LODOTRA 1 MG MODIFIED-RELEASE TABLETS
Active substance: PREDNISONE
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XXXXXX-MMYY
UK00BZT04
Prednisone
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What Lodotra is and what it is used for 2.Before you take Lodotra 3.How to take Lodotra 4.Possible side effects 5.How to store Lodotra 6.Further information 1. What Lodotra is and what it is used for Lodotra is a tablet with a delayed release behaviour of the active compound prednisone, which is a corticosteroid. Corticosteroids have an anti-inflammatory action. Antiinflammatory medicines reduce pain, swelling, stiffness, redness and heat in affected joints. These tablets are used to treat: moderate to severe, active rheumatoid arthritis in adults, particularly when accompanied by morning stiffness These tablets are modified-release tablets. This means that they are designed to release prednisone approximately 4 hours after swallowing. This allows you to take Lodotra at bedtime and feel an improvement in your early morning symptoms such as stiffness.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
XXXXXX-MMYY
Lodotra 1 mg, 2 mg and 5 mg modified-release tablets
Do NOT take Lodotra if you are allergic (hypersensitive) to prednisone or any of the other ingredients of these tablets (see section 6 of this leaflet). Take special care with Lodotra You must tell your doctor if you have (at the moment) or have had (in the past) any of the following conditions or treatments: too high a level of sugar (glucose) in your blood (diabetes). Your doctor may increase your diabetes medication and closely monitor your treatment. weakened bones (osteoporosis). softened bones (osteomalacia). ulcers of the stomach and bowel. severe ulcerative colitis (inflammation of the colon) with high risk of a perforation (hole) in the colon. inflammation of the bowel (diverticulitis). immediately after surgery to connect two parts of your bowel (entero-anastomosis). hepatitis B (a liver disease caused by a virus). tuberculosis (TB) which is a bacterial infection usually affecting the lungs or if you have swelling and inflammation of the lymph nodes after BCG vaccination (a vaccination against TB). polio (an infectious disease caused by a virus affecting the nervous system). acute viral infection (e.g. chickenpox, lip or eye herpes, measles or shingles). acute bacterial infection (e.g. bacterial tonsillitis) or chronic bacterial infections (e.g.TB).
Other things you should know about Lodotra These tablets can affect your immune system. This affects your bodys ability to fight disease. If your immune system is affected: vaccination with an inactivated vaccine (e.g. flu or cholera vaccines) may not be as effective if you are taking, or start taking these tablets. certain viral diseases (chicken pox and measles) may be more severe. You are at particular risk if you have not been vaccinated against these diseases. you may be at a greater risk of other severe infections. Your treatment with these tablets may make you more likely to develop an infection. If you are developing an infection, it may be more difficult to be detected while you are taking these tablets. You may need a smaller dose of these tablets if you have: hypothyroidism (an underactive thyroid gland); cirrhosis of the liver (liver disease caused by alcoholism or hepatitis). You may need a higher dose of these tablets during stressful events such as: a surgical procedure; during infection.
UK00BZT04
Package leaflet : Information for the user
: 2. Before you take Lodotra
acute fungal infection (e.g. thrush). parasitic infection (e.g. roundworms). high blood pressure. You may need more frequent blood pressure checks. eye diseases (glaucoma). You may need closer monitoring of your conditions. injuries or ulcers on the cornea (the transparent front of the eye that covers the iris and pupil). heart problems. You may need closer monitoring of your condition. mental illness. sleep disorder occurs during the treatment and does not improve. In these situations your doctor may prescribe a different medicine. Also tell your doctor if you have recently had (within the last 2 weeks) or plan to have (within the next 8 weeks) a vaccination. These tablets cannot achieve the desired blood concentration of prednisone if taken under fasting conditions. Therefore, these tablets should always be taken with or after the evening meal in order to ensure they work properly. In addition, low plasma concentrations may occur in 6%7% of doses when taken according to the recommendations. This should be considered if these tablets are not sufficiently effective. In these situations your doctor may prescribe a different medicine. Lodotra is a tablet with a delayed release behaviour of the active compound prednisone. Therefore it should only be used to treat the conditions described in section 1 What Lodotra is and what it is used for.
In one of the treatments or conditions above a different type of medicine may be more suitable for you. See also Other things you should know about Lodotra. Your doctor will advise you on what to do.
If you take these tablets for several months or more, your doctor will carry out regular checkups including: eye examination; blood test; blood pressure check. Treatment with these tablets may have a negative effect on the way calcium is metabolised in your bones. Therefore, you should clarify with your doctor the risk of osteoporosis (bone loss and fractures), particularly if you have family members who have a history of bone fractures, you do not take exercise regularly, you are a woman during or after menopause or if you are elderly. When stopping these tablets there is a risk of: the symptoms of your rheumatoid arthritis returning; adrenal failure. This is when your adrenal gland does not produce enough cortisol (a hormone). This is especially likely in stressful situations such as: during infections; after accidents; when you are under increased physical strain; cortisone withdrawal syndrome (a serious illness caused by your body not producing cortisol). Your doctor will advise you what to do.
The effects of the following medicines may be increased by these tablets: heart medication such as cardiac glycosides (e.g. digoxin); laxatives or salt depleting drugs such as some diuretics (water tablets); ciclosporin, a drug used after transplant surgery or occasionally in severe rheumatoid arthritis; muscle relaxants, such as suxamethonium, used in hospitals; cyclophosphamide, a treatment for various types of cancer. The effects of the following medicines may be decreased by these tablets: somatropin, a growth hormone; praziquantel, a treatment for parasitic infections; diabetes medicines, e.g. insulin, metformin, glibenclamide. The following medicines may reduce the effect of these tablets on your rheumatoid arthritis symptoms: treatments for epilepsy such as barbiturates, phenytoin and primidone; rifampicin, a treatment for infection; bupropion, a treatment to help you stop smoking or for depression; aluminium and magnesium antacids. The following medicines may increase the effect of these tablets on your rheumatoid arthritis symptoms: oestrogen containing medicines, for example oral contraceptives, Hormone Replacement Therapy (HRT);
liquorice (used as an expectorant in cough medicines and also present in confectionery). Other effects of medicines: non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid, diclofenac and ibuprofen increase the risk of gastrointestinal bleeding; warfarin may have reduced or increased blood thinning effects depending upon the individual; treatment with ACE inhibitors (e.g. captopril or enalapril) for high blood pressure or heart failure may increase the risk of changes in the numbers of blood cells; anticholinergic medicines (e.g. atropine) may increase the risk of raised pressure in the eye (glaucoma); medications to treat or prevent malaria (e.g. chloroquine, hydroxychloroquine, mefloquine) may increase the risk of muscle weakness, including heart muscle weakness; amphotericine B, an antifungal drug, may increase the risk of hypokalaemia; some diagnostic tests may be affected, for example: skin tests for allergies; a blood test to measure your levels of a hormone produced by the thyroid gland Your doctor will advise you on what to do.
Directions for opening and closing the container: Please follow the instructions below:
ope n
Pregnancy and breastfeeding Ask your doctor for advice before taking any medicine. Pregnancy You must tell your doctor if you think you may be pregnant or you are planning to have a baby. Your doctor will advise you if you can take these tablets. Breastfeeding The active substance of these tablets passes into breast milk. Your doctor will advise you if you can take these tablets while breastfeeding. Driving and using machines These tablets are unlikely to affect your ability to drive or using machines. However, if you develop eye pain or a blurred vision during the treatment, you should avoid these activities. Important information about some of the ingredients of your Lodotra modified-release tablets The medicinal product contains a sugar called lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking these tablets.
Manufacturer Horizon Pharma GmbH, Joseph-Meyer-Str. 13-15, 68167 Mannheim, Germany.
op
en
If you forget to take Lodotra You should contact your doctor on how to proceed. If you stop taking Lodotra Do not suddenly stop taking your tablets. If you stop taking these tablets your rheumatoid arthritis symptoms may return. It is important that your dose is reduced slowly. Your doctor will advise you how to reduce your dose gradually. Lodotra should not be substituted by prednisone immediate-release tablets without first talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Method of administration: How to open and close the bottle especially designed for rheumatoid arthritis patients: see Directions for opening and closing the container. Take the number of tablets that your doctor has told you. Do not break the tablet as the coating is important for these tablets to work properly. Swallow the tablets whole: Do not break, divide or chew the tablets. Take the tablets in the evening (usually at about 10 pm) with a glass of water. You should take these tablets with or after the evening meal. If more than 23 hours. have passed since eating, take the tablet with a light meal or snack.
To Open Place pen or similar object between the raised sections of the lid and turn in the direction shown (anticlockwise).
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on: You will need to give details of the product name and reference number. These are as follows: Product name:Lodotra Reference number:16950/0173
This leaflet was last revised in May 2011. Lodotra is a registered trade mark of Horizon Pharma AG, and is used under licence. NAPP and the NAPP device (logo) are registered trade marks of the Napp Pharmaceutical Group. 2010 - 2011 Napp Pharmaceuticals Limited.
To Close Place pen or similar object between the raised sections of the lid and turn in the direction shown (clockwise).
What Lodotra contains The active substance is prednisone. Each modified-release tablet contains 1mg, 2mg or 5 mg of prednisone. The other ingredients are: Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate Magnesium stearate Povidone K 29/32 Red ferric oxide E 172 Calcium hydrogen phosphate dihydrate Glycerol dibehenate Yellow ferric oxide E 172.
0800 198 5000
close
c lo s e
XXXXXX-MMYY
Taking Lodotra with food and drink Take your tablets in the evening usually around 10 pm. Ideally, you should take your tablets with or after your evening meal. You should swallow the tablets whole, with sufficient liquid, e.g. glass of water. You should not break, divide or chew the tablets. If more than 23 hours have passed since eating, you should take your tablets with a light meal or snack.
Always take the tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose your doctor will prescribe will depend on the severity of your disease. This should not usually be more than 10 mg prednisone per day. Your starting dose may be reduced on your doctors advice in steps to a lower maintenance dose depending on: your rheumatoid arthritis symptoms; your response to Lodotra. If you are changing over from taking standard corticosteroid tablets in the morning to taking Lodotra in the evening, your dose should contain the same amount of active substance (prednisone).
Like all medicines Lodotra can cause side effects although not everybody gets them. The frequency and severity of the undesirable effects listed below depend on dosage and duration of treatment. Common side effects (less than 1 in 10 people but more than 1 in 100 people taking these tablets): A hormone imbalance causing Cushings syndrome (typical symptoms: a round face often called a moon face, upper body weight gain and rash on the face) as well as a reduced production of glucocorticoids in the body. Disturbances of the balance of sugars, fats and salts in the body possibly resulting in: increased appetite and weight gain; diabetes; high cholesterol; heart rhythm disturbances (because of increased potassium excretion); accumulation of water (oedema, because of reduced sodium excretion). Reduced ability to fight infections, infections may be more severe or the symptoms may be masked. Clouding of the lens (cataract) and increased pressure in the eye (glaucoma) with or without eye pain. Stretch marks, bruising or red marks on the skin or in the mouth, wasting of the skin. An increase or decrease in the number of blood cells. Muscle wasting and weakness. Bone wasting resulting in an increased risk of bone fractures (osteoporosis).
Keep out of the reach and sight of children. Do not take these tablets after the expiry date which is stated on the bottle and the carton. The expiry date refers to the last day of that month. Do not store above 25C. Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment. : 6. Further information
Marketing authorisation holder Napp Pharmaceuticals Ltd, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom.
UK00BZT04
3. How to take Lodotra
Always take the tablets after dinner or a light snack (see section 2 Take special care). These modified-release tablets are usually taken for several months or longer. Your doctor will talk to you about how long you need to take your tablets.
If you take more Lodotra than you should Acute intoxications with these tablets are not known. In case of overdosing, you are likely to experience an increase in undesirable effects including: disturbances in hormone function; effects on your metabolism; effects on your electrolyte (salt) balance, leading to increased risk of abnormal heartbeats. Contact your doctor if you are concerned or experience an increase in side effects.
4. Possible side effects
Difficulty in sleeping. Headache. Uncommon side effects (less than 1 in 100 people but more than 1 in 1000 people taking these tablets): High blood pressure. Thickening or inflammation of the lining of the blood vessels and blood clots. Stomach ulcers and bleeding in the bowel. Increased hair growth, spots and other skin blemishes, delayed healing of skin wounds, acne. Rare side effects (less than 1 in 1000 people but more than 1 in 10000 people taking these tablets): Allergic reactions including blistering on the skin. Inflammation of the pancreas causing severe abdominal pain. Disturbances in sex hormone secretion, possibly resulting in absence of monthly periods in women or impotence in men. Disturbance of the thyroid function. Depression (feeling sad), irritability, feelings of happiness that are not justified by reality, increased impulse, loss of contact with reality (psychosis). Increased pressure in the head resulting in headache, vomiting and double vision. Development or worsening of epileptic fits. Worsening of existing eye ulcers or infections. Loss of bone (osteonecrosis).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. : 5. How to store Lodotra
What Lodotra looks like and contents of the pack The 1 mg modified-release tablets are pale yellowish-white, circular with NP1 embossed on one side. The 2 mg modified-release tablets are yellowish-white, circular with NP2 embossed on one side. The 5 mg modified-release tablets are light yellow, circular with NP5 embossed on one side. In each bottle there are 30 or 100 tablets.
Marketing authorisation holder and manufacturer
UK00BZT04
Prednisone
Read all of this leaflet carefully before you start taking this medicine. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1.What Lodotra is and what it is used for 2.Before you take Lodotra 3.How to take Lodotra 4.Possible side effects 5.How to store Lodotra 6.Further information 1. What Lodotra is and what it is used for Lodotra is a tablet with a delayed release behaviour of the active compound prednisone, which is a corticosteroid. Corticosteroids have an anti-inflammatory action. Antiinflammatory medicines reduce pain, swelling, stiffness, redness and heat in affected joints. These tablets are used to treat: moderate to severe, active rheumatoid arthritis in adults, particularly when accompanied by morning stiffness These tablets are modified-release tablets. This means that they are designed to release prednisone approximately 4 hours after swallowing. This allows you to take Lodotra at bedtime and feel an improvement in your early morning symptoms such as stiffness.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
XXXXXX-MMYY
Lodotra 1 mg, 2 mg and 5 mg modified-release tablets
Do NOT take Lodotra if you are allergic (hypersensitive) to prednisone or any of the other ingredients of these tablets (see section 6 of this leaflet). Take special care with Lodotra You must tell your doctor if you have (at the moment) or have had (in the past) any of the following conditions or treatments: too high a level of sugar (glucose) in your blood (diabetes). Your doctor may increase your diabetes medication and closely monitor your treatment. weakened bones (osteoporosis). softened bones (osteomalacia). ulcers of the stomach and bowel. severe ulcerative colitis (inflammation of the colon) with high risk of a perforation (hole) in the colon. inflammation of the bowel (diverticulitis). immediately after surgery to connect two parts of your bowel (entero-anastomosis). hepatitis B (a liver disease caused by a virus). tuberculosis (TB) which is a bacterial infection usually affecting the lungs or if you have swelling and inflammation of the lymph nodes after BCG vaccination (a vaccination against TB). polio (an infectious disease caused by a virus affecting the nervous system). acute viral infection (e.g. chickenpox, lip or eye herpes, measles or shingles). acute bacterial infection (e.g. bacterial tonsillitis) or chronic bacterial infections (e.g.TB).
