you have hay fever, nasal polyps, or chronic obstructive respiratory diseases, you have a higher risk of allergic reactions. Allergic reactions may present as asthma attacks (so-called analgesic-induced asthma), sudden swelling (angioedema), or skin rash.
• Avoid concomitant use with NSAIDs, including selective cyclooxygenase-2 inhibitors.
• Habitual use of (various types of) painkillers may generally lead to long-term severe kidney disease.
• Long-term use of painkillers may lead to headache that cannot be treated with increased doses of the medicine.
• Serious skin reactions, including 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 with ibuprofen. Discontinue Ibuprofen Altan and seek immediate medical help if any symptoms of serious skin reactions described in section 4 occur.

Allergic reactions to ibuprofen, including difficulty breathing, facial and neck swelling (angioedema), and chest pain, have occurred during treatment. If any of these symptoms occur, stop taking Ibuprofen Altan immediately and contact your doctor or emergency medical services without delay.

Infections
Ibuprofen Altan may mask symptoms of infection such as fever and pain. Therefore, Ibuprofen Altan may delay appropriate treatment of infection and consequently increase the risk of complications. This has been observed in bacterial pneumonia and bacterial skin infections associated with chickenpox. If you take this medicine during an existing infection and symptoms persist or worsen, consult your doctor immediately.

Ibuprofen Altan 400 mg and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.

Ibuprofen may affect other medicines or other medicines may affect ibuprofen, for example:

• Other non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors (e.g. celecoxib), may increase the risk of gastric ulcers and bleeding due to additive effects. Concomitant administration of ibuprofen and acetylsalicylic acid is generally not recommended due to the potential for increased adverse effects.
• Anticoagulants (e.g. blood thinners or agents preventing clotting, such as aspirin - acetylsalicylic acid, warfarin, ticlopidine).
• Glucocorticoids (medicines containing cortisone or cortisone-like substances), as they may increase the risk of gastrointestinal ulcers or bleeding.
• Lithium (used in the treatment of depression and bipolar disorder), which may have increased blood levels when taken with ibuprofen.
• Selective serotonin reuptake inhibitors (medicines used for depression), as they may increase the risk of gastrointestinal ulceration or bleeding.
• Methotrexate (used in the treatment of cancer and inflammatory diseases), as its effects may be increased.
• Zidovudine (an anti-AIDS virus drug), as ibuprofen use may increase the risk of intramuscular bleeding or cause bleeding leading to inflammatory conditions.
• Cyclosporine and tacrolimus (used in organ transplantation to prevent rejection), as there is an increased risk of kidney damage.
• Medicines lowering 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 effectiveness of these medicines and increase the risk of kidney dysfunction (using potassium-sparing diuretics with ibuprofen may increase blood potassium levels).
• Sulfonylureas (in diabetes), as interactions may occur.
• Phenytoin (used in the treatment of epilepsy), which may have increased blood levels when taken with ibuprofen.
• Antibiotics known as quinolones (e.g. ciprofloxacin) due to an increased risk of seizures.
• Antibiotics known as aminoglycosides (e.g. gentamicin), as their nephrotoxic effects may be enhanced.
• Voriconazole, fluconazole (CYP2C9 inhibitors) (used in fungal infections), which may increase ibuprofen blood levels.
• Cardiac glycosides such as digoxin, which may have increased blood levels when taken with ibuprofen.
• Mifepristone (a drug with abortifacient action), as its effect may be reduced.
• Probenecid and sulfinpyrazone (used in gout), as ibuprofen metabolism may be reduced.
• Baclofen (used to relieve severe involuntary muscle spasms), as its toxicity may be increased.
• Pentoxifylline (used in the treatment of certain vascular diseases), increasing the risk of bleeding.

Some other medicines may also affect or be affected by Ibuprofen Altan 400 mg treatment. Therefore, always seek advice from your doctor or nurse before using Ibuprofen Altan 400 mg with other medicines.

Ibuprofen use may alter the following laboratory tests:

• Bleeding time (may be prolonged on the first day after discontinuation).
• Blood glucose levels (may decrease).
• Creatinine clearance (may decrease).
• Haematocrit or haemoglobin (may decrease).
• Blood urea nitrogen and serum creatinine and potassium levels (may increase).
• Liver function tests: increased aminotransferase values.

Inform your doctor if you are currently or recently taking ibuprofen if you are planning to undergo clinical laboratory tests.

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.

