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- DICLORON 75 MG/3 ML I.M. SOLUTION FOR INJECTION FOR INTRAMUSCULAR USE STERILE ACTIVE SUBSTANCE: EACH 3 ML SOLUTION FOR INJECTION (TOTAL VOLUME) CONTAINS 75 MG DICLOFENAC SODIUM. EXCIPIENTS: MANNITOL, SODIUM METABISULFITE, BENZYL ALCOHOL, PROPYLENE GLYCOL, SODIUM HYDROXIDE, WATER FOR INJECTION. READ THE PACKAGE LEAFLET CAREFULLY BEFORE STARTING TO TAKE THIS MEDICINE AS IT CONTAINS IMPORTANT INFORMATION FOR YOU. · KEEP THESE INSTRUCTIONS. YOU MAY NEED TO READ THEM 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. · WHEN TAKING THIS MEDICINE, INFORM YOUR DOCTOR ABOUT ITS USE WHEN VISITING A DOCTOR OR HOSPITAL. · FOLLOW THE INSTRUCTIONS IN THIS LEAFLET EXACTLY. DO NOT TAKE MORE OR LESS THAN RECOMMENDED. WHAT IS IN THIS LEAFLET: 1. WHAT DICLORON IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE USING DICLORON 3. HOW TO TAKE DICLORON 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DICLORON 1. WHAT DICLORON IS AND WHAT IT IS USED FOR · DICLORON 75 MG/3 ML, WITH THE ACTIVE INGREDIENT DICLOFENAC SODIUM, IS PRESENTED IN AMPULES CONTAINING A SOLUTION FOR INTRAMUSCULAR INJECTION. · DICLORON BELONGS TO A GROUP OF MEDICINES CALLED NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs), WHICH ARE USED TO TREAT PAIN AND INFLAMMATION. · IT IS AVAILABLE IN PACKS OF 4, 10 OR 100 AMPULES, EACH WITH A VOLUME OF 3 ML. DICLORON INTRAMUSCULAR INJECTION IS USED TO TREAT A NUMBER OF PAINFUL CONDITIONS, INCLUDING: TREATMENT OF SYMPTOMS AND SIGNS OF CALCIFICATION (OSTEOARTHRITIS), PAINFUL AND DEFORMED JOINTS (RHEUMATOID ARTHRITIS). TREATMENT OF PAINFUL PROGRESSIVE RHEUMATISM CHARACTERIZED BY STIFFNESS OF THE NECK, SPINE AND RIBS (ANKYLOSING SPONDYLITIS). TREATMENT OF JOINT INFLAMMATION CAUSED BY ACUTE GOUT (ACUTE GOUTY ARTHRITIS). TREATMENT OF ACUTE MUSCULOSKELETAL PAIN, POST-OPERATIVE PAIN (POST-OPERATIVE PAIN) AND PAINFUL MENSTRUATION (DYSMENORRHEA). PLEASE CONSULT YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT HOW DICLORON WORKS AND WHY YOU HAVE BEEN PRESCRIBED THIS MEDICINE. 2. WHAT YOU NEED TO KNOW BEFORE USING DICLORON FOLLOW ALL INSTRUCTIONS GIVEN BY YOUR DOCTOR OR PHARMACIST CAREFULLY. THESE INSTRUCTIONS MAY DIFFER FROM THE INFORMATION IN THIS LEAFLET. DO NOT USE DICLORON IF: · YOU ARE ALLERGIC TO DICLOFENAC, SODIUM METABISULFITE (OR ANY OTHER SULFITE) OR ANY OTHER INGREDIENT OF DICLORON (LISTED AT THE BEGINNING OF THIS LEAFLET). · YOU HAVE EVER HAD ALLERGIC SYMPTOMS OR SIGNS AFTER TAKING ANTI-INFLAMMATORY OR PAIN RELIEVING MEDICINES (E.G., ACETYLSALICYLIC ACID/ASPIRIN, DICLOFENAC OR IBUPROFEN). THESE REACTIONS MAY INCLUDE ASTHMA, RUNNY NOSE, SKIN RASH AND SWELLING OF THE FACE. SEVERE, RARELY FATAL CLINICAL REACTIONS HAVE BEEN REPORTED IN THESE PATIENTS WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs). CONSULT YOUR DOCTOR IF YOU THINK YOU MAY BE ALLERGIC. · YOU HAVE HAD CORONARY ARTERY SURGERY (CARDIOVASCULAR SURGERY, BYPASS, ETC.) TO RELIEVE PAIN BEFORE OR AFTER SURGERY. · YOU HAVE A STOMACH OR DUODENAL ULCER (WOUND). · YOU HAVE BLEEDING OR PERFORATION IN THE DIGESTIVE TRACT, SYMPTOMS MAY INCLUDE BLOODY OR BLACK STOOLS. · YOU HAVE SEVERE KIDNEY OR LIVER DISEASE. · YOU HAVE SEVERE HEART FAILURE. · YOU ARE IN THE LAST TRIMESTER OF PREGNANCY. CONSULT YOUR DOCTOR BEFORE USING DICLORON, EVEN IF THESE WARNINGS HAVE APPLIED TO YOU BEFORE. YOUR DOCTOR WILL DECIDE IF THIS MEDICINE IS SUITABLE FOR YOU. IF YOU SUSPECT YOU ARE ALLERGIC, CONSULT YOUR DOCTOR. TAKE SPECIAL CARE WHEN USING DICLORON · PATIENTS WITH SIGNIFICANT RISK FACTORS FOR CARDIOVASCULAR DISEASES (SUCH AS HIGH BLOOD PRESSURE, ABNORMALLY HIGH LEVELS OF FAT IN THE BLOOD (CHOLESTEROL, TRIGLYCERIDES), DIABETES AND SMOKING) SHOULD ONLY BE PRESCRIBED DICLOFENAC AFTER THOROUGH EXAMINATION. IN PARTICULAR, THIS RISK INCREASES WITH HIGH DOSES (150 MG PER DAY) AND PROLONGED TREATMENT. THEREFORE, THE LOWEST EFFECTIVE DOSE SHOULD BE USED FOR THE SHORTEST POSSIBLE DURATION OF TREATMENT WITH DICLOFENAC. THE NEED FOR CONTINUED TREATMENT WITH DICLOFENAC SHOULD BE REGULARLY ASSESSED BY HEALTHCARE PROFESSIONALS. · IF YOU HAVE ESTABLISHED HEART OR BLOOD VESSEL DISEASE (ALSO KNOWN AS CARDIOVASCULAR DISEASE, INCLUDING UNCONTROLLED HIGH BLOOD PRESSURE, CONGESTIVE HEART FAILURE (HEART CANNOT PUMP ENOUGH BLOOD TO MEET THE BODY'S NEEDS), ESTABLISHED ISCHEMIC HEART DISEASE (NARROWING OF THE BLOOD VESSELS SUPPLYING OXYGEN AND BLOOD TO THE HEART) OR PERIPHERAL ARTERIAL DISEASE (NARROWING OF ARTERIES AND REDUCED BLOOD FLOW TO CERTAIN AREAS), TREATMENT WITH DICLORON IS GENERALLY NOT RECOMMENDED. IF YOU HAVE ESTABLISHED HEART DISEASE OR ARE AT RISK OF HEART DISEASE AND ARE PARTICULARLY BEING TREATED FOR MORE THAN 4 WEEKS, YOUR DOCTOR WILL DECIDE IF YOU NEED TO CONTINUE TREATMENT WITH DICLORON. · IN GENERAL, IT IS IMPORTANT TO TAKE THE LOWEST DOSE OF DICLORON THAT RELIEVES PAIN AND/OR SWELLING AND FOR THE SHORTEST POSSIBLE TIME TO MINIMIZE THE RISK OF CARDIOVASCULAR SIDE EFFECTS. · IF YOU ARE TAKING DICLORON SIMULTANEOUSLY WITH OTHER ANTI-INFLAMMATORY DRUGS (ACETYLSALICYLIC ACID/ASPIRIN, CORTICOSTEROIDS (CORTISONE AND ASPIRIN-LIKE DRUGS), "BLOOD THINNERS" AND ANTIDEPRESSANTS CLASSIFIED AS SELECTIVE SEROTONIN REUPTAKE INHIBITORS) (SEE "TAKING OTHER MEDICINES"). · IF YOU HAVE ASTHMA OR HAY FEVER (SEASONAL ALLERGIC RHINITIS). · IF YOU HAVE HAD PREVIOUS STOMACH PROBLEMS, SUCH AS STOMACH ULCERS, STOMACH BLEEDING OR BLACK STOOLS, OR IF YOU HAVE HAD STOMACH PROBLEMS OR HEARTBURN AFTER TAKING ANTI-INFLAMMATORY DRUGS. · IF YOU HAVE INFLAMMATION OF THE LARGE INTESTINE (ULCERATIVE COLITIS) OR INFLAMMATION OF THE INTESTINES (CROHN'S DISEASE). · IF YOU HAVE LIVER OR KIDNEY PROBLEMS. · IF YOU MAY BE DEHYDRATED (E.G., DUE TO NAUSEA, DIARRHEA, BEFORE OR AFTER MAJOR SURGERY). · IF YOU HAVE SWELLING IN YOUR LEGS. · IF YOU HAVE A BLEEDING DISORDER OR OTHER BLOOD-RELATED DISORDERS (INCLUDING A RARE LIVER PROBLEM CALLED PORPHYRIA). · IF YOU HAVE CONNECTIVE TISSUE DISORDERS OR SIMILAR DISEASES. IF THESE WARNINGS APPLY TO YOU, EVEN IF THEY HAVE APPLIED IN THE PAST, CONSULT YOUR DOCTOR. · IF AT ANY TIME DURING DICLORON TREATMENT YOU NOTICE ANY SIGNS OR SYMPTOMS THAT MAY INDICATE HEART OR BLOOD DISEASES, SUCH AS CHEST PAIN, SHORTNESS OF BREATH, WEAKNESS OR SPEECH DISTURBANCES, CONTACT YOUR DOCTOR IMMEDIATELY. · DICLORON MAY REDUCE THE SYMPTOMS OF INFECTION (E.G., HEADACHE, HIGH TEMPERATURE) AND THEREFORE MAKE IT MORE DIFFICULT TO DETECT OTHER INFECTIONS. IF YOU FEEL UNWELL AND NEED TO SEE A DOCTOR, DO NOT FORGET TO TELL YOUR DOCTOR THAT YOU ARE USING DICLORON. · IN VERY RARE CASES, DICLORON, LIKE OTHER ANTI-INFLAMMATORY DRUGS, MAY CAUSE SEVERE ALLERGIC REACTIONS (E.G., RASH). IF YOU NOTICE ANY OF THE SYMPTOMS DESCRIBED ABOVE, INFORM YOUR DOCTOR IMMEDIATELY. TAKING DICLORON WITH FOOD AND DRINK IS NOT APPLICABLE PREGNANCY CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING ANY MEDICINE. IF YOU ARE PREGNANT OR THINK YOU MAY BE PREGNANT, INFORM YOUR DOCTOR. DICLORON SHOULD NOT BE USED DURING PREGNANCY UNLESS NECESSARY. LIKE OTHER ANTI-INFLAMMATORY DRUGS, DICLORON SHOULD NOT BE USED DURING THE LAST THREE MONTHS OF PREGNANCY AS IT MAY HARM YOUR FETUS OR CAUSE PROBLEMS DURING CHILDBIRTH. DICLORON MAY MAKE IT DIFFICULT TO CONCEIVE. IF YOU ARE PLANNING TO CONCEIVE OR IF YOU HAVE PROBLEMS CONCEIVING, DO NOT USE DICLORON UNLESS NECESSARY. BREASTFEEDING CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING ANY MEDICINE. IF YOU ARE BREASTFEEDING, INFORM YOUR DOCTOR. IF YOU ARE USING DICLORON, YOU SHOULD STOP BREASTFEEDING AS IT MAY BE HARMFUL TO YOUR BABY. DRIVING AND OPERATING MACHINERY DURING THE USE OF DICLORON PATIENTS MAY RARELY EXPERIENCE SIDE EFFECTS SUCH AS VISUAL DISTURBANCES, DIZZINESS OR DROWSINESS. IF YOU NOTICE ANY OF THESE, YOU SHOULD NOT DRIVE, OPERATE MACHINERY, OR PERFORM ANY WORK THAT REQUIRES CONCENTRATION. CONTACT YOUR DOCTOR IMMEDIATELY AS SOON AS THESE EFFECTS OCCUR. IMPORTANT INFORMATION ABOUT OTHER INGREDIENTS IN DICLORON DICLORON CONTAINS SODIUM METABISULFITE. IT MAY RARELY CAUSE HYPERSENSITIVITY REACTIONS AND BRONCHOSPASM. DICLORON CONTAINS BENZYL ALCOHOL. DICLORON SHOULD NOT BE GIVEN TO PREMATURE INFANTS OR NEWBORNS. IT MAY CAUSE TOXIC REACTIONS AND ALLERGIC REACTIONS IN INFANTS AND CHILDREN UP TO 3 YEARS OF AGE. DICLORON CONTAINS LESS THAN 1 MMOL (23 MG) OF SODIUM PER 1 ML OF SOLUTION, I.E., IT IS SODIUM-FREE. USING DICLORON WITH OTHER MEDICINES IT IS IMPORTANT TO INFORM YOUR DOCTOR IF YOU ARE TAKING THE FOLLOWING MEDICINES: · LITHIUM OR SEROTONIN REUPTAKE INHIBITORS (SSIR); (MEDICINES USED TO TREAT CERTAIN TYPES OF DEPRESSION) · DIGOXIN (MEDICINE TO TREAT HEART PROBLEMS) · MIFEPRISTONE (MEDICINE TO TERMINATE PREGNANCY) · DIURETICS (WATER TABLETS) · ACE INHIBITORS OR BETA-BLOCKERS (MEDICINES USED TO TREAT HIGH BLOOD PRESSURE AND HEART FAILURE) · OTHER ANTI-INFLAMMATORY MEDICINES (SUCH AS ACETYLSALICYLIC ACID/ASPIRIN OR IBUPROFEN) · CORTICOSTEROIDS (MEDICINES USED TO REDUCE INFLAMMATION IN THE BODY) · BLOOD THINNERS (WARFARIN AND SIMILAR MEDICINES USED TO PREVENT BLOOD CLOTS) · MEDICINES FOR DIABETES (EXCEPT INSULIN) · METHOTREXATE (A DRUG USED TO TREAT VARIOUS TYPES OF JOINT INFLAMMATION AND SOME TYPES OF CANCER) · CYCLOSPORINE, TACROLIMUS (DRUGS PRIMARILY USED IN PATIENTS WITH ORGAN TRANSPLANTS) · TRIMETHOPRIM (A DRUG USED TO PREVENT OR TREAT URINARY TRACT INFECTIONS). · QUINOLONE ANTIBIOTICS (DRUGS USED TO TREAT INFECTIONS) · VORICONAZOLE (A DRUG USED TO TREAT FUNGAL INFECTIONS) · PHENYTOIN (A DRUG USED TO TREAT SEIZURES) · COLESTIPOL AND CHOLESTYRAMINE (DRUGS USED TO LOWER CHOLESTEROL). PLEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICINES, INCLUDING MEDICINES OBTAINED WITHOUT A PRESCRIPTION. 