ANAFRANIL Prolonged-release, film-coated tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Anafranil SR 75 mg Prolonged-release Tablets.
Qualitative and quantitative composition
Each tablet contains 75 mg clomipramine hydrochloride. <u>Excipient with known effect:</u> Each tablet contains 235 micrograms polyoxyl hydrogenated castor oil. For a full list of excipients see section ...
Pharmaceutical form
Prolonged-release, film-coated tablet. Pink, capsule shaped, biconvex, film-coated tablet, scored on both sides. One side debossed with CG and the other GD. The tablets should not be broken.
Therapeutic indications
In the management of endogenous depression including manic depression, periodic and involutional depression, reactive and neurotic depression, obsessional and phobic states and as an adjunctive treatment ...
Posology and method of administration
Before initiating treatment with Anafranil, hypokalemia should be treated (see 4.4 Special warnings and precautions for use). As a precaution against possible QTc prolongation and serotonergic toxicity, ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Use in patients who are currently receiving, or have received within 3 weeks, monoamine oxidase inhibitors. ...
Special warnings and precautions for use
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self-harm and suicide (suicide-related events). This risk persists until significant ...
Interaction with other medicinal products and other forms of interaction
Adrenergic neurone blockers Anafranil may diminish or abolish the antihypertensive effects of guanethidine, betanidine, reserpine, clonidine and alpha-methyldopa. Patients requiring comedication for hypertension ...
Fertility, pregnancy and lactation
Women of child-bearing potential There are no data supporting any special recommendations in women of child-bearing potential. Pregnancy There is limited amount of data from the use of Anafranil in pregnant ...
Effects on ability to drive and use machines
Patients receiving Anafranil should be warned that blurred vision, and other nervous system and psychiatric related disorders such as somnolence, disturbance in attention, confusion, disorientation, aggravation ...
Undesirable effects
Unwanted effects are usually mild and transient, disappearing under continued treatment or with a reduction in the dosage. They do not always correlate with plasma drug levels or dose. It is often difficult ...
Overdose
The signs and symptoms of overdose with Anafranil are similar to those reported with other tricyclic antidepressants. Cardiac abnormalities and neurological disturbances are the main complications. In ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Tricyclic antidepressant <b>ATC code:</b> N06AA04 Mechanism of action The pharmacological action includes alpha-adrenolytic, anticholinergic, anti-histaminic and 5-HT ...
Pharmacokinetic properties
Absorption The active substance is completely absorbed following oral administration and intramuscular injection. The systemic bioavailability of unchanged clomipramine is reduced by 50% by hepatic first-pass ...
Preclinical safety data
Repeat-dose toxicity Phospholipidosis and testicular changes, commonly associated with tricyclic compounds, have been observed with clomipramine hydrochloride at doses ≥10-fold greater than the maximum ...
List of excipients
Eudragit E30D (polyacrylate dispersion 30%) Calcium hydrogen phosphate Silicon dioxide Calcium stearate Hypromellose Red iron oxide (E172) Castor oil, polyoxyl hydrogenated Talc Titanium dioxide (E171) ...
Incompatibilities
Not applicable.
Shelf life
5 years.
Special precautions for storage
Do not store above 30°C. Store in the original package in order to protect from moisture.
Nature and contents of container
PVC/Aluminium blister packs in cardboard cartons. Pack sizes of 100, 30 and 28 tablets are available. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
zr pharma& GmbH, Hietzinger Hauptstrasse 37, 1130 Vienna, Austria
Marketing authorization number(s)
PA23086/001/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 19 September 1988 Date of last renewal: 01 April 2008
Date of revision of the text
December 2021
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