Do not take Ibuprofen Altan 400 mg if you are 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 problems in the unborn child. It may increase the tendency to bleeding in both mother and child and may delay or prolong labour. Do not use Ibuprofen Altan 400 mg during the first 6 months of pregnancy unless your doctor considers it absolutely necessary. If treatment is required during this period or when trying to conceive, use the lowest possible dose for the shortest possible time. From week 20 of pregnancy, Ibuprofen Altan 400 mg may cause kidney dysfunction in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume surrounding the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the baby's heart. If treatment is required for longer than a few days, your doctor may recommend additional monitoring.

Inform your doctor or nurse before starting this medicine if you are breastfeeding or in the first 6 months of pregnancy.

This medicine passes into breast milk, but it can be used during breastfeeding at recommended doses and for the shortest possible duration.

Ibuprofen belongs to a group of medicines that may impair fertility in women. This effect is reversible after discontinuation of the medicine. It is unlikely to affect the ability to conceive if the medicine is used occasionally. However, consult your doctor before starting this medicine if you are having difficulty 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 the ability to drive and/or operate machinery. 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 on a controlled sodium diet.

3. How to use Ibuprofen Altan 400 mg infusion solution

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor.

Recommended dose

Adults
The recommended dose is 400 mg of ibuprofen every 6 to 8 hours as needed, not exceeding a maximum total daily dose of 1200 mg.

Your doctor will recommend the lowest effective dose for the shortest possible time to avoid adverse effects. Your doctor will also ensure that you have adequate fluid intake to minimize the risk of kidney-related adverse effects.

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 longer than 3 days.

Use the lowest effective dose for the shortest period necessary to relieve symptoms. If symptoms of infection (such as fever and pain) persist or worsen, consult your doctor immediately (see section 2).

Method of administration
Intravenous administration.

This medicine should be administered as a 30-minute intravenous infusion.

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, safety and efficacy have not been established.

Use of a higher than recommended dose of Ibuprofen Altan 400 mg
Consult your doctor immediately. If you have used more than the recommended dose of Ibuprofen Altan 400 mg or if a child has accidentally taken the medicine, always contact your doctor or go to the nearest hospital for advice on possible health risks and actions to take.

Symptoms of overdose may include nausea, stomach pain, vomiting (possibly with blood), gastrointestinal bleeding (see section 4), diarrhoea, headache, tinnitus, confusion, and nystagmus. In addition, restlessness, drowsiness, confusion, or coma may occur. Seizures may sometimes occur in patients. After ingestion of a large dose, drowsiness, chest pain, palpitations, loss of consciousness, seizures (mainly in children), weakness, dizziness, blood in urine, low blood potassium levels, cold sensation, and breathing difficulties may occur. Furthermore, prothrombin time/INR may be prolonged, likely due to interference with circulating coagulation factors. Acute kidney failure and liver damage may occur. In asthmatics, asthma may worsen. In addition, low blood pressure and slowed breathing may occur.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will
experience them.
Adverse reactions can be minimised by using the lowest effective dose for the shortest
possible duration needed to relieve symptoms. One or more of the known adverse reactions
associated with NSAIDs (see below) may occur.
If any of these adverse reactions occur, treatment should be stopped immediately and
medical advice should be sought. Elderly patients taking this medicine are at greater risk of
complications related to adverse reactions.
The most commonly observed adverse reactions are gastrointestinal (stomach and
intestines). Peptic ulcers (stomach or intestinal ulcers), perforation (a hole in the wall of the
stomach or intestine), or bleeding from the stomach or intestines, sometimes fatal, may occur,
particularly in elderly patients. Nausea, vomiting, diarrhoea, bloating, constipation,
dyspepsia, abdominal pain, tarry stools, vomiting blood, ulcerative stomatitis (inflammation of
the oral mucosa with ulceration), exacerbation of colitis (inflammation of the large intestine),
and Crohn’s disease may also occur. Gastritis (inflammation of the stomach lining) has been
reported less frequently. The risk of gastrointestinal bleeding particularly depends on the dose
and duration of treatment.
Oedema (fluid retention), high blood pressure, and heart failure have been reported during
treatment with NSAIDs. Medicines such as ibuprofen may be associated with a small
increased risk of myocardial infarction ("heart attack") or stroke.
Very rarely, severe allergic reactions (including infusion site reactions, anaphylactic shock)
and adverse skin reactions such as blistering rashes, including Stevens-Johnson syndrome
and toxic epidermal necrolysis (Lyell’s syndrome), erythema multiforme, alopecia (hair loss),
photosensitivity, and allergic vasculitis (inflammation of blood vessels) have been reported.
An exacerbation of infection-related inflammatory conditions (e.g. necrotizing fasciitis)
associated with the use of NSAIDs has been described very rarely.
In exceptional cases, severe skin infections and soft tissue complications may occur during
chickenpox infection.

