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

Like all medicines, CAMCOUT 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 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

•    benign/malignant kidney tumours (microcysts, oncocytoma or collecting duct renal carcinoma) (in long-term 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.

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

Do not use CAMCOUT 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

5. How to Store CAMCOUT

Keep all medicines out of the reach and sight of children.

Do not store above 25°C.

Keep the container tightly closed.

What CAMCOUT contains

The active substance is lithium carbonate. Each tablet contains 400 mg lithium carbonate.

The other ingredients are maize starch, acacia, magnesium stearate, sodium laurylsulfate hypromellose, and macrogol 400, titanium dioxide and Opaspray.

What CAMCOUT looks like & contents of the pack Each bottle contains 100 or 500 white tablets.

CAMCOUT 400 mg are white film-coated tablets with

CAMCOLIT-S on one face and a scoreline on ttie other side.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is Essential Pharma Ltd., Crabtree Road, Egham, Surrey TW20 8RB, UK.

It is made by Famar L’Aigle, Zone Industrielle No1, Route de Crulai, L’AIGLE, 61300, France.

The leaflet was last revised in 05/2015.

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• • •

• •• • • • • •• •• • •

• • •• • •

PACKAGE LEAFLET: INFORMATION FOR THE USER

CAMCOLIT 400 mg controlled release 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 phanmacist.

-    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

1. What CAMCOLIT is and what it is used for

CAMCOLIT 400 mg controlled release 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

Do not take CAMCOLIT 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 f 0 years may have a risk of developing a benign or malignant kidney tumour (microcysts, oncocytoma or collecting duct renal carcinoma).

Whilst you are taking CAMCOLIT

Before you start taking CAMCOLIT, 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. 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

d isease/d iso rder

•    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 ter 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 CAMCOUT

•    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 relaxante used in anaesthesia

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

•    triptans such as sumatriptan used for migraine.

Some medicines when taken with CAMCOUT can cause

serious heart rhythm disorders. These include:

•    quinidine, procainamide, disopyramide, amiodarone,

ajmaline, cibenzoline, hydroquinidine, azimilide, dofetiMdem, ibutide, and sotalol all for heart rhythm disorders

•    ranolazine ter 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 ter 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 or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Taking CAMCOUT with food and drink It does not matter if you take CAMCOUT 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 CAMCOUT if you are pregnant or plan to become pregnant unless otherwise recommended by your doctor. Do not take CAMCOUT whilst breast-feeding. Ask your doctor or pharmacist ter advice before taking any medicine.

Driving and using machines As CAMCOUT may cause dizziness or other nervous disorders, your ability to drive or use machines may be impaired.

3. How to take CAMCOUT

Always take CAMCOUT exactly as your doctor has told you. You should check with your doctor or pharmacist if

you are not sure.

•    When starting CAMCOUT 400 mg 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 te take and when to take them. Your doctor will repeat the blood test regularly whilst you are taking CAMCOUT.

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

If you take more CAMCOUT than you should, contact

a doctor or the nearest hospital immediately.

Signs of taking too much CAMCOUT Include

abdominal pain, loss of appetite and nausea, sickness,

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03/06/2015

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