Document: leaflet MAH BRAND_PLPI 21828-0690 change

• leaflet MAH BRAND_PLPI 15184-1661
• leaflet MAH BRAND_PLPI 21828-0690

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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.

■    Throughout this leaflet Camcolit 250mg film-coated tablets will be referred to as Camcolit tablets.

In this leaflet:

1.    What Camcolit tablets are and what they are used for

2.    Before you take Camcolit tablets

3.    How to take Camcolit tablets

4. Possible side effects

5. How to store Camcolit tablets

6.    Further information

1.    What Camcolit tablets are and what they are used for

Camcolit tablets contain lithium carbonate, which is used to treat and prevent mania or manic depressive illness and recurrent depression. It is sometimes used to treat other behavioural disorders.

2.    Before you take Camcolit tablets

Do not take Camcolit tablets if you:

■    are hypersensitive (allergic) to lithium or to any of the other ingredients

■    have serious kidney disease

■    have hypothyroidism (low thyroid hormones) that is difficult to treat

■    have problems with the rhythm of your heart

■    have a condition called Brugada syndrome (a hereditary syndrome that affects the heart), or if anyone in your family has had Brugada syndrome

■    have low sodium levels in your body. This can happen if you are dehydrated, on a low sodium diet, or if you have an illness called 'Addison's disease' this happens when your body does not produce enough hormones and therefore making you feel tired, weak, lightheaded and areas of your skin may go darker

■    are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist if you:

■    have epilepsy and take medicines    to    treat    it

■    take antipsychotic medications

■    have heart disease

■    develop persistent headaches and    or    visual    disturbances

■    have low amounts of potassium, magnesium and calcium in your blood - your doctor will tell you this.

Kidney tumours: Patients with severe kidney impairment who received lithium for more than 10 years may have a risk of developing a benign or malignant kidney tumour (microcysts, onocytoma or collecting duct renal carcinoma).

Whilst you are taking Camcolit tablets

Before you start taking Camcolit tablets, and while you are taking it, your doctor should check on your:

■    kidneys and urine

■    thyroid

■    heart

It is important that you tell your doctor if you notice any side effects or are ill whilst you are taking Camcolit tablets. 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:

■    if there is a change in your dose or you change brands of lithium tablets

■    you have an infection or other existing disease/disorder

■    large changes in the amount of fluid you drink or sodium (salt) you consume

■    taking other medicines

■    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:

■    any medicine which may cause kidney problems

■    antibiotics called tetracyclines, metronidazole, co-trimoxazole, trimethoprim and spectinomycin

■    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

■    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

■    diuretics (water tablets), including herbal preparations

■    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:

■    theophylline (for asthma), or caffeine

■    anything containing sodium bicarbonate

■    a special group of diuretics (water tablets) called carbonic anhydrase inhibitors

■    urea - used to treat skin conditions.

These medicines may cause other side effects when taken with Camcolit tablets

■    medicines used to treat schizophrenia such as haloperidol, olanzapine or clozapine

■    carbamazepine, phenytoin or clonazepam used for epilepsy

■    methyldopa used for the treatment of high blood pressure

■    anti-depressants called selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine or paroxetine, or tricyclics e.g. amitriptyline or tetracyclics

■    calcium channel blockers for angina, high blood pressure or other heart problems such as amlodipine or diltiazem

■    muscle relaxants used in anaesthesia

■    non-steroidal anti-inflammatory drugs such as indomethacin used to reduce pain and inflammation

■    triptans such as sumatriptan used for migraine

Some medicines when taken with Camcolit tablets can cause serious heart rhythm disorders.

These include:

■    quinidine, procainamide, disopyramide, amiodarone, ajmaline, cibenzoline, hydroquinidine, azimilide, dofetilidem, ibutide, and sotalol all for heart rhythm disorders

■    ranolazine for heart disease (angina)

■    arsenic trioxide for the treatment of leukaemia

■    erythromycin (given into a vein) and sparfloxacin for the treatment of infections

■    amisulpride, haloperidol, pimozide, sertindole, mesoridazine, clozaril, droperidol and thioridazine for schizophrenia and other behavioural disorders

■    terfenadine and astemizole (antihistamines)

■    cisapride used to treat stomach and gut problems

■    mefloquine, artemisinin derivatives and halofantrine used to prevent malaria

■    ketanserin which may be being used for high blood pressure

■    dolasetron which may be being used for nausea (feeling sick) and vomiting (being sick) following chemotherapy.

