Olpinat

Package Leaflet: Information for the Patient

Olpinat, 5 mg, Film-Coated Tablets

Olpinat, 10 mg, Film-Coated Tablets

Olanzapine

Read the Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medication has been prescribed specifically for you. 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 those not listed in this leaflet, inform 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 contradict 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 include 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

• If you are allergic to olanzapine, soy lecithin, or any of the other ingredients of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face, lip swelling, or shortness of breath. If such symptoms occur, inform your doctor.
• If you have eye diseases, such as certain types of glaucoma (increased eye pressure).

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, inform your doctor.
• Very rarely, these types of medications cause a syndrome of symptoms: fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sleepiness. If such symptoms occur, 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. The patient's weight should be checked systematically. If necessary, 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, the doctor should perform blood tests to determine blood sugar levels and the levels of certain lipids.
• Tell your doctor if you or a family member have had blood clots in the past, as similar medications have been associated with the formation of blood clots.

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

• Diabetes;
• Heart disease;
• Liver or kidney disease;
• Parkinson's disease;
• Seizures;
• Prostate problems;
• Intestinal obstruction (paralytic);
• 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 inform your doctor.
Routinely, as a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and Adolescents

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

Olpinat and Other Medications

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

• Medications 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, consult your doctor before taking this medication. Women who are breastfeeding should not take Olpinat, as small amounts of the medication 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 difficulties. If you observe such symptoms in your child, contact your doctor.

Driving and Operating Machinery

Olpinat may cause drowsiness. If drowsiness occurs, do not drive vehicles or operate any tools and machinery.

Olpinat Contains Lactose

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

Olpinat Contains Soy Lecithin

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

3. How to Take Olpinat

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

Taking More Than the Recommended Dose of Olpinat

In patients who have taken more than the recommended dose of Olpinat, the following symptoms have 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. Contact your doctor immediately or go to the hospital. Show the doctor the package with the tablets.

Missing a Dose of Olpinat

Take the tablet as soon as you remember. Do not take a double dose to make up for the missed dose.

Stopping Olpinat Treatment

Do not stop taking the tablets even if you feel better. 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 about taking the medication, consult your doctor.

4. Possible Side Effects

Like all medications, Olpinat can cause side effects, although not everybody gets them.
Inform 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 observe any of these symptoms, 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 resolve on their own, but if they persist, 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 start of treatment, increased blood and urine sugar levels, increased uric acid and creatine phosphokinase levels in the blood, increased appetite, dizziness, anxiety, 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 affect up to 1 in 100 patients) include: hypersensitivity (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 rigidity (including eye movements), restless legs syndrome, speech disorders, slow heart rate, sensitivity to sunlight, nosebleeds, abdominal bloating, salivation, memory loss or lack of memory, urinary 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 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 include flu-like symptoms with a rash on the face, followed by a widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity, and increased levels of a specific type of white blood cell (eosinophilia) in blood tests.
In elderly patients with dementia treated with olanzapine, the following have been reported: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, 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 those not listed in this leaflet, inform 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, 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 gather more information on the safety of this medication.

5. How to Store Olpinat

Store the medication out of sight and reach of children.
Do not use this medication after the expiration date stated on the package and blister after: EXP.
The expiration date refers to the last day of the specified month.
Olpinat should be stored in its original packaging to protect it from light.
Medications should not be disposed of via wastewater or household waste containers. Ask your pharmacist how to dispose of unused medications. This will help protect the environment.

6. Contents of the Pack and Other Information

What Olpinat Contains

• The active substance of Olpinat is olanzapine. Each film-coated tablet contains 5 mg or 10 mg of the active substance.
• Other ingredients are: (tablet core) lactose monohydrate, povidone K30, crospovidone, copovidone, colloidal silicon dioxide, 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 film-coated tablets are white, round, biconvex, with a diameter of 7.9-8.1 mm.
Olpinat 10 mg film-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 Revision of the Leaflet: 05/2020