Aripiprazole 5mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Aripiprazole

Saadav alates:

Zentiva

ATC kood:

N05AX12

INN (Rahvusvaheline Nimetus):

Aripiprazole

Annus:

5mg

Ravimvorm:

Tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 04020100; GTIN: 5000283657521

Infovoldik

• Unusual movements (especially of the face or tongue)
and reduced level of consciousness.
Other symptoms may include:
• Acute confusion, seizures (epilepsy), coma, a
combination of fever, faster breathing, sweating,
• Muscle stiffness, and drowsiness or sleepiness, slower
breathing, choking, high or low blood pressure,
abnormal rhythms of the heart.
Contact your doctor or hospital immediately if you
experience any of the above.
If you forget to take Aripiprazole Zentiva
If you miss a dose, take the missed dose as soon as
you remember but do not take two doses in one day.
If you stop taking Aripiprazole Zentiva
Do not stop your treatment just because you feel better.
It is important that you carry on taking Aripiprazole
Zentiva for as long as your doctor has told you to.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people):
• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to keep still, difficulty
sitting still,
• uncontrollable twitching, jerking or writhing
movements, restless legs,
• trembling,
• headache,
• tiredness,
• sleepiness,
• light-headedness,
• shaking and blurred vision,
• decreased number of or difficulty making bowel
movements,
• indigestion,
• feeling sick,
• more saliva in mouth than normal,
• vomiting,
• feeling tired.
Uncommon side effects (may affect up to 1 in 100
people):
• increased blood levels of the hormone prolactin,
• too much sugar in the blood,
• depression,
• altered or increased sexual interest,
• uncontrollable movements of mouth, tongue and
limbs (tardive dyskinesia),
• muscle disorder causing twisting movements
(dystonia),
• double vision,
• fast heart beat,
• a fall in blood pressure on standing up which causes
dizziness, light-headedness or fainting,
• hiccups.
The

Toote omadused

OBJECT 1
ARIPIPRAZOLE 5MG, 10MG, 15MG AND 30MG TABLETS
Summary of Product Characteristics Updated 19-Feb-2018 | Zentiva
1. Name of the medicinal product
Aripiprazole Zentiva 5 mg tablets
Aripiprazole Zentiva 10 mg tablets
Aripiprazole Zentiva 15 mg tablets
Aripiprazole Zentiva 30 mg tablets
2. Qualitative and quantitative composition
Aripiprazole Zentiva 5 mg tablets
Each tablet contains 5 mg of aripiprazole.
Excipient with known effect: each tablet contains 33 mg of lactose (as
monohydrate).
Aripiprazole Zentiva 10 mg tablets
Each tablet contains 10 mg of aripiprazole.
Excipient with known effect: each tablet contains 66 mg of lactose (as
monohydrate).
Aripiprazole Zentiva 15 mg tablets
Each tablet contains 15 mg of aripiprazole.
Excipient with known effect: each tablet contains 99 mg of lactose (as
monohydrate).
Aripiprazole Zentiva 30 mg tablets
Each tablet contains 30 mg of aripiprazole.
Excipient with known effect: each tablet contains 198 mg of lactose
(as monohydrate).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
Aripiprazole Zentiva 5 mg tablets
White to off-white round flat bevel edged uncoated tablets with '5'
debossed on one side and plain on the
other side with diameter approx. 6 mm.
Aripiprazole Zentiva 10 mg tablets
White to off-white round uncoated tablets with '10' debossed on one
side and snap tab breakline on the
other side with diameter approx. 8 mm.
The score line is not intended for breaking the tablet.
Aripiprazole Zentiva 15 mg tablets
White to off-white round flat bevel edged uncoated tablets with '15'
debossed on one side and plain on the
other side with diameter approx. 8.8 mm.
Aripiprazole Zentiva 30 mg tablets
White to off-white capsule shaped uncoated tablets with '30' debossed
on one side and snap tab breakline
on the other side with dimensions approx. 15.5 x 8 mm.
The score line is not intended for breaking the tablet.
4. Clinical particulars
4.1 Therapeutic indications
Aripiprazole Zentiva is indicated for the treatment of schizophrenia
in adults