Other things you should know about Lodotra These tablets can affect your immune system. This affects your bodys ability to fight disease. If your immune system is affected: vaccination with an inactivated vaccine (e.g. flu or cholera vaccines) may not be as effective if you are taking, or start taking these tablets. certain viral diseases (chicken pox and measles) may be more severe. You are at particular risk if you have not been vaccinated against these diseases. you may be at a greater risk of other severe infections. Your treatment with these tablets may make you more likely to develop an infection. If you are developing an infection, it may be more difficult to be detected while you are taking these tablets. You may need a smaller dose of these tablets if you have: hypothyroidism (an underactive thyroid gland); cirrhosis of the liver (liver disease caused by alcoholism or hepatitis). You may need a higher dose of these tablets during stressful events such as: a surgical procedure; during infection.
UK00BZT04
Package leaflet : Information for the user
: 2. Before you take Lodotra
acute fungal infection (e.g. thrush). parasitic infection (e.g. roundworms). high blood pressure. You may need more frequent blood pressure checks. eye diseases (glaucoma). You may need closer monitoring of your conditions. injuries or ulcers on the cornea (the transparent front of the eye that covers the iris and pupil). heart problems. You may need closer monitoring of your condition. mental illness. sleep disorder occurs during the treatment and does not improve. In these situations your doctor may prescribe a different medicine. Also tell your doctor if you have recently had (within the last 2 weeks) or plan to have (within the next 8 weeks) a vaccination. These tablets cannot achieve the desired blood concentration of prednisone if taken under fasting conditions. Therefore, these tablets should always be taken with or after the evening meal in order to ensure they work properly. In addition, low plasma concentrations may occur in 6%7% of doses when taken according to the recommendations. This should be considered if these tablets are not sufficiently effective. In these situations your doctor may prescribe a different medicine. Lodotra is a tablet with a delayed release behaviour of the active compound prednisone. Therefore it should only be used to treat the conditions described in section 1 What Lodotra is and what it is used for.
In one of the treatments or conditions above a different type of medicine may be more suitable for you. See also Other things you should know about Lodotra. Your doctor will advise you on what to do.
If you take these tablets for several months or more, your doctor will carry out regular checkups including: eye examination; blood test; blood pressure check. Treatment with these tablets may have a negative effect on the way calcium is metabolised in your bones. Therefore, you should clarify with your doctor the risk of osteoporosis (bone loss and fractures), particularly if you have family members who have a history of bone fractures, you do not take exercise regularly, you are a woman during or after menopause or if you are elderly. When stopping these tablets there is a risk of: the symptoms of your rheumatoid arthritis returning; adrenal failure. This is when your adrenal gland does not produce enough cortisol (a hormone). This is especially likely in stressful situations such as: during infections; after accidents; when you are under increased physical strain; cortisone withdrawal syndrome (a serious illness caused by your body not producing cortisol). Your doctor will advise you what to do.
The effects of the following medicines may be increased by these tablets: heart medication such as cardiac glycosides (e.g. digoxin); laxatives or salt depleting drugs such as some diuretics (water tablets); ciclosporin, a drug used after transplant surgery or occasionally in severe rheumatoid arthritis; muscle relaxants, such as suxamethonium, used in hospitals; cyclophosphamide, a treatment for various types of cancer. The effects of the following medicines may be decreased by these tablets: somatropin, a growth hormone; praziquantel, a treatment for parasitic infections; diabetes medicines, e.g. insulin, metformin, glibenclamide. The following medicines may reduce the effect of these tablets on your rheumatoid arthritis symptoms: treatments for epilepsy such as barbiturates, phenytoin and primidone; rifampicin, a treatment for infection; bupropion, a treatment to help you stop smoking or for depression; aluminium and magnesium antacids. The following medicines may increase the effect of these tablets on your rheumatoid arthritis symptoms: oestrogen containing medicines, for example oral contraceptives, Hormone Replacement Therapy (HRT);
liquorice (used as an expectorant in cough medicines and also present in confectionery). Other effects of medicines: non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid, diclofenac and ibuprofen increase the risk of gastrointestinal bleeding; warfarin may have reduced or increased blood thinning effects depending upon the individual; treatment with ACE inhibitors (e.g. captopril or enalapril) for high blood pressure or heart failure may increase the risk of changes in the numbers of blood cells; anticholinergic medicines (e.g. atropine) may increase the risk of raised pressure in the eye (glaucoma); medications to treat or prevent malaria (e.g. chloroquine, hydroxychloroquine, mefloquine) may increase the risk of muscle weakness, including heart muscle weakness; amphotericine B, an antifungal drug, may increase the risk of hypokalaemia; some diagnostic tests may be affected, for example: skin tests for allergies; a blood test to measure your levels of a hormone produced by the thyroid gland Your doctor will advise you on what to do.
