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How does it work?

Synflex tablets contain the active ingredient naproxen sodium, which is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). NSAIDs are used to relieve pain and inflammation. (NB. Naproxen is also available without a brand name, ie as the generic medicine.)

Naproxen 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. Naproxen blocks the production of these prostaglandins and is therefore effective at reducing inflammation and pain.

Naproxen is used to relieve pain and inflammation in a wide range of musculoskeletal conditions, including various forms of arthritis, gout, muscle sprains and strains, back pain, neck pain and tendinitis. It can also be used to relieve period pain.

Naproxen sodium is a form of naproxen that is absorbed into the bloodstream slightly faster than naproxen found in Naprosyn tablets or generic naproxen tablets. This means it starts to work at relieving pain more quickly, so can also be used where a fast painkilling action is needed, for example migraine headaches, or following childbirth or surgery.

Synflex tablets should preferably be taken with food to help avoid irritating the stomach.

What is it used for?

In adults and children over 16 years of age, relief of pain and inflammation in the following conditions:

» Rheumatoid arthritis
» Osteoarthritis
» A form of arthritis affecting the joints of the spine (ankylosing spondylitis)
» Acute gout
» Painful disorders of the muscles and skeleton, such as tendon inflammation (tendinitis), sprains, strains, back pain, neck pain
» Period pain (dysmenorrhoea)
» Pain following childbirth
» Pain following insertion of an intrauterine contraceptive device (coil or IUCD)
» Pain following surgery
» Migraine

Warning!

» NSAIDs can occasionally cause serious side effects on the gut, such as ulceration, bleeding or perforation of the stomach or intestinal lining. This type of side effect is more likely to occur in elderly people and in people taking high doses of the medicine. The risk can also be increased by taking certain other medicines (see below). It is important that these people, as well as people with a history of disorders affecting the stomach or intestines, are closely monitored by a doctor while taking this medicine. If your doctor thinks you are at high risk of side effects on the gut you may be prescribed an additional medicine to help protect your gut. All people taking this medicine should stop treatment and consult their doctor immediately if they experience any sign of bleeding from the stomach or intestine during treatment, for example vomiting blood and/or passing black/tarry/bloodstained stools.

» This medicine may cause dizziness or drowsiness and so may affect your ability to drive or operate machinery safely. Do not drive or operate machinery until you know how this medicine affects you and you are sure it won't affect your performance.

» This medicine may mask the signs and symptoms of infection, such as fever and inflammation. This may make you think mistakenly that an infection is getting better when it isn't, or that an infection is less serious than it is. For this reason you should tell your doctor if you get an infection while you are taking this medicine.

» If you have cirrhosis of the liver, heart failure or kidney disease, you are on a low sodium diet, you are taking diuretic medicines, or you are recovering from major surgery, your kidney function should be assessed before starting and regularly throughout treatment with this medicine.

» During long-term treatment with this medicine you should have regular check-ups with your doctor so that you can be monitored for possible side effects of the medicine. This might include routine blood tests to monitor your kidney function, liver function and levels of blood components, particularly if you are elderly.

» Very rarely, NSAIDS may cause serious blistering or peeling skin reactions (eg Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis). For this reason, you should stop taking this medicine and consult your doctor if you get a skin rash or sores inside your mouth while taking this medicine. This side effect is very rare, but if it occurs, is most likely to happen in the first month of treatment.

» If you need to have a test to monitor the functioning of your adrenal glands while taking this medicine, you should let the doctor performing the test know that you are taking naproxen. They may want you to stop taking the naproxen a couple of days before the test, as it could interfere with the results.

Use with caution in

» Elderly people
» History of disorders affecting the stomach or intestines
» Inflammatory bowel disease such as Crohn's disease or ulcerative colitis
» Decreased kidney function
» Decreased liver function
» Heart failure
» High blood pressure (hypertension)
» History of asthma
» History of allergies
» People with blood clotting disorders or taking anticoagulant medicines
» Diseases affecting connective tissue, eg systemic lupus erythematosus
» People on a restricted salt (sodium) diet

Not to be used in

» 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)

» Active peptic ulcer or bleeding from the gut

» People who have had recurrent peptic ulcers or bleeding from the gut (two or more episodes)

» People who have experienced bleeding or perforation of the gut as a result of previous treatment with an NSAID

» Severe heart failure.

» Synflex is not recommended for children under 16 years of age.

This medicine should not be used if you are allergic to one or 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.

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 is not recommended for use in pregnancy unless considered essential by your doctor. This is particularly important in the first and third trimesters. If taken in the third trimester it 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.

» This medicine passes into breast milk. It is not recommended for use by mothers who are breastfeeding. Seek medical advice from your doctor.

Label warnings

» Take this medication with or after food.

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. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

» Disturbances of the gut such as indigestion, diarrhoea, constipation, nausea, vomiting or abdominal pain
» Headache
» Dizziness
» Difficulty in sleeping (insomnia)
» Balance disorders involving the inner ear (vertigo)
» Sensation of ringing, or other noise in the ears (tinnitus)
» Skin reactions such as rash or itching
» Ulceration or bleeding of the stomach or intestines
» Retention of water in the body tissues (fluid retention), resulting in swelling (oedema)
» Increase in blood pressure
» Visual disturbances
» Drowsiness
» Concentration difficulties
» Depression
» Seizures (convulsions)
» Hypersensitivity reactions such as narrowing of the airways (bronchospasm), swelling of the lips, throat and tongue (angioedema), itchy blistering rash or anaphylactic shock
» Abnormal reaction of the skin to light, usually a rash (photosensitivity)
» Kidney, liver or blood disorders

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

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 ensure that the combination is safe.

Naproxen should not be taken in combination with painkilling doses of aspirin or any other NSAID taken by mouth, 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 from the gut if naproxen is taken with corticosteroids such as prednisolone.

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

» anti-blood-clotting (anticoagulant) medicines such as warfarin
» anti-platelet medicines to reduce the risk of blood clots or 'thin the blood', eg low-dose aspirin, clopidogrel, dipyridamole
» SSRI antidepressants, eg fluoxetine, paroxetine, citalopram
» venlafaxine.

Naproxen 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 naproxen with an anticoagulant should be closely monitored by their doctor.

Naproxen 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 naproxen 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 naproxen is taken with any of the following medicines:

» ACE inhibitors, eg enalapril
» ciclosporin
» diuretics, eg furosemide
» tacrolimus.

Naproxen 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 atenolol
» diuretics such as furosemide.

Probenecid may increase the blood level of naproxen, which may increase the risk of side effects.

Other medicines containing the same active ingredient: Naprosyn & Naprosyn EC

Naproxen tablets and enteric-coated tablets are also available without a brand name, ie as the generic medicine.