Keral 25 mg film-coated tablets

• 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

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

• If you are allergic to dexketoprofen or any of the other ingredients of this medicine (listed in section 6);
• If you are allergic to acetylsalicylic acid or to other non-steroidal anti-inflammatory medicines;
• If you have asthma or 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 acetylsalicylic acid or other non-steroidal anti-inflammatory medicines;
• If you have suffered from photoallergic or phototoxic reactions (a particular form of reddening and/or blistering of the skin exposed to sunlight) while taking ketoprofen (a non-steroidal anti-inflammatory drug) or fibrates (drugs used to lower the level of fats in the blood);
• If you have a peptic ulcer/stomach or bowel bleeding or if you have suffered in the past from stomach or bowel bleeding, ulceration or perforation;
• If you have chronic digestive problems (e.g. indigestion, heartburn);
• If you have suffered in the past from stomach or bowel bleeding or perforation, due to previous use of non-steroidal anti-inflammatory drugs (NSAIDs) used for pain;
• If you have bowel disease with chronic inflammation (Crohn’s disease or ulcerative colitis);
• If you have serious heart failure, moderate or serious kidney problems or serious liver problems;
• If you have a bleeding disorder or a blood clotting disorder;
• If you are severely dehydrated (have lost a lot of body fluids) due to vomiting, diarrhoea or insufficient intake of fluids;
• If you are in the third trimester of pregnancy or breast feeding.

Talk to your doctor or pharmacist before taking Keral:

• If you suffer from allergy, or if you have had allergy problems in the past;
• If you 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;
• If you 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);
• 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 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.
• If you are elderly: you may be more likely to suffer from side effects (see section 4). If any of these occur, consult your doctor immediately;
• If you are a woman with fertility problems (this medicinal product may impair your fertility, therefore you should not take it if you are planning to become pregnant or you are doing fertility tests);
• If you suffer from a disorder in the formation of blood and blood cells;
• If you have systemic lupus erythematosus or mixed connective tissue disease (immune system disorders that affect connective tissue);
• If you have suffered in the past from a chronic inflammatory disease of the bowel (ulcerative colitis, Crohn’s disease);
• If you have or have suffered in the past from other stomach or bowel problems;
• If you an infection - please see heading “Infections” below.
• If you 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 this medicinal product: 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).
• If you suffer from asthma combined with chronic rhinitis, chronic sinusitis, and/or nasal polyposis as you have a higher risk of allergy to acetylsalicylic acid and/or NSAIDs than the rest of the population. Administration of this medicine can cause asthma attacks or bronchospasm, particularly in patients allergic to acetylsalicylic acid or NSAIDs.

Dexketoprofen may hide signs of infections such as fever and pain. It is therefore possible that this medicinal product may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

During chicken pox it is advisable to avoid use of this medicine.

This medicine has not been studied in children and adolescents. Therefore, safety and efficacy have not been established and the product should not be used in children and adolescents.

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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 this one:

Inadvisable combinations:

• Acetylsalicylic acid, corticosteroids or other anti-inflammatory drugs
• Warfarin, heparin or other medicines used to prevent blood clots
• Lithium, used to treat certain mood disorders
• Methotrexate (anti-cancer medicine or immunosuppressant), used at high doses of 15 mg/week
• Hydantoins and phenytoin, used for epilepsy
• Sulphametoxazole, used for bacterial infections

Combinations requiring precautions:

• ACE inhibitors, diuretics and angiotensin II antagonists, used for high blood pressure and heart problems
• Pentoxifylline and oxpentifylline, used to treat chronic venous ulcers
• Zidovudine, used to treat viral infections
• Aminoglycosides antibiotics, used to treat bacterial infections
• Sulfonylureas (e.g. chlorpropamide and glibenclamide), used for diabetes
• Methotrexate, used at low doses, less than 15 mg/week

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
• Beta-blockers, used for high blood pressure and heart problems
• Tenofovir, deferasirox, pemetrexed

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

Take the tablets with an adequate amount of water. Take your tablets with food, as it helps to decrease the risk of stomach or bowel side effects. However, if you have acute pain, take the tablets on an empty stomach, i.e. at least 30 minutes before meals, as this helps the medicine start working a little faster.

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. Do not use this medicine during the final three months of the pregnancy or when breast feeding. It can cause kidney and heart problems in your unborn baby. It may affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected.

You should not take this medicine during the first 6 months of pregnancy unless absolutely necessary and advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used.

If taken for more than a few days from 20 weeks of pregnancy onward, Keral can cause kidney problems in your unborn baby that may lead to low levels of amniotic fluid that surrounds the baby (oligohydramnios) or narrowing of a blood vessel (ductus arteriosus) in the heart of the baby. If you need treatment for longer than a few days, your doctor may recommend additional monitoring.

The use of this medicinal product is not recommended while attempting to conceive or during investigation of infertility.

With regard to potential effects on female fertility, see also section 2, “Warnings and precautions”.

This medicinal product 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.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

This medicine should not be used in children and adolescents (under age 18).

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.

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

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 Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

• The active substance is dexketoprofen (as dexketoprofen trometamol). Each film-coated tablet contains 25 mg of dexketoprofen.

The other ingredients are:

• Tablet core: maize starch, microcrystalline cellulose, sodium starch glycollate, glycerol distearate.
• Film-coating: dry laquer (composed of hypromellose, titanium dioxide, macrogol 6000), propylene glycol.

White, round, scored film-coated tablets with convex sides, provided in blister packs.

Available in packs containing 4, 10, 20, 30, 50 and 500 film-coated tablets. Not all pack sizes may be marketed.

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