3. HOW TO TAKE DICLORON FOLLOW YOUR DOCTOR'S INSTRUCTIONS STRICTLY. DO NOT EXCEED THE RECOMMENDED DOSE AND DURATION OF TREATMENT. INSTRUCTIONS FOR CORRECT USE AND DOSE/FREQUENCY OF ADMINISTRATION: DO NOT EXCEED THE RECOMMENDED DOSE. IT IS IMPORTANT TO USE THE LOWEST DOSE THAT CONTROLS YOUR PAIN AND NOT TO USE DICLORON LONGER THAN NECESSARY. YOUR DOCTOR WILL TELL YOU HOW MANY DICLORON INJECTIONS TO TAKE. YOUR DOCTOR MAY RECOMMEND A HIGHER OR LOWER DOSE DEPENDING ON YOUR RESPONSE TO TREATMENT. IN ADULTS IN ADULTS, 1 AMPULE PER DAY, FOR A MAXIMUM OF 2 DAYS, IN SOME CASES, 2 AMPULES PER DAY MAY BE TAKEN. IF NECESSARY, TREATMENT MAY BE CONTINUED WITH DICLORON TABLETS OR SUPPOSITORIES. ROUTE AND METHOD OF ADMINISTRATION THE SOLUTION IS TRANSFERRED FROM THE AMPULE TO A SYRINGE AND ADMINISTERED DEEP INTO THE GLUTEAL MUSCLE. DIFFERENT AGE GROUPS USE IN CHILDREN DICLORON IS NOT USED IN CHILDREN AND ADOLESCENTS (UNDER 18 YEARS OF AGE). USE IN THE ELDERLY ELDERLY PATIENTS MAY BE MORE SENSITIVE TO THE EFFECTS OF DICLORON THAN OTHER ADULTS. THEREFORE, ELDERLY PATIENTS SHOULD FOLLOW THEIR DOCTOR'S INSTRUCTIONS PARTICULARLY CAREFULLY AND USE THE SMALLEST NUMBER OF TABLETS THAT PROVIDES SYMPTOM RELIEF. IT IS PARTICULARLY IMPORTANT FOR ELDERLY PATIENTS TO REPORT ANY UNDESIRABLE EFFECTS TO THEIR DOCTOR IMMEDIATELY. RENAL IMPAIRMENT DICLORON SHOULD NOT BE USED IN PATIENTS WITH RENAL IMPAIRMENT. NO SPECIFIC STUDIES HAVE BEEN CONDUCTED IN PATIENTS WITH RENAL IMPAIRMENT; THEREFORE, SPECIFIC DOSAGE ADJUSTMENT RECOMMENDATIONS CANNOT BE PROVIDED. IF YOU HAVE MILD TO MODERATE RENAL IMPAIRMENT, YOUR DOCTOR WILL RECOMMEND USING DICLORON WITH CAUTION. PLEASE CONSULT YOUR DOCTOR. HEPATIC IMPAIRMENT DICLORON SHOULD NOT BE USED IN PATIENTS WITH HEPATIC IMPAIRMENT. NO SPECIFIC STUDIES HAVE BEEN CONDUCTED IN PATIENTS WITH HEPATIC IMPAIRMENT; THEREFORE, SPECIFIC DOSAGE ADJUSTMENT RECOMMENDATIONS CANNOT BE PROVIDED. IF YOU HAVE MILD TO MODERATE HEPATIC IMPAIRMENT, YOUR DOCTOR WILL RECOMMEND USING DICLORON WITH CAUTION. PLEASE CONSULT YOUR DOCTOR. IF YOU THINK THE EFFECT OF DICLORON IS TOO STRONG OR TOO WEAK, CONSULT YOUR DOCTOR OR PHARMACIST. IF YOU TAKE MORE DICLORON THAN YOU SHOULD IF YOU TAKE MORE DICLORON THAN YOU SHOULD, CONTACT YOUR DOCTOR OR PHARMACIST IMMEDIATELY OR GO TO THE NEAREST HOSPITAL EMERGENCY DEPARTMENT. YOU MAY NEED MEDICAL ATTENTION. IF YOU HAVE TAKEN AN OVERDOSE OF DICLORON, CONSULT YOUR DOCTOR OR PHARMACIST. IF YOU FORGET TO TAKE DICLORON DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A MISSED DOSE. IF YOU FORGET TO TAKE A DOSE, TAKE IT AS SOON AS YOU REMEMBER. 4. POSSIBLE SIDE EFFECTS LIKE ALL MEDICINES, DICLORON MAY CAUSE SIDE EFFECTS IN PATIENTS WHO ARE HYPERSENSITIVE TO ITS INGREDIENTS. SOME SIDE EFFECTS MAY BE SERIOUS THESE COMMON SIDE EFFECTS MAY OCCUR IN 1 TO 10 OUT OF 1000 PATIENTS, ESPECIALLY WHEN A HIGH DAILY DOSE (150 MG) IS USED FOR A PROLONGED PERIOD. · SUDDEN AND SEVERE CHEST PAIN (SIGN OF MYOCARDIAL INFARCTION OR HEART ATTACK) · SHORTNESS OF BREATH, DIFFICULTY BREATHING WHEN LYING DOWN, SWELLING OF THE ANKLES AND FEET (SIGNS OF HEART FAILURE) · STOMACH PAIN, INDIGESTION, HEARTBURN, FLATULENCE, NAUSEA, VOMITING · ANY SIGN OF BLEEDING FROM THE STOMACH OR INTESTINES (BLOOD IN VOMITUS, BLACK OR TAR-LIKE STOOLS) · ALLERGIC REACTIONS, WHICH MAY INCLUDE SKIN RASH, ITCHING, BRUISES, PAINFUL RED AREAS, SKIN PEELING OR BLISTER FORMATION · SWELLING OF THE FACE, LIPS, HANDS OR FINGERS · YELLOWING OF THE SKIN OR THE WHITES OF THE EYES · PERSISTENT SORE THROAT OR HIGH FEVER · SUDDEN CHANGE IN THE AMOUNT OR CHARACTERISTICS OF URINE FREQUENT SIDE EFFECTS (MAY AFFECT UP TO 10 OUT OF 100 PATIENTS) · HEADACHE · DIZZINESS · VERTIGO (DIZZINESS CAUSED BY IMBALANCE) · NAUSEA · VOMITING · DIARRHEA · INDIGESTION (SIGN OF DYSPEPSIA) · ABDOMINAL PAIN · FLATULENCE · LOSS OF APPETITE · PATHOLOGICAL RESULTS OF LIVER FUNCTION TESTS (E.G., INCREASED TRANSAMINASE LEVELS) · SKIN RASH · REACTION, PAIN AND HARDENING AT THE INJECTION SITE · IRRITATION AT THE SITE OF USE · STOMACH PAIN INFREQUENT SIDE EFFECTS (MAY AFFECT 1 TO 10 OUT OF 10,000 PATIENTS) · SPONTANEOUS BLEEDING OR BRUISING (SIGNS OF THROMBOCYTOPENIA, REDUCED NUMBER OF PLATELETS IN THE BLOOD THAT STOP BLEEDING) · HIGH FEVER, FREQUENT INFECTIONS, PERSISTENT SORE THROAT (SIGNS OF AGRANULOCYTOSIS, REDUCED NUMBER OF CERTAIN CELLS INVOLVED IN PROTECTING THE BODY FROM INFECTIONS) · DIFFICULTY BREATHING AND SWALLOWING, SKIN RASH, ITCHING, HIVES, DIZZINESS (HYPERSENSITIVITY, ANAPHYLACTIC AND ANAPHYLACTOID REACTIONS) · SUDDEN DIFFICULTY BREATHING AND FEELING OF CHEST TIGHTNESS WITH WHEEZING OR COUGHING (SIGNS OF ASTHMA OR A TYPE OF LUNG INFLAMMATION, PNEUMONITIS, IF FEVER IS PRESENT). · SUDDEN AND SEVERE HEADACHE, NAUSEA, DIZZINESS, NUMBNESS, INABILITY OR DIFFICULTY SPEAKING, WEAKNESS OR PARALYSIS (SIGN OF STROKE) ON THE LIPS AND FACE (SIGNS OF CEREBRAL ATTACK, SEIZURES) · STIFF NECK, FEVER, NAUSEA, VOMITING, HEADACHE (SIGN OF ASEPTIC MENINGITIS, INFLAMMATION OF THE MEMBRANES COVERING THE BRAIN) · BLOODY VOMITUS (SIGN OF HEMATEMESIS) AND/OR BLACK OR BLOODY STOOLS (SIGNS OF GASTROINTESTINAL BLEEDING) · BLOODY DIARRHEA (SIGNS OF BLOODY DIARRHEA) · BLACK STOOLS (SIGNS OF MELENA, INTESTINAL BLEEDING) · STOMACH PAIN, NAUSEA (SIGNS OF GASTROINTESTINAL ULCER) · YELLOWING OF THE SKIN OR EYES (SIGN OF JAUNDICE), NAUSEA, LOSS OF APPETITE, DARK URINE (SIGN OF LIVER INFLAMMATION/LIVER FAILURE) · DROWSINESS (SIGN OF DROWSINESS) · STOMACH PAIN (SIGN OF GASTRITIS) · LIVER FAILURE · SKIN ITCHING (SIGN OF HIVES) · PUFFY SWELLING (SIGN OF SWELLING) · NECROSIS AT THE SITE OF ADMINISTRATION · PAIN IN THE LARGE INTESTINE (SOMETIMES WITH BLEEDING AND DISCHARGE) VERY RARE SIDE EFFECTS (MAY AFFECT LESS THAN 1 IN 10,000 PATIENTS) · MAINLY SWELLING OF THE FACE AND THROAT (SIGNS OF ANGIOEDEMA) · SEIZURES (SIGNS OF CONVULSIONS) · HEADACHE, DIZZINESS (SIGNS OF HYPERTENSION) · SKIN RASH, PURPLE-RED SPOTS, FEVER, ITCHING (SIGNS OF VASCULITIS [INFLAMMATION OF BLOOD VESSELS]) · DIARRHEA, STOMACH PAIN, FEVER, NAUSEA, VOMITING (SIGNS OF COLITIS, INCLUDING HEMORRHAGIC COLITIS [INFLAMMATION OF THE LARGE INTESTINE] AND EXACERBATION OF ULCERATIVE COLITIS OR CROHN'S DISEASE) · SEVERE PAIN IN THE UPPER ABDOMEN (SIGNS OF PANCREATITIS) · FLU-LIKE SYMPTOMS, FEELING OF FATIGUE, MUSCLE PAIN, INCREASED LEVELS OF LIVER ENZYMES IN BLOOD TESTS (SIGNS OF LIVER DISORDERS, INCLUDING FULMINANT HEPATITIS, LIVER NECROSIS, LIVER FAILURE) · BLISTER FORMATION ON THE SKIN (SIGNS OF BULLOUS DERMATITIS) · REDNESS OR PURPLE DISCOLORATION OF THE SKIN (POSSIBLE SIGNS OF BLOOD VESSEL INFLAMMATION), SKIN RASH WITH BLISTERS, BLISTER FORMATION ON THE LIPS, EYES AND MOUTH, SKIN INFLAMMATION WITH PEELING (SIGNS OF ERYTHEMA MULTIFORME OR STEVENS-JOHNSON SYNDROME, IF FEVER IS PRESENT (INFLAMMATION CHARACTERIZED BY SWELLING, REDNESS AND ACCUMULATION OF BLOOD IN THE SKIN AND AROUND THE EYES) OR TOXIC EPIDERMAL NECROLYSIS (A SERIOUS ILLNESS WITH BLISTER FORMATION)) · SKIN RASH WITH SKIN PEELING (SIGNS OF EXFOLIATIVE DERMATITIS) · INCREASED SKIN SENSITIVITY TO SUNLIGHT (SIGNS OF PHOTOSENSITIVITY) · PURPLE SPOTS ON THE SKIN (SIGNS OF PURPURA OR HENOCH-SCHÖNLEIN PURPURA, IF CAUSED BY ALLERGY) · SWELLING, FEELING OF WEAKNESS OR URINATION DISTURBANCES (SIGNS OF ACUTE RENAL FAILURE) · EXCESSIVE AMOUNT OF PROTEIN IN URINE (SIGNS OF PROTEINURIA) · SWELLING OF THE FACE OR STOMACH, HIGH BLOOD PRESSURE (SIGNS OF NEPHROTIC SYNDROME) · INCREASED OR DECREASED AMOUNT OF URINE, DROWSINESS, CONFUSION, NAUSEA (SIGNS OF TUBULOINTERSTITIAL NEPHRITIS) · SIGNIFICANTLY REDUCED AMOUNT OF URINE (SIGN OF RENAL PAPILLARY NECROSIS) · REDUCED NUMBER OF RED BLOOD CELLS (SIGN OF ANEMIA) · LOW LEVEL OF WHITE BLOOD CELLS (SIGN OF LEUKOPENIA) · DISTURBANCE OF PERCEPTION OF TIME, PLACE AND DIRECTION (DISORIENTATION) · DEPRESSION · DIFFICULTY SLEEPING (SIGN OF INSOMNIA) · NIGHTMARES · INCREASED SENSITIVITY TO IRRITANTS · DISTURBING THOUGHTS OR MOOD (SIGN OF PSYCHOTIC DISORDER) · TINGLING OR NUMBNESS IN HANDS OR FEET (SIGN OF PARESTHESIA) · MEMORY IMPAIRMENT (SIGN OF MEMORY DISORDER) · ANXIETY · TREMORS · TASTE DISTURBANCES (SIGNS OF DYSGEUSIA) · DIFFICULTY HEARING (SIGN OF HEARING IMPAIRMENT) · VISUAL DISTURBANCES (SIGNS OF VISUAL DISTURBANCE, BLURRED VISION, DOUBLE VISION) · TINNITUS · CONSTIPATION, MOUTH SORES (SIGN OF STOMATITIS [INFLAMMATION OF THE INSIDE OF THE MOUTH]) · SWOLLEN, RED AND PAINFUL TONGUE (SIGN OF GLOSSITIS [INFLAMMATION OF THE TONGUE]) · ESOPHAGEAL DISORDERS · PAIN IN THE UPPER ABDOMEN, ESPECIALLY AFTER EATING (SIGNS OF INTESTINAL DIAPHRAGM DISEASE) · PALPITATIONS · CHEST PAIN · ITCHY, RED, BURNING SKIN RASH (SIGNS OF ECZEMA) · SKIN REDNESS (ERYTHEMA) · HAIR LOSS (ALOPECIA) · ITCHING (PRURITUS) · BLOOD IN URINE (HEMATURIA) · PUS AT THE INJECTION SITE (ABSCESS). INFORM YOUR DOCTOR IF YOU NOTICE ANY OF THESE SIDE EFFECTS. IF YOU ARE TAKING DICLORON FOR MORE THAN A FEW WEEKS, YOU MUST SEE YOUR DOCTOR FOR REGULAR CHECK-UPS TO ENSURE YOU DO NOT HAVE ANY UNDETECTED UNDESIRABLE EFFECTS. IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET, PLEASE INFORM YOUR DOCTOR OR PHARMACIST. REPORTING SIDE EFFECTS IF YOU EXPERIENCE ANY SIDE EFFECTS, WHETHER OR NOT LISTED IN THE PATIENT INFORMATION LEAFLET, PLEASE CONSULT YOUR DOCTOR, PHARMACIST OR NURSE. BY REPORTING ANY SIDE EFFECTS, YOU WILL HELP PROVIDE MORE INFORMATION ABOUT THE SAFETY OF THE MEDICINE YOU ARE USING. 5. HOW TO STORE DICLORON STORE DICLORON OUT OF THE REACH AND SIGHT OF CHILDREN, IN ITS ORIGINAL PACKAGING. STORE BELOW 25°C AT ROOM TEMPERATURE. PROTECT FROM LIGHT. USE ACCORDING TO THE EXPIRY DATE. DO NOT USE DICLORON AFTER THE EXPIRY DATE INDICATED ON THE PACKAGING. DO NOT DISPOSE OF MEDICINES DOWN THE DRAIN OR IN HOUSEHOLD WASTE. ASK YOUR PHARMACIST HOW TO DISPOSE OF UNUSED MEDICINES. THESE MEASURES WILL HELP PROTECT THE ENVIRONMENT. DISPENSING CATEGORY: PHARMACEUTICAL PRODUCT GROUP III, AVAILABLE WITHOUT PRESCRIPTION. SEE ALSO: DICLORON - DIKLORON 75MG/3ML 3ML 4 AMPULES
- Active
- diclofenac
What is it?
DICLORON 75 MG/3 ML I.M. SOLUTION FOR INJECTION FOR INTRAMUSCULAR USE STERILE ACTIVE SUBSTANCE: EACH 3 ML SOLUTION FOR INJECTION (TOTAL VOLUME) CONTAINS 75 MG DICLOFENAC SODIUM. EXCIPIENTS: MANNITOL, SODIUM METABISULFITE, BENZYL ALCOHOL, PROPYLENE GLYCOL, SODIUM HYDROXIDE, WATER FOR INJECTION. READ THE PACKAGE LEAFLET CAREFULLY BEFORE STARTING TO TAKE THIS MEDICINE AS IT CONTAINS IMPORTANT INFORMATION FOR YOU. · KEEP THESE INSTRUCTIONS. YOU MAY NEED TO READ THEM 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. · WHEN TAKING THIS MEDICINE, INFORM YOUR DOCTOR ABOUT ITS USE WHEN VISITING A DOCTOR OR HOSPITAL. · FOLLOW THE INSTRUCTIONS IN THIS LEAFLET EXACTLY. DO NOT TAKE MORE OR LESS THAN RECOMMENDED. WHAT IS IN THIS LEAFLET: 1. WHAT DICLORON IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE USING DICLORON 3. HOW TO TAKE DICLORON 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE DICLORON 1. WHAT DICLORON IS AND WHAT IT IS USED FOR · DICLORON 75 MG/3 ML, WITH THE ACTIVE INGREDIENT DICLOFENAC SODIUM, IS PRESENTED IN AMPULES CONTAINING A SOLUTION FOR INTRAMUSCULAR INJECTION. · DICLORON BELONGS TO A GROUP OF MEDICINES CALLED NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs), WHICH ARE USED TO TREAT PAIN AND INFLAMMATION. · IT IS AVAILABLE IN PACKS OF 4, 10 OR 100 AMPULES, EACH WITH A VOLUME OF 3 ML. DICLORON INTRAMUSCULAR INJECTION IS USED TO TREAT A NUMBER OF PAINFUL CONDITIONS, INCLUDING: TREATMENT OF SYMPTOMS AND SIGNS OF CALCIFICATION (OSTEOARTHRITIS), PAINFUL AND DEFORMED JOINTS (RHEUMATOID ARTHRITIS). TREATMENT OF PAINFUL PROGRESSIVE RHEUMATISM CHARACTERIZED BY STIFFNESS OF THE NECK, SPINE AND RIBS (ANKYLOSING SPONDYLITIS). TREATMENT OF JOINT INFLAMMATION CAUSED BY ACUTE GOUT (ACUTE GOUTY ARTHRITIS). TREATMENT OF ACUTE MUSCULOSKELETAL PAIN, POST-OPERATIVE PAIN (POST-OPERATIVE PAIN) AND PAINFUL MENSTRUATION (DYSMENORRHEA). PLEASE CONSULT YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT HOW DICLORON WORKS AND WHY YOU HAVE BEEN PRESCRIBED THIS MEDICINE. 2. WHAT YOU NEED TO KNOW BEFORE USING DICLORON FOLLOW ALL INSTRUCTIONS GIVEN BY YOUR DOCTOR OR PHARMACIST CAREFULLY. THESE INSTRUCTIONS MAY DIFFER FROM THE INFORMATION IN THIS LEAFLET. DO NOT USE DICLORON IF: · YOU ARE ALLERGIC TO DICLOFENAC, SODIUM METABISULFITE (OR ANY OTHER SULFITE) OR ANY OTHER INGREDIENT OF DICLORON (LISTED AT THE BEGINNING OF THIS LEAFLET). · YOU HAVE EVER HAD ALLERGIC SYMPTOMS OR SIGNS AFTER TAKING ANTI-INFLAMMATORY OR PAIN RELIEVING MEDICINES (E.G., ACETYLSALICYLIC ACID/ASPIRIN, DICLOFENAC OR IBUPROFEN). THESE REACTIONS MAY INCLUDE ASTHMA, RUNNY NOSE, SKIN RASH AND SWELLING OF THE FACE. SEVERE, RARELY FATAL CLINICAL REACTIONS HAVE BEEN REPORTED IN THESE PATIENTS WITH NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs). CONSULT YOUR DOCTOR IF YOU THINK YOU MAY BE ALLERGIC. · YOU HAVE HAD CORONARY ARTERY SURGERY (CARDIOVASCULAR SURGERY, BYPASS, ETC.) TO RELIEVE PAIN BEFORE OR AFTER SURGERY. · YOU HAVE A STOMACH OR DUODENAL ULCER (WOUND). · YOU HAVE BLEEDING OR PERFORATION IN THE DIGESTIVE TRACT, SYMPTOMS MAY INCLUDE BLOODY OR BLACK STOOLS. · YOU HAVE SEVERE KIDNEY OR LIVER DISEASE. · YOU HAVE SEVERE HEART FAILURE. · YOU ARE IN THE LAST TRIMESTER OF PREGNANCY. CONSULT YOUR DOCTOR BEFORE USING DICLORON, EVEN IF THESE WARNINGS HAVE APPLIED TO YOU BEFORE. YOUR DOCTOR WILL DECIDE IF THIS MEDICINE IS SUITABLE FOR YOU. IF YOU SUSPECT YOU ARE ALLERGIC, CONSULT YOUR DOCTOR. TAKE SPECIAL CARE WHEN USING DICLORON · PATIENTS WITH SIGNIFICANT RISK FACTORS FOR CARDIOVASCULAR DISEASES (SUCH AS HIGH BLOOD PRESSURE, ABNORMALLY HIGH LEVELS OF FAT IN THE BLOOD (CHOLESTEROL, TRIGLYCERIDES), DIABETES AND SMOKING) SHOULD ONLY BE PRESCRIBED DICLOFENAC AFTER THOROUGH EXAMINATION. IN PARTICULAR, THIS RISK INCREASES WITH HIGH DOSES (150 MG PER DAY) AND PROLONGED TREATMENT. THEREFORE, THE LOWEST EFFECTIVE DOSE SHOULD BE USED FOR THE SHORTEST POSSIBLE DURATION OF TREATMENT WITH DICLOFENAC. THE NEED FOR CONTINUED TREATMENT WITH DICLOFENAC SHOULD BE REGULARLY ASSESSED BY HEALTHCARE PROFESSIONALS. · IF YOU HAVE ESTABLISHED HEART OR BLOOD VESSEL DISEASE (ALSO KNOWN AS CARDIOVASCULAR DISEASE, INCLUDING UNCONTROLLED HIGH BLOOD PRESSURE, CONGESTIVE HEART FAILURE (HEART CANNOT PUMP ENOUGH BLOOD TO MEET THE BODY'S NEEDS), ESTABLISHED ISCHEMIC HEART DISEASE (NARROWING OF THE BLOOD VESSELS SUPPLYING OXYGEN AND BLOOD TO THE HEART) OR PERIPHERAL ARTERIAL DISEASE (NARROWING OF ARTERIES AND REDUCED BLOOD FLOW TO CERTAIN AREAS), TREATMENT WITH DICLORON IS GENERALLY NOT RECOMMENDED. IF YOU HAVE ESTABLISHED HEART DISEASE OR ARE AT RISK OF HEART DISEASE AND ARE PARTICULARLY BEING TREATED FOR MORE THAN 4 WEEKS, YOUR DOCTOR WILL DECIDE IF YOU NEED TO CONTINUE TREATMENT WITH DICLORON. · IN GENERAL, IT IS IMPORTANT TO TAKE THE LOWEST DOSE OF DICLORON THAT RELIEVES PAIN AND/OR SWELLING AND FOR THE SHORTEST POSSIBLE