Palexia - instructions for use, dose, side effects, contraindications

Active substanceTAPENTADOLTAPENTADOL

Similar drugsTo uncover

Palexia

pills inwards

Grünenthal GmbH Germany

Palexia

pills inwards

Grünenthal GmbH Germany

Dosage form: & nbsp

The tablets covered with a film membrane.

Composition:

Each film-coated tablet contains 50 mg of:

Core tablet: active ingredient - tapentadol hydrochloride 58,24 mg in terms of tapentadol 50.00 mg.

Excipients: microcrystalline cellulose 26.04 mg, lactose monohydrate 26.04 mg, croscarmellose sodium 7.50 mg, povidone-K30 6.25 mg, magnesium stearate 0.94 mg;

White film shell (Opadrai® II white 85F18422) 3.75 mg. Composition: polyvinyl alcohol 1.5000 mg, titanium dioxide (E171) 0.9375 mg, macrogol 3350 0.7575 mg, talc 0.5550 mg.

Each tablet, film-coated, 75 mg contains:

Core tablet: active ingredient - tapentadol hydrochloride 87.36 mg in terms of tapentadol 75.00 mg.

Excipients: microcrystalline cellulose 39.06 mg, lactose monohydrate 39.06 mg, croscarmellose sodium 11.25 mg, povidone-K30 9.38 mg, magnesium stearate 1.41 mg;

Yellow film membrane (Opadrai® II yellow 85E32072) 5.63 mg. Composition: polyvinyl alcohol 2.2520 mg, titanium dioxide (E171) 1.2099 mg, macrogol 3350 1.173 mg mg talc 0.8332 mg, iron oxide yellow (E172) 0.1971 mg, iron oxide red (E172) 0, 0005 mg.

Each film-coated tablet contains 100 mg of:

Tablet core: active ingredient - tapentadol hydrochloride 116.48 mg, at recalculate on tapentadol 100.00 mg.

Excipients: microcrystalline cellulose 52.08 mg, lactose monohydrate 52.08 mg, croscarmellose sodium 15.00 mg, povidone-K30 12.50 mg, magnesium stearate 1.88 mg;

Pink film shell (Opadrai® II pink 85F24141) 7.50 mg. Composition: polyvinyl alcohol 3.0000 mg, titanium dioxide (E171) 1.8315 mg, macropod 3350 1.5150 mg, talc 1,1100 mg, iron oxide yellow (E172) 0.0112 mg, iron oxide red (E172) 0 , 0300 mg, iron oxide black (E172) 0.0023 mg.

Description:

The tablets covered with a film membrane, 50 mg. White biconvex tablets, covered with a film membrane, on one side of the engraving - the Grünenthal logo, on the other side the engraving "116".

The tablets covered with a film membrane, 75 mg. Pale yellow biconvex tablets covered with a film membrane, on one side the engraving is the Grünenthal logo, on the other side is the engraving "117".

The tablets covered with a film membrane, 100 mg. Pale pink biconvex tablets covered with a film membrane, on one side the engraving is the Grünenthal logo, on the other side the engraving "118".

On the cross-section the nucleus is white, covered with a very thin layer of a film coat of white, pale yellow or pale pink for tablets of 50 mg, 75 mg and 100 mg, respectively.

Pharmacotherapeutic group:Analgesic narcotic drug

ATX: & nbsp

N.02.A.X.06 TAPENTADOL

Pharmacodynamics:

Tapentadol is a potent analgesic that is an agonist of mu-opioid receptors and an inhibitor of norepinephrine reuptake. TAPENTADOL directly exerts an analgesic effect of beta participation of pharmacologically active metabolites. TAPENTADOL demonstrated effectiveness in the pain of nociceptive, neuropathic, visceral genesis and pain caused by the inflammatory process. In clinical trials, the analgesic effectiveness of tapentadol was confirmed in nociceptive pains (including postoperative orthopedic and abdominal pains, as well as chronic pain in osteoarthritis of the hip or knee).

Action on the cardiovascular system: with a careful study of the interval QT, no effect from taking therapeutic and exceeding the therapeutic doses of tapentadol with respect to the interval QT was not established. TAPENTADOL did not exert significant effects on other parameters of the ECG (heart rate, interval PR, complex QRS, morphology of the T wave and U).

Pharmacokinetics:

Suction

After taking the drug Palexia in the tablets, covered with a film membrane, tapentadol quickly and completely absorbed.The average absolute bioavailability after ingestion of a single dose on an empty stomach in film-coated tablets is approximately 32% because of intensive pre-systemic metabolism. The maximum concentrations of tapentadol in the blood plasma are observed after 1.25 hours after the ingestion of tablets coated with a film membrane. Proportional dose growth C_max(maximum concentration) and AUC (the area under the concentration-time curve) is noted after the ingestion of film-coated tablets within the therapeutic range of doses.

The long-term administration of tapentadol (every 6 hours) at doses from 75 mg to 175 mg, in film-coated tablets, showed that the accumulation factor of tapentadol is 1.4 to 1.7 and 1.7 to 2.0 for its main metabolite - tapentadol-O-glucuronide, which was mainly determined by the dosage interval and the half-life of tapentadol. The equilibrium concentration of tapentadol in the blood plasma is reached on the second day after the start of the ingestion of the tablets covered with a film membrane.

Effect of food

AUC and C_maxincrease by 25% and 16%, respectively, with the ingestion of film-coated tablets after taking fatty high-calorie food.Time to reach C_max is postponed for 1.5 hours with the intake of high-calorie food. It was is clinically insignificant. The drug Palexia can be taken orally both before and after eating.

Distribution

Tapentadol has a large volume of distribution. After intravenous administration of tapentadol, the volume of distribution in the terminal phase of elimination (Vd) is 540 ± 98 liters. Binding to plasma proteins is low and does not exceed 20%.

Metabolism

Tapentadol undergoes a pronounced metabolism. Around 97 % compound is metabolized. The main way of metabolism of tapentadol is conjugation with glucuronic acid. After ingestion approximately 70 % dose is excreted into the urine in the form of conjugated forms (55% glucuronide and 15% sulphate tapentadol). Uridindifosfatglyukuroniltransferase (UGT) is the main enzyme involved in the glucuronation process (mainly isoenzymes UGT1A6. UGT1A9 and UGT2B7). In total, 3% of the tapentadol is excreted into the urine unchanged. TAPENTADOL also metabolized to N-desmethyltapentadol (13%) by the action of isoenzymes CYP2C9 and CYP2C19 and to hydroxy-tentadol (2%) genus by the action of isoenzyme CYP2D6, which are further subjected to conjugation.For this reason, the metabolism of tapentadol, mediated through the cytochrome P450 isoenzyme system, is of less importance but in comparison with glucuronidation.

None of the metabolites of tapentadol has an analgesic effect.

Excretion

Tapentadol and its metabolites are excreted almost completely (99%) by the kidneys. The total clearance after intravenous administration is 1530 ± 177 ml / min. The final half-life after taking tapentadol inside the tablets covered with a film membrane is an average of 4 hours.

Special categories of patients

Elderly patients

AUC tapentadol is similar in the elderly (65-78 years) and in middle-aged patients (19-43 years), while in elderly patients the average value C_max 16% lower than in middle-aged patients.

Impaired renal function

AUC and C_m_Oh tapentadol are comparable in patients with varying degrees of functional kidney function (from normal to severe disability). And, conversely, with the increase in the severity of renal failure, there was an increase in the area under the concentration-time curve (AUC) tapentadol-O-glucuronide. In patients with mild, moderate and severe renal impairment AUC tapentadol-O-glucuronide in 1.5, 2.5 and 5.5 times compared with patients with normal renal function, respectively.

Impaired liver function

In patients with impaired hepatic function, tapentadol intake was characterized by a higher AUC and serum concentration in comparison with patients with normal liver function. The ratios of the pharmacokinetic indexes of tapentadol for groups of patients with mild to moderate hepatic insufficiency when compared with the group of patients with normal liver function were 1.7 and 4.2, respectively AUC; 1.4 and 2.5 respectively for C_m_Oh; and 1,2 and 1,4 respectively for the half-life. The rate of formation of tapentadol-O-glucuronide in patients with more severe impairment of liver function is lower.

Pharmacokinetic interactions

Tacentadol is mainly metabolized through 2 phases (glucuronation), and only a small amount is metabolized through the oxidation processes of the 1 phase. Since glucuronidation is a high-potency system with low affinity, any clinically meaningful interaction associated with glucuronation is unlikely.This is confirmed by the experience of simultaneous application of tapentadol e with naproxen and probenecid, growth AUC tapentadol by 17% and 57%, respectively. With simultaneous use with paracetamol and acetylsalicylic acid, no changes in the pharmacokinetic index of tapentadol were observed.