Please tell your doctor of pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Camcolit tablets with food and drink

It does not matter if you take Camcolit tablets 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 tablets if you are pregnant or plan to become pregnant unless otherwise recommended by your doctor. Do not take Camcolit tablets whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

As Camcolit tablets may cause dizziness or other nervous disorders, your ability to drive or use machines may be impaired.

3. How to take Camcolit tablets

Always take Camcolit tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

■    When starting Camcolit tablets, 250mg tablets are usually taken twice a day but when your blood tests are stable you may be able to take it once a day.

■    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 tablets.

Try to take your tablets at the same times every day.

If you take more Camcolit tablets than you should,

contact a doctor or the nearest hospital immediately.

Signs of taking too much Camcolit tablets 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.

Like all medicines, Camcolit tablets can cause side effects, although not everybody gets them.

Contact your doctor immediately if you:

■    notice any changes in heart rate, for example a slower, faster or irregular heartbeat

■    have a high fever, agitation, confusion, trembling, and abrupt contractions of muscles, these may be signs of a rare condition called serotonin syndrome

■    experience a high temperature with rigid muscles, confusion or agitation, and sweating, or jerky muscle movements which you can't control, these may be symptoms of a serious condition known as neuroleptic malignant syndrome

■    experience persistent headaches and or visual disturbances.

Other side effects include:

■    heart rhythm problems including a fast or irregular 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 or 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.

■    benign/malignant kidney tumours (mircocysts, oncocytoma or collecting duct renal carcinoma) (in longterm therapy).

■    parkinsonism (a condition characterised by tremor, slow body movements, rigid muscles, inability to stand steady, tendency to stoop, and a shuffling walk)

■    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)

■    oedema (usually seen as swelling caused by too much fluid)

■    weight gain, loss of appetite or too much calcium, magnesium or sugar in the blood

■    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 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

■    sexual problems including being unable to get an erection, having delayed ejaculation or being unable to have an orgasm

■    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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

5.    How to store Camcolit tablets

Keep out of the sight and reach of children.

Do not store above 25^oC.

Keep the container tightly closed to protect from moisture.

Do not use Camcolit tablets 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.

If the medicine become discoloured or show any other signs of deterioration, you should seek the advice of a pharmacist. If your doctor tells you to stop using the medicine, return any unused medicine to the pharmacist for safe disposal. Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

6.    Further information

What Camcolit tablets contain

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 tablets look like and contents of the pack

Camcolit tablets are white, round, convex film-coated tablets engraved 'Camcolit' around one face and having a score line on the reverse.

Each tablet container contains 100 tablets.

Manufacturer

Manufactured by: Norgine Ltd, Hengoed,

Mid Glamorgan, CF82 8SJ, UK.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd.,

7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL: 21828/0690

Leaflet revision and issue date (Ref): 11.11.16

Camcolit® is a registered trademark of Essential Pharma Limited.

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.

■    Throughout this leaflet Lithium Carbonate Essential Pharma 250mg film-coated tablets will be referred to as Lithium Carbonate tablets.

In this leaflet:

1.    What Lithium Carbonate tablets are and what they are used for

2.    Before you take Lithium Carbonate tablets

3.    How to take Lithium Carbonate tablets

4. Possible side effects

5. How to store Lithium Carbonate tablets

6.    Further information

1.    What Lithium Carbonate tablets are and what they are used for

Lithium Carbonate tablets contain lithium carbonate, which is used to treat and prevent mania or manic depressive illness and recurrent depression. It is sometimes used to treat other behavioural disorders.

2.    Before you take Lithium Carbonate tablets

Do not take Lithium Carbonate tablets if you:

■    are hypersensitive (allergic) to lithium or to any of the other ingredients

■    have serious kidney disease

■    have hypothyroidism (low thyroid hormones) that is difficult to treat

■    have problems with the rhythm of your heart

■    have a condition called Brugada syndrome (a hereditary syndrome that affects the heart), or if anyone in your family has had Brugada syndrome

■    have low sodium levels in your body. This can happen if you are dehydrated, on a low sodium diet, or if you have an illness called 'Addison's disease' this happens when your body does not produce enough hormones and therefore making you feel tired, weak, lightheaded and areas of your skin may go darker

■    are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist if you:

■    have epilepsy and take medicines    to    treat    it

■    take antipsychotic medications

■    have heart disease

■    develop persistent headaches and    or    visual    disturbances

■    have low amounts of potassium, magnesium and calcium in your blood - your doctor will tell you this.

Kidney tumours: Patients with severe kidney impairment who received lithium for more than 10 years may have a risk of developing a benign or malignant kidney tumour (microcysts, onocytoma or collecting duct renal carcinoma).

