Ketorolac Trometamol 30 mg/ml solution for injection

• 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 pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

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

• you are allergic (hypersensitive) to Ketorolac trometamol or any of the other ingredients of Ketorolac (listed in Section 6).
• you are allergic (hypersensitive) to acetylsalicylic acid or other NSAIDs (such as ibuprofen or diclofenac).
• You are aged under 16.
• You now have or have ever had any problems with your stomach or gut (intestine) like an ulcer or bleeding.
• You have severe problems with your liver or heart.
• You have moderate or severe problems with your kidneys.
• You have ever had bleeding in your brain.
• You have a problem that causes you to bleed easily, including a condition like haemophilia.
• You are taking medicines to stop your blood clotting, like warfarin, heparin or clopidogrel.
• You have asthma or allergies (like hayfever) or have had swelling of the face, lips, eyes or tongue in the past.
• You have or have had lumps in your nose (polyps).
• You are taking other NSAIDs, like ibuprofen or acetylsalicylic acid
• You are taking oxpentifylline (for your circulation), probenecid (for gout) or lithium (for mental health problems).
• You plan to get pregnant, are pregnant, in labour or are breast-feeding.
• You are about to have an operation.
• You have been advised you have a high risk of bleeding after an operation or are still bleeding after an operation.

You must not be given Ketorolac if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given Ketorolac.

Talk to your doctor or nurse before taking Ketorolac. If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss your treatment with your doctor or nurse.

Tell your doctor if you recently had or you are going to have a surgery of the stomach or intestinal tract before taking Ketorolac, as Ketorolac can sometimes worsen wound healing in your gut after surgery.

Check with your doctor or nurse before taking Ketorolac if any of the following apply to you:

• You are elderly (you are more likely to suffer problems).
• Problems with your kidneys or liver.
• High blood pressure.
• Problems with the blood vessels (arteries) anywhere in your body.
• Too much fat (lipid) in your blood (hyperlipidaemia).
• An autoimmune condition, such as 'systemic lupus erythematosus' (SLE, which causes joint pain, skin rashes and fever) and colitis or Crohn's disease (conditions causing inflammation of the bowel, bowel pain, diarrhoea, vomiting and weight loss).

If you are not sure if any of the above applies to you, talk to your doctor or nurse before being given Ketorolac.

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor or nurse if you are taking any of the following medicines before you are given Ketorolac:

• Other NSAIDs, like acetylsalicylic acid, ibuprofen or diclofenac.
• Medicines to stop your blood clotting, like warfarin, heparin or clopidogrel.
• Oxpentifylline (for your circulation).
• Probenecid (for gout).
• Lithium (for mental health problems).

If you are taking any of the above medicines you must not be given Ketorolac.

Tell your doctor or nurse if you are taking:

• An 'ACE inhibitor' or other medicine for high blood pressure, like cilazapril, enalapril or propranolol.
• A diuretic (water tablet) (for high blood pressure), like furosemide.
• A'cardiac glycoside' (for heart problems), like digoxin.
• Asteroid (for swelling and inflammation), like hydrocortisone, prednisolone and dexamethasone.
• A 'quinolone antibiotic' (for infections), like ciprofloxacin or moxifloxacin.
• Certain medicines for mental health problems 'SSRIs', like fluoxetine or citalopram.
• Methotrexate (used to treat skin problems, arthritis or cancer).
• Ciclosporin or tacrolimus (for skin problems or after an organ transplant).
• Zidovudine (used to treat AIDS and HIV infections).
• Mifepristone (used to end pregnancy or to bring on labour if the baby has died).

If any of the above apply to you, or if you are not sure, talk to your doctor or nurse before you are given Ketorolac.

Ketorolac may make it more difficult to become pregnant. You must not be given Ketorolac if you are pregnant, in labour or are breastfeeding.

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

Ketorolac may make you tired, drowsy, dizzy, have problems with your balance or eyesight, depressed or have difficulty sleeping. Talk to your doctor if any of these happen to you and do not drive or use any tools or machines.

Ketorolac is essentially 'sodium free' as it contains less than 1 mmol sodium (23 mg per 1 ml). This medicine contains a small amount of ethanol (alcohol), 100mg per dose.

Ketorolac is not recommended for use in children under 16 years of age.

• The usual starting dose is 10 mg.
• This can be followed by a dose of 10 to 30 mg every 4 to 6 hours, as needed.
• The maximum dose is 90 mg each day.
• Your doctor may also give you other pain killers (such as pethidine or morphine) if your pain is severe.

• Your doctor will usually give you doses lower than those described for adults.
• The maximum dose is 60 mg each day.
• Your doctor may also give you other pain killers (such as pethidine or morphine) if your pain is severe. Your doctor may also give you other pain killers (such as pethidine or morphine) if your pain is severe.

