Efferalgan Codeine effervescent pellet an average acute analgesic (10 blisters x 4 tablets)

Dosage form Box of 10 blisters x 4 tablets
Specifications Paracetamol, codeine

Ingredient

Composition informationContent
Paracetamol500mg
Codeine30mg

Uses

Indications

Efferalgan Codeine Bristol is indicated in the following cases:

Average acute pain for patients over 12 years old (weighing 31kg or more) to relieve pain when other painkillers such as paracetamol or ibuprofen (single) are ineffective.

Pharmacokinatus

paracemol: pain relief - antipyretic.

Codein phosphate: Opioid group analgesics.

Paracetamol combination with phosphate code will give a stronger pain relief than when using each separate medicine, the effect lasts longer.

paracetamol is an antipyretic analgesic with weak anti -inflammatory effects. Unlike traditional NSAIDs, at the dose of non -inhibited paracetamol treatment.

Codeine is an opioid analgesic that reduces cough. Codeine and morphine metabolites have its activity, which is the phenanthren derivative of opioid. Codeine is a central analgesic with weak effects. Codeine works through receptors µ opioid, but the codeine has low affinity for these receptors and the pain relief effect of the drug is due to the transformed codein into morphine. Codeine, especially when coordinated with other painkillers such as paracetamol, has been shown to be effective in analgesic due to acute nervous sense.

Mechanism of action

The exact mechanism of pain relief and fever effects of paracetamol has not been set up. The mechanism of action can be related to central and peripheral activities.

Analgesic effects of Codeine and its active metabolites through intermediaries by attaching MU (µ) Opioid and peripheral opioid. Codeine has weak affinity for receptors µ-opioid and is about one tenth of the pain relief of morphine.

While it is often thought that the pain relief effect of Codein is due to its active metabolic morphine, there is evidence that the pain reduces through the intermediary codein-4-glucuronide and may be by other metabolites of the codeine.

Codeine cough effects are thought to be the effect on the center.

pharmacokinetics

paracetamol and codeine have similar absorption and therefore, pharmacokinetics of these two components do not change when coordinated.

paracetamol

absorption

Paracetamol's absorption when taken will be fast and completely. Peak concentration in plasma reaches 30-60 minutes after drinking.

Distribution

Paracetamol quickly distributed into all tissues of the body. The concentrations of blood, saliva and plasma are equivalent. Weak attach to plasma protein.

Metabolism

paracetamol metabolizes mainly in the liver. The two main transformation paths are glucuronid and sulfate complexes. Sulfate complex quickly saturated when the dose is higher than the therapy range. Secondary metabolic lines, catalyzed by Cytochrom P450, resulting in toxic intermediaries (N-acetyl-Benzoquinon-Imin), under normal usage conditions, this intermediate will be detoxified with glutathion reduction and excreted urine after being connected to cysteine ​​and mercaptal acid. However, when poisoning with high doses of paracetamol, the amount of toxic metabolites will increase.

Elimination

Elimination mainly through urine. 90%of oral dose will be discharged through the kidneys within 24 hours, mainly in the form of glucuronid conjugate (60 - 80%) and sulfate conjugate (20 - 30%). Under 5% will be discharged in a constant form. Selling time is about 2 hours.

Pathological physiological changes

Renal failure: When severe renal failure (creatinine purification Elderly: The ability to combine does not change.

codeine

absorption

After drinking, Codeine absorbs quickly and is relatively available compared to when intramuscularly is 40 - 70%. The peak concentration in plasma reaches 60 minutes and then decreases and the sale time is 2-4 hours. Codeine is converted into Codeine-6-glucuronid, Morphin and Norcodeine.

Distribution

Codeine's plasma protein bonds and its metabolites correspond to the range of 50-20%. The distribution volume is about 3 - 6l/kg. There is evidence of the accumulation of morphine and its metabolites with the repeated dose of codeine. The active metabolites of codeine are excreted into breast milk (see pregnancy and nursing).

Metabolism

Codeine is converted into Codein-6-Glucuronid, its main metabolites, by glucuronide by isenzyme UGT2B7 liver, norcodeine by n-demethylation by isenzyme CYP3A4 liver and morphine wall by o-remethylation by isenzym cyp2d2d6 liver. Polymorphism CYP2D6 has a clinical impact on the metabolism of Codeine (see warning and caution of specific products, related to Codeine, extremely fast transformers of Codeine and poor transmission of codeine and pregnancy and lactation). Auxiliary metabolites include Normorphin, Morphin-6-Glucuronid, and Morphin-3-Glucuronid.

Elimination

Codeine and its metabolites are eliminated mostly through the kidneys (85 - 90%), mainly in the form of glucuronid complexes, the elimination is considered to be completed after 48 hours. The percentage of the dose (free form + complex product) is encountered in the urine as follows: about 10% in the form of morphine, 10% norcodeine, 50 - 70% Codeine. About 25 - 30% Codein oral Codein will combine with plasma protein.

Special patient groups

kidney failure

In case of severe renal failure (the clearing of creatinine 10 - 30ml/minute), the elimination of paracetamol is a bit slow. For glucuronid and sulfate complexes, the ratio of elimination in people with severe kidney failure is slower than healthy people. Renal failure reduces the excretion of codeine, can lead to the accumulation of toxic metabolites.

Therefore, in patients with severe renal impairment (creatinine clearance

Hepatic failure

Paracetamol has been studied in patients with liver failure. In one study, for Paracetamol 4G/day for 5 days in 6 subjects with stable chronic liver disease. The plasma paracetamol concentration is determined between the third and fourth dose between the third and fourth dose every day ranging from 4.5 to 26,7µg/ml, much lower than the ability to poison. It has been observed that there is no significant accumulation of paracetamol and has no clinical changes or patient tests. The average selling time is 3.4 hours.

After this pilot study, 20 subjects with chronic chronic liver disease were randomly selected in a two -stage cross -study. The patient was used or 4g of paracetamol a day or a placebo for 13 days and then transferred to replacement treatment.

A patient has increased in liver function tests (LFTS), but after recovery from that stage, the patient did not show abnormalities in the next two challenges. The authors conclude that the increase of lfts is not related to the drug and has no contraindications in the use of paracetamol in the treatment doses in patients with stable chronic liver disease.

Some clinical trials show that paracetamol metabolism is moderately reduced in patients with chronic liver failure, including alcoholic cirrhosis, shown by increasing plasma paracetamol levels and longer selling time. In reports, increasing the sale of plasma paracetamols is associated with the impaired synthesis of the liver.

Therefore, paracetamol should be used cautiously in patients with liver failure and contraindicated when there is a liver disease, especially alcoholic hepatitis, due to CYP2E1 induction, leading to an increase in the formation of toxic metabolites for the liver of paracetamol. Opioid, including codeine, is mainly metabolized by the liver enzymes, so the liver failure can lead to the accumulation of toxic metabolites. Efferalgan Codeine 500mg Bristol Contraindicated in cases of severe liver failure or loss of liver disease.

(see the dose and how to use (liver failure), contraindications and caution when used).

CYP2D6 polymorphism

Patients with extremely fast metabolism CYP2D6 with high CYP2D6 activity can produce Morphin's serum levels, even at low doses of Codeine. Patients with slow metabolism CYP2D6 reduces the ability to form morphine from codeine and may have analgesic effect.

(see warnings and caution, especially for drug groups, associated with Codeine, extremely fast transformers and people with poorly transformers, pregnancy and lactation).

Elderly

Elderly patients may manifest more sensitive to opioid analgesics, should take lower starting dose (see the dose and usage, the elderly).

Children and adolescents

Babies, children and children: Paracetamol pharmacokinetics are observed in children and children similar to adults, except for the semi -discharged time in plasma, slightly shorter (about 2 hours) compared to adults. In infants, the time for selling plasma is longer in children (about 3.5 hours).

Babies, children and children under 10 years of age are significantly less than the glucuronid and sulfate match compared to adults. The total excretion of paracetamol and its metabolites is the same at all ages (see the dose and usage).

Before taking Efferalgan Codeine effervescent pellet an average acute analgesic (10 blisters x 4 tablets)

How to use

Take oral use.

Mixed tablets in water before use.

Dosage

Do not recommend long -term use Efferalgan Codeine Bristol without careful consideration of risk compared to benefits.

