Olpinat

Package Leaflet: Information for the Patient

Olpinat, 5 mg, coated tablets

Olpinat, 10 mg, coated tablets

Olanzapine

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

• 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 symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

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

1. What is Olpinat and what is it used for

Olpinat contains the active substance olanzapine. Olpinat belongs to a group of medicines called antipsychotics and is used to treat:

• schizophrenia - a disease characterized by hearing, seeing, or feeling things that do not exist in reality, having beliefs that are contrary to reality, being overly suspicious, and withdrawing from contact with others. The patient may experience depression, anxiety, or tension.
• moderate to severe manic episodes - disease states whose symptoms are agitation or euphoria.

It has been shown that Olpinat prevents the recurrence of these symptoms in patients with bipolar affective disorder who have responded well to olanzapine treatment for a manic episode.

2. Important information before taking Olpinat

When not to take Olpinat

Warnings and precautions

Before starting Olpinat, discuss it with your doctor or pharmacist.

• Medicines in this group may cause abnormal movements, especially in the face or tongue. If such a symptom occurs after taking Olpinat, you should inform your doctor.
• Very rarely, these types of medicines cause a syndrome of symptoms: fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, you should contact your doctor immediately.
• It is not recommended to use Olpinat in elderly patients with a diagnosis of dementia, as it may cause very serious side effects.
• In patients taking Olpinat, weight gain has been observed. You should regularly check your weight. If necessary, you should consider consulting a dietitian or seeking help in establishing a diet.
• In patients taking Olpinat, high blood sugar and high lipid levels (triglycerides and cholesterol) have been observed. Before taking Olpinat and during its use, your doctor should perform blood tests to determine blood sugar levels and certain lipid levels.
• You should tell your doctor if you or a family member have had blood clots in the past, as similar medicines have been associated with the formation of blood clots.

If you have any of the following diseases, you should immediately inform your doctor:

• diabetes;
• heart disease;
• liver or kidney disease;
• Parkinson's disease;
• seizures;
• prostate problems;
• intestinal obstruction (paralytic ileus);
• blood diseases;
• stroke or "mini" stroke (transient stroke symptoms).

If you have dementia and have had a stroke or "mini" stroke, you (or your caregiver) should tell your doctor.
Routinely, as a precaution, in people over 65 years of age, the doctor may check blood pressure.

Children and adolescents

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

Olpinat and other medicines

People taking Olpinat may use other medicines only with the consent of their doctor.
Taking Olpinat in combination with antidepressant, sedative, or sleeping medicines may cause drowsiness.
You should tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
In particular, you should tell your doctor about taking:

• medicines used to treat Parkinson's disease
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) - a dose adjustment of Olpinat may be necessary.

Taking Olpinat with food, drink, and alcohol

It does not matter whether you take the tablets during a meal or not.
People taking Olpinat should not drink alcohol in any form, as Olpinat in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor before taking this medicine. Women who are breastfeeding should not take Olpinat, as small amounts of the medicine may pass into breast milk.
In newborns whose mothers took Olpinat 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 you notice such symptoms in your child, you should contact your doctor.

Driving and using machines

Olpinat may cause drowsiness. If drowsiness occurs, you should not drive vehicles or operate any tools and machines.

Olpinat contains lactose

In case of intolerance to some sugars, you should contact your doctor before taking this medicine.

Olpinat contains soy lecithin

Patients allergic to soy or peanuts should not take this medicine.

3. How to take Olpinat

This medicine should always be taken as directed by your doctor. In case of doubts, you should contact your doctor or pharmacist again.
Your doctor will decide how many tablets and for how long you should take Olpinat. The daily dose of Olpinat is 5 to 20 mg. If the symptoms of the disease recur, you should inform your doctor. However, you should not stop taking Olpinat unless your doctor decides to do so.
Olpinat tablets should be taken once a day as directed by your doctor. You should try to take the medicine at the same time every day. Olpinat coated tablets are taken orally.
The tablet should be swallowed whole, with a glass of water.

Taking a higher dose of Olpinat than recommended

In patients who took a higher dose of Olpinat than recommended, the following symptoms occurred: rapid heartbeat, agitation or aggressive behavior, speech difficulties, involuntary movements (especially of the face and tongue), and decreased consciousness. Other symptoms include:
severe confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness, decreased breathing rate, choking, high or low blood pressure, heart rhythm disturbances. You should contact your doctor immediately or go to the hospital. You should show the doctor the package with the tablets.

Missing a dose of Olpinat

As soon as you remember, you should take the tablet. You should not take a double dose to make up for the missed dose.

Stopping Olpinat treatment

In case of improvement, you should not stop taking the tablets. It is important to take Olpinat for as long as your doctor recommends.
If Olpinat treatment is stopped suddenly, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose of Olpinat before stopping treatment.
In case of doubts related to the use of the medicine, you should consult your doctor.

4. Possible side effects

Like all medicines, Olpinat can cause side effects, although not everybody gets them.
You should contact your doctor immediately if you experience:

• abnormal movements, especially in the face or tongue (a common side effect that may affect up to 1 in 10 patients);
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 patients), especially in the legs (symptoms include swelling, pain, redness of the leg), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties. If you notice any of these symptoms, you should seek medical attention immediately.
• simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness (the frequency of this side effect cannot be determined from the available data).

Very common side effects (which may affect 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 a decrease in heart rate) may occur, especially when standing up from a lying or sitting position. These symptoms usually go away on their own, but if they persist, you should inform your doctor.
Common side effects (which may affect up to 1 in 10 patients) include: changes in the number of certain blood cells, blood lipid levels, and transient increases in liver enzyme activity at the beginning of treatment, increased blood sugar and urine levels, increased uric acid and creatine phosphokinase levels in the blood, increased appetite, dizziness, restlessness, tremors, movement disorders (dyskinesias), 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 affect up to 1 in 100 patients) include:
allergic reactions (e.g., swelling in the mouth and throat, itching, rash), diabetes or worsening of its course, rarely 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, decreased heart rate, sensitivity to sunlight, nosebleeds, abdominal bloating, drooling, memory loss or lack of memory, incontinence, difficulty urinating, hair loss, absence or decrease of menstrual periods, changes in the breasts in men and women, such as milk secretion outside of breastfeeding or unusual breast enlargement.
Rarely reported side effects (which may affect up to 1 in 1000 patients): decreased normal body temperature, heart rhythm disturbances, sudden death from an unknown cause, pancreatitis causing severe abdominal pain, fever, and nausea, liver disease characterized by a change in skin and white eye color to yellow, muscle disease characterized by unexplained muscle pain and weakness, prolonged and (or) painful erections.
Very rare side effects include severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS). In DRESS, initial symptoms are flu-like with a rash on the face, followed by a widespread rash, high fever, enlarged lymph nodes, increased liver enzyme activity, and increased eosinophil counts.
During olanzapine treatment in elderly patients with dementia, the following may occur: stroke, pneumonia, incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and gait disturbances. Several fatal cases have been reported in these patient groups.
In patients with Parkinson's disease, Olpinat may worsen side effects.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, e-mail: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olpinat

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after: EXP.
The expiry date refers to the last day of the month stated.
Olpinat should be stored in its original packaging to protect it from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist 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 Olpinat contains

• The active substance of the medicine is olanzapine. Each coated tablet contains 5 mg or 10 mg of the active substance.
• The other ingredients are: (tablet core) lactose monohydrate, povidone K30, crospovidone, copovidone, colloidal silica anhydrous, magnesium stearate. (tablet coating) polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin, xanthan gum.

What Olpinat looks like and contents of the pack

Olpinat 5 mg coated tablets are white, round, biconvex, with a diameter of 7.9-8.1 mm.
Olpinat 10 mg coated tablets are white, round, biconvex, with a diameter of 9.9-10.1 mm.
The pack contains 28, 30, or 56 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Vipharm S.A.
ul. A. i F. Radziwiłłów 9
05-850 Ożarów Mazowiecki
tel.: (+48 22) 679 51 35
fax: (+48 22) 678 92 87
e-mail: vipharm@vipharm.com.pl

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Czech Republic:
Olpinat 5 mg (10 mg)
Hungary:
Olpinat 5 mg (10 mg) filmtabletta
Poland:
Olpinat, 5 mg (10 mg)
Slovakia:
Olpinat 5 mg (10 mg)

Date of approval of the leaflet: 05/2020