Medicinal Products

DULOXETINE TEVA HEALTH 30 mg gastro-resistant gastrointestinal box of 28

Generic Cymbalta Drug
Therapeutic Class: Neurology-Psychiatry
active ingredients: [Duloxetine, 4405], [Duloxetine, 4405]
laboratory: Teva Sante

Gastrointestinal Gélule
All forms

Indication

Treatment of major depressive disorder.

Treatment of peripheral diabetic neuropathic pain.

Treatment of anxiety disorder generalized.

DULOXETINE TEVA HEALTH is indicated in adults.

For more information, see section on Pharmacodynamic properties .

Dosage DULOXETINE TEVA HEALTH 30 mg gastro-resistant gastrointestinal box of 28

Treatment of major depressive disorder.

Treatment of peripheral diabetic neuropathic pain.

Treatment of anxiety disorder generalized.

DULOXETINE TEVA HEALTH is indicated in adults.

For more information, see section on Pharmacodynamic properties .

Against indications

Hypersensitivity to the active substance or to any of the excipients listed under Composition .

Association with non-selective, irreversible monoamine oxidase inhibitors (MAOIs) (see section Interactions with other medicinal products and other forms of interaction ).

Hepatic disease resulting in liver failure (see section on pharmacokinetic properties ).

Combination with fluvoxamine, ciprofloxacin or esnoxacin (potent CYP1A2 inhibitors), combinations leading to increased plasma concentrations of duloxetine (see section 4.5 Interactions with other medicinal products and other forms of interaction ) .

Severe renal insufficiency (clearance of creatinine <30 ml / min) (see Warnings and Precautions section ).

The initiation of treatment with DULOXETINE TEVA HEALTH is contraindicated in patients with unhealthy arterial hypertension who may expose them to a potential risk of hypertensive crisis (see section Undesirable effects ).

Adverse effects Duloxetine Teva Sante

at. Summary of the safety profile

The most commonly reported undesirable effects in patients treated with duloxetine were: nausea, headache, dry mouth, drowsiness, and dizziness. However, the majority of adverse side effects were mild to moderate in intensity, usually starting at the beginning of treatment and tending to fade despite continued treatment.

b. Summary table of undesirable effects

Table 1 shows the adverse effects observed from spontaneous notification and in placebo-controlled clinical trials (including a total of 9, 454 patients, 5, 703 duloxetine and 3, 751 under placebo) conducted in depression, the disorder of generalized anxieties and diabetic neuropathic pain.

Table 1: Undesirable effects

Frequency Estimate: very common (≥ 1/10), frequent (≥ 1/100, <1/10), not very common (≥ 1/1000, <1/100), rare (≥ 1/10 000, < 1/1 000), very rare (<1 / 10, 000).

Within each frequency category, the undesirable effects are presented in order of decreasing gravity.

Very good

FrÚquent

Not very frequent

Rare

Very rare

Infections and infestations

Laryngitis

Immune system disorders

Anaphylactic reaction

Events of hypersensitivity

Endocrine disorders

HypothyroÂ'die

Metabolism and nutrition disorders

Drop in appetite

Hyperglycemia (reported especially in diabetic patients)

DÚshydratation

HyponatrÚmie

SIADH 6

Psychiatric disorders

Insomnia

agitation

Drop in libido

AnxiÚtÚ

Abnormal orgasms

Abnormal findings

Suicidal Ideas 5, 7

Sleeping troubles

bruxism

DÚsorientation

Apathy

Suicidal behavior 5, 7

Mania

hallucinations

Agressivity and anger 4

Nervous System Affections

CÚphalÚes

Drowsiness

Dizzying sensations

LÚthargie

tremors

ParesthÚsies

myoclonus

Akathisie 7

NervositÚ

Attention disorder

dysgeusia

DyskinÚsie

Restless legs syndrome

Poor sleep

Serotonin syndrome 6

Convulsions 1

Psychomotor agitation 6

Extrapyramidal symptoms 6

Eye disorders

Blurred vision

mydriasis

Visual disorders

Glaucoma

Affections of the ear and labyrinth

AcouphÞnes 1

Dizziness

Ear pain

Heart conditions

palpitations

tachycardia

Supraventricular arrhythmia, mainly at atrial fibrillation type

Vascular disorders

Increased blood pressure 3

Hot flashes

Syncope 2

Hypertension 3, 7

Orthostatic hypotension 2

Extreme coldness

Hypertensive crisis 3, 6

Respiratory, thoracic and mediastinal disorders

BABY "illements

Gone pharyngeal

Epistaxis

Gastrointestinal disorders

NausÚes

Dry mouth

Constipation

DiarrhÚe

Abdominal pain

vomiting

Dyspepsia

Flatulence

Gastrointestinal haemorrhage 7

Gastrointestinal entÚrite

Eructation

Gastritis

dysphagia

stomatitis

Emission of blood in the stool

Halitosis

Hospital diseases

Hepatitis 3

Increase in liver enzymes (ALT, ASAT, alkaline phosphatase)

Acute heel injury

Hepatic insufficiency 6

IctÞre 6

Skin and subcutaneous tissue disorders

sweating

Skin rash

Night sweats

Urticaria

Contact dermatitis

Cold sweat

Photosensitivity Reactions

Increased tendency to bruise

Stevens-Johnson Syndrome 6

Quincke's Dome 6

Musculoskeletal and systemic disorders

Musculoskeletal pain

Muscle spasms

Muscle tension

Muscle contractions

lockjaw

Renal and urinary disorders

Dysuria

Urinary frequency

Urinary retention

Emotional delay

nocturia

polyuria

Decrease in urinary debit

Abnormal smell of urine

Disorders of reproductive organs and breast

Erectile dysfunction

Ejaculation disorder

Delayed cumshot

Gynecological haemorrhage

Menstrual disorders

Sexual dysfunction

Testicular pain

Menopausal symptoms

GalactorrhÚe

Hyper-prolactinÚmie

General disorders and administration site abnormalities

Falls 8

Tired

Chest pain 7

Abnormal sensations

Feeling cold

Thirst

Chills

Discomfort

Hot feeling

Walking disorder

investigations

Weightloss

Weight gain

Increased Serum Phosphokinase (CPK)

HyperkaliÚmie

Hyper-cholestÚrolÚmie

1 Cases of seizures and tinnitus have also been reported after treatment has been discontinued.

2 Cases of orthostatic hypotension and syncope have been reported particularly early in treatment.

3 See Warnings and Precautions section .

4 Cases of aggression and anger have been reported especially at the beginning of treatment or after its termination.

5 Cases of suicidal ideation and suicidal behavior have been reported during or just after duloxetine treatment (see Warnings and Precautions section ).

6 Frequency estimated on the basis of undesirable effects reported during post marketing surveillance; not observed in clinical trials versus placebo.

7 No statistically significant difference from placebo.

8 Falls were more frequent in subjects with gs (≥ 65 years).

c. Description of specific undesirable effects

Stopping treatment with duloxetine (particularly if it is brutal) frequently induces withdrawal symptoms. The most commonly reported withdrawal reactions are: dizziness, sensory disturbances (including paresthesia or sensations of electrical discharge, especially in the head), sleep disturbances (including insomnia and restlessness), fatigue, drowsiness, restlessness or anxiety, nausea and / or vomiting, tremor, headache, myalgia, irritability, diarrhea, hyperhidrosis and vertigo.

Generally, for SSRIs and SNRIs, these symptoms are of mild intensity at "moderate and spontaneously resolving, although they may be severely severe and / or prolonged in some patients. When treatment with duloxetine is no longer necessary, it is therefore advisable to gradually reduce the doses until the treatment is stopped (see sections Posology and method of administration and Warnings and precautions for use ) .

In the acute 12-week phase of three clinical trials of duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting gonorrhea were observed in duloxetine-treated patients. The HbA1c value remained stable in patients treated with placebo and in patients treated with duloxetine. In the extension phase of these trials, which lasted up to 52 weeks, the HbA1c value increased in the duloxetine groups and usual treatment, but the mean increase was 0.3% more important in the duloxetine group. There was also a small increase in fasting and total cholesterol levels in the duloxetine group, whereas laboratory tests showed a slight decrease in these parameters in the usual treatment group.

The QT interval - corrected for heart rate - in patients receiving duloxetine was no different from that observed in placebo-treated patients. Measurement of QT, PR, QRS or QTcB intervals showed no clinically significant differences between the duloxetine and placebo groups.

d. Pediatric population

A total of 509 pediatric patients aged 7 to 17 years with major depressive disorder and 241 pediatric patients aged 7 to 17 years with generalized anxiety disorder have been treated with duloxetine in clinical trials. In general, the undesirable effects profile of duloxetine in children and adolescents was similar to that seen in adults.

In clinical trials, a total of 467 randomized pediatric patients receiving duloxetine showed a mean decrease in body weight of 0.1 kg at 10 weeks compared with an average increase of 0.9 kg in 353 patients treated with the drug. placebo. Subsequently, over an extension period of four to six months, these patients had, on average, a tendency to "recover their expected initial weight percentile, based on population data from the same age. and of the same sex.

In studies up to 9 months, an average decrease of 1% in their height percentile (decrease of 2% in children (7-11 years) and increase of 0.3% in adolescents (12-17 years) years)) has been observed in pediatric patients treated with duloxetine (see Warnings and Precautions section ).

Declaration of suspected undesirable effects

The declaration of undesirable effects suspected after authorization of the drug is important. It allows continuous monitoring of the beneficial / risk ratio of the drug. Healthcare professionals declare any suspected adverse effects via the national system of declaration: National Agency for the Safety of Medicines and Health Products (ANSM) and the Network of Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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