Napratec (naproxen, misoprostol)

- This medicine may cause dizziness 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.
- Although the misoprostol in Napratec is included to reduce the risk of naproxen side effects on the gut, these types of side effects are still possible. They are 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. 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.
- Studies have suggested that use of some NSAIDs may be associated with a small increase in the risk of heart attacks and stroke (particularly if used in high doses or for long periods of time). If you have risk factors for heart disease or stroke, such as diabetes, high blood pressure, high cholesterol or smoking, your doctor will need to assess the overall benefits and risks before deciding if this medicine is suitable for you. You should tell your doctor if you experience shortness of breath, chest pains or ankle swelling while taking the medicine. Ask your doctor or pharmacist for further information.
- 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 have any problems with your heart, liver or kidneys your kidney function should be regularly monitored while you are taking 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.
- 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.
- Decreased kidney function.
- Decreased liver function.
- Heart failure.
- 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.
- Poor circulation in the arteries of the legs or feet (peripheral arterial disease).
- History of high blood pressure.
- Raised levels of fats such as cholesterol in the blood (hyperlipidaemia).
- Diabetes.
- Smokers.
- History of disorders affecting the stomach or intestines, such as ulceration or bleeding.
- Inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
- People with blood clotting disorders or taking anticoagulant medicines.
- History of asthma.
- History of allergies.
- Diseases affecting connective tissue, eg systemic lupus erythematosus.

Not to be used in

- Pregnancy.
- Women planning a pregnancy. (Women who could get pregnant should use an effective method of contraception to prevent pregnancy while taking this medicine - see below).
- Breastfeeding.
- Active stomach or intestinal ulcer.
- 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).
- Severe heart failure.
- Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (the tablets contain lactose).
- This medicine is not recommended for children.

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 must not be used by women who are pregnant, or who are planning a pregnancy, because it can be harmful to an unborn baby. Misoprostol mimicks the effects of prostaglandins involved in starting labour and causes contractions of the womb. This could result in a miscarriage. Naproxen 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.
- Women who could get pregnant must use an effective method of contraception to prevent pregnancy while they are taking this medicine. Seek medical advice from your doctor. If you think you could be pregnant at any point during treatment you should stop taking this medicine and consult your doctor immediately.
- There is no information available about the safety of this medicine during breastfeeding. For this reason, the manufacturer states that it should not be used by women who are breastfeeding. Seek further medical advice from your doctor.

Label warnings

- Take this medication with or after food.

The documents contained in this web site are presented for information purposes only. The material is in no way intended to replace professional medical care or attention by a qualified practitioner. The materials in this web site cannot and should not be used as a basis for diagnosis or choice of treatment. Conditions for use © Copyright 1998 - 2008 NetDoctor.co.uk - All rights reserved