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Naproxen and Misoprostol

Make sure your doctor or pharmacist knows if you are pregnant, trying for a baby or breast-feeding.
Tell your doctor if you have a history of stomach problems including stomach ulcers.
Tell your doctor if you have ever had an allergic reaction to any other non-steroidal anti-inflammatory drug.
Avoid driving, operating machinery or doing other tasks which require you to be alert if you feel dizzy.

About naproxen and misoprostol

Type of medicine	Non-steroidal anti-inflammatory drug (NSAID) with a prostaglandin analogue
Used for	Relief from pain and inflammation in conditions such as rheumatoid arthritis, osteoarthritis and ankylosing spondylitis. Prevention of stomach ulcers caused by NSAIDs.
Also called	Napratec OP®
Available as	Tablets

Naproxen and Misoprostol works in two different ways.
Naproxen is a non-steroidal anti-inflammatory drug which works by blocking the action of a substance in the body called cyclo-oxygenase (COX) therefore relieving pain and inflammation. One of the side effects of naproxen is that it can irritate the lining of the stomach.
Misoprostol is a prostaglandin analogue. It copies the action of prostaglandins that live in the stomach and protects the stomach from the irritating effects of naproxen.

Before taking naproxen and misoprostol

Before taking naproxen and misoprostol make sure your doctor or pharmacist knows:

If you are pregnant, trying for a baby or breast-feeding.
If you have a history of stomach problems including stomach ulcers.
If you have a history of allergic disorders.
If you have ever had an allergic reaction to any other NSAID (eg ibuprofen, diclofenac).
If you suffer from heart failure.
If you suffer from asthma.
If you suffer from liver or kidney problems.
If you have high or low blood pressure.
If you suffer from any blood disorders.
If you suffer from a connective tissue disorder (a disease affecting the connective tissues of the body; a connective tissue is any type of biological tissue that supports and protects organs).
If you have a rare hereditary problem (galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption).

How to take naproxen and misoprostol

Take your tablets with or after food.
Each box of Napratec OP® contains two types of tablet, one type contains naproxen the other contains misoprostol.
Take one of each tablet together, as directed by your doctor, usually twice a day.
Make sure that the person prescribing this medicine knows about any other medicines that you are taking. This includes medicines you buy and herbal and homeopathic medicines.

Getting the most from your treatment

Naproxen may make your skin more sensitive to sunlight. Use a sun cream with sun protection factor 15 or more to protect your skin. Avoid strong sunlight and sunbeds.
If diarrhoea is troublesome, speak to your doctor who may reduce the dose or stop treatment. Avoid indigestion remedies containing magnesium.
It is important that you do not get pregnant while taking these tablets. Speak to your doctor or pharmacist for advice on suitable contraception.

Can naproxen and misoprostol cause problems

Along with their useful effects all medicines can cause unwanted side effects, which usually improve as your body adjusts to the new medicine. Speak with your doctor or pharmacist if any of the following side effects continue or become troublesome.

Common side-effects - these affect less than 1 in 10 people who take this medicine	What can I do if I experience this
Feeling or being sick	Eat little and often. Stick to simple foods such as dry toast. If you are sick, drink plenty of liquid.
Headache	Ask your pharmacist to recommend a suitable pain killer.
Dizziness, drowsiness, disturbance of vision	Make sure your reactions are normal before driving, operating machinery or doing any other jobs which could be dangerous if you were not fully alert.
Diarrhoea	Drink plenty of water to replace lost fluids. Take your tablets with food. If diarrhoea persists, speak to your doctor.
Bleeding from the vagina	Speak to your doctor.
Passing wind, constipation	Try to eat a well-balanced diet containing plenty of fibre and drink 6-8 glasses of water each day.
Rashes	Avoid scrubbing the skin; use a soap substitute; leave the affected area exposed to the air as much as possible.

Important - seek medical attention if you notice any of the following:

Any sign of bleeding in the stomach or intestine, for example passing black bowel movements.
A sudden attack of wheezing or shortness of breath.
Blistering or peeling of the skin.
Swelling of the face or throat.
Yellowing of your skin and the whites of your eyes (jaundice).
A constantly sore throat or high temperature.

How to store naproxen and misoprostol

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

Important information about all medicines

Keep all medicines out of the sight and reach of children.
If you buy any medicines check with a pharmacist that they are safe to take with your other medicines.
Before taking this medicine tell your doctor if you have ever had an allergic reaction after taking any medicine.
Never take more than the prescribed dose. If you suspect that you or someone else has taken an overdose of this medicine go to the accident and emergency department of your local hospital at once. Always take the container with you, if possible, even if it is empty.
If you are having any treatment like an operation or dental treatment tell the person carrying out the treatment which medicines you are taking.
Always read the printed information leaflet that comes with your medicine.
This medicine is for you. Never give it to other people even if their condition appears to be the same as yours.
Never keep out of date or unwanted medicines. Take them to your local pharmacy which will dispose of them for you.
If you have any questions about this medicine ask your pharmacist.

References

Summary of Product Characteristics, Napratec OP®, Pharmacia Ltd, electronic Medicines Compendium. Text revised June 2007, accessed January 2008.
British National Formulary; 54th Edition (September 2007) British Medical Association and Royal Pharmaceutical Society of Great Britain, London (link to current BNF).
Manufactuer's PIL, Napratec OP®, Pharmacia Ltd, electronic Medicines Compendium. Dated August 2007, accessed 16 January 2008.

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3422

DocRef:
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Last Updated:
4 Feb 2008

Date of Next Review:
3 Feb 2010

Version:
22

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