Selincro pills 18mg, 14pcs

Composition

One tablet contains:

Active ingredient-Nalmefenee hydrochloride dihydrate 21.917 mg in terms of Nalmefenee hydrochloride 20.0 mg, in terms of Nalmefenee 18.06 mg;

Excipients-microcrystalline cellulose 61.4 mg,

anhydrous lactose 60.683 mg,

crospovidone (type A) 4.5 mg,

magnesium stearate 1.5 mg;

Film shell-Opadray OY-S-28849 white 4.5 mg (hypromellose (5 MPa. c), macrogol 400, titanium dioxide (E 171)).

Pharmacological action

A drug for the treatment of alcohol dependence.

Nalmefenee is a modulator of the opioid system with a pronounced affinity for mk -, δ-and κ-receptors.

Indications

• reduction of alcohol consumption in adult patients with alcohol dependence who have a high risk of alcohol abuse, in the absence of physical manifestations of withdrawal syndrome or the need for immediate detoxification.

Selincro is recommended to be used in combination with long-term psychosocial support aimed at maintaining treatment adherence and reducing alcohol consumption.

Selincro is prescribed after two weeks of monitoring a patient with a continuing high risk of alcohol abuse.

Contraindications

Hypersensitivity to Nalmefenee or any of the components of the drug; hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Use in patients currently taking opioid analgesics.

Current or recent opioid addiction.

Acute opioid withdrawal symptoms.

Suspected recent opioid use.

Severe hepatic insufficiency (Child-Pugh classification).

Severe renal insufficiency (calculated glomerular filtration rate (eGFR))

Alcohol withdrawal status (including hallucinations, seizures, and alcoholic delirium) in the recent past.

Children and adolescents (under 18 years of age) (efficacy and safety of use have not been confirmed). Pregnancy, breast-feeding period.

With caution:

Related mental disorders in the phase of decompensation (due to the lack of clinical data); convulsive disorders in anamnesis, including convulsions, developing upon the cancellation of alcohol; mild or moderate renal or hepatic insufficiency, elevated levels of ALT and AST (more than 3 times the upper limit of normal); the simultaneous use of potent inhibitors of isoenzyme UGT2B7 for a long time; elderly patients (>65 years).

Side effects

The most common adverse reactions in clinical trials were nausea, dizziness, insomnia, and headaches.

Most of these reactions were mild or moderate, associated with the start of treatment, and short-lived.

Confusion and, less frequently, hallucinations and dissociation have been reported in clinical trials.

Most of these reactions were mild or moderate, associated with the start of treatment, and short-term (from a few hours to several days).

Most adverse reactions resolve with continued treatment and do not recur with repeated use.

Alcohol-related psychoses, alcohol withdrawal symptoms, or concomitant psychiatric illnesses were also observed, usually of short duration.

Frequency is defined as: very common (≥1/10), common (≥1/100

) – From the side of nutrition and metabolism Often: Decreased appetite. Weight loss.

– From the side of the psyche very often: Insomnia. Common: Sleep disorders, confusion, restlessness, decreased libido (including loss of libido). Frequency unknown: Hallucinations (including auditory, tactile, visual and somatic hallucinations), dissociation.

– From the nervous system Very often: Dizziness, headache. Often: Drowsiness, tremor, impaired attention, paresthesia, hypesthesia.

– From the cardiovascular system Often: Tachycardia, palpitations.

– From the digestive system Very often: Nausea. Often: Vomiting, dry mouth.

– From the skin and subcutaneous tissue often: Hyperhidrosis.

– Musculoskeletal system disorders Often: Muscle spasms.

– Common disorders often: Fatigue, asthenia, malaise, unusual sensations.

Interaction

Drug interaction studies have not been conducted in vivo.

Based on in vitro studies, no clinically significant interactions are expected between Nalmefenee or its metabolites and concomitantly targeted medicinal products that are primarily metabolized by CYP450 and UGT enzymes or membrane transporters.

Concomitant use with drugs that are strong inhibitors of the UGT2B7 enzyme (for example, diclofenac, fluconazole, medroxyprogesterone acetate, meclofenamic acid) may significantly increase the effect of Nalmefenee.

This is unlikely to cause a problem with episodic use, but if simultaneous long-term treatment with a powerful UGT2B7 inhibitor is initiated, the potential for increasing the effect of Nalmefene cannot be excluded. On the other hand, concomitant use of an UGT inducer (e. g. dexamethasone, phenobarbital, rifampicin, omeprazole) may result in subtherapeutic plasma concentrations of Nalmefenee.

If Selincro is used simultaneously with opioid agonists (for example, some cough and cold medications, some antidiarrheal medications, and opioid analgesics), the patient may not benefit from the use of opioid agonists.

There are no clinically significant pharmacokinetic interactions between Nalmefenee and alcohol. There may be a slight deterioration in cognitive and psychomotor functions after use of Nalmefenee. However, the effect of Nalmefenee and alcohol in combination does not exceed the sum of the effects of each substance taken separately.

Simultaneous intake of alcohol and Selincro does not prevent alcohol intoxication.

How to take, course of use and dosage

During the initial visit, before prescribing Selincro, the doctor needs to assess the patient’s clinical condition and alcohol consumption level (according to him). In cases where additional information is required, the patient is asked to register the level of alcohol consumption for approximately the next two weeks. For those patients who have maintained a comparable level of alcohol consumption during these two weeks, Selincro may be prescribed at a second visit.

Selincro is recommended to be used in combination with psychosocial support aimed at maintaining treatment adherence and reducing alcohol consumption.

Selincro is not intended to achieve immediate abstinence from alcohol. Reducing alcohol consumption is an intermediate goal on the path to total abstinence.

Selincro is used as needed. The decision to take the drug is made by the patient himself: on those days when, in his opinion, there is a high probability of drinking alcohol,1 tab is taken 1-2 hours before the expected time of admission. Selincro in a dose of 18 mg. If a patient starts taking alcohol without first taking a Selincro tablet, they should do so as soon as possible.

The maximum daily dose of Selincro is 1 tab. Selincro can be taken regardless of food intake.

In clinical trials, the maximum improvement was observed during the first 4 weeks of therapy. The patient’s response to treatment and the appropriateness of continuing pharmacotherapy should be evaluated regularly (for example, monthly). The doctor should constantly monitor the patient’s progress in reducing alcohol consumption, their general condition, adherence to therapy, and the occurrence of side effects.

The duration of clinical trials of Selincro did not exceed 12 months, so its appointment for a period of more than one year should be carried out with caution.

Method of application

Film-coated tablets should be taken whole. Tablets should not be divided or otherwise disturbed, as Nalmefenee may cause irritation in case of direct contact with the skin.

Overdose

In a study in patients diagnosed with pathological gambling addiction, Nalmefenee was used in doses up to 90 mg / day for 16 weeks. In a study in patients with interstitial cystitis,20 patients took Nalmefenee at a dose of 108 mg / day for more than 2 years.

A single 450 mg dose of ialmefen has been reported without any changes in blood pressure, heart rate, respiratory rate, or body temperature.

In these cases, the safety profile of Nalmefenee was consistent with that described in the “Side effects” section above, but there is limited follow-up experience.

Treatment

In case of overdose, symptomatic therapy and monitoring of the patient’s condition are recommended.

Special instructions

Selincro is not intended to achieve immediate abstinence from alcohol. Reducing alcohol consumption is an intermediate goal on the path to total abstinence.

Opioid use

In an emergency situation, when a patient taking Selincro needs to be administered opioids, the doses of the latter required to achieve the desired effect may exceed the standard ones. At the same time, you should carefully monitor the symptoms of respiratory depression resulting from opioid use, and other adverse reactions.

If opioids need to be administered in order to help a patient in an emergency, their doses should be selected individually.If too high doses of opioids are required, the patient’s condition should be carefully monitored.

Selincro should be temporarily discontinued 1 week prior to the intended use of opioids, for example, during elective surgery.

The doctor who prescribes Selincro should recommend that the patient inform the medical professionals about the time of the last use of the drug in cases where opioid use becomes necessary.

Caution should be exercised when opioid-containing medications (such as antitussive medications and opioid analgesics) are used in patients who are already receiving Selincro therapy.

Nalmefenee is contraindicated in patients currently taking opioid analgesics.

Concomitant diseases

Mental disorders

Psychiatric adverse reactions have been reported in clinical trials (see section “Adverse effects”). If the patient experiences mental disorders that are not related to the start of Selincro and/or are not temporary, the doctor should consider alternative causes of these symptoms and evaluate the need to continue therapy with Selincro.

Selincro has not been studied in patients with unstable mental illnesses. Selincro should be used with caution in patients with concomitant mental illnesses in the decompensation phase, including patients diagnosed with major depressive disorder.

Convulsive disorders

Experience of using the drug in patients with a history of convulsive disorders, including seizures that develop when alcohol withdrawal occurs, is limited. Caution is recommended if Selincro is used to reduce alcohol consumption in this group of patients.

Impaired kidney or liver function

Selincro is actively metabolized in the liver and is mainly excreted in the urine. For this reason, caution should be exercised when prescribing Selincro to patients with mild to moderate renal or hepatic insufficiency. Caution should be exercised when prescribing Selincro to patients with elevated ALT and ACT levels (more than 3 times the upper limit of normal), since this category of patients was excluded in clinical studies.

Elderly patients (≥65 years)

Clinical data on the use of Selincro in patients with alcohol dependence aged 65 years and older are limited. Caution should be exercised when prescribing Selincro to patients aged 65 years and older.

Other services

Caution should be exercised when Selincro is co-administered with potent inhibitors of the UGT2B7 isoenzyme.

Lactose

Patients with rare hereditary problems such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not use this medicine.

Influence on the ability to drive vehicles and work with mechanisms

The effect of Nalmefenee on the ability to drive vehicles and work with mechanisms has not been studied.

Selincro may cause undesirable reactions such as nausea, dizziness, insomnia, and headache. Most of these reactions were mild to moderate in severity and were observed only at the beginning of treatment.

Patients taking Selincro are not recommended to drive vehicles or work with mechanisms until the individual reaction to the drug is clarified.

Form of production

Film-coated tablets

Active ingredient

Nalmefenee

Conditions of release from pharmacies

By prescription

Dosage form

Tablets