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Summary of Product Characteristics SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT <[Levomethadone hydrochloride dne]> 5 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 10 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 15 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 20 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 25 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 30 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 35 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 40 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 45 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 50 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 55 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 60 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 65 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 70 mg oral solution in single-dose container <[Levomethadone hydrochloride dne]> 75 mg oral solution in single-dose container 2. QUALITATIVE AND QUANTITATIVE COMPOSITION <[Levomethadone hydrochloride dne]> 5 mg oral solution in single-dose container One dose (10 mL) of oral solution contains 5 mg levomethadone hydrochloride 1 mL of oral solution contains 0.5 mg levomethadone hydrochloride. Excipient(s) with known effect: 1.8 g glycerol (E 422), 10 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 10 mg oral solution in single-dose container One dose (20 mL) of oral solution contains 10 mg levomethadone hydrochloride 1 mL of oral solution contains 0.5 mg levomethadone hydrochloride. Excipient(s) with known effect: 3.60 g glycerol (E 422), 20 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 15 mg oral solution in single-dose container One dose (15 mL) of oral solution contains 15 mg levomethadone hydrochloride 1 mL of oral solution contains 1.0 mg levomethadone hydrochloride. Excipient(s) with known effect: 2.70 g glycerol (E 422), 15 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 20 mg oral solution in single-dose container One dose (20 mL) of oral solution contains 20 mg levomethadone hydrochloride 1 mL of oral solution contains 1.0 mg levomethadone hydrochloride. Excipient(s) with known effect: 3.60 g glycerol (E 422), 20 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 25 mg oral solution in single-dose container One dose (25 mL) of oral solution contains 25 mg levomethadone hydrochloride 1 mL of oral solution contains 1.0 mg levomethadone hydrochloride. Excipient(s) with known effect: 4.50 g glycerol (E 422), 25 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 30 mg oral solution in single-dose container One dose (30 mL) of oral solution contains 30 mg levomethadone hydrochloride 1 mL of oral solution contains 1.0 mg levomethadone hydrochloride. Excipient(s) with known effect: 5.40 g glycerol (E 422), 30 mg methyl parahydroxybenzoate (E218) 2 <[Levomethadone hydrochloride dne]> 35 mg oral solution in single-dose container One dose (14 mL) of oral solution contains 35 mg levomethadone hydrochloride 1 mL of oral solution contains 2.5 mg levomethadone hydrochloride. Excipient(s) with known effect: 2.52 g glycerol (E 422), 14 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 40 mg oral solution in single-dose container One dose (16 mL) of oral solution contains 40 mg levomethadone hydrochloride 1 mL of oral solution contains 2.5 mg levomethadone hydrochloride. Excipient(s) with known effect: 2.88 g glycerol (E 422), 16 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 45 mg oral solution in single-dose container One dose (18 mL) of oral solution contains 45 mg levomethadone hydrochloride 1 mL of oral solution contains 2.5 mg levomethadone hydrochloride. Excipients with known effect: 3.24 g glycerol (E 422), 18 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 50 mg oral solution in single-dose container One dose (20 mL) of oral solution contains 50 mg levomethadone hydrochloride 1 mL of oral solution contains 2.5 mg levomethadone hydrochloride. Excipients with known effect: 3.60 g glycerol (E 422), 20 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 55 mg oral solution in single-dose container One dose (22 mL) of oral solution contains 55 mg levomethadone hydrochloride 1 mL of oral solution contains 2.5 mg levomethadone hydrochloride. Excipients with known effect: 3.96 g glycerol (E 422), 22 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 60 mg oral solution in single-dose container One dose (24 mL) of oral solution contains 60 mg levomethadone hydrochloride 1 mL of oral solution contains 2.5 mg levomethadone hydrochloride. Excipients with known effect: 4.32 g glycerol (E 422), 24 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 65 mg oral solution in single-dose container One dose (26 mL) of oral solution contains 65 mg levomethadone hydrochloride 1 mL of oral solution contains 2,5 mg levomethadone hydrochloride. Excipients with known effect: 4.68 g glycerol (E 422), 26 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 70 mg oral solution in single-dose container One dose (28 mL) of oral solution contains 70 mg levomethadone hydrochloride 1 mL of oral solution contains 2.5 mg levomethadone hydrochloride. Excipients with known effect: 5.04 g glycerol (E 422), 28 mg methyl parahydroxybenzoate (E218) <[Levomethadone hydrochloride dne]> 75 mg oral solution in single-dose container One dose (30 mL) of oral solution contains 75 mg levomethadone hydrochloride 1 mL of oral solution contains 2.5 mg levomethadone hydrochloride. Excipients with known effect: 5.40 g glycerol (E 422), 30 mg methyl parahydroxybenzoate (E218) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral solution in single-dose container. Clear and colourless liquid. 3 4. CLINICAL PARTICULARS 4.1 Therapeutic indications <[Levomethadone hydrochloride dne]> is indicated in adults for substitution therapy for maintenance of opioid dependence in conjunction with appropriate medical, social and psychosocial care. 4.2 Posology and method of administration Levomethadone should always be initiated by an experienced physician as part of an integrated treatment program with drug-assisted rehabilitation of opioid addiction in adults, which includes medical, social and psychological care, approved by the relevant authority. Levomethadone is approximately twice as potent as the methadone racemate and they can generally be safely replaced by each other on a 2:1 ratio, i.e. 30 mg levomethadone equals 60 mg methadone racemate. Posology Adults The dose is established based on the onset of withdrawal symptoms and must be adjusted for each patient according to the individual situation and to the subjective perception. Generally, the maintenance dose is the minimum dose that controls withdrawal symptoms. The usual initial dose is 5-15 mg. For patients with high opioid tolerance, the initial dose is 10-20 mg. The dose is increased in steps of 5 mg at a time over a period of three weeks, usually to 35 or 40 mg. After a recommended stabilisation period of four weeks, the dose is adjusted until the patient has no intoxication dependence and does not show clinical signs of psychomotor function effects or abstinence symptoms. The usual dose is 30-60 mg of levomethadone per day, but some individuals may require higher doses. A dose higher than 50-60 mg of levomethadone may be administered in exceptional cases of proven necessity only, after having excluded reliably the concomitant use of other narcotic substances. Levomethadone is normally administered once daily. If the patient has been treated with a combined agonist/antagonist (e.g. buprenorphine), the dose should be reduced gradually when the levomethadone treatment is initiated. If the levomethadone treatment is interrupted and a switch to sublingual buprenorphine treatment is planned (especially in combination with naloxone), the levomethadone dose should be reduced to 15 mg/day initially to avoid withdrawal symptoms caused by buprenorphine/naloxone. As a consequence of interactions and/or enzymatic induction caused by other medicinal products (see section 4.5) the daily dose of levomethadone needed can be increased. For this reason, even patients with adjusted stable treatment should be monitored for possible withdrawal symptoms and the dose further adjusted, if needed. Reference is made to National Guidelines for methadone treatment. Discontinuation of treatment Treatment should be discontinued if the efficacy is not sufficient or if the patient cannot tolerate it. The effect must be evaluated in accordance with national guidelines. 4 When the treatment is to be discontinued, this should be done with a gradual dose reduction. The dose may be reduced relatively rapidly in the beginning, but reduction must be slow in the final phase (from 20 mg daily and downwards). Special populations Elderly It is recommended to reduce the dose in elderly patients. Hepatic impairment Chronic viral hepatitis is common in drug addicts. Caution is advised if levomethadone must be used in patients with hepatic
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