CAMCOLIT 250 MG LITHIUM CARBONATE
Active substance: LITHIUM CARBONATE
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Camcolit 250 mg Lithium Carbonate
Norgine Limited Moorhall Road, Harefield Middlesex UB9 6NS UK
PL 0322/5900R
PEEL HERE
100 film coated tablets
Each tablet contains 250 mg Lithium Carbonate To be taken orally as directed by the doctor. Please read the pack leaflet Do not store above 25C. Keep container tightly closed. Keep out of the reach and sight of children
012748 561014
Camcolit 250 mg Lithium Carbonate
100 film coated tablets
Each tablet contains 250 mg Lithium Carbonate To be taken orally as directed by the doctor. Please read the pack leaflet
PL 0322/5900R POM HK - 22378
HK - 22378 POM
56802002
PACKAGE LEAFLET: INFORMATION FOR THE USER CAMCOLIT 250 mg film coated tablets Lithium Carbonate 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 become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What CAMCOLIT is and what it is used for 2. Before you take CAMCOLIT 3. How to take CAMCOLIT 4. Possible side effects 5. How to store CAMCOLIT 6. Further information
N have hypothyroidism (low thyroid hormones) that is 1. What CAMCOLIT is and what it is used for difficult to treat. CAMCOLIT 250 mg tablets contain lithium carbonate, N have problems with the rhythm of your heart. which is used to treat and prevent mania or manic N have a condition called Brugada syndrome (a depressive illness and recurrent depression. It is hereditary syndrome that effects the heart), or if sometimes used to treat other behavioural disorders. anyone in your family has had Brugada syndrome. N have low sodium levels in your body. This can happen 2. Before you take CAMCOLIT if you are dehydrated, on a low sodium diet, or if you have an illness called Addisons disease this happens Do not take CAMCOLIT if you: when your body does not produce enough hormones N are hypersensitive (allergic) to lithium or to any of the and therefore making you feel tired, weak, lightother ingredients. headed and areas of your skin may go darker. N are breast-feeding. N have serious kidney disease.
Warnings and precautions Talk to your doctor or pharmacist if you: N have epilepsy and take medicines to treat it N take antipsychotic medications N have heart disease N develop persistent headaches and or visual disturbances N have low amounts of potassium, magnesium and calcium in your blood - your doctor will tell you this. Whilst you are taking CAMCOLIT Before you start taking CAMCOLIT, and while you are taking it, your doctor should check on your: N kidneys and urine
N thyroid N heart It is important that you tell your doctor if you notice any side effects or are ill whilst you are taking CAMCOLIT. These could be early signs that your doctor should give you another check-up. Elderly patients should take particular care about this. Possible side effects are described later in this leaflet. Other situations where you may need your blood monitoring more often are: N If there is a change in your dose or you change brands of lithium tablets.
N You have an infection or other existing disease/ disorder. N Large changes in the amount of fluid you drink or sodium (salt) you consume. N Taking other medicines. N You have kidney disease that you have been told by your doctor is not serious. Taking other medicines: You should tell your doctor if you are taking any of the following: These medicines may increase the amount of lithium in your body making you more likely to have side effects:
N Any medicine which may cause kidney problems. N Antibiotics called tetracyclines, metronidazole, co-trimoxazole, trimethoprim and spectinomycin. N Non-steroidal anti-inflammatory drugs (e.g. diclofenac or ibuprofen) including COX-II inhibitors such as celecoxib. These are used for rheumatism and for other pains. You can also get pain killers of this type without a prescription so check with your pharmacist before you buy them. N A group of medicines for your heart or blood pressure called ACE inhibitors such as ramipril or lisinopril or angiotensin II receptor antagonists such as losartan or irbesartan.
N Diuretics (water tablets, including herbal diuretics). N Steroids - used for inflammation and allergies (such as prednisolone, betamethasone or hydrocortisone). These medicines may decrease the amount of lithium in your body meaning it will not work as well: N Theophylline (for asthma), or caffeine N Anything containing sodium bicarbonate N A special group of diuretics (water tablets) called carbonic anhydrase inhibitors. N Urea used to treat skin conditions.
