Generic drug of the therapeutic class: Analgesics
Active ingredients: Clomipramine
laboratory: Sigma Tau France
Box of 50
- Major depressive episodes (that is, characterized).
- Obsessive compulsive disorders.
- Prevention of panic attacks with or without agoraphobia.
- Some depressive states appearing during schizophrenia, in association with a neuroleptic treatment.
- Neuropathic pain of the adult.
Dosage ANAFRANIL 25 mg Coated tablet Box of 50
Use the appropriate dosage according to the prescribed daily dose.
The usual dosage for the treatment of depression ranges from 75 to 150 mg per day.
The initial dose is usually 75 mg, but can be individually adjusted within the recommended dose range. This dosage may be re-evaluated after 3 weeks of effective treatment at effective doses.
- Administration mode :
The pharmacokinetic characteristics of this medicine allow for a single daily dose, during or at a distance from meals.
- Duration of the treatment :
Antidepressant treatment is symptomatic.
The treatment of an episode is several months (usually about 6 months) to prevent the risk of relapse of the depressive episode.
OBSESSIVE DISORDERS COMPULSIVE :
- Adult: The usual dosage is between 75 and 150 mg. The treatment usually starts at a low dose (25 mg / day), increasing in steps depending on the tolerance, up to 75 to 150 mg / day. This dose may possibly be increased in steps beyond a sufficiently long period to judge the inefficiency of the previous doses (several weeks or months). The maximum dose is 250 mg per day. - Child and teenager:
Limited data exists from short-term clinical trials in children over 10 years of age and adolescents. The initial dose of 25 mg per day will be gradually increased if necessary depending on the tolerance. The maximum daily dosage is 3 mg / kg / day. The dosage may not exceed 100 mg / day during the first 2 weeks and 200 mg / day thereafter. The interest of the treatment will have to be reevaluated periodically.
PREVENTING PANIC ATTACKS :
Clomipramine does not treat the anxiety attack (indication of anxiolytic drugs) but prevents recurrence and complications (agoraphobia) in the context of "Panic Disorder" (DSM III R).
The treatment will be progressive installation, the useful doses ranging from 20 to 150 mg depending on the case.
A temporary recrudescence of the disorders can be observed at the beginning of treatment. This one will be prolonged several weeks after the disappearance of the troubles and diminished progressively. NEUROPATHIC PAIN OF ADULT :
Treatment should start at low doses: 10 to 25 mg per day for one week. The dose is then gradually increased in increments of 10 to 25 mg every week, depending on the tolerance. The dosage is individual (from 10 to 150 mg per day), and must take into account any associated analgesic treatments.
Maintenance treatment should be at the lowest effective dose, and the benefit of treatment should be reevaluated periodically. RISK POPULATIONS :
The ability to metabolize and eliminate drugs may be reduced, leading to a risk of increased plasma levels at therapeutic doses. Treatment will be initiated at a low dosage, that is, in practice at half the recommended minimum dosage (see pharmacokinetic properties). The increase in doses, if necessary, will be gradual, with clinical surveillance: the adverse effects of imipramines (in particular anticholinergic, neurological and psychiatric effects) can have serious consequences for the elderly (falls, confusion). - Hepatic and renal impairment:
The dosage should be reduced (see section 5.2).
- This medicine MUST NEVER be prescribed in the following cases:
. hypersensitivity to clomipramine or any of its excipients,
. known risk of glaucoma by closing the angle,
. risk of urinary retention related to urethroprostatic disorders,
. recent myocardial infarction,
. combination with non-selective MAOIs (iproniazide, nialamide) and sultopride (neuroleptic benzamide) (see section on interactions).
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
- Due to the presence of sucrose, this drug is contraindicated in case of fructose intolerance, glucose-galactose malabsorption syndrome or sucrase-isomaltase deficiency.
NOT RECOMMENDED :
- Breast-feeding: The passage into breast milk is poorly known but probably weak; however, as a precaution, breastfeeding should be avoided during the course of treatment.
- Associations advised against : alcohol; clonidine, guanfacine; MAOI selective A (moclobemide, toloxatone); alpha and beta sympathomimetics (adrenaline, norepinephrine, dopamine for parenteral systemic action); linezolid.
Adverse effects Anafranil
It can be difficult to distinguish certain side effects from certain symptoms of depression such as asthenia, sleep disorders, agitation, anxiety, constipation and dryness of the mouth, the appearance of manic episodes or hypomanic.
Frequency estimate: very common: ≥ 10%; frequent: ≥1% - <10%; uncommon: ≥ 0.1% - <1%; rare: ≥ 0.01% - 0.1%; very rare: <0.01%.
Very common : asthenia often associated with other side effects of clomipramine.
Very rare : fever sometimes in the context of a serotonin syndrome or malignant syndrome.
Very common : drowsiness.
Common : confusion, agitation (sometimes as part of a serotonin syndrome or malignant syndrome), delusions, memory problems, insomnia.
Cases of suicidal ideation and behavior have been reported during treatment with ANAFRANIL or shortly after discontinuation (see Warnings and Precautions section ).
Cases of aggression have been reported occasionally.
Neurological and muscular effects
Very common : vertigo, tremors, myoclonus.
Frequent : headache, paresthesia.
Uncommon : convulsions (whose risk of occurrence increases with the dosage and especially above 250 mg per day), ataxia.
Very rare : subclinical modification of encephalographic frequencies.
Cases of dysarthria and syncope have been reported.
Hypertonic and muscular hypotonia, sometimes in the context of serotonin syndrome or malignant syndrome, have been reported.
Akathisias have been reported.
Very common : dry mouth, constipation, blurred vision, accommodation disturbance, urination disorder.
Frequent : hot flashes, sweat, mydriasis.
Very rare : glaucoma, urinary retention.
Very common : orthostatic hypotension.
Frequent : tachycardia, palpitation (see Warnings and Precautions section ).
Very rare : disorders of conduction or rhythm, cardiomyopathy.
Very common : nausea.
Common : vomiting, abdominal pain, anorexia.
Frequent : asymptomatic elevation of liver enzymes.
Very rare : cholestatic or cytolytic hepatitis.
Common : skin reactions including urticaria, maculopapular rash, vasculitis and pruritus.
Rare : photosensitivity reaction that may cause skin pigmentation.
Very rare : alopecia.
Very common : weight gain, libido disorder, impotence.
Rare : galactorrhea, breast hypertrophy.
Very rare : syndrome of inappropriate secretion of anti-diuretic hormone, peripheral edema.
Very rare : infiltrating pneumopathy.
Very rare : anaphylactic or anaphylactoid reaction.
Very rare : leukopenia, agranulocytosis, thrombocytopenia and thrombocytopenic purpura, eosinophilia.
Organs of the senses
Common : taste alteration, tinnitus
· Withdrawal reaction with the following side effects: nausea, vomiting, abdominal pain, insomnia, headache, nervousness, anxiety, frequently occur upon abrupt cessation of treatment or reduction of dosage.
· Serotonin syndrome, exceptionally monotherapy, most commonly described in case of drug interaction or overdose (see sections Interactions with other drugs and other forms of interaction and Overdose ).
· Class effect:
Epidemiological studies, mainly in patients aged 50 years and older, show an increased risk of bone fractures in patients receiving selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants. The mechanism leading to this risk is unknown.
Some of these side effects can be prevented or prevented by adjuvant or corrective therapies, or even reduction of the dosage.
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system: National Agency for the Safety of Medicines and Health Products (ANSM) and the network of Regional Pharmacovigilance Centers. www.ansm.sante.fr.