Medicinal Products

DULOXETINE MYLAN PHARMA 60 mg gastro-resistant gastrointestinal box of 28

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

Gastrointestinal Gélule
All forms

Indication

Treatment of major depressive disorder.

Treatment of peripheral diabetic neuropathic pain.

Treatment of anxiety disorder generics.

DULOXETINE MYLAN PHARMA is indicated in adults.

For more information, see section on Pharmacodynamic properties .

Dosage DULOXETINE MYLAN PHARMA 60 mg gastro-resistant gastrointestinal box of 28

Treatment of major depressive disorder.

Treatment of peripheral diabetic neuropathic pain.

Treatment of anxiety disorder generics.

DULOXETINE MYLAN PHARMA 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 mono-amine 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 ).

DULOXETINE MYLAN PHARMA treatment is contraindicated in patients with unhealthy arterial hypertension who may expose them to a potential risk of hypertensive crisis (see sections Warnings and Precautions and Undesirable Effects ).

Adverse effects Duloxetine Mylan Pharma

at. Summary of the safety profile

The most commonly reported undesirable effects in patients treated with DULOXETINE MYLAN PHARMA 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 presents the undesirable effects observed from spontaneous notification and in placebo-controlled clinical trials (including a total of 9454 patients, 5703 duloxetine and 3751 placebo) conducted in depression, anxiety disorder and generalized 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

AT

AT

Laryngitis

AT

AT

Immune system disorders

AT

AT

AT

RÚaction

anaplasty

events

of hypersensibilitÚ

AT

Endocrine disorders

AT

AT

AT

HypothyroÂ'die

AT

Metabolism and nutrition disorders

AT

Drop in appetite

HyperglycÚmie

(rapportÚe

particuliÞrement

in patients

diabÚtiques)

DÚshydratation

HyponatrÚmie

SIADH 6

AT

Psychiatric disorders

AT

Insomnia

agitation

Drop in libido

AnxiÚtÚ

orgasms

abnormal

Abnormal findings

Suicidal Ideas 5.7

Disorders of

sleep

bruxism

DÚsorientation

Apathy

Behaviours

suicidal 5.7

Mania

hallucinations

Agressivity and anger 4

AT

Nervous System Affections

CÚphalÚes

Drowsiness

sensations

vertiginous

LÚthargie

tremors

ParesthÚsies

myoclonus

Akathisie 7

NervositÚ

Trouble of

attention

dysgeusia

DyskinÚsie

Syndrome of

restless legs

Sleep

poor quality

Syndrome

serotonergic 6

Convulsions 1

Psychomotor agitation 6

Sympt¶mes

extrapyramidal 6

AT

Eye disorders

AT

Blurred vision

mydriasis

Visual disorders

Glaucoma

AT

Affections of the ear and labyrinth

AT

Tinnitus 1 to

Dizziness

Ear pain

AT

AT

Heart conditions

AT

palpitations

tachycardia

arrhythmia

supraventricular,

mainly

à "type of fibrillation

auricular

AT

AT

Vascular disorders

AT

Increase of

pressure

arterial 3

Bouffes of

heat

Syncope 2

Hypertension 3.7

hypotension

orthostatic 2

Coldness of

extrÚmitÚs

Hypertensive crisis 3.6

AT

Respiratory, thoracic and mediastinal disorders

AT

BABY "illements

Gone pharyngeal

Epistaxis

AT

AT

Gastrointestinal disorders

NausÚes

Drought of the

stuffy

Constipation

DiarrhÚe

Pain

abdominal

vomiting

Dyspepsia

Flatulence

HÚmorragie

gastrointestinal 7

Gastrointestinal entÚrite

Eructation

Gastritis

dysphagia

stomatitis

Emission of blood

in the stool

Halitosis

AT

Hospital diseases

AT

AT

Hepatitis 3

Increase in

enzymes

hepatics (ALAT, ASAT,

phosphatase

alkaline)

Hepatic damage

acute ™

insufficiency

hepatic 6

IctÞre 6

AT

Skin and subcutaneous tissue disorders

AT

sweating

Skin rash

Night sweats

Urticaria

Dermatitis of

contact

Cold sweat

Reactions

photosensibilitÚ

Increase of

the tendency to

bruising

Syndrome of

Stevens-Johnson 6

Quincke's Essence 6

AT

Musculoskeletal and systemic disorders

AT

pains

musculo

skeletal

spasms

muscle

Voltage

muscular

contractions

muscle

lockjaw

AT

Renal and urinary disorders

AT

Dysuria

Urinary frequency

Urinary retention

Emotional delay

nocturia

polyuria

Decrease of the flow

urinary

Abnormal odor

urine

AT

Disorders of reproductive organs and breast

AT

dysfunction

Úrectile

Trouble of

the Újaculation

Ejaculation

retardÚe

HÚmorragie

gynÚcologique

unrest

menstrual

Sexual dysfunction

Pain

testicular

Sympt¶mes

mÚnopausiques

GalactorrhÚe

Hyperprolac-tinÚmie

AT

General disorders and administration site abnormalities

Falls 8

Tired

Pain

thoracic 7

Abnormal sensations

Feeling cold

Thirst

Chills

Discomfort

Sensation of

hot

Trouble of the

market

investigations

AT

Weightloss

Weight gain

Increase of

the creatinine

phosphokinase

Serial (CPK)

HyperkaliÚmie

Hypercholes-tÚrolÚmie

AT

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 based on undesirable effects reported during postmarketing 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 frequently reported withdrawal reactions are: dizziness, sensory disturbances (including paresthesia or sensations of electrical discharge, especially in the head), sleep disturbances (including insomnia and restlessness), atigue, 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. It is therefore advisable to gradually reduce the doses when treatment with duloxetine is no longer necessary (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 presenting 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 an increase of 0.3% in adolescents (12- 17 years) have 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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