Medicinal Products

DULOXETINE KRKA 30 mg gastro-resistant capsule box of 28

Generic Cymbalta Drug
Therapeutic Class: Neurology-Psychiatry
active ingredients: Duloxetine, Duloxetine
laboratory: Krka France

Gastroresistant capsule
All forms

Indication

· Treatment of major depressive disorder.

· Treatment of peripheral diabetic neuropathic pain.

· Treatment of generalized anxiety disorder.

DULOXETINE KRKA is indicated in adults.

For more information, see section 5.1 Pharmacodynamic properties .

Dosage DULOXETINE KRKA 30 mg gastro-resistant capsule box of 28

· Treatment of major depressive disorder.

· Treatment of peripheral diabetic neuropathic pain.

· Treatment of generalized anxiety disorder.

DULOXETINE KRKA is indicated in adults.

For more information, see section 5.1 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 resulting in liver failure (see section 5.2 Pharmacokinetic properties ).

· Combination with fluvoxamine, ciprofloxacin or enoxacin (potent CYP1A2 inhibitors), combinations causing increased plasma concentrations of duloxetine (see section 4.5).

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

· Treatment with DULOXETINE KRKA is contraindicated in patients with unbalanced hypertension who may expose them to a potential risk of hypertensive crisis (see Warnings and Precautions and Adverse Reactions sections).

Adverse effects Duloxetine Krka

at. Summary of the security profile

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

b. Summary table of adverse effects

Table 1 presents the adverse events observed from spontaneous notification and in placebo-controlled clinical studies (including a total of 9454 patients, 5703 on duloxetine and 3751 on placebo) conducted in depression, generalized anxiety disorder and neuropathic pain. diabetic.

Table 1: Undesirable effects

Frequency estimate: very common (≥ 1/10), common (≥ 1/100, <1/10), uncommon (≥ 1/1000, <1/100), rare (≥ 1/10 000, < 1/1 000), very rare (<1 / 10, 000).

Within each frequency category, adverse effects are presented in order of decreasing severity.

Very common

Frequent

Rare

Rare

Very rare

Infections and infestations

Laryngitis

Immune system disorders

Anaphylactic reaction

Hypersensitivity manifestations

Endocrine disorders

Hypothyroidism

Metabolism and nutrition disorders

Decreased appetite

Hyperglycemia (reported especially in diabetic patients)

dehydration

hyponatremia

SIADH 6

Psychiatric disorders

Insomnia

agitation

Drop in libido

Anxiety

Abnormal orgasms

Abnormal dreams

Suicidal Ideas 5, 7

Sleeping troubles

bruxism

disorientation

Apathy

Suicidal behavior 5.7

Mania

hallucinations

Aggressiveness and anger 4

Nervous system disorders

headaches

Drowsiness

Dizzying sensations

lethargies

tremors

paresthesia

myoclonus

Akathisie 7

Nervousness

Attention disorder

dysgeusia

dyskinesia

Restless legs syndrome

Poor sleep

Serotoninergic syndrome 6

Convulsions 1

agitation

psychomotor 6

Extrapyramidal symptoms 6

Eye disorders

Blurred vision

mydriasis

Visual disorders

Glaucoma

Affections of the ear and labyrinth

Tinnitus 1

Dizziness

Ear pain

Heart conditions

palpitations

tachycardia

Supraventricular arrhythmia, mainly atrial fibrillation

Vascular disorders

Increased blood pressure 3

Hot flashes

Syncope 2

Hypertension 3, 7

Orthostatic hypotension 2

Coldness of the extremities

Hypertensive crisis 3, 6

Respiratory, thoracic and mediastinal disorders

yawning

Pharyngeal discomfort

Epistaxis

Gastrointestinal disorders

nausea

Dryness of the mouth

Constipation

Diarrhea

Abdominal pain

vomiting

Dyspepsia

Flatulence

Gastrointestinal bleeding 7

Gastroenteritis

Eructation

Gastritis

dysphagia

stomatitis

Emission of blood in the stool

Halitosis

Hepatobiliary disorders

Hepatitis 3

Increased liver enzymes (ALT, ASAT, alkaline phosphatase)

Acute liver injury

Hepatic insufficiency 6

Icter 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 edema 6

Musculoskeletal and connective tissue disorders

Musculoskeletal pain

Muscle spasms

Muscle tension

Muscle contractions

lockjaw

Renal and urinary disorders

Dysuria

Urinary frequency

Urinary retention

Emotional delay

nocturia

polyuria

Decreased urinary flow

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

galactorrhoea

hyperprolactinemia

General disorders and administration site conditions

Falls 8

Tired

Chest pain 7

Abnormal sensations

Feeling cold

Thirst

Chills

Discomfort

Hot feeling

Walking disorder

investigations

Weightloss

Weight gain

Serum phosphokinase creatinine increase (CPK)

hyperkalemia

hypercholesterolemia

1 Cases of convulsions and tinnitus have also been reported after discontinuation of treatment.

2 Cases of orthostatic hypotension and syncope have been reported particularly at the beginning of treatment.

3 See warnings and precautions for use .

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

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

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

7 No statistically significant difference compared to placebo.

Falls were more common in elderly subjects (≥ 65 years).

c. Description of specific adverse events

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 electrical discharge sensations, especially in the head), sleep disturbances (including insomnia and restlessness), fatigue, drowsiness, agitation or anxiety, nausea and / or vomiting, tremors, headache, myalgia, irritability, diarrhea, hyperhidrosis and vertigo.

Generally, for SSRIs and SNRIs, these symptoms are mild to moderate and self-limiting, although they may be 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 blood glucose were observed in duloxetine-treated patients. The HbA1c value 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 groups and usual treatment, but the mean increase was 0.3% greater in the duloxetine group. There was also a slight increase in fasting blood glucose and total cholesterol in the duloxetine group, whereas laboratory tests showed a slight decrease in these parameters in the usual treatment group.

The heart rate-adjusted QT interval - in duloxetine-treated patients was no different from that observed in placebo-treated patients. Measurement of QT, PR, QRS or QTcB intervals showed no clinically significant difference 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 were treated with duloxetine in clinical studies. In general, the adverse event profile 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 with 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, on average, tended to return to their expected initial percentile weight, based on data from populations of the same age and 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) years) have been observed in pediatric patients treated with duloxetine (see Warnings and Precautions ).

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 declare any suspected adverse reaction via the national reporting system: 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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