Whilst you are taking Lithium Carbonate tablets

Before you start taking Lithium Carbonate tablets, and while you are taking it, your doctor should check on your:

■    kidneys and urine

■    thyroid

■    heart

It is important that you tell your doctor if you notice any side effects or are ill whilst you are taking Lithium Carbonate tablets. 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:

■    if there is a change in your dose or you change brands of lithium tablets

■    you have an infection or other existing disease/disorder

■    large changes in the amount of fluid you drink or sodium (salt) you consume

■    taking other medicines

■    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:

■    any medicine which may cause kidney problems

■    antibiotics called tetracyclines, metronidazole, co-trimoxazole, trimethoprim and spectinomycin

■    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

■    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

■    diuretics (water tablets), including herbal preparations

■    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:

■    theophylline (for asthma), or caffeine

■    anything containing sodium bicarbonate

■    a special group of diuretics (water tablets) called carbonic anhydrase inhibitors

■    urea - used to treat skin conditions.

These medicines may cause other side effects when taken with Lithium Carbonate tablets

■    medicines used to treat schizophrenia such as haloperidol, olanzapine or clozapine

■    carbamazepine, phenytoin or clonazepam used for epilepsy

■    methyldopa used for the treatment of high blood pressure

■    anti-depressants called selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine or paroxetine, or tricyclics e.g. amitriptyline or tetracyclics

■    calcium channel blockers for angina, high blood pressure or other heart problems such as amlodipine or diltiazem

■    muscle relaxants used in anaesthesia

■    non-steroidal anti-inflammatory drugs such as indomethacin used to reduce pain and inflammation

■    triptans such as sumatriptan used for migraine

Some medicines when taken with Lithium Carbonate tablets can cause serious heart rhythm disorders.

These include:

■    quinidine, procainamide, disopyramide, amiodarone, ajmaline, cibenzoline, hydroquinidine, azimilide, dofetilidem, ibutide, and sotalol all for heart rhythm disorders

■    ranolazine for heart disease (angina)

■    arsenic trioxide for the treatment of leukaemia

■    erythromycin (given into a vein) and sparfloxacin for the treatment of infections

■    amisulpride, haloperidol, pimozide, sertindole, mesoridazine, clozaril, droperidol and thioridazine for schizophrenia and other behavioural disorders

■    terfenadine and astemizole (antihistamines)

■    cisapride used to treat stomach and gut problems

■    mefloquine, artemisinin derivatives and halofantrine used to prevent malaria

■    ketanserin which may be being used for high blood pressure

■    dolasetron which may be being used for nausea (feeling sick) and vomiting (being sick) following chemotherapy.

Please tell your doctor of pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Lithium Carbonate tablets with food and drink

It does not matter if you take Lithium Carbonate tablets 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 Lithium Carbonate tablets if you are pregnant or plan to become pregnant unless otherwise recommended by your doctor. Do not take Lithium Carbonate tablets whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

As Lithium Carbonate tablets may cause dizziness or other nervous disorders, your ability to drive or use machines may be impaired.

3. How to take Lithium Carbonate tablets

Always take Lithium Carbonate tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

■    When starting Lithium Carbonate tablets, 250mg tablets are usually taken twice a day but when your blood tests are stable you may be able to take it once a day.

■    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 Lithium Carbonate tablets.

Try to take your tablets at the same times every day.

If you take more Lithium Carbonate tablets than you should, contact a doctor or the nearest hospital immediately.

Signs of taking too much Lithium Carbonate tablets include abdominal pain, loss of appetite and nausea, sickness, diarrhoea, blurred vision, passing a lot of water, light-headedness, 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.

Like all medicines, Lithium Carbonate tablets can cause side effects, although not everybody gets them.

Contact your doctor immediately if you:

■    notice any changes in heart rate, for example a slower, faster or irregular heartbeat

■    have a high fever, agitation, confusion, trembling, and abrupt contractions of muscles, these may be signs of a rare condition called serotonin syndrome

■    experience a high temperature with rigid muscles, confusion or agitation, and sweating, or jerky muscle movements which you can't control, these may be symptoms of a serious condition known as neuroleptic malignant syndrome

■    experience persistent headaches and or visual disturbances.

Other side effects include:

■    heart rhythm problems including a fast or irregular 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 or 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.

■    benign/malignant kidney tumours (mircocysts, oncocytoma or collecting duct renal carcinoma) (in longterm therapy).

■    parkinsonism (a condition characterised by tremor, slow body movements, rigid muscles, inability to stand steady, tendency to stoop, and a shuffling walk)

■    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)

■    oedema (usually seen as swelling caused by too much fluid)

■    weight gain, loss of appetite or too much calcium, magnesium or sugar in the blood

■    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 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

■    sexual problems including being unable to get an erection, having delayed ejaculation or being unable to have an orgasm

■    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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Keep out of the sight and reach of children.

