Aripiprazole Ascend 10 mg tablets

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Prieinama:

Ascend GmbH c/o Pollux Business Center GmbH Sebastian-Kneipp-Straße 41, 60439 Frankfurt am Main, Germany

ATC kodas:

N05AX12

INN (Tarptautinis Pavadinimas):

ARIPIPRAZOLE 10 mg

Vaisto forma:

TABLET

Sudėtis:

ARIPIPRAZOLE 10 mg

Recepto tipas:

POM

Gydymo sritis:

PSYCHOLEPTICS

Produkto santrauka:

Licence number in the source country: NOT APPLICAPABLE

Autorizacija statusas:

Authorised

Leidimo data:

2022-12-21

Pakuotės lapelis

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE ASCEND 5 MG TABLETS
ARIPIPRAZOLE ASCEND 10 MG TABLETS
ARIPIPRAZOLE ASCEND 15 MG TABLETS
ARIPIPRAZOLE ASCEND 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 Ascend is and what it is used for
2.
What you need to know before you take Aripiprazole Ascend
3.
How to take Aripiprazole Ascend
4.
Possible side effects
5.
How to store Aripiprazole Ascend
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE ASCEND IS AND WHAT IT IS USED FOR
Aripiprazole Ascend contains 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.
Aripiprazole Ascend is used to treat adults and adolescents aged 13
years and older who suffer from a
condition with symptoms such as feeling "high", having excessive
amounts of energy, needing much
less sleep than usual, talking very quickly with racing ideas and
sometimes severe irritability. In adults it
also prevents this condition from returning in patients who have
responded to the treatment with
Aripiprazole Ascend.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE ASCEND
DO NOT TAKE ARIPI

Prekės savybės

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aripiprazole Ascend 5 mg tablets
Aripiprazole Ascend 10 mg tablets
Aripiprazole Ascend 15 mg tablets
Aripiprazole Ascend 30 mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aripiprazole Ascend 5 mg tablets
Each tablet contains 5 mg of aripiprazole.
Aripiprazole Ascend 10 mg tablets
Each tablet contains 10 mg of aripiprazole.
Aripiprazole Ascend 15 mg tablets
Each tablet contains 15 mg of aripiprazole.
Aripiprazole Ascend 30 mg tablets
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect
Each 5 mg tablets contains 63.46 mg lactose (as monohydrate) per
tablet
Each 10 mg tablets contains 59.365 mg lactose (as monohydrate) per
tablet
Each 15 mg tablets contains 88.73 mg lactose (as monohydrate) per
tablet
Each 30 mg tablets contains 178.096 mg lactose (as monohydrate) per
tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Aripiprazole Ascend 5 mg tablets
Blue colored, modified rectangular shaped uncoated tablets debossed
with “ARI” on one side and “5”on
other side, with a length of about 8.0 mm and a width of about 4.5 mm.
Aripiprazole Ascend 10 mg tablets
Pink colored, modified rectangular shaped uncoated tablets debossed
with “ARI” on one side and “10” on
other side, with a length of about 8.0 mm and a width of about 4.5 mm.
Aripiprazole Ascend 15 mg tablets
Yellow colored, round shaped uncoated tablets debossed with “ARI”
on one side and “15” on other side,
with a diameter of about 7.0 mm.
Aripiprazole Ascend 30 mg tablets
Pink colored, round shaped uncoated tablets debossed with “ARI” on
one side and “30” on other side, with
a diameter of about 9.0 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
2
Aripiprazole is indicated for the treatment of schizophrenia in adults
and in adolescents aged 15 years and
older.
Aripiprazole
is indicated for the treatment of moderate to severe manic episodes in
Bipolar I Disorder and
for the prevention of a new ma