A.Menarini Pharmaceuticals Ltd

Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1. What Keral is and what it is used for
2. Before you use Keral
3. How to use Keral
4. Possible side effects
5. How to store Keral
6. Further information

Do not take Keral and tell your doctor if you:

• are allergic (hypersensitive) to dexketoprofen trometamol or to any of the other ingredients of Keral (see section 6);
• are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory medicines;
• have suffered attacks of asthma, acute allergic rhinitis (a short period of inflamed lining of the nose), nasal polyps (lumps within the nose due to allergy), urticaria (skin rash), angioedema (swollen face, eyes, lips, or tongue, or respiratory distress) or wheezing in the chest, after taking aspirin or other non-steroidal anti-inflammatory medicines;
• have or have previously suffered from a peptic ulcer;
• have or have previously suffered in the past from stomach or bowel bleeding, due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs);
• have chronic digestive problems (e.g. indigestion, heartburn) or bowel disease with chronic inflammation (Crohn’s disease or ulcerative colitis);
• have serious heart failure, moderate or serious kidney problems or serious liver problems;
• have a bleeding disorder or a blood clotting disorder;
• suffer or have previously suffered from asthma;
• are in third trimester of pregnancy or breast feeding;

Take special care with Keral and tell your doctor if you:

• have suffered in the past from a chronic inflammatory disease of the bowel (ulcerative colitis, Crohn’s disease);
• have or have suffered in the past from the other stomach or bowel problems;
• are taking other medicines that increase the risk of peptic ulcer or bleeding, e.g. oral steroids, some antidepressants (those of the SSRI type, i.e. selective serotonin reuptake inhibitors), agents that prevent blood clots such as aspirin or anticoagulants such as warfarin. In such cases, consult your doctor before taking Keral: he/she may want you to take an additional medicine to protect your stomach (e.g. misoprostol or medicines that block the production of stomach acid);
• 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 pharmacist; Medicines such as Keral may be associated with a small increased risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose or duration of treatment;
• are elderly: you may be more likely to suffer from side effects (see section 4). If any of these occur, consult your doctor immediately;
• suffer from allergy, or if you have had allergy problems in the past;
• have kidney, liver or heart problems (hypertension and/or heart failure) as well as fluid retention, or have suffered from any of these problems in the past;
• are taking diuretics or you suffer from very poor hydration and reduced blood volume due to an excessive loss of fluids (e.g. from excessive urination, diarrhoea or vomiting);
• are a woman with fertility problems (Keral may impair your fertility, therefore you should not take it if you are planning to become pregnant or you are doing fertility tests);
• are in the first or second trimester of pregnancy;
• suffer from a disorder in the formation of blood and blood cells;
• have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect connective tissue);
• are less than 18 years of age;

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. There are some medicines that should not be taken together and others that may need their doses to be altered when taken together.

Always inform your doctor, dentist or pharmacist if you are using or receiving any of the following medicines in addition to Keral:

Inadvisable combinations:

• Acetylsalicylic acid (aspirin), corticosteroids or other anti-inflammatory drugs
• Warfarin, heparin or other medicines used to prevent blood clots
• Lithium, used to treat certain mood disorders
• Methotrexate, used for rheumatoid arthritis and cancer
• Hydantoins and phenytoin, used for epilepsy
• Sulfamethoxazole, used for bacterial infections

Combinations requiring precautions:

• ACE inhibitors, diuretics, beta-blockers and angiotensin II antagonists, used for high blood pressure and heart conditions
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
• Zidovudine, used to treat viral infections
• Aminoglycosides antibiotics, used to treat bacterial infections
• Chlorpropamide and glibenclamide used for diabetes

Associations to be considered carefully:

• Quinolone antibiotics (e.g. ciprofloxacin, levofloxacin) used for bacterial infections
• Cyclosporin or tacrolimus, used to treat immune system diseases and in organ transplant
• Streptokinase and other thrombolytic or fibrinolytic medicines, i.e. medicines used to break-up blood clots
• Probenecid, used in gout
• Digoxin, used to treat chronic heart failure
• Mifepristone, used as an abortifacient (to terminate a pregnancy)
• Antidepressants of the selective serotonin reuptake inhibitors type (SSRIs)
• Anti-platelet agents used to reduce platelet aggregation and the formation of blood clots

If you have any doubt about taking other medicines with Keral, consult your doctor or pharmacist.

Children and adolescents

Do not take Keral if you are less than 18 years of age.

Pregnancy and breast-feeding

Do not use Keral during pregnancy or when breast feeding.

Ask your doctor or pharmacist for advice before taking any medicine:

• tell your doctor if you are pregnant, or if you are planning to become pregnant, as Keral may not be right for you.
• you must not take Keral if you are breast-feeding. Ask your doctor for advice.

Driving and using machines

Keral may slightly affect your ability to drive and handle machines, due to the possibility of dizziness or drowsiness as side effects of treatment. If you notice such effects, do not drive or use machines until the symptoms wear off. Ask your doctor for advice.

Important information about some of the ingredients of Keral

Each ampoule of Keral contains 200mg of ethanol, equivalent to 5 ml beer or 2.08 ml wine per dose.

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.

This medicinal product contains less than 1 mmol sodium (23mg) per dose, i.e. essentially “sodium-free”.

Method of administration:

Keral can be administered either by intramuscular or by intravenous route (technical details for the intravenous injection are given in the section 7):

When Keral is given intramuscularly, the solution should be injected immediately after its removal from the coloured ampoule, by slow injection deep into the muscle.

Only a clear and colourless solution should be used.

If you use more Keral than you should

If you use too much of this medicine, tell your doctor or pharmacist immediately or go to the emergency department of your nearest hospital. Please remember to take this medicine pack or this leaflet with you.

If you forget to use Keral

Do not take a double dose to make up for a forgotten dose. Take the next regular dose when it is due (according to section 3 “How to use Keral”).

What each 2 ml ampoule of KERAL contains

The active substance is dexketoprofen trometamol (73,80 mg) corresponding to dexketoprofen (INN) 50 mg.

The other ingredients are alcohol (ethanol), sodium chloride, sodium hydroxide and water for injections.

What KERAL looks like and contents of the pack

Keral is a solution for injection or a concentrate for solution for infusion. It is supplied in packs containing 1, 5, 6, 10, 20, 50 and 100 type I glass coloured ampoules each one with 2 ml of a clear and colourless solution. Not all pack sizes may be marketed.

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