IBUPROFEN 600 MG SOLUTION FOR INFUSION - patient leaflet, side effects, dosage

1. What Ibuprofen is and what it is used for

2. What you need to know before you use Ibuprofen

3. How to use Ibuprofen

4. Possible side effects

5. How to store Ibuprofen

6. Contents of the pack and other information

1. 1

What Ibuprofen is and what it is 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 acute moderate pain, when administration by intravenous route is clinically justified when other routes of administration are not possible.

2. What you need to know before you use Ibuprofen

Do not use Ibuprofen

• if you are allergic to ibuprofen or any of the other ingredients of this medicine (listed in section 6), to acetylsalicylic acid (aspirin) or other anti-inflammatory analgesic drugs
• if you have (or have had two or more episodes) of gastrointestinal ulcer, perforation or stomach bleeding
• if you suffer from a severe liver, kidney or heart disease
• if you have had a perforation or bleeding in the stomach or intestine when taking NSAIDs
• if you have a condition which increases your tendency for active bleeding
• if you have suffered from shortness of breath, asthma, skin rash, prurito, swelling of face or nose when taking previously ibuprofen, acetylsalicylic acid (aspirin) or other analgesics drugs (NSAIDs)
• if you suffer severe dehydration (caused by vomits, diarrhoea or inadequate liquid intake)
• if you suffer cerebrovascular bleeding or other active bleeding
• if you suffer unclarified blood formation disturbances
• if you are in the third trimester of pregnancy.

Warnings and precautions

Talk to your doctor or nurse before using this medicine:

• if you have just had major surgery
• if you have oedemas (fluid retention)
• if you have, or previously had, asthma
• if you have kidney, heart, liver or intestine disorders or you are elderly
• if you use ibuprofen long-term, your doctor may need to carry out checks on regular basis
• if you suffer dehydration symptoms e.g. severe diarrhoea or vomits, drink suitable liquids and contact your doctor immediately, as ibuprofen in this case can lead to renal failure as a consequence of the dehydration
• Serious skin reactions have been reported in association with Ibuprofen treatment. You should stop taking Ibuprofen and seek medical attention immediately, if you develop any skin rash, lesions of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction. See section 4.
• if you suffer from systemic lupus erythematosus (immune system disease which causes pain in joints, changes in the skin and other organ disorders) and related connective tissue diseases
• if you have a history of gastrointestinal disease (such as ulcerative colitis or Crohn's disease)
• if you are using medicines which alter blood coagulation, such as oral anticoagulants agents, anti-platelet agents type acetylsalicylic acid. Also you should inform your doctort if you are using other medicines which can increase the risk of haemorrahges suh as corticoids and selective serotonin reuptake inhibitors
• if you are using diuretics (medicines for urinate) as your doctor should control the functioning of your kidneys
• if you are in your first 6 months of pregnancy
• if you have chicken pox
• if you suffer from hereditary disorder of the porphyrine metabolism (e.g. acute intermitent porphyria)
• if you drink alcohol around the same time of receiving this medicine, side effects related to stomach, intestines and nervous system may be increased.

Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a minor increase in the risk of suffering a heart attack or stroke, especially when high doses are used. Do not exceed the recommended dose or the treatment duration.

You should discuss your treatment with your doctor or nurse before using Ibuprofen if:

• you have heart problems including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blocked arteries), or any kind of stroke (including “mini-stroke” or transient ischaemic attack “TIA”)
• you have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if you are smoker.
• NSAIDs may mask infection symptoms.
• It is important that you are given the lowest dose that alleviates and control pain and are not given this medicine for longer than necessary to control your symptoms.
• Allergic reactions may occur with this medicine, mainly at the start of treatment. In this case, treatment should be discontinued.
• If you suffer from hay fever, nasal polyps or chronic obstructive respiratory disorders, you are at higher risk of allergic reaction occurring. The allergic reactions may present as asthma attacks (so-called analgesic asthma), rapid swelling (Quincke's oedema) or a rash.
• The use with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided.
• In general the habitual use of (several sort of) analgesics can lead to lasting severe kidney problems.
• On prolonged use of painkillers, headache may occur that must not be treated with increased doses of the medicine.

