Duloxetine 30mg gastro-resistant capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Duloxetine hydrochloride

Available from:

DE Pharmaceuticals

ATC code:

N06AX21

INN (International Name):

Duloxetine hydrochloride

Dosage:

30mg

Pharmaceutical form:

Gastro-resistant capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04030400

Patient Information leaflet

1. WHAT DULOXETINE IS AND WHAT IT IS USED FOR
This medicine contains the active substance duloxetine. Duloxetine
increases the levels of serotonin and noradrenaline in the nervous
system.
Duloxetine is used in adults to treat:
•
depression
•
generalised anxiety disorder (chronic feeling of anxiety or
nervousness)
•
diabetic neuropathic pain (often described as burning, stabbing,
stinging, shooting or aching or like an electric shock. There may
be loss of feeling in the affected area, or sensations such as
touch, heat, cold or pressure may cause pain)
Duloxetine starts to work in most people with depression or
anxiety within two weeks of starting treatment, 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. Your doctor may continue to give you
Duloxetine when you are feeling better to prevent your depression or
anxiety from returning
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
DULOXETINE
Do not take Duloxetine if you:
•
are allergic to Duloxetine or any of the other ingredients of this
medicine (listed in section 6).
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. See
section 4.
What is in this leaflet
1. What Duloxetine is and what it is used for
2. What you need to know before you take Duloxetine
3. How to take Duloxetine
4. Possible side effects
5. How to store Duloxetine
6. Contents of the pack and other informa

Summary of Product characteristics

OBJECT 1
DULOXETINE 30MG GASTRO-RESISTANT CAPSULES
Summary of Product Characteristics Updated 29-Nov-2018 | Consilient
Health Ltd
•
1. Name of the medicinal product
•
2. Qualitative and quantitative composition
•
3. Pharmaceutical form
•
4. Clinical particulars
•
4.1 Therapeutic indications
•
4.2 Posology and method of administration
•
4.3 Contraindications
•
4.4 Special warnings and precautions for use
•
4.5 Interaction with other medicinal products and other forms of
interaction
•
4.6 Fertility, pregnancy and lactation
•
4.7 Effects on ability to drive and use machines
•
4.8 Undesirable effects
•
4.9 Overdose
•
5. Pharmacological properties
•
5.1 Pharmacodynamic properties
•
5.2 Pharmacokinetic properties
•
5.3 Preclinical safety data
•
6. Pharmaceutical particulars
•
6.1 List of excipients
•
6.2 Incompatibilities
•
6.3 Shelf life
•
6.4 Special precautions for storage
•
6.5 Nature and contents of container
•
6.6 Special precautions for disposal and other handling
•
7. Marketing authorisation holder
•
8. Marketing authorisation number(s)
•
9. Date of first authorisation/renewal of the authorisation
•
10. Date of revision of the text
1. Name of the medicinal product
Duloxetine 30 mg gastro-resistant capsules
2. Qualitative and quantitative composition
Each hard gastro-resistant capsule contains 30 mg duloxetine (as
duloxetine hydrochloride).
Excipient with known effect: sucrose.
Each 30 mg capsule contains 40.1 mg – 43.4 mg sucrose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Gastro-resistant capsule, hard
White to almost white pellets in a hard gelatine capsule size 3. The
capsule body is white and the cap dark
blue. The capsule body is imprinted with 30 in black.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of major depressive disorder.
Treatment of diabetic peripheral neuropathic pain.
Treatment of generalised anxiety disorder.
Duloxetine is indicated in adults.
For further information see section 5.1.
4.2 Po