Keral Tablets/Sachets

• Pain in the muscles, bones or joints.
• Period pain (dysmenorrhoea).
• Toothache.

How does it work?

• Keral tablets contain the active ingredient dexketoprofen, which is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). NSAIDs are used to relieve pain and inflammation.
• Dexketoprofen works by blocking the action of a substance in the body called cyclo-oxygenase (COX). Cyclo-oxygenase is involved in the production of various chemicals in the body, some of which are known as prostaglandins.
• Prostaglandins are produced by the body in response to injury and certain diseases and conditions, and cause pain, swelling and inflammation. Dexketoprofen blocks the production of these prostaglandins and is therefore effective at reducing inflammation and pain.
• Dexketoprofen is used to relieve painful problems of the muscles and bones and other pain of mild to moderate intensity, for example period pain and toothache.

Use with caution in

• Elderly people.
• History of disorders affecting the stomach or intestines.
• Decreased kidney function.
• Decreased liver function.
• Heart failure.
• High blood pressure (hypertension).
• Heart disease caused by inadequate blood flow to the heart (ischaemic heart disease), eg angina or history of heart attack.
• Disease of the blood vessels in and around the brain (cerebrovascular disease), eg history of stroke or mini-stroke (TIA).
• Poor circulation in the arteries of the legs or feet (peripheral arterial disease).
• Raised levels of fats such as cholesterol in the blood (hyperlipidaemia).
• Diabetes.
• Smokers.
• History of allergies.
• Diseases affecting connective tissue, eg systemic lupus erythematosus.

Contraindications

Not to be used in

• History of asthma.
• People in whom aspirin or other NSAIDs, eg ibuprofen, cause allergic reactions such as asthma attacks, itchy rash (urticaria), nasal inflammation (rhinitis) or swelling of the lips, tongue and throat (angioedema).
• People who have been suffering from chronic indigestion.
• People with an active peptic ulcer or bleeding in the gut.
• People who have had recurrent peptic ulcers or bleeding from the gut (two or more episodes).
• People who have ever experienced bleeding or perforation in the gut as a result of taking an NSAID.
• Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
• People with blood clotting disorders or taking anticoagulant medicines.
• Moderate to severely decreased kidney function.
• Severely decreased liver function.
• Severe heart failure.
• Pregnancy.
• Breastfeeding.
• This medicine should not be used in children and adolescents, because the manufacturer has not studied its safety and effectiveness in this age group.
• This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Disturbances of the gut, such as indigestion, nausea, vomiting, diarrhoea, heartburn, abdominal pain.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Dry mouth.
• Constipation.
• Flatulence.
• Difficulty sleeping (insomnia).
• Anxiety.
• Headache.
• Dizziness.
• Spinning sensation (vertigo).
• Palpitations.
• Flushing.
• Fatigue.
• Skin rash.
• Weakness or loss of strength (asthenia).
• A general feeling of being unwell (malaise).

Rare (affect between 1 in 1000 and 1 in 10,000 people)

• Loss of appetite.
• Pins and needles sensations.
• Fainting (syncope).
• High blood pressure.
• Ulceration or bleeding in the stomach or intestines.
• Retention of water in the body tissues (fluid retention), resulting in swelling (oedema).
• Nettle rash (urticaria).
• Acne.
• Increased sweating.
• Back pain.
• Increased production of urine (polyuria).
• Abnormal liver function tests.

Very rare (affect less than 1 in 10,000 people)

• Allergic reactions such as skin rashes, swelling of the lips, tongue and throat (angioedema) or narrowing of the airways (bronchospasm).
• Blurred vision.
• Sensation of ringing or other noise in the ears (tinnitus).
• Inflammation of the pancreas (pancreatitis).
• Severe blistering skin reaction affecting the tissues of the eyes, mouth, throat and genitals (Stevens-Johnson Syndrome).
• Abnormal reaction of the skin to light, usually a rash (photosensitivity).
• Increased heart rate (tachycardia).
• Decreased blood pressure.
• Kidney, liver or blood disorders.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before taking this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

Dexketoprofen should not be taken in combination with painkilling doses of aspirin or any other oral NSAID, eg ibuprofen, as this increases the risk of side effects on the stomach and intestines. Selective inhibitors of COX-2 such as celecoxib or etoricoxib should also be avoided for the same reason.

There may be an increased risk of ulceration or bleeding in the gut if dexketoprofen is taken with corticosteroids such as prednisolone.

There may also be an increased risk of bleeding in the gut if dexketoprofen is taken with the following medicines:

• anti-blood-clotting (anticoagulant) medicines such as warfarin or heparins
• anti-platelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, clopidogrel, dipyridamole
• dabigatran
• erlotinib
• SSRI antidepressants, eg fluoxetine, paroxetine, citalopram
• venlafaxine.
• Dexketoprofen may enhance the effect of blood-thinning or anti-clotting medicines (anticoagulants) such as warfarin. As this may increase the risk of bleeding, people taking dexketoprofen with an anticoagulant should have their blood clotting time (INR) closely monitored by their doctor.

Dexketoprofen may reduce the removal of the following medicines from the body and so may increase the blood levels and risk of side effects of these medicines. People taking dexketoprofen with any of these should be closely monitored by their doctor:

• digoxin
• lithium
• methotrexate.

There may be an increased risk of side effects on the kidneys if dexketoprofen is taken with any of the following medicines:

• ACE inhibitors, eg enalapril
• angiotensin II receptor blockers, eg losartan
• ciclosporin
• diuretics, eg furosemide
• tacrolimus.

Dexketoprofen may oppose the blood pressure lowering effects of certain medicines to treat high blood pressure, such as the following:

• ACE inhibitors such as captopril
• beta-blockers such as propranolol
• diuretics such as bendroflumethiazide.
• Probenecid may increase the blood level of dexketoprofen, which may increase the risk of side effects.

If this medicine is used in combination with quinolone antibiotics, such as ciprofloxacin or norfloxacin there may be an increased risk of seizures (fits). This may occur in people with or without a previous history of epilepsy or convulsions.

Pregnancy and breastfeeding

• Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
• This medicine should not be used during pregnancy. This is particularly important in the first and third trimesters. If taken in the third trimester NSAIDs may delay labour, increase the length of labour and cause complications in the newborn baby. Some evidence suggests that NSAIDs should also be avoided by women attempting to conceive, as they may temporarily reduce female fertility during treatment and may also increase the risk of miscarriage or malformations. Seek medical advice from your doctor.
• It is not known if this medicine passes into breast milk. It should not be used by breastfeeding mothers. Seek medical advice from your doctor.

If you have any more questions please ask your Pharmacist.

Remember to keep all medicines out of reach of children
Please Note: We have made every effort to ensure that the content of this information sheet is correct at time of publish, but remember that information about drugs may change. This sheet does not list all the uses and side-effects associated with this drug. For full details please see the drug information leaflet which comes with your medicine. Your doctor will assess your medical circumstances and draw your attention to any information or side-effects which may be relevant in your particular case.

References:

http://www.drugs.com/uk/keral-25mg-film-coated-tablets-leaflet.html

http://patient.info/medicine/dexketoprofen-for-pain-keral

http://www.netdoctor.co.uk/medicines/aches-and-pains/a6691/keral-dexketoprofen/

https://en.wikipedia.org/wiki/Dexketoprofen