n

Camcolit

Lithium Carbonate

Controlled

Release

100 film -coated tablets

Each tablet contains 400 mg Lithium Carbonate

To be taken orally as directed by the doctor*. Please read the pack leaflet.

Do not store above 25°C. Keep container tightly closed. Keep out of the reach and sight of children

EP00132

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 pharmacist.

-    This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-    If any of the side effects become serious, or you notice any side effects not listed in this leaflet

please tell your doctor or pharmacist.

In this leaflet:

1.    What CAMCOLIT is and what it is used for

2.    Before you take CAMCOLIT

3.    How to take CAMCOLIT

4.    Possible side effects

5.    How to store CAMCOLIT

6.    Further information

1. WhatCAMCOLITisandwhatitis usedfor

CAMCOLIT 400 mgcontrol led release tablets contain lithium carbonate, wflchis used to treat and prevent Rania or manic depreesiveillness and reeurrent depression. his sometimes used to treat other behavi ouryl disorders.

2. Beforeyou takeCAMCOLIT

Do not take CAMCOLIT if you:

•    are sypersensitiva (allergic) So litbium or to any of tha other ingredients

•    have serious Sidney disease

•    have hypothyroidism (lew thyroid hormones) thatis

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 anyonein your fdmily has had Brugsda nyndrome

•    have low sodium levels in your body. This can happenifyou are dehydrated, on a low sodium diet, or if you have an il lness callad Addison's disease’ this happens whe n your body does not produce enough hormones Cnd therefore making you feel tired, weak, lightheaded and areas of your skin may go darker

•    are breast-feedinig_l Warnings and ptecauCions

Telit to your doctor or pharmacist in you:

•    have epilepsy and take medicines to ^freat ^|s

•    tetce ^ntiplsychotic medteaflonn

•    have heart diseaea

•    develop persistent headaches and or visual disterbances

•    have low amount:? of potassium, magnesium and calcium in your bl ood - your doctor will te l a yy u this.

Kidney tumours: Patients with severe ktoney impairmertwho received lithium for more than 10

yeaes may have a ritk of doveloping a benign or malignanr kidney tumour (microcysts, oncocytoma or collecvng duct renal carcinoma).

Whilat you ace tatting CAMCOLIT

Befo^hr^ee^{r e}y^doⁱu^tas^rt^yar^st^ytⁿa^dki^rn^og^mC^eA^tM^haC^tOL^aI^fT^f,^ea^cn^tsd ^tw^hh^ei le^{h e}y^ao^ru^t)a^, r^oe^r taking it yonr ductor should h°dck on your:

•    kidneys ans urine

•    thyroiC

•    heart.

It is ^|mporton^t teat you tell your doctor if you notice any side effects or areill whilst you are taking CAN¹ COLIT These could be eady signs tha° your

aoctor should give you another check-up. Elderly patients should take particular care about this. Pessible sits effetts kre describedlater In this leaflet. Other situasons whore you may need your blood mhoanvietohrienagrtmdiosreaoseften are:

•is them is a change in your dose or you changv brands oflithium tablets

•    you have an infection or other existing disriase/d isordbr

•    large uhangesin the amount of fluid you drink or sodtoru (salt) you consume

•    takin^y other medicrnes

•    you have kidney disease that you have been told by yent doctor is not serious.

Taking other medicines:

You should ten yoer doctor if you are taking any of the followinoi

These medicines may increase the amotnt of lithium in your Sody makino you morelikely to have side efefsecrtisb:edtlatertintthistleaflet.

•    any meitricine which may cuuse kidney problems _m antibioticssalled tetraeyclines, metronidazole,

co-trtmoxazole, trimethoprim sna spectinomycin

•    non-steroidal arti-inflammatory ^orugs (e.g.

diclofenac on i:ruc)ofcu) inctoding COX-II in Tiiritsrs sucii as celecoxib. These are used for rheumatism and foc offier pains. You can uIso get pam killers of mis tope without a prescr.ption so check with your pharmartist before yeu buy them

•    a grosp ok medicines for yrour heart or blood pressure called ACs isVibhors such as ramipril or lisinopril or angiotensin II receptor antagonists such

^akaⁱⁿs^glo^os^ta^hr^eta^r n^mo^er^diⁱr^cbⁱeⁿs^ea^sr^:tan

•    diuretics (w ater tablets), mcluding herbal preparations

•    steroids - used for irtlammation and allergies (such

as nrednisolone, hetamethasone ot hydrocortisone). These medicines may decreanrn the amotnt otlithizm in yosr body meaning it will no^ork as wcIIi

•    theonhylline (foa asthma), or caffeine

•    anything containino sdrtism bixarbonate

•    a special gro up os d iuretics (water fabletsi cali ed carbonip anliydrase inhibi^tots

