Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Selincro

Selincro 18 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-127557 · Präparat HOS-096425

Confusional state and, rarely, hallucinations and dissociation were reported in the clinical studies. The majority of these reactions were mild or moderate, associated with treatment initiation, and of short duration (a few hours to a few days). Most of these adverse reactions resolved during continued treatment and did not recur upon repeated administration. While these events were generally short- lasting, they could represent alcoholic psychosis, alcohol withdrawal syndrome, or comorbid psychiatric disease.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Selincro

Selincro 18 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-127558 · Präparat HOS-096425

Tabulated list of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Selincro

Selincro 18 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6

HOS-127559 · Präparat HOS-096425

Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Selincro

Selincro 18 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 6–7

HOS-127560 · Präparat HOS-096425

6 Table 1. Frequencies of adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Selincro

Selincro 18 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-127561 · Präparat HOS-096425

System Organ Class Frequency Adverse Reaction Metabolism and nutrition disorders Common Decreased appetite Very common Insomnia Common Sleep disorder Confusional state Restlessness Libido decreased (including loss of Psychiatric disorders libido) Uncommon Hallucination (including hallucination auditory, hallucination tactile, hallucination visual, and somatic hallucination) Dissociation Very Common Dizziness Headache Common Somnolence Nervous system disorders Tremor Disturbance in attention Paraesthesia Hypoaesthesia Not known Visual impairment (mostly Eye disorders transient) Common Tachycardia Cardiac disorders Palpitations Very Common Nausea Common Vomiting Gastrointestinal disorders Dry mouth Diarrhoea Common Hyperhidrosis Not known Angioedema Skin and subcutaneous tissue Urticaria disorders Pruritus Rash Erythema Musculoskeletal and connective Common Muscle spasms tissue disorders Not known Myalgia Reproductive system and breast Not known Priapism disorder Common Fatigue General disorders and Asthenia administration site conditions Malaise Feeling abnormal Investigations Common Weight decreased

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Selincro

Selincro 18 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-127562 · Präparat HOS-096425

Reporting of suspected adverse reactions

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Nebenwirkungen · Selincro

Selincro 18 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 7

HOS-127563 · Präparat HOS-096425

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

Gegenanzeigen · Zubsolv

Zubsolv 0.7 mg/0.18 mg sublingual tablets Zubsolv 1.4 mg/0.36 mg sublingual tablets Zubsolv 2.9 mg/0.71 mg sublingual tablets Zubsolv 5.7 mg/1.4 mg sublingual tablets Zubsolv 8.6 mg/2.1 mg sublingual tablets Zubsolv 11.4 mg/2.9 mg sublingual tablets · Abschnitt 4.3 · PDF-Seite 5

HOS-138576 · Präparat HOS-098216

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1. Severe respiratory insufficiency. Severe hepatic impairment. Acute alcoholism or delirium tremens. Concomitant administration of opioid antagonists (naltrexone, nalmefene) for the treatment of alcohol or opioid dependence.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): naltrexone (HOS-115836) nalmefene (HOS-115837)

Wechselwirkungen · Zubsolv

Zubsolv 0.7 mg/0.18 mg sublingual tablets Zubsolv 1.4 mg/0.36 mg sublingual tablets Zubsolv 2.9 mg/0.71 mg sublingual tablets Zubsolv 5.7 mg/1.4 mg sublingual tablets Zubsolv 8.6 mg/2.1 mg sublingual tablets Zubsolv 11.4 mg/2.9 mg sublingual tablets · Abschnitt 4.5 · PDF-Seite 9–10

HOS-138581 · Präparat HOS-098216

Zubsolv should be used cautiously when co-administered with: • Sedatives such as benzodiazepines or related medicinal products The concomitant use of opioids with sedative medicinal products such as benzodiazepines or related medicinal products increases the risk of sedation, respiratory depression, coma and death because of additive CNS depressant effect. The dose and duration of concomitant use of sedative medicinal products should be limited (see section 4.4). Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines while taking this medicinal product and should also be cautioned to use benzodiazepines concurrently with this medicinal product only as directed by their physician (see section 4.4). • The concomitant use of Zubsolv with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death (see section 4.4). • Other central nervous system depressants, other opioid derivatives (e.g. methadone, analgesics and antitussives), certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, neuroleptics, clonidine and related substances: these combinations increase central nervous system depression. The reduced level of alertness can make driving and using machines hazardous. • Furthermore, adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine/naloxone. Therefore the potential to overdose with a full agonist exists, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining • Serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4) • naltrexone and nalmefene are opioid antagonists that can block the pharmacological effects of buprenorphine. Co-administration during buprenorphine/naloxone treatment is 9  contraindicated due to the potentially dangerous interaction that may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms (see section 4.3). • CYP3A4 inhibitors: an interaction study of buprenorphine with ketoconazole (a potent inhibitor of CYP3A4) resulted in increased Cmax and AUC (area under the curve) of buprenorphine (approximately 50 % and 70 % respectively) and, to a lesser extent, of norbuprenorphine Patients receiving Zubsolv should be closely monitored, and may require dose-reduction if combined with potent CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir or azole antifungals such as ketoconazole or itraconazole, macrolide antibiotics). • CYP3A4 inducers: Concomitant use of CYP3A4 inducers with buprenorphine may decrease buprenorphine plasma concentrations, potentially resulting in sub-optimal treatment of opioid dependence with buprenorphine. It is recommended that patients receiving buprenorphine/naloxone should be closely monitored if inducers (e.g. phenobarbital, carbamazepine, phenytoin, rifampicin) are co-administered. The dose of buprenorphine or the CYP3A4 inducer may need to be adjusted accordingly. • The concomitant use of monoamine oxidase inhibitors (MAOI) might produce exaggeration of the effects of opioids, based on experience with morphine.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) pregabalin (HOS-112893) norepinephrine (HOS-090547) nelfinavir (HOS-084520) methadone (HOS-086198) protease (HOS-085623) phenobarbital (HOS-085617) ketoconazole (HOS-084513) clonidine (HOS-088594) carbamazepine (HOS-085618) naltrexone (HOS-115836) nalmefene (HOS-115837) morphine (HOS-086053) gabapentin (HOS-090745) serotonin (HOS-085477) itraconazole (HOS-084516) ritonavir (HOS-084521) phenytoin (HOS-084531)

Wechselwirkungen · Buvidal

Buvidal 8 mg prolonged-release solution for injection Buvidal 16 mg prolonged-release solution for injection Buvidal 24 mg prolonged-release solution for injection Buvidal 32 mg prolonged-release solution for injection · Abschnitt 4.5 · PDF-Seite 8

HOS-140298 · Präparat HOS-098498

Buprenorphine should be used cautiously when co-administered with: • naltrexone and nalmefene: These are opioid antagonists that can block the pharmacological effects of buprenorphine. For opioid-dependent patients currently receiving buprenorphine treatment, naltrexone may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms. For patients currently receiving naltrexone treatment, the intended therapeutic effects of buprenorphine administration may be blocked by naltrexone. • alcoholic drinks or medicinal products containing alcohol as alcohol increases the sedative effect of buprenorphine (see section 4.7). • benzodiazepines: This combination may result in death due to respiratory depression of central origin. Therefore, dosages must be closely monitored and this combination must be avoided in cases where there is a risk of misuse. Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines whilst taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their physician (see section 4.4). • gabapentinoids: The concomitant use of Buvidal with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death. Therefore, dosages must be closely monitored and this combination must be avoided in cases where there is a risk of misuse. Patients should be cautioned to use gabapentinoids concurrently with this product only as directed by their physician (see section 4.4). • Serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4). • other central nervous system depressants: Other opioid derivatives (e.g. methadone, analgesics and antitussives); certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, antipsychotics, clonidine and related substances. These combinations increase central nervous system depression. The reduced level of alertness can make driving and using machinery hazardous (see section 4.7). • opioid analgesics: Adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine. The potential for overdose also exists with a full agonist, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining (see section 4.4) • Buprenorphine is metabolised to norbuprenorphine primarily by CYP3A4. Interaction with co- administered inducers or inhibitors have been established in studies using transmucosal and transdermal buprenorphine. Buprenorphine is also metabolised to buprenorphine-3β- glucuronide by UGT1A1. • CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine. Buvidal avoids first-pass effects and CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole or itraconazole, or macrolide antibiotics) are

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) pregabalin (HOS-112893) norepinephrine (HOS-090547) nelfinavir (HOS-084520) methadone (HOS-086198) protease (HOS-085623) ketoconazole (HOS-084513) clonidine (HOS-088594) naltrexone (HOS-115836) nalmefene (HOS-115837) gabapentin (HOS-090745) serotonin (HOS-085477) itraconazole (HOS-084516) ritonavir (HOS-084521)

Wechselwirkungen · Buvidal

Buvidal 64 mg prolonged-release solution for injection Buvidal 96 mg prolonged-release solution for injection Buvidal 128 mg prolonged-release solution for injection Buvidal 160 mg prolonged-release solution for injection · Abschnitt 4.5 · PDF-Seite 24

HOS-140339 · Präparat HOS-098498

Buprenorphine should be used cautiously when co-administered with: • naltrexone and nalmefene: These are opioid antagonists that can block the pharmacological effects of buprenorphine. For opioid-dependent patients currently receiving buprenorphine treatment, naltrexone may precipitate a sudden onset of prolonged and intense opioid withdrawal symptoms. For patients currently receiving naltrexone treatment, the intended therapeutic effects of buprenorphine administration may be blocked by naltrexone. • alcoholic drinks or medicinal products containing alcohol as alcohol increases the sedative effect of buprenorphine (see section 4.7). • benzodiazepines: This combination may result in death due to respiratory depression of central origin. Therefore, dosages must be closely monitored and this combination must be avoided in cases where there is a risk of misuse. Patients should be warned that it is extremely dangerous to self-administer non-prescribed benzodiazepines whilst taking this product, and should also be cautioned to use benzodiazepines concurrently with this product only as directed by their physician (see section 4.4). • gabapentinoids: The concomitant use of Buvidal with gabapentinoids (gabapentin and pregabalin) may result in respiratory depression, hypotension, profound sedation, coma or death. Therefore, dosages must be closely monitored and this combination must be avoided in cases where there is a risk of misuse. Patients should be cautioned to use gabapentinoids concurrently with this product only as directed by their physician (see section 4.4). • Serotonergic medicinal products, such as MAO inhibitors, selective serotonin re-uptake inhibitors (SSRIs), serotonin norepinephrine re-uptake inhibitors (SNRIs) or tricyclic antidepressants as the risk of serotonin syndrome, a potentially life-threatening condition, is increased (see section 4.4). • other central nervous system depressants: Other opioid derivatives (e.g. methadone, analgesics and antitussives); certain antidepressants, sedative H1-receptor antagonists, barbiturates, anxiolytics other than benzodiazepines, antipsychotics, clonidine and related substances. These combinations increase central nervous system depression. The reduced level of alertness can make driving and using machinery hazardous (see section 4.7). • opioid analgesics: Adequate analgesia may be difficult to achieve when administering a full opioid agonist in patients receiving buprenorphine. The potential for overdose also exists with a full agonist, especially when attempting to overcome buprenorphine partial agonist effects, or when buprenorphine plasma levels are declining (see section 4.4) • Buprenorphine is metabolised to norbuprenorphine primarily by CYP3A4. Interaction with co- administered inducers or inhibitors have been established in studies using transmucosal and transdermal buprenorphine. Buprenorphine is also metabolised to buprenorphine-3β- glucuronide by UGT1A1. • CYP3A4 inhibitors may inhibit the metabolism of buprenorphine resulting in increased Cmax and AUC of buprenorphine and norbuprenorphine. Buvidal avoids first-pass effects and CYP3A4 inhibitors (e.g. protease inhibitors like ritonavir, nelfinavir or indinavir, or azole antifungals such as ketoconazole or itraconazole, or macrolide antibiotics) are expected to have less effects on buprenorphine metabolism when co-administered with Buvidal as compared to when co-administered with sublingual buprenorphine. When switching from sublingual buprenorphine to Buvidal, patients may need to be monitored to ensure plasma buprenorphine levels are adequate. Patients already on Buvidal who start treatment with CYP3A4 inhibitors should be treated with weekly Buvidal and be monitored for signs and symptoms of overtreatment. Conversely, if a patient who is concomitantly treated with Buvidal and a CYP3A4

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.

RxNorm-Namen im Text (wörtliche Treffer, Rolle nicht bewertet): indinavir (HOS-084518) pregabalin (HOS-112893) norepinephrine (HOS-090547) nelfinavir (HOS-084520) methadone (HOS-086198) protease (HOS-085623) ketoconazole (HOS-084513) clonidine (HOS-088594) naltrexone (HOS-115836) nalmefene (HOS-115837) gabapentin (HOS-090745) serotonin (HOS-085477) itraconazole (HOS-084516) ritonavir (HOS-084521)