Lamictal DC chewable 25mg 30 tablets

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LAMOTRIGINE DC 25 MG SOLUBLE/CHEWABLE TABLET IS FOR ORAL ADMINISTRATION. ACTIVE SUBSTANCE: EACH TABLET CONTAINS 25 MG LAMOTRIGINE. EXCIPIENTS: CALCIUM CARBONATE, CROSCARMELLOSE SODIUM, MAGNESIUM ALUMINOSILICATE, SODIUM STARCH GLYCOLATE, POVIDONE K30, SODIUM SACCHARIN, BLACKCURRANT FLAVOR, MAGNESIUM STEARATE, PURIFIED WATER. BEFORE YOU START USING THIS MEDICINE, READ THIS INSTRUCTION CAREFULLY AS IT CONTAINS IMPORTANT INFORMATION FOR YOU. · KEEP THIS INSTRUCTION. YOU MAY NEED TO READ IT AGAIN LATER. · IF YOU HAVE ANY ADDITIONAL QUESTIONS, CONSULT YOUR DOCTOR OR PHARMACIST. · THIS MEDICINE HAS BEEN PRESCRIBED INDIVIDUALLY FOR YOU, DO NOT GIVE IT TO OTHERS. · IF YOU ARE SEEING A DOCTOR OR GOING TO A HOSPITAL DURING TREATMENT WITH THIS MEDICINE, INFORM THE DOCTOR THAT YOU ARE USING THIS MEDICINE. · FOLLOW THE INSTRUCTIONS IN THIS LEAFLET EXACTLY. DO NOT USE THE MEDICINE AT A HIGHER OR LOWER DOSE THAN RECOMMENDED FOR YOU. THIS LEAFLET CONTAINS THE FOLLOWING SECTIONS: 1. WHAT IS LAMOTRIGINE AND WHAT IS IT USED FOR? 2. THINGS TO CONSIDER BEFORE USING LAMOTRIGINE 3. HOW TO USE LAMOTRIGINE? 4. WHAT ARE THE POSSIBLE SIDE EFFECTS? 5. HOW TO STORE LAMOTRIGINE 1. WHAT IS LAMOTRIGINE AND WHAT IS IT USED FOR? LAMOTRIGINE BELONGS TO A GROUP OF MEDICINES USED TO TREAT EPILEPTIC SEIZURES. THE TABLET IS WHITE-OFF-WHITE IN COLOR, WITH A BLACKCURRANT SCENT, WITHOUT A NOTCH, WITH SLIGHTLY ROUNDED CORNERS, ENGRAVED WITH "GSCL5" ON ONE SIDE AND "25" ON THE OTHER. THE TABLET MAY HAVE FAINT SPOTS. EACH BOX CONTAINS 30 TABLETS IN CHILD-RESISTANT BLISTERS. LAMOTRIGINE IS USED IN THE FOLLOWING CASES: • IN CHILDREN AGED 2-12 YEARS, IT IS USED IN COMBINATION WITH OTHER MEDICINES TO TREAT EPILEPSY, PARTIAL SEIZURES, AND GENERALIZED SEIZURES, INCLUDING TONIC-CLONIC SEIZURES (SEIZURES CHARACTERIZED BY CONVULSIONS AND SHAKING) AND SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (A SPECIFIC FORM OF EPILEPSY CHARACTERIZED BY VARIOUS TYPES OF SEIZURES). ONCE SEIZURES ARE CONTROLLED, IT MAY BE CONTINUED AS MONOTHERAPY. • IN CHILDREN AGED 2-12 YEARS, IT IS USED AS MONOTHERAPY TO TREAT A TYPE OF EPILEPTIC SEIZURE - TYPICAL ABSENCE SEIZURES (SEIZURES CHARACTERIZED BY SUDDEN ONSET AND CESSATION). • IN CHILDREN OVER 12 YEARS OF AGE AND ADULTS, IT IS USED IN COMBINATION WITH OTHER MEDICINES OR AS MONOTHERAPY TO TREAT EPILEPSY, PARTIAL SEIZURES, AND GENERALIZED SEIZURES, INCLUDING TONIC-CLONIC SEIZURES AND SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME. • IN ADULTS AGED 18 YEARS AND OVER, IT IS USED TO TREAT BIPOLAR DISORDER. 2. THINGS TO CONSIDER BEFORE USING LAMOTRIGINE DO NOT USE LAMOTRIGINE IF: YOU ARE ALLERGIC TO LAMOTRIGINE OR ANY OTHER INGREDIENT OF LAMOTRIGINE (SEE THE LIST OF EXCIPIENTS AT THE BEGINNING OF THE INSTRUCTION LEAFLET). USE LAMOTRIGINE WITH CAUTION IN THE FOLLOWING CASES: CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING LAMOTRIGINE IN THE FOLLOWING CASES: · IF YOU HAVE ANY KIDNEY PROBLEMS; · IF YOU HAVE PREVIOUSLY DEVELOPED A RASH AFTER USING LAMOTRIGINE OR OTHER MEDICINES FOR BIPOLAR DISORDER OR EPILEPSY; · IF YOU HAVE DEVELOPED A RASH OR SUNBURN AFTER TAKING LAMOTRIGINE AND EXPOSURE TO SUNLIGHT OR ARTIFICIAL LIGHT (E.G., SOLARIUM). YOUR DOCTOR WILL REVIEW YOUR TREATMENT AND MAY ADVISE YOU TO AVOID SUNLIGHT OR PROTECT YOURSELF FROM THE SUN (E.G., BY USING SUNSCREEN AND/OR WEARING PROTECTIVE CLOTHING). · IF YOU HAVE HAD MENINGITIS (INFLAMMATION OF THE BRAIN MEMBRANES) DURING TREATMENT WITH LAMOTRIGINE (SEE SECTION 4 OF THIS INSTRUCTION LEAFLET TITLED RARE SIDE EFFECTS FOR A DESCRIPTION OF THESE SYMPTOMS); · IF YOU ARE USING OTHER MEDICINES CONTAINING LAMOTRIGINE; · IF YOU HAVE A CONDITION CALLED "BRUGADA SYNDROME" OR HAVE OTHER HEART PROBLEMS. BRUGADA SYNDROME IS A GENETIC DISEASE THAT CAUSES ABNORMAL ELECTRICAL ACTIVITY IN THE HEART. LAMOTRIGINE CAN ACTIVATE AN ABNORMALITY ON THE ELECTROCARDIOGRAM THAT CAUSES ARRHYTHMIAS (HEART RHYTHM DISORDERS). · IF YOU HAVE LIVER DISEASE; · IF YOU HAVE STARTED OR STOPPED USING HORMONAL CONTRACEPTIVES. IN WOMEN, THE USE OF HORMONAL CONTRACEPTIVES DURING LAMOTRIGINE TREATMENT MAY REDUCE THE EFFECTIVENESS OF THE CONTRACEPTIVE. THIS MAY LEAD TO MENSTRUAL CYCLE DISORDERS, SUCH AS UNEXPECTED VAGINAL BLEEDING. IN THIS CASE, THE LAMOTRIGINE DOSE MAY NEED TO BE ADJUSTED. INFORM YOUR DOCTOR IF ANY OF THESE APPLY TO YOU. YOUR DOCTOR MAY DECIDE TO REDUCE THE DOSE OF THE MEDICINE OR DECIDE THAT LAMOTRIGINE IS NOT SUITABLE FOR YOU. IMPORTANT INFORMATION ABOUT POTENTIALLY LIFE-THREATENING REACTIONS SKIN RASHES ARE KNOWN TO OCCUR DURING LAMOTRIGINE TREATMENT, USUALLY WITHIN THE FIRST 8 WEEKS. THESE RASHES ARE MOSTLY MILD AND LIMITED, BUT SERIOUS RASHES CAN DEVELOP REQUIRING HOSPITALIZATION AND DISCONTINUATION OF LAMOTRIGINE TREATMENT. THESE INCLUDE: STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN), AND DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS - DRUG HYPERSENSITIVITY SYNDROME). YOU SHOULD BE AWARE OF THE SYMPTOMS TO WATCH FOR WHILE TAKING LAMOTRIGINE. THE RISK OF SERIOUS SKIN RASH IS HIGHER IN CHILDREN THAN IN ADULTS. THE RISK OF RASH GENERALLY INCREASES IN THE FOLLOWING CASES: · HIGH INITIAL DOSES OF LAMOTRIGINE · EXCEEDING THE RECOMMENDED DOSE INCREASE DURING LAMOTRIGINE TREATMENT · CONCOMITANT USE OF VALPROATE WITH LAMOTRIGINE. THE INITIAL APPEARANCE OF A RASH IN CHILDREN MAY BE MISTAKEN FOR AN INFECTION. SEE THE BEGINNING OF SECTION 4 OF THIS INSTRUCTION LEAFLET FOR A DESCRIPTION OF THESE SYMPTOMS. HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH) RARE BUT VERY SERIOUS IMMUNE SYSTEM REACTIONS HAVE BEEN REPORTED IN PATIENTS USING LAMOTRIGINE. IF YOU EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS DURING LAMOTRIGINE USE, CONSULT YOUR DOCTOR OR PHARMACIST IMMEDIATELY: FEVER, RASH, NEUROLOGICAL SYMPTOMS (E.G., SHAKING OR TREMOR, CONFUSION, IMPAIRED BRAIN FUNCTION). SELF-HARM OR SUICIDAL THOUGHTS ANTIEPILEPTIC MEDICINES ARE USED TO TREAT CERTAIN CONDITIONS, INCLUDING EPILEPSY AND BIPOLAR DISORDER. INDIVIDUALS WITH BIPOLAR DISORDER MAY EXPERIENCE SELF-HARM OR SUICIDAL THOUGHTS. IF YOU HAVE BIPOLAR DISORDER, SUCH THOUGHTS ARE MORE LIKELY IN THE FOLLOWING CASES: · AT THE START OF TREATMENT, · IF YOU HAVE PREVIOUSLY HAD SELF-HARM OR SUICIDAL THOUGHTS, · IF YOU ARE UNDER 25 YEARS OF AGE. IF YOU EXPERIENCE DISTRESSING THOUGHTS OR IMPULSES, OR FEEL WORSE, OR DEVELOP NEW SYMPTOMS DURING LAMOTRIGINE TREATMENT, SEE A DOCTOR OR SEEK HELP AT THE NEAREST HOSPITAL AS SOON AS POSSIBLE. IT MAY BE HELPFUL TO TELL A FAMILY MEMBER, CAREGIVER, OR CLOSE FRIEND THAT YOU MAY BE PRONE TO DEPRESSION OR SIGNIFICANT MOOD CHANGES, AND ASK THEM TO READ THIS INSTRUCTION LEAFLET. THEY MAY BE ASKED TO LET YOU KNOW IF THEY ARE CONCERNED ABOUT YOUR DEPRESSION OR ANY CHANGES IN YOUR BEHAVIOR. A SMALL NUMBER OF PATIENTS TREATED WITH ANTIEPILEPTIC MEDICINES SUCH AS LAMOTRIGINE HAVE REPORTED SELF-HARM OR SUICIDAL THOUGHTS. IF YOU HAVE SUCH THOUGHTS AT ANY TIME, CONTACT YOUR DOCTOR IMMEDIATELY. PATIENTS WITH BIPOLAR DISORDER MAY EXPERIENCE INCREASED RISKS SUCH AS WORSENING OF SYMPTOMS, DEVELOPMENT OF SUICIDAL THOUGHTS AND BEHAVIORS, AND SELF-HARM. PATIENTS WITH A HISTORY OF SUICIDAL THOUGHTS, YOUNG ADULTS, AND PATIENTS WHO HAD CLEAR SUICIDAL THOUGHTS BEFORE STARTING TREATMENT MAY BE AT HIGHER RISK. THEREFORE, INTENSIVE MONITORING OF PATIENTS TAKING LAMOTRIGINE IS NECESSARY, ESPECIALLY AT THE BEGINNING OF TREATMENT. PATIENTS WITH HYPERSENSITIVITY SYNDROME MAY DEVELOP VARIOUS SYMPTOMS, INCLUDING FEVER WITH RASH, LYMPHADENOPATHY (A CONDITION CHARACTERIZED BY ENLARGED LYMPH NODES IN THE NECK, ARMPIST, AND GROIN), FACIAL SWELLING, BLOOD AND LIVER DISORDERS. DUE TO THE RISK OF RASH, OVERDOSING IS NOT ALLOWED AT THE START AND DURING SUBSEQUENT DOSE INCREASES. IF YOU ARE USING LAMOTRIGINE FOR EPILEPSY: IN SOME TYPES OF EPILEPSY, LAMOTRIGINE MAY CAUSE SEIZURES TO WORSEN OR BECOME MORE FREQUENT. SOME PATIENTS MAY DEVELOP A SEVERE SEIZURE THAT CAUSES SERIOUS HEALTH PROBLEMS. IF YOUR SEIZURES BECOME MORE FREQUENT DURING LAMOTRIGINE USE OR IF YOU HAVE A SEVERE SEIZURE, CONTACT YOUR DOCTOR AS SOON AS POSSIBLE. LAMOTRIGINE CANNOT BE USED TO TREAT BIPOLAR DISORDER IN ADOLESCENTS AND CHILDREN UNDER 18 YEARS OF AGE. MEDICINES USED TO TREAT DEPRESSION (MOOD DISORDERS) AND OTHER MENTAL HEALTH PROBLEMS MAY INCREASE THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE. PLEASE CONSULT YOUR DOCTOR FOR ADVICE, EVEN IF THESE WARNINGS APPLY OR HAVE APPLIED TO YOU IN THE PAST, AT ANY TIME. USING LAMOTRIGINE WITH FOOD AND DRINK LAMOTRIGINE CAN BE TAKEN WITH OR WITHOUT FOOD. PREGNANCY CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING THE MEDICINE. IF YOU ARE PREGNANT OR THINK YOU MAY BE PREGNANT, OR PLAN TO BECOME PREGNANT, CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE. YOUR DOCTOR WILL DECIDE WHETHER TO USE LAMOTRIGINE DURING PREGNANCY. · DO NOT STOP TREATMENT WITHOUT TALKING TO YOUR DOCTOR. THIS IS ESPECIALLY IMPORTANT IF YOU HAVE EPILEPSY. PREGNANCY MAY ALTER THE EFFECTIVENESS OF LAMOTRIGINE, REQUIRING BLOOD TESTS AND DOSE ADJUSTMENT OF LAMOTRIGINE. TAKING LAMOTRIGINE IN THE FIRST TRIMESTER OF PREGNANCY MAY SLIGHTLY INCREASE THE RISK OF CONGENITAL MALFORMATIONS IN NEWBORNS, INCLUDING CLEFT LIP AND PALATE. IF YOU PLAN TO BECOME PREGNANT OR ARE PREGNANT, YOUR DOCTOR MAY RECOMMEND SUPPLEMENTAL FOLIC ACID. IF YOU FIND OUT YOU ARE PREGNANT DURING TREATMENT, CONSULT YOUR DOCTOR OR PHARMACIST IMMEDIATELY. LACTATION CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING THE MEDICINE. IF YOU ARE BREASTFEEDING OR PLAN TO BREASTFEED, CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE. THE ACTIVE SUBSTANCE OF LAMOTRIGINE PASSES INTO BREAST MILK AND MAY AFFECT THE BABY. YOUR DOCTOR WILL ASSESS THE RISKS AND BENEFITS OF BREASTFEEDING DURING LAMOTRIGINE USE, AND IF YOU DECIDE TO BREASTFEED, THE DOCTOR WILL PERIODICALLY CHECK THE BABY FOR WEAKNESS, RASH, OR LACK OF WEIGHT GAIN. IF YOU NOTICE ANY OF THESE SYMPTOMS IN THE BABY, INFORM YOUR DOCTOR. DRIVING AND OPERATING MACHINERY LAMOTRIGINE TREATMENT MAY CAUSE SIDE EFFECTS SUCH AS DIZZINESS AND DOUBLE VISION, SO DO NOT DRIVE OR OPERATE MACHINERY UNTIL YOU ARE SURE THE MEDICINE DOES NOT AFFECT YOU. IF YOU HAVE EPILEPSY, CONSULT YOUR DOCTOR REGARDING DRIVING. IMPORTANT INFORMATION ABOUT SOME EXCIPIENTS IN LAMOTRIGINE LAMOTRIGINE DOES NOT CONTAIN EXCIPIENTS THAT REQUIRE A WARNING. USE WITH OTHER MEDICINES CONSULT YOUR DOCTOR IF YOU ARE TAKING, HAVE RECENTLY TAKEN, OR MIGHT TAKE ANY OTHER MEDICINE. THIS APPLIES TO HERBAL MEDICINES AS WELL AS OVER-THE-COUNTER MEDICINES. LAMOTRIGINE INTERACTS WITH CERTAIN MEDICINES OR INCREASES THE LIKELIHOOD OF SIDE EFFECTS IN PATIENTS. THESE MEDICINES INCLUDE: • VALPROATE (TREATMENT OF EPILEPSY AND MENTAL HEALTH PROBLEMS) • CARBAMAZEPINE (TREATMENT OF EPILEPSY AND MENTAL HEALTH PROBLEMS) • PHENYTOIN (TREATMENT OF EPILEPSY) • PRIMIDONE (TREATMENT OF EPILEPSY) • PHENOBARBITAL (TREATMENT OF EPILEPSY) • RIFAMPICIN (TREATMENT OF INFECTIONS) • RISPERIDONE (TREATMENT OF PSYCHIATRIC DISORDERS) • LOPINAVIR/RITONAVIR OR ATAZANAVIR AND RITONAVIR (TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION) • ETHINYLESTRADIOL/LEVONORGESTREL COMBINATION (HORMONAL CONTRACEPTIVE). IF YOU ARE TAKING OTHER MEDICINES FOR EPILEPSY OR MENTAL HEALTH PROBLEMS, YOUR DOCTOR SHOULD BE AWARE OF THIS TO ENSURE YOU ARE TAKING THE CORRECT DOSE OF LAMOTRIGINE. THESE MEDICINES INCLUDE: • LITHIUM (TREATMENT OF PSYCHIATRIC DISORDERS) • BUPROPION (TREATMENT OF PSYCHIATRIC DISORDERS OR SMOKING CESSATION) • OLANZAPINE (TREATMENT OF PSYCHIATRIC DISORDERS) • OXCARBAZEPINE (TREATMENT OF EPILEPSY) • FELBAMATE (TREATMENT OF EPILEPSY) • GABAPENTIN (TREATMENT OF EPILEPSY) • LEVETIRACETAM (TREATMENT OF EPILEPSY) • PREGABALIN (TREATMENT OF EPILEPSY) • TOPIRAMATE (TREATMENT OF EPILEPSY) • ZONISAMIDE (TREATMENT OF EPILEPSY) • ARIPIPRAZOLE (TREATMENT OF PSYCHIATRIC DISORDERS) • PARACETAMOL (TREATMENT OF PAIN AND FEVER) HORMONAL CONTRACEPTIVES (SUCH AS BIRTH CONTROL PILLS) MAY AFFECT THE WAY LAMOTRIGINE WORKS. YOUR DOCTOR MAY RECOMMEND A SPECIFIC TYPE OF HORMONAL CONTRACEPTIVE OR ANOTHER METHOD OF CONTRACEPTION, SUCH AS A CONDOM, DIAPHRAGM, INTRAUTERINE DEVICE, ETC. IF YOU ARE USING A CONTRACEPTIVE SUCH AS BIRTH CONTROL PILLS, YOUR DOCTOR MAY TAKE A BLOOD SAMPLE TO CHECK YOUR LAMOTRIGINE LEVELS. IF YOU ARE USING OR PLAN TO USE HORMONAL CONTRACEPTIVES, CONSULT YOUR DOCTOR TO DISCUSS APPROPRIATE CONTRACEPTIVE METHODS. LAMOTRIGINE MAY ALSO AFFECT THE WAY HORMONAL CONTRACEPTIVES WORK, BUT IT IS UNLIKELY TO REDUCE THEIR EFFECTIVENESS. IF YOU ARE USING HORMONAL CONTRACEPTIVES AND NOTICE ANY CHANGES IN YOUR MENSTRUAL CYCLE, SUCH AS UNEXPECTED VAGINAL BLEEDING OR SPOTTING BETWEEN PERIODS, CONSULT YOUR DOCTOR. THIS SYMPTOM MAY INDICATE THAT LAMOTRIGINE IS AFFECTING THE WAY THE CONTRACEPTIVES WORK. IF YOU ARE CURRENTLY TAKING OR HAVE RECENTLY TAKEN ANY MEDICINES, WHETHER PRESCRIPTION OR OVER-THE-COUNTER, PLEASE INFORM YOUR DOCTOR OR PHARMACIST. 3. HOW TO USE LAMOTRIGINE? INSTRUCTIONS ON PROPER USE AND DOSAGE/FREQUENCY OF ADMINISTRATION: ALWAYS USE THE MEDICINE AS PRESCRIBED BY YOUR DOCTOR. IF YOU ARE UNSURE, ASK YOUR DOCTOR OR PHARMACIST. USE FOR EPILEPSY TREATMENT: CHILDREN OVER 12 YEARS OF AGE AND ADULTS: THE DOSE USED TO CONTROL EPILEPSY IS 100 MG TO 700 MG, TAKEN ONCE DAILY OR DIVIDED INTO TWO DOSES. WHEN YOU FIRST START TAKING LAMOTRIGINE, YOUR DOCTOR WILL PRESCRIBE A MUCH LOWER DOSE THAN THIS AND GRADUALLY INCREASE IT OVER SEVERAL WEEKS. CHILDREN AGED 2-12 YEARS: DOSAGE IS CALCULATED BASED ON BODY WEIGHT. THE DOSE DEPENDS ON THE MEDICINE USED IN COMBINATION WITH LAMOTRIGINE. TREATMENT STARTS WITH A MINIMUM DOSE OF 0.15-0.6 MG/KG DAILY, TAKEN ONCE DAILY OR DIVIDED INTO TWO DOSES, AND THE DOSE MAY THEN BE GRADUALLY INCREASED TO 1-15 MG/KG DAILY, TAKEN ONCE DAILY OR DIVIDED INTO 2 DOSES. IN CHILDREN WITH TYPICAL ABSENCE SEIZURES, THE DOSE USED IN MONOTHERAPY WITH LAMOTRIGINE IS 1 MG/KG TO 15 MG/KG, TAKEN ONCE DAILY OR DIVIDED INTO TWO DOSES. USE FOR BIPOLAR DISORDER TREATMENT: ADULTS AGED 18 YEARS AND OVER: THE DOSE USED TO TREAT BIPOLAR DISORDER IS 100 MG TO 400 MG DAILY, TAKEN ONCE DAILY OR DIVIDED INTO TWO DOSES. WHEN YOU FIRST START TAKING LAMOTRIGINE, YOUR DOCTOR WILL PRESCRIBE A MUCH LOWER DOSE THAN THIS AND GRADUALLY INCREASE IT OVER SEVERAL WEEKS. TAKE LAMOTRIGINE AS PRESCRIBED BY YOUR DOCTOR. THE DOSE PRESCRIBED BY YOUR DOCTOR DEPENDS ON WHETHER YOU ARE TAKING OTHER MEDICINES. THIS IS ESPECIALLY IMPORTANT IF YOU ARE TAKING ANY MEDICINE CONTAINING VALPROATE. YOUR DOCTOR OR PHARMACIST WILL TELL YOU HOW MANY TABLETS TO TAKE AND WHEN TO TAKE THEM. IF A RASH DEVELOPS DURING LAMOTRIGINE TREATMENT, CONTACT YOUR DOCTOR IMMEDIATELY. LAMOTRIGINE CANNOT BE USED TO TREAT BIPOLAR DISORDER IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE. METHOD AND ROUTE OF ADMINISTRATION: YOU CAN CHEW LAMOTRIGINE, DISSOLVE IT IN A SMALL AMOUNT OF WATER, OR SWALLOW IT WHOLE WITH A SMALL AMOUNT OF WATER. IT IS IMPORTANT TO DRINK ALL THE LIQUID. INSTRUCTIONS FOR USING CHILD-RESISTANT BLISTER PACKAGED TABLETS: BACK OF CHILD-RESISTANT BLISTER: PEEL ALONG THE PERFORATED LINE INDICATED BY ARROW NO. 1 AND SEPARATE THE BLISTER POUCH CONTAINING THE TABLET. PULL THE PAPER UNDER THE BLISTER POUCH FROM THE CORNER INDICATED BY ARROW NO. 2, WHICH SHOWS A COLORED TRIANGLE, AND REMOVE IT. ALUMINUM FOIL WILL APPEAR UNDER THE PAPER. PRESS THE BLISTER POUCH AND REMOVE THE TABLET. DIFFERENT AGE GROUPS: USE IN CHILDREN: USE FOR EPILEPSY TREATMENT: THERE IS NO INFORMATION REGARDING USE IN CHILDREN UNDER 2 YEARS OF AGE. DO NOT USE IN THIS AGE GROUP WITHOUT CONSULTING YOUR DOCTOR. USE FOR BIPOLAR DISORDER: LAMOTRIGINE CANNOT BE USED TO TREAT BIPOLAR DISORDER IN ADOLESCENTS AND CHILDREN UNDER 18 YEARS OF AGE. USE IN THE ELDERLY: NO DOSE ADJUSTMENT IS REQUIRED FOR THIS AGE GROUP. SPECIAL CONDITIONS OF USE: USE IN RENAL IMPAIRMENT: IF YOU HAVE KIDNEY IMPAIRMENT, YOUR DOCTOR WILL ADJUST THE DOSE OF THE MEDICINE ACCORDING TO THE SEVERITY OF THE DISEASE. USE IN HEPATIC IMPAIRMENT: IF YOU HAVE LIVER DISEASE, YOUR DOCTOR WILL ADJUST THE DOSE OF THE MEDICINE ACCORDING TO THE SEVERITY OF THE DISEASE. OTHER: USE IN PATIENTS TAKING HORMONAL CONTRACEPTIVES: YOUR DOCTOR WILL ADJUST THE DOSE ACCORDING TO THE TYPE OF CONTRACEPTIVE YOU ARE USING. IF YOU FEEL THAT LAMOTRIGINE IS TOO STRONG OR TOO WEAK, CONSULT YOUR DOCTOR OR PHARMACIST. IF YOU USE MORE LAMOTRIGINE THAN YOU SHOULD: IF YOU TAKE MORE LAMOTRIGINE THAN YOU SHOULD, THE LIKELIHOOD OF SERIOUS SIDE EFFECTS, WHICH CAN BE FATAL, MAY INCREASE. IF YOU TAKE MORE LAMOTRIGINE THAN YOU SHOULD, THE EXPECTED SIDE EFFECTS INCLUDE: RAPID, SPONTANEOUS EYE MOVEMENTS (NYSTAGMUS) STIFFNESS AND LOSS OF COORDINATION AFFECTING BALANCE (ATAXIA) CONFUSION OR LOSS OF CONSCIOUSNESS, SEIZURES (CONVULSIONS) OR COMA CHANGES IN HEART RHYTHM (USUALLY SEEN ON ELECTROCARDIOGRAM) IF YOU TAKE MORE LAMOTRIGINE THAN YOU SHOULD, CALL YOUR DOCTOR IMMEDIATELY OR GO TO THE NEAREST HOSPITAL EMERGENCY DEPARTMENT. IF POSSIBLE, SHOW THE MEDICINE BOX TO THE HOSPITAL. IF YOU TAKE MORE LAMOTRIGINE THAN YOU SHOULD, INFORM YOUR DOCTOR OR PHARMACIST IMMEDIATELY. IF YOU FORGET TO TAKE LAMOTRIGINE DO NOT TAKE EXTRA TABLETS TO MAKE UP FOR A MISSED DOSE. IT IS ENOUGH TO TAKE THE NEXT DOSE AT THE USUAL TIME. IF YOU MISS MORE THAN ONE DOSE OF LAMOTRIGINE, CONSULT YOUR DOCTOR FOR ADVICE ON HOW TO RESTART LAMOTRIGINE. THIS IS IMPORTANT. ASK YOUR DOCTOR WHAT TO DO IF YOU MISS A DOSE. DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A MISSED DOSE. EXPECTED REACTION WHEN DISCONTINUING LAMOTRIGINE TREATMENT LAMOTRIGINE SHOULD BE TAKEN FOR THE DURATION RECOMMENDED BY YOUR DOCTOR. DO NOT STOP TAKING LAMOTRIGINE WITHOUT YOUR DOCTOR'S INSTRUCTIONS. PATIENTS BEING TREATED FOR EPILEPSY: SUDDEN DISCONTINUATION OF LAMOTRIGINE MAY PROVOKE THE RECURRENCE OF EPILEPTIC SEIZURES. IF IMMEDIATE DISCONTINUATION IS NOT NECESSARY DUE TO SAFETY REASONS (E.G., RASH), YOUR DOCTOR WILL GRADUALLY REDUCE THE DOSE OVER 2 WEEKS. PATIENTS WITH BIPOLAR DISORDER: DISCONTINUATION MAY BE DONE WITHOUT GRADUAL DOSE REDUCTION. LAMOTRIGINE MAY TAKE SOME TIME TO SHOW ITS EFFECT. THEREFORE, IMPROVEMENT MAY NOT BE FELT QUICKLY. IF YOU STOP TAKING LAMOTRIGINE, GRADUAL DOSE REDUCTION IS NOT NECESSARY. HOWEVER, IF YOU WISH TO STOP LAMOTRIGINE, YOU SHOULD FIRST TALK TO YOUR DOCTOR. 4. WHAT ARE THE POSSIBLE SIDE EFFECTS? LIKE ALL MEDICINES, LAMOTRIGINE CAN CAUSE SIDE EFFECTS IN PEOPLE SENSITIVE TO ITS INGREDIENTS. IF YOU DEVELOP ANY OF THE SYMPTOMS LISTED BELOW, STOP USING LAMOTRIGINE AND INFORM YOUR DOCTOR IMMEDIATELY OR GO TO THE NEAREST HOSPITAL EMERGENCY DEPARTMENT: A SMALL NUMBER OF PATIENTS MAY EXPERIENCE AN ALLERGIC REACTION OR A POTENTIALLY LIFE-THREATENING SKIN REACTION WHEN TAKING LAMOTRIGINE. WITHOUT TREATMENT, THESE CAN LEAD TO MORE SERIOUS PROBLEMS. THESE SYMPTOMS ARE MORE LIKELY TO OCCUR WITHIN THE FIRST FEW MONTHS OF STARTING LAMOTRIGINE TREATMENT, ESPECIALLY IF THE INITIAL DOSE IS TOO HIGH, THE DOSE IS INCREASED TOO QUICKLY, OR IF LAMOTRIGINE IS USED WITH ANOTHER MEDICINE - VALPROATE. SOME SYMPTOMS ARE MORE COMMON IN CHILDREN. THEREFORE, PARENTS SHOULD PAY PARTICULAR ATTENTION TO THESE SYMPTOMS. THE SYMPTOMS OF THESE REACTIONS ARE LISTED BELOW: LIFE-THREATENING SKIN REACTIONS, INCLUDING RASH OR REDNESS OF THE SKIN; ESPECIALLY RASH SPREADING TO THE MOUTH, NOSE, EYES, AND GENITAL ORGANS IN THE FORM OF BLISTERS AND SKIN PEELING (STEVENS-JOHNSON SYNDROME), SEVERE SKIN PEELING (OVER MORE THAN 30% OF THE BODY SURFACE - TOXIC EPIDERMAL NECROLYSIS) OR A WIDESPREAD RASH INVOLVING THE LIVER, BLOOD, OR OTHER ORGANS (DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS, ALSO KNOWN AS DRESS - DRUG HYPERSENSITIVITY SYNDROME). SORES IN THE MOUTH, THROAT, NOSE, OR GENITAL ORGANS EYE LESIONS OR RED, SWOLLEN EYES (CONJUNCTIVITIS) SWELLING AROUND THE FACE OR ENLARGED GLANDS IN THE NECK FEVER, FLU-LIKE SYMPTOMS, OR DROWSINESS ENLARGED LYMPH NODES IN THE NECK, ARMPIST, AND GROIN, FACIAL SWELLING (LYMPHADENOPATHY) SUDDEN BLEEDING OR BRUISING OR BLUE FINGERS (DISSEMINATED INTRAVASCULAR COAGULATION) SORE THROAT OR MORE FREQUENT INFECTIONS THAN USUAL (COLD-LIKE) HIGH LEVELS OF LIVER ENZYMES IN BLOOD TESTS INCREASE IN CERTAIN TYPES OF WHITE BLOOD CELLS (EOSINOPHILS) ENLARGED LYMPH NODES INVOLVEMENT OF OTHER ORGANS, INCLUDING THE LIVER AND KIDNEYS. MOST OF THESE SYMPTOMS ARE SIGNS OF LESS SERIOUS SIDE EFFECTS. HOWEVER, DO NOT FORGET THAT THESE SIDE EFFECTS ARE POTENTIALLY LIFE-THREATENING AND CAN LEAD TO MORE SERIOUS PROBLEMS. IF YOU NOTICE ANY OF THESE SYMPTOMS, INFORM YOUR DOCTOR IMMEDIATELY. YOUR DOCTOR MAY DECIDE TO PERFORM LIVER, KIDNEY, OR BLOOD TESTS AND ASK YOU TO STOP USING LAMOTRIGINE. IN CASE OF STEVENS-JOHNSON SYNDROME OR TOXIC EPIDERMAL NECROLYSIS, YOUR DOCTOR WILL WARN YOU THAT YOU MUST NOT TAKE LAMOTRIGINE. HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH) (SEE SECTION 2: THINGS TO CONSIDER BEFORE USING LAMOTRIGINE) THESE ARE VERY SERIOUS SIDE EFFECTS. YOU MAY REQUIRE EMERGENCY MEDICAL INTERVENTION OR HOSPITALIZATION. SUCH VERY SERIOUS SIDE EFFECTS ARE QUITE RARE. SIDE EFFECTS ARE LISTED IN THE FOLLOWING CATEGORIES: VERY COMMON: MAY AFFECT AT LEAST 1 IN 10 PEOPLE. COMMON: MAY AFFECT LESS THAN 1 IN 10 PEOPLE BUT MORE THAN 1 IN 100 PEOPLE. UNCOMMON: MAY AFFECT LESS THAN 1 IN 100 PEOPLE BUT MORE THAN 1 IN 1,000 PEOPLE. RARE: MAY AFFECT LESS THAN 1 IN 1,000 PEOPLE BUT MORE THAN 1 IN 10,000 PEOPLE. VERY RARE: MAY AFFECT LESS THAN 1 IN 10,000 PEOPLE. UNKNOWN: CANNOT BE ESTIMATED FROM AVAILABLE DATA. VERY COMMON: • HEADACHE • SKIN RASH COMMON: • IRRITABILITY • FEELING DROWSY OR NUMB • DIZZINESS • TREMOR • SLEEP PROBLEMS (INSOMNIA) • FEELING ANXIOUS • DIARRHEA • DRY MOUTH • NAUSEA OR VOMITING • FEELING TIRED • BACK OR JOINT PAIN OR PAIN IN OTHER AREAS UNCOMMON: • STIFFNESS AND LACK OF COORDINATION (ATAXIA) • DOUBLE VISION OR BLURRED VISION • SEVERE HAIR LOSS AND THINNING (ALOPECIA) • RASH OR SUNBURN AFTER EXPOSURE TO SUNLIGHT OR ARTIFICIAL LIGHT (PHOTOSENSITIVITY) RARE: • RAPID, SPONTANEOUS EYE MOVEMENTS (NYSTAGMUS) • ASEPTIC MENINGITIS (INVOLVES A GROUP OF SYMPTOMS INCLUDING FEVER, NAUSEA, VOMITING, HEADACHE, NECK STIFFNESS, AND HYPERSENSITIVITY TO BRIGHT LIGHT. IT DEVELOPS AS A RESULT OF INFLAMMATION OF THE BRAIN AND SPINAL CORD MEMBRANES. USUALLY, THESE SYMPTOMS RESOLVE UPON DISCONTINUATION OF TREATMENT. HOWEVER, IF SYMPTOMS PERSIST OR WORSEN, CONSULT YOUR DOCTOR.) • LIFE-THREATENING SKIN REACTIONS (STEVENS-JOHNSON SYNDROME): (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • ITCHY EYES, DISCHARGE, AND CRUSTING ON EYELIDS (CONJUNCTIVITIS) VERY RARE: • LIFE-THREATENING SKIN REACTIONS MANIFESTING AS SEVERE SKIN PEELING (TOXIC EPIDERMAL NECROLYSIS): (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • MULTIPLE ORGAN FAILURE OR SEVERE BLOOD CLOTTING DISORDERS THAT CAN CAUSE SUDDEN BLEEDING, BRUISING (DISSEMINATED INTRAVASCULAR COAGULATION): (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • FACIAL SWELLING (EDEMA) OR ENLARGED GLANDS IN THE NECK, ARMPIST, AND GROIN (LYMPHADENOPATHY): (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • HIGH FEVER: (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • INCREASED SEIZURES IN PATIENTS WITH EPILEPSY • INVOLUNTARY BODY MOVEMENTS (TICS), INVOLUNTARY MUSCLE SPASMS AFFECTING THE EYES, HEAD, AND BODY (CHOREOATHETOSIS) OR UNUSUAL BODY MOVEMENTS SUCH AS TICS, SHAKING, OR STIFFNESS • FEELING OF LOSS OF BALANCE • DISORIENTATION (CONFUSION) • SEEING OR HEARING THINGS THAT ARE NOT THERE (HALLUCINATIONS) • WORSENING OF PARKINSON'S DISEASE SYMPTOMS • LUPUS-LIKE REACTIONS (SYMPTOMS: FEVER AND PAIN IN THE BACK AND JOINTS, ACCOMPANIED BY GENERAL DETERIORATION OF HEALTH) • REDUCED WHITE BLOOD CELL COUNT (NEUTROPENIA, LEUKOPENIA, AGRANULOCYTOSIS) • CHANGES IN LIVER FUNCTION TESTS OR LIVER FAILURE: (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • REDUCED RED BLOOD CELL COUNT (ANEMIA) • REDUCED PLATELET COUNT (THROMBOCYTOPENIA) • REDUCED COUNT OF ALL BLOOD CELLS (PANCYTOPENIA) • BONE MARROW DISORDERS (APLASTIC ANEMIA) • INCREASE IN EOSINOPHILS (A TYPE OF ALLERGY CELL) IN THE BLOOD (EOSINOPHILIA) AND DRUG REACTION WITH SYSTEMIC SYMPTOMS (DRESS): (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH) (A SEVERE CHRONIC DISEASE RESULTING FROM OVERSTIMULATION OF THE IMMUNE SYSTEM, WITH SYMPTOMS AFFECTING VARIOUS SYSTEMS) (SEE SECTION 2: THINGS TO CONSIDER BEFORE USING LAMOTRIGINE). UNKNOWN: • NIGHTMARES • KNOWN BONE DISORDERS, INCLUDING OSTEOPENIA AND OSTEOPOROSIS (BONE THINNING) AND FRACTURES. IF YOU HAVE BEEN TAKING ANTIEPILEPTIC MEDICINES FOR A LONG TIME, HAVE A HISTORY OF OSTEOPOROSIS, OR ARE TAKING STEROIDS, CONSULT YOUR DOCTOR OR PHARMACIST. • WEAKENED IMMUNITY DUE TO LOW LEVELS OF ANTIBODIES PROTECTING AGAINST INFECTIONS IN THE BLOOD - IMMUNOGLOBULINS. • KIDNEY INFLAMMATION (TUBULOINTERSTITIAL NEPHRITIS) OR KIDNEY AND EYE INFLAMMATION (TUBULOINTERSTITIAL NEPHRITIS AND UVEITIS SYNDROME). IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS INSTRUCTION LEAFLET, INFORM YOUR DOCTOR OR PHARMACIST. REPORTING SIDE EFFECTS IF YOU EXPERIENCE ANY SIDE EFFECTS, WHETHER LISTED OR NOT IN THIS INSTRUCTION LEAFLET, INFORM YOUR DOCTOR, PHARMACIST, OR NURSE. BY REPORTING SIDE EFFECTS, YOU ARE HELPING TO PROVIDE MORE INFORMATION ABOUT THE SAFETY OF THE MEDICINE YOU ARE USING. 5. HOW TO STORE LAMOTRIGINE STORE LAMOTRIGINE OUT OF THE REACH OF CHILDREN, IN ITS ORIGINAL PACKAGING. STORE AT ROOM TEMPERATURE BELOW 30 °C, IN A DRY AND LIGHT-PROTECTED PLACE. USE BY THE EXPIRY DATE. DO NOT USE LAMOTRIGINE AFTER THE EXPIRY DATE INDICATED ON THE PACKAGING. DO NOT DISPOSE OF EXPIRED OR UNUSED MEDICINES! HAND THEM OVER TO THE COLLECTION SYSTEM DEFINED BY THE MINISTRY OF ENVIRONMENT AND URBANIZATION. SEE ALSO: LAMOTRIGINE DC - LAMOTRIGINE DC CHEWABLE 50MG 30 TABLETS

Active

lamotrigine

What is it?

LAMOTRIGINE DC 25 MG SOLUBLE/CHEWABLE TABLET IS FOR ORAL ADMINISTRATION. ACTIVE SUBSTANCE: EACH TABLET CONTAINS 25 MG LAMOTRIGINE. EXCIPIENTS: CALCIUM CARBONATE, CROSCARMELLOSE SODIUM, MAGNESIUM ALUMINOSILICATE, SODIUM STARCH GLYCOLATE, POVIDONE K30, SODIUM SACCHARIN, BLACKCURRANT FLAVOR, MAGNESIUM STEARATE, PURIFIED WATER. BEFORE YOU START USING THIS MEDICINE, READ THIS INSTRUCTION CAREFULLY AS IT CONTAINS IMPORTANT INFORMATION FOR YOU. · KEEP THIS INSTRUCTION. YOU MAY NEED TO READ IT AGAIN LATER. · IF YOU HAVE ANY ADDITIONAL QUESTIONS, CONSULT YOUR DOCTOR OR PHARMACIST. · THIS MEDICINE HAS BEEN PRESCRIBED INDIVIDUALLY FOR YOU, DO NOT GIVE IT TO OTHERS. · IF YOU ARE SEEING A DOCTOR OR GOING TO A HOSPITAL DURING TREATMENT WITH THIS MEDICINE, INFORM THE DOCTOR THAT YOU ARE USING THIS MEDICINE. · FOLLOW THE INSTRUCTIONS IN THIS LEAFLET EXACTLY. DO NOT USE THE MEDICINE AT A HIGHER OR LOWER DOSE THAN RECOMMENDED FOR YOU. THIS LEAFLET CONTAINS THE FOLLOWING SECTIONS: 1. WHAT IS LAMOTRIGINE AND WHAT IS IT USED FOR? 2. THINGS TO CONSIDER BEFORE USING LAMOTRIGINE 3. HOW TO USE LAMOTRIGINE? 4. WHAT ARE THE POSSIBLE SIDE EFFECTS? 5. HOW TO STORE LAMOTRIGINE 1. WHAT IS LAMOTRIGINE AND WHAT IS IT USED FOR? LAMOTRIGINE BELONGS TO A GROUP OF MEDICINES USED TO TREAT EPILEPTIC SEIZURES. THE TABLET IS WHITE-OFF-WHITE IN COLOR, WITH A BLACKCURRANT SCENT, WITHOUT A NOTCH, WITH SLIGHTLY ROUNDED CORNERS, ENGRAVED WITH "GSCL5" ON ONE SIDE AND "25" ON THE OTHER. THE TABLET MAY HAVE FAINT SPOTS. EACH BOX CONTAINS 30 TABLETS IN CHILD-RESISTANT BLISTERS. LAMOTRIGINE IS USED IN THE FOLLOWING CASES: • IN CHILDREN AGED 2-12 YEARS, IT IS USED IN COMBINATION WITH OTHER MEDICINES TO TREAT EPILEPSY, PARTIAL SEIZURES, AND GENERALIZED SEIZURES, INCLUDING TONIC-CLONIC SEIZURES (SEIZURES CHARACTERIZED BY CONVULSIONS AND SHAKING) AND SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME (A SPECIFIC FORM OF EPILEPSY CHARACTERIZED BY VARIOUS TYPES OF SEIZURES). ONCE SEIZURES ARE CONTROLLED, IT MAY BE CONTINUED AS MONOTHERAPY. • IN CHILDREN AGED 2-12 YEARS, IT IS USED AS MONOTHERAPY TO TREAT A TYPE OF EPILEPTIC SEIZURE - TYPICAL ABSENCE SEIZURES (SEIZURES CHARACTERIZED BY SUDDEN ONSET AND CESSATION). • IN CHILDREN OVER 12 YEARS OF AGE AND ADULTS, IT IS USED IN COMBINATION WITH OTHER MEDICINES OR AS MONOTHERAPY TO TREAT EPILEPSY, PARTIAL SEIZURES, AND GENERALIZED SEIZURES, INCLUDING TONIC-CLONIC SEIZURES AND SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME. • IN ADULTS AGED 18 YEARS AND OVER, IT IS USED TO TREAT BIPOLAR DISORDER. 2. THINGS TO CONSIDER BEFORE USING LAMOTRIGINE DO NOT USE LAMOTRIGINE IF: YOU ARE ALLERGIC TO LAMOTRIGINE OR ANY OTHER INGREDIENT OF LAMOTRIGINE (SEE THE LIST OF EXCIPIENTS AT THE BEGINNING OF THE INSTRUCTION LEAFLET). USE LAMOTRIGINE WITH CAUTION IN THE FOLLOWING CASES: CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING LAMOTRIGINE IN THE FOLLOWING CASES: · IF YOU HAVE ANY KIDNEY PROBLEMS; · IF YOU HAVE PREVIOUSLY DEVELOPED A RASH AFTER USING LAMOTRIGINE OR OTHER MEDICINES FOR BIPOLAR DISORDER OR EPILEPSY; · IF YOU HAVE DEVELOPED A RASH OR SUNBURN AFTER TAKING LAMOTRIGINE AND EXPOSURE TO SUNLIGHT OR ARTIFICIAL LIGHT (E.G., SOLARIUM). YOUR DOCTOR WILL REVIEW YOUR TREATMENT AND MAY ADVISE YOU TO AVOID SUNLIGHT OR PROTECT YOURSELF FROM THE SUN (E.G., BY USING SUNSCREEN AND/OR WEARING PROTECTIVE CLOTHING). · IF YOU HAVE HAD MENINGITIS (INFLAMMATION OF THE BRAIN MEMBRANES) DURING TREATMENT WITH LAMOTRIGINE (SEE SECTION 4 OF THIS INSTRUCTION LEAFLET TITLED RARE SIDE EFFECTS FOR A DESCRIPTION OF THESE SYMPTOMS); · IF YOU ARE USING OTHER MEDICINES CONTAINING LAMOTRIGINE; · IF YOU HAVE A CONDITION CALLED "BRUGADA SYNDROME" OR HAVE OTHER HEART PROBLEMS. BRUGADA SYNDROME IS A GENETIC DISEASE THAT CAUSES ABNORMAL ELECTRICAL ACTIVITY IN THE HEART. LAMOTRIGINE CAN ACTIVATE AN ABNORMALITY ON THE ELECTROCARDIOGRAM THAT CAUSES ARRHYTHMIAS (HEART RHYTHM DISORDERS). · IF YOU HAVE LIVER DISEASE; · IF YOU HAVE STARTED OR STOPPED USING HORMONAL CONTRACEPTIVES. IN WOMEN, THE USE OF HORMONAL CONTRACEPTIVES DURING LAMOTRIGINE TREATMENT MAY REDUCE THE EFFECTIVENESS OF THE CONTRACEPTIVE. THIS MAY LEAD TO MENSTRUAL CYCLE DISORDERS, SUCH AS UNEXPECTED VAGINAL BLEEDING. IN THIS CASE, THE LAMOTRIGINE DOSE MAY NEED TO BE ADJUSTED. INFORM YOUR DOCTOR IF ANY OF THESE APPLY TO YOU. YOUR DOCTOR MAY DECIDE TO REDUCE THE DOSE OF THE MEDICINE OR DECIDE THAT LAMOTRIGINE IS NOT SUITABLE FOR YOU. IMPORTANT INFORMATION ABOUT POTENTIALLY LIFE-THREATENING REACTIONS SKIN RASHES ARE KNOWN TO OCCUR DURING LAMOTRIGINE TREATMENT, USUALLY WITHIN THE FIRST 8 WEEKS. THESE RASHES ARE MOSTLY MILD AND LIMITED, BUT SERIOUS RASHES CAN DEVELOP REQUIRING HOSPITALIZATION AND DISCONTINUATION OF LAMOTRIGINE TREATMENT. THESE INCLUDE: STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN), AND DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS - DRUG HYPERSENSITIVITY SYNDROME). YOU SHOULD BE AWARE OF THE SYMPTOMS TO WATCH FOR WHILE TAKING LAMOTRIGINE. THE RISK OF SERIOUS SKIN RASH IS HIGHER IN CHILDREN THAN IN ADULTS. THE RISK OF RASH GENERALLY INCREASES IN THE FOLLOWING CASES: · HIGH INITIAL DOSES OF LAMOTRIGINE · EXCEEDING THE RECOMMENDED DOSE INCREASE DURING LAMOTRIGINE TREATMENT · CONCOMITANT USE OF VALPROATE WITH LAMOTRIGINE. THE INITIAL APPEARANCE OF A RASH IN CHILDREN MAY BE MISTAKEN FOR AN INFECTION. SEE THE BEGINNING OF SECTION 4 OF THIS INSTRUCTION LEAFLET FOR A DESCRIPTION OF THESE SYMPTOMS. HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH) RARE BUT VERY SERIOUS IMMUNE SYSTEM REACTIONS HAVE BEEN REPORTED IN PATIENTS USING LAMOTRIGINE. IF YOU EXPERIENCE ANY OF THE FOLLOWING SYMPTOMS DURING LAMOTRIGINE USE, CONSULT YOUR DOCTOR OR PHARMACIST IMMEDIATELY: FEVER, RASH, NEUROLOGICAL SYMPTOMS (E.G., SHAKING OR TREMOR, CONFUSION, IMPAIRED BRAIN FUNCTION). SELF-HARM OR SUICIDAL THOUGHTS ANTIEPILEPTIC MEDICINES ARE USED TO TREAT CERTAIN CONDITIONS, INCLUDING EPILEPSY AND BIPOLAR DISORDER. INDIVIDUALS WITH BIPOLAR DISORDER MAY EXPERIENCE SELF-HARM OR SUICIDAL THOUGHTS. IF YOU HAVE BIPOLAR DISORDER, SUCH THOUGHTS ARE MORE LIKELY IN THE FOLLOWING CASES: · AT THE START OF TREATMENT, · IF YOU HAVE PREVIOUSLY HAD SELF-HARM OR SUICIDAL THOUGHTS, · IF YOU ARE UNDER 25 YEARS OF AGE. IF YOU EXPERIENCE DISTRESSING THOUGHTS OR IMPULSES, OR FEEL WORSE, OR DEVELOP NEW SYMPTOMS DURING LAMOTRIGINE TREATMENT, SEE A DOCTOR OR SEEK HELP AT THE NEAREST HOSPITAL AS SOON AS POSSIBLE. IT MAY BE HELPFUL TO TELL A FAMILY MEMBER, CAREGIVER, OR CLOSE FRIEND THAT YOU MAY BE PRONE TO DEPRESSION OR SIGNIFICANT MOOD CHANGES, AND ASK THEM TO READ THIS INSTRUCTION LEAFLET. THEY MAY BE ASKED TO LET YOU KNOW IF THEY ARE CONCERNED ABOUT YOUR DEPRESSION OR ANY CHANGES IN YOUR BEHAVIOR. A SMALL NUMBER OF PATIENTS TREATED WITH ANTIEPILEPTIC MEDICINES SUCH AS LAMOTRIGINE HAVE REPORTED SELF-HARM OR SUICIDAL THOUGHTS. IF YOU HAVE SUCH THOUGHTS AT ANY TIME, CONTACT YOUR DOCTOR IMMEDIATELY. PATIENTS WITH BIPOLAR DISORDER MAY EXPERIENCE INCREASED RISKS SUCH AS WORSENING OF SYMPTOMS, DEVELOPMENT OF SUICIDAL THOUGHTS AND BEHAVIORS, AND SELF-HARM. PATIENTS WITH A HISTORY OF SUICIDAL THOUGHTS, YOUNG ADULTS, AND PATIENTS WHO HAD CLEAR SUICIDAL THOUGHTS BEFORE STARTING TREATMENT MAY BE AT HIGHER RISK. THEREFORE, INTENSIVE MONITORING OF PATIENTS TAKING LAMOTRIGINE IS NECESSARY, ESPECIALLY AT THE BEGINNING OF TREATMENT. PATIENTS WITH HYPERSENSITIVITY SYNDROME MAY DEVELOP VARIOUS SYMPTOMS, INCLUDING FEVER WITH RASH, LYMPHADENOPATHY (A CONDITION CHARACTERIZED BY ENLARGED LYMPH NODES IN THE NECK, ARMPIST, AND GROIN), FACIAL SWELLING, BLOOD AND LIVER DISORDERS. DUE TO THE RISK OF RASH, OVERDOSING IS NOT ALLOWED AT THE START AND DURING SUBSEQUENT DOSE INCREASES. IF YOU ARE USING LAMOTRIGINE FOR EPILEPSY: IN SOME TYPES OF EPILEPSY, LAMOTRIGINE MAY CAUSE SEIZURES TO WORSEN OR BECOME MORE FREQUENT. SOME PATIENTS MAY DEVELOP A SEVERE SEIZURE THAT CAUSES SERIOUS HEALTH PROBLEMS. IF YOUR SEIZURES BECOME MORE FREQUENT DURING LAMOTRIGINE USE OR IF YOU HAVE A SEVERE SEIZURE, CONTACT YOUR DOCTOR AS SOON AS POSSIBLE. LAMOTRIGINE CANNOT BE USED TO TREAT BIPOLAR DISORDER IN ADOLESCENTS AND CHILDREN UNDER 18 YEARS OF AGE. MEDICINES USED TO TREAT DEPRESSION (MOOD DISORDERS) AND OTHER MENTAL HEALTH PROBLEMS MAY INCREASE THE RISK OF SUICIDAL THOUGHTS AND BEHAVIOR IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE. PLEASE CONSULT YOUR DOCTOR FOR ADVICE, EVEN IF THESE WARNINGS APPLY OR HAVE APPLIED TO YOU IN THE PAST, AT ANY TIME. USING LAMOTRIGINE WITH FOOD AND DRINK LAMOTRIGINE CAN BE TAKEN WITH OR WITHOUT FOOD. PREGNANCY CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING THE MEDICINE. IF YOU ARE PREGNANT OR THINK YOU MAY BE PREGNANT, OR PLAN TO BECOME PREGNANT, CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE. YOUR DOCTOR WILL DECIDE WHETHER TO USE LAMOTRIGINE DURING PREGNANCY. · DO NOT STOP TREATMENT WITHOUT TALKING TO YOUR DOCTOR. THIS IS ESPECIALLY IMPORTANT IF YOU HAVE EPILEPSY. PREGNANCY MAY ALTER THE EFFECTIVENESS OF LAMOTRIGINE, REQUIRING BLOOD TESTS AND DOSE ADJUSTMENT OF LAMOTRIGINE. TAKING LAMOTRIGINE IN THE FIRST TRIMESTER OF PREGNANCY MAY SLIGHTLY INCREASE THE RISK OF CONGENITAL MALFORMATIONS IN NEWBORNS, INCLUDING CLEFT LIP AND PALATE. IF YOU PLAN TO BECOME PREGNANT OR ARE PREGNANT, YOUR DOCTOR MAY RECOMMEND SUPPLEMENTAL FOLIC ACID. IF YOU FIND OUT YOU ARE PREGNANT DURING TREATMENT, CONSULT YOUR DOCTOR OR PHARMACIST IMMEDIATELY. LACTATION CONSULT YOUR DOCTOR OR PHARMACIST BEFORE USING THE MEDICINE. IF YOU ARE BREASTFEEDING OR PLAN TO BREASTFEED, CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE. THE ACTIVE SUBSTANCE OF LAMOTRIGINE PASSES INTO BREAST MILK AND MAY AFFECT THE BABY. YOUR DOCTOR WILL ASSESS THE RISKS AND BENEFITS OF BREASTFEEDING DURING LAMOTRIGINE USE, AND IF YOU DECIDE TO BREASTFEED, THE DOCTOR WILL PERIODICALLY CHECK THE BABY FOR WEAKNESS, RASH, OR LACK OF WEIGHT GAIN. IF YOU NOTICE ANY OF THESE SYMPTOMS IN THE BABY, INFORM YOUR DOCTOR. DRIVING AND OPERATING MACHINERY LAMOTRIGINE TREATMENT MAY CAUSE SIDE EFFECTS SUCH AS DIZZINESS AND DOUBLE VISION, SO DO NOT DRIVE OR OPERATE MACHINERY UNTIL YOU ARE SURE THE MEDICINE DOES NOT AFFECT YOU. IF YOU HAVE EPILEPSY, CONSULT YOUR DOCTOR REGARDING DRIVING. IMPORTANT INFORMATION ABOUT SOME EXCIPIENTS IN LAMOTRIGINE LAMOTRIGINE DOES NOT CONTAIN EXCIPIENTS THAT REQUIRE A WARNING. USE WITH OTHER MEDICINES CONSULT YOUR DOCTOR IF YOU ARE TAKING, HAVE RECENTLY TAKEN, OR MIGHT TAKE ANY OTHER MEDICINE. THIS APPLIES TO HERBAL MEDICINES AS WELL AS OVER-THE-COUNTER MEDICINES. LAMOTRIGINE INTERACTS WITH CERTAIN MEDICINES OR INCREASES THE LIKELIHOOD OF SIDE EFFECTS IN PATIENTS. THESE MEDICINES INCLUDE: • VALPROATE (TREATMENT OF EPILEPSY AND MENTAL HEALTH PROBLEMS) • CARBAMAZEPINE (TREATMENT OF EPILEPSY AND MENTAL HEALTH PROBLEMS) • PHENYTOIN (TREATMENT OF EPILEPSY) • PRIMIDONE (TREATMENT OF EPILEPSY) • PHENOBARBITAL (TREATMENT OF EPILEPSY) • RIFAMPICIN (TREATMENT OF INFECTIONS) • RISPERIDONE (TREATMENT OF PSYCHIATRIC DISORDERS) • LOPINAVIR/RITONAVIR OR ATAZANAVIR AND RITONAVIR (TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION) • ETHINYLESTRADIOL/LEVONORGESTREL COMBINATION (HORMONAL CONTRACEPTIVE). IF YOU ARE TAKING OTHER MEDICINES FOR EPILEPSY OR MENTAL HEALTH PROBLEMS, YOUR DOCTOR SHOULD BE AWARE OF THIS TO ENSURE YOU ARE TAKING THE CORRECT DOSE OF LAMOTRIGINE. THESE MEDICINES INCLUDE: • LITHIUM (TREATMENT OF PSYCHIATRIC DISORDERS) • BUPROPION (TREATMENT OF PSYCHIATRIC DISORDERS OR SMOKING CESSATION) • OLANZAPINE (TREATMENT OF PSYCHIATRIC DISORDERS) • OXCARBAZEPINE (TREATMENT OF EPILEPSY) • FELBAMATE (TREATMENT OF EPILEPSY) • GABAPENTIN (TREATMENT OF EPILEPSY) • LEVETIRACETAM (TREATMENT OF EPILEPSY) • PREGABALIN (TREATMENT OF EPILEPSY) • TOPIRAMATE (TREATMENT OF EPILEPSY) • ZONISAMIDE (TREATMENT OF EPILEPSY) • ARIPIPRAZOLE (TREATMENT OF PSYCHIATRIC DISORDERS) • PARACETAMOL (TREATMENT OF PAIN AND FEVER) HORMONAL CONTRACEPTIVES (SUCH AS BIRTH CONTROL PILLS) MAY AFFECT THE WAY LAMOTRIGINE WORKS. YOUR DOCTOR MAY RECOMMEND A SPECIFIC TYPE OF HORMONAL CONTRACEPTIVE OR ANOTHER METHOD OF CONTRACEPTION, SUCH AS A CONDOM, DIAPHRAGM, INTRAUTERINE DEVICE, ETC. IF YOU ARE USING A CONTRACEPTIVE SUCH AS BIRTH CONTROL PILLS, YOUR DOCTOR MAY TAKE A BLOOD SAMPLE TO CHECK YOUR LAMOTRIGINE LEVELS. IF YOU ARE USING OR PLAN TO USE HORMONAL CONTRACEPTIVES, CONSULT YOUR DOCTOR TO DISCUSS APPROPRIATE CONTRACEPTIVE METHODS. LAMOTRIGINE MAY ALSO AFFECT THE WAY HORMONAL CONTRACEPTIVES WORK, BUT IT IS UNLIKELY TO REDUCE THEIR EFFECTIVENESS. IF YOU ARE USING HORMONAL CONTRACEPTIVES AND NOTICE ANY CHANGES IN YOUR MENSTRUAL CYCLE, SUCH AS UNEXPECTED VAGINAL BLEEDING OR SPOTTING BETWEEN PERIODS, CONSULT YOUR DOCTOR. THIS SYMPTOM MAY INDICATE THAT LAMOTRIGINE IS AFFECTING THE WAY THE CONTRACEPTIVES WORK. IF YOU ARE CURRENTLY TAKING OR HAVE RECENTLY TAKEN ANY MEDICINES, WHETHER PRESCRIPTION OR OVER-THE-COUNTER, PLEASE INFORM YOUR DOCTOR OR PHARMACIST. 