Package leaflet: Information for the patient

Ibuprofen Altan
600 mg, infusion solution
Ibuprofenum
Please read all of this leaflet carefully before use, 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 consult your doctor or nurse.
This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse effects, including any not listed in this leaflet, tell your doctor or nurse. See section 4.

Table of contents

What Ibuprofen Altan 600 mg infusion solution is and what it is used for
Important information before using Ibuprofen Altan 600 mg infusion solution
How to use Ibuprofen Altan 600 mg infusion solution
Possible side effects
How to store Ibuprofen Altan 600 mg infusion solution
Contents of the pack and other information

1. What Ibuprofen Altan 600 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 600 mg infusion solution

When not to use Ibuprofen Altan 600 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 pain-relieving 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 use 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 experience swelling (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 checks.
If you show signs 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 600 mg. If you develop any skin rash, mucosal changes, blisters, or other allergic symptoms, stop taking Ibuprofen Altan 600 mg and seek immediate medical help, 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 metabolic disorder such as porphyria (e.g. acute intermittent porphyria).
Alcohol consumption together with this medicine may increase gastrointestinal, intestinal, and nervous system side effects. Taking anti-inflammatory and pain-relieving medicines such as ibuprofen may be associated with a small increased risk of heart attack or stroke, particularly when used in high doses. Do not exceed the recommended dose or duration of treatment. Before using Ibuprofen Altan 600 mg, discuss treatment with your doctor or nurse if:
You have heart conditions such as heart failure, angina (chest pain), a 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 high blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or if you smoke.
NSAIDs may mask signs of infection.
You have an infection – see section below titled “Infections”.
It is important that you receive the lowest effective dose to relieve and control pain and 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 nasal polyps, hay fever, or chronic obstructive respiratory disease, 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 painkillers may lead to long-term, severe kidney disease.
Long-term use of painkillers may lead to medication-overuse headache, which cannot be treated by increasing the dose.
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 use of Ibuprofen Altan and seek immediate medical help if any symptoms of serious skin reactions described in section 4 occur.

Allergic reactions to ibuprofen, including breathing difficulties, facial and neck swelling (angioedema), and chest pain, have been reported. 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 signs 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 are taking this medicine during an existing infection and symptoms persist or worsen, consult your doctor immediately.

Ibuprofen Altan 600 mg and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any 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 use 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 antiviral drug for AIDS), as ibuprofen use may increase the risk of intrastitial haemorrhage or cause bleeding leading to inflammation.
Cyclosporine and tacrolimus (used in organ transplants to prevent rejection), as there is an increased risk of kidney damage.
Medicines for 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 (concomitant use of potassium-sparing diuretics with ibuprofen may increase blood potassium levels).
Sulfonylureas (in diabetes), as interactions may occur.
Phenytoin (used in epilepsy treatment), 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 (an abortifacient), 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 600 mg treatment. Therefore, always consult your doctor or nurse before using Ibuprofen Altan 600 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 using ibuprofen if you plan to undergo clinical laboratory tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor before using this medicine.

Do not take Ibuprofen Altan 600 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 bleed in both mother and child and may delay or prolong labour. During the first 6 months of pregnancy, do not use Ibuprofen Altan 600 mg 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 600 mg may cause kidney function disorders in the unborn child if taken for longer than a few days. This may lead to reduced amniotic fluid volume (oligohydramnios) or narrowing of the blood vessel (ductus arteriosus) in the child’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 six months of pregnancy.

This medicine passes into breast milk, but it may 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 upon discontinuation of the medicine. It is unlikely to affect the ability to conceive if the medicine is used only occasionally. However, consult your doctor before starting this medicine if you are having difficulty conceiving.

Driving and operating machinery

The effect of Ibuprofen Altan 600 mg on the ability to drive and operate machinery is minimal.

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 600 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 600 mg infusion solution

Always use this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor.

