How does it work?

Lodotra modified-release tablets contain the active ingredient prednisone, which is a type of medicine known as a corticosteroid.

Corticosteroids are hormones that are produced naturally by the adrenal glands. They have many important functions in the body, including control of inflammatory responses. Corticosteroid medicines are man-made derivatives of the natural hormones. They are often simply called steroids, but it should be noted that they are very different from another group of steroids, called anabolic steroids, which have gained notoriety because of their abuse by some athletes and body builders.

Prednisone decreases inflammation by acting within cells to prevent the release of certain chemicals that are important in the immune system. These chemicals are normally involved in producing immune and allergic responses. By decreasing the release of these chemicals in a particular area, inflammation is reduced. This can help control a wide number of disease states characterised by excessive inflammation, including inflammation of the joints in arthritis.

Arthritis symptoms of joint pain and stiffness are often worse first thing in the morning. Lodotra tablets are designed to release prednisone in a way that particularly helps with these morning symptoms.

Lodotra tablets are modified-release tablets. They are designed to start releasing the prednisone about four to six hours after taking the tablet. You should take the medicine at bedtime so that the prednisone is released during the night. This will act on the inflammation over the night and will help to reduce the early morning joint pain and stiffness.

What is it used for?

• Moderate to severe rheumatoid arthritis in adults, particularly if joint pain and stiffness is worse in the morning.

How do I take it?

• Lodotra tablets should be taken before going to bed at night, at about 10pm.
• The tablets should be swallowed whole with liquid. They should not be broken, crushed or chewed, as this will affect their modified-release action.
• The tablets should be taken with or after food. If two or three hours have passed since your evening meal then you should have a light snack before taking the tablets. Taking these tablets on an empty stomach can reduce the amount of prednisone absorbed into the blood and could make it less effective.

Warning!

• You must not stop taking this medicine suddenly if you have been taking it for more than three weeks. This is because long-term use of corticosteroids can suppress the natural production of corticosteroids by the adrenal glands, which means that the body becomes temporarily reliant on the medicine. When it is time to stop treatment the dose should be tapered down gradually, to allow the adrenal glands to start producing adequate amounts of natural steroids again. Follow the instructions given by your doctor or pharmacist. Your doctor may also want you to stop treatment gradually if you have been taking a high dose for more than a week; if you have recently taken repeated short courses; if you have taken a short course within a year of stopping long-term treatment; if you had problems with your adrenal glands before treatment was started; or if you have been repeatedly taking doses in the evening.
• You will be given a steroid card with this medicine that you should carry with you at all times. Show it to anyone who treats you (eg doctor, nurse, pharmacist, dentist or anaesthetist).The card contains details of your prescriber, type of steroid, dose taken and the duration of treatment. Its purpose is to act as a reminder that your medicine should not be stopped suddenly, and to provide information of your treatment to other people treating you. This is important because the effects that corticosteroids have on the body may affect other medical treatment you may be given.If you have an accident the card contains information that could save your life. You should also show your steroid card to anyone who treats you for three months after you stop treatment with steroids.
• During times of physical stress, for example illnesses, trauma or surgery, your adrenal glands would normally produce more steroid hormones to cope. However, during long-term treatment with this medicine the action of your adrenal glands will be suppressed, so this increase in hormones won't happen naturally. As a result your steroid dose will normally need to be increased temporarily during these kinds of events. Discuss this with your doctor.
• Corticosteroids decrease the body's natural immune and inflammatory responses. They may increase your susceptibility to infections and can also mask the symptoms of infections, making you think they are less serious than they are. For this reason, it is important to consult your doctor if you get any signs of infection during treatment.
• If you have never had chickenpox you could be at risk of severe chickenpox while having treatment with this medicine and should avoid close personal contact with people who have chickenpox or shingles (herpes zoster). You should also avoid contact with people who have measles. If you are exposed to people with these diseases either during treatment, or in the three months after stopping treatment, you should consult your doctor urgently, as you will need an injection of immunoglobulin to help you stop getting the diseases. This is very important as these diseases can be life-threatening in people treated with long-term corticosteroids.
• Corticosteroid treatment, especially with high doses, can alter mood and behaviour early in treatment. People may experience confusion, irritability, nightmares, difficulty sleeping, mood changes and depression, and suffer from delusions and suicidal thoughts. In a few cases these effects have also occurred when corticosteroid treatment is being withdrawn. For this reason, it is important to let your doctor know if you notice any change in your mood or behaviour during treatment or when stopping treatment, particularly if you begin to feel depressed, or have any disturbing thoughts or feelings. Most of these problems go away if the dose is lowered or the medicine is stopped. However if problems do happen they might need treatment.

Use with caution in

• Elderly people.
• Decreased kidney function.
• Liver failure.
• Liver cirrhosis.
• Peptic ulcer.
• Inflammation of the bowel and back passage (ulcerative colitis).
• Painful inflammation of small sacs or pouches in the wall of the gut (diverticulitis).
• People who have recently had a surgical procedure called intestinal anastomosis, which involves the joining together of ends of the intestine after a section has been removed.
• People at risk of blood clots in the blood vessels (thromboembolism).
• Heart failure.
• People who have recently had a heart attack.
• High blood pressure (hypertension).
• Diabetes, or a family history of diabetes.
• Underactive thyroid gland (hypothyroidism).
• Epilepsy.
• Glaucoma, or a family history of glaucoma.
• People with ulceration or injury of the cornea.
• Herpes simplex virus infection of the eye.
• Current severe psychiatric illness, or a personal or family history of psychiatric illness, including depression, manic depression or schizophrenia.
• History of psychiatric illness caused by the use of a corticosteroid.
• Osteoporosis.
• Women who have passed the menopause.
• Abnormal muscle weakness (myasthenia gravis).
• People who have previously experienced muscle disorders (myopathy) caused by steroids.
• People with a history of tuberculosis (TB).
• People with abscesses or other pus-producing infections.
• People with a low level of potassium in their blood (hypokalaemia).

Not to be used in

• People with widespread infection, unless this is being treated with specific anti-infectives.
• Corticosteroids should not be used for the management of head injury or stroke because they are unlikely to be of benefit and may even be harmful.
• Rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Lodotra tablets contain lactose).
• This medicine is not recommended for children and adolescents.

This medicine should not be used if you are allergic to 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 be used with caution during pregnancy, and only if the expected benefit to the mother is greater than any possible risk to the developing baby. When administered for long periods or repeatedly during pregnancy, corticosteroids may increase the risk of slowed growth in the developing baby. They may also cause the baby to make less of its own steroid hormones after birth, though this usually resolves on its own and rarely causes any problems. Seek further medical advice from your doctor.
• If you think you could be pregnant while you are taking this medicine you should consult your doctor for advice. It is important that you do not suddenly stop taking the medicine unless your doctor tells you to - see the warnings above.
• This medicine passes into breast milk. It should be used with caution in mothers who are breastfeeding and only if the benefits to the mother outweigh any risks to the nursing infant. Doses of up to 10mg prednisone daily taken by the mother are unlikely to significantly affect the baby, but if the mother is taking higher than 10mg doses for long periods of time, the medicine could cause the baby's adrenal glands to make less of their own steroid hormones. Seek medical advice from your doctor.

Label warnings

• This medication is to be swallowed whole, not chewed or broken.
• Take with or just after food, or a meal.
• Follow the printed instructions you have been given with this medication.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Common (affect between 1 in 10 and 1 in 100 people)

• Headache.
• Increased appetite and weight gain.
• Cushing's syndrome, characterised by a moon-shaped face.
• Decrease in the production of natural steroids by the adrenal glands (adrenal suppression – see warning section above).
• Increased susceptibility to infections and increased severity of infections (see warnings above).
• Sodium and water retention.
• Decrease in the level of potassium in the blood.
• Raised blood sugar level and diabetes.
• Raised levels of triglycerides in the blood (hypertriglyceridaemia).
• Raised levels of cholesterol in the blood. (hypercholesterolaemia).
• Eye problems such as cataract or glaucoma.
• Insomnia (tell your doctor if you have lots of difficulty sleeping, as other steroids not taken at night may be better for you).
• Disturbance in the normal numbers of blood cells in the blood.
• Skin reactions such as skin thinning, stretch marks, bruising.
• Muscle weakness or wasting.
• Thinning of the bones (osteoporosis) and increased risk of breaking a bone.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• High blood pressure (hypertension).
• Thickening of arterial walls (arteriosclerosis).
• Formation of blood clots in the blood vessels.
• Peptic ulcers.
• Bleeding in the gut.
• Change in skin pigmentation.
• Increased hair growth (hirsutism).
• Acne.
• Delayed healing of wounds.

Rare (affect between 1 in 1000 and 1 in 10000 people)

• Psychiatric reactions, such as mood changes (including irritability and depression) or psychotic reactions (including mania, delusions and hallucinations) - see warning section above.
• Inflammation of the pancreas (pancreatitis).
• Disturbance of thyroid function.
• Disturbance of the menstrual cycle, including stopping of periods.
• Impotence.
• Allergic reactions.

The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines while taking this one, to make sure that the combination is safe.

Prednisone can cause fluid and salt retention and so may oppose the effects of the following medicines:

• antihypertensive medicines used to treat high blood pressure
• diuretics, eg furosemide.

The following medicines may increase the removal of prednisone from the body, thus reducing its effects. You may need a larger dose of prednisone if you are also taking any of these medicines:

• barbituates, eg amobarbital,phenobarbital
• carbamazepine
• phenytoin
• primidone
• rifabutin
• rifampicin.

There may be an increased chance of the level of potassium in the blood falling too low (hypokalaemia) if prednisone is used in combination with any of the following medicines, which can also lower the amount of potassium in the blood:

• acetazolamide
• amphotericin (should not be used with prednisone)
• beta agonists, eg salbutamol, salmeterol, terbutaline
• carbenoxolone
• potassium-losing diuretics, eg furosemide, bendroflumethiazide
• theophylline.

If the amount of potassium in the blood falls too low as a result of taking prednisone, this can increase the risk of side effects from digoxin.

Prednisone may increase blood sugar levels and so may oppose the blood sugar lowering effects of antidiabetic medicines such as insulin and metformin. People with diabetes may need an increase in their dose of insulin or antidiabetic tablets.

Prednisone may enhance or reduce the anti-blood-clotting effect of anticoagulant medicines such as warfarin. People taking anticoagulant medicines in combination with prednisone should have their blood clotting time (INR) regularly monitored, particularly after starting or stopping treatment with prednisone and after any dose changes.

If prednisone is used in combination with non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, diclofenac or naproxen) there may be an increased risk of side effects on the gut, such as stomach ulceration and bleeding.

Prednisone may decrease the blood levels of salicylates such as aspirin. When prednisone is stopped in people taking regular salicylates, the blood level of the salicylate may subsequently rise excessively, unless the dose is readjusted.

Prednisone may decrease the body's immune response. Thismeans that vaccines may be less effective if given during treatment, becausethe body does not produce sufficient antibodies. Live vaccines may causeserious infections. Live vaccines include: measles, mumps, rubella, MMR, BCG, chickenpox, oralpolio, oral typhoid and yellow fever. These should not be given to peoplewhose immune system is underactive due to treatment with this medicine.

The effect of corticosteroids may be reduced in the three to four days following use of mifepristone.

The following medicines may reduce the removal of prednisone from the body and so may increase its effects or side effects:

• ciclosporin (prednisone may also increase the blood level and risk of side effects of ciclosporin)
• itraconazole
• ketoconazole
• liquorice (found in many OTC cough remedies and throat lozenges)
• macrolide-type antibiotics, eg erythromycin
• oestrogens (found in contraceptives and hormone replacement therapy)
• protease inhibitors, eg ritonavir.

The effect of the following medicines may be reduced by prednisone:

• the growth hormone somatropin
• the anti-parasitic medicine praziquantel.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain prednisone as the active ingredient.