BY ACTAVIS – EU
What Aritavi is and what it is used for
Aritavi contains the active substance duloxetine. Aritavi raises levels of serotonin and norepinephrine in the nervous system.
Aritavi is used in adults to treat:
• Generalized anxiety disorder (constant feeling of anxiety or nervousness)
• Diabetic neuropathic pain (often described as burning, piercing, stinging, shooting or electroshock-like pain. There may be a loss of sensation in the affected area or sensations such as touch, heat, cold or pressure can cause pain.)
In most people with depression or anxiety, Aritavi starts to work within two weeks of starting treatment, but it can take 2-4 weeks before you feel better. Tell your doctor if you do not feel better after this time has passed. When you feel better, your doctor may continue to prescribe Aritavi to prevent your depression or anxiety from recurring.
In patients with diabetic neuropathic pain, treatment may take several weeks before you feel better. Tell your doctor if you do not feel better after 2 months.
How to store Aritavi
Keep out of the reach and sight of children.
Store below 25 ° C.
Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines in sewage or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Aritavi contains
The active substance is duloxetine.
Each capsule contains 30 or 60 mg of duloxetine (as hydrochloride).
The other ingredients are:
Capsule content: sugar spheres (sucrose, corn starch), hypromellose phthalate (HP-55), hypromellose (E 15 LV), triethyl citrate, hydroxypropyl cellulose, talc
Composition of the capsule of 30 mg \ hypromellose (E464), titanium dioxide (E 171), brilliant blue FCF (E133), black iron oxide (E172), printing ink.
Composition of the 60 mg capsule: hypromellose (E464), titanium dioxide (E 171), black iron oxide (E 172), printing ink
Printing ink contains: shellac, propylene glycol, black iron oxide (E 172), potassium hydroxide.
What Aritavi looks like and contents of the pack
Aritavi capsule is a hard, gastro-resistant capsule. Each Aritavi capsule contains duloxetine hydrochloride coated pellets for protection against gastric acid.
Aritavi is available in two dosage forms: 30 mg and 60 mg.
The 30 mg capsules have an opaque gray body labeled ‘DLX 30’ and an opaque blue cap labeled T) LX 30 ‘and a length of 18.0 mm.
The 60 mg capsules have an opaque gray body labeled ‘DLX 60’ and an opaque white cap labeled ‘DLX 60’ and a length of 20.4 mm.
Aritavi 30 mg is available in:
Plastic (HDPE) capsule packs with screw cap with built-in packs of 28, 30, 56, 60, 84, 90, 98 and 100 capsules.
Blisters (A1 / A1) in packs of 28, 30 and 100 capsules.
Aritavi 60 mg is available in:
Plastic (HDPE) capsule packs with screw cap with built-in silicone dryer in packs of 28, 30, 56, 60, 84 and 90 capsules.
Blisters (A1 / A1) in packs of 28, 30 and 56 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Actavis Group PTC ehf.
3 Samupovsko Shose Street Dupnitsa,
More about ARITAVI 60 mg capsules. * 28 (ARITAVI capsules 60 mg * 28)