About naproxen and misoprostol

Napratec® OP is a combination pack containing two types of tablet, naproxen and misoprostol. It is used to relieve pain and inflammation in rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.

Naproxen is a non-steroidal anti-inflammatory drug. It is also known as an NSAID. It works by blocking a substance in the body called cyclo-oxygenase (also known as COX) which is involved in the production of certain irritant chemicals in response to disease. By blocking the action of COX, naproxen reduces the symptoms of pain and inflammation.

One of the side-effects of naproxen is that it can irritate the lining of the stomach. Misoprostol helps to protect the stomach against irritation and ulcers which can be caused by taking naproxen over a long period of time. It works by copying the action of protective chemicals in the stomach, called prostaglandins.

Before taking naproxen and misoprostol

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking these tablets it is important that your doctor or pharmacist knows:

• If you are a woman and have not yet been through the menopause.
• If you have asthma or any other allergic disorder.
• If you have ever had stomach or bowel problems, such as an ulcer or an inflammatory bowel disorder.
• If you have a heart condition or any disease of your blood vessels.
• If you have low or high blood pressure.
• If you have ever had blood clotting problems.
• If you have blood in your stools.
• If you have liver or kidney problems.
• If you have a connective tissue disorder such as systemic lupus erythematosus (an inflammatory condition also called lupus or SLE).
• If you are taking other medicines, including those available to buy without a prescription, herbal and complementary medicines.
• If you have ever had an allergic or unusual reaction to any other NSAID (this includes aspirin, ibuprofen, diclofenac and indometacin) or to any other medicine.

How to take naproxen and misoprostol

• Before you start these tablets, read the manufacturer's printed information leaflet from inside the pack. The leaflet will give you more information about Napratec® and a full list of possible side-effects from taking it.
• Take these tablets exactly as your doctor has told you. Your dose will also be on the label of the pack. You should take one white tablet and one yellow tablet together, twice each day. Take the tablets with or straight after a meal.
• Try to take Napratec® at the same times each day. This will help you to remember to take your doses.
• If you do forget to take a dose, take it as soon as you remember unless it is nearly time for your next dose, in which case leave out the missed tablets. Do not take two doses together to make up for a forgotten dose.

Getting the most from your treatment

• Keep your regular doctor's appointment so your progress can be monitored.
• If you are a woman who has not yet been through the menopause, it is important that you speak with your doctor about suitable contraception. You must not become pregnant while you are taking these tablets.
• If you are having an operation or dental treatment, tell the person carrying out the treatment that you are taking these tablets.
• If you buy any medicines, check with a pharmacist that they are suitable to take with these tablets.

Can naproxen and misoprostol cause problems?

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. These usually improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following side-effects continue or become troublesome.

Important: if you get any of the following, speak with your doctor or go to your local accident and emergency department straightaway:

• Any sign of bleeding in your stomach or intestine, such as blood in vomit or dark stools.
• Any wheezing or shortness of breath, or any swelling of your mouth or face.
• A severe skin rash.
• A severe headache with a high temperature and a stiff neck.

If you experience any other symptoms which you think may be due to this medicine, discuss them with your doctor or pharmacist.

How to store naproxen and misoprostol

• Keep all medicines out of the reach and sight of children.
• Store in a cool, dry place, away from direct heat and light.

Important information about all medicines