3. HOW TO USE LAMOTRIGINE? INSTRUCTIONS ON PROPER USE AND DOSAGE/FREQUENCY OF ADMINISTRATION: ALWAYS USE THE MEDICINE AS PRESCRIBED BY YOUR DOCTOR. IF YOU ARE UNSURE, ASK YOUR DOCTOR OR PHARMACIST. USE FOR EPILEPSY TREATMENT: CHILDREN OVER 12 YEARS OF AGE AND ADULTS: THE DOSE USED TO CONTROL EPILEPSY IS 100 MG TO 700 MG, TAKEN ONCE DAILY OR DIVIDED INTO TWO DOSES. WHEN YOU FIRST START TAKING LAMOTRIGINE, YOUR DOCTOR WILL PRESCRIBE A MUCH LOWER DOSE THAN THIS AND GRADUALLY INCREASE IT OVER SEVERAL WEEKS. CHILDREN AGED 2-12 YEARS: DOSAGE IS CALCULATED BASED ON BODY WEIGHT. THE DOSE DEPENDS ON THE MEDICINE USED IN COMBINATION WITH LAMOTRIGINE. TREATMENT STARTS WITH A MINIMUM DOSE OF 0.15-0.6 MG/KG DAILY, TAKEN ONCE DAILY OR DIVIDED INTO TWO DOSES, AND THE DOSE MAY THEN BE GRADUALLY INCREASED TO 1-15 MG/KG DAILY, TAKEN ONCE DAILY OR DIVIDED INTO 2 DOSES. IN CHILDREN WITH TYPICAL ABSENCE SEIZURES, THE DOSE USED IN MONOTHERAPY WITH LAMOTRIGINE IS 1 MG/KG TO 15 MG/KG, TAKEN ONCE DAILY OR DIVIDED INTO TWO DOSES. USE FOR BIPOLAR DISORDER TREATMENT: ADULTS AGED 18 YEARS AND OVER: THE DOSE USED TO TREAT BIPOLAR DISORDER IS 100 MG TO 400 MG DAILY, TAKEN ONCE DAILY OR DIVIDED INTO TWO DOSES. WHEN YOU FIRST START TAKING LAMOTRIGINE, YOUR DOCTOR WILL PRESCRIBE A MUCH LOWER DOSE THAN THIS AND GRADUALLY INCREASE IT OVER SEVERAL WEEKS. TAKE LAMOTRIGINE AS PRESCRIBED BY YOUR DOCTOR. THE DOSE PRESCRIBED BY YOUR DOCTOR DEPENDS ON WHETHER YOU ARE TAKING OTHER MEDICINES. THIS IS ESPECIALLY IMPORTANT IF YOU ARE TAKING ANY MEDICINE CONTAINING VALPROATE. YOUR DOCTOR OR PHARMACIST WILL TELL YOU HOW MANY TABLETS TO TAKE AND WHEN TO TAKE THEM. IF A RASH DEVELOPS DURING LAMOTRIGINE TREATMENT, CONTACT YOUR DOCTOR IMMEDIATELY. LAMOTRIGINE CANNOT BE USED TO TREAT BIPOLAR DISORDER IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE. METHOD AND ROUTE OF ADMINISTRATION: YOU CAN CHEW LAMOTRIGINE, DISSOLVE IT IN A SMALL AMOUNT OF WATER, OR SWALLOW IT WHOLE WITH A SMALL AMOUNT OF WATER. IT IS IMPORTANT TO DRINK ALL THE LIQUID. INSTRUCTIONS FOR USING CHILD-RESISTANT BLISTER PACKAGED TABLETS: BACK OF CHILD-RESISTANT BLISTER: PEEL ALONG THE PERFORATED LINE INDICATED BY ARROW NO. 1 AND SEPARATE THE BLISTER POUCH CONTAINING THE TABLET. PULL THE PAPER UNDER THE BLISTER POUCH FROM THE CORNER INDICATED BY ARROW NO. 2, WHICH SHOWS A COLORED TRIANGLE, AND REMOVE IT. ALUMINUM FOIL WILL APPEAR UNDER THE PAPER. PRESS THE BLISTER POUCH AND REMOVE THE TABLET. DIFFERENT AGE GROUPS: USE IN CHILDREN: USE FOR EPILEPSY TREATMENT: THERE IS NO INFORMATION REGARDING USE IN CHILDREN UNDER 2 YEARS OF AGE. DO NOT USE IN THIS AGE GROUP WITHOUT CONSULTING YOUR DOCTOR. USE FOR BIPOLAR DISORDER: LAMOTRIGINE CANNOT BE USED TO TREAT BIPOLAR DISORDER IN ADOLESCENTS AND CHILDREN UNDER 18 YEARS OF AGE. USE IN THE ELDERLY: NO DOSE ADJUSTMENT IS REQUIRED FOR THIS AGE GROUP. SPECIAL CONDITIONS OF USE: USE IN RENAL IMPAIRMENT: IF YOU HAVE KIDNEY IMPAIRMENT, YOUR DOCTOR WILL ADJUST THE DOSE OF THE MEDICINE ACCORDING TO THE SEVERITY OF THE DISEASE. USE IN HEPATIC IMPAIRMENT: IF YOU HAVE LIVER DISEASE, YOUR DOCTOR WILL ADJUST THE DOSE OF THE MEDICINE ACCORDING TO THE SEVERITY OF THE DISEASE. OTHER: USE IN PATIENTS TAKING HORMONAL CONTRACEPTIVES: YOUR DOCTOR WILL ADJUST THE DOSE ACCORDING TO THE TYPE OF CONTRACEPTIVE YOU ARE USING. IF YOU FEEL THAT LAMOTRIGINE IS TOO STRONG OR TOO WEAK, CONSULT YOUR DOCTOR OR PHARMACIST. IF YOU USE MORE LAMOTRIGINE THAN YOU SHOULD: IF YOU TAKE MORE LAMOTRIGINE THAN YOU SHOULD, THE LIKELIHOOD OF SERIOUS SIDE EFFECTS, WHICH CAN BE FATAL, MAY INCREASE. IF YOU TAKE MORE LAMOTRIGINE THAN YOU SHOULD, THE EXPECTED SIDE EFFECTS INCLUDE: RAPID, SPONTANEOUS EYE MOVEMENTS (NYSTAGMUS) STIFFNESS AND LOSS OF COORDINATION AFFECTING BALANCE (ATAXIA) CONFUSION OR LOSS OF CONSCIOUSNESS, SEIZURES (CONVULSIONS) OR COMA CHANGES IN HEART RHYTHM (USUALLY SEEN ON ELECTROCARDIOGRAM) IF YOU TAKE MORE LAMOTRIGINE THAN YOU SHOULD, CALL YOUR DOCTOR IMMEDIATELY OR GO TO THE NEAREST HOSPITAL EMERGENCY DEPARTMENT. IF POSSIBLE, SHOW THE MEDICINE BOX TO THE HOSPITAL. IF YOU TAKE MORE LAMOTRIGINE THAN YOU SHOULD, INFORM YOUR DOCTOR OR PHARMACIST IMMEDIATELY. IF YOU FORGET TO TAKE LAMOTRIGINE DO NOT TAKE EXTRA TABLETS TO MAKE UP FOR A MISSED DOSE. IT IS ENOUGH TO TAKE THE NEXT DOSE AT THE USUAL TIME. IF YOU MISS MORE THAN ONE DOSE OF LAMOTRIGINE, CONSULT YOUR DOCTOR FOR ADVICE ON HOW TO RESTART LAMOTRIGINE. THIS IS IMPORTANT. ASK YOUR DOCTOR WHAT TO DO IF YOU MISS A DOSE. DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A MISSED DOSE. EXPECTED REACTION WHEN DISCONTINUING LAMOTRIGINE TREATMENT LAMOTRIGINE SHOULD BE TAKEN FOR THE DURATION RECOMMENDED BY YOUR DOCTOR. DO NOT STOP TAKING LAMOTRIGINE WITHOUT YOUR DOCTOR'S INSTRUCTIONS. PATIENTS BEING TREATED FOR EPILEPSY: SUDDEN DISCONTINUATION OF LAMOTRIGINE MAY PROVOKE THE RECURRENCE OF EPILEPTIC SEIZURES. IF IMMEDIATE DISCONTINUATION IS NOT NECESSARY DUE TO SAFETY REASONS (E.G., RASH), YOUR DOCTOR WILL GRADUALLY REDUCE THE DOSE OVER 2 WEEKS. PATIENTS WITH BIPOLAR DISORDER: DISCONTINUATION MAY BE DONE WITHOUT GRADUAL DOSE REDUCTION. LAMOTRIGINE MAY TAKE SOME TIME TO SHOW ITS EFFECT. THEREFORE, IMPROVEMENT MAY NOT BE FELT QUICKLY. IF YOU STOP TAKING LAMOTRIGINE, GRADUAL DOSE REDUCTION IS NOT NECESSARY. HOWEVER, IF YOU WISH TO STOP LAMOTRIGINE, YOU SHOULD FIRST TALK TO YOUR DOCTOR. 4. WHAT ARE THE POSSIBLE SIDE EFFECTS? LIKE ALL MEDICINES, LAMOTRIGINE CAN CAUSE SIDE EFFECTS IN PEOPLE SENSITIVE TO ITS INGREDIENTS. IF YOU DEVELOP ANY OF THE SYMPTOMS LISTED BELOW, STOP USING LAMOTRIGINE AND INFORM YOUR DOCTOR IMMEDIATELY OR GO TO THE NEAREST HOSPITAL EMERGENCY DEPARTMENT: A SMALL NUMBER OF PATIENTS MAY EXPERIENCE AN ALLERGIC REACTION OR A POTENTIALLY LIFE-THREATENING SKIN REACTION WHEN TAKING LAMOTRIGINE. WITHOUT TREATMENT, THESE CAN LEAD TO MORE SERIOUS PROBLEMS. THESE SYMPTOMS ARE MORE LIKELY TO OCCUR WITHIN THE FIRST FEW MONTHS OF STARTING LAMOTRIGINE TREATMENT, ESPECIALLY IF THE INITIAL DOSE IS TOO HIGH, THE DOSE IS INCREASED TOO QUICKLY, OR IF LAMOTRIGINE IS USED WITH ANOTHER MEDICINE - VALPROATE. SOME SYMPTOMS ARE MORE COMMON IN CHILDREN. THEREFORE, PARENTS SHOULD PAY PARTICULAR ATTENTION TO THESE SYMPTOMS. THE SYMPTOMS OF THESE REACTIONS ARE LISTED BELOW: LIFE-THREATENING SKIN REACTIONS, INCLUDING RASH OR REDNESS OF THE SKIN; ESPECIALLY RASH SPREADING TO THE MOUTH, NOSE, EYES, AND GENITAL ORGANS IN THE FORM OF BLISTERS AND SKIN PEELING (STEVENS-JOHNSON SYNDROME), SEVERE SKIN PEELING (OVER MORE THAN 30% OF THE BODY SURFACE - TOXIC EPIDERMAL NECROLYSIS) OR A WIDESPREAD RASH INVOLVING THE LIVER, BLOOD, OR OTHER ORGANS (DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS, ALSO KNOWN AS DRESS - DRUG HYPERSENSITIVITY SYNDROME). SORES IN THE MOUTH, THROAT, NOSE, OR GENITAL ORGANS EYE LESIONS OR RED, SWOLLEN EYES (CONJUNCTIVITIS) SWELLING AROUND THE FACE OR ENLARGED GLANDS IN THE NECK FEVER, FLU-LIKE SYMPTOMS, OR DROWSINESS ENLARGED LYMPH NODES IN THE NECK, ARMPIST, AND GROIN, FACIAL SWELLING (LYMPHADENOPATHY) SUDDEN BLEEDING OR BRUISING OR BLUE FINGERS (DISSEMINATED INTRAVASCULAR COAGULATION) SORE THROAT OR MORE FREQUENT INFECTIONS THAN USUAL (COLD-LIKE) HIGH LEVELS OF LIVER ENZYMES IN BLOOD TESTS INCREASE IN CERTAIN TYPES OF WHITE BLOOD CELLS (EOSINOPHILS) ENLARGED LYMPH NODES INVOLVEMENT OF OTHER ORGANS, INCLUDING THE LIVER AND KIDNEYS. MOST OF THESE SYMPTOMS ARE SIGNS OF LESS SERIOUS SIDE EFFECTS. HOWEVER, DO NOT FORGET THAT THESE SIDE EFFECTS ARE POTENTIALLY LIFE-THREATENING AND CAN LEAD TO MORE SERIOUS PROBLEMS. IF YOU NOTICE ANY OF THESE SYMPTOMS, INFORM YOUR DOCTOR IMMEDIATELY. YOUR DOCTOR MAY DECIDE TO PERFORM LIVER, KIDNEY, OR BLOOD TESTS AND ASK YOU TO STOP USING LAMOTRIGINE. IN CASE OF STEVENS-JOHNSON SYNDROME OR TOXIC EPIDERMAL NECROLYSIS, YOUR DOCTOR WILL WARN YOU THAT YOU MUST NOT TAKE LAMOTRIGINE. HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH) (SEE SECTION 2: THINGS TO CONSIDER BEFORE USING LAMOTRIGINE) THESE ARE VERY SERIOUS SIDE EFFECTS. YOU MAY REQUIRE EMERGENCY MEDICAL INTERVENTION OR HOSPITALIZATION. SUCH VERY SERIOUS SIDE EFFECTS ARE QUITE RARE. SIDE EFFECTS ARE LISTED IN THE FOLLOWING CATEGORIES: VERY COMMON: MAY AFFECT AT LEAST 1 IN 10 PEOPLE. COMMON: MAY AFFECT LESS THAN 1 IN 10 PEOPLE BUT MORE THAN 1 IN 100 PEOPLE. UNCOMMON: MAY AFFECT LESS THAN 1 IN 100 PEOPLE BUT MORE THAN 1 IN 1,000 PEOPLE. RARE: MAY AFFECT LESS THAN 1 IN 1,000 PEOPLE BUT MORE THAN 1 IN 10,000 PEOPLE. VERY RARE: MAY AFFECT LESS THAN 1 IN 10,000 PEOPLE. UNKNOWN: CANNOT BE ESTIMATED FROM AVAILABLE DATA. VERY COMMON: • HEADACHE • SKIN RASH COMMON: • IRRITABILITY • FEELING DROWSY OR NUMB • DIZZINESS • TREMOR • SLEEP PROBLEMS (INSOMNIA) • FEELING ANXIOUS • DIARRHEA • DRY MOUTH • NAUSEA OR VOMITING • FEELING TIRED • BACK OR JOINT PAIN OR PAIN IN OTHER AREAS UNCOMMON: • STIFFNESS AND LACK OF COORDINATION (ATAXIA) • DOUBLE VISION OR BLURRED VISION • SEVERE HAIR LOSS AND THINNING (ALOPECIA) • RASH OR SUNBURN AFTER EXPOSURE TO SUNLIGHT OR ARTIFICIAL LIGHT (PHOTOSENSITIVITY) RARE: • RAPID, SPONTANEOUS EYE MOVEMENTS (NYSTAGMUS) • ASEPTIC MENINGITIS (INVOLVES A GROUP OF SYMPTOMS INCLUDING FEVER, NAUSEA, VOMITING, HEADACHE, NECK STIFFNESS, AND HYPERSENSITIVITY TO BRIGHT LIGHT. IT DEVELOPS AS A RESULT OF INFLAMMATION OF THE BRAIN AND SPINAL CORD MEMBRANES. USUALLY, THESE SYMPTOMS RESOLVE UPON DISCONTINUATION OF TREATMENT. HOWEVER, IF SYMPTOMS PERSIST OR WORSEN, CONSULT YOUR DOCTOR.) • LIFE-THREATENING SKIN REACTIONS (STEVENS-JOHNSON SYNDROME): (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • ITCHY EYES, DISCHARGE, AND CRUSTING ON EYELIDS (CONJUNCTIVITIS) VERY RARE: • LIFE-THREATENING SKIN REACTIONS MANIFESTING AS SEVERE SKIN PEELING (TOXIC EPIDERMAL NECROLYSIS): (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • MULTIPLE ORGAN FAILURE OR SEVERE BLOOD CLOTTING DISORDERS THAT CAN CAUSE SUDDEN BLEEDING, BRUISING (DISSEMINATED INTRAVASCULAR COAGULATION): (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • FACIAL SWELLING (EDEMA) OR ENLARGED GLANDS IN THE NECK, ARMPIST, AND GROIN (LYMPHADENOPATHY): (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • HIGH FEVER: (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • INCREASED SEIZURES IN PATIENTS WITH EPILEPSY • INVOLUNTARY BODY MOVEMENTS (TICS), INVOLUNTARY MUSCLE SPASMS AFFECTING THE EYES, HEAD, AND BODY (CHOREOATHETOSIS) OR UNUSUAL BODY MOVEMENTS SUCH AS TICS, SHAKING, OR STIFFNESS • FEELING OF LOSS OF BALANCE • DISORIENTATION (CONFUSION) • SEEING OR HEARING THINGS THAT ARE NOT THERE (HALLUCINATIONS) • WORSENING OF PARKINSON'S DISEASE SYMPTOMS • LUPUS-LIKE REACTIONS (SYMPTOMS: FEVER AND PAIN IN THE BACK AND JOINTS, ACCOMPANIED BY GENERAL DETERIORATION OF HEALTH) • REDUCED WHITE BLOOD CELL COUNT (NEUTROPENIA, LEUKOPENIA, AGRANULOCYTOSIS) • CHANGES IN LIVER FUNCTION TESTS OR LIVER FAILURE: (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • REDUCED RED BLOOD CELL COUNT (ANEMIA) • REDUCED PLATELET COUNT (THROMBOCYTOPENIA) • REDUCED COUNT OF ALL BLOOD CELLS (PANCYTOPENIA) • BONE MARROW DISORDERS (APLASTIC ANEMIA) • INCREASE IN EOSINOPHILS (A TYPE OF ALLERGY CELL) IN THE BLOOD (EOSINOPHILIA) AND DRUG REACTION WITH SYSTEMIC SYMPTOMS (DRESS): (SEE THE BEGINNING OF SECTION 4 FOR INFORMATION) • HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH) (A SEVERE CHRONIC DISEASE RESULTING FROM OVERSTIMULATION OF THE IMMUNE SYSTEM, WITH SYMPTOMS AFFECTING VARIOUS SYSTEMS) (SEE SECTION 2: THINGS TO CONSIDER BEFORE USING LAMOTRIGINE). UNKNOWN: • NIGHTMARES • KNOWN BONE DISORDERS, INCLUDING OSTEOPENIA AND OSTEOPOROSIS (BONE THINNING) AND FRACTURES. IF YOU HAVE BEEN TAKING ANTIEPILEPTIC MEDICINES FOR A LONG TIME, HAVE A HISTORY OF OSTEOPOROSIS, OR ARE TAKING STEROIDS, CONSULT YOUR DOCTOR OR PHARMACIST. • WEAKENED IMMUNITY DUE TO LOW LEVELS OF ANTIBODIES PROTECTING AGAINST INFECTIONS IN THE BLOOD - IMMUNOGLOBULINS. • KIDNEY INFLAMMATION (TUBULOINTERSTITIAL NEPHRITIS) OR KIDNEY AND EYE INFLAMMATION (TUBULOINTERSTITIAL NEPHRITIS AND UVEITIS SYNDROME). IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS INSTRUCTION LEAFLET, INFORM YOUR DOCTOR OR PHARMACIST. REPORTING SIDE EFFECTS IF YOU EXPERIENCE ANY SIDE EFFECTS, WHETHER LISTED OR NOT IN THIS INSTRUCTION LEAFLET, INFORM YOUR DOCTOR, PHARMACIST, OR NURSE. BY REPORTING SIDE EFFECTS, YOU ARE HELPING TO PROVIDE MORE INFORMATION ABOUT THE SAFETY OF THE MEDICINE YOU ARE USING. 5. HOW TO STORE LAMOTRIGINE STORE LAMOTRIGINE OUT OF THE REACH OF CHILDREN, IN ITS ORIGINAL PACKAGING. STORE AT ROOM TEMPERATURE BELOW 30 °C, IN A DRY AND LIGHT-PROTECTED PLACE. USE BY THE EXPIRY DATE. DO NOT USE LAMOTRIGINE AFTER THE EXPIRY DATE INDICATED ON THE PACKAGING. DO NOT DISPOSE OF EXPIRED OR UNUSED MEDICINES! HAND THEM OVER TO THE COLLECTION SYSTEM DEFINED BY THE MINISTRY OF ENVIRONMENT AND URBANIZATION. SEE ALSO: LAMOTRIGINE DC - LAMOTRIGINE DC CHEWABLE 50MG 30 TABLETS