TAPENTADOL is not an inducer or inhibitor of cytochrome P450 isoenzymes. Therefore, clinically significant interactions mediated through the cytochrome P450 isoenzyme system are unlikely.

The pharmacokinetics of tapentadol did not change under the influence of increased pH or peristalsis of the gastrointestinal tract caused by omeprazole and metoclopramide, respectively.

The binding of tapentadol to plasma proteins is low (approximately 20%). For this reason, the probability of pharmacokinetic interactions due to substitution from the connection with plasma proteins is small.

Indications:Acute pain syndrome of medium and high severity. The drug is used only for pain syndrome of medium and high intensity, requiring the appointment of opioid analgesics.

Contraindications:

- hypersensitivity to tapentadol or any of the excipients included in the formulation;

- in situations where agonist drugs of mu-opioid receptors are contraindicated, i.e. in patients with significant respiratory depression (with the impossibility of observation or absence of resuscitation equipment), as well as in patients with exacerbation or severe bronchial asthma or hypercapnia;

- presence or suspicion of paralytic ileus;

- acute intoxication with alcohol, sleeping pills, central analgesics and psychotropic drugs;

- in patients receiving monoamine oxidase inhibitors (MAO) or taking them within the last 14 days;

- severe renal insufficiency;

- severe hepatic impairment;

- age to 18 years;

- deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

Carefully:Palladium should be used with caution:

- at increased risk of misuse or abuse of the drug;

- when the respiratory function is impaired;

- in patients with craniocerebral trauma and oppression of consciousness;

- in patients with a history of convulsive syndrome or any conditions that increase the risk of seizures;

- in patients with moderate hepatic impairment;

- in patients with pathology of the bile duct and acute pancreatitis;

- in patients with low blood pressure.

It is recommended that the dose of Palexia is gradually reduced before complete cancellation. Caution is necessary when using the drug Palexia with serotonergic drugs at the same time.

Pregnancy and lactation:

Pregnancy

Data on the use of tapentadol during pregnancy are limited. In animal studies of teratogenic effects associated with tapentadol, ns was detected. However, in doses exceeding the upper limit of the therapeutic, a delay in embryonic development and embryotoxicity (effects on the central nervous system associated with agonism to mu-opioid receptors) were detected. Influence on postnatal development of offspring was revealed with the appointment of tapentadol in doses that did not cause undesirable phenomena in pregnant females.

The use of the drug Palexia during pregnancy is permissible only if the potential benefit to the mother exceeds the potential risk to the fetus.

Childbirth

The effect of tapentadol when administered during labor is unknown. Use tapentadol at childbirth and immediately before childbirth is not recommended. Due to the affinity of tapentadol for mu-opioid receptors, newborns whose mothers took tapentadol, should be carefully observed for possible development of respiratory depression.

Lactation

Information on the excretion of tapentadol in breast milk is limited. Physico-chemical and pharmacodynamic / toxicological data on tapentadol indicate excretion into breast milk, therefore the risk of exposure to a child fed can not be ruled out. The drug Palexia should not be prescribed during breastfeeding.

Dosing and Administration:

As with other analgesics with a central mechanism of action, the dose of the drug should be selected individually in accordance with the severity of the pain syndrome, previously conducted therapy and the possibility of monitoring the patient. The recommended initial dose of the drug Palexia in film-coated tablets for ingestion is 50 mg, 75 mg or 100 mg every 4 to 6 hours, depending on the initial pain intensity.On the first day of taking the drug, if the pain control could not be achieved, a second dose of the drug may be taken as early as 1 hour after taking the initial dose. Subsequently, the usual recommended dose is from 50 mg to 100 mg of tapentadol every 4 to 6 hours and should be matched to maintain adequate analgesia with acceptable tolerability.

The drug Palexia in the tablets, covered with a film membrane, is taken internally with a sufficient amount of liquid, without chewing, not breaking and dissolving ns.

The preparation of Palexia in film-coated tablets can be prescribed both before and after meals.

The total initial daily dose of more than 700 mg of tapentadol in film-coated tablets on the first day of treatment and maintaining a daily dose of more than 600 mg of tapentadol has not been prescribed and therefore not recommended.

End of treatment

With the simultaneous discontinuation of taking tapentadol, the syndrome of "cancellation" is possible. It is recommended to gradually reduce the dose before complete withdrawal of the drug in order to prevent the development of the "withdrawal" syndrome.

Adults with chronic diseases

Impaired renal function

Dose adjustments in patients with mild or moderate renal failure are not it takes.

