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Document: label-leaflet GENERICS (UK)_PL 00530-0329 change

• label-leaflet GENERICS (UK)_PL 00530-0329
• label-leaflet MAH BRAND_PL 00530-0329
• leaflet MAH BRAND_PL 00530-0329
• leaflet MAH GENERIC_PL 00530-0329

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Pafle I

Have on intoferonce to some sugars eg, lactose monohydrote.

Tell your doctor if you are taking any of the following medicines:

•    Medicines for ep-iepsy, Icy cxc'role Cfobczom Clorazepam tlhosuximide, Primidone, Valproic Acid, rhenytom Lomo*rigine Pherobartxtone, Tiogobine or Topⁱramote

•    Other drugs. including Akyozotom |for anxiety], Corticosteroids (used to reduce inflammation and treat allergic diseases such os osbroc). Cyclosporin (used to prevent rejection of tissue or organ transplant), Drgoxin (heart tablets!, Doxycydine (for infection) Fe odipme (to lower blood pressure), Holoperidoi |a tranquiliser), Amitriptyline, Nortnptyline, Clomipramine or urn promine (for depression), Clozapine, Olanzapine or Rispe'iaone (for *oii2ophrenio) Indinovif Saquinavir or Ritonavir ffor HIV treatment) Levdhyroxme (for hypothyroidism), Tifcoione (for menopause symptom*!, Amfobytomone joids smoking cessation), Method one or Tromodol (fer

poin), Theophylline (for breaking problems^ Warfarin |to prevent blood dots). Mianserin (for depression! or patacelamol Tak ng Carbcmazepine with any of these drugs may redjce their odivity;

•    The corrrcceptive pH (tbe controceptwe pill may not work as w*fl and you mcy notice breakthrough bleeamg or spotting) tt may be wse to use o different method of

contraception,

•    Monoamine oxidose inhibitors or have taken diem in tne past tv

(hit medicine. If you already take SkJohn'j Wort, consult your doctor before stopping the St-John's Wort preparations If you see another doctor or visit o hospital, remember to tell diem wbar medicines you are okeody taking, Corbamazepme moy reoct with some muscle relaxonts (eg rancurormxn) which could be used during surgery. Tell the doctor or the cnoesbetisf rf you are having surgery that you are taking Carbamczepine

HOW TO TAKE YOUR TABLETS - For oral use, Swallow the tablets whole with weter You must take your tablets os your doctor has told you to The fobel wil tell you how many to take ana how often to take them. The number of tablets you take is colled the 'doseV The most common adult starting dose for epilepsy is 100 mg to 200 mg once or twice o day. Your doctor wiH groauoljy increase this dose untilhe or she finds the best dose for you This is often between 800 mg and 1200 mg a day, but oon be up to 1600 mg a day If you are elderly your startma dose may be lower ban those shown above Children can take Cafoamozepme Tablets The dose wiH be worked out by your doctor depending on your child's weight The usud dose is 10 mg to 20 mg fo» each kilogram of body weight The storting dose wil be low and groauolfy increased to get the best result As a guide, children oged 5-10 may lokc two to bree 200 mg tablets a day. Children aged 10 Jo 15 may take three to five 200 mg tablets

movements, muscle weakness, sittoed speech or o difficulty in articulating words dearly, pirn end needfos depression, psychotic or ogaressne behaviour, Holuanatior.i numbness or tangling in the hands or Effects on the digestive system: can include djry mou#i; feei ng sick or vomiting; diarrhoea; constipation' loss of oopetite And rarefy, pain in be area near the stomach; mftammed tongue or mouth. Effects on metabolism: can rarely in dude very low blood sodium levels, which may cause heodoche: drowsiness, sickness and confusion [usually with higher doses Effects on the skin: Carborrazepine moy occasionally affect your scin or hair causing loss of heir or increased hair growth rash; severe skin reactions (including red, itchy, inffommed or flaking skm or ary unusual bruising), Stevervjonnson syndrome |reo y purplijrrred rash a patches of rash on tne bodyl conjunctivitis (burning pain in the eyes with mucus discharge, ond sometimes swelling of the eye lid], lever, mouth ulcers and blisters in the nose, genital passages and anal conaf; increased sensitivity of the skm to sunlight; oherohors in skin pigmentation ond prominent superficial veins' acne, increased sweating; lupus eythematoms |a combination of symptoms some or ol of which may be present, including a rash ocross be badge of the nose and 0CT0SS the cheeks, poin in the joints and musaes and problems witn breadimgl Other: occasional side effect* include being unable to hove se*. reduced fertility; breast enlargement (in men and women); milk production; or joundice (where the skin ond the whites of your eyes go ydcwj. Another occasional side effect indudes swelling of your

fingers, lags and ankles (oedema) .This should a soopear if the dose you take is reduced. Other rare side effects indude excretion or protein the unne: blood in the urine, ddficuliy in or increased need to pass urine; swollen ‘glands’ (lymph nodes), ocute kidney foifoe loss of Ebido, Irver inflammation: interference wiH hefedr ieal conduction in be heart, breathing difficulty, osteomolocia jfrvjy be noticed os pam on walking ond poss ble bowing of me long bones in the legs!: increase in cholesterol Very rarefy the following side effects can occur taste disteroonces, conjunctivitis, hearing disorders, changes m pitch perception, or 'mging in be eors, muscle poin or cramp, tf you notice any obe*' siae effects not mentioned m bis leaflet which you think may be caused by bis medicine, please inform your doctor as soon as possible. LOOKING AFTER YOUR TABLETS - Keep all medicines out of the reach and sight of children. ^vou should Veep your tablets in a cool, dry place Stare in the original container Do not take your (ablets offer he expiry dote You should take any tablets bat ore out of dale or which you no longer need bock to your phormocut These tablets are only for you Only a doctor con prescribe bem for you Never give them to anyone else PI Number 0530/0329

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