•    ureia - used to treat skin conditiows¹

Thebe medicines tray cause other side effects when taken with CAMCObIT

•    medicines used So treaUchizophrenia such os halosendol, otenzapine on clgzapine

•    carbamazepinei phenytoic or nlon^^epam psed for efSIepsy

•    metnyldona used tor the treatment of hri^h 16)0od pressure

•    anti-depressants called et^lecfive^ sero-oltin reuptake i nhibitors (USRi s) e.g . °uoxetine or [raroxerine, or tricyclics e.g. amitripthline or tetracyclics

•    calcium channel bteckers for angina, high blood pressnre or other hsort probiems such as amlodipine or diltiazem

•    muscle retorts used irt anaesthesia

•    nob-steroidal as^ti inflammatory drugs such as

indomethacin usea to reduce pam and inflammation

•    triptann Cuch as sumatriptan used for migraine.

Some megicines when taken with CAMCOLIT can

cause seriohs henrl rhythm disorders. These include:

•    quinidite, procainamide, disopyramide, amiodarone, ajmaline, cibenzoline, hydroquinidine, azimilide, dofetilidem, ibutide, ond sotolol all tor heart rhyttrm disotdvrs

•    ranolazine for heart disaase (angina)

•    arsente ^rrioxⁱde ter the ^retct^r^ein-of leutorerma

•    erythsomycm (givien into s vein| and scnr^tloxacin for the treatmes^t ofinfections

•    nmisulpriOe, haloperidol, simozidn, sertindole, mesoridezine, clozaril, droperidol and thioridazine fern schizophrenia and other Sehavioural disorders

•    terfenadise and astemlzote (antihistdminest

•    ciaazride used to treat stomach and gut probiems

•    mefloqume, attemisicin derivatives atd haiofantrine usml to prevent malaria

s ketanserin which may b e being used for hisS blood pressure

•    dolasetron vzhictl may be being used for nausea (feeling sick) and vomiting (being niak) following chemotherapy.

Please tell you r doctor or pharmacistif you are taking or have recently taken any other mediciuks_l including medicines obtained without a prescription.

Taking CAMCOLiT witls food and drink

It does not matteMf you ta^ge CAMCOLIT with or without food but if you want to go on any sort of TIs^-talk to your doctor first Any large chan^des in flow mucls water you drink or how much sodium (nah) is in your dfet may mean you need your blood monitoring more often.

Pregnancy and breast-feeding

Do not take CAMCOLIT if you are pregnant oc plan to

PL 41871/0003

|pom|

Camcolit®400 mg

Lithium Carbonate

100 film-coated tablets

Each taeiet contains    Do not store above 25°C.

400 mg Lithium Carbonate    Keep container tightly closed.

To be taken orally as directed by the ^{Keep o}U^{t of the reach and} doctor. Please read the pack: leaflet.    ^{sight of chlldren}

EssentialPharma Ltd. Crabtr ee Road, Egham Sdrrey TW20 8RB UK

become pregnaht unless otherwise reco mmended by yoprdoctor. Do not take CAMCOLIT whilst breasS-feedins. Ask your d octor os pharmauisS for advice tutoro taking ang medicine.

Driving and using machines

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

3. How to take CAMCOLIT

Always toyo CAMCOLIT exactly as your dcctor has told you. You stiould cCecU with your doctoi ar pharmacist it uo h are i^ot: sure.

•    When Parting CAMCOLIT 400 mg tablets are usually taken twice a deer butwhen your blood tests are stable you may be able to take h gnce a day

•    You doctor will give you a blood west to tell you how maty terete to take and when to tatrs tlrom. Your doctor wHl repeat the blood test regularly whilst yeu are taking CAMCOLIT.

Try tor take your table°s at the same times every

^dD^ar^yiv^. ing and using machines

If you takO more CAMCOLIT than you should ,

con tCd a d octet or the riserest hos^sital immed iately.

Signs of taking too much CAMCOLIT include

abdominal pram, loss ofaspetite and nausea_i sic Yness, diarrhoea, blurred vision, sassi ng a lot of water, light-headedness, tremor, muscle twitching, muscte waakness or drowsiness and feelins very titcd_l In sxtreme cases unconsciousness, coma, tits, heort rhythm problem s (slow oi irregular heartbeat) and ki dney failure can occ ur.

Tell your family about litbium side effects so they ktow wliat to look for' too.

If you forget to take your tablets, take them as soon as you remember. It you forget for morv tha n 6

houru, just take the next dose when his due. Teti your doctor if yeu miss a few dosem.

If you h ave any further ou estions on the use Tf this Sroduct as k your doctor or pharmacist.

4. Possiblesideeffects

Uke all mndicicos, CAMCOL IT can gauze side sffects, ah.ougti notevuTybody getethem.

