HEXALGIN 500 mg. / Ml. 20 ml
Medicinal product belonging to the group of pyrazolones, which applies to pain and fever.
HEXALGIN apply to:
acute and severe pain after an injury or surgery;
colic (spasmodic abdominal pain);
other severe acute or chronic pain are contraindicated if other therapeutic measures;
high temperature, which is not affected by other treatments.
2. BEFORE YOU TAKE HEXALGIN
Do not take HEXALGIN:
are allergic (hypersensitivity) to the active ingredient metamizole, other pyrazolones (e. phenazone, propyphenazone) or pyrazolidine (eg. phenylbutazone, oxyphenbutazone) (this also includes such reactions. agranulocytosis after use of these compounds), and any of the other components;
if you have a known intolerance protivobolkovi products (analgesic asthma or analgesic intolerance type urticaria - angioedema). In these cases, react to protivobolkovi products (analgesics) as salicylates, paracetamol, diclofenac, ibuprofen, indomethacin or naproxen with bronchospasm (contraction of the bronchi resulting in hindering breath) or other hypersensitivity reactions;
if you have impaired bone marrow function (eg. after treatment with cytostatics - products used in cancer) or diseases of the hematopoietic system (impaired hematopoiesis);
if you have a congenital glucose-6-phosphate dehydrogenase deficiency (a rare disease associated with metabolism) due to the risk of hemolysis (destruction of red blood cells);
if you have acute hepatic porphyria (a rare disease associated with metabolism) because the risk of attack of porphyria;
in neonates and infants under 3 months or weighing less than 5 kg, since there is no data available for use of metamizole;
in the last trimester of pregnancy.
Take special care with HEXALGIN
HEXALGIN contain pyrazolone derivative metamizole and includes a rare but life-threatening risk of shock (circulatory collapse) and agranulocytosis (severe disease associated with a significantly reduced number of certain white blood cells).
For children up to '12, the product should be used only on prescription.
If you react to HEXALGIN with hypersensitivity (anaphylactic) reactions, you are under increased risk of such a reaction to other analgesics.
If an allergic or other (immune) defense reaction (eg. Agranulocytosis) to HEXALGIN, you are under increased risk of such a reaction to other pyrazolones and pvrazolidin (chemically related substances).
If there are signs of agranulocytosis or thrombocytopenia HEXALGIN use should be discontinued immediately.
Patients with analgesic intolerance (see section "Do not take HEXALGIN") are under increased risk of severe hypersensitivity reactions to HEXALGIN.
The risk of possible severe hypersensitivity reactions to HEXALGIN is significantly increased if you have any of the following diseases / intolerances:
intolerance to analgesics and antirheumatic products exhibited such. itching and swelling (urticaria, angioedema);
bouts of breathlessness due to the narrowing of the small airways (bronchial asthma), especially if you suffer from inflammation of the nose and nasal sinuses (rhinosinusitis) and nasal polyps;
hypersensitivity to dyes (eg. tartrazine) or preservatives (benzoate);
alcohol intolerance. If you react to even small amounts of alcohol with symptoms such as sneezing, watery and greater flushing. Such alcohol intolerance may be evidence of undiagnosed syndrome analgesic asthma.
HEXALGIN can cause lowering of blood pressure (see also section 4).
The risk of such reactions is increased:
if you have low blood pressure (hypotension) or fluid loss, poor circulation or initial circulatory collapse (eg. as myocardial infarction or severe injuries);
if you have a fever.
Therefore, the use should be considered carefully and be closely monitored. May take preventive measures (eg. Circulatory stabilization) to reduce the risk of a drop in blood pressure.
For patients who must avoid lowering blood pressure in patients with severe coronary heart disease or narrowing of cerebral vessels, leading to impaired dew HEXALGIN can only be administered under close monitoring of cardiovascular function.
If you have kidney or liver problems, HEXALGIN should be used after careful risk-benefit ratio and after appropriate precautions (see section 3).
Separation of metamizole of the body can be delayed in the elderly.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Coadministration of HEXALGIN and chlorpromazine (medicine to treat psychiatric disorders) may lead to a decrease in body temperature (severe hypothermia).
Group of pyrazolones (to which it belongs and HEXALGIN) is known interactions with certain drugs:
that inhibit blood clotting (oral anticoagulants);
lowering high blood pressure and used in some heart diseases (captopril);
to treat mental disorders (lithium);
for treating cancer or rheumatism (methotrexate);
It is unknown to what extent this also applies to HEXALGIN.
HEXALGIN may decrease plasma concentrations of cyclosporine (that suppress the immune reactions in organ transplants), therefore the levels of cyclosporine should be monitored during concomitant use with the product.
Taking HEXALGIN with food and drink
Coadministration with alcohol should generally be avoided as negative interactions can not be excluded.
Pregnancy and lactation
You should not take HEXALGIN during the first 3 months of pregnancy, as there is no experience in humans.
Over the next three months can take HEXALGIN only after consulting a doctor and only after he / she has carefully evaluate the benefit / risk.
Do not take HEXALGIN in the last three months of pregnancy.
The product inhibits the natural function of the platelets (platelet aggregation), which can lead to increased bleeding, particularly in childbirth. It is possible premature closure of important for the unborn child blood vessel (ie. The ductus arteriosus, which closes naturally only after birth).
In the first 48 hours after administration of HEXALGIN You should not breast-feed because its breakdown products pass into breast milk.
Driving and using machines
Administration of the recommended dose has no known disturbances in concentration and reactivity. As a precautionary measure, especially in high dosages should be avoided driving, operating machinery, or other dangerous activities, especially after drinking.
Important information about some of the ingredients of HEXALGIN
20 drops (1 ml) solution containing 1,5 mmol (34,3 mg) sodium. This should be taken into account if you are on a low-salt diet.
3. HOW TO TAKE HEXALGIN
Always take HEXALGIN exactly as prescribed by your doctor. If you are not sure, ask your doctor or pharmacist.
Unless otherwise prescribed, the usual dose is:
The dose depends on the severity of pain and degree of fever and individual sensitivity to metamizole.
Your doctor will tell you how to take HEXALGIN oral drops. He / she will comply with these recommendations.
Generally have to choose the lowest dose that controls pain and temperature.
At high temperature, a dose of 10 mg / kg body weight is generally sufficient for children.
Children and adolescents up to 14 years receive 8 to 16 mg / kg body weight single dose metamizole.
Adults and adolescents 15 years of age (over 53 kg) can take up to 1000 mg single dose. If the response is unsatisfactory, that a single dose can be given up to 4 times daily.
The following table lists the recommended dosage unit dose and the maximum daily dose.
age / body weight single dose maximum daily dose
3-11 months (5-8 kg)
2-4 drops (equivalent to 50-100 mg metamizole sodium monohydrate) and 12 drops (equivalent to 300 mg metamizole sodium monohydrate)
1-3 years (9-15 kg) 3-10 drops (equivalent to 75-250 mg metamizole sodium monohydrate) and 30 drops (equivalent to 750 mg metamizole sodium monohydrate)
4-6 years (16-23 kg)
5-15 drops (equivalent to 125-375 mg metamizole sodium monohydrate) to 45 drops (equivalent to 1125 mg metamizole sodium monohydrate)
7-9 yr. (24-30 kg) 8-20 drops (equivalent to 200-500 mg metamizole sodium monohydrate) and 60 drops (equivalent to 1500 mg metamizole sodium monohydrate)
10-12 years (31-45 kg) 10-30 drops (equivalent to 250-750 mg metamizole sodium monohydrate) and 90 drops (equivalent to 2250 mg metamizole sodium monohydrate)
13-14 years (46-53 kg) 15-35 drops (equivalent to 375-875 mg metamizole sodium monohydrate) dropwise to 105 (equivalent to 2625 mg metamizole sodium monohydrate)
Adults and adolescents 15 years (over 53 kg) 20-40 drops (equivalent to 500-1000 mg metamizole sodium monohydrate) drops to 120 (equivalent to 3000 mg metamizole sodium monohydrate)
In elderly patients the dose should be reduced as the excretion of breakdown products of HEXALGIN may be delayed.
General ill health and impaired creatinine clearance
The dose should be reduced in patients with reduced performance status and impaired creatinine clearance as urinary breakdown products of HEXALGIN may be delayed.
Impaired renal and hepatic function
Since the rate of elimination is reduced in renal and liver function, high doses should be avoided. In short-term use is not required dose reduction. There is no experience of continuous use.
Method of administration
HEXALGIN oral drops should be taken with sufficient liquid.
Note for use
Packaging is tamper children. To open it, press the cap down and at the same time rotate the direction of the arrow. Hold upside down and gently tap the bottom of the bottle. Drops fall evenly and easily counted. After use, close well. The bottle is closed in position a child when you hear clicking while turning without pressing.
Duration of treatment
The duration of administration depends on the type and severity of the disease and is determined by your doctor. It is recommended painkillers drugs should not be taken more than 3 to 5 days without consulting again with your doctor or dentist.
If you take more dose HEXALGIN
If taken too much of HEXALGIN may experience nausea, vomiting, abdominal pain, abnormal renal function in acute renal failure (manifested as an example. Interstitial nephritis) and in rare cases, dizziness, drowsiness, unconsciousness, seizures, low blood pressure to shock and arrhythmia (tachycardia).
Please inform your doctor if you take a large amount of HEXALGIN, so that he / she can take the necessary measures.
After taking very high doses release of harmless metabolic product (rubazonova acid) may lead to red coloration of urine.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, HEXALGIN can cause side effects, although not everybody gets them.
Assessment of adverse reactions is based on the following information on frequency:
Very common: more than 1 in 10 patients treated;
Common: 1 to 10 of 100 patients treated;
Uncommon: 1 to 10 of 1000 patients treated;
Rare: 1 to 10 of 10,000 patients treated;
Very rare: less than 1 in 10 000 patients treated
Not known: from the available data can not be estimated.
Allergic skin reactions:
Uncommon: Violet to dark, partly bullous rash (typical drug rash);
Rare: Skin rash (maculopapular exanthema), hypersensitivity (anaphylactic or anaphylactoid) reactions may occur even with repeated administration without complications;
Very rare: asthma attack (shortness of breath due to narrowing of the small airways), severe manifestation of skin blistering and peeling (syndrome of Stevens-Johnson or Lyell), sudden circulatory shock.
Milder reactions occur with typical symptoms such as itching and redness of the eyes, coughing, runny nose, sneezing, chest tightness, redness of the skin (especially of the face and head), hives and swelling of the face, and, rarely, nausea and abdominal pain. Specific warning signs are itching and a feeling of warmth and under the tongue, especially on the palms and soles.
Milder reactions may progress to more severe forms with severe urticaria, angioedema heavy (also in the area of the larynx), severe bronchospasm (spasmodic narrowing of the small airways), rapid heart rate (sometimes too slow heart rate), arrhythmias , drop in blood pressure (sometimes first started as hypertension), loss of consciousness and circulatory shock.
In patients with analgesic asthma (see section 2 "Do not take HEXALGIN"), hypersensitivity reactions usually occur in the form of asthma attacks.
Blood and lymphatic system disorders:
Rare: Decrease the number of white blood cells (leukopenia);
Very rare: A significant reduction of certain white blood cells (agranulocytosis) or decrease of platelets (thrombocytopenia).
These reactions were primarily determined immunologically. They may also arise if metamizole administered without complications were in history. It has been shown that the risk of agranulocytosis may be increased in individual cases metamizole use more than 1 week.
Typical signs of agranulocytosis include fever, chills, sore throat, difficulty swallowing, and inflammatory changes of the oral, nasal, pharyngeal, genital and anal mucous membranes.
In patients receiving antibiotics, these symptoms may be mild.
Typical signs of thrombocytopenia are increased bleeding and petechial hemorrhages in the skin and mucous membranes.
Uncommon: Decrease in blood pressure (hypotensive reactions) caused by the drug directly and not accompanied by other signs of hypersensitivity reactions. Such a reaction is rarely may lead to severe hypotension. The risk of a critical drop in blood pressure may rise at very high temperature.
Typical symptoms of low blood pressure are rapid pulse, pallor, dizziness, nausea and loss of consciousness
Renal and urinary disorders:
Very rare: acute worsening of renal function with insufficient or no urine output, blood proteins in the urine or acute renal failure, inflammation of the kidneys (interstitial nephritis).
The following side effects may have serious consequences. Do not take HEXALGIN again and immediately consult a doctor.
Some side effects (eg. Severe hypersensitivity syndromes Stevens-Johnson or Lyell, agranulocytosis) can be life-threatening. In such cases HEXALGIN should be taken only under medical supervision. The immediate cessation of the drug is essential for recovery.
If signs of agranulocytosis or thrombocytopenia (see above), you should immediately discontinue use of the product. You should not wait to treatment interruption until the results of laboratory tests.
Taking HEXALGIN should be discontinued in the event of the characteristic signs of agranulocytosis:
sudden worsening of the general condition;
high temperature does not fall or reappears;
appearance of painful mucosal changes, especially in the mouth, nose and throat.
If any of the side effects gets serious, or if you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE HEXALGIN
Keep out of reach of children.
HEXALGIN stable 6 months after first opening of the vial.
HEXALGIN not use after the expiry date stated on the carton and label. 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. FURTHER INFORMATION
The active substance is metamizole sodium monohydrate. 1 ml (20 drops) oral drops contains 500 mg metamizole sodium monohydrate.
The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dodecahydrate, sodium saccharin, two-component bitter flavor distilled water.
HEXALGIN looks like and contents of the pack
HEXALGIN oral drops is a clear yellow solution.
Brown glass bottle (type III), containing 20 ml, 50 ml and 100 ml of solution.