Do not store above 25^oC.

Keep the container tightly closed to protect from moisture.

Do not use Lithium Carbonate tablets 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.

If the medicine become discoloured or show any other signs of deterioration, you should seek the advice of a pharmacist. If your doctor tells you to stop using the medicine, return any unused medicine to the pharmacist for safe disposal. Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

6. Further information

What Lithium Carbonate tablets contain

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 Lithium Carbonate tablets look like and contents of the pack

Lithium Carbonate tablets are white, round, convex film-coated tablets engraved 'Camcolit' around one face and having a score line on the reverse.

Each tablet container contains 100 tablets.

Manufacturer

Manufactured by: Norgine Ltd, Hengoed,

Mid Glamorgan, CF82 8SJ, UK.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd.,

7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL: 21828/0690

Leaflet revision and issue date (Ref): 11.11.16

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.

■    Throughout this leaflet Lithium Carbonate Landmark Pharma 250mg film-coated tablets will be referred to as Lithium Carbonate tablets.

In this leaflet:

1.    What Lithium Carbonate tablets are and what they are used for

2.    Before you take Lithium Carbonate tablets

3.    How to take Lithium Carbonate tablets

4. Possible side effects

5. How to store Lithium Carbonate tablets

6.    Further information

1.    What Lithium Carbonate tablets are and what they are used for

Lithium Carbonate tablets contain lithium carbonate, which is used to treat and prevent mania or manic depressive illness and recurrent depression. It is sometimes used to treat other behavioural disorders.

2.    Before you take Lithium Carbonate tablets

Do not take Lithium Carbonate tablets if you:

■    are hypersensitive (allergic) to lithium or to any of the other ingredients

■    have serious kidney disease

■    have hypothyroidism (low thyroid hormones) that is difficult to treat

■    have problems with the rhythm of your heart

■    have a condition called Brugada syndrome (a hereditary syndrome that affects the heart), or if anyone in your family has had Brugada syndrome

■    have low sodium levels in your body. This can happen if you are dehydrated, on a low sodium diet, or if you have an illness called 'Addison's disease' this happens when your body does not produce enough hormones and therefore making you feel tired, weak, lightheaded and areas of your skin may go darker

■    are breast-feeding.

Warnings and precautions

Talk to your doctor or pharmacist if you:

■    have epilepsy and take medicines    to    treat    it

■    take antipsychotic medications

■    have heart disease

■    develop persistent headaches and    or    visual    disturbances

■    have low amounts of potassium, magnesium and calcium in your blood - your doctor will tell you this.

Kidney tumours: Patients with severe kidney impairment who received lithium for more than 10 years may have a risk of developing a benign or malignant kidney tumour (microcysts, onocytoma or collecting duct renal carcinoma).

Whilst you are taking Lithium Carbonate tablets

Before you start taking Lithium Carbonate tablets, and while you are taking it, your doctor should check on your:

■    kidneys and urine

■    thyroid

■    heart

It is important that you tell your doctor if you notice any side effects or are ill whilst you are taking Lithium Carbonate tablets. 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:

■    if there is a change in your dose or you change brands of lithium tablets

■    you have an infection or other existing disease/disorder

■    large changes in the amount of fluid you drink or sodium (salt) you consume

■    taking other medicines

■    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:

■    any medicine which may cause kidney problems

■    antibiotics called tetracyclines, metronidazole, co-trimoxazole, trimethoprim and spectinomycin

■    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

■    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

■    diuretics (water tablets), including herbal preparations

■    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:

■    theophylline (for asthma), or caffeine

■    anything containing sodium bicarbonate

■    a special group of diuretics (water tablets) called carbonic anhydrase inhibitors

■    urea - used to treat skin conditions.

These medicines may cause other side effects when taken with Lithium Carbonate tablets

■    medicines used to treat schizophrenia such as haloperidol, olanzapine or clozapine

■    carbamazepine, phenytoin or clonazepam used for epilepsy

■    methyldopa used for the treatment of high blood pressure

■    anti-depressants called selective serotonin reuptake inhibitors (SSRIs) e.g. fluoxetine or paroxetine, or tricyclics e.g. amitriptyline or tetracyclics

■    calcium channel blockers for angina, high blood pressure or other heart problems such as amlodipine or diltiazem

■    muscle relaxants used in anaesthesia

■    non-steroidal anti-inflammatory drugs such as indomethacin used to reduce pain and inflammation

■    triptans such as sumatriptan used for migraine

Some medicines when taken with Lithium Carbonate tablets can cause serious heart rhythm disorders.

These include:

■    quinidine, procainamide, disopyramide, amiodarone, ajmaline, cibenzoline, hydroquinidine, azimilide, dofetilidem, ibutide, and sotalol all for heart rhythm disorders

■    ranolazine for heart disease (angina)

■    arsenic trioxide for the treatment of leukaemia

■    erythromycin (given into a vein) and sparfloxacin for the treatment of infections

■    amisulpride, haloperidol, pimozide, sertindole, mesoridazine, clozaril, droperidol and thioridazine for schizophrenia and other behavioural disorders

■    terfenadine and astemizole (antihistamines)

■    cisapride used to treat stomach and gut problems

■    mefloquine, artemisinin derivatives and halofantrine used to prevent malaria

■    ketanserin which may be being used for high blood pressure

■    dolasetron which may be being used for nausea (feeling sick) and vomiting (being sick) following chemotherapy.

Please tell your doctor of pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking Lithium Carbonate tablets with food and drink

It does not matter if you take Lithium Carbonate tablets 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 Lithium Carbonate tablets if you are pregnant or plan to become pregnant unless otherwise recommended by your doctor. Do not take Lithium Carbonate tablets whilst breast-feeding. Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

As Lithium Carbonate tablets may cause dizziness or other nervous disorders, your ability to drive or use machines may be impaired.

3. How to take Lithium Carbonate tablets

Always take Lithium Carbonate tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

■    When starting Lithium Carbonate tablets, 250mg tablets are usually taken twice a day but when your blood tests are stable you may be able to take it once a day.

■    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 Lithium Carbonate tablets.

Try to take your tablets at the same times every day.

If you take more Lithium Carbonate tablets than you should, contact a doctor or the nearest hospital immediately.

Signs of taking too much Lithium Carbonate tablets include abdominal pain, loss of appetite and nausea, sickness, diarrhoea, blurred vision, passing a lot of water, light-headedness, 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.

Like all medicines, Lithium Carbonate tablets can cause side effects, although not everybody gets them.

Contact your doctor immediately if you:

■    notice any changes in heart rate, for example a slower, faster or irregular heartbeat

■    have a high fever, agitation, confusion, trembling, and abrupt contractions of muscles, these may be signs of a rare condition called serotonin syndrome

■    experience a high temperature with rigid muscles, confusion or agitation, and sweating, or jerky muscle movements which you can't control, these may be symptoms of a serious condition known as neuroleptic malignant syndrome

■    experience persistent headaches and or visual disturbances.

Other side effects include:

■    heart rhythm problems including a fast or irregular 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 or 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.

■    benign/malignant kidney tumours (mircocysts, oncocytoma or collecting duct renal carcinoma) (in longterm therapy).

■    parkinsonism (a condition characterised by tremor, slow body movements, rigid muscles, inability to stand steady, tendency to stoop, and a shuffling walk)

■    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)

■    oedema (usually seen as swelling caused by too much fluid)

■    weight gain, loss of appetite or too much calcium, magnesium or sugar in the blood

■    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 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

■    sexual problems including being unable to get an erection, having delayed ejaculation or being unable to have an orgasm

■    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.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

Keep out of the sight and reach of children.

Do not store above 25^oC.

Keep the container tightly closed to protect from moisture.

Do not use Lithium Carbonate tablets 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.

If the medicine become discoloured or show any other signs of deterioration, you should seek the advice of a pharmacist. If your doctor tells you to stop using the medicine, return any unused medicine to the pharmacist for safe disposal. Medicines should not be thrown away in waste water or in household waste. Please ask your pharmacist how to throw away any medicine you do not need anymore. If you do this you will help protect the environment.

6. Further information

What Lithium Carbonate tablets contain

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 Lithium Carbonate tablets look like and contents of the pack

Lithium Carbonate tablets are white, round, convex film-coated tablets engraved 'Camcolit' around one face and having a score line on the reverse.

Each tablet container contains 100 tablets.

Manufacturer

Manufactured by: Norgine Ltd, Hengoed,

Mid Glamorgan, CF82 8SJ, UK.

Procured from within the EU and repackaged by: Doncaster Pharmaceuticals Group Ltd., Kirk Sandall, Doncaster, DN3 1QR.

Product Licence holder: Landmark Pharma Ltd.,

7 Regents Drive, Prudhoe, Northumberland, NE42 6PX.

PL: 21828/0690

Leaflet revision and issue date (Ref): 11.11.16

By reporting side effects, you can help provide more

information on the safety of this medicine.

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