ESPRANOR Oral lyophilisate (2020)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Espranor 2 mg oral lyophilisate.

2. Qualitative and quantitative composition

Each oral lyophilisate contains 2 mg of buprenorphine (as hydrochloride). Excipient with known effect: Each oral lyophilisate contains 0.50 mg aspartame. For the full list of excipients, see section ...

3. Pharmaceutical form

Oral lyophilisate. White to off-white circular oral lyophilisate with a diameter of 10.3 mm, debossed with M2 on one side.

4.1. Therapeutic indications

Substitution treatment for opioid drug dependence, within a framework of medical, social and psychological treatment. Treatment with Espranor oral lyophilisate is intended for use in adults and adolescents ...

4.2. Posology and method of administration

Treatment should be under the supervision of a clinician experienced in the management of opiate dependence/addiction. Espranor is not interchangeable with other buprenorphine products. Different ...

4.3. Contraindications

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.

4.4. Special warnings and precautions for use

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 ...

4.5. Interaction with other medicinal products and other forms of interaction

Espranor should not be taken together with alcoholic drinks or medications containing alcohol. Alcohol increases the sedative effect of buprenorphine (see section 4.7). Espranor should be used cautiously ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no adequate data from the use of buprenorphine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown. Towards ...

4.7. Effects on ability to drive and use machines

Buprenorphine has minor to moderate influence on the ability to drive and use machines when administered to opioid dependent patients. This may cause drowsiness, dizziness or impaired thinking, especially ...

4.8. Undesirable effects

Summary of the safety profile The most commonly reported treatment related adverse reaction reported during the pivotal clinical trials were constipation and symptoms commonly associated with opioid withdrawal ...

4.9. Overdose

Symptoms: respiratory depression as a result of central nervous system depression is the primary symptom requiring intervention in the case of overdose because it may lead to respiratory arrest ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Drugs used in opioid dependence ATC code: N07BC01 The Espranor oral lyophilisate dosage form is designed to rapidly disperse on the tongue usually in less than ...

5.2. Pharmacokinetic properties

Absorption When taken orally, buprenorphine undergoes first-pass hepatic metabolism with N-dealkylation and glucuroconjugation in the small intestine and liver. The use of this medication by the oral route ...

5.3. Preclinical safety data

Pre-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat dose toxicity, genotoxicity or carcinogenicity. From teratology studies in rats and rabbits, ...

6.1. List of excipients

Gelatin Mannitol Aspartame (E951) Mint flavour (051296 TP0551) Anhydrous citric acid

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

3 years.

6.4. Special precautions for storage

This medicinal product does not require any special temperature storage conditions. Store in the original package (blister) to protect from light and moisture.

6.5. Nature and contents of container

Unit dose blisters composed of PVC/OPA/Al/OPA/PVC film with Al/PET/paper lidding with 7 1 or 28 1 oral lyophilisates, in a cardboard carton. Not all pack sizes may be marketed.

6.6. Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

7. Marketing authorization holder

Martindale Pharmaceuticals Ltd, Bampton Road, Romford, Essex, RM3 8UG, United Kingdom

8. Marketing authorization number(s)

PL 00156/0364

9. Date of first authorization / renewal of the authorization

22/06/2015

10. Date of revision of the text

24/09/2020

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