Aktiprol 100mg Tablets

Country: Malta

Language: English

Source: Malta Medicines Authority

Active ingredient:

AMISULPRIDE

Available from:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATC code:

N05AL05

INN (International Name):

AMISULPRIDE 100 mg

Pharmaceutical form:

TABLET

Composition:

AMISULPRIDE 100 mg

Prescription type:

POM

Therapeutic area:

PSYCHOLEPTICS

Authorization status:

Authorised

Authorization date:

2015-05-20

Patient Information leaflet

Page 1 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
AKTIPROL 50MG TABLETS
AKTIPROL 100MG TABLETS
AKTIPROL 200MG TABLETS
AKTIPROL 400MG TABLETS
Amisulpride
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 symptoms are the same as yours.
•
If any of the side effects get serious, 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 Aktiprol is and what it is used for
2.
What you need to know before you take Aktiprol
3.
How to take Aktiprol
4.
Possible side effects
5.
How to store Aktiprol
6.
Content of the pack and other information
1.
WHAT AKTIPROL IS AND WHAT IT IS USED FOR
Aktiprol is a medicine used for mental disorders (antipsychotic). It
reduces the activity of a particular
region of the brain that is important for the symptoms of mental
disorders.
Aktiprol is used to treat an illness called schizophrenia.
Always follow your doctor's instructions.
Page 2 of 10
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE AKTIPROL
DO NOT TAKE AKTIPROL:
•
if you are allergic to amisulpride or any of the other ingredients of
this medicine (listed in section
6);
•
if you have breast cancer;
•
if you have a tumour in the pituitary gland;
•
if you have a tumour on the adrenal gland (phaeochromocytoma);
•
if you are breast-feeding;
•
if you have a rare inherited heart disease manifested by slow heart
rate and irregular heartbeats
(QT prolongation syndrome);
•
if you are taking medicines that affect the heart (prolong QT interval
) for example medicines for
-
Parkinson's disease (levodopa),
-
Heart rhythm disturbances (for example amiodarone, sotalol, quinidine
and disopyramide).
•
If you are taking other medicin

Summary of Product characteristics

Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Aktiprol 50mg tablets
Aktiprol 100mg tablets
Aktiprol 200mg tablets
Aktiprol 400mg tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Aktiprol 50 mg tablets: Each tablet contains 50 mg of amisulpride.
Aktiprol 100 mg tablets: Each tablet contains 100 mg of amisulpride.
Aktiprol 200 mg tablets: Each tablet contains 200 mg of amisulpride.
Aktiprol 400 mg tablets: Each tablet contains 400 mg of amisulpride.
Excipient with known effect: Lactose monohydrate.
Each 50 mg tablet contains 25.00 mg lactose monohydrate.
Each 100 mg tablet contains 50.00 mg lactose monohydrate.
Each 200 mg tablet contains 100.00 mg lactose monohydrate.
Each 400 mg tablet contains 200.00 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Aktiprol 50 mg tablets:
White, round, flat, tablets, with diameter 7 mm
Page 2 of 16
Aktiprol 100 mg tablets:
White, round, flat, tablets, with diameter 9.5 mm, embossed
MC on one side
Aktiprol 200 mg tablets:
White, round, flat, scored on one side tablets, with diameter
11.5 mm. The score line is only to facilitate breaking for ease of
swallowing and not to divide into
equal doses.
Aktiprol 400 mg tablets:
White, biconvex, capsule shaped tablets, scored on both sides,
with dimensions 19 x 10 mm. The score line is only to facilitate
breaking for ease of swallowing and
not to divide into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aktiprol is indicated for the treatment of acute and chronic
schizophrenic disorders with:
•
positive symptoms (such as delusions, hallucinations, thought
disorders, hostility and
paranoid delusions).
•
Negative symptoms (such as blunted affect, emotional and social
withdrawal).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For acute psychotic episodes, oral doses between 400 mg/d and 800 mg/d
are recommended. In
individual cases, the daily dose may be increased up to 1200 mg/d.
Doses above 1200 mg/d have not
been extens