Medicinal Products

DULOXETINE MYLAN PHARMA 60 mg gastro-resistant gastro-resistant box of 1 vial of 28

Generic Cymbalta Drug
Therapeutic Class: Neurology-Psychiatry
Active ingredients: [Duloxetine, 3012], [Duloxetine, 3012]
laboratory: Mylan

Gastro-resistant gastro-resistant
All forms

Indication

Treatment of major depressive disorder.

Treatment of peripheral diabetic neuropathic pain.

Treatment of the anxiety disorder generalized.

DULOXETINE MYLAN PHARMA is indicated in adults.

For more information, see the section titled Pharmacodynamic Properties .

Dosage DULOXETINE MYLAN PHARMA 60 mg gastro-resistant gastro-resistant box of 1 vial of 28

Treatment of major depressive disorder.

Treatment of peripheral diabetic neuropathic pain.

Treatment of the anxiety disorder generalized.

DULOXETINE MYLAN PHARMA is indicated in adults.

For more information, see the section titled Pharmacodynamic Properties .

Against indications

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

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

Hepatic disease leading to hepatic insufficiency (see section Pharmacokinetic properties ).

Combination with fluvoxamine, ciprofloxacin or hexoxine (potent CYP1A2 inhibitors), combinations resulting in increased plasma concentrations of duloxetine (see section 4.5). Interactions with other medicinal products and other forms of duloxetine interactions ).

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

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

Adverse effects Duloxetine Mylan Pharma

at. Summary of the security profile

The most common adverse events reported in patients treated with DULOXETINE MYLAN PHARMA were: nausea, headache, dry mouth, drowsiness and dizziness . However, the majority of frequent adverse effects were of mild to moderate intensity, generally 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 reporting and placebo-controlled clinical trials (including a total of 9454 patients, 5703 patients treated with duloxetine and 3751 under placebo) conducted in depression, generalized anxiety disorder and diabetic neuropathic pain.

Table 1: Inadmissible Effects

Frequency Estimate: very common (≥ 1/10), frequent (≥ 1/100, <1/10), slightly infrequent (≥ 1/1000, <1/100), rare (≥ 1/10 000, <1/1000), very rare (<1 / 10, 000).

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

Very frequent

Frà © Quent

Not very frequent

Rare

Very rare

Infections and infestations

AT

AT

Laryngitis

AT

AT

Immune system disorders

AT

AT

AT

Book © Action

anaplasty

events

of hypersensibilità ©

AT

Endocrine disorders

AT

AT

AT

Hypothyroïdie

AT

Metabolism and nutrition disorders

AT

Drop in appetite

Hyperglycà © mie

(Reported © e

particularly

in patients

© diabetics ticks)

