ARIPIPRAZOLO 5 mg Coated Tablet

Зміст інструкції

1. Aripiprazolo Olpha 5 mg tablets, 10 mg tablets, 15 mg tablets, 30 mg tablets
   1. What is Aripiprazolo Olpha and what is it used for
   2. What you need to know before you take Aripiprazolo Olpha
   3. How to take Aripiprazolo Olpha
   4. Possible side effects
   5. How to store Aripiprazolo Olpha
   6. Package contents and other information

Aripiprazolo Olpha 5 mg tablets, 10 mg tablets, 15 mg tablets, 30 mg tablets

Generic medicine

Read this leaflet carefully before taking this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Aripiprazolo Olpha is and what it is used for
• 2. What you need to know before you take Aripiprazolo Olpha
• 3. How to take Aripiprazolo Olpha
• 4. Possible side effects
• 5. How to store Aripiprazolo Olpha
• 6. Contents of the pack and other information

1. What is Aripiprazolo Olpha and what is it used for

Aripiprazolo Olpha contains the active ingredient aripiprazole and belongs to a group of medicines
called antipsychotics. It is used for the treatment of adults and adolescents starting from 15 years of age who
suffer from an illness characterized by symptoms such as hearing, seeing or perceiving things that are not
present, suspiciousness, false beliefs, incoherent speech and behavior, and flattening of
emotions. People who present this condition may also feel depressed,
guilty, anxious or tense.
Aripiprazolo Olpha is used for the treatment of adults and adolescents starting from 13 years of age who are
affected by a condition characterized by symptoms such as feeling “revved up”, having excessive energy,
not needing to sleep as much as usual, talking very quickly with “racing thoughts” and
sometimes severe irritability. Furthermore, it prevents this condition in adults who have responded to
treatment with Aripiprazolo Olpha.

2. What you need to know before you take Aripiprazolo Olpha

Do not take Aripiprazolo Olpha:

• if you are allergic to aripiprazole or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor before taking Aripiprazolo Olpha
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole.
Tell your doctor immediately if you are having any thoughts or feelings of self-harm.
Before starting treatment with Aripiprazolo Olpha, tell your doctor if you suffer from:

• high blood sugar levels (characterised by symptoms such as excessive thirst, producing large amounts of urine, increased appetite and feeling weak) or a family history of diabetes;
• epilepsy (seizures) as your doctor may decide to monitor you more closely;
• involuntary, irregular muscle movements, especially of the face; cardiovascular diseases (heart and circulation diseases), a family history of cardiovascular disease, stroke or transient ischaemic attack, blood pressure abnormalities; blood clots or a family history of blood clots, as antipsychotics have been associated with the formation of blood clots; a previous experience of excessive gambling. If you notice that your weight is increasing, if you develop unusual movements, if you feel sleepy to the point it interferes with your normal daily activities, if you have difficulty swallowing or if you have allergic symptoms, tell your doctor.

If you are an elderly patient suffering from dementia (loss of memory and other mental abilities), you or your caregiver must inform the doctor if you have had a stroke or a transient ischaemic attack (TIA) in the past.
Tell your doctor immediately if you are thinking about harming yourself.
Thoughts and behaviours of self-harm have been reported during treatment with aripiprazole.
Tell your doctor immediately if you suffer from stiffness or muscle rigidity with high fever, sweating, altered mental status or a very fast or irregular heartbeat.
Tell your doctor if you, your family members or your caregivers notice that you are developing an urge or desire to behave in ways that are unusual for you and that you are unable to resist the impulse, urge or temptation to carry out certain activities that may harm yourself or others. These phenomena are called impulse control disorders and may include behaviours such as compulsive gambling, excessive eating or spending, an unusually high sexual drive or preoccupation with sexual thoughts or feelings.
Your doctor may need to adjust your dose or stop your therapy.
Aripiprazole can cause drowsiness, low blood pressure when getting up, dizziness and changes in your ability to move and maintain balance, which may lead to falls. Be careful, especially if you are elderly or in some way debilitated.

Children and adolescents
Do not use this medicine in children and adolescents under the age of 13 years. It is not known whether it is safe and effective in these patients.

Other medicines and Aripiprazolo Olpha
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Medicines that lower blood pressure: Aripiprazolo Olpha may increase the effect of medicines used to lower blood pressure. Tell your doctor if you are taking a medicine to control your blood pressure.

• Taking Aripiprazolo Olpha together with certain medicines may mean that your doctor will need to change the dose of Aripiprazolo Olpha or the other medicines. It is particularly important to inform your doctor about the following medicines: medicines to correct heart rhythm (e.g. quinidine, amiodarone, flecainide);
• antidepressants or herbal remedies used to treat depression and anxiety (e.g. fluoxetine, paroxetine, venlafaxine, St John's wort); antifungal medicines (e.g. ketoconazole, itraconazole);
• some medicines to treat HIV infection (e.g. efavirenz, nevirapine, a protease inhibitor such as indinavir, ritonavir);
• anticonvulsants used to treat epilepsy (e.g. carbamazepine, phenytoin, phenobarbital);
• some antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effect of Aripiprazole Olpha. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Olpha.
The medicines that increase the level of serotonin are typically used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia, as well as migraine and pain:

• triptans, tramadol and tryptophan used in conditions such as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD) and social phobia, as well as migraine and pain;
• selective serotonin reuptake inhibitors (SSRIs) (e.g. paroxetine and fluoxetine) used for depression, OCD, panic and anxiety;
• other antidepressants (e.g. venlafaxine and tryptophan) used in major depression;
• tricyclics (e.g. clomipramine and amitriptyline) used for depressive illness;
• St John's wort (Hypericum perforatum), used as a herbal remedy for mild depression;
• painkillers (e.g. tramadol and pethidine) used to relieve pain;
• triptans (e.g. sumatriptan and zolmitriptan) used for the treatment of migraine.

These medicines may increase the risk of side effects. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazolo Olpha.

Aripiprazolo Olpha with food, drinks and alcohol
This medicine can be taken independently of food.
Alcohol should be avoided.

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, ask your doctor for advice before taking this medicine.
The following symptoms may occur in newborns of mothers who have used Aripiprazolo Olpha in the last trimester (last three months of pregnancy): tremor, rigidity and/or muscle weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If the baby presents any of these symptoms, it may be necessary to contact the doctor.
If you are taking Aripiprazolo Olpha, your doctor will discuss with you whether you should breastfeed, considering the benefit you receive from the therapy and the benefit for the baby from breastfeeding. One choice excludes the other. If you are taking this medicine, discuss with your doctor the best way to feed your baby.

Driving and operating machinery
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account in cases where full alertness is required, for example when driving a vehicle or operating machinery.

Aripiprazolo Olpha contains lactose
If you have been diagnosed with intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Aripiprazolo Olpha

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.

The recommended dose for adults is 15 mg once a day. However, your doctor may
prescribe a lower or higher dose up to a maximum of 30 mg once a day.

Use in children and adolescents
This medicine may be started with a low dose using Aripiprazolo Macleods
oral solution (liquid).
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 up to a
maximum of 30 mg once a day.
If you feel that the effect of Aripiprazolo Olpha is too strong or too weak, contact your
doctor or pharmacist.

Try to take Aripiprazolo Olphaevery day at the same time. It doesn't matter if you take it with
food or not. Always take the tablet with water, swallowing it whole.

Even if you feel well, do not change or stop the daily dose of Aripiprazolo Olpha without
first consulting your doctor.

If you take more Aripiprazolo Olphathan you should
If you should realize that you have taken more Aripiprazolo Olpha than your
doctor has recommended (or if someone has taken Aripiprazolo Olpha tablets), contact your doctor
immediately. If you cannot reach your doctor, go to the nearest hospital and bring the
package with you.
Patients who have taken too much aripiprazole have experienced the following symptoms:

• rapid heartbeat, agitation/aggression, speech problems;
• 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, rapid breathing, sweating;
• muscle rigidity and drowsiness or sleepiness, slowed breathing, feeling of suffocation, high or low blood pressure, heart rhythm changes.

Contact your doctor or hospital immediately if you experience any of these symptoms.

If you forget to take Aripiprazolo Olpha
If you forget a dose, take it as soon as you remember, but do not take two in the same
day.

If you stop taking Aripiprazolo Olpha
Do not stop treatment just because you feel better. It is important to continue taking
Aripiprazolo Olpha for the entire period indicated by your doctor.
If you have any questions about 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 everyone will experience them.
Common side effects (may affect up to 1 in 10 people):

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to stay still, difficulty remaining seated,
• akathisia (an unpleasant feeling of inner restlessness and an irresistible need to move continuously),
• uncontrollable muscle contractions, jerking or twisting movements,
• tremors,
• headache,
• fatigue,
• drowsiness,
• feeling lightheaded,
• agitation and blurred vision,
• reduced number of bowel movements or difficulty evacuating,
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling tired.

Uncommon side effects (may affect up to 1 in 100 people):

• increase or decrease in prolactin hormone levels in the blood,
• high blood sugar levels,
• depression,
• alteration or increase in sexual interest,
• uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscle disorder causing twisting movements (dystonia),
• restless legs,
• double vision,
• eye sensitivity to light,
• fast heart rate,
• lowering of blood pressure when getting up, which causes dizziness, lightheadedness or fainting,
• hiccups.

The following side effects have been reported since Aripiprazole Olpha oral began to be marketed but the frequency with which they have occurred is not known:

• low levels of white blood cells,
• low platelet levels,
• allergic reaction (e.g. swelling of 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 levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• thoughts of suicide, attempted suicide and suicide,
• feeling aggressive,
• agitation,
• nervousness,
• combination of fever, muscle rigidity, rapid breathing, sweating, reduced consciousness and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome),
• seizures,
• serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle rigidity),
• speech disorders,
• eyeballs fixed in one position,
• sudden unexplained death,
• potentially fatal irregular heartbeat,
• heart attack,
• slowed heartbeat,
• blood clots in the veins, especially in the legs (symptoms include swelling, pain and redness of the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty 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 larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhea,
• abdominal discomfort,
• stomach discomfort,
• liver failure,
• inflammation of the liver,
• yellowing of the skin and whites of the eyes,
• cases of abnormal liver function test values,
• skin rash,
• skin sensitivity to light,
• hair loss,
• excessive sweating,
• severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially manifests with flu-like symptoms and a rash on the face that then spreads, high temperature, enlarged lymph nodes, increased levels of liver enzymes found in blood tests and an increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscles that can cause kidney problems,
• muscle pain,
• rigidity,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns if exposed during pregnancy,
• prolonged and/or painful erection,
• difficulty controlling internal body temperature or condition of excessive heat,
• chest pain,
• swelling of the hands, ankles or feet,
• in blood tests: fluctuation of blood sugar levels, increased glycated hemoglobin,
• inability to resist the urge, impulse or temptation to perform an action that may be harmful to you or others, which may include:
• strong urge to gamble excessively despite serious personal or family consequences,
• altered or increased sexual interest and behavior that causes significant concern to you or others, for example an increase in sexual drive,
• excessive and uncontrollable shopping or spending,
• uncontrolled eating (eating large amounts of food in a short period of time) or compulsive eating (eating more food than normal and more than needed to satisfy your appetite),
• tendency to wander. Tell your doctor if you experience any of these behaviors; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, more fatal cases have been reported during the use of aripiprazole. In addition, cases of stroke or “mini” strokes have been reported.

Additional side effects in children and adolescents
Adolescents aged 13 years and over have had side effects similar in frequency and type to those of adults, except for drowsiness, uncontrollable muscle contractions or jerking movements, restlessness and fatigue which were very common (more than 1 in 10) and for upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, involuntary movements of the limbs and feeling dizzy, especially when getting up from a lying or sitting position, which were common (more than 1 in 100).

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Aripiprazolo Olpha

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after
EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Aripiprazolo Olpha contains

• The active ingredient is aripiprazole. Each tablet contains 5 mg or 10 mg or 15 mg or 30 mg of aripiprazole.
• The other ingredients are lactose monohydrate, microcrystalline cellulose (PH101), corn starch, indigotine (E132) [for Aripiprazolo Olpha 5 mg tablets], Red iron oxide (E172) [for Aripiprazolo Olpha 10 mg and 30 mg tablets], Yellow iron oxide (E172) [for Aripiprazolo Olpha 15 mg tablets] low-substituted hydroxypropyl cellulose (LH21), magnesium stearate.

Description of the appearance of Aripiprazolo Olpha and package contents
Aripiprazolo Olpha 5 mg tablets are blue, modified rectangle-shaped, uncoated tablets with “CL 73” on one side and smooth on the other side.
Aripiprazolo Olpha 10 mg tablets are pink, modified rectangle-shaped, uncoated tablets with “CL 74” on one side and smooth on the other side.
Aripiprazolo Olpha 15 mg tablets are yellow, round, uncoated tablets with “CL 75” on one side and smooth on the other side.
Aripiprazolo Olpha 30 mg tablets are pink, round, uncoated tablets with “CL 78” on one side and smooth on the other side.
They are supplied in a cold-formed blister pack (Aluminum-Aluminum). Aripiprazolo Olpha is available in packs of 14, 28, 49, 56 and 98 tablets.
Not all pack sizes may be marketed.

Marketing authorization holder
Olpha AS,
Rupnicu iela 5,
Olaine, Olaines novads, LV-2114,
Latvia

Manufacturer
Macleods Pharma UK Limited
Wynyard Park House,
Wynyard Avenue, Wynyard,
Billingham, TS22 5TB
United Kingdom
Synoptis Industrial Sp. z o.o.
ul. Rabowicka 15
62-020 Swarzędz
Poland
Glenmark Pharmaceuticals s.r.o.
Fibichova 143
56617 Vysoké Mýto
Czech Republic