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► Anafranil SR (clomipramine) - Practical Medicine

Anafranil SR (clomipramine) - prolonged release coated tablets

The name of the preparation Character; dose; package Manufacturer Price 100% Price after refund In which pharmacy?
Anafranil SR prolonged release coated tablets; 75 mg; 20 tables Teva Pharmaceuticals Polska 23.14 0.00
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Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.

The preparation contains the substance:clomipramine

The drug is available on prescription

What is Anafranil SR?

An antidepressant medication belonging to the group of tricyclic antidepressants.

What does Anafranil SR contain and how does it work?

Clomipramine is a psychotropic medicine from the group of tricyclic antidepressants. It has pronounced antidepressant action, affecting all components of the depressive syndrome, including psychomotor slowing, anxiety, depressed mood; it works poorly calming. The mechanism of action is to inhibit the reuptake of certain neurotransmitters (noradrenaline and serotonin) by appropriate neurons. Serotonin uptake is inhibited to a greater extent than after the use of other antidepressants. It shows antagonistic activity towards M-type cholinergic receptors (M1, M2), histamine receptors (more strongly against H1 than to H2), adrenergic receptors (more strongly against α1 than to a2) and serotonin receptors (more strongly against 5-HT2 than up to 5-HT1).

When should I use Anafranil SR?

The preparation is indicated for the treatment of:
· Depressive states of various origins and symptoms (endogenous, reactive, neurotic, organic, masked and involutive forms of depression and depression associated with schizophrenia and personality disorders)
· Depressive syndromes associated with the elderly, in the course of chronic pain and chronic somatic diseases
· Obsessive compulsive disorder
· Phobias and anxiety attacks.
In children and adolescents after the age of 5, the preparation is indicated for the treatment of nocturnal enuresis (after excluding organic causes).

When not to use this preparation?

Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients or other tricyclic antidepressants.

Contraindications to the use of the preparation are also:
· Cross-sensitivity to tricyclic antidepressants from the benzodiazepine group
· Use of MAO inhibitors (monoamine oxidase) in parallel or in the last 14 days; this group includes, among others, moclobemide and selegiline
· Period immediately after myocardial infarction
· Congenital prolongation of the QT interval in the ECG.

Take special care with Anafranil SR?

Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In some situations it may be necessary to carry out specific check-ups.
The effects of using the product may occur only after a few weeks of treatment, sometimes this time is longer. Patients should be under strict medical supervision until they recover. Other psychiatric disorders in which clomipramine is used may also be associated with an increased risk of suicidal behavior.In addition, these conditions can co-exist with severe depressive disorders. People treated with clomipramine for reasons other than depression, as well as people who have attempted suicide and those who have a significant degree of suicidal tendency before starting treatment should be closely monitored by a doctor.
The group of special risk are people under 25 years of age. Also, during the change of dosage, the patient should be covered by special medical care. Patients and those around them should pay attention to any clinical sign of disease severity, suicidal behavior or thoughts or abnormal changes in behavior, and contact their physician immediately if they occur.

In some people suffering from panic attacks, the increased symptoms of anxiety occur at the beginning of treatment. The severity of anxiety is greatest during the first few days of treatment and usually resolves within two weeks. In people with schizophrenia receiving tricyclic antidepressants, sometimes psychosis was observed. There have also been reports of manic episodes or mild manic states during the depressive phase in patients with cyclical affective disorders treated with tricyclic antidepressants. In case of disturbing changes in behavior, please contact your doctor immediately.

Drugs from this group can cause, especially at night, drug-induced psychosis (with delirium), especially in people prone to such reactions and in elderly patients. They disappear within a few days after discontinuation of the drug.

If you experience symptoms such as:
· stimulation
· hyperthermia
· Epileptic seizures
· Muscle clonic convulsions
· delirium
· coma
you should immediately contact your doctor, because their cause may be dangerous for life so-called "serotonin syndrome".

Special care should be taken in people:
· With diseases of the cardiovascular system (especially with cardiac insufficiency, conduction abnormalities or arrhythmia); monitoring of cardiac function and ECG is recommended (these activities are also recommended in the elderly)
· Using in parallel drugs such as: selective serotonin reuptake inhibitors, serotonin and noradrenaline reuptake inhibitors, tricyclic antidepressants, lithium, due to the risk of serotonin syndrome
· With epilepsy or other factors predisposing to convulsions (brain damage of different etiology, parallel use of neuroleptics, conditions after discontinuation of alcohol or anticonvulsant drugs), because clomipramine causes a dose-dependent decrease of the convulsive threshold
· With elevated intraocular pressure, a history of glaucoma with a closing angle of the disease, or diseases with urinary retention (eg prostate disease), because clomipramine may exacerbate these symptoms
· In people who use contact lenses because reduced lacrimal fluid production and accumulation of mucus secretions can damage the Corn eal epithelium
· With severe liver disease and adrenal medulla tumors, because clomipramine may cause hypertensive crisis in them
· With hyperthyroidism and those taking thyroid products, due to the possibility of toxic effects on the heart
· With chronic constipation (especially in the elderly and lying patients), because there is a risk of paralytic ileus.

If you have a fever and a sore throat, you should consult your doctor as this may indicate a change in the number of white blood cells.

Do not stop the treatment suddenly because it leads to withdrawal syndrome. If you need to stop using the product, your doctor will determine how to gradually reduce the dose.

If the patient needs general anesthesia, the doctor should be informed about the use of clomipramine.

In people with liver disease, liver enzymes should be checked periodically.
During long-term use of the preparation one should remember about periodic dental check, because the risk of caries is increased.

The experience of clomipramine treatment of people who have had electroconvulsive therapy is very low.For this reason, caution is recommended in this group of patients.

To prevent the occurrence of cardiac arrhythmias in the form of QT prolongation:
· Avoid parallel use of drugs that may cause QT interval prolongation
· Avoid parallel administration of drugs that increase clomipramine in the blood (eg selective serotonin reuptake inhibitors, serotonin and noradrenaline reuptake inhibitors)
· Compensate potential potassium deficiencies before starting treatment.

Before starting treatment, the patient's blood pressure should be checked, because in patients with orthostatic hypotension or unstable circulation, the preparation may cause pressure drops.

Additional information about the other ingredients of the preparation:
The preparation contains lactose; should not be used in people with rare hereditary galactose intolerance, primary lactase deficiency or malabsorption of Glucose -galactose.

Does this preparation affect the ability to drive vehicles?

Opioid analgesics impair the mental and / or physical fitness required to perform potentially dangerous tasks (eg driving or operating machines). Do not drive or use machines while using the product.

Dosage of Anafranil SR

It has the form of film-coated tablets (10 mg and 20 mg) and prolonged-release tablets (75 mg). Do not exceed the recommended doses because it will not increase the effectiveness of the drug and may harm your health and life. If you have any doubts regarding the use of the preparation, consult a physician.

Dosage for each patient is individually selected by the physician, depending on the clinical condition and tolerance of the drug.
Clinical response usually occurs after 2-3 weeks of treatment.
Adults.
Depression, obsessive-compulsive disorder, phobias.
Initially, 25 mg 2-3 × / day as standard coated release tablets or 75 mg 1 × / day (preferably in the evening) in sustained release form. If the starting dose is insufficient, your doctor may recommend a gradual increase in the dose of the first week to 100-150 mg / day (in severe cases up to 250 mg / day).
After clinical improvement, your doctor will probably recommend a dose reduction of up to 50-100 mg / day (standard release coated tablets) or 75 mg / day (prolonged release tablets).
Fear anxiety, agoraphobia.
Initially, 10 mg / day in the form of standard-coated tablets. Depending on the individual tolerance of the preparation, the doctor may recommend increasing the dose until the desired reaction is obtained. The daily dose is usually 25-100 mg, if necessary up to 150 mg / day.
It is not recommended to discontinue treatment before 6 months, during which time the dose should be gradually reduced
In elderly people, treatment usually starts with a dose of 10 mg / day, then increases gradually so that the optimal daily dose (30-50 mg) is achieved after about 10 days and maintain it throughout the treatment period.

Children after 5 years old.
Bedwetting.
The preparation should be used 1 × / day after the evening meal in the form of a tabl. powl. with standard release. In the case of children soaking in the early hours of the night, a part of the dose should be given earlier (around 4 pm).
Children 5-8. year of life: initially 20-30 mg / day.
Children 9-12. year of life: initially 25-50 mg / day.
Children after the age of 12: initially 25-75 mg / day.
Your doctor will probably recommend increasing your dose if you have not responded fully to treatment within 1 week. After clinical improvement, the preparation should be continued in consultation with a physician for 1-3 months.

Can Anafranil SR be used during pregnancy and breastfeeding?

During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or planning to become pregnant, consult your doctor before using the product.

Do not use this preparation during pregnancy unless your doctor prescribes that it is absolutely necessary.
Do not use the product during breastfeeding.

Can I use other preparations in parallel?

Tell your doctor about all medicines you have recently taken, including those that are over the counter.

The use of MAO inhibitors with clomipramine may cause serious side effects such as hypertension, high fever, convulsions, agitation, delirium and coma. Administration of clomipramine may be started 14 days after discontinuation of the MAOI inhibitor, MAO inhibitor therapy may be initiated at least 14 days after discontinuation of clomipramine.
Do not use the preparation in parallel with antiarrhythmics, which are strong inhibitors of CYP2D6 (eg quinidine, propafenone).

Caution should be exercised when using it in parallel:
· Drugs with a cholinolytic effect; Intensification of central and peripheral nervous system symptoms may occur
· Drugs that inhibit the re-uptake of serotonin, methylphenidate, neuroleptics or cimetidine; an increase in clomipramine in the blood may occur; your doctor will probably recommend the use of lower doses of the preparation
· Barbiturates and phenytoin, because they accelerate the elimination of the preparation
· Sympathomimetics, mainly vasoconstrictors (e.g. adrenaline, noradrenaline, ephedrine, phenylephrine), used, e.g., in combination with local anesthetics; clomipramine may significantly increase their effect
· Guanethidine, betanidins, clonidines, reserpines, α-methyldopa, clomipramine may weaken their hypotensive effect
· Anticoagulant coumarin derivatives; the coagulation parameters should be controlled
· Diuretic drugs; this may lead to hypokalaemia (lowering potassium in the blood), which increases the risk of QT prolongation and the occurrence oftorsade de pointes
· Selective serotonin reuptake inhibitors, serotonin and noradrenaline reuptake inhibitors, tricyclic antidepressants or lithium; because it can cause a serotonin syndrome
· High doses of estrogen; monitoring of the therapeutic response is recommended

Clomipramine may potentiate the effects of alcohol or other central nervous system depressants (eg barbiturates, benzodiazepine derivatives).

In smokers, drug concentrations in are two times lower than in non-smokers.

In patients treated with clonidine, there is a risk of a re-increase in blood pressure (rebound effect).

What side effects can occur?

Like all medicines, Anafranil can also cause side effects, although it will not occur in all patients who use this medicine. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects.
Very often you may experience: drowsiness, tiredness, anxiety, increased appetite, dizziness, tremor, headache, accommodation disorders, reduced visual acuity, urination disorders, nausea, dry mouth, constipation, muscle clonic convulsions, libido disorder, potency disorders, excessive perspiration, weight gain.
Often may occur: confusion, confusion, hallucinations (especially in the elderly and Parkinson's), anxiety, agitation, sleep disturbances, mania, mild manic states, aggression, impaired memory, depersonalization, severity of depression, impaired concentration, insomnia nightmares, yawning, delirium, speech disorders, paraesthesia, orthostatic hypotension, sinus tachycardia, palpitations, clinically insignificant ECG changes, vomiting, abdominal discomfort, diarrhea, anorexia, transaminase elevation, allergic skin reactions, sensitivity to light, pruritus, milkworm, breast enlargement, taste disturbances, tinnitus, hot flushes.
Uncommon: psychotic symptoms, convulsions, ataxia, increase in blood pressure, arrhythmia.
Very rarely: changes in EEG, glaucoma, urinary retention, conduction abnormalities, hepatitis, edema, hair loss, syndrome of abnormal secretion of antidiuretic hormone, pneumonia with allergic etiology, anaphylactic or anaphylactoid reactions, high fever, leukopenia, agranulocytosis, thrombocytopenia , eosinophilia, purpura.
If you suddenly stop or reduce your dose, you may experience: nausea, vomiting, abdominal pain, diarrhea, insomnia, headache, nervousness, anxiety.

Other preparations on the Polish market containing clomipramine

Anafranil (coated tablets)