Detail © dehydration

Hyponatrà © mie

SIADH 6

AT

Psychiatric disorders

AT

Insomnia

agitation

Drop in libido

Anxia been © ©

orgasms

abnormal

Abnormal dreams

Suicidal Ideas 5.7

Disorders of

sleep

bruxism

Detail © disorientation

Apathy

Behaviours

suicidal 5.7

Mania

hallucinations

Aggressiveness and anger 4

AT

Nervous system disorders

CÃ © Phala © es

Drowsiness

sensations

vertiginous

LÃ © thargie

tremors

Paresthà © sies

myoclonus

Akathisie 7

© nervousness

Trouble of

attention

dysgeusia

Dyskinà © sie

Syndrome of

restless legs

Sleep

poor quality

Syndrome

Serontonergic 6

Convulsions 1

Psychomotor agitation 6

symptoms

extrapyramidal 6

AT

Eye disorders

AT

Blurred vision

mydriasis

Visual disorders

Glaucoma

AT

Affections of the ear and labyrinth

AT

Tinnitus 1 Â

Dizziness

Ear pain

AT

AT

Heart conditions

AT

palpitations

tachycardia

arrhythmia

supraventricular,

mainly

At fibrillation type

auricular

AT

AT

Vascular disorders

AT

Increase of

pressure

arterial 3

Puffs of

heat

Syncope 2

Hypertension 3.7

hypotension

orthostatic 2

Coldness of

Extra Mita © © s

Hypertensive crisis 3.6

AT

Respiratory, thoracic and mediastinal disorders

AT

BÃ ¢ illements

Pharyngeal gene

Epistaxis

AT

AT

Gastrointestinal disorders

Nausea © es

Drought of the

stuffy

Constipation

Diarrha © e

Pain

abdominal

vomiting

Dyspepsia

Flatulence

HÃ © hemorrhage

gastrointestinal 7

Gastrointestinal Enta © rite

Eructation

Gastritis

dysphagia

stomatitis

Emission of blood

in the stool

Halitosis

AT

Hereditary conditions

AT

AT

Hepatitis 3

Increase in

enzymes

Hepatocytes (ALAT, ASAT,

phosphatase

alkaline)

Hematological attack

acute "

insufficiency

hepatic 6

Icter 6

AT

Skin and subcutaneous tissue disorders

AT

sweating

Skin rash

Night sweats

Urticaria

Dermatitis of

contact

Cold sweat

Reactions of

© photosensitivity

Increase of

the tendency to

bruising

Syndrome of

Stevens-Johnson 6

Essence of Quincke 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

Drop in the flow

urinary

Abnormal odor

urine

AT

Disorders of reproductive organs and breast

AT

dysfunction

à © Erectile

Trouble of

the à © cumshot

Ejaculation

delayed © e

HÃ © hemorrhage

© Ecological Gyna

unrest

menstrual

Sexual dysfunction

Pain

testicular

symptoms

mà © nopausiques

Galactorrhà © e

Hyperprolac-tina © mie

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

creatinine

phosphokinase

Serial (CPK)

Hyperkalià © mie

Hypercholes-summer © Rola © mie

AT

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

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

3 See Warnings and Precautions .

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

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

6 Estimated frequency based on adverse effects reported during post-marketing surveillance; not observed in placebo-controlled clinical trials.

7 No statistically significant difference from placebo.

8 Falls were more frequent among elderly subjects (≥ 65 years).

c. Description of specific undesirable effects

Stopping treatment with duloxetine (especially 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, tremors, headache, myalgia, irritability, diarrhea, hyperhidrosis and vertigo.

Generally, for SSRIs and SNRIs, these symptoms are of mild to moderate intensity and spontaneously resolving, although they may be of intensity. 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 ).

In the acute 12-week phase of three clinical trials investigating duloxetine in patients with diabetic neuropathic pain, small but statistically significant increases in fasting glycaemia were observed. observed in patients on duloxetine. The value of HbA1c remained stable in placebo-treated patients 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 and usual treatment groups, but the mean increase was 0.3% higher in the duloxetine group. There was also a slight increase in fasting glycaemia and total cholesterol in the duloxetine group, whereas laboratory tests show a slight decrease in these parameters in the group usual treatment.

The QT interval - corrected for heart rate - in patients on duloxetine was not different from that observed in placebo-treated patients. The 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 an anxiety disorder generalized have been treated with duloxetine in clinical studies. In general, the profile of the undesirable effects of duloxetine in children and adolescents was similar to that seen in adults.

In clinical studies, a total of 467 randomized pediatric patients receiving duloxetine showed a mean decrease in body weight of 0.1 kg at 10 weeks compared to an average increase of 0, 9 kg in 353 patients treated with 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 data from populations of 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 a 0.3% increase in adolescents (12%) -17 years) have been observed in pediatric patients treated with duloxetine (see Warnings and Precautions ).

Declaration of suspected untoward effects

The declaration of suspected adverse effects after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals disclose any suspected adverse effects via the national reporting system: National Agency for Drug and Health Product Safety (ANSM) and network Regional Pharmacovigilance Centers - Website: www.ansm.sante.fr.

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