These medicines may cause other side effects when taken with CAMCOLIT: N Medicines used to treat schizophrenia such as haloperidol, olanzapine or clozapine. N Carbamazepine, phenytoin or clonazepam used for epilepsy. N Methyldopa used for the treatment of high blood pressure. N Anti-depressants called selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine or paroxetine, or tricyclics e.g. amitriptyline or tetracyclics. N Calcium channel blockers for angina, high blood
pressure or other heart problems such as amlodipine or diltiazem. N Muscle relaxants used in anaesthesia. N Non-steroidal anti inflammatory drugs such as indomethacin used to reduce pain and inflammation. N Triptans such as sumatriptan used for migraine.
N Ranolazine for heart disease (angina). N Arsenic trioxide for the treatment of leukaemia. N Erythromycin (given into a vein) and sparfloxacin for the treatment of infections. N Amisulpride, haloperidol, pimozide, sertindole, mesoridazine, clozaril, droperidol and thioridazine for schizophrenia and other behavioural disorders. Some medicines when taken with CAMCOLIT can cause serious heart rhythm disorders. These include: N Terfenadine and astemizole, antihistamines. N Quinidine, procainamide, disopyramide, amiodarone, ajmaline, cibenzoline, hydroquinidine, azimilide, N Cisapride used to treat stomach and gut problems cibenzoline, dofetilidem, ibutide, and sotalol all for heart N Mefloquine, artemisinin derivatives and halofantrine used to prevent malaria rhythm disorders
Do not store above 25C. Keep container tightly closed. Keep out of the reach and sight of children
Norgine Limited Moorhall Road, Harefield Middlesex UB9 6NS UK
N Ketanserin which may be used for high blood pressure N Dolasetron which may be used for nausea (feeling sick) and vomiting (being sick) following chemotherapy. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking CAMCOLIT with food and drink It does not matter if you take CAMCOLIT with or without food but if you want to go on any sort of diet talk to your doctor first. Any large changes in how much water you drink or how much sodium (salt) is in your diet may mean
you need your blood monitoring more often. Pregnancy and breast-feeding Do not take CAMCOLIT if you are pregnant or plan to become pregnant unless otherwise recommended by your doctor. Do not take CAMCOLIT whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines As CAMCOLIT may cause dizziness or other nervous disorders, your ability to drive or use machines may be impaired.
5 6802002
3. How to take CAMCOLIT Always take CAMCOLIT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. N When starting CAMCOLIT 250 mg tablets are usually taken twice a day but when your blood tests are stable you may able to take it once a day. N Your doctor will give you a blood test to tell you how many tablets to take and when to take them. Your doctor will repeat the blood test regularly whilst you are taking CAMCOLIT. Try to take your tablets at the same times every day.
If you take more CAMCOLIT than you should, contact a doctor or the nearest hospital immediately. Signs of taking too much CAMCOLIT include abdominal pain, loss of appetite and nausea, sickness, diarrhoea, blurred vision, passing a lot of water, lightheadedness, tremor, muscle twitching, muscle weakness or drowsiness and feeling very tired. In extreme cases unconsciousness, coma, fits, heart rhythm problems (slow or irregular heartbeat) and kidney failure can occur. Tell your family about lithium side effects so they know what to look for too. If you forget to take your tablets, take them as soon as
you remember. If you forget for more than 6 hours, just take the next dose when it is due. Tell your doctor if you miss a few doses. If you have any further questions on the use of this product, ask your doctor or pharmacist.
N Have a high fever, agitation, confusion, trembling, and abrupt contractions of muscles, these may be signs of a rare condition called serotonin syndrome. N Experience a high temperature with rigid muscles, confusion or agitation, and sweating, or jerky muscle movements which you cant control, these may be 4. Possible side effects symptoms of a serious condition known as neuroleptic Like all medicines, CAMCOLIT can cause side effects, malignant syndrome. although not everybody gets them. N Experience persistent headaches and or visual disturbances. Contact your doctor immediately if you: N Notice any changes in heart rate, for example a slower, Other side effects include: N Heart rhythm problems including a fast or irregular faster or irregular heartbeat.
N N N
N
heartbeat and abnormal heart muscle function. Tests on your heart may show changes in the way your heart is working. Encephalopathy (alteration of brain function). Syndrome of irreversible lithium effectuated neurotoxicity (permanent nerve tissue damage). Kidney problems, which may not be reversible. Symptoms may include passing a lot of urine, or feeling thirsty and swollen ankles. Parkinsonism (a condition characterised by tremor, slow body movements, rigid muscles, inability to stand steady, tendency to stoop, and a shuffling walk).
N Thyroid problem and a condition known as parathyroid adenoma (a non-cancerous tumour close to the thyroid gland in the neck that controls the use and removal of calcium). N Oedema (usually seen as swelling caused by too much fluid). N Weight gain, loss of appetite or too much calcium, magnesium or sugar in the blood. N Hand tremor, vertigo, dazed feeling, not being able to think clearly, difficulty remembering, fits, changes of the sense of taste, shaky movements, slurred speech, dizziness, rapid eye movements, blurred vision, or
N
N N N
blind spots in your eyesight, unconsciousness, coma and myasthenia gravis (a long-term disease characterised by abnormal tiredness and muscle weakness). Skin problems including worsening of psoriasis, hair loss, acne, soreness around the hair root, itching rashes and redness of the skin. Low blood pressure. Blood tests can show an increase in white blood cells (leucocytosis). Sickness, feeling sick, diarrhoea, upset stomach, dry mouth or too much saliva.
N Sexual problems including being unable to get an erection, having delayed ejaculation or being unable to have an orgasm. N Abnormal taste sensation. It is important to have the right level of lithium in the blood. If it is too high, then you are more likely to get a side effect. Tell your family about lithium side effects so they know what to look for too. If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store CAMCOLIT Keep all medicines out of the reach and sight of children. Do not store above 25C. Keep the container tightly closed. Do not use CAMCOLIT after the expiry date which is printed or embossed on the bottle label as month/year. The expiry date refers to the last day of the month. 6. Further information What CAMCOLIT contains The active substance is lithium carbonate. Each tablet contains 250 mg lithium carbonate.
The other ingredients are maize starch, magnesium stearate, pregelatinised maize starch, hypromellose and macrogol 400. What CAMCOLIT looks like & contents of the pack Each bottle contains 100 or 1000 white tablets. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is Norgine Ltd., Moorhall Road, Harefield, Middlesex, UB9 6NS, UK. It is made by Norgine Ltd. Hengoed, Mid Glamorgan, CF82 8SJ UK The leaflet was last approved in April 2012.
5
Norgine Limited Moorhall Road, Harefield Middlesex UB9 6NS UK
PL 0322/5900R
PEEL HERE
100 film coated tablets
Each tablet contains 250 mg Lithium Carbonate To be taken orally as directed by the doctor. Please read the pack leaflet Do not store above 25C. Keep container tightly closed. Keep out of the reach and sight of children
012748 561014
Camcolit 250 mg Lithium Carbonate
100 film coated tablets
Each tablet contains 250 mg Lithium Carbonate To be taken orally as directed by the doctor. Please read the pack leaflet
PL 0322/5900R POM HK - 22378
HK - 22378 POM
56802002
PACKAGE LEAFLET: INFORMATION FOR THE USER CAMCOLIT 250 mg film coated tablets Lithium Carbonate 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 become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. In this leaflet: 1. What CAMCOLIT is and what it is used for 2. Before you take CAMCOLIT 3. How to take CAMCOLIT 4. Possible side effects 5. How to store CAMCOLIT 6. Further information
N have hypothyroidism (low thyroid hormones) that is 1. What CAMCOLIT is and what it is used for difficult to treat. CAMCOLIT 250 mg tablets contain lithium carbonate, N have problems with the rhythm of your heart. which is used to treat and prevent mania or manic N have a condition called Brugada syndrome (a depressive illness and recurrent depression. It is hereditary syndrome that effects the heart), or if sometimes used to treat other behavioural disorders. anyone in your family has had Brugada syndrome. N have low sodium levels in your body. This can happen 2. Before you take CAMCOLIT if you are dehydrated, on a low sodium diet, or if you have an illness called Addisons disease this happens Do not take CAMCOLIT if you: when your body does not produce enough hormones N are hypersensitive (allergic) to lithium or to any of the and therefore making you feel tired, weak, lightother ingredients. headed and areas of your skin may go darker. N are breast-feeding. N have serious kidney disease.