To avoid the risk of overdose, check to be sure that simultaneous drugs do not contain paracetamol or codeine (including drugs sold by applications and non -sold drugs) (See more: Precautions when using, warning and prudent special products).

Codeine needs to be used at the lowest doses that are effective in the shortest time. This dose can be used up to 4 times a day with the distance between drug use no less than 6 hours. The maximum daily dose of Codeine should not exceed 240mg.

Duration of pain relief should be limited to less than 3 days and in case of failure to achieve pain relief, patients/patients should see a doctor for advice.

In children, paracetamol dose must be determined by weight of children.

effervescent tablets should be dissolved in water. Do not swallow or chew.

weight (kg)
Age of approximation* (five years old) (mg)
Codeine/dose (mg)
The number of tablets/dose
The minimum distance between drug use (hour)
Maximum daily dose (tablets) 50 12 - 15
500 30
1 6 4 (2000mg Paracetamol + 120mg Codeine) - 2 6 6 (3000mg Paracetamol + 180mg Codeine) - 240mg Codeine) Use age based on local standard growth curves.

Adults

There is no need to use more than 6 capsules per day. However, in the case of severe pain, it may increase to 8 capsules daily (maximum dose). Paracetamol's maximum daily dose must not exceed 4g per day; Maximum daily dose of Codeine should not exceed 240mg.

Children

Children under 12 years old

Do not use drugs to treat analgesic in children under 12 years of age due to the risk of Opioid poisoning because of unpredictable changes in the transformation of codeine into morphine (see contraindications and warnings and caution when using, warning and prudent special products).

Children from 12 - 18 years old

It is necessary to comply with the dose by weight to choose the appropriate dose adjustment.

Daily recommended dose:

  • about 60mg/kg/day Paracetamol is divided into 4 doses, about 15mg/kg every 6 hours. However, in the case of severe pain, it can be used to increase to 2 capsules in each use, not more than 6 tablets per day (maximum dose).

    Special subjects

    Elderly

    Elderly patients show signs of increased sensitivity to opioid analgesics. A lower -dose should be used lower than that of adults for elderly patients and adjust the dose based on the tolerance and needs of each patient (see warning and caution when used, used in elderly people and pharmacokinetics, special patients, elderly people).

    kidney failure

    In case of renal failure, there is an increased risk of paracetamol and codeine accumulation. Note:

  • The distance between the drug use minimum is 8 hours.

    Hepatic failure increases the risk of accumulating paracetamol and codeine. In patients with chronic liver disease or liver disease, it is still compensated, especially those who have mild to medium liver cells, chronic alcoholism, adults weighing less than 50kg, prolonged malnutrition (low liver glutathion reserves) and dehydration, need to consider reducing the dose or prolonging the distance between each use of the drug. The maximum daily dose should not exceed 60mg/kg/day (no more than 2g/day).

    It is necessary to consider reducing the dosein dosein in patients with hepatic failure.

    (See also pharmacokinetics, special patients, liver failure).

    Precautions: To avoid overdose, check all the drugs being used, including non -prescribing drugs.

    Maximum daily dose of Codeine should not exceed 240mg.

    Paracetamol's maximum daily dose does not exceed:

  • 60mg/kg/day in children weighing less than 37kg. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do

    do when overdose?

    Paracetamol overdose symptoms

    There is a risk of overdose, especially in patients with liver disease, in the case of chronic alcoholism, in patients with chronic malnutrition and in patients taking drugs that cause enzyme induction. Taking overdose drugs can be fatal, especially in these cases (See also: Precautions when using, warning and caution, especially in the product, related to paracetamol and drug interactions).

    Symptoms usually appear within the first 24 hours including nausea, vomiting, pale, anorexia, discomfort and sweat.

    Acute oral overdose of 7.5 g paracetamol or more in adults, or 140 mg/kg body weight in children causing cell resection hepatitis, potentially causing complete necrosis and non -recovery, leading to liver failure, metabolic acidosis and brain disease, which can lead to coma and death.

    At the same time, increasing the concentration of liver transaminase (AST, ALT), lactat dehydrogenase and bilirubin have been observed along with reducing prothrombin levels that can appear after taking medicine 12 - 48 hours. Clinical symptoms of liver damage are usually pronounced at first after 1-2 days and reach a maximum after 3-4 days.

