Olanzapine apc

Package leaflet: Information for the user

Olanzapine APC, 5 mg, orodispersible tablets
Olanzapine APC, 10 mg, orodispersible tablets
Olanzapine APC, 15 mg, orodispersible tablets
Olanzapine APC, 20 mg, orodispersible tablets
Olanzapinum
Please read all of this leaflet carefully before 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, please ask your doctor or pharmacist.
­ This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
­ If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.
Contents of the leaflet:

1. What Olanzapine APC is and what it is used for
2. What you need to know 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 Olanzapine APC is and what it is 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 conditions:

• Schizophrenia, a disorder in which the patient hears, sees or feels things that do not exist in reality, has beliefs that are not in accordance with reality, is excessively suspicious and withdraws from contact with others. The patient may also experience depression, anxiety or tension.
• Moderate to severe manic episodes – a condition characterized by excessive excitement or euphoria.

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

2. Important information before taking Olanzapine APC

When not to take Olanzapine APC

• if the patient is allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may present as rash, itching, facial swelling, swollen lips, or difficulty breathing. If such symptoms occur, inform the doctor immediately.
• if the patient has eye problems such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions
Before starting treatment with Olanzapine APC, discuss this with your doctor or
pharmacist.
­ Olanzapine APC is not recommended for elderly patients with dementia due to the risk of serious adverse effects.
­ Medicines of this class may cause involuntary movements, especially of the face or tongue. If such symptoms occur after taking Olanzapine APC, inform your doctor.
­ Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or excessive sleepiness. If any of these symptoms occur, contact your doctor immediately.
­ Weight gain has been observed in patients taking Olanzapine APC. The patient and their doctor should monitor body weight regularly. If necessary, consider consulting a dietitian or seeking help with establishing a proper diet.
­ Elevated blood sugar levels and increased levels of fats (cholesterol, triglycerides) have been observed in patients taking olanzapine. Your doctor should order blood tests to check blood sugar and certain fat levels before starting Olanzapine APC and regularly during treatment.
­ Inform your doctor if the patient or their family has a history of blood clots after taking medicines like this.
If the patient has any of the following conditions, inform the treating doctor immediately:

• Stroke or “mini” stroke (transient ischemic attack)
• Parkinson’s disease
• Prostate problems
• Intestinal obstruction (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If the patient knows they may have lost body salts due to prolonged, severe diarrhea and vomiting (nausea with vomiting) or use of diuretics (water pills). If the patient has dementia and has ever had a stroke or “mini” stroke, the patient (or caregiver) should inform the doctor.

As a routine precaution, doctors may monitor blood pressure in patients over 65 years of age.
Children and adolescents
Olanzapine APC is not intended for use in patients under 18 years of age.
Olanzapine APC and other medicines
Patients taking Olanzapine APC should use other medicines only with the approval of a doctor.
Taking Olanzapine APC together with antidepressants, sedatives, or sleeping pills may cause drowsiness.
Inform your doctor or pharmacist about all medicines currently taken or recently taken, as well as any medicines the patient plans to take.
In particular, inform your doctor if taking:

• medicines used for Parkinson’s disease.
• carbamazepine (an anticonvulsant and mood-stabilizing medicine), fluvoxamine (an antidepressant) – dose adjustment of Olanzapine APC may be necessary.

Taking Olanzapine APC with alcohol
Patients taking Olanzapine APC must not drink alcohol, as it may increase drowsiness when combined with the medicine.
Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or planning to have a child, she should consult her doctor before taking this medicine.
Do not take this medicine during breastfeeding, as small amounts of Olanzapine APC may pass into breast milk.
Newborns whose mothers took Olanzapine APC during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If such symptoms are observed in the newborn, contact the doctor immediately.
Driving and operating machinery
Olanzapine APC may cause drowsiness. If drowsiness occurs, do not drive or operate any machinery or mechanical equipment. Inform your doctor.
Olanzapine APC contains aspartame
This medicine contains 2.4 mg (5 mg dose), 4.8 mg (10 mg dose), 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 improper excretion.
Olanzapine APC contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per orally disintegrating tablet, meaning the medicine is considered "sodium-free".
3. How to take Olanzapine APC
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will decide how many Olanzapine APC tablets to take and how long treatment should last. The daily dose of Olanzapine APC ranges from 5 mg to 20 mg. If symptoms of illness reappear, inform your doctor. However, do not stop taking Olanzapine APC unless instructed by your doctor.
Take Olanzapine APC tablets once daily as directed by your doctor. Try to take the medicine at the same time each day. It does not matter whether the tablets are taken with or without food. Orally disintegrating tablets of Olanzapine APC are taken by mouth.
Olanzapine APC tablets are delicate; therefore, handle them carefully.
Do not touch orally disintegrating tablets with wet hands, as they may disintegrate.
Place the tablet in the mouth. The tablet dissolves quickly and can be easily swallowed.
The tablet may 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 the tablet is added and mixed. The prepared liquid should be consumed immediately.
Taking more than the recommended dose of Olanzapine APC
In patients who have taken more than the recommended dose of Olanzapine APC, the following symptoms have been reported: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, unusual movements (especially of facial muscles and tongue), and reduced consciousness.
Other symptoms include: acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, drowsiness or excessive sleepiness, reduced breathing rate, choking, high or low blood pressure, and heart rhythm disturbances. Seek immediate medical attention or go to the hospital if any of these symptoms occur. Show the tablet packaging to the doctor.
Missed dose of Olanzapine APC
Take the tablet as soon as you remember. Do not take a double dose within the same day.
Stopping Olanzapine APC treatment
Do not stop taking the tablets immediately when the patient starts feeling better. It is important to continue taking the medicine for as long as your doctor recommends.
If Olanzapine APC is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
You should immediately inform your doctor if any of the following occur:

• unusual movements (a common adverse reaction which may occur in up to 1 in 10 people), mainly of the face or tongue;
• blood clots in veins (an uncommon adverse reaction which may occur in up to 1 in 100 people), especially in the lower limbs (which may present as swelling, pain and redness of the limb), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If you notice any of the above symptoms, you should seek medical advice immediately;
• concurrent occurrence of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy (the frequency of this adverse reaction cannot be determined from available data).

Very common adverse reactions (may occur in more than 1 in 10 patients)
include weight gain, drowsiness and increased prolactin levels in the blood. At the beginning of treatment,
dizziness or fainting (with slowed heart function) may occur, especially when rising from a lying or sitting position.
These symptoms usually resolve spontaneously, but if they persist, you should inform your doctor.
Common adverse reactions (may occur in up to 1 in 10 patients) include changes in the count of certain blood cells and blood lipid levels, transient increases in liver enzyme activity at the beginning of treatment; increased blood and urine glucose levels; increased uric acid and creatine phosphokinase activity in the blood, increased appetite; dizziness; restlessness; tremor, movement disorders (dyskinesias), constipation; dryness of the oral mucosa; rash; weakness; extreme fatigue; fluid retention 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 adverse reactions (may occur in up to 1 in 100 patients)
include hypersensitivity reactions (e.g. swelling of the mouth and throat, itching, rash),
diabetes or worsening of pre-existing diabetes, occasionally with ketoacidosis (presence of ketone compounds in blood and urine) or coma, seizures, usually in patients with a previous history of seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, stuttering, slowed heart function;
photosensitivity; nosebleeds, abdominal distension, salivation, memory loss or amnesia, urinary incontinence, inability to urinate; hair loss; absence or reduction of menstruation and breast changes in men and women, such as abnormal milk production or unusual breast enlargement.
Rare adverse reactions (may occur in up to 1 in 1000 patients) include
lowering of normal body temperature; heart rhythm disturbances; sudden death of unknown cause; pancreatitis causing severe abdominal pain, fever and nausea; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease manifesting as unexplained muscle aches and pains; prolonged and/or painful erection.
Very rare adverse reactions include severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, initial symptoms resemble influenza with a rash on the face, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity evident in blood tests, and increased levels of a specific type of white blood cells (eosinophilia).
During treatment with olanzapine in elderly patients diagnosed with dementia, the following may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness and walking difficulties. Fatal cases have been reported in this patient group.
In patients with Parkinson's disease, treatment with Olanzapine APC may worsen the symptoms of this disease.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, you should inform your doctor, pharmacist or nurse. Adverse reactions can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49-21-301
Fax: +48 22 49-21-309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Olanzapine APC

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
There are no special requirements for the storage of this medicinal product.
Medicines must not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. Such measures will help
protect the environment.

6. Contents of the pack and other information

What Olanzapine APC contains
­ The active substance is olanzapine. Each orally disintegrating tablet of Olanzapine APC contains 5 mg, 10 mg, 15 mg or 20 mg of the active substance.
­ Other components of the medicine are: mannitol (E 421), crospovidone, aspartame (E 951), orange flavour (flavouring preparations, natural flavouring substances, flavouring substances, corn maltodextrin, alpha-tocopherol (E 307)), colloidal anhydrous silica, sodium stearyl fumarate.

What Olanzapine APC looks like and contents of the pack
Olanzapine APC is available as orally disintegrating tablets. An orally disintegrating tablet is a tablet that dissolves directly in the mouth, facilitating swallowing.

Olanzapine APC, 5 mg: yellow, round, flat tablets with bevelled edges, 6 mm in diameter, with the number "5" embossed on one side.
Olanzapine APC, 10 mg: yellow, round, flat tablets with bevelled edges, 6 mm in diameter, with the number "10" embossed on one side.
Olanzapine APC, 15 mg: yellow, round, flat tablets with bevelled edges, 6 mm in diameter, with the number "15" embossed on one side.
Olanzapine APC, 20 mg: yellow, round, flat tablets with bevelled edges, 6 mm in diameter, with the number "20" embossed on one side.

Orally disintegrating tablets are packed in blisters made of oPA/Aluminium/PVC // Aluminium foil.

Olanzapine APC is available in packs containing 28 orally disintegrating tablets.

Marketing Authorisation Holder
APC Instytut Sp. z o.o.
ul. Aleje Jerozolimskie 146c
02-305 Warsaw
Poland

Manufacturer
Adamed Pharma S.A.
ul. Marszałka Józefa Piłsudskiego 5
95-200 Pabianice
Poland

The medicine is authorised for marketing in the European Economic Area countries under the following names:
Poland: Olanzapine APC
Italy: Olanzapina APC