TIME TO MINIMIZE THE RISK OF CARDIOVASCULAR SIDE EFFECTS. · IF YOU ARE TAKING DICLORON SIMULTANEOUSLY WITH OTHER ANTI-INFLAMMATORY DRUGS (ACETYLSALICYLIC ACID/ASPIRIN, CORTICOSTEROIDS (CORTISONE AND ASPIRIN-LIKE DRUGS), "BLOOD THINNERS" AND ANTIDEPRESSANTS CLASSIFIED AS SELECTIVE SEROTONIN REUPTAKE INHIBITORS) (SEE "TAKING OTHER MEDICINES"). · IF YOU HAVE ASTHMA OR HAY FEVER (SEASONAL ALLERGIC RHINITIS). · IF YOU HAVE HAD PREVIOUS STOMACH PROBLEMS, SUCH AS STOMACH ULCERS, STOMACH BLEEDING OR BLACK STOOLS, OR IF YOU HAVE HAD STOMACH PROBLEMS OR HEARTBURN AFTER TAKING ANTI-INFLAMMATORY DRUGS. · IF YOU HAVE INFLAMMATION OF THE LARGE INTESTINE (ULCERATIVE COLITIS) OR INFLAMMATION OF THE INTESTINES (CROHN'S DISEASE). · IF YOU HAVE LIVER OR KIDNEY PROBLEMS. · IF YOU MAY BE DEHYDRATED (E.G., DUE TO NAUSEA, DIARRHEA, BEFORE OR AFTER MAJOR SURGERY). · IF YOU HAVE SWELLING IN YOUR LEGS. · IF YOU HAVE A BLEEDING DISORDER OR OTHER BLOOD-RELATED DISORDERS (INCLUDING A RARE LIVER PROBLEM CALLED PORPHYRIA). · IF YOU HAVE CONNECTIVE TISSUE DISORDERS OR SIMILAR DISEASES. IF THESE WARNINGS APPLY TO YOU, EVEN IF THEY HAVE APPLIED IN THE PAST, CONSULT YOUR DOCTOR. · IF AT ANY TIME DURING DICLORON TREATMENT YOU NOTICE ANY SIGNS OR SYMPTOMS THAT MAY INDICATE HEART OR BLOOD DISEASES, SUCH AS CHEST PAIN, SHORTNESS OF BREATH, WEAKNESS OR SPEECH DISTURBANCES, CONTACT YOUR DOCTOR IMMEDIATELY. · DICLORON MAY REDUCE THE SYMPTOMS OF INFECTION (E.G., HEADACHE, HIGH TEMPERATURE) AND THEREFORE MAKE IT MORE DIFFICULT TO DETECT OTHER INFECTIONS. IF YOU FEEL UNWELL AND NEED TO SEE A DOCTOR, DO NOT FORGET TO TELL YOUR DOCTOR THAT YOU ARE USING DICLORON. · IN VERY RARE CASES, DICLORON, LIKE OTHER ANTI-INFLAMMATORY DRUGS, MAY CAUSE SEVERE ALLERGIC REACTIONS (E.G., RASH). IF YOU NOTICE ANY OF THE SYMPTOMS DESCRIBED ABOVE, INFORM YOUR DOCTOR IMMEDIATELY. TAKING DICLORON WITH FOOD AND DRINK IS NOT APPLICABLE PREGNANCY CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING ANY MEDICINE. IF YOU ARE PREGNANT OR THINK YOU MAY BE PREGNANT, INFORM YOUR DOCTOR. DICLORON SHOULD NOT BE USED DURING PREGNANCY UNLESS NECESSARY. LIKE OTHER ANTI-INFLAMMATORY DRUGS, DICLORON SHOULD NOT BE USED DURING THE LAST THREE MONTHS OF PREGNANCY AS IT MAY HARM YOUR FETUS OR CAUSE PROBLEMS DURING CHILDBIRTH. DICLORON MAY MAKE IT DIFFICULT TO CONCEIVE. IF YOU ARE PLANNING TO CONCEIVE OR IF YOU HAVE PROBLEMS CONCEIVING, DO NOT USE DICLORON UNLESS NECESSARY. BREASTFEEDING CONSULT YOUR DOCTOR OR PHARMACIST BEFORE TAKING ANY MEDICINE. IF YOU ARE BREASTFEEDING, INFORM YOUR DOCTOR. IF YOU ARE USING DICLORON, YOU SHOULD STOP BREASTFEEDING AS IT MAY BE HARMFUL TO YOUR BABY. DRIVING AND OPERATING MACHINERY DURING THE USE OF DICLORON PATIENTS MAY RARELY EXPERIENCE SIDE EFFECTS SUCH AS VISUAL DISTURBANCES, DIZZINESS OR DROWSINESS. IF YOU NOTICE ANY OF THESE, YOU SHOULD NOT DRIVE, OPERATE MACHINERY, OR PERFORM ANY WORK THAT REQUIRES CONCENTRATION. CONTACT YOUR DOCTOR IMMEDIATELY AS SOON AS THESE EFFECTS OCCUR. IMPORTANT INFORMATION ABOUT OTHER INGREDIENTS IN DICLORON DICLORON CONTAINS SODIUM METABISULFITE. IT MAY RARELY CAUSE HYPERSENSITIVITY REACTIONS AND BRONCHOSPASM. DICLORON CONTAINS BENZYL ALCOHOL. DICLORON SHOULD NOT BE GIVEN TO PREMATURE INFANTS OR NEWBORNS. IT MAY CAUSE TOXIC REACTIONS AND ALLERGIC REACTIONS IN INFANTS AND CHILDREN UP TO 3 YEARS OF AGE. DICLORON CONTAINS LESS THAN 1 MMOL (23 MG) OF SODIUM PER 1 ML OF SOLUTION, I.E., IT IS SODIUM-FREE. USING DICLORON WITH OTHER MEDICINES IT IS IMPORTANT TO INFORM YOUR DOCTOR IF YOU ARE TAKING THE FOLLOWING MEDICINES: · LITHIUM OR SEROTONIN REUPTAKE INHIBITORS (SSIR); (MEDICINES USED TO TREAT CERTAIN TYPES OF DEPRESSION) · DIGOXIN (MEDICINE TO TREAT HEART PROBLEMS) · MIFEPRISTONE (MEDICINE TO TERMINATE PREGNANCY) · DIURETICS (WATER TABLETS) · ACE INHIBITORS OR BETA-BLOCKERS (MEDICINES USED TO TREAT HIGH BLOOD PRESSURE AND HEART FAILURE) · OTHER ANTI-INFLAMMATORY MEDICINES (SUCH AS ACETYLSALICYLIC ACID/ASPIRIN OR IBUPROFEN) · CORTICOSTEROIDS (MEDICINES USED TO REDUCE INFLAMMATION IN THE BODY) · BLOOD THINNERS (WARFARIN AND SIMILAR MEDICINES USED TO PREVENT BLOOD CLOTS) · MEDICINES FOR DIABETES (EXCEPT INSULIN) · METHOTREXATE (A DRUG USED TO TREAT VARIOUS TYPES OF JOINT INFLAMMATION AND SOME TYPES OF CANCER) · CYCLOSPORINE, TACROLIMUS (DRUGS PRIMARILY USED IN PATIENTS WITH ORGAN TRANSPLANTS) · TRIMETHOPRIM (A DRUG USED TO PREVENT OR TREAT URINARY TRACT INFECTIONS). · QUINOLONE ANTIBIOTICS (DRUGS USED TO TREAT INFECTIONS) · VORICONAZOLE (A DRUG USED TO TREAT FUNGAL INFECTIONS) · PHENYTOIN (A DRUG USED TO TREAT SEIZURES) · COLESTIPOL AND CHOLESTYRAMINE (DRUGS USED TO LOWER CHOLESTEROL). PLEASE TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY OTHER MEDICINES, INCLUDING MEDICINES OBTAINED WITHOUT A PRESCRIPTION. 3. HOW TO TAKE DICLORON FOLLOW YOUR DOCTOR'S INSTRUCTIONS STRICTLY. DO NOT EXCEED THE RECOMMENDED DOSE AND DURATION OF TREATMENT. INSTRUCTIONS FOR CORRECT USE AND DOSE/FREQUENCY OF ADMINISTRATION: DO NOT EXCEED THE RECOMMENDED DOSE. IT IS IMPORTANT TO USE THE LOWEST DOSE THAT CONTROLS YOUR PAIN AND NOT TO USE DICLORON LONGER THAN NECESSARY. YOUR DOCTOR WILL TELL YOU HOW MANY DICLORON INJECTIONS TO TAKE. YOUR DOCTOR MAY RECOMMEND A HIGHER OR LOWER DOSE DEPENDING ON YOUR RESPONSE TO TREATMENT. IN ADULTS IN ADULTS, 1 AMPULE PER DAY, FOR A MAXIMUM OF 2 DAYS, IN SOME CASES, 2 AMPULES PER DAY MAY BE TAKEN. IF NECESSARY, TREATMENT MAY BE CONTINUED WITH DICLORON TABLETS OR SUPPOSITORIES. ROUTE AND METHOD OF ADMINISTRATION THE SOLUTION IS TRANSFERRED FROM THE AMPULE TO A SYRINGE AND ADMINISTERED DEEP INTO THE GLUTEAL MUSCLE. DIFFERENT AGE GROUPS USE IN CHILDREN DICLORON IS NOT USED IN CHILDREN AND ADOLESCENTS (UNDER 18 YEARS OF AGE). USE IN THE ELDERLY ELDERLY PATIENTS MAY BE MORE SENSITIVE TO THE EFFECTS OF DICLORON THAN OTHER ADULTS. THEREFORE, ELDERLY PATIENTS SHOULD FOLLOW THEIR DOCTOR'S INSTRUCTIONS PARTICULARLY CAREFULLY AND USE THE SMALLEST NUMBER OF TABLETS THAT PROVIDES SYMPTOM RELIEF. IT IS PARTICULARLY IMPORTANT FOR ELDERLY PATIENTS TO REPORT ANY UNDESIRABLE EFFECTS TO THEIR DOCTOR IMMEDIATELY. RENAL IMPAIRMENT DICLORON SHOULD NOT BE USED IN PATIENTS WITH RENAL IMPAIRMENT. NO SPECIFIC STUDIES HAVE BEEN CONDUCTED IN PATIENTS WITH RENAL IMPAIRMENT; THEREFORE, SPECIFIC DOSAGE ADJUSTMENT RECOMMENDATIONS CANNOT BE PROVIDED. IF YOU HAVE MILD TO MODERATE RENAL IMPAIRMENT, YOUR DOCTOR WILL RECOMMEND USING DICLORON WITH CAUTION. PLEASE CONSULT YOUR DOCTOR. HEPATIC IMPAIRMENT DICLORON SHOULD NOT BE USED IN PATIENTS WITH HEPATIC IMPAIRMENT. NO SPECIFIC STUDIES HAVE BEEN CONDUCTED IN PATIENTS WITH HEPATIC IMPAIRMENT; THEREFORE, SPECIFIC DOSAGE ADJUSTMENT RECOMMENDATIONS CANNOT BE PROVIDED. IF YOU HAVE MILD TO MODERATE HEPATIC IMPAIRMENT, YOUR DOCTOR WILL RECOMMEND USING DICLORON WITH CAUTION. PLEASE CONSULT YOUR DOCTOR. IF YOU THINK THE EFFECT OF DICLORON IS TOO STRONG OR TOO WEAK, CONSULT YOUR DOCTOR OR PHARMACIST. IF YOU TAKE MORE DICLORON THAN YOU SHOULD IF YOU TAKE MORE DICLORON THAN YOU SHOULD, CONTACT YOUR DOCTOR OR PHARMACIST IMMEDIATELY OR GO TO THE NEAREST HOSPITAL EMERGENCY DEPARTMENT. YOU MAY NEED MEDICAL ATTENTION. IF YOU HAVE TAKEN AN OVERDOSE OF DICLORON, CONSULT YOUR DOCTOR OR PHARMACIST. IF YOU FORGET TO TAKE DICLORON DO NOT TAKE A DOUBLE DOSE TO MAKE UP FOR A MISSED DOSE. IF YOU FORGET TO TAKE A DOSE, TAKE IT AS SOON AS YOU REMEMBER. 4. POSSIBLE SIDE EFFECTS LIKE ALL MEDICINES, DICLORON MAY CAUSE SIDE EFFECTS IN PATIENTS WHO ARE HYPERSENSITIVE TO ITS INGREDIENTS. SOME SIDE EFFECTS MAY BE SERIOUS THESE COMMON SIDE EFFECTS MAY OCCUR IN 1 TO 10 OUT OF 1000 PATIENTS, ESPECIALLY WHEN A HIGH DAILY DOSE (150 MG) IS USED FOR A PROLONGED PERIOD. · SUDDEN AND SEVERE CHEST PAIN (SIGN OF MYOCARDIAL INFARCTION OR HEART ATTACK) · SHORTNESS OF BREATH, DIFFICULTY BREATHING WHEN LYING DOWN, SWELLING OF THE ANKLES AND FEET (SIGNS OF HEART FAILURE) · STOMACH PAIN, INDIGESTION, HEARTBURN, FLATULENCE, NAUSEA, VOMITING · ANY SIGN OF BLEEDING FROM THE STOMACH OR INTESTINES (BLOOD IN VOMITUS, BLACK OR TAR-LIKE STOOLS) · ALLERGIC REACTIONS, WHICH MAY INCLUDE SKIN RASH, ITCHING, BRUISES, PAINFUL RED AREAS, SKIN PEELING OR BLISTER FORMATION · SWELLING OF THE FACE, LIPS, HANDS OR FINGERS · YELLOWING OF THE SKIN OR THE WHITES OF THE EYES · PERSISTENT SORE THROAT OR HIGH FEVER · SUDDEN CHANGE IN THE AMOUNT OR CHARACTERISTICS OF URINE FREQUENT SIDE EFFECTS (MAY AFFECT UP TO 10 OUT OF 100 PATIENTS) · HEADACHE · DIZZINESS · VERTIGO (DIZZINESS CAUSED BY IMBALANCE) · NAUSEA · VOMITING · DIARRHEA · INDIGESTION (SIGN OF DYSPEPSIA) · ABDOMINAL PAIN · FLATULENCE · LOSS OF APPETITE · PATHOLOGICAL RESULTS OF LIVER FUNCTION TESTS (E.G., INCREASED TRANSAMINASE LEVELS) · SKIN RASH · REACTION, PAIN AND HARDENING AT THE INJECTION SITE · IRRITATION AT THE SITE OF USE · STOMACH PAIN INFREQUENT SIDE EFFECTS (MAY AFFECT 1 TO 10 OUT OF 10,000 PATIENTS) · SPONTANEOUS BLEEDING OR BRUISING (SIGNS OF THROMBOCYTOPENIA, REDUCED NUMBER OF PLATELETS IN THE BLOOD THAT STOP BLEEDING) · HIGH FEVER, FREQUENT INFECTIONS, PERSISTENT SORE THROAT (SIGNS OF AGRANULOCYTOSIS, REDUCED NUMBER OF CERTAIN CELLS INVOLVED IN PROTECTING THE BODY FROM INFECTIONS) · DIFFICULTY BREATHING AND SWALLOWING, SKIN RASH, ITCHING, HIVES, DIZZINESS (HYPERSENSITIVITY, ANAPHYLACTIC AND ANAPHYLACTOID REACTIONS) · SUDDEN DIFFICULTY BREATHING AND FEELING OF CHEST TIGHTNESS WITH WHEEZING OR COUGHING (SIGNS OF ASTHMA OR A TYPE OF LUNG INFLAMMATION, PNEUMONITIS, IF FEVER IS PRESENT). · SUDDEN AND SEVERE HEADACHE, NAUSEA, DIZZINESS, NUMBNESS, INABILITY OR DIFFICULTY SPEAKING, WEAKNESS OR PARALYSIS (SIGN OF STROKE) ON THE LIPS AND FACE (SIGNS OF CEREBRAL ATTACK, SEIZURES) · STIFF NECK, FEVER, NAUSEA, VOMITING, HEADACHE (SIGN OF ASEPTIC MENINGITIS, INFLAMMATION OF THE MEMBRANES COVERING THE BRAIN) · BLOODY VOMITUS (SIGN OF HEMATEMESIS) AND/OR BLACK OR BLOODY STOOLS (SIGNS OF GASTROINTESTINAL BLEEDING) · BLOODY DIARRHEA (SIGNS OF BLOODY DIARRHEA) · BLACK STOOLS (SIGNS OF MELENA, INTESTINAL BLEEDING) · STOMACH PAIN, NAUSEA (SIGNS OF GASTROINTESTINAL ULCER) · YELLOWING OF THE SKIN OR EYES (SIGN OF JAUNDICE), NAUSEA, LOSS OF APPETITE, DARK URINE (SIGN OF LIVER INFLAMMATION/LIVER FAILURE) · DROWSINESS (SIGN OF DROWSINESS) · STOMACH PAIN (SIGN OF GASTRITIS) · LIVER FAILURE · SKIN ITCHING (SIGN OF HIVES) · PUFFY SWELLING (SIGN OF SWELLING) · NECROSIS AT THE SITE OF ADMINISTRATION · PAIN IN THE LARGE INTESTINE (SOMETIMES WITH BLEEDING AND DISCHARGE) VERY RARE SIDE EFFECTS (MAY AFFECT LESS THAN 1 IN 10,000 PATIENTS) · MAINLY SWELLING OF THE FACE AND THROAT (SIGNS OF ANGIOEDEMA) · SEIZURES (SIGNS OF CONVULSIONS) · HEADACHE, DIZZINESS (SIGNS OF HYPERTENSION) · SKIN RASH, PURPLE-RED SPOTS, FEVER, ITCHING (SIGNS OF VASCULITIS [INFLAMMATION OF BLOOD VESSELS]) · DIARRHEA, STOMACH PAIN, FEVER, NAUSEA, VOMITING (SIGNS OF COLITIS, INCLUDING HEMORRHAGIC COLITIS [INFLAMMATION OF THE LARGE INTESTINE] AND EXACERBATION OF ULCERATIVE COLITIS OR CROHN'S DISEASE) · SEVERE PAIN IN THE UPPER ABDOMEN (SIGNS OF PANCREATITIS) · FLU-LIKE SYMPTOMS, FEELING OF FATIGUE, MUSCLE PAIN, INCREASED LEVELS OF LIVER ENZYMES IN BLOOD TESTS (SIGNS OF LIVER DISORDERS, INCLUDING FULMINANT HEPATITIS, LIVER NECROSIS, LIVER FAILURE) · BLISTER FORMATION ON THE SKIN (SIGNS OF BULLOUS DERMATITIS) · REDNESS OR PURPLE DISCOLORATION OF THE SKIN (POSSIBLE SIGNS OF BLOOD VESSEL INFLAMMATION), SKIN RASH WITH BLISTERS, BLISTER FORMATION ON THE LIPS, EYES AND MOUTH, SKIN INFLAMMATION WITH PEELING (SIGNS OF ERYTHEMA MULTIFORME OR STEVENS-JOHNSON SYNDROME, IF FEVER IS PRESENT (INFLAMMATION CHARACTERIZED BY SWELLING, REDNESS AND ACCUMULATION OF BLOOD IN THE SKIN AND AROUND THE EYES) OR TOXIC EPIDERMAL NECROLYSIS (A SERIOUS ILLNESS WITH BLISTER FORMATION)) · SKIN RASH WITH SKIN PEELING (SIGNS OF EXFOLIATIVE DERMATITIS) · INCREASED SKIN SENSITIVITY TO SUNLIGHT (SIGNS OF PHOTOSENSITIVITY) · PURPLE SPOTS ON THE SKIN (SIGNS OF PURPURA OR HENOCH-SCHÖNLEIN PURPURA, IF CAUSED BY ALLERGY) · SWELLING, FEELING OF WEAKNESS OR URINATION DISTURBANCES (SIGNS OF ACUTE RENAL FAILURE) · EXCESSIVE AMOUNT OF PROTEIN IN URINE (SIGNS OF PROTEINURIA) · SWELLING OF THE FACE OR STOMACH, HIGH BLOOD PRESSURE (SIGNS OF NEPHROTIC SYNDROME) · INCREASED OR DECREASED AMOUNT OF URINE, DROWSINESS, CONFUSION, NAUSEA (SIGNS OF TUBULOINTERSTITIAL NEPHRITIS) · SIGNIFICANTLY REDUCED AMOUNT OF URINE (SIGN OF RENAL PAPILLARY NECROSIS) · REDUCED NUMBER OF RED BLOOD CELLS (SIGN OF ANEMIA) · LOW LEVEL OF WHITE BLOOD CELLS (SIGN OF LEUKOPENIA) · DISTURBANCE OF PERCEPTION OF TIME, PLACE AND DIRECTION (DISORIENTATION) · DEPRESSION · DIFFICULTY SLEEPING (SIGN OF INSOMNIA) · NIGHTMARES · INCREASED SENSITIVITY TO IRRITANTS · DISTURBING THOUGHTS OR MOOD (SIGN OF PSYCHOTIC DISORDER) · TINGLING OR NUMBNESS IN HANDS OR FEET (SIGN OF PARESTHESIA) · MEMORY IMPAIRMENT (SIGN OF MEMORY DISORDER) · ANXIETY · TREMORS · TASTE DISTURBANCES (SIGNS OF DYSGEUSIA) · DIFFICULTY HEARING (SIGN OF HEARING IMPAIRMENT) · VISUAL DISTURBANCES (SIGNS OF VISUAL DISTURBANCE, BLURRED VISION, DOUBLE VISION) · TINNITUS · CONSTIPATION, MOUTH SORES (SIGN OF STOMATITIS [INFLAMMATION OF THE INSIDE OF THE MOUTH]) · SWOLLEN, RED AND PAINFUL TONGUE (SIGN OF GLOSSITIS [INFLAMMATION OF THE TONGUE]) · ESOPHAGEAL DISORDERS · PAIN IN THE UPPER ABDOMEN, ESPECIALLY AFTER EATING (SIGNS OF INTESTINAL DIAPHRAGM DISEASE) · PALPITATIONS · CHEST PAIN · ITCHY, RED, BURNING SKIN RASH (SIGNS OF ECZEMA) · SKIN REDNESS (ERYTHEMA) · HAIR LOSS (ALOPECIA) · ITCHING (PRURITUS) · BLOOD IN URINE (HEMATURIA) · PUS AT THE INJECTION SITE (ABSCESS). INFORM YOUR DOCTOR IF YOU NOTICE ANY OF THESE SIDE EFFECTS. IF YOU ARE TAKING DICLORON FOR MORE THAN A FEW WEEKS, YOU MUST SEE YOUR DOCTOR FOR REGULAR CHECK-UPS TO ENSURE YOU DO NOT HAVE ANY UNDETECTED UNDESIRABLE EFFECTS. IF YOU NOTICE ANY SIDE EFFECTS NOT LISTED IN THIS LEAFLET, PLEASE INFORM YOUR DOCTOR OR PHARMACIST. REPORTING SIDE EFFECTS IF YOU EXPERIENCE ANY SIDE EFFECTS, WHETHER OR NOT LISTED IN THE PATIENT INFORMATION LEAFLET, PLEASE CONSULT YOUR DOCTOR, PHARMACIST OR NURSE. BY REPORTING ANY SIDE EFFECTS, YOU WILL HELP PROVIDE MORE INFORMATION ABOUT THE SAFETY OF THE MEDICINE YOU ARE USING. 5. HOW TO STORE DICLORON STORE DICLORON OUT OF THE REACH AND SIGHT OF CHILDREN, IN ITS ORIGINAL PACKAGING. STORE BELOW 25°C AT ROOM TEMPERATURE. PROTECT FROM LIGHT. USE ACCORDING TO THE EXPIRY DATE. DO NOT USE DICLORON AFTER THE EXPIRY DATE INDICATED ON THE PACKAGING. DO NOT DISPOSE OF MEDICINES DOWN THE DRAIN OR IN HOUSEHOLD WASTE. ASK YOUR PHARMACIST HOW TO DISPOSE OF UNUSED MEDICINES. THESE MEASURES WILL HELP PROTECT THE ENVIRONMENT. DISPENSING CATEGORY: PHARMACEUTICAL PRODUCT GROUP III, AVAILABLE WITHOUT PRESCRIPTION. SEE ALSO: DICLORON - DIKLORON 75MG/3ML 3ML 4 AMPULES