Aripiprazole Olpha

Patient Information Leaflet: Information for the User

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

Equivalent Medicine
Please 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Aripiprazole Olpha contains the active substance aripiprazole and belongs to a group of medicines
called antipsychotics. It is used to treat adults and adolescents from the age of 15 who are affected by
a disorder characterised by symptoms such as hearing, seeing or perceiving things that are not present,
suspiciousness, false beliefs, disorganised speech and behaviour, and flattening of emotions.
Individuals with this condition may also feel depressed, guilty, anxious or tense.
Aripiprazole Olpha is used to treat adults and adolescents from the age of 13 who are affected by a
condition characterised by symptoms such as feeling “high”, having excessive energy, needing less sleep
than usual, speaking very rapidly with racing thoughts, and sometimes severe irritability. In addition, it
prevents the recurrence of this condition in adults who have responded to treatment with Aripiprazole
Olpha.

2. What you need to know before taking Aripiprazole Olpha

Do not take Aripiprazole 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 Aripiprazole Olpha.
Suicidal thoughts and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you are experiencing any self-harming thoughts or feelings.
Before starting treatment with Aripiprazole Olpha, inform your doctor if you have:

• high blood sugar levels (characterized by symptoms such as excessive thirst, production of 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 disorders), family history of cardiovascular disease, stroke or transient ischemic attack (TIA), blood clotting disorders or family history of blood clots, since antipsychotics have been associated with blood clot formation; or a history of excessive gambling. If you notice weight gain, develop unusual movements, feel drowsy to the point of interfering with normal daily activities, have difficulty swallowing, or experience allergic symptoms, inform your doctor.

If you are an elderly patient with dementia (loss of memory and other mental abilities), you or your caregiver should inform your doctor if you have previously had a stroke or transient ischemic attack (TIA).
Inform your doctor immediately if you are thinking about harming yourself.
Suicidal ideation and behaviours have been reported during treatment with aripiprazole.
Inform your doctor immediately if you experience muscle stiffness or rigidity accompanied by high fever, sweating, altered mental state, or very rapid or irregular heartbeat.
Inform your doctor if you, your family members, or your caregiver notice that you are developing an urge or desire to behave in ways that are unusual for you and that you cannot resist the impulse, drive, or temptation to carry out certain activities that could harm yourself or others. These phenomena are known as impulse control disorders and may include behaviours such as pathological gambling, excessive eating or spending, abnormally increased sexual desire, or preoccupation due to increased sexual thoughts or sensations.
Your doctor may consider it necessary to adjust your dose or discontinue your treatment.
Aripiprazole may cause drowsiness, low blood pressure when standing up, dizziness, and changes in motor function and balance, which may lead to falls. Be cautious, especially if you are elderly or otherwise weakened.

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

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

• Taking Aripiprazole Olpha together with certain medicines may require your doctor to adjust the dose of Aripiprazole Olpha or of the other medicines. It is particularly important to inform your doctor about the following medicines: medicines used 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);
• certain medicines used 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);
• certain antibiotics used to treat tuberculosis (rifabutin, rifampicin).

These medicines may increase the risk of side effects or reduce the effectiveness of Aripiprazole Olpha. Consult your doctor if you experience any unusual symptoms while taking any of these medicines together with Aripiprazole Olpha.
Medicines that increase serotonin levels are typically used for 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 for 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 for major depression;
• tricyclics (e.g., clomipramine and amitriptiline) 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 to treat 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 Aripiprazole Olpha.

Aripiprazole Olpha with food, drinks, and alcohol
This medicine can be taken with or without food.
Alcohol should be avoided.

Pregnancy, breastfeeding, and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
The following symptoms may occur in newborns of mothers who have used Aripiprazole Olpha during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
If you are taking Aripiprazole Olpha, your doctor will discuss with you whether you should breastfeed, considering the benefit you receive from the treatment and the benefit to 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 using machines
Dizziness and visual disturbances may occur during treatment with this medicine (see section 4). This should be taken into account in situations requiring full alertness, such as driving a vehicle or operating machinery.

Aripiprazole Olpha contains lactose
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Aripiprazole Olpha

Take this medicine exactly as directed by your doctor or pharmacist. If
you have any doubts, consult your doctor or pharmacist.
The recommended dose for adults is 15 mg once daily. However, your doctor may
prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
Use in children and adolescents
This medicine may be started at a low dose using Aripiprazole Macleods oral solution (liquid).
The dose may be gradually increased to the recommended dose for adolescents of 10 mg
once daily. However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once daily.
If you feel that the effect of Aripiprazole Olpha is too strong or too weak, consult your doctor or pharmacist.
Try to take Aripiprazole Olpha at the same time every day. It does not matter whether 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 Aripiprazole Olpha without first consulting your doctor.
If you take more Aripiprazole Olpha than you should
If you realize you have taken more Aripiprazole Olpha than your doctor prescribed (or if someone else has taken Aripiprazole Olpha tablets), contact your doctor immediately. If you cannot reach your doctor, go to the nearest hospital and take the package with you.
Patients who have taken an overdose of 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 stiffness and drowsiness or sedation, slowed breathing, feeling of suffocation, high or low blood pressure, changes in heart rhythm.

Contact your doctor or go to hospital immediately if you experience any of these symptoms.
If you forget to take Aripiprazole Olpha
If you forget a dose, take it as soon as you remember, but do not take two doses on the same day.
If you stop taking Aripiprazole Olpha
Do not stop treatment just because you feel better. It is important to continue taking Aripiprazole Olpha for the entire duration indicated by your doctor.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Common side effects (may affect up to 1 in 10 people):

• diabetes mellitus,
• difficulty sleeping,
• feeling anxious,
• feeling restless and unable to sit still, difficulty remaining seated,
• akathisia (an unpleasant sensation of inner restlessness and an irresistible urge to keep moving),
• uncontrollable muscle contractions, jerking movements or twisting,
• tremors,
• headache,
• tiredness,
• drowsiness,
• feeling of light-headedness,
• agitation and blurred vision,
• reduced number of bowel movements or difficulty passing stools,
• indigestion,
• nausea,
• increased saliva production,
• vomiting,
• feeling of fatigue.

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

• increase or decrease in blood levels of the hormone prolactin,
• high blood sugar levels,
• depression,
• change or increase in sexual interest,
• uncontrollable movements of the mouth, tongue and limbs (tardive dyskinesia),
• muscular disorder causing twisting movements (dystonia),
• restlessness in the legs,
• double vision,
• sensitivity of the eyes to light,
• rapid heartbeat,
• drop in blood pressure when standing up, causing dizziness, light-headedness or fainting,
• hiccups.

The following side effects have been reported since the start of marketing of oral Aripiprazole Olpha, but their frequency is unknown:

• low levels of white blood cells,
• low levels of platelets,
• allergic reaction (e.g. swelling of the mouth, tongue, face and throat, itching, hives),
• onset or worsening of diabetes, ketoacidosis (ketones in blood and urine) or coma,
• high blood sugar levels,
• low sodium levels in the blood,
• loss of appetite (anorexia),
• weight loss,
• weight gain,
• suicidal thoughts, suicide attempt and suicide,
• feeling of aggression,
• agitation,
• nervousness,
• a combination of fever, muscle stiffness, rapid breathing, sweating, reduced consciousness, sudden changes in blood pressure and heart rate, fainting (neuroleptic malignant syndrome),
• seizures,
• serotonin syndrome (a reaction that may cause extreme happiness, drowsiness, clumsiness, restlessness, feeling drunk, fever, sweating or muscle stiffness),
• speech disorders,
• eyes fixed in one position,
• unexplained sudden death,
• potentially fatal irregular heartbeat,
• heart attack,
• slow heartbeat,
• 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 breathing difficulties (if you notice any of these symptoms, seek immediate medical advice),
• high blood pressure,
• fainting,
• accidental inhalation of food with risk of pneumonia (lung infection),
• muscle spasm around the larynx,
• inflammation of the pancreas,
• difficulty swallowing,
• diarrhoea,
• 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 results,
• 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 presents with flu-like symptoms and a skin rash on the face which then spreads, high temperature, swollen lymph nodes, increased liver enzyme levels found in blood tests, and increase in a type of white blood cells (eosinophilia),
• abnormal breakdown of muscle tissue which may cause kidney problems,
• muscle pain,
• stiffness,
• involuntary loss of urine (incontinence),
• difficulty urinating,
• withdrawal symptoms in newborns if exposed during pregnancy,
• prolonged and/or painful erection,
• difficulty in controlling internal body temperature or condition of excessive heat,
• chest pain,
• swelling of the hands, ankles or feet,
• in blood tests: fluctuation in blood sugar levels, increased glycated haemoglobin,
• inability to resist the impulse, urge or temptation to perform an action that could be harmful to oneself or others, which may include:
  • strong urge to gamble excessively despite serious personal or family consequences,
  • altered or increased sexual interest and behaviour causing significant concern to oneself or others, for example increased 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 appetite),
  • tendency to wander away. Inform your doctor if you experience any of these behaviours; they will explain how to manage or reduce the symptoms.

In elderly patients with dementia, there have been more reports of fatal cases during treatment with aripiprazole. In addition, cases of stroke or "mini" strokes have been reported.

Additional side effects in children and adolescents

Adolescents aged 13 years and older have experienced side effects similar in frequency and type to those in adults, except for drowsiness, uncontrollable muscle contractions or jerking movements, restlessness and fatigue, which have been very common (more than 1 in 10 patients), and upper abdominal pain, dry mouth, increased heart rate, weight gain, increased appetite, muscle contraction, uncontrollable limb movements and dizziness, especially when rising from a lying or sitting position, which have been common (more than 1 in 100 patients).

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Aripiprazole Olpha

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
Do not dispose of medicines via wastewater 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 Aripiprazole Olpha contains

• The active substance is aripiprazole. Each tablet contains 5 mg, 10 mg, 15 mg, or 30 mg of aripiprazole.
• The other components are monohydrate lactose, microcrystalline cellulose (PH101), maize starch, indigo carmine (E132) [for Aripiprazole Olpha 5 mg tablets], red iron oxide (E172) [for Aripiprazole Olpha 10 mg and 30 mg tablets], yellow iron oxide (E172) [for Aripiprazole Olpha 15 mg tablets], low-substituted hydroxypropyl cellulose (LH21), magnesium stearate.

Description of the appearance of Aripiprazole Olpha and the contents of the pack
Aripiprazole Olpha 5 mg tablets are blue, modified rectangular, uncoated tablets with "CL 73" on one side and smooth on the other side.
Aripiprazole Olpha 10 mg tablets are pink, modified rectangular, uncoated tablets with "CL 74" on one side and smooth on the other side.
Aripiprazole Olpha 15 mg tablets are yellow, round, uncoated tablets with "CL 75" on one side and smooth on the other side.
Aripiprazole 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 cold-form blister packs (aluminium-aluminium). Aripiprazole Olpha is available in pack sizes 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