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LITHIUM CARBONATE LANDMARK PHARMA 250MG FILM-COATED TABLETS

Active substance(s): LITHIUM CARBONATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

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

In this leaflet:
1.
2.
3.
4.
5.
6.

What Camcolit tablets are and what they are used for
Before you take Camcolit tablets
How to take Camcolit tablets
Possible side effects
How to store Camcolit tablets
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, cotrimoxazole, 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
Page 1 of 2



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.

4. Possible side effects

5. How to store Camcolit tablets

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

Keep out of the sight and reach of children.
Do not store above 25oC.
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.

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.


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

POM

Leaflet revision and issue date (Ref): 11.11.16
Camcolit® is a registered trademark of Essential Pharma
Limited.

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.
By reporting side effects, you can help provide more
information on the safety of this medicine.

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

In this leaflet:
1.
2.
3.
4.
5.
6.

What Lithium Carbonate tablets are and what they are
used for
Before you take Lithium Carbonate tablets
How to take Lithium Carbonate tablets
Possible side effects
How to store Lithium Carbonate tablets
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, cotrimoxazole, 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
Page 1 of 2



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.

4. Possible side effects

5. How to store Lithium Carbonate tablets

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

Keep out of the sight and reach of children.
Do not store above 25oC.
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.

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.


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 filmcoated 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

POM

Leaflet revision and issue date (Ref): 11.11.16

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.
By reporting side effects, you can help provide more
information on the safety of this medicine.

Page 2 of 2

PACKAGE LEAFLET: INFORMATION FOR THE USER

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

In this leaflet:
1.
2.
3.
4.
5.
6.

What Lithium Carbonate tablets are and what they are
used for
Before you take Lithium Carbonate tablets
How to take Lithium Carbonate tablets
Possible side effects
How to store Lithium Carbonate tablets
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, cotrimoxazole, 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
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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.

4. Possible side effects

5. How to store Lithium Carbonate tablets

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

Keep out of the sight and reach of children.
Do not store above 25oC.
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.

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.


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 filmcoated 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

POM

Leaflet revision and issue date (Ref): 11.11.16

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.
By reporting side effects, you can help provide more
information on the safety of this medicine.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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