Mirtazapine 30mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Mirtazapine

Beschikbaar vanaf:

Kent Pharma (UK) Ltd

ATC-code:

N06AX11

INN (Algemene Internationale Benaming):

Mirtazapine

Dosering:

30mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 04030400

Bijsluiter

PATIENT INFORMATION LEAFLET
MIRTAZAPINE 30MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
IF YOU HAVE FURTHER QUESTIONS, PLEASE ASK YOUR DOCTOR OR YOUR
PHARMACIST.
THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU PERSONALLY AND YOU SHOULD
NOT PASS IT ON TO
OTHERS. IT MAY HARM THEM, EVEN IF THEIR SYMPTOMS ARE THE SAME AS
YOURS.
1.
WHAT YOUR MEDICINE IS AND WHAT IT IS USED FOR
Mirtazapine 30mg Tablets contain the active substance, mirtazapine.
Mirtazapine is one of a group of medicines called antidepressants.
Depression is linked to a shortage of
substances which carry messages in the brain (including serotonin and
noradrenaline). Mirtazapine helps
to relieve the shortage of these ‘brain messages’. Common signs of
depression include feelings of
worthlessness or deep sadness; difficulty with everyday tasks;
sleeping too much or not being able to
sleep; feeling anxious; and changes in appetite.
It may take 2 to 4 weeks before you start to feel better and sleep
better. It is important to take your
medicine every day and not to stop taking it unless your doctor tells
you to. If you do, your symptoms
may come back.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE THIS MEDICINE
DO NOT TAKE MIRTAZAPINE 30MG TABLETS:
if you are allergic to mirtazapine or any of the other ingredients of
Mirtazapine 30mg Tablets
if you are taking or have recently taken (within the last two weeks)
medicines called monoamine
oxidase inhibitors (MAOIs)
WARNINGS AND PRECAUTIONS
USE IN CHILDREN AND ADOLESCENTS UNDER 18 YEARS OF AGE
Mirtazapine 30mg Tablets should normally not be used for children and
adolescents under 18 years
because efficacy was not demonstrated. Patients under 18 have an
increased risk of side effects such as
suicide attempt, suicidal thoughts and hostility (predominantly
aggression, oppositional (defiant)
behaviour and anger) when they take this class of medicines. Despite
this, your doctor may prescribe
Mirtazapine 30mg Tablets for patients under 18

Productkenmerken

OBJECT 1
MIRTAZAPINE 30MG TABLETS
Summary of Product Characteristics Updated 21-Jan-2014 | Kent
Pharmaceuticals 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 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
Mirtazapine 30 mg Tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 30mg of mirtazapine.
For excipients, see 6.1.
3. Pharmaceutical form
Film-coated tablet.
Brownish, scored on both sides, 12.7 x 6.5 mm oval, biconvex,
film-coated tablets.
Marked with I on one side.
4. Clinical particulars
4.1 Therapeutic indications
Major depressive episode
4.2 Posology and method of administration
The tablets should be swallowed whole without chewing, with a
sufficient amount of fluid.
The tablets can be taken with or without food.
Adults: The initial dose is 15 or 30mg, taken preferably in the
evening. The maintenance dose is usually
between 15mg and 45mg per day.
Elderly patients: As in adults. Changes, especially increments of
dosage must be made cautiously and
under close supervision.
Children and