Recommended dose

Adults

The recommended dose is 600 mg of ibuprofen. If clinically justified, a further 600 mg dose may be administered 6 to 8 hours later, depending on the intensity of pain and response to treatment. The maximum daily dose is 1200 mg.

Your doctor will prescribe the lowest effective dose for the shortest possible time to avoid adverse effects. Your doctor will also ensure 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 time 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

Ibuprofen Altan 600 mg should not be used in children and adolescents. The use of Ibuprofen Altan 600 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 600 mg

Seek immediate medical advice. If you have used more than the recommended dose of Ibuprofen Altan 600 mg or if a child accidentally takes the medicine, always contact your doctor or go to the nearest hospital to assess potential health risks and receive advice on necessary actions.

Symptoms of overdose may include nausea, stomach pain, vomiting (blood may be present), gastrointestinal bleeding (see section 4), diarrhoea, headache, tinnitus, disorientation, and nystagmus. Additionally, agitation, drowsiness, disorientation, or coma may occur. Seizures may sometimes occur in patients. After 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. Moreover, 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. Additionally, 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 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 possible duration needed to treat symptoms. One or more of the known adverse effects associated with NSAIDs (see below) may occur.
The most commonly observed adverse effects involve the gastrointestinal tract (stomach and intestines). Gastrointestinal ulcers (stomach or intestinal ulcers), perforation (a hole in the stomach or intestinal wall), or bleeding from the stomach or intestines, sometimes fatal, may occur, particularly in elderly individuals. Nausea, vomiting, diarrhoea, bloating, constipation, indigestion, 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 occur. Gastritis (inflammation of the stomach lining) has been observed less frequently. The risk of gastrointestinal bleeding increases with higher doses and longer duration of treatment.

During treatment with NSAIDs, oedema (fluid retention), high blood pressure and heart failure have been reported. 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.

Exacerbation of infection-related inflammation (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 varicella (chickenpox) infection.

Very common adverse effects (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 rare 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 effects (may affect up to 1 in 10 people):

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

Uncommon adverse effects (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 associated with acute renal 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 effects (may affect up to 1 in 1,000 people):

Transient toxic visual disturbances (double vision).
Hearing impairment.
Oesophageal stricture (narrowing of the oesophagus), complications of diverticulosis of the large intestine, non-specific haemorrhagic colitis. Gastrointestinal bleeding which may lead to anaemia.
Kidney damage (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.
Psychotic reactions, nervousness, irritability, disorientation and depression.
Neck stiffness.

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

Blood cell formation disorders (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). Initial symptoms include: fever, sore throat, superficial oral ulceration, 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 narrowing, breathing difficulties, rapid heartbeat, low blood pressure and life-threatening shock).

Frequency not known (frequency cannot be estimated from 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, predominantly located in skin folds, trunk and upper limbs, accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis). If such symptoms occur, treatment with Ibuprofen Altan 600 mg must be discontinued immediately and medical help 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 called Kounis syndrome.

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

Reddish, flat, round or target-like lesions on the trunk, often with blisters in the center, skin peeling, ulceration of the mouth, throat, nose, genital organs and eyes. These severe skin reactions 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, generalized rash with subcutaneous nodules and associated fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis)

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse.
Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Ibuprofen Altan 600 mg infusion solution
Keep 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 stated month.
No special storage conditions apply.
Inspect the solution before administration. Do not use the medicine if any particles are visible or if the solution has changed colour.
For single use only. After opening, the solution must be used immediately. Any unused solution must be discarded.

6. Contents of the pack and other information

What Ibuprofen Altan contains
The active substance 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 600 mg looks like and contents of the pack
Ibuprofen Altan 600 mg is a clear, colourless solution contained in 150 ml polyolefin bags within an aluminium outer packaging.
Ibuprofen Altan 600 mg infusion solution is available in cardboard boxes containing 20 and 50 bags of 150 ml.

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 600 mg Solução para perfusão
Spain: Solibu 600 mg Solución para perfusión
Germany: Solibu 600 mg Infusionslösung