Buvidal · 4.6 Fertility, pregnancy and lactation · 1

HOS-098511 · has-adverse-reaction-information · PDF-Seite 26

Summary of the safety profile The adverse reactions most frequently reported for buprenorphine are headache, nausea, hyperhidrosis, insomnia, drug withdrawal syndrome and pain. Tabulated list of adverse reactions Table 2 presents adverse reactions reported for buprenorphine, including Buvidal. The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100) and frequency not known (cannot be estimated from available data). Table 2. Adverse reactions listed by body system System Organ Class Very common Common Uncommon Not known Infections and Infection Injection site infestations Influenza cellulitis Pharyngitis Rhinitis Blood and Lymphadenopathy lymphatic system disorders Immune system Hypersensitivity disorders Metabolism and Decreased appetite nutrition disorders Psychiatric Insomnia Anxiety Hallucinations disorders Agitation Euphoric mood Depression Hostility Nervousness Thinking abnormal Paranoia Medical dependence Nervous system Headache Somnolence disorders Dizziness Migraine Paraesthesia Syncope Tremor Hypertonia Speech disorders Eye disorders Lacrimal disorder Mydriasis Miosis Ear and labyrinth Vertigo disorders Cardiac disorders Palpitations Vascular disorders Vasodilation Hypotension Respiratory, Cough thoracic and

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HOS-098505 · has-adverse-reaction-information · PDF-Seite 10

Summary of the safety profile The adverse reactions most frequently reported for buprenorphine are headache, nausea, hyperhidrosis, insomnia, drug withdrawal syndrome and pain. Tabulated list of adverse reactions Table 2 presents adverse reactions reported for buprenorphine, including Buvidal. The following terms and frequencies are applied: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100) and frequency not known (cannot be estimated from available data). Table 2. Adverse reactions listed by body system System Organ Class Very common Common Uncommon Not known Infections and Infection Injection site infestations Influenza cellulitis Pharyngitis Rhinitis Blood and lymphatic Lymphadenopathy system disorders Immune system Hypersensitivity disorders Metabolism and Decreased appetite nutrition disorders Psychiatric disorders Insomnia Anxiety Hallucinations Agitation Euphoric mood Depression Hostility Nervousness Thinking abnormal Paranoia Medical dependence Nervous system Headache Somnolence disorders Dizziness Migraine Paraesthesia Syncope Tremor Hypertonia Speech disorders Eye disorders Lacrimal disorder Mydriasis Miosis 10 Table 2. Adverse reactions listed by body system System Organ Class Very common Common Uncommon Not known Ear a

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HOS-098501 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Severe respiratory insufficiency Severe hepatic impairment Acute alcoholism or delirium tremens

HOS-098507 · has-contraindication-information · PDF-Seite 20

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 Severe respiratory insufficiency 20 Severe hepatic impairment Acute alcoholism or delirium tremens

HOS-098506 · has-indication-information · PDF-Seite 18

Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.

HOS-098500 · has-indication-information · PDF-Seite 2

Treatment of opioid dependence within a framework of medical, social and psychological treatment. Treatment is intended for use in adults and adolescents aged 16 years or over.

HOS-098503 · has-interaction-information · PDF-Seite 8

No interaction studies have been performed with Buvidal. 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 sectio

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HOS-098509 · has-interaction-information · PDF-Seite 24

No interaction studies have been performed with Buvidal. 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 sectio

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HOS-098504 · has-pregnancy-information · PDF-Seite 9

Pregnancy There are no or limited data from the use of buprenorphine in pregnant women. Animal studies do not indicate reproductive toxicity (see section 5.3). Buprenorphine should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus. Towards the end of pregnancy, buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration. Long-term administration during the last three months of pregnancy may cause a withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions). The syndrome is generally delayed from several hours to several days after birth. Due to the long half-life of buprenorphine, neonatal monitoring for several days after birth should be considered to prevent the risk of respiratory depression or withdrawal syndrome in neonates. Breast-feeding Buprenorphine and its metabolites are excreted in human breast milk and Buvidal should be used with caution during breast-feeding. Fertility There are no or limited data on effects of buprenorphine on human fertility. An effect of buprenorphine on fertility in animals has not been seen (see section 5.3). 9

HOS-098510 · has-pregnancy-information · PDF-Seite 25

Pregnancy There are no or limited data from the use of buprenorphine in pregnant women. Animal studies do not indicate reproductive toxicity (see section 5.3). Buprenorphine should be used during pregnancy only if the potential benefit outweighs the potential risk to the foetus. Towards the end of pregnancy, buprenorphine may induce respiratory depression in the newborn infant even after a short period of administration. Long-term administration during the last three months of pregnancy may cause a withdrawal syndrome in the neonate (e.g. hypertonia, neonatal tremor, neonatal agitation, myoclonus or convulsions). The syndrome is generally delayed from several hours to several days after birth. Due to the long half-life of buprenorphine, neonatal monitoring for several days after birth should be considered to prevent the risk of respiratory depression or withdrawal syndrome in neonates. Breast-feeding Buprenorphine and its metabolites are excreted in human breast milk and Buvidal should be used with caution during breast-feeding. Fertility There are no or limited data on effects of buprenorphine on human fertility. An effect of buprenorphine on fertility in animals has not been seen (see section 5.3).

HOS-098502 · has-warning-information · PDF-Seite 5

Administration Care must be taken to avoid inadvertent injection of Buvidal. The dose must not be administered intravascularly (intravenously), intramuscularly or intradermally. Intravascular such as intravenous injection would present a risk of serious harm as Buvidal forms a solid mass upon contact with body fluids, which potentially could cause blood vessel injury, occlusion, or thromboembolic events. To minimise the risk of misuse, abuse and diversion, appropriate precautions should be taken when prescribing and dispensing buprenorphine. Healthcare professionals should administer Buvidal directly to the patient. Take-home use or self-administration of the product by patients is not allowed. Any attempts to remove the depot should be monitored throughout treatment. Prolonged-release properties The prolonged-release properties of the product should be considered during treatment including initiation and termination (see section 4.2). In particular, patients with concomitant medicinal products and/or co-morbidities, should be monitored for signs and symptoms of toxicity, overdose or withdrawal caused by increased or decreased levels of buprenorphine (see sections 4.5 and 5.2). Respiratory depression A number of cases of death due to respiratory depression have been reported for patients being treated with buprenorphine, particularly when used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information. Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol, gabapentinoids (such as pregabalin and gabapentin) (see section 4.5) or other opioids. Buprenorphine should be used with care in patients with respiratory insufficiency (e.g. chronic obstructive pulmonary disease, asthma, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis). Buprenorphine may cause severe, possibly fatal, respiratory depression in children and non-opioid dependent persons who accidentally or deliberately use it. CNS depression Buprenorphine may cause drowsiness particularly when taken together with alcohol or central nervous system depressants such as benzodiazepines, tranquilisers, sedatives, gabapentinoids or hypnotics (see sections 4.5 and 4.7). Tolerance and opioid use disorder (abuse and dependence) Buprenorphine is a partial agonist at the mu-opiate receptor

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HOS-098508 · has-warning-information · PDF-Seite 21

Administration Care must be taken to avoid inadvertent injection of Buvidal. The dose must not be administered intravascularly (intravenously), intramuscularly or intradermally. Intravascular such as intravenous injection would present a risk of serious harm as Buvidal forms a solid mass upon contact with body fluids, which potentially could cause blood vessel injury, occlusion, or thromboembolic events. To minimise the risk of misuse, abuse and diversion, appropriate precautions should be taken when prescribing and dispensing buprenorphine. Healthcare professionals should administer Buvidal directly to the patient. Take-home use or self-administration of the product by patients is not allowed. Any attempts to remove the depot should be monitored throughout treatment. Prolonged-release properties The prolonged-release properties of the product should be considered during treatment including initiation and termination (see section 4.2). In particular, patients with concomitant medicinal products and/or co-morbidities, should be monitored for signs and symptoms of toxicity, overdose or withdrawal caused by increased or decreased levels of buprenorphine (see sections 4.5 and 5.2). Respiratory depression A number of cases of death due to respiratory depression have been reported for patients being treated with buprenorphine, particularly when used in combination with benzodiazepines (see section 4.5) or when buprenorphine was not used according to prescribing information. Deaths have also been reported in association with concomitant administration of buprenorphine and other depressants such as alcohol, gabapentinoids (such as pregabalin and gabapentin) (see section 4.5) or other opioids. Buprenorphine should be used with care in patients with respiratory insufficiency (e.g. chronic obstructive pulmonary disease, asthma, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression or kyphoscoliosis). Buprenorphine may cause severe, possibly fatal, respiratory depression in children and non-opioid dependent persons who accidentally or deliberately use it. CNS depression Buprenorphine may cause drowsiness particularly when taken together with alcohol or central nervous system depressants such as benzodiazepines, tranquilisers, sedatives, gabapentinoids or hypnotics (see sections 4.5 and 4.7). Tolerance and opioid use disorder (abuse and dependence) Buprenorphine is a partial agonist at the mu-opiate receptor

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