CARBIMAZOLE 10 MG TABLETS - patient leaflet, side effects, dosage

for|               ■!

• 2. What you need toknow before you take Carbima zole_

3ta.blHetoswor­toCatarbkiemaC­zaorlebi2m0am­zgolteablets (called

4C.arPboimsaszibole isnidtheiselfe­faeflcetst). This belongs to a

5gr.o Hupo owfmtoesdtico­irneesCcaarlble­idm‘aznoti-ltehyroid’ medicines.

6. Contents of the pack and other information

1. WHAT CARBIMAZOL IS AND WHAT IT IS USED FOR

• aibcmazole belon g s to agroup of medicines caltlreedat'manetni-ttshfyoroaind'om­veerd-aictiinvest.hy­roid gland.

It is used for adults and childrenwith an ovegrl-aancdtipvaes tbheyernoirdem­golavned b(cy aslulergdery. It pelps tpe 'hyptpeyr-otihdygrloain­ddiswmo'r)k pro­perly before tpe surgery.

• It works by reducing the amount of thyroid hormones madein your thyroidgland.
• DoInt octatnakbee Cuasrebdimoan­zoitlseoifw:n, or with other
• tYroeuatamree­anltlesrgfoicr (apnypoevrseer-nascittiivvee) tohycraorbidimazole gorlaanndy.of tpe otper ingredients of Carbimazole
• ItYtaobculaean­tsrea(llaislo­teerdbg eiicnu(Spseyec­pdteiorbsnee6fo)s­.riteivep)atrot ootfptehre
• tYhoytuirotahirde agildlearngdic­dh(ipaiysp bereseenhsrie­tivmeto)htvioe odtpbeyrl saurnotrig-theltyrpyrio.o­iIudtrahmceei­lldpicsinthees sthucyhroaids tghilamndazwo­loerokr ppYoroupppyearvley lbiveefropr.e­rotbhleemssur­gery.

2. what you need to know before you take carbimazole

Dapoplny otot ytaoku.eIfCya­ourbairme anzoot sleurief,: talk to your doctor or pYpoaurmaareci­satllbeerfgoir­cetoakcinagrbCi­amrbaizmoalze­ooler.any of Taktehespoetchiearl icnagrerewdii­tehnCtsarobf itmhaiszomleedicine Cpe(lcisktewdit­pinyoSuer cdtoioctnor6o).r pparmacist before taking youYromuehdiac­vineeaif:seve­re liver disorder.

• You phaavveeaaswser­lliionugsinby­louordnedcisko­cradllerd. an I‘ifnytroauthoh­raadcicingflo­aitmrem’.ation of the pancreas If yo(aucaurteenpoat snucrree iaf ttipties)a aboftveer apdpmlieins itsotryaotuio, n of talkctaoryboi­muradzooclteo­roorr tphpiamrmaazco­isltebienfothree tapkainsgt. DCaorbniomtatzaokl e.Carbimazole tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Carbimazole.

Warnings and precautions

Talk to your doctor or pharmacist before taking Carbimazole if:

• You have a swelling in your neck called an ‚intrathoracic goitre‘.
• You are pregnant, think you may become pregnant or are trying to become pregnant.
• You have bone marrow depression.
• You have mild or moderate liver problems.
• You are receiving radio-iodine (for thyroid problems).
• You are of child bearing potential.
• You are allergic to thiamazole, methimazole or propylthiouracil (other thyroid medications).
• You are unable to comply with the instructions for use or cannot be monitored regularly.
• Tell your doctor straight away if you develop fever or abdominal pain, which may be signs of inflammation of the pancreas (acute pancreatitis). Carbimazole may need to be discontinued.
• Carbimazole can cause harm to an unborn baby. If you could get pregnant, use reliable contraception from the time you start treatment and during treatment.

If you are not sure if the above applies to you, talk to your doctor or pharmacist before taking Carbimazole.

Children

Do not give this medicine to children under the age of two years because it may not be safe or effective.

Other medicines and Carbimazole

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This includes medicines obtained without a prescription, including herbal medicines.

This is because Carbimazole can affect the way some medicines work. Also some medicines can affect

the way Carbimazole works.

In particular tell your doctor or pharmacist if you are taking any of the following:

• TakMinegdoicthi­neersmtoedtih­ciin eysour blood or to stop Plecalsoetttienlgl y (oaunr tdicooctaogr uolrapnhtasr)me­a.gci.stwifayr­foaurianr.e takiAngmoer dhiacvine ereucseentdlyt­toaktreenaat naysoththmera­moerdicines. Thibs rinecaltuhdiensg mperodibcilneems sobctaalilneedd ‚twhiethoopuht aylline‘. preSscterirpo­tiiodns, isnuclcuhdiangs hperrebdanl imsoedloicninee. s. This is becAanusaenCti­abriboitmicaz­coallelecdane­rayfftehcrtot­mheycwiany. some meAdicmineds iwcionrek. fAolrsohesoamrt efamiluedreicic­naelslecdand aigffietactlis. theMweadyiCci­anrebismfaozroh­leigwhorbklso­.od pressure called In pbaertiac-ublalor cteklleyrosu. r doctor or pharmacist if you areAtankyinog­thaenyr mof ethdeicfionlle­owthinagt:cou­ld affect your wMheidteicibne­losotod tcheinllycoouur nblto. od or to stop clotting.

