Duzela® delay release capsules are used for the treatment of depression, generalised anxiety disorder (GAD), diabetic neuropathy with nerve pain in the feet, legs or hands. Duzela® can be taken only in patients aged 18 years and older.

Active Ingredient

Duloxetine.

Description

Duzela® is manufactured by Sun Pharmaceuticals. These delayed release capsules contain Duloxetine as an active ingredient, which is a type of antidepressant known as a serotonin-noradrenaline reuptake inhibitor (SNRI). Delay release allows safe passing of Duloxetine through the stomach to prevent the drug from being damaged or inactivated by gastric juices or where it may irritate the gastric mucosa.

Indications:

- depression or MDD – major depressive disorder (long-term lowering of enjoyment of life, extremely low mood, suicidal thoughts);

- generalised anxiety disorder (GAD) (exaggerated anxiety and worry about everyday life events with no obvious reasons);

- diabetic neuropathy (numbness or tingling in your fingers, toes, hands, and feet; burning, sharp, or aching pain);

- off-label prematurity of ejaculation (PE), a condition when a man ejaculates too rapidly after penetration, in severe cases even before it.

MOA (mechanism of action):

Serotonin and noradrenaline are neurotransmitters released from nerve cells in the brain to enhance mood. When they are reabsorbed into the nerve cells, they do not affect the mood anymore. Duloxetine prevents serotonin and noradrenaline from being reabsorbed back into the nerve cells in the brain. This aids in prolonging the mood lightening effect of the released serotonin and noradrenaline.

Dosage

Swallow a capsule whole with a drink of water.

For depression and diabetic neuropathic pain: 60 mg once a day. Your doctor should determine the dose that is right for you.

For generalised anxiety disorder: 30 mg once a day after which most patients will receive 60 mg once a day. Your doctor should determine the dose that is right for you. The dosage may be adjusted up to 120 mg a day based on individual response to Duzela®.

Take capsules at the same times every day.

Talk with your doctor about how long you should keep taking Duzela®.

Do not stop taking Duzela®, or change your dose, without discussing with your doctor.

Duzela® starts to work in most cases of depression or anxiety within 2 weeks of starting taking, but it may take 2-4 weeks before you feel better. Tell your doctor if you do not start to feel better after this time.

Missing a dose

If you miss a dose you should take it as soon as you remember about your missing. If it is the time for the next dose you should continue your regular dosing schedule. Do not take a double dose of Duzela® to compensate the missed dose.

Overdose

If you take an overdose of Duzela®, you should seek emergency medical attention or contact your healthcare provider immediately.

Storage

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F) and away from excess moisture and heat. Throw away any unused medicine after the expiration date. Keep out of the reach of children.

Side effects

The most common side effects associated with Duzela® are:

• feeling dizzy
• headache
• feeling sick
• feeling irritable
• feeling numb
• sweating
• flushing
• diarrhea
• constipation
• stomach pain
• bloating
• problems sleeping
• feeling tired or sleepy, yawning
• blocked nose
• a rise in blood pressure
• difficulty concentrating
• shaking or trembling
• lower interest in sex
• ringing in the ears
• blurred vision
• indigestion
• dry mouth

Side effect occurrence does not only depend on medication you are taking, but also on your overall health and other factors.

Contraindications

Do not take Duzela® if you are allergic to Duloxetine, other SNRIs or to any of the medication's components.

Do not take Duzela® if you have taken recreational drugs such as ecstasy (MDMA), ketamine, LSD, poppers (amyl nitrate), narcotics or benzodiazepines.

Do not take Duzela® if you are taking other medications, including erythromycin, alpha-blockers, antifungal medications (ketoconazole and itraconazole), medications for HIV (ritonavir, saquinavir, nelfinavir and atazanavir), certain antibiotics (telithromycin), alprazolam (Xanax), anticoagulants (warfarin), antidepressants (Elavil, Asendin, Anafranil, Norpramin), MAOI antidepressants (Marplan, Nardil, Eldepryl, Emsam, Zelapar), SSRI antidepressants (fluvoxamine), herbal remedy St. John’s Wort, NSAIDs (Advil, Motrin, Aleve, Naprosyn), clopidogrel (Plavix), diazepam (Valium), digoxin (Lanoxin), diuretics ('water pills'), linezolid, flecainide (Tambocor), medications for diabetes, lithium (Eskalith, Lithobid), medications for anxiety and Parkinson's disease, methylene blue, medications for mental illness (Clozaril, Haldol), medications for migraine (Axert, Relpax, Frova, Amerge), medications for seizures (Tegretol, Dilantin), sedatives, sibutramine (Meridia), sleeping pills, tramadol (Ultram), tranquilizers, and vinblastine (Velban).

Do not take Duzela® if you experience seizures (convulsions or fits).

Do not take Duzela® if you suffer from or have history of cardiovascular disease, liver or kidney disorders, hypotension, leukemia, peptic ulcer disease, rhinitis, glaucoma, epilepsy.

Do not take Duzela® if you have a history of fainting, mania (feeling overexcited, irritable or not being able to think clearly) or severe depression.

Do not take Duzela® if you have recently undergone a surgery.

Do not to consume alcohol, drive or operate machinery while using Duzela®, as it can lower your blood pressure, causing dizziness, drowsiness.

Duzela® is not for use in patients under age 18 years.