Tell a doctor or nurse straight away if any of the following side effects happen. You may need urgent medical treatment:

Serious stomach or gut problems, signs include:

• Bleeding from the stomach, seen as vomit which has blood in it, or bits that look like coffee grounds.
• Bleeding from your back passage (anus), seen as passing black sticky bowel motions (stools) or bloody diarrhoea.
• Ulcers or holes forming in your stomach or gut. This may be seen as upset stomach with stomach pain, fever, feeling or being sick.
• Problems with your pancreas, seen as severe stomach pain which spreads to your back.
• Worsening of ulcerative colitis or Crohn's disease, seen as pain, diarrhoea, vomiting and weight loss.

Allergic reactions, signs include:

• Sudden swelling of your throat, face, hands or feet.
• Difficulty breathing, tightness in your chest.
• Skin rashes, blisters or itching.

Severe skin rashes, signs include:

• A severe rash that develops quickly, with blisters or peeling of your skin and possibly blisters in your mouth, throat or eyes. Fever, headache, cough and aching body may happen at the same time.

Heart attack, signs include:

• Chest pain which may spread to your neck and shoulders and down your left arm.

Stroke, signs include:

• Muscle weakness and numbness. This may only be on one side of your body.
• A suddenly altered sense of smell, taste, hearing or vision, confusion.

Meningitis, signs include:

• Fever, feeling or being sick, a stiff neck, headache, sensitivity to bright light and confusion (most likely in people with autoimmune conditions such as 'systemic lupus erythematosus').

Liver problems, signs include:

• Yellowing of your skin or the whites of your eyes (jaundice).
• Feeling tired, loss of appetite, feeling or being sick and pale coloured stools (hepatitis) and problems (including hepatitis), shown in blood tests.

Problems passing water (urine), signs include:

• A feeling of fullness and a need to empty your bladder, but then difficulty in emptying it.

If you notice any of the serious side effects mentioned above, tell your doctor or nurse straight away.

Stomach and gut

• Heartburn, indigestion, stomach ache, feeling sick or being sick, constipation, diarrhoea, wind.
• Burping or a feeling of fullness.

Blood

• Bleeding from your wound after an operation or nosebleeds.
• A swelling filled with blood.
• Blood problems, like too much potassium or not enough sodium.
• Blood problems, like anaemia, not enough platelets or changes to the numbers of white blood cells.

Mental illness

• Having difficulty sleeping or changes in your patterns of dreaming.
• Depression.
• Feeling worried (anxious) or nervous or extremely happy (euphoria).
• Seeing and possibly hearing things that are not really there (hallucinations).
• Mental problems which may make you feel confused, restless and disturbed (agitated) and lose contact with reality.

Nervous system

• Headache.
• Fits or seizures, feeling dizzy or light-headed or sleepy.
• Pins and needles or numbness of your hands and feet.
• Difficulty with your memory or concentration.

Eyes and ears

• Changes to your eyesight, eye pain.
• Changes to your hearing, including ringing in the ears (tinnitus) and hearing loss.
• Dizziness that causes problems with your balance.

Heart and circulation

• Swelling of your hands, feet or legs (oedema). This may be with chest pains, tiredness, shortness of breath (cardiac failure).
• A fluttering feeling in your heart (palpitations) slow heart beat or high blood pressure.
• Problems with the way your heart pumps blood around the body. Signs may include tiredness, shortness of breath, feeling faint.

Chest

• Difficulty breathing, including shortness of breath, wheezing or coughing.
• Swelling of your lungs.

Skin and hair

• Light sensitivity, skin rashes including redness, hives, pimples and blisters on your body and face.
• Itching or sweating, pale skin or redness of the face and neck (flushing).

Urinary

• Blood in your water (urine) or kidney problems.
• Going to the toilet more often to pass water, or going less often.
• Pain in your side.

Other

• Pain where the injection was given.
• Thirst, dry mouth, taste changes, fever, weight gain or weight loss.
• Feeling tired or generally unwell.
• A sore mouth.
• Muscle spasms, pain or weakness.
• Problems for women in getting pregnant.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report any side effects directly (See details below).

By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

The active substance in 'Ketorolac Trometamol 30 mg/ml solution for injection' is ketorolac trometamol. Each 1 ml of solution contains 30 mg (milligrams) of ketorolac trometamol, respectively.

Other ingredients are ethanol, sodium chloride, Hydrochloric acid (for pH adjustment), Sodium hydroxide (for PH adjustment) and water for injections.

Ketorolac is a clear, slightly yellow solution.

Ketorolac is supplied in glass ampoules containing 1 ml of solution, in pack of 5, 10 & 25.

Not all pack sizes may be marketed.