Keral (Dexketoprofen Trometamol)

Keral 25 mg tablets

Dexketoprofen Trometamol

What Keral Is and What It Is Used for

Keral is a pain killer from a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs). It treats mild to moderate pain, such as muscular pain, painful periods (dysmenorrhoea), and toothache.

Keral is supplied in packs containing 4, 10, 20 or 50 film-coated tablets. Not all pack sizes may be marketed. The tablets can be divided into equal halves.

Ingredients

The active substance is dexketoprofen trometamol (36.90 mg), corresponding to dexketoprofen (INN) 25 mg. The other ingredients are maize starch, microcrystalline cellulose, sodium starch glycollate, glycerol palmitostearate, hypromellose, titanium dioxide, propylene glycol, and macrogol 6000.

How to Take Keral

Always use Keral exactly as your doctor has told you. You should check with your doctor if you need more information.

The dose of Keral that you need depends on the type, severity, and duration of your pain. Your doctor will tell you how many tablets you must take daily and for how long.

The recommended dosage is 1 tablet (25 mg) every 8 hours, with no more than 3 daily (75 mg).

If you are a senior patient or suffer from kidney or liver problems, you should start treatment with a total daily dose of no more than two tablets (50 mg).

In elderly patients, this initial dose can later be increased to that generally recommended (75 mg) if Keral has been well tolerated.

If your pain is intense and you need quicker relief, take the tablets on an empty stomach (at least 30 minutes before food) because they will be more easily absorbed (see section 2, “Taking Keral with food and drink”).

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 tablet. Please take the next regular dose when it is due.

Ask your doctor or pharmacist if you have any questions about using this product.

Before You Take Keral

Do Not Take Keral:

• if you are allergic (hypersensitive) to dexketoprofen, trometamol, or any of the other ingredients of Keral;
• if you are allergic to aspirin or other non-steroidal anti-inflammatory medicines;
• if you have asthma or have suffered from asthma attacks, acute allergic rhinitis (a short period of the 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;
• if you have or have suffered in the past from a peptic ulcer, stomach or bowel bleeding, or 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 severe heart failure, moderate or serious kidney problems, or severe liver problems;
• if you have a bleeding disorder or a blood clotting disorder;
• if you are pregnant or breast-feeding;
• if you are less than 18 years of age.

Take Special Care with 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, diarrhea, 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 a senior patient, you may be more likely to suffer from side effects;
• if you 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);
• 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 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, please consult your doctor before taking Keral: they may want you to take additional medicine to protect your stomach (e.g., misoprostol or medicines that block the production of stomach acid).

Taking Keral with Food and Drink

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.

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 breast-feeding.

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

• tell your doctor if you are pregnant or planning to become pregnant, as Keral may not suit 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 disappear. Ask your doctor for advice.

Interactions

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Some medicines should not be taken together, and others 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 problems;
• Pentoxifylline and oxpentifylline used to treat chronic venous ulcers;
• Zidovudine, used to treat viral infections;
• Chlorpropamide and glibenclamide used for diabetes.

Combinations 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 transplants;
• 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 doubts about taking other medicines with Keral, consult your doctor or pharmacist.

Possible Side Effects

Keral can cause side effects like all medicines, although not everybody gets them.

Possible side effects are listed below according to how likely they are to occur. This table tells you how many patients might get these side effects:  

Common side effects	more than 1 out of 100 persons and less than 1 out of 10 persons.
Uncommon side effects	more than 1 out of 1000 persons and less than 1 out of 100 persons.
Rare side effects	more than 1 out of 10000 persons and less than 1 out of 1000 persons.
Very rare side effects	more than 1 out of 10000 persons, including isolated reports.

Common Side Effects

Nausea and/or vomiting, stomach pain, diarrhea, digestive problems (dyspepsia).

Uncommon Side Effects

Spinning sensation (vertigo), dizziness, sleepiness, disturbed sleep, nervousness, headache, palpitations, flushing, stomach problems, constipation, dry mouth, flatulence, skin rash, tiredness, pain, feeling feverish and shivering, generally feeling unwell (malaise).

Rare Side Effects

Peptic ulcer, peptic ulcer perforation or bleeding, which may be seen as vomiting blood or black stools, fainting, high blood pressure, too-slow breathing, water retention, and peripheral swelling (e.g., swollen ankles), loss of appetite (anorexia), abnormal sensation, itchy rash, acne, increased sweating, back pain, passing water frequently, menstrual disorders, prostate problems, abnormal liver function tests (blood tests).

Very Rare

Anaphylactic reaction (a hypersensitive reaction which may also lead to collapse), open sores on skin, mouth, eyes, and genital areas (Stevens-Johnson and Lyell’s syndromes), face swelling or swelling of the lips and throat (angioneurotic edema), breathlessness due to narrowing of the airways (bronchospasm), shortness of breath, fast heartbeat, low blood pressure, inflammation of the pancreas, liver cell damage (hepatitis), blurred vision, ringing in the ears (tinnitus), sensitive skin, sensitivity to light, itching, kidney problems. Reduced white blood cell count (neutropenia) fewer platelets in the blood (thrombocytopenia).

Tell your doctor immediately if you notice any stomach/bowel side effects at the start of treatment (e.g., stomach pain, heartburn, or bleeding), if you have previously suffered from any such side effects due to long-term use of anti-inflammatory drugs, and especially if you are elderly.

Stop using Keral if you notice a skin rash, any lesion inside the mouth or on the genitals, or any sign of an allergy.

During treatment with non-steroidal anti-inflammatory drugs, fluid retention and swelling (especially in the ankles and legs), increased blood pressure, and heart failure have been reported.

Medicines such as Keral may be associated with a small increased risk of heart attack (“myocardial infarction”) or stroke.

In patients with immune system disorders that affect connective tissue (systemic lupus erythematosus or mixed connective tissue disease), anti-inflammatory medicines may rarely cause fever, headache, and neck stiffness.

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

How to Store Keral

Keep out of the reach and sight of children.

Do not use Keral after the expiry date, which is stated on the carton and on the blister. The expiry date refers to the last day of that month.

Do not store above 30 °C. Keep the blister packs away from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.

Other Keral Brand Names in Different Countries

This medicinal product is authorized in the Member States of the EEA under the following names:

Country	Keral Brand Name	Country	Keral Brand Name
Spain (RMS)	Ketesse	Italy	Ketesse
Austria	Ketesse	Latvia	Dolmen
Belgium	Ketesse	Lithuania	Dolmen
Cyprus	Nosatel	Luxembourg	Ketesse
Czech republic	Dexoket	Malta	Keral
Denmark	Ketesse	Norway	Ketesse
Estonia	Dolmen	Poland	Dexak
Finland	Ketesse	Portugal	Ketesse
France	Ketesse	Slovakia	Dexadol
Germany	Sympal	Slovenia	Menadex
Greece	Nosatel	Sweden	Ketesse
Hungary	Ketodex	The Netherlands	Stadium
Iceland	Ketesse	United Kingdom	Keral
Ireland	Keral