CYMBALTA 60 CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Eli Lilly (S.A.) (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS DULOXETINE HYDROCHLORIDE EQUIVALENT TO DULOXETINE 60,0 mg

Authorization status:

Registered

Authorization date:

2005-05-09

Patient Information leaflet

Eli Lilly (S.A.) (Pty) Ltd
Cymbalta 30
Cymbalta 60
Capsules; Each capsule contains 30/60 mg
duloxetine
Date: 24 January 2022
UC9542&UC9543_ZA_PIL_v01_MTC
Page
1
of
15
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS S5
CYMBALTA 30 (hard gastro-resistant capsules)
CYMBALTA 60 (hard gastro-resistant capsules)
Duloxetine (as hydrochloride)
Contains sugar: 56/111 mg sucrose
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING CYMBALTA
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
CYMBALTA has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them even if their symptoms
are the same as
yours.
WHAT IS IN THIS LEAFLET
1. What CYMBALTA is and what it is used for
2. What you need to know before you take CYMBALTA
3. How to take CYMBALTA
4. Possible side effects
5. How to store CYMBALTA
6. Contents of the pack and other information
Eli Lilly (S.A.) (Pty) Ltd
Cymbalta 30
Cymbalta 60
Capsules; Each capsule contains 30/60 mg
duloxetine
Date: 24 January 2022
UC9542&UC9543_ZA_PIL_v01_MTC
Page
2
of
15
1. WHAT CYMBALTA IS AND WHAT IT IS USED FOR
The active substance is duloxetine hydrochloride.
CYMBALTA is a serotonin and norepinephrine reuptake inhibitor and
increases the levels of
serotonin and noradrenaline in the nervous system.
CYMBALTA is used in adults to treat
•
depression
•
diabetic peripheral neuropathic pain.
CYMBALTA may take 2 to 4 weeks to start working in most people with
depression. Talk to
your doctor if you do not start to feel better after this time.
In people with diabetic neuropathic pain, it can take some weeks
before you feel better. Talk
to your doctor if you do not feel better after 2 months.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE CYMBALTA
DO NOT TAKE CYMBALTA:
•
If you are hypersensitive (allergic) to duloxetine or any of the other
ingredients of
CYMBALTA (listed in section 6).
•
If you are taking or have recently taken

Summary of Product characteristics

Eli Lilly (S.A.) (Pty) Ltd
Cymbalta 30
Cymbalta 60
Capsules; Each capsule contains 30/60 mg duloxetine
Date: 24 January 2022
UC9542&UC9543_ZA_PI_v01_MTC
Page 1 of 28
APPROVED PROFESSIONAL INFORMATION
SCHEDULING STATUS S5
1.
NAME OF THE MEDICINE
CYMBALTA 30 (hard gastro-resistant capsules)
CYMBALTA 60 (hard gastro-resistant capsules)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Cymbalta 30 _
Each capsule contains 30 mg duloxetine (as hydrochloride).
Each capsule may contain up to 56 mg sucrose.
_Cymbalta 60 _
Each capsule contains 60 mg duloxetine (as hydrochloride).
Each capsule may contain up to 111 mg sucrose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gastro-resistant capsule.
CYMBALTA 30 (Capsule)
Opaque white body, imprinted with “30 mg” in green ink, and opaque
blue cap. The capsule contains
white to light greyish white enteric coated pellets.
CYMBALTA 60 (Capsule)
Opaque green body, imprinted with “60 mg” in white ink, and opaque
blue cap. The capsule contains
white to light greyish white enteric coated pellets.
Eli Lilly (S.A.) (Pty) Ltd
Cymbalta 30
Cymbalta 60
Capsules; Each capsule contains 30/60 mg duloxetine
Date: 24 January 2022
UC9542&UC9543_ZA_PI_v01_MTC
Page 2 of 28
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
CYMBALTA is indicated for:
•
The treatment of depression (as defined by DSM-IV criteria)
•
The treatment of Diabetic Peripheral Neuropathic Pain (DPNP)
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_DEPRESSION_
CYMBALTA should be initiated and maintained at a dose of 60 mg once
daily without regard to
meals. Although doses up to 120 mg per day have been used the efficacy
of the 120 mg dose was
not statistically different from that of the 60 mg once daily dose and
the adverse event rate was
higher with the 120 mg dose.
Therapeutic response is usually seen after 2 to 4 weeks of treatment.
_DIABETIC PERIPHERAL NEUROPATHIC PAIN _
CYMBALTA should be administered at a dose of 60 mg once daily without
regard to meals.
Although doses up to