Contort eour doctor ^tmmediatTry f you:

• notice acy changes in heart fate, for example a slower, fastci nrirrasular heartbeat. s have a high fever, agitation, confusion, trembling, aod abrupt co ntrac tions of muscles, these msy be

signs of a .are condition csIIoT serotonin s°udrome

•    experience a high temperatsre whli rigid muscles, cantos ion es agitation, and sweating, or jerky muscle movements which you can’t nortrol, ofese may be symptoms oSaserious condition known as neuroleptic malignant syndrome

•experience persisted headaches and or visual disturbances.

Other side effects inc tode :

•    heart ohytlim probleme incleding a fast or irregular heartbeat and abnormal heart innacle function. Tests an your heart may show c^san^xesin the way

your heart it working

•    encephalonathy (alteration of brain function)

•    syndrome of hreversibte litltium effectuated neurotoxicity (permanert serve sssue damage)

•    kidney problems, whinh mty wot be reverrsible. Symptoms mayinclude pass’ng a lot of hrise, or feeling thirsty and swollen ankles

•    bonignUmaiignart Zihney tumours (microcysts, oncoeytoma op colincting TccI fsnsl carnin oma) (in ^lodⁿis^gt^-u^tr^eb^ra^mn c^the^es.^rapy)

•    parkinsonism (a condition characterised by tremor, ntew Itody movements, rigid muscles, inability to

stand steady, tenderey to sreoro, and a shuffling walk)

•    thyroid problem and a condition known as paraChyroid adenoma (a non-cancerous tumour close totTe ofyroid gland in the neckthat cortrals the use and removal of calctom)

•    otdema (usually seen as swetiing caused eyv too much fluid)

•    woigMgain, losts of appetite or too much calcium, magnantom or sugar intTe blood

• hand ^tremor, vertigo, idazed feeling¹, not being able to hunk clearly, dfficu Ity rezremberi ng, fits, changes

of the senso of Haste, shaky movements, slprred

sp^aeecⁿh^o,^mt ^aiz^tz⁽i^an^tesⁿs^o,ⁿtr^-a^cp^ai^nctey^re^ot^um^sto^tv^uem^oe^un^rt^ts,^ctb^lolu^sr^er^te^td^ot^{t th}

v^|sion, or b^|ind spo^fs m your eyesight, unconscteus-ness, coma and myasthenia gravis (a long-term disease characterised by aSnormal fireebess and muscle weakness)

•    skin problems mctodiny vcorsening ot psotiesis, hair loss, acne, sor^n^^s around the hair root, itching rashes asdredness of the skin

•    loot blood presscre

• blood toste can show yn itcrease in whhe ttlood cells (leucosytosis)

•    sicdness, feeling sic^y, ⁿiafrhoea, n^etstomdcls, (try mouth or toe mush sa^|lva

•    sexua^{f |}tro^tl^|emsincⁱuding being unable to getan erectios, having delayed ejaculation or being unable to have an orgasm

•    abnormal taste sgssntion.

It is rnpo rtan t ta have the rigrtlevel of lithium in the blood. If hit too high,then you are more likely to get a side affect.

Te(l yous family about lithium side effects so they know what to look for too.

Reporting of side effecto

If you ge^any stou effcsrs, talktoyour doc tor, pharmacist or nurse. This includes any possible side effecto not lis tas in thisleoflet. You can also report side effects directly via the Yellew Card Scheme at: www.mhra.gov. uk/yel,owcard.

By reporting side effects you can help provide more informaPo n on the safety of this medic iee.

5. How to store CAMCOLIT

Keep all medicinen out of the reach and sight of chUd sen.

Do nor store above 25°C.

Keep the cortal ner tinhtiy closed.

Do not use CAMCOLIT after the expiry date which is printed or emSossed on the bottle label as monthSyear. The expiry date refers to the last day of ^to^{h e}n^mot^ouⁿs^the^. CAMCOLIT after the expiry date which

6. Furtherinformation

What CAMCOLIT contains

The active substynca is lithium carbonate. Each tablet contams 400 mg ihhium carbonate.

The otheringredients ars maize srarsh, acacia, magcestom btearate, sodium laurylsuffate hyprozrellose, arid macrogol 400. titanium dioxide

and Opanprey,

Wfat CAMCOLIT looks like & contents of the pack

Each bottle contains 100 or500 white toblete. EAMCOLIT 40U mg are white film-coated tablets with CAMCOLIT-S on one foce and a scoreline on the other side.

Marketing Authorisation Homer and Mnnuecrturer

The Marketing Authorisation Oolderis Essential Pharma Ltd., Crabtree Road. EgSam,Surrey TW20 8RB,UK. Itis made by Norgine Ltd. Oengoat, Mid Clamorgan, CF82 8SJ UK.

The leafletwas last revised in Marph Z015.