Depixol 3mg tablets

Country: Bretland

Tungumál: enska

Heimild: MHRA (Medicines & Healthcare Products Regulatory Agency)

Virkt innihaldsefni:

Flupentixol dihydrochloride

Fáanlegur frá:

Lundbeck Ltd

ATC númer:

N05AF01

INN (Alþjóðlegt nafn):

Flupentixol dihydrochloride

Skammtar:

3mg

Lyfjaform:

Oral tablet

Stjórnsýsluleið:

Oral

Tegund:

No Controlled Drug Status

Gerð lyfseðils:

Valid as a prescribable product

Vörulýsing:

BNF: 04020100; GTIN: 5702157122158

Upplýsingar fylgiseðill

Package leaflet: Information for the user
DEPIXOL
® 3 MG FILM-COATED TABLETS
FLUPENTIXOL
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 DEPIXOL TABLETS ARE AND WHAT THEY ARE USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEPIXOL TABLETS
3.
HOW TO TAKE DEPIXOL TABLETS
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE DEPIXOL TABLETS
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT DEPIXOL TABLETS ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Depixol 3 mg film-coated tablets (called
Depixol Tablets in
this leaflet).
Depixol Tablets contain the active substance flupentixol. Depixol
Tablets belong to a group
of medicines known as antipsychotics (also called neuroleptics).
These medicines act on nerve pathways in specific areas of the brain
and help to correct
certain chemical imbalances in the brain that are causing the symptoms
of your illness.
Depixol Tablets are used for the treatment of schizophrenia and other
psychoses.
Your doctor, however, may prescribe Depixol Tablets for another
purpose. Ask your doctor if
you have any questions about why Depixol Tablets have been prescribed
for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DEPIXOL TABLETS
DO NOT TAKE DEPIXOL TABLETS:
•
If you are allergic (hypersensitive) to flupentixol, other
thioxanthene drugs or
antipsychotic drugs or any of the other ingredients of this medicine
(listed in section 6).
•
If you are feeling less alert than usual, or are drowsy or sleepy, or
have serious
problems with your blood circulation
•
If

Vara einkenni

OBJECT 1
DEPIXOL TABLETS 3MG
Summary of Product Characteristics Updated 21-Apr-2021 | Lundbeck
Limited
•
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
Depixol
®
3 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 3 mg flupentixol (as 3.504 mg
flupentixol dihydrochloride).
Excipients with known effect:
Lactose monohydrate
Sunset yellow (E110)
For the full list of excipients, see section 6.1
3. Pharmaceutical form
Film-coated tablet
Round, slightly biconvex, ochre, film-coated tablet marked FI.
4. Clinical particulars
4.1 Therapeutic indications
The treatment of schizophrenia and other psychoses.
4.2 Posology and method of administration
Posology
_Adults_
1 - 3 tablets twice daily to a maximum of 18 mg (6 tablets) per day.
It is recommended that commencement
of treatment and increase in dosage should be carried out under close
supervision. As with all antipsychotic
drugs, the dose of Depixol should be titrated to the needs