ESPRANOR

Posology Treatment should be under the supervision of a clinician experienced in the management of opiate dependence/addiction. The route of administration for Espranor is on the tongue, not under it. Espranor is not interchangeable with other buprenorphine products.

Different buprenorphine products have different bioavailability. Therefore, the dose in mg can differ between products. Once the appropriate dose has been identified for a patient with a certain product (brand), the product cannot readily be exchanged with another product.

e. long- or short-acting opioid), the time since last opioid use and the degree of opioid dependence. g. by a score indicating mild to moderate withdrawal on the validated Clinical Opioid Withdrawal Scale, COWS). g. heroin; short acting opioids).

Patients receiving methadone:

Before beginning Espranor therapy, the dose of methadone must be reduced to a maximum of 30 mg/day. The long half-life of methadone should be considered when starting buprenorphine therapy. The first dose of Espranor should be taken when signs of withdrawal appear, but not less than 24 hours after the patient last used methadone.

Buprenorphine may precipitate symptoms of withdrawal in patients dependent upon methadone. Because of the partial agonist profile of buprenorphine, the patient should be warned that the first 24 hours of buprenorphine substitution therapy may feel uncomfortable with some mild opiate withdrawal symptoms.

Treatment goals and discontinuation; Before initiating treatment with Espranor, a treatment strategy including treatment duration and treatment goals, should be agreed together with the patient. During treatment, there should be frequent contact between the physician and the patient to evaluate the need for continued treatment, consider discontinuation and to adjust dosages if needed.

4).

Initiation therapy (induction):

The recommended starting dose is 2 mg of Espranor (1 Espranor 2 mg oral lyophilisate). An additional one to two Espranor 2 mg oral lyophilisates may be administered on day one depending on the individual patient's requirement. During the initiation of treatment, daily supervision of dosing is recommended to ensure proper placement of the dose on the tongue and to observe patient response to treatment as a guide to effective dose titration according to clinical effect.

g. insomnia, headache, nausea and hyperhidrosis) and pain. Tabulated list of adverse reactions Table 1 summarises: • adverse reactions reported from pivotal clinical studies. The frequency of possible side effects listed below is defined using the following convention: Very common (>1//10), common (>1/100 to <1/10).

• the most commonly reported adverse drug reactions during post-marketing surveillance. Events occurring in at least 1% of reports by healthcare professionals and considered expected are included. Frequency of events not reported in pivotal studies cannot be estimated and is given as not known.

4). ● In patients presenting with marked drug dependence, initial administration of buprenorphine can produce a drug withdrawal syndrome similar to that associated with naloxone. ● The most common signs and symptoms of hypersensitivity include rashes, urticaria and pruritus.

8). 4). ● Neonatal drug withdrawal syndrome has been reported among newborns of women who have received buprenorphine during pregnancy. The syndrome may be milder and more protracted than that from short acting full μ-opioid agonists.

6). ● Hallucination, orthostatic hypotension, urinary retention, syncope and vertigo have been reported. Drug dependence Repeated use of Espranor can lead to drug dependence, even at therapeutic doses. 4). Reporting of suspected adverse reactions 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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Warnings Espranor oral lyophilisate is recommended only for the treatment of opioid drug dependence. It is also recommended that the treatment is prescribed by a physician who ensures comprehensive management of the drug addicted patient(s).

g. IV administrations) particularly at the beginning of the treatment.

Misuse, abuse and diversion:

Buprenorphine can be misused or abused in a manner similar to other opioids, legal or illicit. Some risks of misuse and abuse include overdose, spread of blood borne viral or localised and systemic infections, respiratory depression and hepatic injury.

Buprenorphine misused by someone other than the intended patient poses the additional risk of new drug dependent individuals using buprenorphine as the primary drug of abuse, and may occur if the medicine is distributed for illicit use directly by the intended patient or if the medicine is not safeguarded against theft.

Sub-optimal treatment with buprenorphine may prompt medication misuse by the patient, leading to overdose or treatment dropout. A patient who is under-dosed with buprenorphine may continue responding to uncontrolled withdrawal symptoms by self-medicating with opioids, alcohol or other sedative-hypnotics such as benzodiazepines.

To minimise the risk of misuse, abuse and diversion, physicians should take appropriate precautions when prescribing and dispensing buprenorphine, such as to avoid take-home dosing early in treatment, and to conduct patient follow-up visits with clinical monitoring that is appropriate to the patient’s need.

Removal of Espranor from the mouth following supervised administration is virtually impossible due to its rapid dispersal on the tongue.

Tolerance and opioid use disorder (abuse and dependence):

1 - Severe respiratory insufficiency - Severe hepatic impairment - Acute alcoholism or delirium tremens - Use during acute asthma attack - Head injury and increased intracranial pressure - Breast feeding