Other medicines and Ibuprofen

Tell your doctor if you are using, have recently used or might use any other medicines.

Ibuprofen can affect or be affected by other medicines, e.g.:

• other nonsteroidal anti-inflammatory drugs (NSAIDs) including COX-2 (e.g. celecoxib) may increase the risk of gastrointestinal ulcers and bleeding due to an additive effect. Concomitant administration of ibuprofen and acetylsalicylic acid is not generally recommended because of the potential of increased adverse effects
• anti-coagulants medicines (e.g. thin blood/prevent clotting such as aspirin/acetyl­salicylic acid, warfarin, ticlodipine)
• glucocorticoids (medicines which contain cortisone or substances similar to cortisone),) as it can increase the risk of suffer ulcers or gastrointestinal haemorrhages
• lithium (used for treating depression and bipolar disorder), may increase its blood levels when taking with ibuprofen
• selective serotonin-reuptake inhibitors (medines used for depression) as it can increase the risk of suffer ulcers or gastrointestinal haemorrhages
• methotrexate (used to treat cancer and inflammatory diseases) as it increases the toxicity of methotrexate
• zidovudine (drug against AIDS virus) as the use of ibuprofen can increase the risk of haemorrhage in a joint or produce a bleeding which entails inflammation
• ciclosporin and tacrolimus (used in organ transplants to avoid rejection) as a higher risk of suffer kidney disorders exist
• medicines that reduce 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 can reduce the effects of these medicines and it can exist a higher risk for the kidney (use of potassium-sparing diuretics with ibuprofen can increase blood potassium levels)
• sulfonylureas (for diabetes) as interactions can appear
• phenytoin (used in the treatment of epilepsy), may increase its blood levels when taking with ibuprofen
• antibiotics called quinolones (e.g. ciprofloxacin) due to the risk of suffer convulsions can be increased
• antibiotics called aminoglycosides (e.g. gentamicin), as its nephrotoxic effect can be promoted
• voriconazole, fluconazole (CYP2C9 inhibitors) (used for fungal infections) can increase blood levels of ibuprofen
• cardiac glycosides such as digoxin, may increase its blood levels when taking with ibuprofen
• mifepristone (used for gestation interruption) as its effect can be reduced
• probenecid and sulfinpyrazone (used for gout), as the excretion of ibuprofen can be reduced
• baclofen (used to relief severe involuntary contractions of some muscles) as its toxicity can be increased
• pentoxyfilline (used to treat certain blood vessel problems) increases the risk of bleeding
• ginkgo biloba (a herbal medicine) may increase the risk of bleeding.

Some other medicines may also affect or be affected by the treatment of Ibuprofen. You should therefore always seek the advice of your doctor or nurse before you use Ibuprofen with other medicines.

Using of ibuprofen may alter the following analytical test:

• haemorrhage time (can be prolongued during 1 day after withdrawn the treatment)
• glucose concentration in blood (may decrease)
• creatinine clearance (may decrease)
• hematocrit or hemoglobin (may decrease)
• blood concentrations of ureic nitrogen and seric concentrations of creatinin and potassium (may increase)
• in hepatic function tests: increase in transaminases values.

Inform your doctor if you are going to subject to any clinical analysis and you are using or have recently used ibuprofen.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.

Do not use ibuprofen during the third trimester of pregnancy. Inform your doctor or nurse before taking this medicine if you are on your first six months of pregnancy or if you are breastfeeding.

This medicine passes to mother's milk, but it may be used during breastfeeding at the recommended doses and for the shortest period of time.