Warnings and precautions Talk to your doctor or pharmacist if you: N have epilepsy and take medicines to treat it N take antipsychotic medications N have heart disease N develop persistent headaches and or visual disturbances N have low amounts of potassium, magnesium and calcium in your blood - your doctor will tell you this. Whilst you are taking CAMCOLIT Before you start taking CAMCOLIT, and while you are taking it, your doctor should check on your: N kidneys and urine
N thyroid N heart It is important that you tell your doctor if you notice any side effects or are ill whilst you are taking CAMCOLIT. These could be early signs that your doctor should give you another check-up. Elderly patients should take particular care about this. Possible side effects are described later in this leaflet. Other situations where you may need your blood monitoring more often are: N If there is a change in your dose or you change brands of lithium tablets.
N You have an infection or other existing disease/ disorder. N Large changes in the amount of fluid you drink or sodium (salt) you consume. N Taking other medicines. N You have kidney disease that you have been told by your doctor is not serious. Taking other medicines: You should tell your doctor if you are taking any of the following: These medicines may increase the amount of lithium in your body making you more likely to have side effects:
N Any medicine which may cause kidney problems. N Antibiotics called tetracyclines, metronidazole, co-trimoxazole, trimethoprim and spectinomycin. N Non-steroidal anti-inflammatory drugs (e.g. diclofenac or ibuprofen) including COX-II inhibitors such as celecoxib. These are used for rheumatism and for other pains. You can also get pain killers of this type without a prescription so check with your pharmacist before you buy them. N A group of medicines for your heart or blood pressure called ACE inhibitors such as ramipril or lisinopril or angiotensin II receptor antagonists such as losartan or irbesartan.
N Diuretics (water tablets, including herbal diuretics). N Steroids - used for inflammation and allergies (such as prednisolone, betamethasone or hydrocortisone). These medicines may decrease the amount of lithium in your body meaning it will not work as well: N Theophylline (for asthma), or caffeine N Anything containing sodium bicarbonate N A special group of diuretics (water tablets) called carbonic anhydrase inhibitors. N Urea used to treat skin conditions.
These medicines may cause other side effects when taken with CAMCOLIT: N Medicines used to treat schizophrenia such as haloperidol, olanzapine or clozapine. N Carbamazepine, phenytoin or clonazepam used for epilepsy. N Methyldopa used for the treatment of high blood pressure. N Anti-depressants called selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine or paroxetine, or tricyclics e.g. amitriptyline or tetracyclics. N Calcium channel blockers for angina, high blood
pressure or other heart problems such as amlodipine or diltiazem. N Muscle relaxants used in anaesthesia. N Non-steroidal anti inflammatory drugs such as indomethacin used to reduce pain and inflammation. N Triptans such as sumatriptan used for migraine.
N Ranolazine for heart disease (angina). N Arsenic trioxide for the treatment of leukaemia. N Erythromycin (given into a vein) and sparfloxacin for the treatment of infections. N Amisulpride, haloperidol, pimozide, sertindole, mesoridazine, clozaril, droperidol and thioridazine for schizophrenia and other behavioural disorders. Some medicines when taken with CAMCOLIT can cause serious heart rhythm disorders. These include: N Terfenadine and astemizole, antihistamines. N Quinidine, procainamide, disopyramide, amiodarone, ajmaline, cibenzoline, hydroquinidine, azimilide, N Cisapride used to treat stomach and gut problems cibenzoline, dofetilidem, ibutide, and sotalol all for heart N Mefloquine, artemisinin derivatives and halofantrine used to prevent malaria rhythm disorders
Do not store above 25C. Keep container tightly closed. Keep out of the reach and sight of children
Norgine Limited Moorhall Road, Harefield Middlesex UB9 6NS UK
N Ketanserin which may be used for high blood pressure N Dolasetron which may be used for nausea (feeling sick) and vomiting (being sick) following chemotherapy. Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Taking CAMCOLIT with food and drink It does not matter if you take CAMCOLIT with or without food but if you want to go on any sort of diet talk to your doctor first. Any large changes in how much water you drink or how much sodium (salt) is in your diet may mean
you need your blood monitoring more often. Pregnancy and breast-feeding Do not take CAMCOLIT if you are pregnant or plan to become pregnant unless otherwise recommended by your doctor. Do not take CAMCOLIT whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines As CAMCOLIT may cause dizziness or other nervous disorders, your ability to drive or use machines may be impaired.
5 6802002
3. How to take CAMCOLIT Always take CAMCOLIT exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. N When starting CAMCOLIT 250 mg tablets are usually taken twice a day but when your blood tests are stable you may able to take it once a day. N Your doctor will give you a blood test to tell you how many tablets to take and when to take them. Your doctor will repeat the blood test regularly whilst you are taking CAMCOLIT. Try to take your tablets at the same times every day.
If you take more CAMCOLIT than you should, contact a doctor or the nearest hospital immediately. Signs of taking too much CAMCOLIT include abdominal pain, loss of appetite and nausea, sickness, diarrhoea, blurred vision, passing a lot of water, lightheadedness, tremor, muscle twitching, muscle weakness or drowsiness and feeling very tired. In extreme cases unconsciousness, coma, fits, heart rhythm problems (slow or irregular heartbeat) and kidney failure can occur. Tell your family about lithium side effects so they know what to look for too. If you forget to take your tablets, take them as soon as
you remember. If you forget for more than 6 hours, just take the next dose when it is due. Tell your doctor if you miss a few doses. If you have any further questions on the use of this product, ask your doctor or pharmacist.
N Have a high fever, agitation, confusion, trembling, and abrupt contractions of muscles, these may be signs of a rare condition called serotonin syndrome. N Experience a high temperature with rigid muscles, confusion or agitation, and sweating, or jerky muscle movements which you cant control, these may be 4. Possible side effects symptoms of a serious condition known as neuroleptic Like all medicines, CAMCOLIT can cause side effects, malignant syndrome. although not everybody gets them. N Experience persistent headaches and or visual disturbances. Contact your doctor immediately if you: N Notice any changes in heart rate, for example a slower, Other side effects include: N Heart rhythm problems including a fast or irregular faster or irregular heartbeat.
N N N
N
heartbeat and abnormal heart muscle function. Tests on your heart may show changes in the way your heart is working. Encephalopathy (alteration of brain function). Syndrome of irreversible lithium effectuated neurotoxicity (permanent nerve tissue damage). Kidney problems, which may not be reversible. Symptoms may include passing a lot of urine, or feeling thirsty and swollen ankles. Parkinsonism (a condition characterised by tremor, slow body movements, rigid muscles, inability to stand steady, tendency to stoop, and a shuffling walk).
N Thyroid problem and a condition known as parathyroid adenoma (a non-cancerous tumour close to the thyroid gland in the neck that controls the use and removal of calcium). N Oedema (usually seen as swelling caused by too much fluid). N Weight gain, loss of appetite or too much calcium, magnesium or sugar in the blood. N Hand tremor, vertigo, dazed feeling, not being able to think clearly, difficulty remembering, fits, changes of the sense of taste, shaky movements, slurred speech, dizziness, rapid eye movements, blurred vision, or
N
N N N
blind spots in your eyesight, unconsciousness, coma and myasthenia gravis (a long-term disease characterised by abnormal tiredness and muscle weakness). Skin problems including worsening of psoriasis, hair loss, acne, soreness around the hair root, itching rashes and redness of the skin. Low blood pressure. Blood tests can show an increase in white blood cells (leucocytosis). Sickness, feeling sick, diarrhoea, upset stomach, dry mouth or too much saliva.
N Sexual problems including being unable to get an erection, having delayed ejaculation or being unable to have an orgasm. N Abnormal taste sensation. It is important to have the right level of lithium in the blood. If it is too high, then you are more likely to get a side effect. Tell your family about lithium side effects so they know what to look for too. If any of the side effects become serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. How to store CAMCOLIT Keep all medicines out of the reach and sight of children. Do not store above 25C. Keep the container tightly closed. Do not use CAMCOLIT after the expiry date which is printed or embossed on the bottle label as month/year. The expiry date refers to the last day of the month. 6. Further information What CAMCOLIT contains The active substance is lithium carbonate. Each tablet contains 250 mg lithium carbonate.
The other ingredients are maize starch, magnesium stearate, pregelatinised maize starch, hypromellose and macrogol 400. What CAMCOLIT looks like & contents of the pack Each bottle contains 100 or 1000 white tablets. Marketing Authorisation Holder and Manufacturer The Marketing Authorisation Holder is Norgine Ltd., Moorhall Road, Harefield, Middlesex, UB9 6NS, UK. It is made by Norgine Ltd. Hengoed, Mid Glamorgan, CF82 8SJ UK The leaflet was last approved in April 2012.
5
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.
