Aripiprazole 15mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aripiprazole

Available from:

DE Pharmaceuticals

ATC code:

N05AX12

INN (International Name):

Aripiprazole

Dosage:

15mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
ARIPIPRAZOLE 5 MG TABLETS
ARIPIPRAZOLE 10 MG TABLETS
ARIPIPRAZOLE 15 MG TABLETS
ARIPIPRAZOLE 30 MG TABLETS
aripiprazole
P1518038
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 contains the active substance
aripiprazole and belongs 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 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. 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 i

Summary of Product characteristics

OBJECT 1
ARIPIPRAZOLE 15MG TABLETS
Summary of Product Characteristics Updated 26-Oct-2018 | Aurobindo
Pharma - Milpharm 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 Milpharm 15 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect: 99.750 mg lactose monohydrate per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White colored, round shaped (diameter 7 mm), uncoated tablets debossed
with '64' on one side and 'H' on
other side.
4. Clinical particulars
4.1 Therapeutic indications
Aripiprazole Milpharm 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 manic episode in adults who experienced
predominantly manic episodes and
whose manic episodes responded to arip