Package leaflet: Information for the patient

Olpinat, 5 mg, coated tablets
Olpinat, 10 mg, coated tablets
Olanzapine
Please read the entire leaflet before taking the medicine, as it contains important information for the patient.

Keep this leaflet for future reference.
If you have any doubts, consult your doctor or pharmacist.
This medicine has been prescribed for a specific individual. Do not share it with others. This medicine may harm someone else, even if their symptoms are similar.
If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Olpinat is and what it is used for
Important information before taking Olpinat
How to take Olpinat
Possible side effects
How to store Olpinat
Contents of the pack and other information

1. What Olpinat is and what it is 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 sensing things that do not exist in reality, having beliefs that are not based in reality, excessive suspiciousness, and social withdrawal. The patient may also experience depression, anxiety, or tension.
moderate to severe manic episodes – medical conditions characterized by excitement or euphoria.

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

2. Important information before using Olpinat

When not to use Olpinat

if the patient is allergic to olanzapine, soybean lecithin, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, facial swelling, lip swelling, or shortness of breath. If such symptoms occur, inform the doctor immediately.
if the patient has eye disorders, such as certain types of glaucoma (increased pressure in the eye).

Warnings and precautions
Before starting treatment with Olpinat, discuss this with your doctor or pharmacist.

Medicines of this class may cause abnormal movements, especially of the face or tongue. If such a symptom occurs after taking Olpinat, inform your doctor immediately.
Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness, or lethargy. If these symptoms occur, seek immediate medical attention.
Olpinat is not recommended for elderly patients diagnosed with dementia, as it may cause very serious adverse effects.
Weight gain has been observed in patients taking Olpinat. The patient's body weight should be monitored regularly. If necessary, consider consulting a dietitian or seeking help in establishing an appropriate diet.
Elevated blood sugar levels and increased lipid levels (triglycerides and cholesterol) have been observed in patients taking Olpinat. Before starting and during treatment with Olpinat, the doctor should perform blood tests to monitor blood glucose and certain lipid levels.
Inform the doctor if the patient or a family member has a history of blood clots, as similar medicines have been associated with blood clot formation.

If the patient has any of the following conditions, inform the treating doctor immediately:

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

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

Olpinat and other medicines
Patients taking Olpinat should use other medicines only with the approval of a doctor.
Concomitant use of Olpinat with antidepressants, sedatives, or sleeping medicines may cause drowsiness.
Inform the doctor about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to use.
In particular, inform the doctor if the patient is taking:

medicines used to treat Parkinson's disease;
carbamazepine (an anticonvulsant and mood-stabilizing medicine), 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 the tablets are taken with or without food.
Patients taking Olpinat must not consume alcohol in any form, as Olpinat combined with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult a doctor before using this medicine. Breastfeeding women should not take Olpinat, as small amounts of the medicine may pass into breast milk.
Newborns whose mothers took Olpinat during the third trimester (last 3 months of pregnancy) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems. If such symptoms are observed in your child, contact a doctor immediately.

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

Olpinat contains lactose
If the patient has an intolerance to certain sugars, consult a doctor before taking this medicine.

Olpinat contains soybean lecithin
Patients allergic to soy or peanuts should not take this medicine.

3. How to take Olpinat

This medicine should always be taken exactly as prescribed by the doctor. If in doubt, consult the doctor or pharmacist again.
The doctor will decide how many tablets to take and for how long. The daily dose of Olpinat ranges from 5 to 20 mg. If symptoms reappear, inform the doctor. However, do not stop taking Olpinat unless instructed by the doctor.

Olpinat tablets should be taken once daily as directed by the doctor. Try to take the medicine at the same time each day. Olpinat coated tablets are taken orally. Swallow the tablet whole with water.

