INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo LANTANON® (tablets)
LANTANON® 30 mg (tablets)
        RU 1000.031.007

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

LANTANON® (tablets)
LANTANON® 30 mg (tablets)

COMPOSITION
Each Lantanon -tablet contains 10 mg mianserin hydrochloride.
Each Lantanon 30 mg -tablet contains 30 mg mianserin hydrochloride.

PHARMACOLOGICAL CLASSIFICATION
A/1.2/Psychoanaleptics (antidepressants)

PHARMACOLOGICAL ACTION
Lantanon is an antidepressant. Its active substance belongs to the piperazino-azepine group of compounds which are chemically not related to the tricyclic antidepressants (TADs). Its structure lacks the basic side-chain which is considered to be responsible for the anticholinergic activity of the TADs. It possesses anxiolytic properties. At normal dosage Lantanon has less effect on the cardiovascular system than tricyclics. Lantanon does not antagonise the action of sympathomimetic agents and antihypertensive medicines which block adrenergic neurons (e.g. bethanidine) or alpha2- receptors (e.g. clonidine, methyldopa), nor does it affect the action of coumarin-type anticoagulants such as phenprocoumon.

INDICATIONS
For relief of symptoms of depression in those cases of depressive illness where medicinal therapy is indicated.

CONTRA-INDICATIONS
Mania.

WARNINGS
Lantanon may potentiate the central nervous system depressant action of alcohol and patients should be advised to avoid taking alcohol during treatment. Lantanon should not be administered concomitantly with, or within two weeks of cessation of therapy with MAO-inhibitors.

DOSAGE AND DIRECTIONS FOR USE
Adults: Treatment should begin with 30-40 mg daily and dosage should be adjusted according to the clinical response. The effective dose usually lies between 30 and 90 mg (mostly 60 mg) daily.
Elderly: Not more than 30 mg initially. The dose should be slowly increased under close supervision. A lower than the normal maintenance dose may be sufficient for a satisfactory clinical response.
Children: A dosage scheme cannot be given as there is no clinical experience.
N.B. The daily dose can be taken either in divided doses or preferably (in view of a favourable effect on sleep) as a single dose at night. The single night-time dose should not exceed 60 mg. It is often more advantageous to maintain antidepressant treatment for several months after clinical improvement has occurred.
Administration:
The tablets should be swallowed without chewing.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS
Blood dyscrasias, convulsions, hypomania, hypotension or hypertension, coma, disturbances of liver function, arthralgia, oedema and gynaecomastia have been reported. Tachycardia or bradycardia, dilated or constricted pupils, vomiting and dizziness and ataxia have also been reported. Drowsiness has been reported to occur in the first days of treatment. In order to ensure an optimal antidepressant effect, the dosage of Lantanon need not be reduced.
Anticholinergic effects are infrequent. Weight changes and changes in blood sugar concentrations may occur.
Depressed patients treated with Lantanon should avoid the performance of such hazardous tasks as driving a motor vehicle or operating machinery. Lantanon may precipitate hypomania in susceptible subjects with bipolar depressive illness. In such a case treatment with Lantanon should be withdrawn.
Treatment should be withdrawn if jaundice or convulsions occur.
Bone-marrow depression, usually presenting as granulocytopenia or agranulocytosis, has been reported during treatment with Lantanon. These reactions have occurred most commonly after 4 to 6 weeks of treatment and were generally reversible on stopping treatment. If a patient shows fever, sore throat, stomatitis or other signs of infection, a full blood count should be obtained. This adverse reaction has been observed in all age groups but appears to be more common in the elderly.
When treating patients with diabetes or epilepsy, hepatic or renal insufficiency, normal precautions should be exercised and the dosages of any concomitant therapy kept under review. Patients with narrow angle glaucoma or symptoms suggestive of prostatic hypertrophy should also be monitored even though anticholinergic side-effects are not anticipated with Lantanon therapy. Lantanon should be used with caution in patients with cardiovascular disorders, such as ischaemic heart disease.
Lantanon does not interact with bethanidine, guanethidine or propranolol (either alone or in combination with hydralazine). Nevertheless, it is recommended to monitor the blood pressure of those patients who are concomitantly treated with antihypertensive medicines. Some interaction occurs with clonidine.
The sedative effects of Lantanon may be enhanced by concurrent adminiswith alcohol, and concomitant administration with barbiturates is not recommended.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms of acute overdosage are prolonged sedation, tachycardia and/or bradycardia. There is no specific antidote. Treatment is by gastric lavage with appropriate symptomatic and supportive therapy for vital functions.

CONDITIONS OF REGISTRATION
Advertising to the professions only.

IDENTIFICATION
Lantanon:                White, round and biconvex watercoated tablets, CT above 4 on one side and Organon on the reverse.
Lantanon 30 mg: White, oval and biconvex watercoated tablets, coded CT above 7 on both sides of the score on one side and Organon on the reverse.

PRESENTATION
Lantanon:                Press-through strips with 30 or 90 tablets.
                Amber bottles with 300 tablets.
                Tampertainers with 300 tablets
Lantanon 30 mg: Press-through strips with 40 tablets.
                Amber bottles with 100 tablets
                Tampertainers with 100 tablets

STORAGE INSTRUCTIONS
Protect from light. Store below 30°C. Keep out of reach of children.

REGISTRATION NUMBERS
Lantanon tablets:                         J/1.2/64
Lantanon 30 mg tablets:         N/1.2/180

NAME AND BUSINESS ADDRESS OF THE APPLICANT
DONMED PHARMACEUTICALS (PTY.) LIMITED *
Donmed House, Cambridge Place
cnr Kirkby & Oxford Roads
Bedfordview 2007

DATE OF PUBLICATION OF THIS PACKAGE INSERT
1987.05.29

* Under license of NV Organon Oss

Updated on this site: March 2004
Source: Pharmaceutical Industry

SAEPI HOME PAGE      TRADE NAME INDEX      GENERIC NAME INDEX      FEEDBACK
Information presented by Malahyde Information Systems © Copyright 1996-2004