Ibuprofen belongs to a group of medicines that may impair female fertility. This effect is reversible if the medicine is suspended. It is unlikely it may affect the possibilities to conceive if it is used occasionally. However, consult your doctor before start taking this medicine if you have difficulties conceiving.

Driving and using machines

The influence of Ibuprofen on the ability to drive and use machines is minor.

Some isolated patients may experience dizziness and fatigue, so that the ability to drive a vehicle and/or use machines can be affected. This applies to a greater extent in combination with alcohol.

Ibuprofen contains sodium

This medicine contains 303 mg sodium (main component of cooking/table salt) in 100 ml. This is equivalent to 15% of the recommended maximum daily dietary intake of sodium for an adult.

3. how to use ibuprofen

Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.

Posology

Adults

The recommended dose is 600 mg of ibuprofen. If clinically justified, another 600 mg dose can be administered after 6 to 8 hours, depending on the intensity and response to treatment. The maximum total daily dose is 1200 mg.

Your doctor will give you the lowest effective dose for the shortest time possible in order to avoid side effects.

Your doctor will also make sure that you have had enough fluids in order to minimize the risk of side effects to the kidney.

Use should be limited to situations where oral administration is inappropriate. Patients must switch to oral treatment as soon as this is possible.

This medicine is indicated for short-term acute treatment only and should not be used for more than 3 days.

Method of administration

Intravenous use.

This medicinal product should be administered as an intravenous infusion for 30 minutes.

This medicine is restricted to hospital use only. The medicine will be given to you by doctor or nurse.

Use in children and adolescents

This medicine should not be used in children and adolescents (below 18 years of age). The use of Ibuprofen has not been studied in children and adolescents. Therefore, the safety and efficacy have not been established.

If you use more Ibuprofen 600 mg than you should

Consult a doctor immediately. You may experience, nausea, stomach ache or headache, vomiting, diarrhoea, ringing in the ears, dizziness, vomiting blood and blood in stools. More serious poisoning can lead to drowsiness, excitation, disorientation, low blood pressure, kidney failure, liver damage, reduced breathing (respiratory depression), blue discolouring of the skin and mucosa (cyanosis), loss of consciousness, coma, convulsions, metabolic acidosis and increased bleeding tendency. Worsening of asthma in asthmatics may occur.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The side effects can be minimized by using the lowest effective dose for the shortest time possible to treat the symptoms. You can get one or more of the known side effects of NSAIDs (see below).

If you experience any of these side effects, you should stop taking this medicine and consult a doctor as soon as possible. Elderly patients who take this drug are at greater risk for developing problems associated with side effects.

The most commonly observed adverse events are gastrointestinal side effects (affecting stomach and intestines). Peptic ulcers (stomach or intestinal ulcer), perforation (hole the wall of the stomach or intestine) or bleeding from the stomach or intestines, sometimes fatal, particularly in the elderly may occur. Nausea, vomiting, diarrhoea, flatulence, constipation, indigestion, abdominal pain, tarry stools, vomiting blood, ulcerative stomatitis (inflammation of the oral mucosa with ulceration), exacerbation of colitis (inflammation of large intestine) and Crohn’s disease. Less frequently, gastritis (stomach inflammation) has been observed. Particularly the risk of bleeding into stomach and intestines occurring is dependent on the dose range and the duration of use.

Edema (fluid accumulation in the tissues), high blood pressure and heart failure have been reported in association with NSAID treatment. Medicines like ibuprofen may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

Very rarely severe allergic reactions (including infusion site reactions, anaphylactic shock) and serious skin side effects such as bullous (blistering) reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, alopecia, (hair loss), sensitivity to light reactions and allergic vasculitis (inflammation of a blood vessel) have been reported.

Exacerbation of inflammation related to infections (for example development necrotising fasciitis) coinciding with the use of NSAIDs has been described very rarely. In exceptional cases, severe skin infections and soft-tissue complications may occur during a varicella infection.

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

• tiredness or sleeplessness, headache and dizziness
• heartburn, abdominal pain, nauseas, vomiting, flatulence, diarrhoea, constipation and slight blood losses in stomach and intestines that may cause anaemia in exceptional cases

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

• vertigo
• skin eruption
• pain and burning sensation in the administration site
• gastrointestinal ulcer, potentially with bleeding and perforation; ulcerative stomatitis, exacerbation of colitis and Crohn's disease

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

• insomnia (problems sleeping), agitation, irritability or tiredness, anxiety and restlessness
• visual disturbances
• tinnitus (ringing or buzzing in the ears) reduced production of urine and, particularly in patients with high blood pressure or kidney problems, nephrotic syndrome, interstitial nephritis that may be accompanied by acute renal insufficiency
• urticaria, pruritus, purpura (including allergic purpura), skin rash
• allergic reactions with skin rashes and itching, as well as asthma attacks (possibly with drop of blood pressure)

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

• reversible toxic amblyopia (double vision)
• difficulty hearing
• narrowing of the oesophagus (blood vessels in gullet), complications of diverticula of the large bowel, unspecific haemorrhagic colitis. If there is bleeding into stomach or intestines, it can cause anemia
• damage of kidney tissue (papillary necrosis), particularly in long-term therapy, increased serum uric acid concentration in the blood
• yellowing of the skin or whites of the eyes, liver dysfunction, liver damage, particularly in long-term therapy acute hepatitis (inflammation of the livers)
• psychotic reactions, nervousness, irritability, confusion or disorientation and depression
• stiff neck

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

• disorders of blood cell formation (anaemia, leukopenia, thrombocytopenia, pancytopenia, agranulocytosis). The first symptoms are: fever, sore throat, surface mouth ulcers, flu-like symptoms, severe fatigue, nasal and skin bleeding
• palpitations (rapid heartbeat), heart failure, myocardial infarction
• arterial hypertension
• aseptic meningitis (stiff neck, headache, nausea, vomiting, fever or confusion). Patients with autoimmune disorders (SLE, mixed connective-tissue disease) appear to be predisposed
• inflammation of oesophagus (gullet) or pancreas, narrowing of the bowel
• asthma, difficulty breathing (bronchospasm), shortness of breath and wheezing
• systemic lupus erythematosus (an autoimmune disease), severe allergic reaction (face oedema, swelling of the tongue, swelling of the throat with constriction of the airways, difficulty breathing, rapid heartbeat and decreased blood pressure and life threatening shock)

Not known side effects (frequency cannot be estimated from the available data):

• liver insufficiency
• site of injection reactions such as swelling, bruising or bleeding
• a severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include: skin rash, fever, swelling of lymph nodes and an increase of eosinophils (a type of white blood cells)
• A red, scaly widespread rash with bumps under the

5. how to store ibuprofen

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

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

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

Only for single use. Once the product is opened it should be used immediately. The remaining solution should not be used, it should be discarded.

6. contents of the pack and other information

What Ibuprofen Solution contains

The active substance is ibuprofen. Each ml of solution contains 4 mg of ibuprofen.

Each bag of 150 ml contains 600 mg of ibuprofen.

The other excipients are trometamol, sodium chloride, hydrochloric acid, sodium hydroxide and water for injections.

What Ibuprofen 600 mg Solution looks like and contents of the pack

Ibuprofen 600 mg is a clear and colourless solution for infusion packed in polyolefin bags of 150 ml with aluminium overwrapping.

Ibuprofen 600 mg solution for infusion is available in cardboard boxes containing 20 and 50 bags of 150 ml.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Dr. Reddy’s Labora­tories (UK) Ltd., 6 Riverview Road, Beverley, East Yorkshire, HU17 0LD, United Kingdom

Manufacturer

ALTAN PHARMACEUTICALS, S.A.

PoHgono Industrial de Bernedo s/n 01118 Bernedo (Alava)

Spain

This leaflet was last revised in November 2019.