Naproxen

Naproxen is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). The active ingredient naproxen reduces fever, inflammation and pain (such as redness and swelling in joints and muscles). Naproxen is used to treat: 

• Diseases of joints such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. 

• Acute tendinitis or bursitis. 

• Arthrosis (joint disease caused by chronic wear of cartilage). 

• Attacks of gout. 

• Pain from surgery or dental procedures. 

• Menstrual pain. 

• Fever. 

The tablets should be taken with a half glass of water, preferably during or directly after a meal. 

Dosage 

Naproxen is available in various strengths. Your doctor will decide which strength is best for you. 

The general recommended dose for adults is: 

• Diseases of joints such as rheumatoid arthritis and osteoarthritis: 375-750 mg a day in two doses, at 12-hour intervals (morning and evening). For severe pain, the usual starting dose is 750 mg a day. In some cases one dose a day is sufficient. 

• Pain and swelling after an operation and period pain: the usual starting dose is 500 mg a day, followed by 250 mg every 8 to 12 hours. 

• Acute gout: the usual starting dose is 750 mg, followed by 500 mg 8 hours later, followed by 250 mg every 8 hours as needed. 

Children aged six and above: the usual dose is 10 mg per kilogram of body weight each day. The total daily dose is split into two doses, to be given 12 hours apart. Do not give more than 15 mg in any 24-hour period. 

Alcohol/driving 

This medicine does not interact with alcohol. 

Naproxen may cause dizziness and drowsiness. Do not drive or operate any tools or machines if affected. 

Naproxen is not suitable for everyone. Do not take this medicine if: 

• You are allergic (hypersensitive) to naproxen, acetylsalicylic acid, indomethacin or other medicines for rheumatic disorders. 

• You have or have had stomach or duodenum (gut) ulcers. 

• You suffer from severe heart failure. 

• You have severe kidney failure. 

• You have chronic stomach problems (e.g., gastritis). 

• You are in the last three months of pregnancy. 

When should Naproxen be used with caution? 

Medicines such as Naproxen 250 mg and Naproxen 500 mg 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. 

Check with your doctor before taking Naproxen tablets if: 

• You have or have a history of gastrointestinal disease (e.g., stomach or duodenum (gut) ulcers). 

• You have a blood clotting disorder (Naproxen could interfere with normal blood clotting, which could raise the risk of bleeding). 

• You have an impaired heart function (this increases the risk of retention of fluids and salts). 

• You have an impaired renal function (with prolonged use you are advised to drink plenty of water). 

• You have an impaired liver function (this increases the risk of side effects). 

• You are elderly or frail (you have a higher risk of getting side effects, therefore your doctor will most likely prescribe a lower dosage). 

• You are under six years of age. 

• Naproxen tablets may hide the symptoms of an infection. 

• 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. 

• You are taking Aspirin or acetylsalicylic acid to prevent blood clots. 

• Severe skin reactions (including Stevens-Johnson syndrome, toxic epidermal necrolysis and drug reaction with eosinophilia and systemic symptoms, the DRESS syndrome) have been reported in patients taking this medicine. Stop taking Naproxen tablets and contact your doctor immediately if you have any symptoms of a severe skin reaction (see section ‘Side Effects’). 

Pregnancy and breastfeeding 

Do not take Naproxen tablets during the last three months of pregnancy. This medicine may affect your unborn child and can cause problems during labour and birth.  

You should not take Naproxen tablets during the first six months of pregnancy, unless absolutely necessary and advised by your doctor. For more information on the risks of the use of Naproxen during pregnancy, please see the package leaflet. 

Do not use this medicine if you are breastfeeding. For more information on the use of Naproxen during breastfeeding, please see the package leaflet. 

Other medicines and Naproxen 

Please tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including medicines obtained without a prescription, herbal medicines or other natural products. 

Naproxen can affect the way some medicines work and some medicines can have an effect on Naproxen. For a list of these medicines, please see the package leaflet. Your doctor will have a list of medicines that you should avoid mixing Naproxen with. 

Common side effects include:  

• Nausea, vomiting, bloating, headache, dizziness, constipation, daytime sleepiness (hypersomnia), ringing in the ears, hypersensitivity reactions (red, itchy patches on the skin), fluid retention and breathing problems. 

Uncommon side effects include:  

• Diarrhoea, heart palpitations, blurred vision, hearing difficulties, sweating and stomach pain. 

Medicines such as Naproxen 250 mg and Naproxen 500 mg may be associated with a small increased risk of heart attack (myocardial infarction) or stroke. Rare side effects include: high blood pressure (hypertension) and heart failure. 

If any of the side effects persist or if you experience side effects that are not listed above, please contact your doctor. Contact your doctor if you have an allergic reaction (skin rash, breathing problems), black tarry looking stools (signs of bleeding and perforation of the stomach and intestines), feel fatigued and develop a sore throat (signs of haematological abnormalities), have yellow discolouration of the skin with stomach pain and a general feeling of being unwell (signs of jaundice), or suffer from insomnia and severe nervousness. 

Stop taking this medicine and talk to your doctor immediately if you have any of the following side effects: 

Frequency not known: cannot be estimated from the available data. 

• Widespread rash, high body temperature, elevated liver enzymes, haematological abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (drug reaction with eosinophilia and systemic symptoms, also known as the DRESS syndrome). See also section ‘Special Warnings’. 

• A distinctive cutaneous allergic reaction known as fixed drug eruption, that usually recurs at the same site(s) on re-exposure to the medication and may look like round or oval patches of redness and swelling of the skin, blistering (hives) and itching. 

• Naproxen 250 mg tablets contain 250 mg of naproxen per tablet.
• Naproxen 500 mg tablets contain 500 mg of naproxen per tablet.