Skip to Content

UK Edition. Click here for US version.

ARIPIPRAZOLE TEVA 30MG TABLETS

Active substance(s): ARIPIPRAZOLE

PDF options:  View Fullscreen   Download PDF

PDF Transcript

Package leaflet: Information for the user
ARIPIPRAZOLE 5 mg, 10 mg, 15 mg, 20 mg AND 30 mg TABLETS

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 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 Tablets
• if you are allergic to aripiprazole or any of the other ingredients of this medicine (listed in section
6).
Warnings and precautions
Talk to your doctor before taking Aripiprazole Tablets if you suffer from
• high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of
urine, increase in appetite, and feeling weak) or family history of diabetes
• seizure
• involuntary, irregular muscle movements, especially in the face
• cardiovascular diseases, family history of cardiovascular disease, stroke or “mini” stroke, abnormal
blood pressure

• blood clots, or family history of blood clots, as antipsychotics have been associated with formation
of blood clots
• past experience of excessive gambling.
If you notice you are gaining weight, develop unusual movements, experience somnolence that
interferes with normal daily activities, any difficulty in swallowing or allergic symptoms, please tell
your doctor.
If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you
or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.
Tell your doctor immediately if you are having any thoughts or feelings about hurting yourself.
Suicidal thoughts and behaviours have been reported during aripiprazole treatment.
Tell your doctor immediately if you suffer from muscle stiffness or inflexibility with high fever,
sweating, altered mental status, or very rapid or irregular heart beat.
Children and adolescents
Do not use this medicine in children and adolescents under 13 years of age. It is not known if it is safe
and effective in these patients.
Other medicines and Aripiprazole Tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
Blood pressure-lowering medicines: Aripiprazole Tablets may increase the effect of medicines used to
lower the blood pressure. Be sure to tell your doctor if you take a medicine to keep your blood
pressure under control.
Taking Aripiprazole Tablets with some medicines may need to change your dose of Aripiprazole
Tablets. It is especially important to mention the following to your doctor:
• medicines to correct heart rhythm
• antidepressants or herbal remedy used to treat depression and anxiety
• antifungal agents
• certain medicines to treat HIV infection
• anticonvulsants used to treat epilepsy.
Medicines that increase the level of serotonin: triptans, tramadol, tryptophan, selective serotonin reuptake inhibitors (SSRIs (such as paroxetine and fluoxetine)), tricyclics (such as clomipramine,
amitriptyline), pethidine, St John’s Wort and venlafaxine. These medicines increase the risk of side
effects; if you get any unusual symptom taking any of these medicines together with Aripiprazole
Tablets, you should see your doctor.
Aripiprazole Tablets with food and alcohol
Aripiprazole Tablets can be taken regardless of meals. Alcohol should be avoided.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor for advice before taking this medicine.
The following symptoms may occur in newborn babies, of mothers that have used Aripiprazole
Tablets in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or
weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops
any of these symptoms you may need to contact your doctor.

Be sure to tell your doctor immediately if you are breast-feeding.
If you are taking Aripiprazole Tablets, you should not breast-feed.
Driving and using machines
Do not drive or use any tools or machines, until you know how Aripiprazole Tablets affects you.
Aripiprazole Tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor
before taking this medicine.

3.

How to take Aripiprazole Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
The recommended dose for adults is 15 mg once a day. However your doctor may prescribe a lower
or higher dose to a maximum of 30 mg once a day.
Use in children and adolescents
Treatment may be started at a low dose, e.g. with an oral solution. The dose may be gradually
increased to the recommended dose for adolescents of 10 mg once a day. However your doctor may
prescribe a lower or higher dose to a maximum of 30 mg once a day.
If you have the impression that the effect of Aripiprazole Tablets is too strong or too weak, talk to
your doctor or pharmacist.
Aripiprazole Tablets are for oral use.
Try to take the tablet at the same time each day. It does not matter whether you take it with or
without food.
5 mg only: Always take the tablet with water and swallow it whole.
10 mg/15 mg/20 mg/30 mg only: Always take the tablet with water. The tablet can be divided into
equal doses.
Even if you feel better, do not alter or discontinue the daily dose of Aripiprazole Tablets without first
consulting your doctor.
If you take more Aripiprazole Tablets than you should
If you realise you have taken more tablets than your doctor has recommended (or if someone else has
taken some of your tablets), contact your doctor right away. If you cannot reach your doctor, go to the
nearest hospital and take the pack with you.
If you forget to take Aripiprazole Tablets
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 Tablets
Do not stop your treatment just because you feel better. It is important that you carry on taking your
tablets 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 following side effects have been reported since the marketing of oral aripiprazole but the
frequency for them to occur is not known (frequency cannot be estimated from the available data)
• low levels of white blood cells
• low levels of blood platelets
• allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives)
• onset or worsening of diabetes, ketoacidosis (ketones in the blood and urine) or coma
• not enough sodium in the blood
• loss of appetite (anorexia)
• weight loss
• weight gain
• thoughts of suicide, suicide attempt and suicide
• excessive gambling
• feeling aggressive
• agitation
• nervousness
• neuroleptic malignant syndrome (combination of fever, muscle stiffness, faster breathing, sweating,
reduced consciousness and sudden changes in blood pressure and heart rate, fainting)

• seizure
• serotonin syndrome (a reaction which may cause feelings of great happiness, drowsiness,
clumsiness, restlessness, feeling of being drunk, fever, sweating or rigid muscles)
• speech disorder
• sudden unexplained death
• life-threatening irregular heart beat
• heart attack
• slower heart beat
• blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the
leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in
breathing (if you notice any of these symptoms, seek medical advice immediately)
• high blood pressure
• fainting
• accidental inhalation of food with risk of pneumonia (lung infection)
• spasm of the muscles around the voice box
• inflammation of the pancreas
• difficulty swallowing
• diarrhoea
• abdominal discomfort
• stomach discomfort
• liver failure
• inflammation of the liver
• yellowing of the skin and white part of eyes
• reports of abnormal liver tests values
• skin rash
• sensitivity to light
• baldness
• excessive sweating
• abnormal muscle breakdown which can lead to kidney problems
• muscle pain
• stiffness
• involuntary loss of urine (incontinence)
• difficulty in passing urine
• withdrawal symptoms in newborn babies in case of exposure during pregnancy
• prolonged and/or painful erection
• difficulty controlling core body temperature or overheating
• chest pain
• swelling of hands, ankles or feet
• in blood tests: fluctuating blood sugar, increased glycosylated haemoglobin.

In elderly patients with dementia, more fatal cases have been reported while taking aripiprazole. In
addition, cases of stroke or “mini” stroke have been reported.
Additional side effects in children and adolescents
Adolescents aged 13 years and older experienced side effects that were similar in frequency and type
to those in adults except that sleepiness, uncontrollable twitching or jerking movements, restlessness,
and tiredness were very common (may affect more than 1 in 10 people) and upper abdominal pain, dry
mouth, increased heart rate, weight gain, increased appetite, muscle twitching, uncontrolled
movements of the limbs, and feeling dizzy, especially when getting up from a lying or sitting position,
were common (may affect up to 1 in 10 people).
Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard, or search for MHRA Yellow Card in the Google Play or Apple App
Store.
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store Aripiprazole Tablets

Keep this medicine out of the sight and reach of children.
Blister
Do not use this medicine after the expiry date which is stated on the blister and on the carton. The
expiry date refers to the last day of that month.
HDPE bottle (5 mg, 10 mg, 15 mg, 30 mg)
Do not use this medicine after the expiry date which is stated on the label and on the carton. The
expiry date refers to the last day of that month.
Blister + HDPE bottle (5 mg, 10 mg, 15 mg, 30 mg)
This medicine does not require any special storage conditions.
HDPE bottle (5 mg, 10 mg, 15 mg, 30 mg)
Shelf life after first opening: 6 months.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Aripiprazole Tablets contain
• The active substance is aripiprazole.
Each 5 mg tablet contains 5 mg of aripiprazole.
Each 10 mg tablet contains 10 mg of aripiprazole.
Each 15 mg tablet contains 15 mg of aripiprazole.
Each 20 mg tablet contains 20 mg of aripiprazole.
Each 30 mg tablet contains 30 mg of aripiprazole.
The other ingredients are lactose monohydrate, microcrystalline cellulose, maize starch, iron oxide
yellow (E172) (5 mg + 15 mg only), iron oxide red (E172) (10 mg + 30 mg only),
hydroxypropylcellulose, croscarmellose sodium, magnesium stearate.
What Aripiprazole Tablets look like and contents of the pack
5 mg
Light yellow coloured, round, flat-faced bevelled edge tablets with debossed “5” on one side and plain
on the other side.
10 mg
Pink to light pink coloured, oblong tablets with debossed “10” on one side and breakline on the other
side.
The tablet can be divided into equal doses.

15 mg
Light yellow coloured, round, flat-faced bevelled edged tablets with debossed “15” on one side and
breakline on the other side.
The tablet can be divided into equal doses.
20 mg
White to off white or pale cream coloured, capsule shaped, biconvex tablets with debossed “20” on
one side and breakline on the other side.
The tablet can be divided into equal doses.
30 mg
Pink to light pink coloured, round, biconvex tablets with debossed “30” on one side and breakline on
the other side.
The tablet can be divided into equal doses.
Aripiprazole 5 mg Tablets are available in packs of 7, 7x1, 14, 14x1, 15, 28, 28x1, 30, 49, 56, 56x1,
60, 98, 98x1 and 100 tablets.
Aripiprazole 10 mg Tablets are available in packs of 7, 7x1, 14, 14x1, 28, 28x1, 30, 49, 56, 56x1, 60,
98, 98x1 and 100 tablets.
Aripiprazole 15 mg Tablets are available in packs of 7, 7x1, 14, 14x1, 28, 28x1, 30, 49, 56, 56x1, 60,
98, 98x1 and 100 tablets.
Aripiprazole 20 mg Tablets are available in packs of 7, 7x1, 14, 14x1, 28, 28x1, 30, 49, 56, 56x1, 98
and 98x1 tablets.
Aripiprazole 30 mg Tablets are available in packs of 7, 7x1, 14, 14x1, 28, 28x1, 30, 49, 56, 56x1, 60,
98, 98x1 and 100 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
TEVA UK Limited, Eastbourne, BN22 9AG, UK
Manufacturer
Merckle GmbH, Ludwig-Merckle-Straße 3, Blaubeuren, 89143, Germany
*OR
Teva Pharma B.V., Swensweg 5, Haarlem, 2031 GA, The Netherlands
*OR
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.), Prilaz baruna Filipovica 25, Zagreb, 10000, Croatia
*OR
Teva Operations Poland Sp. z.o.o, ul. Mogilska 80., Krakow, 31-546, Poland
*OR
Actavis Ltd. BLB016 Bulebel Industrial Estate, Zejtun ZTN 3000, Malta

This leaflet was last revised in October 2017
PL 00289/1910
PL 00289/1911
PL 00289/1912
PL 00289/1913
PL 00289/1914
* Only the actual site of batch release will appear on the printed version of the leaflet

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide