SPAZMALGON 5 amp. 2ml
SPAZMALGON 5 amp. 2ml
SPAZMALGON WHAT IS AND WHAT IT IS USED
Spazmalgon combined product that eliminates spasms of smooth muscle in the gastrointestinal tract, biliary and urinary system , reproductive organs , and has a pronounced analgesic effect .
Spazmalgon applied briefly to influence accompanied by acute umerenosilna to colic pain of the gastrointestinal tract , biliary tract , renal colic, kidney stone disease, in painful menstruation ( dysmenorrhea ) .
2 . BEFORE USING SPAZMALGON
Should not apply Spazmalgon
• if you are allergic (hypersensitive ) to the active substances Spazmalgon ;
• if you are allergic ( hypersensitive) to pyrazolone derivatives or other non-steroidal anti-inflammatory drugs ;
• if you have severe liver and / or kidney disease ;
• if you have gastro- intestinal obstruction and megacolon ( an extension of the colon ) ;
• if you have acute hepatic porphyria (an inherited disease with abnormal formation of red blood cells ) or glucose -6- phosphate dehydrogenase deficiency (an inherited disease with deficiency of this enzyme ) ;
• if you have impaired bone marrow function (after cytostatic treatment) or hematologic (blood ) diseases such as aplastic anemia (a decrease in the number of blood cells , causing weakness , bruising or increased likelihood of infection ) , agranulocytosis ( strong reduction of the number of white blood cells , which increases the likelihood of infections) and leukopenia (reduction in the total number of leukocytes ) ;
• prostate adenoma ;
• and atony of the gall bladder ;
• if you have hypotension ( low blood pressure) or unstable blood circulation ;
• if you are pregnant or breastfeeding.
This medicinal product must not be used in children under 15 years of age.
Take special care with Spazmalgon
Before starting treatment with Spazmalgon tell your doctor if you have kidney or liver diseases associated with narrowing of the gastrointestinal
tract and difficulty passing the gastro- intestinal contents ( achalasia , pyloroduodenal stenosis ), gastroesophageal reflux disease , intestinal atony , paralytic ileus , glaucoma ( increased eye pressure), myasthenia gravis (muscle weakness) , heart disease (arrhythmias , ischemic heart disease, congestive heart failure).
When treated with Spazmalgon risk of developing severe hypersensitivity reactions , including . and anaphylactic reactions. At the first sign of hypersensitivity product introduction is terminated immediately and take urgent measures to address the situation (adrenaline , glucocorticoids, antihistamines ) .
The risk of possible severe hypersensitivity reactions to Metamizol is significantly increased in the following patient groups :
• patients with asthma analgesic syndrome ;
• patients with bronchial asthma , especially suffering from rhinosinusitis (inflammation of the nose and nasal cavity ) and nasal polyps ;
• patients with hypersensitivity to dyes (eg tartrazine ) or preservatives ( benzoates ) ;
• patients with alcohol intolerance . Such patients react to even small amounts of alcohol with symptoms such as sneezing , watery and flushing . Such alcohol intolerance may be a sign of undiagnosed syndrome analgesic asthma.
Upon treatment with drugs containing Metamizol , there is a risk of the occurrence of shock ( circulatory collapse ) and agranulocytosis ( strongly reduced number of white blood cells , which increases the likelihood of infection ) . It is independent of dose and can not be predicted.
Upon treatment with Spazmalgon of patients with diseases of the blood or those in the past to monitoring of the blood counts during treatment .
Spazmalgon injectable solution may cause a reduction in blood pressure.
The risk of such a reaction is increased also in :
• patients with low blood pressure or fluid loss , poor circulation or early circulatory collapse (eg in patients with heart attack or serious injury ), patients with fever . In such patients, intramuscular injection of Spazmalgon should be in the supine position of the patient and under constant control of blood pressure, heart rate and breathing.
Taking other medicines
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Adverse interactions may occur with concomitant administration of Spazmalgon following drugs : drugs that affect blood clotting such as warfarin and acenocoumarol , medicines used to treat psychosis ( chlorpromazine and other phenothiazine derivatives ), drugs that suppress the immune system (cyclosporine ) and chloramphenicol other drugs affecting the bone marrow medications le ¬ ing depression , sleeping pills , oral contraceptive products , medicines for gout ( allopurinol ), other pain relieving and anti-inflammatory drugs such as pyroxene - pics , aspirin , ibuprofen , indomethacin . Spazmalgon may be reacted with captopril (for the treatment of heart disease and high blood pressure), lithium ( used to treat mental disorders) , methotrexate (used to treat rheumatic diseases and tumor ) and triamterene (water ) , and to alter the effect of antihypertensive ( blood pressure lowering ) products and diuretics ( water pills ) .
Taking Spazmalgon with food and drink
During treatment with Spazmalgon not recommended alcohol consumption due to the potential increase in adverse effects of the drug.
Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine .
Spazmalgon not to be administered during pregnancy . In need of treatment during lactation breastfeeding should be discontinued .
Driving and using machines
Spazmalgon may cause dizziness , impaired vision and adversely affect alertness and impairment of response to unexpected situations and therefore should avoid driving or operating machines during treatment with it.
3 . HOW TO APPLY SPAZMALGON
Always use Spazmalgon exactly as your doctor tells you . If you are not sure, ask your doctor or pharmacist.
Spazmalgon injection administered intramuscularly. Applies only to short-term treatment ! Inject under medical supervision and readiness for emergency assistance because of a risk of anaphylactic shock in patients with hypersensitivity .
Adults and children over 15 years
For adults and children over 15 years of age ( > 53 kg ) usual dose is 2-5 ml intramuscularly once. The dose was repeated after 6-8 hours. The maximum daily dose should not exceed 6 ml injection solution ( eq. 3g metamizole sodium). Treatment duration 2-3 days.
After achieving a therapeutic effect can be switched to treatment with oral analgesics and antispasmodic agents .
Patients over the age of 65
Usually do not require dose reduction . In patients with age renal and hepatic function is necessary to reduce the dose. The dose will be determined physician.
Patients with impaired renal function
If you have kidney disease , the treatment was given 1 /4 of the adult dose , as the rate of excretion is reduced in these conditions.
Patients with impaired hepatic function
If you have impaired liver function , high doses should be avoided . In brief application is not to be decreased doses. Treatment duration 2-3 days. After achieving a therapeutic effect can be switched to treatment with oral analgesics and antispasmodic agents .
If you have any further questions on the use of this product, ask your doctor or pharmacist.
If you are given more than the amount Spazmalgon
If overdose is possible nausea , vomiting, menieropodobni phenomena , tinnitus , shock, acute renal and liver failure, seizures.
Treatment is symptomatic and is held in a medical facility .
If signs such as cold sweats , dizziness , nausea , discoloration of the skin and shortness of breath, seek medical attention immediately .
If omitted to apply the dose Spazmalgon
You should not apply a double dose to make up for a forgotten dose.
4 . POSSIBLE SIDE EFFECTS
Like all medicines, Spazmalgon can cause side effects, although not everybody gets them. Adverse reactions are classified according to the following frequency : very common (> 1/10 ), common (> 1/100 and <1 /10) , uncommon (21 /1, 000 and <1 /100) , rare (> 1 / 10, 000 and <1 /1, 000 ), very rare (<1 /10, 000 ), not known ( data can not be estimated ) .
The following side effects are mainly due metamizole , which is incorporated in the composition of the medicinal product.
Uncommon (affects less than 1 in 100 people ) Fixed drug exanthema ( round, plate-like , viola ¬ you to dark red bubbles ) . During or after use - lowering blood pressure which is not accompanied by other signs of hypersensitivity reactions , increased heart rate .
Rare (occurring in less than 1 per 1000 persons) Leukopenia (decrease the number of white blood cells , which increases the likelihood of infection) , maculopapular rash (formation of skin patches and lymph) , anaphylactic or anaphylactoid reactions especially after parenteral administration. Such reactions may occur during the injection or immediately after it , but they can occur hours later. Typically they occur mostly during the first hour after administration . Milder reactions occur with typical reactions of the skin and mucous membranes (such as itching, burning, redness , rashes , hives, swelling) , dyspnea and rarely gastrointestinal complaints . Such milder reactions can go in more severe forms of generalized urticaria , severe angioedema (including laryngeal ), severe bronchospasm, heart-rhythm disorders , low blood pressure (sometimes with a preceding increase in blood pressure), kidney damage , and appearance of protein in the urine , decreased or increased amount of urine , inflammation of the kidney.
Very rare (occurring in less than 1 out of 10 000 people )
Agranulocytosis (severe reduction in the number of white blood cells , which increases the likelihood of infection ¬ tions ) . Agranulocytosis may occur in patients who Metamizol is applied in the past with no adverse effects . The risk of agranulocytosis increases with prolonged use (over 1 week) of Metamizol .
Characteristic signs of agranulocytosis include sore ¬ tional changes in the skin and mucous membranes of the mouth , throat, genitals , sore throat and fever. A sudden deterioration in the general condition , if the fever does not belong or reappears , the occurrence of painful changes in the mucous membranes and skin , stop the Annex of Spazmalgon and consult your doctor. Very rarely is also observed thrombocytopenia (reduced platelet count , which increases the risk of bleeding or bruising) , hemolytic anemia (decreased red blood cells, which can lead to pallor or yellowing of the skin , weakness or dyspnea) , aplastic anemia (severe reduction in the number of blood cells , causing weakness , bruising or increased likelihood of infection ) . In patients with anal ¬ getic asthma , hypersensitivity reactions usually occur in the form of asthma syndrome Stivens-Johnson or Lyell ( severe reaction accompanied by education ¬ ings blistering of the skin , mouth , eyes and genitals) .
Not known: dry mouth, nausea , vomiting , abdominal pain and discomfort, constipation , exacerbation of gastritis and gastric ulcer disease , in rare cases, ulceration and bleeding , dizziness, headache, visual disturbance, accommodation disorders , difficulty urinating.
During treatment with Spazmalgon your urine may be colored red.
Following termination of the treatment the color will be normalized .
For parenteral administration may occur pain at the injection site and local reactions rarely even phlebitis .
When events occur, the data on renal and hematopoietic function , the application of Spazmalgon be suspended .
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor.
5 . HOW TO STORE SPAZMALGON
Store in the original package to protect from light.
Do not store above 25 ° C. Do not freeze !
Keep out of reach of children.
Spazmalgon not use after the expiry date stated on the carton. The expiry date refers to the last day of that month.
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 Spazmalgon
• The active substances are:
metamizole sodium, 1000 mg, pitofenon hydrochloride 4 mg , fenpiverin bromide 0.04 mg in 2 ml of solution for injection , metamizole sodium, 2500 mg, pitofenon hydrochloride 10 mg fenpiverin bromide 0.1 mg in 5 ml of solution for injection .
• The other ingredients are water for injections.
Spazmalgon looks like and contents of pack
Clear, pale yellow , transparent liquid in brown glass ampoules mark opening - colored dot / ring.
Ampoules of 2 ml
5 ampoules in blister PVC film 1 blister in a carton with leaflet.
10 ampoules in blister PVC foil , 1 or 10 blisters per carton (10 or 100 ampoules per box ), along with a leaflet .
Ampoules of 5 ml
5 ampoules in blister PVC film 1 blister in a carton with leaflet.
10 ampoules in blister PVC film 1 or 5 blisters in a cardboard box (10 or 50 ampoules per box ), along with a leaflet .