Cymbalta 60 mg 28 tablets

Trade name:

Cymbalta 60 mg 28 tablets.

Compositions:

Each capsule contains 30 mg of duloxetine (as hydrochloride).

Description:

Cymbalta increases the levels of serotonin and noradrenaline in the nervous system.

Cymbalta is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may be unbalanced in people with depression.

Cymbalta is used to treat major depressive disorder in adults. 

Indications:

Treatment of major depressive disorder.

Treatment of diabetic peripheral neuropathic pain.

Treatment of generalised anxiety disorder.

Cymbalta is indicated in adults.

Mechanism of action:

Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA) reuptake inhibitor. It weakly inhibits dopamine reuptake, with no significant affinity for histaminergic, dopaminergic, cholinergic, and adrenergic receptors. 

Dosage and method of administration:

Therapeutic response is usually seen after 2-4 weeks of treatment.

Major Depressive Disorder:

The starting and recommended maintenance dose is 60 mg once daily with or without food.

Maximum dose is 120 mg per day.

Generalised Anxiety Disorder:

The recommended starting dose in patients with generalised anxiety disorder is 30 mg once daily with or without food. In patients with insufficient response the dose should be increased to 60 mg, which is the usual maintenance dose in most patients.

Diabetic Peripheral Neuropathic Pain:

The starting and recommended maintenance dose is 60 mg daily with or without food. Dosages above 60 mg once daily, up to a maximum dose of 120 mg per day.

Contraindications:

Cymbalta must not be used in patients with liver disease resulting in hepatic impairment

Duloxetine should not be used in children and adolescents under the age of 18 years.

Hypersensitivity to the active substance or to any of the excipients.

Concomitant use of Cymbalta with non-selective, irreversible monoamine oxidase inhibitors (MAOIs) is contraindicated.

Liver disease resulting in hepatic impairment.

Cymbalta should not be used in combination with fluvoxamine, ciprofloxacin or enoxacin (i.e. potent CYP1A2 inhibitors).

Severe renal impairment (creatinine clearance <30 ml/min).

The initiation of treatment with Cymbalta is contraindicated in patients with uncontrolled hypertension that could expose patients to a potential risk of hypertensive crisis.

Special warnings and precautions for use:

Mania and Seizures:

Cymbalta should be used with caution in patients with a history of mania or a diagnosis of bipolar disorder, and/or seizures.

Mydriasis:

Mydriasis has been reported in association with duloxetine, therefore, caution should be used when prescribing Cymbalta to patients with increased intraocular pressure or those at risk of acute narrow-angle glaucoma.

Blood Pressure and Heart Rate:

In patients with known hypertension and/or other cardiac disease, blood pressure monitoring is recommended, especially during the first month of treatment. 

St John’s Wort:

Adverse reactions may be more common during concomitant use of Cymbalta and herbal preparations containing St John’s Wort (Hypericum perforatum).

Elderly:

Caution should be exercised when treating the elderly with the maximum dosage.

Hepatitis/Increased Liver Enzymes:

Cases of liver injury, including severe elevations of liver enzymes (>10 times upper limit of normal), hepatitis, and jaundice have been reported with duloxetine. 

Sexual dysfunction:

Selective serotonin reuptake inhibitors (SSRIs)/serotonin norepinephrine reuptake inhibitors (SNRIs) may cause symptoms of sexual dysfunction.

Sucrose:

Cymbalta hard gastro-resistant capsules contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

Pregnancy and lactation:

Pregnancy:

Cymbalta should be used in pregnancy only if the potential benefit justifies the potential risk to the foetus. 

Breast-Feeding:

As the safety of duloxetine in infants is not known, the use of Cymbalta while breast-feeding is not recommended.

Side Effects:

Nausea, Dry mouth, Decreased appetite, Insomnia Agitation, Libido decreased, Anxiety, Abnormal dreams, Dizziness, Lethargy, Tremor, Paraesthesia, Blurred vision, Tinnitus, Palpitations, Blood pressure increase, Flushing, Yawning, Constipation, Diarrhoea, Abdominal pain, Vomiting, Dyspepsia, Flatulence, Sweating increased, Rash, Musculoskeletal pain, Muscle spasm, Erectile dysfunction, Ejaculation disorder, Ejaculation delayed, Falls, Fatigue, Weight decrease

Storage Method:

Store in the original package in order to protect from moisture.

Do not store above 30° C.

Keep out of reach of children

Package:

A carton box contains 28 tablets and leaflet.