The experience of application in patients with severe renal dysfunction is not, therefore, the use of the drug in this group of patients is contraindicated.

Impaired liver function

Dose adjustments in patients with mild hepatic impairment are not required. Care should be taken when prescribing to patients with moderate hepatic impairment. Treatment in such patients should start with 50 mg of tapentadol in film-coated tablets, not more often than once every 8 hours (maximum three doses per day). The further therapy should be aimed at maintaining the analgesic effect with an acceptable level of tolerance, which is achieved by increasing or decreasing the interval between the medications.

The experience of application in patients with severe impairment of liver function is not, and therefore the use in this group of patients is contraindicated.

Elderly patients (65 years and over)

In general, the recommended doses for elderly patients with normal liver and kidney function are the same as for middle-aged patients with normal kidney and liver function.Since elderly patients are more likely to have decreased kidney and liver function, care should be taken when choosing a dose and not exceeding recommended.

Use in children

The drug Palexia is contraindicated for use in patients under the age of 18 due to insufficient data on efficacy and safety.

Side effects:

Approximately 65% of patients who took the drug Palexia in film-coated tablets observed side effects, mostly of mild or moderate intensity. The most frequent of them were disorders of the gastrointestinal tract and central nervous system (nausea, dizziness, vomiting, drowsiness and headache).

The table below shows the side effects of the drug Palexia, identified during its use. They are represented by classes and frequency: very frequent (≥1 / 10); frequent (≥1 / 100, <1/10); infrequent (≥1 / 1 000, <1/100); rare (≥1 / 10,000, <1/1 000); very rare (<1/10 000).

System-Organ Classes	Frequency
System-Organ Classes	very frequent (≥1 / 10)	frequent (≥1/100, <1/10)	infrequent (≥1/1 000, <1/100)	rare (≥1/10 000, <1/1 000)
Violations from the nominal system				Hypersensitivity *
Disorders from the metabolism and nutrition		Decreased appetite
Disorders of the psyche		Anxiety, confusion, hallucinations, sleep disorders, unusual dreams	Depressed mood, disorientation in place and in time, psychomotor agitation, increased excitability, anxiety, euphoria	Pathological thinking
Disturbances from the nervous system	Dizziness, drowsiness headache,	Tremor	Attention disorder, memory impairment, pre-memory condition, sedation, ataxia, dysarthria, hypesthesia, paresthesia, involuntary muscle contraction	Convulsions, depression of consciousness, coordination disorders
Disturbances on the part of the organ of sight			Visual impairment
Violations from the heart and blood vessels		"Tides"	Increase heart rate, palpitations, lower blood pressure	Decreased heart rate
Disturbances from the respiratory system, chest and mediastinal organs			Inhibition of breathing, decreased oxygen saturation, shortness of breath
Disorders from the gastrointestinal tract	Nausea, vomiting	Constipation, diarrhea, indigestion, dry mouth	Discomfort in the abdomen	Disruption of evacuation of stomach contents
Disturbances from the skin and subcutaneous tissues		Itching, hyperhidrosis, rash	Hives
Disturbances from musculoskeletal and connective tissue		Muscle spasms	A feeling of heaviness
Disorders from the kidneys and urinary tract			Obstruction of urination, pollakiuria
General disorders and disorders at the site of administration		Asthenia, fatigue, sensation of changes in body temperature	The "cancellation" syndrome, swelling, unusual sensations, a feeling of intoxication, irritability, a sense of relaxation

* Note: In the post-marketing application, drugs reported on rare cases of angioedema, anaphylaxis and anaphylactic shock.

When taking the drug Palexia inside of the tablets covered with a film membrane, the duration of up to 90 days, there are cases of a mild "withdrawal" syndrome with a sudden interruption of therapy, but they were classified as light. However, less, doctors should take into account the possibility of the occurrence of the "withdrawal" syndrome and provide the necessary treatment in case of its occurrence.

In the post-marketing application of tapentadol, reports of the occurrence of suicidalthoughts. The causal relationship between the onset of suicidal thoughts and the use of tapentadol has not been established.

If any of the following side effects occur, or if there are other side effects not indicated in the instructions, tell your doctor.

Overdose:

Data on overdose are very limited.

Symptoms: it is necessary to expect inherent in all drugs with central analgesic effect and characterized by affinity for mu-opioid receptors of symptoms - miosis, vomiting, collapse, impaired consciousness up to coma, convulsions and respiratory depression with the possibility of stopping it.

Urgent care: treatment of overdose should be focused on eliminating the symptoms of stimulation of mu-opioid receptors. If suspicion of an overdose of tapentadol, attention should be focused on restoring airway patency and the use of controlled or controlled ventilation of the lungs. Complete opioid receptor antagonists, such as naloxone, are specific antidotes for respiratory depression associated with an overdose of narcotic analgesics.Respiratory depression after an overdose may exceed the duration of the opioid receptor antagonist. The appointment of an opioid receptor antagonist does not replace the continuous monitoring of the airway, the control of breathing disorders and blood circulation that have developed as a result of an overdose of narcotic analgesics. If the response to the introduction of opioid receptor antagonists is insufficient or short-term, an additional amount of antagonist may be administered.

Purification of the gastrointestinal tract can be performed to remove unabsorbed tapentadol. The use of activated carbon or gastric lavage can be performed within 2 hours after ingestion. Before cleaning the gastrointestinal tract, it is necessary to protect the respiratory tract.

Interaction:

The simultaneous use of tapentadol with benzodiazepines, barbiturates and opioids (analgesic, antitussives and remedies for withdrawal) may increase the risk of respiratory depression. Drugs that inhibit the central nervous system (CNS) (benzodiazepines, neuroleptics, H blockers₁-cystamine receptors, opioids, alcohol), can enhance the sedative effect of tapentadol and CNS depression. If a combination of tapentadol and drugs that cause respiratory depression or the central nervous system is necessary, the question of reducing the dose of drugs should be addressed.

Agonists-antagonists of opioid receptors. Caution should be exercised with the simultaneous use of tapentadol with agonist antagonists of mu-opioid receptors (eg, pentazocine, nalboufine) or partial agonists of mu-opioid receptors (eg, buprenorphine). With simultaneous use with buprenorphine, there was a need to increase the dose of agonists of the mu-opioid receptors, and in these circumstances careful monitoring of side effects such as respiratory depression is necessary.

There are isolated reports of the development of serotonin syndrome, but the timing coincided with the simultaneous use of tapentadol and serotonergic drugs, for example, selective serotonin reuptake inhibitors (SSRIs). Possible symptoms of serotonin syndrome may be, for example: confusion, agitation, fever, increased sweating, ataxia, hyperreflexia, myoclonia and diarrhea.The abolition of serotonergic drugs usually led to the rapid disappearance of symptoms. Therapy is determined by the nature and severity of the symptoms.

Since the main way of metabolism of tapentadol is conjugation with glucuronic acid with the participation of isoenzymes UGT1A6, UGT1A9 and UGT2B7. simultaneous use with potent inhibitors of these isoenzymes (such as ketoconazole, fluconazole, meclofenamic acid) can increase the systemic exposure of tapentadol.

Patients in the treatment of tapentadol should be careful at the beginning and at the end of the simultaneous use of powerful inducers of microsomal liver enzymes (for example, rifampicin, phenobarbital, drugs Hypericum perforatum), as this may lead to a decrease in efficacy or a risk of side effects, respectively.

Tapentadol is contraindicated in patients receiving monoamine oxidase inhibitors (MAO) or taking them for the last 14 days, it is possible to increase the content of I norepinephrine, which can cause side effects from the cardiovascular system, such as hypertensive crisis.

With the simultaneous use of tapentadol with naproxen and probenecid, growth AUC tapentadol by 17% and 57%, respectively. With simultaneous use with paracetamol and acetylsalicylic acid, no changes in the pharmacokinetic index of tapentadol were observed.

Special instructions:

Possible abuse of the drug

There is a potential risk of abuse of the drug Palexia. This should be taken into account when prescribing the drug in situations where there is a risk of misuse, abuse of the drug or transfer of the drug to others.

All patients treated with mu-opioid receptor agonist drugs are closely monitored for drug abuse and dependence.

Inhibition of respiration

In high doses and in patients with hypersensitivity to agonists of mu-opioid receptors tapentadol can provoke a dose-dependent respiratory depression. For this reason, patients with respiratory function impairment drug Palexia should be administered with caution. Consideration should be given to analgesics not belonging to agonists of mu-opioid receptors, and the drug Palexia in such patients should be used only under close medical supervision and in minimal effective doses. With respiratory depression, treatment should be performed as in the case of respiratory depression against the background of the use of any other agonist of mu-opioid receptors.

Craniocerebral injury and increased intracranial pressure

As with the use of other drugs - agonists of mu-opioid receptors, tapentadol should not be given to patients who may be particularly sensitive to pathophysiological reactions developing with increasing partial pressure of carbon dioxide in the intracranial vessels and brain tissue, for example, with increased intracranial pressure, oppression or coma. Analgesics, characterized by their affinity for mu-opioid receptors, can mask the clinical manifestations of craniocerebral trauma. The drug Palexia should be used with caution in patients with craniocerebral trauma and brain tumors.

Convulsions

A systematic study of tapentadol in patients with convulsive syndrome was not performed. Nevertheless, like other analgesics with an affinity for mu-opioid receptors, the preparation Palexia should be administered with caution to patients with a history of convulsive syndrome or any conditions that put the patient at risk for seizures.

Liver failure

In patients with impaired hepatic function, an increase in serum concentrations of tapentadol was found compared with patients with normal liver function. The drug Palexia should be used with caution in patients with moderate hepatic impairment. The drug Palexia in patients with severe a violation of the liver was not studied, and therefore contraindicated in the use of this group of patients.

Use in the pathology of the pancreas and bile ducts

Drugs that have an affinity for mu-opioid receptors can cause spasm of the sphincter of Oddi. The drug Palexia should be used with caution in patients with pathology of the biliary tract and acute pancreatitis.

The "cancellation" syndrome

With the simultaneous discontinuation of taking tapentadol, the syndrome of "cancellation" is possible. The following symptoms may occur: anxiety, increased sweating, insomnia, chills, pain, nausea, tremors, diarrhea, symptoms from the upper respiratory tract, piloerection and, rarely, hallucinations. In order to prevent the syndrome of "withdrawal", it is recommended that the dose of the drug be gradually reduced before complete cancellation.

Inhibition of the central nervous system

The simultaneous use of tapentadol with other analgesics-agonists of mu-opioid receptors, narcosis drugs, phenothiazine derivatives, tranquilizers, sedatives, hypnotics and other drugs depressing the central nervous system (CNS), including alcohol and drugs, can increase CNS depression. Drug interactions leading to Deep sedation and coma may develop if these preparations with tapentadol. If such a combination is necessary, the question of reducing the dose of one of the drugs should be resolved.

Reduction of blood pressure

The drug Palexia can cause a significant reduction in blood pressure especially in patients with hypovolemia or taking concomitantly with tapentadol drugs that reduce the tone of peripheral vessels (eg, phenothiazine derivatives, anesthesia products).

Serotonin syndrome

There are reports of the development of a life-threatening serotonin syndrome with the simultaneous use of tapentadol even in therapeutic doses with serotonergic drugs: selective serotonin reuptake inhibitors (SSRIs), serotonin and noradrenaline reuptake inhibitors, tricyclic antidepressants, tryptanes, drugs that affect serotonergic transmission in the central nervous system (for example, mirtazapine, trazodone and tramadol), and drugs that interfere with the metabolism of serotonin (eg, MAO inhibitors). Possible symptoms of serotonin syndrome may be, for example: confusion, agitation, coma, tachycardia, fever, disruption of movement coordination, nausea, vomiting and diarrhea.

Tapentadol should be used with caution in patients with adrenocortical insufficiency (eg, in Addison's disease), in the case of nazis with alcoholic delirium, toxic psychosis, with myxedema and hypothyroidism, as well as prostatic hypertrophy and urethral strictures.

Effect on the ability to drive transp. cf. and fur:Like other agonist drugs, mu-opioid receptors, Palexia can adversely affect the ability to drive vehicles and complex mechanisms, because has an effect on the central nervous system. Especially often this effect is possible at the beginning of treatment, with any changes in the dose of the drug, while taking with tranquilizers or alcohol. Patients should refrain from driving a car and practicing potentially hazardous activities.

Form release / dosage:

The tablets covered with a film membrane, 50 mg, 75 mg, 100 mg.

Packaging:

For 10 tablets, coated with a film membrane, in the contour cell packaging of PVC / PVDC / aluminum. For 2 or 6 contour packagings together with instructions for use in a cardboard bundle.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:3 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002637

Date of registration:22.09.2014

The owner of the registration certificate:Grünenthal GmbHGrünenthal GmbH Germany

Manufacturer: & nbsp

FARMACEUTICI FORMENTI, S.p.A. Italy

Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia

Information update date: & nbsp28.10.2015

Illustrated instructions

Instructions

Palexia (Palexia)