Patient Information Leaflet: Information for the user

30 mg/ml solution for injection ketorolac trometamol

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or nurse. • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What is and what it is used for 2. What you need to know before you are given 3. How is given 4. Possible side effects 5. How to store 6. Contents of the pack and other information

1. What is and what it is used for contains an active substance called ketorolac trometamol and belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). Ketorolac is used in hospital, for short-term relief of moderate to severe pain after operations and in the case of acute kidney stone pain, in adults and adolescents ≥16 years.

2. What you need to know before you are given

should not be used before or during surgery due to increased risk of bleeding.

must not be given by epidural or intrathecal administration .

Severe anaphylactic-like reactions have been observed in patients with a history of allergic reactions (symptoms of asthma, inflammation of the nasal mucosa or skin reactions) to the use of acetylsalicylic acid (e.g. aspirin) or other anti-inflammatory pain-relief drugs (NSAIDs).

Do not use :

 if you are allergic to ketorolac or any of the other ingredients of this medicine (listed in section 6).  in combination with other anti-inflammatory pain relief drugs (NSAIDs) or acetylsalicylic acid  if you have or have had any problems with your stomach or gut, like an ulcer or bleeding  if you have severe problems with your liver or heart  if you have moderate to severe problems with your kidneys, or are at risk for kidney failure due to dehydration  if you are pregnant and in the final trimester (have been pregnant for more than six months)  during labour or delivery  if you are breast-feeding  if you have, or have had bleeding in your brain or other bleeding disorders

 if you are taking oxpentifylline (a medicine used to improve blood circulation)

. Warnings and precautions Medicines like may be associated with a slight increase in the risk of heart attack or stroke, especially in high doses or when used in the long term. It is therefore important that you are not given for longer than recommended and you do not use more than the recommended dose. If you have heart problems, have had a stroke or believe that you may be at risk of such problems (for example, if you have high blood pressure, diabetes, high cholesterol or if you smoke), you should ask your doctor or nurse for advice before starting treatment.

Talk to your doctor before you are given and tell your doctor if:  you have problems with your kidney, liver or heart  have high blood pressure and/or problems with the blood vessels (arteries) in your body  you have ischaemic heart disease also called coronary artery disease  you have a very low blood volume (hypovolemia) or if you are dehydrated  you are taking other non-steroidal anti-inflammatory drugs (NSAIDs) for pain relief or to reduce fever (e.g. ibuprofen or aspirin)  you may be pregnant or are planning to have a baby or undergoing testing for infertility  you have a coagulation disorder  you have chickenpox  you have systemic lupus erythematosus, an autoimmune disease  you suffer from ulcerative colitis or Crohns disease  you have a family history of asthma, nasal polyps (lumps in your nose), long-term swelling of the sinus (chronic sinusitis) or hives  you have a history of hypersensitivity to acetylsalicylic acid, other NSAIDs, or ketorolac

If you experience gastrointestinal bleeding or ulceration, signs of liver disease or other manifestations such as rash, stop the treatment with this medicine.

Severe skin and soft-tissue reactions have been reported in very rare cases when using a NSAID. Stop the treatment with and contact your doctor if you develop a severe skin and soft-tissue reactions.

Allergic or anaphylactoid reactions (anaphylactoid reaction is a severe allergic reaction which causes severe problems breathing or dizziness), have been reported in patients with a history of hypersensitivity to acetylsalicylic acid, other NSAIDs, or ketorolac. However, these reactions may also occur in patients without a history of allergy to these drugs.

is not recommended if you are undergoing dialysis.

Children and adolescents Safety and efficacy in children and adolescents under 16 years of age has not been assessed. Injection of is not recommended for children under16 years of age.

Elderly If you are elderly you are more likely to suffer problems, especially bleeding and perforation in the digestive tract.

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

Tell your doctor if you are using any of the following types of medicines:

 Blood-thinning agents (antiplatelet drugs and anti-coagulants; warfarin, heparin and dextrans)  Diuretics (water tablets)  Beta-blockers (heart medicine)  Methotrexate (amongst other things for psoriasis, arthritis, other autoimmune diseases, cancer)  Cyclosporine (immunosuppressive drug)  Lithium (mood stabiliser)  ACE inhibitors/Angiotensin-II_antagonists (heart medicine/for high blood pressure)  Oxpentoxifylline (for claudicatio intermittens)  Alcohol  SSRIs (preparations to treat depression/anxiety)  Other NSAIDs such as acetylsalicylic acid (ASA), celecoxib, diclofenac, diflunisal, etodolac, fenoprofen, flurbiprofen, ibuprofen, indomethacin, ketoprofen, ketorolac, mefenamic acid, meloxicam, nabumetone, naproxen, oxaprozin, piroxicam, rofecoxib, sulindac, tenoxicam, tiaprofenic acid, tolmetin, or valdecoxib (NOT a complete list)  Corticosteroids  Opioid analgesics  Tacrolimus (immunosuppressive drug)  Probenecid (a medicine used for treating problems caused by too much uric acid in your body (e.g. gout, gouty arthritis)

Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

can make it more difficult to become pregnant. Tell your doctor if you are planning to become pregnant or if you have difficulties becoming pregnant.

