Olanzapine Apc

PATIENT INFORMATION LEAFLET

Enclosed leaflet: information for the user

Olanzapine APC, 5 mg, orally disintegrating tablets

Olanzapine APC, 10 mg, orally disintegrating tablets

Olanzapine APC, 15 mg, orally disintegrating tablets

Olanzapine APC, 20 mg, orally disintegrating tablets

Olanzapine

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

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Keep this leaflet, you may need to read it again.
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In case of any doubts, consult a doctor or pharmacist.
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This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
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If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor or pharmacist.
See section 4.

Table of contents of the leaflet:

• 1. What is Olanzapine APC and what is it used for
• 2. Important information before taking Olanzapine APC
• 3. How to take Olanzapine APC
• 4. Possible side effects
• 5. How to store Olanzapine APC
• 6. Contents of the pack and other information

1. What is Olanzapine APC and what is it used for

Olanzapine APC contains the active substance olanzapine.
Olanzapine APC belongs to a group of medicines called antipsychotics and is used in the following cases:

• Schizophrenia, a disease in which the patient hears, sees or feels things that do not exist in reality, has beliefs that contradict reality, is overly suspicious and withdraws from contact with others. The patient may experience depression, anxiety or tension.
• In moderate or severe manic episodes - a condition characterized by excessive excitement or euphoria.

It has been shown that Olanzapine APC prevents the recurrence of the above symptoms in patients with bipolar affective disorder, who have responded positively to olanzapine treatment in manic episodes.

2. Important information before taking Olanzapine APC

When not to take Olanzapine APC

Warnings and precautions

Before starting to take Olanzapine APC, the patient should discuss it with their doctor or pharmacist.
­ It is not recommended to use Olanzapine APC in elderly patients with dementia due to the possibility of severe side effects.
­ Medicines of this class may cause involuntary movements, especially in the face or tongue. If such a symptom occurs after taking Olanzapine APC, the doctor should be informed.
­ Very rarely, medicines of this type cause a syndrome of symptoms - fever, rapid breathing, sweating, muscle stiffness, drowsiness or sleepiness. If such symptoms occur, the doctor should be contacted immediately.
­ Weight gain has been observed in patients taking Olanzapine APC. The patient and their doctor should regularly monitor the patient's weight. If necessary, consider consulting a dietitian or seeking help in establishing a diet.
­ High blood sugar and high fat levels (cholesterol, triglycerides) have been observed in patients taking olanzapine. The doctor should order a blood test to check blood sugar levels and the level of certain fats before using Olanzapine APC and regularly during treatment.
­ The doctor should be informed if the patient or their family members have had blood clots after taking medicines like this.
If the patient has any of the following diseases, they should immediately inform their doctor:

• Stroke or "mini" stroke (transient stroke symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal obstruction (paralytic)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If the patient knows that they may have lost salt due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or the use of diuretics (urinary medicines). If the patient has dementia and has had a stroke or "mini" stroke, the patient (or their caregiver) should inform the doctor.

As a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and adolescents

Olanzapine APC is not intended for use in patients under 18 years of age.

Olanzapine APC and other medicines

People taking Olanzapine APC may only take other medicines with the doctor's consent.
Taking Olanzapine APC in combination with antidepressant, sedative or sleeping medicines may cause drowsiness.
The doctor or pharmacist should be informed about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
In particular, the doctor should be informed if the patient is taking:

• medicines used in Parkinson's disease.
• carbamazepine (an antiepileptic and mood disorder medicine), fluvoxamine (an antidepressant) - may require a change in the dose of Olanzapine APC.

Taking Olanzapine APC with alcohol

People taking Olanzapine APC should not drink alcohol, as it may cause drowsiness when combined with alcohol.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant or plans to have a child, they should consult their doctor before taking this medicine.
Olanzapine APC should not be taken during breastfeeding, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers took Olanzapine APC in the last trimester (last 3 months of pregnancy), the following symptoms may occur: trembling, muscle stiffness and (or) weakness, drowsiness, agitation, breathing difficulties and feeding problems. If such symptoms are observed in the patient's child, they should contact their doctor.

Driving and operating machinery

Olanzapine APC may cause drowsiness. If drowsiness occurs, the patient should not drive vehicles or operate any machines and devices. The doctor should be informed.

Olanzapine APC contains aspartame

This medicine contains 2.4 mg (5 mg dose) or 4.8 mg (10 mg dose) or 7.2 mg (15 mg dose) or 9.6 mg (20 mg dose) of aspartame in each orally disintegrating tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion.

Olanzapine APC contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per orally disintegrating tablet, which means the medicine is considered "sodium-free".

3. How to take Olanzapine APC

This medicine should always be taken as directed by the doctor. In case of doubts, the doctor or pharmacist should be consulted.
The doctor will decide how many Olanzapine APC tablets to take and how long the treatment should last. The daily dose of Olanzapine APC is from 5 mg to 20 mg. If the symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Olanzapine APC unless the doctor decides to do so.
Olanzapine APC tablets should be taken once a day as directed by the doctor. The patient should try to take the medicine at the same time every day. It does not matter whether the tablets are taken with or without food. Olanzapine APC orally disintegrating tablets are taken orally.
Olanzapine APC tablets are fragile, so they should be handled carefully.
The orally disintegrating tablets should not be touched with wet hands, as they may disintegrate.
Place the tablet in the mouth. The tablet will dissolve quickly and can be easily swallowed.
The tablet can also be placed in a full glass of water, orange juice, apple juice, milk or coffee, and then stirred. Some drinks may change color and become cloudy after adding the tablet and stirring. The resulting liquid should be drunk immediately.

Taking a higher dose of Olanzapine APC than recommended

In patients who have taken a higher dose of Olanzapine APC than recommended, the following symptoms have occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, unusual movements (especially of the face and tongue) and decreased consciousness.
Other symptoms include: acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, drowsiness or excessive sleepiness, decreased breathing rate, choking, high or low blood pressure, heart rhythm disorders. The doctor should be contacted immediately if any of the above symptoms occur. The doctor should be shown the packaging of the tablets.

Missing a dose of Olanzapine APC

The tablet should be taken as soon as the patient remembers. A double dose should not be taken within 24 hours.

Stopping Olanzapine APC treatment

The patient should not stop taking the tablets as soon as they feel better. It is important to take the medicine for as long as the doctor recommends.
If Olanzapine APC treatment is stopped abruptly, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea or vomiting. The doctor may recommend gradually reducing the dose of Olanzapine APC before stopping treatment.
In case of any further doubts about taking this medicine, the doctor or pharmacist should be consulted.

4. Possible side effects

Like all medicines, Olanzapine APC can cause side effects, although not everybody gets them.
The doctor should be informed immediately if the following occur:

• unusual movements (frequent side effect, which may occur in no more than 1 in 10 people), mainly of the face or tongue;
• blood clots in the veins (uncommon side effect, which may occur in no more than 1 in 100 people), especially in the legs (may manifest as swelling, pain and redness of the leg), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If any of the above symptoms are noticed, the doctor should be consulted immediately;
• simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, drowsiness or sleepiness (the frequency of this side effect cannot be determined from the available data).

Very common side effects(which may occur in more than 1 in 10 patients)
include weight gain, drowsiness and increased prolactin levels in the blood. In the early stages of treatment, dizziness or fainting (with slowed heart rate) may occur, especially when getting up from a lying or sitting position. These symptoms usually go away on their own, but if they persist, the doctor should be informed.
Common side effects(which may occur in no more than 1 in 10 patients) include changes in the number of certain blood cells and lipid levels in the blood, and transient increases in liver enzyme activity at the start of treatment; increased blood sugar and urine levels; increased uric acid and creatine phosphokinase levels in the blood, increased appetite; dizziness; restlessness; trembling, movement disorders (dyskinesia), constipation; dry mouth; weakness; extreme fatigue; water retention in the body causing swelling of the hands, feet or ankles, fever, joint pain and sexual disorders, such as decreased libido in men and women or erectile dysfunction in men.
Uncommon side effects(which may occur in no more than 1 in 100 patients)
include allergic reactions (e.g. swelling in the mouth and throat, itching, rash), diabetes or worsening of its course, occasionally with ketoacidosis (presence of ketone bodies in the blood and urine) or coma, seizures, usually in patients who have had seizures (epilepsy) before, muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, stuttering, slowed heart rate; sensitivity to sunlight; nosebleeds, abdominal bloating, drooling, memory loss or lack of memory, urinary incontinence, inability to urinate; hair loss; absence or decrease of menstrual periods and changes in the breasts in men and women, such as abnormal milk production or unusual breast enlargement.
Rare side effects(which may occur in no more than 1 in 1000 patients) include lowered body temperature; heart rhythm disorders; sudden death from an unknown cause; pancreatitis causing severe abdominal pain, fever and nausea; liver disease manifesting as a change in skin and white eye color to yellow; muscle disease manifesting as unexplained muscle pain and weakness; prolonged and (or) painful erection.
Very rare side effectsinclude severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, flu-like symptoms with a rash on the face occur initially, followed by a widespread rash, high fever, enlarged lymph nodes, elevated liver enzyme activity and increased eosinophil count in the blood.
During olanzapine treatment in elderly patients with dementia, the following have been reported: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness and walking problems. In this patient group, fatal cases have been reported.
In patients with Parkinson's disease, taking Olanzapine APC may worsen the symptoms of the disease.
Reporting side effects
If side effects occur, including those not listed in this leaflet, the doctor or pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Jerozolimskie Avenue 181C
02-222 Warsaw
tel.: 22 49-21-301
fax: 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Olanzapine APC

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging.
There are no special precautions for storing the medicinal product.
Medicines should not be disposed of via wastewater or household waste.
The pharmacist should be asked how to dispose of medicines that are no longer used. This will help protect the environment.

6. Contents of the pack and other information

What Olanzapine APC contains

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The active substance is olanzapine. Each Olanzapine APC orally disintegrating tablet contains 5 mg, 10 mg, 15 mg or 20 mg of the active substance.
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The other ingredients of the medicine are: mannitol (E 421), crospovidone, aspartame (E 951), orange flavor (flavoring preparations, natural flavoring substances, flavoring substances, corn maltodextrin, alpha-tocopherol (E 307)), colloidal anhydrous silica, sodium stearylfumarate.

What Olanzapine APC looks like and contents of the pack

Olanzapine APC is available in the form of orally disintegrating tablets. The orally disintegrating tablet means a tablet that dissolves directly in the mouth, making it easier to swallow.
Olanzapine APC, 5 mg: yellow, round, flat tablets with a broken edge, 6 mm in diameter, with the number "5" embossed on one side.
Olanzapine APC, 10 mg: yellow, round, flat tablets with a broken edge, 6 mm in diameter, with the number "10" embossed on one side.
Olanzapine APC, 15 mg: yellow, round, flat tablets with a broken edge, 6 mm in diameter, with the number "15" embossed on one side.
Olanzapine APC, 20 mg: yellow, round, flat tablets with a broken edge, 6 mm in diameter, with the number "20" embossed on one side.
The orally disintegrating tablets are packaged in blisters of oPA/Aluminum/PVC//Aluminum foil.
Olanzapine APC is available in packs containing 28 orally disintegrating tablets.

Marketing authorization holder

APC Institute Ltd.
Jerozolimskie Avenue 146c
02-305 Warsaw

Manufacturer

Adamed Pharma S.A.
Piłsudski Marshal Street 5
95-200 Pabianice

The medicine is authorized for use in the Member States of the European Economic Area under the following names:

Poland
Olanzapine APC
Italy
Olanzapina APC

Date of last revision of the leaflet: