Aripiprazole 5mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Aripiprazole

Verfügbar ab:

Consilient Health Ltd

ATC-Code:

N05AX12

INN (Internationale Bezeichnung):

Aripiprazole

Dosierung:

5mg

Darreichungsform:

Tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 04020100; GTIN: 5391512452742

Gebrauchsinformation

PACKAGE LEAFLET:
INFORMATION FOR THE USER
ARIPIPRAZOLE 5 MG
TABLETS
ARIPIPRAZOLE 10 MG
TABLETS
ARIPIPRAZOLE 15 MG
TABLETS
ARIPIPRAZOLE 30 MG
TABLETS
aripiprazole
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 Aripiprazole is and what it is used for
2. What you need to know before you take
Aripiprazole
3. How to take Aripiprazole
4. Possible side effects
5. How to store Aripiprazole
6. Contents of the pack and other information
1. WHAT ARIPIPRAZOLE IS AND WHAT
IT IS USED FOR
Aripiprazole tablets contain the active
substance aripiprazole and belong to a group
of medicines called antipsychotics.
It is used to treat adults and adolescents aged
15 years and older who suffer from a disease
characterised by symptoms such as hearing,
seeing or sensing things which are not there,
suspiciousness, mistaken beliefs, incoherent
speech and behaviour and emotional flatness.
People with this condition may also feel
depressed, guilty, anxious or tense.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE ARIPIPRAZOLE
Do not take Aripiprazole:
•
if you are allergic to aripiprazole or any of
the other ingredients of this medicine (listed
in section 6).
Warnings and precautions
Talk to your doctor before taking Aripiprazole
tablets if you suffer from
•
high blood sugar (characterised by
symptoms such as excessive thirst, passing
of large amounts of urine, increase in
appetite, and feeling weak) or family history
of diabetes
•
seizure
•
involuntary, irregular muscle movements,
especially in the face
•
cardiov

Fachinformation

OBJECT 1
ARIPIPRAZOLE 5MG TABLETS
Summary of Product Characteristics Updated 09-Nov-2017 | 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
Aripiprazole 5 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 5 mg aripiprazole.
Excipient with known effect: lactose monohydrate.
Each tablet contains 29.94 mg lactose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Blue, round tablets with bevelled edges and with possible darker and
lighter spots.
4. Clinical particulars
4.1 Therapeutic indications
Aripiprazole is indicated for the treatment of schizophrenia in adults
and in adolescents aged 15 years and
older.
4.2 Posology and method of administration
Posology
_Adults _
_Schizophrenia: _the recommended starting dose for Aripiprazole is 10
or 15 mg/day with a maintenance
dose of 15 mg/day administered on a once-a-day schedule without regard
to meals.
Aripiprazole is effective in a dose range of 10 to