NAKLOFEN. 75 mg. 3 ml. 5 ampules
NAKLOFEN. 75 mg. 3 ml. 5 ampules
WHAT NAKLOFEN INJECTION AND WHAT IT IS USED FOR ?
Ingredients: 3 ml solution for injection ( 1 ampoule ) contains 75 mg diclofenac sodium (diclofenac sodium).
Packaging: Cardboard box with 5 vials of 3 ml solution for injection What Naklofen injection ?
Naklofen is a non-steroidal anti-inflammatory drug with anti-inflammatory, analgesic and temperature decreasing effect. The main mechanism of action is inhibition of prostaglandin synthesis . It is used to treat all forms of rheumatic joint diseases and for the relief of various aches . The injection is usually used for short-term treatment of acute conditions .
What is it used Naklofen injection ?
Physicians prescribe the medicinal product for the treatment of diseases which require anti-inflammatory and / or analgesic effects : Treatment :
• Step of inflammatory and degenerative forms of joint diseases , rheumatoid arthritis , juvenile chronic arthritis , ankylosing spondylitis , osteoarthritis and spondilatroza , pain syndromes of the spine, non-arthritic rheumatism
• painful and inflammatory conditions in gynecology (primary dysmenorrhea
• Renal and biliary colic
• Postgravmatichna and postoperative pain
• Severe migraine attacks
2 . BEFORE YOU TAKE NAKLOFEN INJECTION
Do not use Naklofen
• if you are allergic (hypersensitive) to diclofenac or to any of the excipients of the medicinal product to salicylates and other nonsteroidal anti-inflammatory drugs ;
• if after use of nonsteroidal anti-inflammatory drugs or aspirin are given breathing problems ( asthma ) , rash ( urticaria), inflammation of the lining of the nose ( allergic rhinitis) or hypersensitivity reactions with sudden swelling of lips and face , neck, it is also the arms and legs, or in case of choking and hoarseness (angioedema) ;
• if you have or have had gastric or duodenal ulcers , gastrointestinal bleeding ;
• if you have stomach or intestinal problems after taking other NSAIDs ;
• if you have severe heart , liver or kidney failure.
• if you are pregnant in the last trimester of pregnancy :
Naklofen injection is not suitable for use in children and adolescents under 18 years of age.
Pay attention to Naklofen
• if you suffer from gastrointestinal disorders , or a history of these conditions should be carefully monitored by a doctor ;
• if you have severe renal or hepatic impairment or are elderly ;
• If you are being treated for epilepsy or if you have it , otherwise very rare, can occur in violation metabolism of blood pigments ( porphyria ) ;
• if you have impaired blood clotting , or if you are taking medicines to prevent blood clotting (anticoagulants ) or medicines that dissolve existing blood clots ( fibrinolytics ) ;
• if you have heart problems, including heart failure, angina (chest pain ) or have had a heart attack , bypass surgery , peripheral arterial disease (poor circulation in the legs or feet due to narrowing or blockage of the arteries) , or any type of stroke ( including "mini - stroke or transient ischemic attack) , you should discuss this with your doctor before taking Naklofen .
• if you have high blood pressure, diabetes , high cholesterol, family history of heart disease or stroke, or if you are a smoker ;
• If you have asthma, allergic rhinitis , swelling of the nasal mucosa , chronic obstructive pulmonary disease or chronic respiratory tract infections , you should discuss this with your doctor before taking Naklofen .
• if you have had serious skin reactions;
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines , even those available without a prescription. Due to interactions with other drugs , the effect of these drugs Naklofen can be increased or decreased . This can occur with some medications that are used for:
• treatment of mental health problems ( lithium) ;
• treat heart problems ( digoxin ) ;
• medicines to increase urine flow ( diuretics)
• painkillers ( aspirin or other nonsteroidal anti-inflammatory drugs )
• medicines to prevent blood clotting (warfarin ) ;
• depression ( drugs known as SSRIs)
• drugs for the treatment of diabetes ,
• immunosuppression ( cyclosporin )
• the treatment of malignancies ( methotrexate)
• treatment of infections ( quinolone antibiotics )
• treat seizures ( phenytoin )
• the treatment of high blood pressure (ACE inhibitors, beta - blockers) ,
• treatment of inflammation (corticosteroids )
• lowering cholesterol ( colestipol / cholestyramine )
• gout ( sulfinpyrazone ) and for the treatment of fungal infections ( voriconazole ) .
Pregnancy, lactation and fertility
Ask your doctor or pharmacist before taking any medicine. Naklofen not recommended for use during pregnancy. The doctor will decide if the benefit to the pregnant woman outweigh the risk to the child. So, you should take the drug during pregnancy only on the advice of your doctor. You should not take the drug in the last trimester of pregnancy. Breastfeeding is not recommended during treatment with Naklofen
Effects on ability to drive and use machines Naklofen has minor or moderate influence on the ability to drive and use machines. If you feel dizzy , tired or drowsy , do not drive or operate dangerous machinery
Special warnings about some of the ingredients
Should not be given to premature newborns. May cause toxic and allergic reactions in infants and children under 3 years of age.
Metabisulfatite can rarely cause severe hypersensitivity reactions and bronchospasm . This medicinal product contains less than 1 mmol ( 23 mg) of sodium per dose , which practically means that it is ' free ' of sodium.
3 . HOW TO TAKE NAKLOFEN INJECTION ?
Naklofen injection is to be administered deep intramuscular . The solution for injection is used to treat acute conditions . As soon as possible , treatment should be continued with tablets or suppositories.
Solution for injection ( 75 mg / 3 ml),
1 ampoule i.m. once or twice a day
Patients with renal colic may be placed after the second injection of 30-minute intervals .
Naklofen injection is not suitable for children .
Undesirable effects may be minimized by controlling the symptoms used the lowest effective dose for the shortest possible period of time ( see section 4.4). .
If you feel that the effect of Naklofen is too strong or too weak, talk to your doctor or pharmacist .
If you give more than Naklofen injection should
When treated with a solution for injection can be expected to an overdose . The physician will determine the size of the dose and duration of treatment. If there are signs of overdose or you suspect you have received a higher dose than you should , you should consult your doctor who will take the necessary measures to treat or reduce the dose.
If a dose is missed Naklofen injection
The doctor will decide the frequency of repeated injections . If you do not receive the injection scheme , inform your doctor as soon as possible .
If you stop using Naklofen
It can be dangerous to stop treatment without consulting your doctor. If you take diclofenac for short-term pain relief , you can stop taking it as soon as you do not need more than that. When your doctor prescribes it for long term use should be consulted before stopping treatment . If you have any further questions on the use of this product, ask your doctor or pharmacist.
4 . POSSIBLE SIDE EFFECTS
Like all medicines , Naklofen duo can cause side effects, although not everybody gets them
Adverse reactions are classified into the following groups in order of frequency :
Very common: They can affect more than 1 user in 10
Common: may affect 1 to 10 users in 100
Uncommon: may affect 1 to 10 users in 1000
Rare: may affect 1 to 10 users in 10,000
Very rare: can occur in less than 1 user in 10,000
Not known: frequency can not be predicted from the available data
Common: affects 1 to 10 users in 100): nausea , diarrhea, constipation , abdominal pain, dyspepsia, flatulence, headache, dizziness, increased activity of liver enzymes, rash, injection site , pain , irritation and induration ;
Rare ( affects 1 to 10 users in 10,000 ) : bleeding , ulcers, perforation , jaundice, liver function abnormalities ( asymptomatic hepatitis, acute hepatitis, chronic active hepatitis), violation of the normal flow of bile from the liver to the intestine ( cholestasis ) , drowsiness , fatigue , kidney failure , blood in the urine ( hematuria ) , hives ( urticaria), hypersensitivity reactions (bronchospasm , angioedema , anaphylactic shock) , fluid retention (edema), respiratory (asthma, dyspnoea) .
Very rare ( affects less than 1 in 10,000 ): changes in the number of blood cells (thrombocytopenia , leukopenia, agranulocytosis) , swelling of the face , disorientation , depression, sleep disorders (insomnia ) , nightmares , irritability, psychotic disorder violation of sensation (paraesthesia) , memory impairment , seizures, anxiety, tremor , aseptic meningitis, taste disturbances, cerebrovascular accident , visual disturbance , blurred vision , double vision ( diploliya ) , tinnitus , impaired hearing abnormalities pulse (palpitations ) , chest pain, heart failure , myocardial infarction, high blood pressure , inflammation of the blood vessels and the lung tissue , inflammatory bowel disease (non- hemorrhagic colitis , recurrence or exacerbation of ulcerative colitis or Crohn's disease) , constipation , stomatitis (including ulcerative stomatitis ), inflammation of the tongue ( glossitis ) ezofagiapno disorder, inflammation of the lining of the stomach, pancreas and intestinal strictures , hepatic disorders ( fulminant hepatitis, hepatic failure and necrosis) , urinary tract (interstitial nephritis , nephrotic syndrome, papillary necrosis , proteinuria , bullous reactions, including syndrome Stevens-Johnson ( severe rash that affects the skin , mouth, eyes and genital area ) and toxic epidermal necrolysis ( severe rash that affects large parts with blistering and peeling of the skin) , hair loss sensitivity to sunlight ( phototoxic reactions), red or purple discolorations on the skin ( purpura) , itching (pruritus ) , abscess at the injection site ;
Not known ( frequency can not be estimated from available data): confusion, hallucinations, general discomfort ( malaise ) .
Clinical trials and epidemiological data suggest that the use of diclofenac sodium, especially at high doses (150 mg daily) , and in long term treatment may be associated with a slightly increased risk of arterial thrombotic events (such as the risk of myocardial infarction or stroke) .
If you notice any side effects not listed in this leaflet , please tell your doctor
5 . HOW TO KEEP NAKLOFEN INJECTION ?
Keep out of reach of children
Do not use the medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Do not store above 25 ° C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required . These measures will help to protect the environment.
6 . ADDITIONAL INFORMATION
What does Naklofen ?
The active substance is diclofenac sodium (diclofenac sodium). Each ml of solution for injection contains 25 mg of diclofenac sodium. Each 3 ml solution for injection ( 1 vial ) containing 75 mg of diclofenac sodium.
Other ingredients are benzyl alcohol, propylene glycol ( E1520 ), sodium metabisulphite ( E223 ), sodium hydroxide ( E542 ), water for injections.
Naklofen looks like and contents of the pack ?
The solution for injection is a clear, colorless or slightly yellow liquid. It is available in boxes of 5 vials of 3 ml solution for injection.