Trolac contains a medicine called Ketorolac Trometamol This is a ‘Non-Steroidal Anti-Inflammatory Drug’ (NSAID).

Trolac is used in hospitals, for pain relief after operations in patients of 16 years of age or older. Trolac can lessen pain, swelling, redness and heat (inflammation).

You must not be given Trolac if you are allergic (hypersensitive) to:

-        Ketorolac or any of the other ingredients of this medicine (listed in section 6).

-        Aspirin or other NSAIDs (such as ibuprofen or diclofenac).

You must not be given Trolac if:

-        You are under 16 years of age.

-      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 a low blood volume (caused by bleeding or severe dehydration).

-      You have asthma or allergies (like hay fever) 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 aspirin.

-      You are taking Oxpentifylline (for your circulation), Probenecid (for gout) or Lithium (for mental health problems).

-      You plan to get pregnant, are pregnant, in labor 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 Trolac if any of the above apply to you. If you are not sure, talk to your doctor or nurse before you are given Trolac.

-      Trolac contains alcohol and is therefore not for epidural or intrathecal use (injection into the spine).

Warnings and precautions

Talk to your doctor or nurse before being given Trolac. If you have heart problems, a 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.

Check with your doctor or nurse before being given Trolac if:

-      You are elderly (you are more likely to suffer problems).

-      You have problems with your kidneys or liver.

-      You have any diseases related to the kidneys.

-      You have or may suffer from any diseases.

-      You have high blood pressure.

-      You have problems with the blood vessels (arteries) anywhere in your body.

-      You have too much fat (lipid) in your blood (hyperlipidemia).

-      You have 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, diarrhea, vomiting and weight loss).

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

Children and adolescents

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

Other medicines and Trolac

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 Trolac

-      Other NSAIDs, like aspirin, 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 Trolac. 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.

-      A steroid (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 labor if the baby has died).

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

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 you are given this medicine.

Trolac may make it more difficult to become pregnant. Inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

You must not be given Trolac if you are pregnant, in labor or are breast-feeding.

Driving and using machines

Trolac 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.

Trolac contains sodium and alcohol

This medicine contains less than 1 mmol sodium (23 mg) per each ampoule of 1 ml, essentially ‘sodium free’.

This medicine contains 12.4 vol % ethanol (alcohol), i.e. up to 100 mg ethanol (96 %) per dose, equivalent to 2.5 ml beer and 1 ml wine per dose.

This may be harmful for those suffering from alcoholism.

To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy

Trolac will be given to you by a doctor or nurse. It will be given to you by injection into a muscle (such as into your arm) or into a vein.

Medicines such as Trolac may be associated (linked) with a small increased risk of heart attack (‘myocardial infarction’) or stroke. Any risk is more likely with higher doses and prolonged (longer term) treatment.

The maximum length of treatment should be two days.

Use in children and adolescents

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

Use in adults

·     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.

Use in patients over 65 years of age, or with kidney problems or who weigh less than 50 kg

·     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.

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

Like all medicines, this medicine can cause side effects, although not everybody gets them. Medicines such as Trolac may be associated with a small increased risk of heart attack (‘myocardial infarction’) or stroke.

Serious side effects

Tell a doctor or nurse IMMEDIATELY if any of the following occur. 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 diarrhea.

-        Ulcers or holes forming in your stomach or gut. This may be seen as an 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 colored 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.

Other side effects

Tell your doctor or nurse if you have any of the following:

·       Stomach and gut

-        heartburn, indigestion, stomachache, feeling sick or being sick, constipation, diarrhea, 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 in the number 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 heartbeat 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.

-      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.

Reporting of side effects

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 side effects directly via the national reporting system

listed in Appendix V. By reporting side affects you can help provide more information on the safety of this medicine

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 carton or ampoules label after the abbreviation EXP. The expiry date refers to the last day of that month.

Keep the ampoules in the outer carton in order to protect from light.

Short-term low temperature excursions (up to 3 weeks) down to -20°C are allowed.

Before administration, the product should be inspected visually. Do not use this medicine if you notice any particulate matter.

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.