Aripiprazole 5 mg tablets

Main information

  • Trade name:
  • Aripiprazole 5 mg tablets
  • Dosage:
  • 5 milligram(s)
  • Pharmaceutical form:
  • Tablet
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Aripiprazole 5 mg tablets
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Other antipsychotics; aripiprazole

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Not marketed
  • Authorization number:
  • PA1240/024/001
  • Authorization date:
  • 06-10-2017
  • Last update:
  • 21-04-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Package leaflet: Information for the patient

Aripiprazole 5 mg tablets

Aripiprazole 10 mg tablets

Aripiprazole 15 mg tablets

Aripiprazole 20 mg tablets

Aripiprazole 30 mg tablets

Aripiprazole

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

What Aripiprazole is and what it is used for

What you need to know before you take Aripiprazole

How to take Aripiprazole

Possible side effects

How to store Aripiprazole

Contents of the pack and other information

1.

What Aripiprazole is and what it is used for

This medicine 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.

This medicine 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 the active substance or any of the other ingredients of this

medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Aripiprazole 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

Aripiprazole is not for use in children and adolescents under 13 years. It is not known if

it is safe and effective in these patients.

Other medicines and Aripiprazole

Tell your doctor or pharmacist if you are taking or have recently taken or might take

any other medicines, including medicines obtained without a prescription

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, 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, you should see your doctor.

Aripiprazole with food and drink

Aripiprazole can be taken regardless of meals.

Alcohol should be avoided when taking Aripiprazole.

Pregnancy, breast-feeding and fertility

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 new-born babies, of mothers that have used

aripiprazole 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 this medicine, you should not breast-feed.

Driving and using machines

Do not drive or use any tools or machines, until you know how Aripiprazole affects

you.

Aripiprazole tablets contain 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

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

Aripiprazole may be started at a low dose with the oral solution (liquid) form. 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 is too strong or too weak, talk

to your doctor or pharmacist.

Try to take your Aripiprazole tablets at the same time each day. It does not matter

whether you take it with or without food. Always take the tablet with water and

swallow it whole.

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 Aripiprazole tablets than your doctor has

recommended (or if someone else has taken some of your Aripiprazole 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 your Aripiprazole tablets

If you forget to take a dose at the usual time, take it as soon as you remember, unless it

is time to take your next dose. Do not take a double dose to make up for a forgotten

dose.

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 Aripiprazole 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,

pharmacist or nurse.

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:

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,

high blood sugar,

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,

combination of fever, muscle stiffness, faster breathing, sweating, reduced

consciousness and sudden changes in blood pressure and heart rate, fainting

(neuroleptic malignant syndrome),

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 (greater than 1 in 10

patients) 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

(greater than 1 in 100 patients).

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 for UK and at: HPRA

Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353

1 6762517, Website: www.hpra.ie, email: medsafety@hpra.ie for Ireland. By reporting

side effects, you can help provide more information on the safety of this medicine..

5.

How to store Aripiprazole

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the label after EXP.

The expiry date refers to the last day of that month.

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 tablet contains 5mg, 10mg, 15mg, 20mg or

30mg of aripiprazole.

The other ingredients are: Lactose monohydrate, Maize starch, Microcrystalline

cellulose, Hydroxypropyl cellulose, Magnesium stearate. In addition 5 mg tablet

contains Indigo carmine aluminium lake (E132), 10mg and 30mg tablets contain Iron

oxide red (E172), 15mg tablet contains Iron oxide yellow (E172).

What Aripiprazole tablets look like and contents of the pack

5 mg: Light blue to blue, modified rectangular bevel edged biconvex tablets debossed

with ‘I’ on one side and ‘95’ on other side.

10 mg: Light pink to pink, modified rectangular, bevel edged biconvex tablets

debossed with ‘I’ on one side and ‘96’ on other side.

15 mg: Light yellow to yellow, round, bevel edged biconvex tablets debossed with ‘I’

on one side and ‘97’on other side.

20 mg: White to off-white, round, bevel edged biconvex tablets debossed with ‘I’ on

one side and ‘98’ on other side.

30 mg: Light pink to pink, round, bevel edged biconvex tablets debossed with ‘I’ on

one side and ‘99’ on other side.

This medicine is available in packs of 14, 28, 30, 48, 49, 50, 56, 60, 84, 90, 98 and

100. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd.

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire HP4 1EG, United Kingdom.

Telephone:01442 200922

Fax: 01442 873717

Email: info@bristol-labs.co.uk

This medicinal product is authorised in the Member States of the EEA under the

following names:

NL: Aripiprazole Bristol 5 mg, 10 mg, 15mg, 20mg and 30 mg tabletten

UK: Aripiprazole 5 mg, 10 mg, 15mg, 20mg and 30 mg Tablets

IE: Aripiprazole 5 mg, 10 mg, 15mg, 20mg and 30 mg Tablets

DE: Aripiprazol axcount 5 mg, 10 mg, 15mg, 20mg and 30 mg tabletten

This leaflet was last revised in August 2017

To request a copy of this leaflet in Braille, large print or audio format then please contact

the marketing authorisation holder at the address (or telephone, fax, email) above.