SEDALGIN NEO 20 tablets

WHAT SEDALGIN-NEO AND WHAT IT IS USED
Sedalgin-neo is a combined product with expressed protivobolkovo and high temperature operation. In combination protivobolkovoto action of the individual components is enhanced, reducing side effects and the possibility of establishing a tolerance due to the use of lower doses of the components. The combination occurs more following effects: some relaxing the smooth muscle of the bile, urinary tract and uterus action; sedative / soothing / central nervous system; beneficial effect on brain vessels and reduce intracerebral pressure / to effect reduction of the headache /. The ingredient caffeine decreases the sedative effects of other ingredients and the combination generally does not affect performance significantly. Codeine possesses pronounced antitussive and enhances the analgesic effect of paracetamol and metamizole.
Sedalgin-neo is used for short-term treatment and symptomatic of the less responsive (when administered alone individual components) pain of various origins:
headache, migraine, toothache;
pain after injuries, operations and incineration;
neuritis and neuralgia, severe joint and muscle pain.

2. BEFORE USE SEDALGIN-NEO
Do not use Sedalgin neo-:
if you are allergic (hypersensitive) to any of the active or the excipients;
if you have certain blood disorders (bleeding diathesis, aplastic anemia, leukopenia, and agranulocytosis);
if you suffer from bronchial asthma ( "ASA");
in some rare diseases associated with metabolism (glucose 6 phosphate dehydrogenase congenital failure, hepatic porphyria);
with severe renal and hepatic failure;
abuse of narcotic analgesics, hypnotics and sedatives;
during pregnancy and lactation;
in children.
Take special care with neo-Sedalgin
Treatment with product benefits of its application must clearly exceed the level of risk or otherwise, should be given other therapy.
The application of the product should be stopped immediately when symptoms of anaphylaxis (sudden occurrence of a severe allergic reaction with skin rashes, shortness of breath, gastrointestinal and cardiovascular symptoms) and agranulocytosis (severe reduction in granulocytes - a type of white blood cells, fever ; infections).
Patients who have ever shown allergic to metamizole should not take it again.
Caution should be exercised with the concomitant use with other medicinal products containing paracetamol because of the risk of overdose.
When taking higher doses than recommended, there is a risk of serious liver damage.
In more frequent and continuous adoption of neo-Sedalgin it is necessary to conduct monitoring of blood counts and indicators of kidney and liver function.
Avoid use in patients with active peptic ulcer disease and renal and liver failure.
Metamizole contained in Sedalgin-neo may color urine red, which is not clinically significant.
Use with caution in elderly patients because of the frequent manifestations of intoxication.
It is possible to occur or worsen available headaches after prolonged analgesic therapy (> 3 months) using analgesics every other day or more frequently. Headaches caused by excessive use of analgesics should not be treated with increasing their dose. In such cases analgesic treatment should be discontinued after consulting a doctor.
Prolonged intake Sedalgin-neo may develop dependence and tolerance contained therein codeine.
In some people with a certain type of metabolism (ie. Pomegranate. Ultrafast metabolizers) may be expected symptoms of an overdose of codeine, such as excessive sleepiness, confusion, shallow breathing, even at recommended doses.

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.
The ingredients of the combination to intervene in the metabolism (absorption) of many drugs, and therefore should be avoided combination with other products.
Metamizole - reduces the activity of coumarin anticoagulants, lowers plasma levels of cyclosporine. Its effects are enhanced by tricyclic antidepressants, oral contraceptives, allopurinol. Concomitant administration of metamizole with chloramphenicol and other disabling bone marrow products leads to increased myelotoxic effect (suppress bone marrow function).

Paracetamol - co-administration with aminophenazone can lead to amplification effects of both products, as well as increasing their toxicity. Paracetamol enhances the effects of coumarin anticoagulants. Oral contraceptive products weaken its effects Rifampicin reduces the analgesic effect. Cimetidine reduce toxicity and enhance analgesia. Paracetamol extended degradation of chloramphenicol and leads to an increased risk of bone marrow involvement. Co-administration of alcohol and liver-damaging drugs leads to an increased risk of impairment of liver function.

Codeine - amplified depressing the central nervous system effect of alcohol, barbiturates, benzodiazepines, hypnotics and sedatives products. The use of MAO inhibitors or tricyclic antidepressants with codeine may enhance their mutual effects. Co-administration of anticholinergics with codeine may cause intestinal paralysis.

Caffeine - reduces the power of the hypnotic products. Enhances the effect of NSAIDs.

Phenobarbital - lowered plasma levels of dicumarol and its anticoagulant activity; accelerates the degradation of the griseofulvin, quinidine, doxycycline, estrogens, sometimes phenytoin, carbamazepine. Suppressive effect is amplified when co-administered with alcohol, tricyclic antidepressants, phenothiazines, narcotic analgesics. Sodium valproate and valproic acid inhibit the metabolism of phenobarbital.

Taking Sedalgin neo-Food & Beverage
Given the reduced tolerance to alcohol should be avoided its consumption during the treatment with the product.

Pregnancy and lactation
Ask your doctor or pharmacist before taking any medicine.
The active substances can cause fetal harm when administered during pregnancy. They pass into breast milk. Therefore, neo-Sedalgin not be used during pregnancy and lactation.

Driving and using machines
Most of the ingredients of neo-Sedalgin affect the central nervous system, altered sensory and motor reactions, so during treatment with this product is recommended not to drive or operate machinery or that this be done with caution.

Important information about some of the ingredients of neo-Sedalgin
This product is suitable for people with celiac disease (gluten enteropathy). Patients with wheat allergy (different from celiac disease) should not take this product.
Contained as an excipient sodium metabisulfite may rarely cause severe hypersensitivity reactions and bronchospasm.

3. HOW TO TAKE SEDALGIN-NEO
Always take Sedalgin neo-exactly as stated in this leaflet. If you're not sure, ask your doctor or pharmacist!
It is administered orally and the dose is determined by your doctor. Usually take 1 tablet 3-4 times daily.
The maximum single dose of 2 tablets, and the maximum daily dose is 6 tablets. The course of treatment is maximum three days.
The tablets are taken with meals, with fluid. This product is not suitable for children!

If you take more than the amount of neo-Sedalgin
When taking a higher dose than prescribed, immediately contact a doctor!
Overdose can occur any of the following symptoms: depression of the central nervous system marked by dizziness, drowsiness, slow reactions, respiratory depression, extreme fatigue to loss of consciousness, slow heart rate, lowering blood pressure, serious damage to the liver function.
When observing some of the symptoms of an overdose need to stop taking the product to perform gastric lavage and appoint charcoal and symptomatic means. To radiation from the body needs to maintain adequate breathing and stable blood pressure.

If you forget to take Sedalgin-neo
Do not take a double dose to make up the missed dose. Do this in the next regular intake.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS
Like all medicines, neo-Sedalgin can cause side effects, although not everybody gets them.
Most often they are temporary and resolved upon discontinuation of treatment. Some patients can be observed:
Immune System Disorders
increased risk of anaphylaxis (a severe life-threatening allergic reaction) and agranulocytosis (decrease in white blood cells prone to infections) that can occur at any stage of the treatment and are not dependent on a daily dose;
Allergic reactions: itching, skin rashes, provoking an asthma attack, dyspnea (shortness of breath).
Gastrointestinal disorders - dry mouth, abdominal pain, nausea, vomiting, constipation or disorder, elevations in liver transaminases.

Nervous system disorders - drowsiness, fatigue, loss of coordination, tremors, restlessness, irritability, development of dependence during prolonged use.

Cardiac and vascular disorders - lowering blood pressure, palpitations, premature (irregular heartbeat).

Renal and urinary disorders - prolonged high doses of possible renal impairment (interstitial nephritis, renal failure).

Blood and lymphatic system - in very rare cases, hemolytic anemia, thrombocytopenia (a decrease in red blood cells and platelets).

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 SEDALGIN-NEO
Keep out of reach of children. At temperatures below 25 ° C!
Do not use neo-Sedalgin 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 in 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
What neo-Sedalgin
The active ingredients in one tablet are: Paracetamol 300 mg, sodium Metamizole 150 mg, caffeine 50 mg, Phenobarbital 15 mg, codeine phosphate hemihydrate 10 mg.
Other ingredients are: microcrystalline cellulose, corn starch, povidone, crospovidone, sodium metabisulfite, talc and magnesium stearate.

Looks Sedalgin-neo and contents of the pack
Sedalgin-neo is a round flat tablets with bilateral facet, on one side, with a diameter of 13 mm, a white or off-white color.