Taking more Olpinat than prescribed
In patients who have taken more than the prescribed dose of Olpinat, the following symptoms have occurred: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of facial muscles and tongue), and reduced consciousness. Other symptoms include acute confusion (disorientation), seizures (epilepsy), coma, concurrent occurrence of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy, decreased breathing rate, choking, high or low blood pressure, and heart rhythm disturbances. Seek immediate medical help or go to a hospital. Show the doctor the medicine packaging.

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

Stopping Olpinat treatment
Do not stop taking the tablets even if you feel better. It is important to continue taking Olpinat for as long as your doctor recommends.
If Olpinat is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety, nausea, or vomiting. The doctor may advise gradually reducing the dose before stopping treatment.

If you have any doubts about using this medicine, consult your doctor.

4. Possible adverse reactions

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

abnormal movements, especially of the face or tongue (a frequently reported adverse reaction, which may affect up to 1 in 10 patients);
blood clots in the veins (a not uncommon adverse reaction, which may affect up to 1 in 100 patients), particularly in the legs (symptoms include swelling, pain, redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms are observed, medical advice should be sought immediately.
concurrent occurrence of fever, rapid breathing, sweating, muscle stiffness, and lethargy or drowsiness (the frequency of this adverse reaction cannot be determined from available data).

Very common adverse reactions (which may affect more than 1 in 10 patients) include:
weight gain, drowsiness, and increased blood prolactin levels. In the early stages of
treatment, dizziness or fainting (with slowed heart function) may occur, particularly
when standing up from a lying or sitting position. These symptoms usually resolve on their own, but if they persist, you should inform your doctor.
Common adverse reactions (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 and urine glucose levels,
increased uric acid and creatine phosphokinase activity in blood, increased appetite,
dizziness, anxiety, tremor, movement disorders (dyskinesias), constipation, dryness of the oral mucosa, rash, weakness, extreme fatigue, fluid retention
leading to swelling of hands, feet, or ankles, fever, joint pain, and sexual disorders, such as reduced libido in men and women or erectile dysfunction in men.
Uncommon adverse reactions (which may affect up to 1 in 100 patients) include:
hypersensitivity (e.g. swelling of the mouth and throat, itching, rash), diabetes or worsening of existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in blood and
urine) or coma, seizures, usually in patients who previously experienced seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, slowed heart function, photosensitivity,
nosebleeds, abdominal bloating, drooling, memory loss or amnesia, urinary incontinence,
difficulty urinating, hair loss, absence or reduction of menstruation, changes in
breasts in men and women, such as milk discharge outside of breastfeeding or unusual breast enlargement.
Rare adverse reactions (which may affect up to 1 in 1000 patients): lowered body temperature,
heart rhythm disturbances, sudden unexplained death, pancreatitis causing severe abdominal pain,
fever, and nausea, liver disease manifested by yellowing of the skin and whites of the eyes, muscle disease manifested by unexplained muscle aches and pain, 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 facial rash, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzyme activity evident in blood tests, and elevated levels of a specific type of white blood cell (eosinophilia).
During olanzapine treatment 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 gait disturbances. Several fatal cases have been reported in these patient groups.
In patients with Parkinson's disease, Olpinat may worsen adverse reaction symptoms.
Reporting of adverse reactions
If any adverse symptoms occur, including any adverse reactions not listed in this leaflet, you should inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department for Monitoring Adverse Drug Reactions of the 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
Reporting adverse reactions helps to provide more information on the safety of the medicine.
5. How to store Olpinat
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following EXP.
The expiry date refers to the last day of the stated month.
Olpinat should be stored in the original packaging to protect it from light.
Medicines must not be disposed of via the sewage system or household waste. Ask your
pharmacist how to dispose of medicines no longer required. These measures will help protect
the environment.

6. Contents of the package and other information

What Olpinat contains

The active substance is olanzapine. Each coated tablet contains 5 mg or 10 mg of the active substance.
The other ingredients are: (tablet core) monohydrate lactose, povidone K30, crospovidone, copovidone, anhydrous 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 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 Authorisation 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: [email protected]
This medicinal product is authorised in the European Economic Area countries 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)