    Emergency measures

    Admission immediately.

    Before starting treatment, take a blood tube to quantify paracetamol in plasma as soon as possible but not earlier 4 hours after taking paracetamol.

    Quickly remove the amount of oral medication by gastric lavage.

    Overdose treatment includes an antidote, N-acetylcystein (NAC) by intravenous or oral intravenously, if possible, within 8 hours after drinking. NAC can provide a level of protection even after 16 hours.

    Symptomatic treatment.

    Must conduct liver tests at the beginning of treatment and repeat every 24 hours. In most cases of liver transaminase back to normal for 1-2 weeks with the full recovery of the liver function. However, in very heavy cases, it may be necessary to graft the liver.

    Codeine overdose symptoms

    Signs and symptoms: The maximum opioid dose depends on the change of each individual. Respiratory failure within a decrease in breathing to apnea, too sedative in the range from stunning to coma and pupils are the main symptoms of Codeine overdose or other opioids. Other symptoms related to the effect on the central nervous system include headache, vomiting, urinary retention, intestinal decrease, slow heart rate and hypotension can also occur.

    Emergency measures

    Use an opioid antagonistic drug, the most common is Naloxon.

    Naloxon has a semi -destructive time in short plasma compared to the metabolites of the activity code. To achieve a complete reversal of open respiratory failure, naloxon injections often have to be repeated through bolus injection or transmission, depending on the level of overdose and serum morphine levels.

    Supported ventilation and other symptom treatment.

    What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.

  • Side Effects

    When using Efferalgan Codeine 500mg Bristol, you may experience unwanted effects (ADR).

    Related to paracetamol

    The hypersensitivity reaction to paracetamol can be manifested by urticaria, erythema and rash (unknown). Cases of hypersensitivity reactions such as anaphylaxis and angioedema have been reported to paracetamol (see contraindicated).

    The following side effects have been reported from after -sales experience with paracetamol.

    Unknown frequency

    Blood and lymphatic system: thrombocytopenia, neutropenia.

    Digestive system: diarrhea, abdominal pain.

    Liver: Increase liver enzyme.

    The immune system: Anaphylaxis, angioed, hypersensitivity.

    Testing: Reduce international standardization ratio, increase international standardization ratio.

    Skin and subcutaneous tissue: urticaria, erythema, rash, external rash all over the body, poisoned epidermal necrosis, Stevens-Johnson syndrome.

    circuit: hypotension (as a symptom of anaphylaxis.

    Regarding Efferalgan Codeine 500mg Bristol

    The following side effects have been reported from experience with Efferalgan Codeine 500mg Bristol.

    Unknown frequency

    Blood and lymphatic system: platelets.

    ears and mesmerizing: dizziness.

    Digestive system: abdominal pain, constipation, diarrhea, nausea, vomiting, pancreatitis.

    Body: weakness, discomfort, edema.

    Hepatoma: abdominal pain caused by bile, hepatitis.

    The immune system: Anaphylaxis, hypersensitivity.

    Testing: Increasing alanin aminotransferase, increasing aspartat aminotransferase, increased alkaline phosphatase in the blood, increased blood amylase, increased Gama-glutamyltranferase, increased international standard ratio.

    Bone muscle and connective tissue: Muscle pattern.

    Nervous system: dizziness, muscle shock, paresthesia, drowsiness, fainting, tremor.

    Mental: Concentrated state, drug abuse, drug dependence, hallucinations.

    kidney and urinary: renal failure, urinary retention.

    Respiratory, chest and mediastinum: Difficulty breathing, respiratory failure.

    Skin and subcutaneous tissue: angioedema, erythema, itching, urticaria.

    circuit: lower blood pressure.

    Instructions on how to handle ADR

    Notify the doctor the unwanted effects when using the drug.

    Warnings

    Before using the drug you need to read the instructions carefully and refer to the information below.

    Contraindicated

    Efferalgan Codeine Bristol contraindicated in the following cases:

    Hypersensitivity to paracetamol or proparacetamol hydrochloride (precursor of paracetamol), codeine or any excipients of the drug (see caution when using, warning and prudent special products, associated with paracetamol and side effects, related to paracetamol).

    Severe liver failure or liver disease is unsuccessful (see pharmacokinetics, special patients, liver failure).

    Respiratory failure, regardless of the level (see caution when using, warning and careful caution about drug groups, associated with opioid, respiratory effects and cautious use when used, used in children).

    Children under 12 years of age due to the risk of Opioid poisoning because of unpredictable changes in the transformation of codeine into morphine (see caution when using, warning and careful caution about the product, related to Codeine, extremely fast transformers of Codeine).

    All patients with children under 50kg (children from 0 to 18 years old) have just performed tonsillectomy or VA curt to treat sleep apnea syndrome associated with airway obstruction because these patients are at high risk of serious and life -threatening reactions (see caution when using, warning and prudent special products, related to Codein, for children).

    Women breastfeeding (see breastfeeding period, related to codeine).

    Patients with gene metabolic genes through CYP2D6 super fast (see caution when using, warning and careful caution about products, related to Codeine, extremely fast transformers).

    Precautions when used

    This drug contains paracetamol. Meet your doctor immediately when overdose or random use too high.

    This drug contains paracetamol and codeine. Many other drugs also contain these ingredients. You must not combine these drugs together to not exceed the maximum recommendation (see dose and use).

    Only use this medication for children when prescribed by a doctor. Do not be treated for children, but before not asking for a doctor's opinion. This medication must be accompanied by children, if you feel that children are too sleepy, then you should not give other children.

    This long -term medication can cause medication. Do not take the drug for a long time without applying for a doctor.

    Do not overdose and immediately report to the doctor when overdose.

    Do not use for a long time without expertise, especially when disorders lasting more than 5 days in the phenomenon of starting other symptoms when continuing the drug.

    This drug contains sorbitol, so it is not used for patients with fructose intolerance (genetic metabolic disease).

    Warning and caution especially with the drug group

    Efferalgan Codeine 500mg Bristol contains Codeine as an analgesic opioid.

    Related to Opioid

    (See more warnings and prudent products especially about products, related to codeine).

    Effects on the central nervous system

    The effect of opioid on the central nervous system (CNS) can cause serious respiratory failure, potentially fatal.

    The central nervous system inhibitors of Opioid, including respiratory and sedative inhibitors, must be considered in case of known or suspected intracranial disease such as head injuries or other intracranial injuries. These effects on the central nervous system can also complicate neurological evaluation.

    Should be cautious when using opioid in patients with epilepsy due to the ability to reduce seizures.

    For extension of painkillers including opioids increases the risk of headache due to drug abuse.

    Opioid treatment, especially for long -term use, can increase pain in some people.

    Simultaneous use of alcohol and Codeine can increase the inhibition of the central nervous system. Do not recommend drinking while treating with Efferalgan Codeine 500mg Bristol (see more warnings and prudent special products, related to paracetamol).

    Effects on respiratory

    Contraindicated using Efferalgan Codeine 500mg Bristol in respiratory conditions characterized by respiratory failure at any level.

    Opioid causes respiratory failure through the central nervous system inhibitors. The risk of respiratory failure may increase due to simultaneous use of drugs (see drug interactions) and genetic factors (see warnings and prudent products, especially products, related to Codeine, people who transform extremely fast Codeine and pregnancy, associated with codeine).

    Be careful when using Efferalgan Codeine 500mg Bristol in asthma patients. Opioids, especially morphine and derivatives, can cause histamine release. Opioid cough activity may be detrimental to respiratory conditions that cough with phlegm is beneficial.

    Effects on gastrointestinal

    Constipation, can be resistant to laxative treatment, is a side effect of opioid treatment and need to monitor intestinal function.

    Nausea and vomiting are also the side effects of opioid treatment, in some people, the rate of nausea and vomiting may be reduced with the use or arising of drug tolerance (familiar drugs).

    Using opioid can cover the symptoms of acute abdominal condition. Some opioids, including morphine, are thought to increase ODDI sphincter pressure, indicates caution when used in cases of biliary pathogens such as pancreatitis and gallstones, although obvious effects have not been determined.

    Effects on skin

    Itching is a side effect of opioid treatment.

    Effects on hormones

    Opioid can reduce hormones and should be used cautiously in patients with hormone disorders.

    Immune effect

    Some opioids, including morphine, may have the effect of inhibiting immune function. Clinical significance of this effect has not been determined.

    Effects on skeletal system

    Muscle hard and muscle vibration can occur with opioid therapy.

    Effects on the urinary system - genital

    Opioid may cause urinary retention due to reducing smooth muscle tone in the bladder, reducing the awareness of bladder fullness and urinary reflex inhibition. Therefore, caution should be used when using opioid in patients with urethra or prostate hypertrophy.

    Effects on cardiovascular and cerebrovascular

    Patients with hypoglycemia or hypoglycemia that use opioids should be monitored for hemodynamic effects that may occur.

    Medicine tolerance (familiar medicine)

    Analgesic effects or drug intolerance may occur when prolonged opioid use. Diagonal tolerance between opioids incomplete and tolerance can appear at different degrees for different opioids.

    Prolonged Codeine uses can lead to physical and psychological dependence. Therefore, it is not recommended for extending the Efferalgan Codeine 500mg Bristol. Should be cautious when using Efferalgan Codeine 500mg Bristol in patients currently or once dependent on opioid and should consider alternative pain relief therapies.

    Warning and special caution about products

    It is not recommended to extend the use of Efferalgan Codeine 500mg Bristol without careful consideration of the risk compared to the benefits (see the dose and how to use).

    To avoid the risk of overdose or serious side effects, check to make sure other drugs used without opioids or other medications inhibit the central nervous system (including prescription drugs and non -prescription drugs). (See: drug interaction).

    (See also: Warning and careful caution about products and breastfeeding periods, associated with codeine).

    Due to the risk of respiratory, only the use of Codeine drugs to reduce acute analgesic at an average level for children over 12 years old when other painkillers such as paracetamol and ibuprofen are ineffective.

    Codeine should only be used at the lowest doses that are effective and in the shortest time.

    Extremely fast transformer (metabolized through CYP2D6)

    Codeine is converted into morphine (active metabolites) through the liver enzyme CYP2D6 in the liver. If part or all of this enzyme is deficient, the patient will not achieve appropriate treatment effect. It is estimated that up to 7% of the white population may lack this enzyme. However, if the patient has a strong or super -fast metabolic gene, the risk of harmful reactions caused by opioid poisoning even in the common prescription dose. These patients have the ability to convert codeine into morphine faster, leading to higher serum morphine levels than expected.

    The common symptoms of Opioid poisoning include consciousness, drowsiness, shallow breathing, pupils, nausea, vomiting, constipation and anorexia. In serious cases, symptoms of circulatory and respiratory decline may appear, may be life -threatening and rarely fatal.

    The estimated ratio of people carrying drug metabolism via CYP2D6 super fast in different races is summarized in the table below:

    racial
    percentage% 6.5%

    Asians 1.2%to 2% Hungary 1.90% People with phenotypes of poor metabolic people of CYP2D6 have the ability to decrease to form morphine from Codeine and therefore do not show analgesic effect from codium therapy but may experience side effects.

    Use after surgery for children

    There have been reports in the literature published that the use of Codeine used after surgery for children has just performed tonsils and scraping procedures to treat sleep apnea syndrome associated with airway obstruction may cause rare but life -threatening reactions, even death (see contrary). All of these patients use Codeine in the prescribed dose, but there is evidence that these children carry the gene to convert the codeine to the strong or super fast morphine.

    Related to paracetamol

    To avoid the risk of overdose, check to make sure other drugs used without paracetamol (including drugs sold by prescriptions and non -sold drugs) (See also: drug interaction).

    Use higher doses of paracetamol than the recommended dose that leads to the risk of very serious liver damage. The clinical symptoms of liver damage are usually found first after 1 to 2 days after the paracetamol overdose. The most severe symptoms of liver damage are usually observed after 3-4 days. Must be treated with antidote as soon as possible (see: overdose, overdose Paracetamol).

    Doctors need to warn patients on signs of serious skin reactions such as Stevens-Johnson syndrome (SJS), poisoned epidermal necrosis (Ten) or Lyell syndrome and acute all-body pustules (AGEP).

    Be careful when using paracetamol in the following cases:

    Mild to moderate liver failure.

    Contraindicated using Efferalgan Codeine 500mg Bristol in case of severe liver failure or liver disease is not compensated.

    medium and severe renal failure (creatinine clearance

    Glucose-6-phosphate dehydrogenase deficiency (G6PD) (can lead to hemolytic anemia).

    Chronic alcoholism, excessive drinking (3 or more glasses of alcohol per day).

    Anorexia, incorrect or worn, chronic malnutrition (low liver glutathion reserves).

    Dehydration, reducing blood flow.

    Related to Efferalgan Codeine 500mg Bristol

    Efferalgan code for 500mg Bristol should be used carefully in people:

    Disease phenylceton (drug containing aspartam).

    Fructose intolerance (Sorbitol -containing drugs).

    Controlled sodium consumption (the drug contains about 16.5mmol or MEQ (or 380mg of sodium). This information should be considered in controlled sodium consumption patients.

    Use in children

    Patients with children need to be closely monitored on the progression of the central nervous system inhibition associated with Codeine such as excessive drowsiness and breathing reduction. The difference in genetic pharmaceuticals in the metabolism of codeine may increase the risk of side effects or reduce treatment response in some patients.

    (See: Warning and careful caution about products, related to Codeine, extremely fast transformers and warnings and prudent products, especially products, related to codeine, poor transformers of Codeine, overdose, overdose Codeine and pharmacokinetics, special groups of patients, children and teenagers).

    Children impaired respiratory function

    Codeine is not recommended for use in children with respiratory function, including neuromuscular disorders, heart or respiratory diseases, upper or lung respiratory infections, multiple trauma or have just undergone major surgery. These factors can worsen the symptoms of Morphin poisoning.

    Used in the elderly

    Elderly patients may have an increased risk of side effects associated with opioids such as respiratory failure and constipation. It is recommended to use a slightly low starting dose compared to adults for elderly patients (see: dose and usage, recommended dose and dosage and usage, elderly people). Elderly patients also have the ability to increase the use of drugs simultaneously, this may increase the risk of drug interaction (see: drug interaction).

    The ability to drive and operate machinery

    Because the use of this drug is at risk of drowsiness, so it is necessary to be wary, especially when driving or operating machinery, because the drug contains Codeine. This phenomenon decreases gradually after taking the drug many times, maybe useful if they start taken in the evening. This harmful phenomenon will increase when drinking alcohol.

    Pregnancy

    Do not recommend using Efferalgan Codeine 500mg Bristol during pregnancy without careful consideration of risks, benefits and replacement therapies.

    Related to paracetamol

    Clinical experience on the use of paracetamol during pregnancy is limited. Epidemic data from the use of Paracetamol's treatment dose for orally instead of unwanted effect on pregnant women or on the health of the fetus or babies. Studies on reproduction with oral paracetamol does not show any effects of deformities or toxic to embryos.

    Related to Codeine

    There is no complete and controlled reproductive studies on the use of codeine during pregnancy. While there is no clear evidence of birth defects in humans due to the use of Codeine during pregnancy, it is impossible to eliminate the involvement.

    Condensation syndrome in newborns, characterized by the symptoms of opium preparations including restlessness, excessive crying, tremor, tone of tone, fast breathing, fever, vomiting and diarrhea, related to the use of Codeine in the mother in the last three months of pregnancy.

    Using Codeine in mothers in any stage of pregnancy can be associated with a caesarean section as planned and used in the last three months of pregnancy may be associated with increased risk of emergency cesarean cesarean section and postpartum bleeding.

    If you find out that you have Thai during this medication, report it to your doctor, because only the doctor has the right to decide you to continue or stop taking this medication.

    The breastfeeding period

    This drug is through breast milk, so it must be contraindicated during breastfeeding, unless randomly used.

    Related to paracetamol

    After oral use, paracetamol is excreted in breast milk in small quantities. There have been reports on the babies in breastfeeding.

    Related to Codeine

    Efferalgan Codeine 500mg Bristol is not used for breastfeeding women (see contraindicated).

    In the usual dose of treatment, Codeine and active metabolites can be available in breast milk at very low doses and does not seem to cause adverse effects on breastfeeding.

    However, if the patient is a super -fast CYP2D6 metabolic gene, Morphin (the active metabolite of the codeine) may be found in breast milk with higher concentrations and in very rare cases, which can lead to symptoms of opioid poisoning in infants, can be fatal, need to tell the mother about the risks and signs Mom.

    generally during pregnancy or breastfeeding always have to consult your doctor or pharmacist before taking a drug.

    Drug interaction

    The effect of other drugs on Efferalgan Codeine 500mg Bristol

    Related to paracetamol

    Phenytoin is used simultaneously, which can lead to reduced paracetamol effectiveness and increases the risk of liver toxicity. Patients who are being treated with phenytoin should avoid high -doses of paracetamol. Need to monitor patients on evidence of liver poisoning.

    Probenecid causes reduction in the clearance of paracetamol nearly twice by inhibiting the combination with glucuronic acid. Paracetamol dose should be considered when used simultaneously with probenecid.

    salicylamid can extend the disposal time (t1/2) of paracetamol.

    Enzyme induction: Be cautious when paracetamol is used simultaneously with enzyme induction substances. These substances include, but unlimited, barbiturates, isoniazid, carbamazepine, rifampin and ethanol (see: overdose, overdose of paracetamol).

    Related to Codeine

    Other opioids: Concomitance Codeine with other opioid -containing drugs such as opioid bronze (Alfentanil, Dextromoramid, Dextropropoxyphen, dihyrdocodein, Fentanyl, Hydromorphon, Morphin, Oxycodon, Pethidin, Phenoperidin, KookInil, Sufentanil, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, Tramadol, TramADO methadon) and cough inhibitors like morphine (dextromethorphan, noscapin, pholcodin, codeine, ethylmorphin) can enhance the inhibition effect of the central nervous system, including sedatives and respiratory failure, increasing the risk of death overdose.

    Use with opioid antagonists/antagonists and opioid bronze drugs in part (buprenorphin, butorphanol, nalbuphin, nalorphin, pentazocin) can lead to reducing pain and symptoms of opioids.

    Other medications inhibit the central nervous system, such as Barbiturat, anti -anxious drugs and antidepressants, including three -round antidepressants (TCA), selective Serotonin Restrain inhibitors (SSRIs), Monoamin Oxidase inhibitors (IMAO), Benzodiazepine and sleeping pills can enhance the central neurological inhibitors of Codein.

    Other drugs can cause drowsiness, such as morphine derivatives (painkillers, cough inhibitors and alternative treatments), sedative drugs, barbiturat, benzodiazepin, anti -anxiety drugs other than benzodiazepin (meprobamate), sleeping pills, antidepressants that cause drowsiness (amitreptylin, dormepin, mianserin, mirtazapin, mirtazapin, mirtazapin, mirtazapin Trimipramine) H1 anti -histamine drugs, causing drowsiness, medications for hypertension, the central effect, Baclofen and thalidomid may have the effect of drowsiness plus the code.

    Other drugs are metabolized by CYP2D6 or CYP2D6 inhibitors such as selective Serotonin reabsorption (SSRI) (SSRI) (Paroxetin, Fluoxetin, Bupropion and Sertralin), Sedative (Chlorpromazin, Haloperidol, Levomepromazin, Thioridazin) and antidepressants (IMIPRAMIN) Clomipramine, amitriptylin, nortriptylin), celecoxib, quinidine, dexamethasone and rifampin can reduce the pain effect of codeine. Anticholinergic anti -cholinergic drugs simultaneously with opioids, including codeine, can increase the inhibition of intestinal function and increase the risk of intestinal stagnation.

    Alcohol is simultaneously used with opioid analgesic to increase sedative effects.

    naltrexon, an opioid antagonist, prevents the analgesic effect of codeine.

    Effective of Efferalgan Codeine 500mg Bristol on other drugs

    Efferalgan Codeine 500mg Bristol may increase the likelihood of unwanted effects when used with other drugs.

    Anticoagulant: Concomitant use of paracetamol with cooumarin including warfarin can lead to a slight change in Inr value (international standardized ratio). In this case, it is advisable to monitor the Inr values ​​during simultaneous use as well as a week after stopping treatment with paracetamol.

    Storage

    Do not use the drug beyond the time limit stated on the box.

    Store less than 25 ° C in a dry place.

    Other drugs

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