Skip to Content

ARIPIPRAZOLE NORMON 10 MG ORODISPERSIBLE TABLETS

Active substance(s): ARIPIPRAZOLE / ARIPIPRAZOLE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

Package leaflet: Information for the user

Laetus
Pharmacode

Aripiprazole NORMON 10 mg orodispersible tablets
Aripiprazole NORMON 15 mg orodispersible 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 NORMON is and what it is used for
2. What you need to know before you take Aripiprazole NORMON
3. How to take Aripiprazole NORMON
4. Possible side effects
5 How to store Aripiprazole NORMON
6. Contents of the pack and other information
1. What Aripiprazole NORMON is and what it is used for
Aripiprazole NORMON is one of 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 NORMON 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 NORMON.
2. What you need to know before you take Aripiprazole
NORMON
Do not take aripiprazole
- 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 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. Ask your doctor or pharmacist for advice before taking
aripiprazole.
Other medicines and aripiprazole
Tell your doctor or pharmacist if you are taking, have recently
taken or might take any other medicines.
Blood pressure-lowering medicines: aripiprazole 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 with some medicines may need to change your
dose of aripiprazole. 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, drink and alcohol
Aripiprazole can be taken regardless of meals.
Alcohol should be avoided when taking aripiprazol.
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 newborn 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 aripiprazole, 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.
3. How to take Aripiprazole NORMON
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 NORMON
is too strong or too weak, talk to your doctor or pharmacist.

Laetus
Pharmacode

Anverso /
Front

Laetus
Pharmacode

Try to take the Aripiprazole NORMON orodispersible
tablet at the same time each day. It does not matter whether
you take it with or without food.

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.

Do not open the blister until ready to administer. For single tablet
removal, open the package and peel back the foil on the blister to
expose the tablet. Do not push the tablet through the foil because
this could damage the tablet. Immediately upon opening the
blister, using dry hands, remove the tablet and place the entire
orodispersible tablet on the tongue. Tablet disintegration occurs
rapidly in saliva. The orodispersible tablet can be taken with or
without liquid. Alternatively, disperse the tablet in water and drink
the resulting suspension.

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).

Even if you feel better, do not alter or discontinue the daily
dose of Aripiprazole NORMON without first consulting your
doctor.
If you take more Aripiprazole NORMON than you should
If you realise you have taken more Aripiprazole NORMON
orodispersible tablets than your doctor has recommended (or if
someone else has taken some of your Aripiprazole NORMON
orodispersible 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 Aripiprazol NORMON
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 have any further questions on the use of this medicine, ask
your doctor or pharmacist.

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 national reporting system
listed
in
Yellow
Card
Scheme,
Website:
www.mhra.gov.uk/yellowcard. By reporting side effects you can
help provide more information on the safety of this medicine.
5. How to store Aripiprazole NORMON
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on
the blister and on the carton. Store in the original package in order
to protect from moisture.

4. Possible side effects

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.

Like all medicines, this medicine can cause side effects, although
not everybody gets them.

6. Contents of the pack and other information

Common side effects (may affect up to 1 in 10 people):
uncontrollable twitching or jerking movements, headache,
tiredness, nausea, vomiting, an uncomfortable feeling in the
stomach, constipation, increased production of saliva,
light-headedness, trouble sleeping, restlessness, feeling anxious,
sleepiness, shaking and blurred vision.
Uncommon side effects (may affect up to 1 in 100
people): some people may feel dizzy, especially when getting up
from a lying or sitting position, or may experience a fast heart rate
or double vision. Some people may experience hiccups. Some
people may feel depressed and increased blood levels of the
hormone prolactin.
The following side effects have been reported since the marketing
of oral aripiprazole but the frequency for them to occur is not
known: Changes in the levels of some blood cells; unusual heart
beat, sudden unexplained death, heart attack; allergic reaction (e.g.
swelling in the mouth, tongue, face and throat, itching, rash); high
blood sugar, onset or worsening of diabetes, ketoacidosis
(ketones in the blood and urine) or coma, low sodium level in the
blood; weight gain, weight loss, anorexia; nervousness, agitation,
aggression, feeling anxious, excessive gambling; thoughts of
suicide, suicide attempt and suicide; speech disorder, seizure,
serotonin syndrome (a reaction which may cause feelings of great
happiness, drowsiness, clumsiness, restlessness, feeling of being
drunk, fever, sweating or rigid muscles), combination of fever,
muscle stiffness, faster breathing, sweating, reduced
consciousness and sudden changes in blood pressure and heart
rate; fainting, high blood pressure, 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); spasm
of the muscles around the voice box, accidental inhalation of food
with risk of pneumonia, difficulty in swallowing; inflammation of
the pancreas; liver failure, inflammation of the liver, yellowing of
the skin and white part of eyes, reports of abnormal liver test
values, abdominal and stomach discomfort, diarrhoea; skin rash
and sensitivity to light, unusual hair loss or thinning, excessive
sweating; stiffness or cramps, muscle pain, weakness; involuntary
loss of urine, difficulty in passing urine; prolonged and/or painful
erection; difficulty controlling core body temperature or
overheating, chest pain, and swelling of hands, ankles or feet.

Laetus
Pharmacode

Reverso /
Back

What Aripiprazole 10 mg NORMON
- The active substance is aripiprazole. Each orodispersible tablet
contains 10 mg of aripiprazole.
- The other ingredients are mannitol/maize starch, tartaric acid,
microcrystalline cellulose, sodium potato starch glycolate, tutti
frutti flavor, iron oxide red, sodium saccharin, colloidal silica
anhydrous, magnesium stearate.
What Aripiprazole 15 mg NORMON
- The active substance is aripiprazole. Each orodispersible tablet
contains 15 mg of aripiprazole.
- The other ingredients are mannitol/maize starch, tartaric acid,
microcrystalline cellulose, sodium potato starch glycolate, tutti
frutti flavor, iron oxide yellow, sodium saccharin, colloidal
silica anhydrous, magnesium stearate.
What Aripiprazole NORMON looks like and contents of
the pack
Aripiprazole 10 mg NORMON is supplied as pink, round, flat and
debossed with A10 on one sideorodispersible tablets. Aripiprazole
10 mg NORMON orodispersible are available as packs of 14, 28
and 49.
Aripiprazole 15 mg NORMON is supplied as yellow, round,
biconvex and debossed with A15 on one sideorodispersible
tablets. Aripiprazole 15 mg NORMON orodispersible are available
as packs of 14, 28 and 49.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 28760 Tres Cantos, Madrid España
This leaflet was last revised in: June 2016

----/-

Código interno
Internal code

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide