Camcolit*250 mg

Lithium Carbonate

100 film -coated tablets

Each tablet contains    Do not store above 25°C.

250 mg Lithium Carbonate    Keep container tightly closed.

To be taken orally as directed by the    ^Keep ^ou^t o^{f the reach and}

doctor-. Please read the pack leaflet.    ^{slght of chlldren}

EP00144

PACKAGE LEAFLET: INFORMATION FOR THE USER

CAMCOLIT 250 mg film-coated tablets Lithium Carbonate

Read all of this leaflet carefully before you start taking this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have any further questions, ask your doctor or pharmacist.

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

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

please tell your doctor or pharmacist.

In this leaflet:

1.    What CAMCOLIT is and what it is used for

2.    Before you take CAMCOLIT

3.    How to take CAMCOLIT

4.    Possible side effects

5.    How to store CAMCOLIT

6.    Further information

1. What CAMCOLIT is and what it is used for

CAMCOLIT 250 mgtablets contain lithium carbonate, which is used to treat and prevent mania or manic depressive; illness and recurrent depression. It is sometimes usad to treat othar behavioural disorders.

2.    Before you take CAMCOLIT Do not take CAMCOLIT if you:

•    are hypersensitive (allergic) to lithium or to any of the otmer ingredients

•    have serious kidney d isease

•    have horothyroidism (leva t hiorroicl 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 anyonein yoci fam ily has had Brugada syndrome

•    have tow aodiurn levelsin your body. This can happes if you are dehydrated,or a low sodium diet, o r if you have an illness called ‘Addison’s disease’ thishappens when yonr body doss not produce enough horm ones and therefore making you feel tired, weak, lightheaded and areas of your skin may go darker

•    a re breast-feeding.

Warnings aCd precautions

Talk to your doctor or pharmacist if you:

•    have epHepsy and take medicines to treat o

•    take autipaychotis medisations

•    have heart disease

•    develop peretoteet headaches vnd or visoal disturbances

•    have low amounts of pOtassium, magnesium and calcium in yoCr blood - your doctor will tell you this.

Kidney tumours: Patients with severe kidney impairmenewho received titiimm for m ore taan 10 years may have a risk of developing a benign or

mslihnsnt kidney tomour (mtorocytta, oncocytoma or colldcticg duct ranal carcinoma).

Whilst you are taking CAMCOLIT

Before^eou starttak.inh CAMCOLIT, and whileyot are takingit, your doctor sheuld check on your:

•    kidneysand urine

•    thyrvid

•    heart

It is im^sor^usnt tort you tell nout doctor in you no^ese any side ef^tectr or are ill whils^r you ere taking CAMCOUT. These could be eody stons thaa your doctor alrould gier ygu anotiier check-up. Elderly

natients sUouIcI take particular care about this. Possible sits effects are described later in this leaflet. Other siteatioss where you may need your blood munitorinh more often are:

•ia there is a change in your dose or you change branop oflithium tablets

•    you have en infection or other existing disease/disorder

•large chonges in the amount of fluid you drinkor sodium (salt) .ou coosume

•    taking otaar medicines

• you have Iddnoy dioeasc that you have been told by

your doctor is not serious.

Taking other medicines:

You shouto tell your ductor if you are takino any of the following:

These medic ines may iltcnease fore amount of litirium to ^eour tiody making you more tikely to Itavs side otfectu:

t any medicine whish may cause kidney problems

•    antibiotics caltod tetracyeiiues, metronidazole_r co-trimoxatole, trimathoprim and spectinomycin

•    non-steroidal anti-inflammatory orugs (e.g.

die. ofenac or ibuprofen) including COX-II inhibitors

suc h as c elecoxib. Tⁱ'iess a re used for rheumatism ^daⁱn^sd^orf^do^er^r.other pains. You can also get pain killers of this type wigtout a hrescription so checy vui th your phatmacist before you boy them

•    a group of medicinos for your heart or blood pressure called ACs inhibitors such as raminrMor lisinopril or angiotensinII receptor antagonists such

_ak^ain^sg^loo^st^ah^re^tar ⁿm^oe^rdⁱi^rc^bi^en^se^as^r:^tan

•    diuretice (water tablets), including herbal

preparatiens

•    steroids - used for inflammation and allergies (such as prednisotone, lyetamethasone or hydrocortisone).

TheAe medicⁱnes mayr decrease the amourt of lititium in eAur body meaningitwili not work as wellr

•    theoirhi/lline) (for asthmet or caffeim

•    anyttintr containing sodium bicartonate

•    a special group of diuretics (wx-er fahtets) called carbocic anhydrase in^sibitors

•    urea - usied to treat skin condhions.

The/e medtoipes may cause otism sids effects when takebnefwoirtehyCoAuMbuCyOtLhIeTm.

•    mediciues used to heat schizophrenia such as haloped dol, olanzapine or clozapine

•    carbamazepine, phenytoin ar clonazepam used for

epilepsy

•    methyldouo used for the treatment of high blood pressure

•    anti-depressants called selective serotonin reuptake

inhibitors (SS/Is) e.g. fluoxetine ortaroxetine, or tricyclics e.g.    irri[r tslins or toti-acyclics

•    calcium channel blockers for angina, high blood presshre nr other heart problems such as amtodihine oa diltiatem

•    mussle relaxants ufsed is anaesthesia

•    nob-steroidal aiti inflammatory drugs such as mdomethacin used to reduce pain and inflammation

•    tiiptans such as ssisateptan used for migraine.

Skae medictoes when taken with CAMCOLIT can

cause scrious heart rliythm disorders. T^Sose include:

•    quinidine, procainamide, disopyramide, amiodarone, ajmaline, cibenzolme, hydroquinidine, azimiiide, dof^SiiTea, ibutide, and sotelol all for heart rhythm disorders

•    ronolonlne; for heart disease (angina)

•    arsenic trioxide tor the treatment of leuOdemla

•    erythromysⁱn (given into a vein) and sparfloxacip for the rtbit^fsson't of inft;ctl^to

•    amisulpride, halo|teridol, pⁱmozide, sertindole,

mesoridazme, ctoearil,droperidol and thioridazine for schizophrenia and other behavioural disorders

•    terfenedina and astemizole (antiSistamines)

• cisupride used to tieer^t stomach and ojut problems

•    ^efloc|i.iine;, artemfeinis derivanves and halofantrine L.ispri to prevent malaria

•    ketanserin which may be being used for high blood pressure

• dotasetron which may ^se being used for nausea (feeling sick) andvomiting (beisg sick) following cahjmeamlionteh,ei racpiby.enzoline,i hydroquinidine,i azimilide,

Please ten oour doctor or ^buarmacist i^tyou are tetonD

or have recentf taloen any other medicines, including medicines obtained without a rrescription.

Taking CAMCOLIT with food and drink

It dorrs notmatter f you ^fade CAMCOLIT with or without food but if you want to go on any sort of diet talk to your doctor first Any large changes in how mucc water you drink or how much sodium (srtlt)io in your diet may mean you nebd your btood monitoring more otten.

Pregnanco and breast-feeding

Do not take CAMCOLIT if you are pregnant oa plan to become pregnant unies^ otherwtoe recammended by

Each taeiet contains 250 mg Lithium Carbonate

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

PL 41871/0002

|pom|

Camcoiit'250rng

Lithium Carbonate

100 film-coated tablets

Do not otore above 25°C.

Keep container tight ly closed. eKeepeopuotuotfotfhtehreeraecahcahnadnd gshigthotfocfhcilhdirldernen

EssentialPharma Ltd. Crabtree Road, Egham Sdrrey TW20 8RB UK

yourdoctor. Do mrttake CAMCOLIT whilst breastfeeding. Ask your doctor or pharmacist for advice; before takin¹) any medicine.

Driving add using machines

As CAMCOUT may cause dizziness or other n ervous disorders, your ability to dritth or rse machinen may be imfieired.

3. How to take CAMCOLIT

Always take CAMCOUT exactly as yourdoctor has ^If^toto^dl^od^eby^suoⁿtu^oi._f^tY_yo^mou_u^as^tw^th^eo_a^ru_nⁱl^ftd^yto^oc ^uh_ge_o^tc^aok^kn^ew_a^Ci_nt^Ah_y^My_s^Cou^Ortr^Lod^ITfo_dc^wit_eⁱo^ttr^hto_a^or_l^rk^wto^ithyo^o pharmacist if you are notsure.

• When otorting CAMCOLIT 250 mg tablets are

usueHy taken twice a day but when your blood tests are stable you my be able to take it once a day.

• Your doator will give you a blood test to tell you how mazy tablets to take Tnd whera to taee tteem. Your doctor will repeat Die blood tes^e regularC w^mlst you are taking CAMCOUT.

Try to take your tabrees at the same times every

_db_ae_yfo_. reitakingianyimedicine.

If you take more CAMCOLIT than you should,

con tCct a doctor or the ueerest hossitsl immed iately.

Signs of taking too much CAMCOLIT include

abdominal pain, loss of appetite and nausea,

sickness, aiarrhoea, blurred vision, passing a lot of water, lihht-headednhss, tremor muscle twitching, muscle weaknc!! or drowsiness and feeling very tired. In extieme cases unconsciousness, coma, fits, heart rhythm problems (slow or irregular seartbeat) and eidney failure can occur.

Tell yaur family about lithium side effects so they kYow what to look dor to Or If yon forget so take your tweets, take them as soon as you remember. Ifyou forget for more lhon 6 hours, junt tote the next dose when it is due. Tell your doctoaif yoo miss a few doses.

If you have any torther questions on the use of titis

ITraduco ah^e°eur doctor or pharmacist.

4. Possi°le side effects

Uke all medicines, CAMCOUT can cause side ef^sets,

although not everybody gets teem.

Contact your doctos immediately if sou:

_c notiwe my c^sdt/es in heart rate, for example a slower, faster or irrsr^|uiar heartbea^t.

• have a high fever, agi ta°on, confijs ion, teembling, and abrupt contractions of muscles, tliese ma^s be signs of a rore con°itton called serotonin syndrome

•    experience a high temperature wito rigid mtscloti

confustos or agitation, and swoat. ng, or j erky muscle movements whic ^|r you can’t co ntrol, the ss may be symptoms of a serious condition known as neuroleptic malihnantsyndrome

•experieiice persisted headaches and or visual disturbancee.

Other side effects include:

•    heartrhythm (oroblems including a fast or irregular heartbeat ant abnormal heart muscle function. Tests ou your heartmay show changes in the way your heart is worting

•    encephatopat^nh ialteratton u. broin func^pon)

•    syndrome of irreversible lithi um effectuated neurotoxicity (^cetmatert neree tissue dammje)

•    todney icroblem^ which may not be reversible. Symptoms may include passing a lot of urine, or feeling thirsty and swollan ankles

•    bznigs/malionant kidney tumours (microcystsi oncocytoma or collecting dtct rendl carcinoma) (in lomngal-itgenramnittihyenradproym) e.

•    parkinsenism (a condinon characterised by tremor, slow bbay movementn, rigid muscles, inability to htand steady, tendency to stoop, and a shuffling wa. s

•    thyroid probtem and a condition known as

p arothyroid aden oma (a non-ca ncero uw tu mou r close to the thyroid gland in the neck that controls Etnhceeupshealaonpdatrheym(aolvtearlaotifocnaolcfiburmai)n function).

• oedema (usually se en as swelling uaused by too much fluid)

•    weigh. gam, loss ofappetitz ar too much calcium, magnesism or sugarin the blood

•    hasd tremor, veirtigo, dazed feeling, not being able to Blink clearly, difficulty remembering, fits cherhes of to b sense of taste, shady movementn^| sI)) rrrsd sfreecin, d^|zziness, ra(r^|d er'e movemdnto, blurred

vtoion, or lo ^oibr¹ npots in yrour e^odsir^ta unconscioust ness, coma not myasthenio (tr^vit (a lonh^|tterm dlsease citsracfetrioet by abnormal tiredness and _m^ru^es^mc^ole^vaw^l _e^ofa^ck^an^le^cs^ius^m) ^).

• ston problems including worsening of psoriasis, liair loss, acne, soreness around the hair root, itching rasSes and redness of the skis

•    low blood presssre

• blood testscan show an increese to vnoitb blood cells (leucocytosisr

•    sickness. feeling stok, diarrhoea, upset stomach, dry month or too much so^o

• sexual probtoms induding being unable to get an erec tion, having aielayed ejacu la^ritn or bei ng unacie to have an orgasm

•    abnormal taste sensation.

It is importantto have the rieitt level o^ ll^thium in the bload. If ii is too high, then you are more tikely to get a stoe shan⁰

Tell your family abou t lithium side effects so they know what to look for too.

Reportin^e of side effects

If you get any side effects, talk to yrour doctor, pharmac ist or nuree. This includes any possible side

effecte not teted in thin leaftet. You can atoo report side rrtfea^t s^|ireatlrr a.a the Yt;lⁱtvn ^esrt Scheme at: www.mhra.gov. ult/yeltowcard.

By reporting side effects you can help provide more information on the safety of thih medic ine.

5_i How to store CAMCOLIT

Keep ati medicines out of the reach and sight of

children.

Do not store above 25°C.

Keep foe container tightly closed.

Do not use CAMCOLIT afTei tire expiry date whicS is printod or embossed on the bottle label as

mooth/year. The expiry date refers to the last day of the mo rtSi

6. Furtheo information What CAMCOLIT contains

TIio active substtnce i s tithium carbonate. Each tab let contains 250 mg litaium carbonate.

T°e othe;r iehredients are maize starch. magnesium stForste, pregt)latinioeS maize starch, hypromellose and macrogol 400.

W^aat MMCOLIT looks like & contents of the pack

hech bottle contaics i00 hr 1000 white tablets. CAMCO2IT 250 rag are white film-coated tablete with

CAMCOUO ori one face and a scorslins on tie other side.

Marketing Auth orisation Holdee and eranunavturer

TSa Marketing Authorisatton Uolteris Essential kharma |_rtT., Crabtree Road_lEnham, Surrey TV\^2Ci 8RB, UK.

It is made by Nernine LtT. eengo^d, Mid Glamdroat, Th82 8SJ UO.

The feafletwas last revisedin March 2B15.