DICLAC. 75 mg. Ml 3. 5 ampules
The solution was injected intramuscularly or after dilution is administered intravenously in an infusion system.
DICLAC. 75 mg. / Ml 3. 5 ampules
DICLAC WHAT IS AND WHAT IT IS USED
Diclac is a medicine that relieves pain and suppresses inflammatory ( NSAID / analgesic - NSAIDs).
The solution was injected intramuscularly or after dilution is administered intravenously in an infusion system .
Diclac , intramuscular , is used for the treatment of :
Pain in rheumatic joints crisis ( arthritis ) , back pain syndrome, " frozen shoulder ", " tennis elbow " , and other painful conditions in the bones and joints ;
attacks of gout ;
acute pain gallstones or kidney ;
pain and swelling after surgery and trauma ;
severe migraine attacks .
Intravenous infusions are used to treat or prevent pain after surgery and are applied in a hospital setting.
2 . WHAT YOU SHOULD KNOW BEFORE YOU USE DICLAC
Do not use Diklak
if you are allergic to the active ingredient diclofenac sodium metabisulphite or to any of the other ingredients of this medicine (listed in Section 6) ;
if you have previously reacted with an asthma attack , swelling of the nasal mucosa or skin reactions after taking aspirin or other NSAIDs ;
if you have a stomach ulcer or duodenum ;
if you have a history of gastrointestinal bleeding ( blood in the stool , black stools) ;
if you have severe liver or kidney problems ;
if you have severe heart failure ;
If you are in the last three months of pregnancy.
Diklak not suitable for children and adolescents under 18 years.
Warnings and Precautions
If you are taking anti-inflammatory or pain medicines, including aspirin , corticosteroids, anticoagulants, or some antidepressants ( selective serotonin re-uptake of serotonin ) ;
If you suffer from asthma, seasonal allergic rhinitis , swelling of the lining of the nose ( polyps ), chronic obstructive pulmonary disease or chronic respiratory infections , reactions to NSAIDs (ie . Intolerance to pain medication ) , resulting in deterioration of asthma swelling of the throat and facial parts or urticaria are more frequent ;
If you have or have ever had gastrointestinal problems such as stomach ulcer , bleeding or black stools , stomach discomfort or heartburn after taking NSAIDs should report any unusual signs in the abdomen (especially bleeding ) to your doctor and stop taking of Diklak ;
If you have inflammatory bowel disease (ulcerative colitis ) or the small intestine (Crohn's disease ) ;
If you have or have had heart problems or high blood pressure;
If you have kidney or liver disease ;
If you are dehydrated (from disease , diarrhea, before or after surgery ) ;
If you have swollen feet ;
If you have an increased tendency to bleed or other blood disease , including rare liver disease called porphyria .
In any non-steroidal anti-inflammatory drugs (NSAIDs ) , including Diklak may arise gastrointestinal bleeding , ulceration or perforation, at any time during treatment with or without warning symptoms or serious gastrointestinal events in the past. In case of bleeding or ulceration application of Diklak should be discontinued .
Very rarely in association with NSAID therapy , severe cutaneous hypersensitivity reactions. At the first sign of a skin rash or other hypersensitivity reactions Diklak treatment should be discontinued .
Diklak can suppress symptoms of infection ( fever) , make it hard to find and difficult to treat it
Drugs such as diclofenac may be associated with a slightly increased risk of heart attack ( myocardial infarction ), or stroke . Any risk is more likely with high doses and prolonged treatment. Do not exceed the recommended dose and duration of treatment.
If you have heart problems, previous stroke or think that you might be at risk of these conditions (for example if you have high blood pressure, diabetes or high cholesterol or are a smoker) you should discuss treatment with your doctor or pharmacist.
If you are elderly and taking other medicines or basic groups are underweight , it is recommended by your doctor to prescribe the lowest effective
Diklak not suitable for children and adolescents under the age of 18 years .
Other medicines and Diklak
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Lithium inhibitors or selective serotonin reuptake inhibitors ( drugs used for treating certain types of depression ) ;
Digoxin (used to treat heart disease ) ;
Diuretics (drugs that increase the amount of urine and is often used to treat high blood pressure) ;
ACE inhibitors and beta -blockers ( used to treat high blood pressure and heart failure ) ;
Other anti-inflammatory drugs such as aspirin , ibuprofen, and the like . ;
Corticosteroids ( anti-inflammatory drugs ) ;
Medicines that inhibit blood clotting and blood clots ;
Drugs for the treatment of diabetes (except insulin ) ;
Methotrexate (used to treat certain types of cancer or arthritis ) ;
Ciclosporin ( a medicine used in patients undergoing transplantation) ;
Some antibacterial agents ( quinolone ) used to treat infections ;
Medications for gout ( sulphinpyrazone ) ;
Medicines for fungal infections ( voriconazole ) ;
Medicines to treat epilepsy ( phenytoin) ;
Colestipol and cholestyramine or medicinal products containing them ( for lowering cholesterol in the blood) ;
Drugs that can increase levels of potassium in your blood. These include potassium -sparing diuretic ( increasing urine flow ) , cyclosporine , tacrolimus (medicines that suppress the immune system) and trimethoprim (used to treat infections) . It is frequent monitoring of blood levels of potassium in your blood.
Fertility, pregnancy and lactation
Women of childbearing potential
There is no evidence to suggest recommendations for women of childbearing age.
If pregnancy is detected during use of Diklak , you should immediately inform your doctor. In the first and second trimester of pregnancy Diklak should be used only after consultation with the doctor and the dose should be as low and duration of use as short as possible , as it is considered that the possible risk to the fetus increases with dose and duration of the application . The product should not be administered during the last trimester of pregnancy due to increased risk of complications for mother and child at birth .
The active ingredient diclofenac passes into breast milk in small amounts. Therefore, diclofenac should not be taken during breast-feeding in order to avoid adverse effects on the infant.
Diklak can complicate pregnancy and is therefore not recommended in women attempting to conceive. In women with pregnancy and those who conduct research for infertility should consider discontinuation of treatment with diclofenac .
3 . HOW TO USE DICLAC
Always use Diklak exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
Diklak injection is given deep in the gluteal muscle .
The solution was diluted with physiological saline or a glucose solution and slowly infused into the vein .
Your doctor will determine the dosage and duration of treatment. It is important to take the lowest effective dose for the shortest period of time. In most adults Diklak injections administered over two days. If necessary, the treatment is continued with the tablets or suppositories.
Please consult your doctor or pharmacist if you think the effect of Diklak is too strong or too weak .
If you use more than the amount Diklak
Overdose no typical clinical picture. May occur following overdose symptoms : disorders of the central nervous system such as headache, dizziness , tinnitus , drowsiness and unconsciousness as well as convulsions and abdominal pain, nausea and vomiting, diarrhea. Possible bleeding in the gastrointestinal tract , as well as disorders in the function of liver and kidneys.
There is no known specific antidote.
In suspected overdose Diklak injection , tell your doctor. He / she will decide what measures are necessary depending on the severity of intoxication .
If you forget to use Diklak
Do not take a double dose to make up for a missed dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them .
If you notice any of the following side effects please consult your doctor. He / she will take the next step .
Assessment of adverse reactions is based on their frequency :
Very common: occurring in more than 1 in 10 treated patients ;
Common: fewer than 1 in 10 , but more than 1 in 100 patients treated ;
Uncommon : at less than 1 in 100 , but more than 1 1, 000 -treated patients ;
Rare: with less than 1 1, 000, but more than 1 in 10 000 patients treated ;
Very rare in less than 1 in 10, 000 ;
Not known from the available data can not be estimated .
Side effects depend mainly on the dose and are different for each individual.
Indicated below side effects include those that have been reported as following brief and after prolonged treatment with diclofenac in various formulations . Serious side effects are:
unusual bleeding or injury ;
fever or sore throat constantly ;
allergic with swelling of the face, lips , mouth, tongue or throat , often accompanied by itching and rash , which leads to difficulty swallowing , hypotension and seizure ; wheezing in the chest or shortness of breath (symptoms of asthma) ;
chest pain (symptoms of heart attack) ;
sudden and severe headache , nausea, dizziness , numbness , difficulty or inability to speak , paralysis ( signs of stroke) ;
stiffness of the neck (symptoms of viral meningitis ) ;
high blood pressure ;
red or purple skin (possible signs of inflammation of blood vessels) , skin rash with blisters on lips, eyes and mouth , skin inflammation with blisters and peeling;
severe stomach pain bloody or black stools ; vomiting of blood;
yellowing of the skin or eyes ( signs of hepatitis) ;
blood in the urine , excess protein in the urine, severe reduction in the amount of urine ( signs of kidney disorders) .
Drugs such as diclofenac may be associated with a small increased risk of heart attack ( myocardial infarction ) or stroke.
Other common side effects:
Headache, dizziness, vertigo , nausea, vomiting , diarrhea, indigestion , abdominal pain , flatulence, loss of appetite , changes in liver function (the values of certain enzymes are elevated ), skin rash, injection site such as pain, swelling and hardening .
Other rare side effects:
Hypersensitivity, drowsiness , trouble breathing (asthma ) , abdominal pain, gastritis, gastrointestinal tract, bloody vomiting , bloody diarrhea, stomach or intestinal ulcers , hepatitis , jaundice, liver disorders , hives, swelling of the hands and feet (edema ) , necrosis at the injection site .
Other rare side effects:
Reducing the number of platelets , reducing the number of white blood cells , anemia , swelling of the soft tissues of the face , disorientation , depression, difficulty sleeping , nightmares , irritability, mental disorders , numbness , memory impairment , seizures , anxiety , tremor , meningitis, taste disturbances, cerebrovascular accident , vision or hearing disorders , double vision , tinnitus , colitis, including exacerbation of ulcerative colitis and Crohn's disease , constipation, inflammation of the mouth , including the occurrence of ulcers , inflammation the vocal cords , esophagus ulcer , pancreatitis, heart rhythm disorders , chest pain , heart failure, heart attack , high blood pressure , inflammation of the blood vessels , hair loss, redness, dark red - purple rash , swelling of the skin ( due to increased sensitivity to the sun ) , severe rash with blisters , eczema, dermatitis , pruritus syndrome, Stevens-Johnson, toxic epidermal necrolysis ( syndrome Lyell), fast flowing hepatitis , liver failure and other serious liver problems, acute kidney failure, blood urine, protein in the urine , nephrotic syndrome, tubulointerstitial nephritis, renal papillary necrosis.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor or pharmacist.
5 . HOW TO STORE DICLAC
Keep out of reach of days.
Do not store above 25 ° C. Protect from light.
Diklak not use after the expiry date stated on the pack . The expiry date refers to the last day of that month.
6 . CONTENTS OF PACKAGE AND ADDITIONAL INFORMATION
What does Diklak
The active agent is diclofenac sodium. One ampoule of 3 ml of solution for injection contains 75 mg of diclofenac sodium and 120 mg of benzyl alcohol .
Other ingredients are : N- acetylcysteine , benzyl alcohol , mannitol , propylene glycol , sodium hydroxide, water for injections.
Diklak looks like and contents of pack
Injection ( clear, colorless to yellowish solution). Containing 1 or 5 with 3 ml vials for injection.