Directions for opening and closing the container: Please follow the instructions below:
ope n
Pregnancy and breastfeeding Ask your doctor for advice before taking any medicine. Pregnancy You must tell your doctor if you think you may be pregnant or you are planning to have a baby. Your doctor will advise you if you can take these tablets. Breastfeeding The active substance of these tablets passes into breast milk. Your doctor will advise you if you can take these tablets while breastfeeding. Driving and using machines These tablets are unlikely to affect your ability to drive or using machines. However, if you develop eye pain or a blurred vision during the treatment, you should avoid these activities. Important information about some of the ingredients of your Lodotra modified-release tablets The medicinal product contains a sugar called lactose. If you have been told that you have an intolerance to some sugars, contact your doctor before taking these tablets.
Manufacturer Horizon Pharma GmbH, Joseph-Meyer-Str. 13-15, 68167 Mannheim, Germany.
op
en
If you forget to take Lodotra You should contact your doctor on how to proceed. If you stop taking Lodotra Do not suddenly stop taking your tablets. If you stop taking these tablets your rheumatoid arthritis symptoms may return. It is important that your dose is reduced slowly. Your doctor will advise you how to reduce your dose gradually. Lodotra should not be substituted by prednisone immediate-release tablets without first talking to your doctor. If you have any further questions on the use of this product, ask your doctor or pharmacist.
Method of administration: How to open and close the bottle especially designed for rheumatoid arthritis patients: see Directions for opening and closing the container. Take the number of tablets that your doctor has told you. Do not break the tablet as the coating is important for these tablets to work properly. Swallow the tablets whole: Do not break, divide or chew the tablets. Take the tablets in the evening (usually at about 10 pm) with a glass of water. You should take these tablets with or after the evening meal. If more than 23 hours. have passed since eating, take the tablet with a light meal or snack.
To Open Place pen or similar object between the raised sections of the lid and turn in the direction shown (anticlockwise).
This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on: You will need to give details of the product name and reference number. These are as follows: Product name:Lodotra Reference number:16950/0173
This leaflet was last revised in May 2011. Lodotra is a registered trade mark of Horizon Pharma AG, and is used under licence. NAPP and the NAPP device (logo) are registered trade marks of the Napp Pharmaceutical Group. 2010 - 2011 Napp Pharmaceuticals Limited.
To Close Place pen or similar object between the raised sections of the lid and turn in the direction shown (clockwise).
What Lodotra contains The active substance is prednisone. Each modified-release tablet contains 1mg, 2mg or 5 mg of prednisone. The other ingredients are: Colloidal anhydrous silica Croscarmellose sodium Lactose monohydrate Magnesium stearate Povidone K 29/32 Red ferric oxide E 172 Calcium hydrogen phosphate dihydrate Glycerol dibehenate Yellow ferric oxide E 172.
0800 198 5000
close
c lo s e
XXXXXX-MMYY
Taking Lodotra with food and drink Take your tablets in the evening usually around 10 pm. Ideally, you should take your tablets with or after your evening meal. You should swallow the tablets whole, with sufficient liquid, e.g. glass of water. You should not break, divide or chew the tablets. If more than 23 hours have passed since eating, you should take your tablets with a light meal or snack.
Always take the tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. The dose your doctor will prescribe will depend on the severity of your disease. This should not usually be more than 10 mg prednisone per day. Your starting dose may be reduced on your doctors advice in steps to a lower maintenance dose depending on: your rheumatoid arthritis symptoms; your response to Lodotra. If you are changing over from taking standard corticosteroid tablets in the morning to taking Lodotra in the evening, your dose should contain the same amount of active substance (prednisone).
Like all medicines Lodotra can cause side effects although not everybody gets them. The frequency and severity of the undesirable effects listed below depend on dosage and duration of treatment. Common side effects (less than 1 in 10 people but more than 1 in 100 people taking these tablets): A hormone imbalance causing Cushings syndrome (typical symptoms: a round face often called a moon face, upper body weight gain and rash on the face) as well as a reduced production of glucocorticoids in the body. Disturbances of the balance of sugars, fats and salts in the body possibly resulting in: increased appetite and weight gain; diabetes; high cholesterol; heart rhythm disturbances (because of increased potassium excretion); accumulation of water (oedema, because of reduced sodium excretion). Reduced ability to fight infections, infections may be more severe or the symptoms may be masked. Clouding of the lens (cataract) and increased pressure in the eye (glaucoma) with or without eye pain. Stretch marks, bruising or red marks on the skin or in the mouth, wasting of the skin. An increase or decrease in the number of blood cells. Muscle wasting and weakness. Bone wasting resulting in an increased risk of bone fractures (osteoporosis).
Keep out of the reach and sight of children. Do not take these tablets after the expiry date which is stated on the bottle and the carton. The expiry date refers to the last day of that month. Do not store above 25C. Medicines should not be disposed of in wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment. : 6. Further information
Marketing authorisation holder Napp Pharmaceuticals Ltd, Cambridge Science Park, Milton Road, Cambridge, CB4 0GW, United Kingdom.
UK00BZT04
3. How to take Lodotra
Always take the tablets after dinner or a light snack (see section 2 Take special care). These modified-release tablets are usually taken for several months or longer. Your doctor will talk to you about how long you need to take your tablets.
If you take more Lodotra than you should Acute intoxications with these tablets are not known. In case of overdosing, you are likely to experience an increase in undesirable effects including: disturbances in hormone function; effects on your metabolism; effects on your electrolyte (salt) balance, leading to increased risk of abnormal heartbeats. Contact your doctor if you are concerned or experience an increase in side effects.
4. Possible side effects
Difficulty in sleeping. Headache. Uncommon side effects (less than 1 in 100 people but more than 1 in 1000 people taking these tablets): High blood pressure. Thickening or inflammation of the lining of the blood vessels and blood clots. Stomach ulcers and bleeding in the bowel. Increased hair growth, spots and other skin blemishes, delayed healing of skin wounds, acne. Rare side effects (less than 1 in 1000 people but more than 1 in 10000 people taking these tablets): Allergic reactions including blistering on the skin. Inflammation of the pancreas causing severe abdominal pain. Disturbances in sex hormone secretion, possibly resulting in absence of monthly periods in women or impotence in men. Disturbance of the thyroid function. Depression (feeling sad), irritability, feelings of happiness that are not justified by reality, increased impulse, loss of contact with reality (psychosis). Increased pressure in the head resulting in headache, vomiting and double vision. Development or worsening of epileptic fits. Worsening of existing eye ulcers or infections. Loss of bone (osteonecrosis).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. : 5. How to store Lodotra
What Lodotra looks like and contents of the pack The 1 mg modified-release tablets are pale yellowish-white, circular with NP1 embossed on one side. The 2 mg modified-release tablets are yellowish-white, circular with NP2 embossed on one side. The 5 mg modified-release tablets are light yellow, circular with NP5 embossed on one side. In each bottle there are 30 or 100 tablets.
Marketing authorisation holder and manufacturer
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