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

• Fatigue or insomnia, headache, and dizziness.
• Heartburn, abdominal pain, nausea, vomiting, bloating, diarrhoea, constipation, and minor gastrointestinal bleeding, which in exceptional cases may lead to anaemia.
• Gastric and intestinal ulcers, sometimes with bleeding and perforation. Ulcerative stomatitis, exacerbation of colitis, and Crohn’s disease.

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

• Dizziness.
• Rash.
• Pain and burning at the site of administration.

Uncommon adverse reactions (may affect up to 1 in 100 people):

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

Rare adverse reactions (may affect up to 1 in 1,000 people):

• Transient toxic visual impairment (double vision).
• Hearing loss.
• Oesophageal stricture (narrowing of blood vessels in the oesophagus), complications of colonic diverticulum, non-specific haemorrhagic colitis. Gastrointestinal bleeding which may lead to anaemia.
• Kidney damage (renal papillary necrosis), particularly with long-term therapy, increased serum uric acid levels.
• Jaundice (yellowing of the skin or whites of the eyes), liver function abnormalities, liver damage, particularly after prolonged therapy for acute hepatitis (liver inflammation).
• Psychotic reactions, nervousness, irritability, disorientation, and depression.
• Neck stiffness.

Very rare adverse reactions (may affect up to 1 in 10,000 people):

• Blood cell disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial ulceration of the oral mucosa, flu-like symptoms, severe fatigue, nosebleeds, and skin bleeding.
• Palpitations (rapid heartbeat), heart failure, myocardial infarction.
• Hypertension.
• Aseptic meningitis (neck stiffness, headache, nausea, vomiting, fever, or disorientation). Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue disease) appear to be predisposed.
• Oesophagitis or pancreatitis, intestinal stricture.
• Asthma, breathing difficulties (bronchospasm), shortness of breath, and wheezing.
• Discoid lupus erythematosus (an autoimmune disease), severe allergic reaction (facial swelling, tongue swelling, throat swelling with airway obstruction, breathing difficulties, rapid heartbeat, low blood pressure, and 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.
• Red, scaly rash with subcutaneous nodules and blisters, mainly located in skin folds, trunk, and upper limbs, accompanied by fever at the beginning of treatment (acute generalised exanthematous pustulosis). If such symptoms occur, treatment with Ibuprofen Altan 400 mg should be discontinued immediately and medical help should be sought without delay. See also section 2.
• Skin becomes sensitive to light.
• Drug reaction with eosinophilia and systemic symptoms (DRESS): severe skin reactions known as DRESS syndrome may occur. Symptoms of DRESS syndrome include skin rash, fever, lymphadenopathy (swollen lymph nodes), and increased eosinophil count (a type of white blood cell).
• Chest pain, which may be a sign of a potentially serious allergic reaction known as Kounis syndrome.

Treatment should be discontinued and immediate medical attention sought if the patient
experiences:

• Reddish, flat, round spots on the trunk, often with blisters in the centre, skin peeling, and ulceration of the mouth, throat, nose, genital organs, and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms [exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis]

• Widespread rash, high fever, and swollen lymph nodes (DRESS syndrome)

• Red, scaly, generalised rash with subcutaneous nodules and accompanying fever. Symptoms usually occur at the beginning of treatment (acute generalised exanthematous pustulosis)

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor,
pharmacist, or nurse. Adverse reactions can also be reported directly to the Department of
Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49-21-301, fax: +48 22 49-21-309, e-
mail: [email protected] .
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

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

Keep out of the 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 stated month.
No special storage conditions required.
Inspect the solution visually before administration. Do not use this medicine if any particles or discolouration are observed.
For single use only. After opening, the medicine should be used immediately. Any unused solution must be discarded.

6. Contents of the packaging and other information

What Ibuprofen Altan, 400 mg contains
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 ingredients are: tromethamine, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

What Ibuprofen Altan, 400 mg looks like and contents of the pack
Ibuprofen Altan, 400 mg is a clear, colourless solution contained in 100 ml polyolefin bags, packed in an aluminium outer container.
Ibuprofen Altan, 400 mg infusion solution is available in cardboard boxes containing 20 and 50 bags of 100 ml each.

Marketing Authorisation 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 authorised in the EEA Member States under the following names:
Portugal: Solibu 400 mg Perfusion Solution
Spain: Peribu 400 mg Solución para perfusión
Germany: Solibu 400 mg Infusionslösung