As with other drugs containing aspirin or other NSAIDs, you must inform your doctor before using if you are pregnant. Do not use if you have been pregnant for more than 6 months.

Ketorolac passes into breast milk and the breast-feeding child may be affected. should not therefore be used when breast-feeding.

Driving and using machines can affect the ability to drive and use machines, as dizziness, drowsiness and headaches can occur. must not therefore be used if you are driving or using machines.

contains ethanol and sodium This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose. This medicinal product contains less than 1 mmol sodium (23 mg) per ampoule, that is to say essentially ‘sodium-free’.

3. How is given is administered by healthcare professionals and the treatment should only be started in hospital. is given by injection into a muscle (intramuscularly) or into a blood vessel (into a vein, also known as intravenously). The dose will vary from one patient to another. Your doctor will decide a suitable dose for you.

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

4. Possible side effects Like all medicines, can cause side effects, although not everybody gets them.

Common (≥1/100 to <1/10)  headache, drowsiness, sweating, dizziness,  swelling at the injection site (oedema),  nausea, dyspepsia (indigestion), abdominal pain, diarrhoea.

Uncommon (≥1/1,000 to <1/100)  inflammation of the lining of the stomach (gastritis), gastrointestinal ulceration, bloody stools (melaena), intestinal gas (flatulence), constipation, rectal bleeding, inflammation of the mouth (stomatitis), vomiting, dry mouth,  abnormal taste, tingling of the skin,  depression, sleeping disorder (insomnia), nervousness, intense feeling of well-being (euphoria), inability to concentrate, abnormal thoughts,  elevated liver enzymes (ASAT)  abnormal vision,  muscle pain,  increased frequency of urination, problems passing water (urine retention), small amounts of urine,  shortness of breath, asthma, nosebleeds,  itching, flushing, rash, blood spots on the skin (purpura),  weakness (asthenia), thirst, pale skin,

Rare (≥1/10,000 to <1/1,000)  heart failure  low amount of platelets,  low or high blood pressure, bleeding after surgery,  convulsions (seizures), muscle spasm,  abnormal dreams, hallucinations,  hearing loss,  acute kidney failure, flank pain with or without blood in the urine) and/or increased urea in the blood (azotemia),  fluid accumulation in lungs (pulmonary oedema),  serious allergic reaction (anaphylactic reactions), such as difficulty in breathing (bronchospasm), throat swelling (laryngeal oedema), low blood pressure (hypotension), flushing and rashes  severe skin reactions, such as Stevens-Johnsons syndrome, TEN syndrome, redness and peeling of the skin (exfoliative dermatitis), elevated rash  exacerbation of colitis (inflammation of the large intestine) and Crohn's disease (chronic intestinal disorder), perforations or gastrointestinal bleeding, seen as vomit not known (cannot be estimated from the available data)  slow heartbeat, palpitations,  tinnitus,  inflammation of the pancreas (pancreatitis), inflammation of the oesophagus (oesophagitis), painful sore inside the stomach (peptic ulcer) , acid reflux (eructation), satiety,  inflammation of the kidneys (nephritis/nephrotic syndrome, haemolytic uraemic syndrome (HUS),  bruise (haematoma),  swelling in the skin (angioedema),  fever, reaction at the site of injection, chest pain,  anxiety, psychotic reactions (severe alterations of psychic balance),  anorexia, low sodium level in blood, high potassium level in blood  inflammation of the membranes surrounding your brain (meningitis) ,  female infertility,  inflammation of the liver (hepatitis), liver failure, icterus (yellowish pigmentation of the skin and eyes),  Extended bleeding duration, elevated S-urea, elevated creatinine, abnormal liver function values

Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V.* By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Keep this medicine out of the sight and reach of children. This medicinal product does not require any special storage conditions must not be given after the expiry date which is stated on the packaging and label. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

6. Contents of the pack and other information

What contains  The active substance is ketorolac trometamol. 1 ml solution for injection contains 30 mg of ketorolac trometamol.  The other ingredients are ethanol, sodium chloride, water for injections, sodium hydroxide and hydrochloric acid.

What looks like and contents of the pack is a clear, colourless or slightly yellow sterile solution available in packs of 5 glass ampoules containing 1 ml.

Marketing Authorisation Holder MACURE PHARMA ApS, Hejrevej 39, DK-2400 Copenhagen NV- Denmark

Manufacturer S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 - Cenate Sotto (BG) – Italia

This leaflet was last revised in: