ADEPEND Film-coated tablet Ref.[7824] Active ingredients: Naltrexone

Before treatment, it has to be assured that the patient is free of opioids (see section 4.4).

Treatment with naltrexone should according to national guidelines only be initiated and monitored by physicians experienced with the treatment of alcohol-addicted patients.

Treatment with naltrexone should only be considered for patients who have been for a sufficiently long period free of opioids (see section 4.4).

The treatment should be initiated with low doses of naltrexone according to the treatment induction schedule.

Higher doses than 150 mg even for only one day may result in an increase in side effects and are therefore not recommended.

Use in adults

The recommended dose of naltrexone hydrochloride in adults is 50 mg per day (1 tablet per day).

Use in children and adolescents (<18 years)

Adepend 50 mg film-coated tablets are not recommended for use in children and adolsecents below 18 in this indication due to a lack of data on safety and efficacy.

Use in elderly

Safe use for the treatment of opiate dependence in the elderly has not been established.

Use in patients with liver and/or kidney diseases

Adepend 50 mg film-coated tablets are contraindicated for patients with severe liver and/or kidney diseases.

In patients with slight or moderate disorder of liver and/or kidney Adepend 50 mg film-coated tablets should be applied only with special caution and close-meshed supervision (see section 4.4). A dose adaptation should be considered (see section 5.2).

Method of administration

Adepend 50 mg film-coated tablets should be taken with a liquid.

Duration of administration

A common duration of administration cannot be specified as Adepend 50 mg film- coated tablets are used as concomitant therapy and recovery is individually different for patients addicted to alcohol, even if they are psychologically attended. A treatment duration of at least 3 months is recommended whereas a prolongation might be necessary. Efficacy is proven by controlled studies over a period up to 12 months.

Naltrexone hydrochloride neither causes psychical nor physic addiction. There is no decrease of antagonistic effects during long term treatments.

Symptoms

There is limited experience with overdose of naltrexone hydrochloride. There was no evidence of toxicity in volunteers receiving 800 mg naltrexone hydrochloride per day for one week.

Treatment

In case of overdose, patients should be closely monitored and treated symptomatically.

3 years.

Do not store above 25°C.

Store in the original package in order to protect from light.

7, 10, 14, 28, 30 or 100 tablets in PVC/PVDC/Aluminium blister packed in a carton.

Not all pack sizes may be marketed.

No special requirements.