Aripiprazole 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aripiprazole

Available from:

Actavis UK Ltd

ATC code:

N05AX12

INN (International Name):

Aripiprazole

Dosage:

5mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04020100; GTIN: 5012617025296

Patient Information leaflet

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.
• The full name of this medicine is Aripiprazole 5mg, 10mg, 15mg and
30mg Tablets but within the leaflet it will be referred to as
Aripiprazole
tablets.
WHAT IS IN THIS LEAFLET
1.
What Aripiprazole tablets are and what they are used for
2.
What you need to know before you take Aripiprazole tablets
3.
How to take Aripiprazole tablets
4.
Possible side effects
5
How to store Aripiprazole tablets
6.
Contents of the pack and other information
1.
WHAT ARIPIPRAZOLE TABLETS ARE AND WHAT THEY ARE USED FOR
Aripiprazole tablets contain 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 tablets are 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
tablets.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ARIPIPRAZOLE TABLETS
DO NOT TAKE ARIPIPRAZOLE

Summary of Product characteristics

OBJECT 1
ARIPIPRAZOLE 5MG TABLETS
Summary of Product Characteristics Updated 01-Oct-2018 | Accord-UK 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 5mg Tablets
2. Qualitative and quantitative composition
Each tablet contains 5mg of aripiprazole.
Excipient with known effect: 27.9 mg lactose monohydrate per tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Round, biconvex and white, 5 mm, debossed "5" on one side and "ZL" on
one side.
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.
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 aripiprazole treatment (see section
5.1).
Aripiprazole is indicated for the treatment up to