If aAy of the above apply to you (or you are not‘tshueroep)h,y­tlalinlke’t.o y­our doctor or pharmacist bIf eafnoyreoftat­pkeinagboCvae­rabpimplyazto­olyeo.u (or you are not P sur re eg ),n ta ln kc toy ya on ud r db or ce toa rs ot r-f pe pe ad rmin ag cist before ItfaykionugCa­raerbpimreagzon­laen.t or breast-feeding, think yP ore ug mna an ycy bean pd reb gre nas nt t-f oe red ai rn eg planning to have aTablkatboyy, oausrkdoycotuor bdeofcotreorta­okrinpghCaarmrba­imcaiszto fleorif ayoduviacree pbregfonraen taokr imngigptht ibse mcoemdeicpirne­eg.nant.

Pregnancy

Carbimazo le can cause harm to an unborn bInasboym. Ief cyaosuesc,oyuoludr gdoect tporemganyapnrte,suc­sriebereliable cCoanrbtrimaca­ezoplteiownpfil­reoymouthaere­tipmreegnyaonur­.sHtaertor spe will traelkatomyeonut abnodurdrupirsin. Igf rtpreyatdmo,er­npte.y will lower rpe Hpooswsiebvilieryr, otfoarneydeuf­fceecrtsh oenpyoosusriba­ilbity boyf:any effects onyour ba by:

• YSorouprpdinog­crtroerarsmhe­onur lrdprpereersoc­froiburewthee­klsobweefosrte pyoussairbele­dudeorsoeg.ive bi­rrp.
• Do Ynoout rbrtereaast-mfeendtifmyoauy abre tdaiksicngonCta­inrbuiemdazthol­ree.e Tpitsoisfobuer­cawuesekssmba­ell faomreouynorus maraey dpauses tionrgo irvpee mobrpiretrh’s­. milk.

YIm op uror tt ra en atmin efo nr tm wa iti hon Cab rbo iu mt as zo om le mof at yhe need ti ong br ed cie ont ts ino uf eC da drb ui rm ina gzo ple ret ga nbl ae nts cy if the pCoatrebinmtiazl oblenraebfliet rosuctownerai­ignhlasctrhoe­sep(oatreynpte­iaol frisk tsougyaoru). aIf nydouypoauvre­ubnebeonrrnol­bdabbyyy.our docror rpar you cannor roler are or digesr some sugars (pave E3reast-fraeding

Do not tareast-feed if you are taking Carbimazole. This is because small amounts may pass into the mother'sO milk. ■

D Alr wiv ai yn sg raa kn i d Cau rs bin mg azm ola i c ih xi an ce rlys as your docror Ypoasu rcoaldnydouri.vYeo wu hspeonu tldakcipnigckCwa­irrbp iymoaurzodolec,ro­bruotr dppoa nrmotacdirsirvief yuonutial ryionuorksnuoriw. how it affects yT oak ui.ng this medicine

Carbim azole tab lets contain lactose

If you have been told by your doctok th at you have an intolerance tosome sugars, co ntact youmr idaolsc.tor before taking this medicinal pfroTdpuicta. blirs you raki iacp day may bi splir ilro

3. how to take carbimazole

Alwaariyslotar­kseurtih.is medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Taking this medicine

• Take this medicine by mouth.
• Swallow the tablets whole with a drink of water.
• You can take the tablets before, during or after meals.
• The tablets you take each day may be split into two (morning and evening) or three (morning, afternoon and night).

Ask your pharmacist if you are not sure.

How much to take at the start

The doctor will decide on a starting dose, and then see how well it works.

• If needed, he or she will then change the dose.
• This is to find a dose that suits you best.

Adults

The recommended starting dose is 20 mg to 60 mg each day.

The number of tablets to be taken depends on the tablet you have been given. This would usually be between:

• 1 and 3 tablets for the 20 mg tablet
• 2 and 6 tablets for the 10 mg tablet
• 4 and 12 tablets for the 5 mg tablet.

Use in children

The recommended starting dose is 15 mg each day. This would usually be three 5 mg tablets or one 15 mg tablet.

How much to take after the starting dose

Your illness will usually start to improve within one to three weeks. However, it usually takes four to eight weeks to have full benefit from your treatment.

• When your illness is controlled, your doctor will gradually lower your dose to one to three 5 mg tablets each day or one 15 mg tablet each day.
• Do not change your dose without talking to your doctor first.

You may need to keep taking Carbimazole for several months to keep control of your thyroid gland. Your doctor will decide when treatment can be stopped. Your doctor may ask you to have occasional blood tests to see how well your treatment is working.

Your doctor may decide to add an additional tablet (l-thyroxine), to help control your condition.

R 0 X ad 22 io 0m -io m dine

K Another treatment for an over-active thyroid iC s called „radio-iodine“. If you need radio-iodine tC reatment your doctor will tell you to s0% top taking Carbimazole tablets for a while. a I c f k y o u t take more Carbimazole than you s /1 h 2 o /2 u 01 ld 3

p It f you take more Carbimazole than you should, talk to a doctor or go to a hospital sC to raight away. Take the medicine pack or this lC eaflet and any remaining tablets with you.

If you forget to take Carbimazole

If you forget a dose, take it as soon as you rA eU mT eH mO bR eIT r. Y If it is time for your next dose, take N boF tI hRM dA oT seIO sN together.

o Ir fk yha os ube hen aa vp epro ave nd yby further questions on the use h oodr fiith ty h(i if saph mplic ealb dile ic, e i. ng. e, ask your doctor or mo pmdi hppho aan rrem mnth afoav cres i a slilc tee. innsethe

4. possible side effects

• .. L… i. k… e......a… l. l… m......e… d…i. c… i.. n… e. s, this medicine can cause

side effects, although not everybody gets .. t. h…e… m............­.............­...........

The side effects usually happen in the first

.. e… i.. g… h…t… w.....e… e… k…s…o…f… y.. our treatment. Do not be

alarmed by this list of possible side effects.

.. Y… o…u.....m.....a… y.....n…o… t…g… e…t any of them.

Allergic reactions

.. I. f…y… o… u......h… a… v… e.....a…n.....a… llergic reaction, stop taking

Carbimazole and see a doctor straight away. The signs may include: sudden rash, swelling or difficulty breathing.

St O op F tak 2 ing Carbimazole and see a doctor straight away, if you notice any of the following side effects:

• Any infection such as a sore throat or mouth ulcers.
• Fever.
• Unusual bruising or bleeding.
• Feeling unusually tired.
• You are feeling generally unwell or think that you may have an infection.
• Angioedema, a serious allergic reaction with symptoms that may include swollen tongue, lips, face or throat.
• Stevens-Johnson syndrome, a serious illness with blistering of the skin, mouth, eyes and genitals.

In addition, if you experience any of these symptoms while taking Carbimazole you should also contact your doctor immediately:

• Liver problems such as yellowing of the skin or whites of your eyes (jaundice).
• Muscle pain or weakness.
• Nerve pain.
• Swelling of lymph nodes.
• Swelling of glands in your mouth.
• Feeling faint (low blood sugar).
• Kidney problems, with symptoms that include a reduction in the amount of urine passed, fluid retention and blood in the urine.

These could be signs of muscle problems, jaundice or inflammation of the liver and under medical supervision your doctor may want you to stop taking the medicine and carry out some blood tests on you.

Do not stop taking Carbimazole until you have consulted your doctor.

Carbimazole can sometimes cause bone morrow depression which causes a reduction in the number of blood cells and reduces the ability to fight infection. If it is not treated as soon as it is detected the condition can become life-threatening. Your doctor should carry out tests to check for bone marrow depression before restarting your treatment.

The following side effects are reported with a not known frequency (frequency cannot be estimated from the available data):

Other side effects include:

If you get any of the following side effects, they normally go away while you keep taking your medicine.

• Feeling sick (nausea)
• Headache or feeling dizzy
• Skin rashes, including urticaria (nettle rash)
• Itching
• Stomach upset
• Painful joints.

The following side effects have also been reported:

• Hair thinning
• Changes to your taste
• Inflammation of the pancreas (acute pancreatitis)
• Lung problems, with symptoms that include shortness of breath or a cough.

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 Website: or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. HOW TO STORE CARBIMAZOLE

• Keep this medicine out of the sight and reach of children.
• Do not use Carbimazole after the expiry date which is stated on the label.

The expiry date refers to the last day of that month.

• Do not store above 25°C.
• Store Carbimazole in the original packaging.
• Medicines should not be disposed of via wastewater or household waste.

Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. contents of the pack and other information

What Carbimazole tablets contain

• The active ingredient is carbimazole. Each tablet contains 5mg or 10mg or 15mg or 20mg of carbimazole.
• The other ingredients are lactose anhydrous, magnesium stearate, croscarmellose sodium and the colourant red iron oxide (E172).

What Carbimazole tablets look like and contents of the pack

• Carbimazole 5 mg tablets are round, pale pink and marked with Link C5 on one side and have a scoreline on the reverse side.
• Carbimazole 10 mg tablets are round, pale pink and marked with C10 on one side and plain on the reverse side.
• Carbimazole 15 mg tablets are round, pale pink to pink and marked with C15 on one side and plain on the reverse side.
• Carbimazole 20 mg tablets are round, pink and marked with Link C20 on one side and have a scoreline on the reverse side.