Pardelprin MR

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How does it work?

Pardelprin MR modified release capsules contain the active ingredient indometacin (previously spelt indomethacin in the UK), which is a type of medicine called a non-steroidal anti-inflammatory drug (NSAID). (NB. Indometacin is also available without a brand name, ie as the generic medicine.)

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

Indometacin 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, tendinitis and pain following orthopaedic procedures. It can also be used to relieve period pain.

Pardelprin MR modified release capsules are designed to release the indometacin slowly and continuously over several hours. This provides prolonged pain relief, so these capsules are taken once or twice a day, as directed by your doctor. The capsules must be swallowed whole to avoid damaging the modified release action.

The capsules should preferably be taken with food to help avoid irritating the stomach.

What is it used for?

In adults, relief of pain and inflammation in a wide range of conditions, including the following:

- Rheumatoid arthritis
- Osteoarthritis
- A form of arthritis affecting the joints of the spine (ankylosing spondylitis)
- Acute gout
- Acute inflammatory disorders of the joints, such as tendon inflammation (tendinitis), bursitis, tenosynovitis, capsulitis
- Painful disorders of the muscles and skeleton, such as sprains, strains, dislocations, fractures
- Lower back pain
- Pain and inflammation following orthopaedic (bone) surgery or other orthopaedic procedures
- Painful periods

Warning!

- Pardelprin MR capsules should be swallowed whole with water and not broken, chewed or crushed. They should be taken with or after food to help avoid irritating the stomach.
- 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 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 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.
- During long-term treatment with this medicine it is also recommended that you have regular eye examinations, as it can sometimes cause eye problems. Consult your doctor if you experience any disturbances in your vision while taking this medicine.
- 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.

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
- History of asthma
- History of allergies
- People with blood clotting disorders or taking anticoagulants
- Epilepsy
- Parkinson's disease
- Psychiatric disorders

Not to be used in

- Children
- 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
- Pregnancy
- Breastfeeding.

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 should not be used during pregnancy. 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. Women who are breastfeeding should not use this medicine. Seek medical advice from your doctor.

Label warnings

- Take this medication with or after food.
- This medication is to be swallowed whole, not chewed.

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