Zopridoxin

Leaflet accompanying the packaging: information for the user

Zopridoxin, 5 mg, orally disintegrating tablets

Zopridoxin, 10 mg, orally disintegrating tablets

Zopridoxin, 15 mg, orally disintegrating tablets

Zopridoxin, 20 mg, orally disintegrating tablets

Olanzapine

You should carefully read the contents of the leaflet before taking the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Zopridoxin and what is it used for

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

• Schizophrenia - a disease in which the patient hears, sees, or feels things that do not exist in reality, has beliefs that are contrary to reality, is overly suspicious, and withdraws from contact with others. Patients with this disease may also experience depression, anxiety, or tension.
• Moderate to severe manic episodes - states with symptoms of excitement or euphoria.

It has been shown that Zopridoxin prevents the recurrence of these symptoms in patients with bipolar affective disorder, in whom manic episodes subsided after treatment with olanzapine.

2. Important information before taking Zopridoxin

When not to take Zopridoxin

Warnings and precautions

Before starting treatment with Zopridoxin, the patient should discuss it with their doctor or pharmacist.

• Taking Zopridoxin in elderly patients with dementia is not recommended, as it may cause very serious side effects.
• Medicines in this group may cause the occurrence of abnormal movements, mainly in the face or tongue. If such a symptom occurs after taking Zopridoxin, the doctor should be informed.
• Very rarely, medicines in this group cause a syndrome of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness, or excessive sleepiness. If such symptoms occur, the doctor should be contacted immediately.
• A weight gain has been observed in patients taking olanzapine. The patient, with the support of the doctor, should regularly monitor their weight. If necessary, it is recommended to consult a dietitian or seek help in establishing a diet.
• High levels of sugar and lipids (cholesterol and triglycerides) have been observed in the blood. The doctor should perform blood tests to check the levels of sugar and some lipids in the blood before taking Zopridoxin and regularly during treatment.
• The patient should inform the doctor about the occurrence of blood clots in themselves or any family member, as medicines like this one may cause blood clots.

If the patient has any of the following diseases, they should inform their doctor as soon as possible:

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

If the patient has dementia, they or their caregiver should inform the doctor if they have ever had a stroke or "mini" stroke. As a precaution, in people over 65 years of age, the doctor may monitor blood pressure.

Children and adolescents

Zopridoxin is not intended for use in patients under the age of 18.

Zopridoxin and other medicines

Patients taking Zopridoxin may take other medicines only on the recommendation of a doctor. Taking Zopridoxin in combination with antidepressant, sedative, or sleeping medicines may cause drowsiness. The doctor should be told 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 for Parkinson's disease;
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to change the dose of Zopridoxin.

Taking Zopridoxin with alcohol

While taking Zopridoxin, the patient should not drink alcohol, as the medicine in combination with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before taking this medicine. There is a lack of adequate data on pregnant women. Olanzapine should be used in pregnancy only when the benefit outweighs the potential risk to the fetus. Women who are breastfeeding should not take Zopridoxin, as small amounts of olanzapine may pass into breast milk. In newborns of mothers who took Zopridoxin in the last trimester (last three months) of pregnancy, the following symptoms may occur: trembling, stiffness, and (or) muscle weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If the child experiences any of these symptoms, the doctor should be contacted.

Driving and using machines

While taking Zopridoxin, drowsiness may occur - if it does, the patient should not drive vehicles, use mechanical tools, or operate machines. The doctor should be informed about drowsiness.

Zopridoxin contains aspartame

Each 5 mg orally disintegrating tablet contains 1.25 mg of aspartame. Each 10 mg orally disintegrating tablet contains 2.5 mg of aspartame. Each 15 mg orally disintegrating tablet contains 3.75 mg of aspartame. Each 20 mg orally disintegrating tablet contains 5 mg of aspartame. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disease in which phenylalanine accumulates in the body due to its improper excretion.

Zopridoxin contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their doctor before taking the medicine.

3. How to take Zopridoxin

This medicine should always be taken according to the doctor's recommendations. In case of doubts, the patient should consult a doctor or pharmacist. The doctor will decide how many orally disintegrating tablets to take and for how long. The daily dose of Zopridoxin is from 5 to 20 mg. If the symptoms of the disease recur, the doctor should be informed. However, the patient should not stop taking Zopridoxin unless the doctor decides to do so. Zopridoxin should be taken once a day, according to the doctor's recommendations. The patient should try to take the medicine at the same time every day. It does not matter whether the tablets are taken with food or not. Zopridoxin orally disintegrating tablets should be taken orally. Zopridoxin orally disintegrating tablets dissolve easily, so they should be handled carefully. The tablets should not be touched with wet hands, as they may dissolve.

• 1. Carefully peel off the bottom layer of the blister.
• 2. Carefully press the tablet out of the blister.
• 3. Put the tablet in the mouth. The tablet will dissolve directly in the mouth, making it easy to swallow.

The tablet can also be placed in a glass filled with water, orange juice, apple juice, milk, or coffee, and then mixed. Some drinks may change color or become cloudy when mixed with the tablet. The resulting liquid should be drunk immediately.

Taking a higher dose of Zopridoxin than recommended

In patients who took a higher dose of Zopridoxin than recommended, the following symptoms occurred: rapid heartbeat, agitation, or aggressive behavior, difficulty speaking, involuntary movements (especially of the face and tongue), and decreased consciousness. Other symptoms that may occur include: acute confusion (disorientation), seizures (epilepsy), coma, simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, and 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 these symptoms occur. The doctor should be shown the packaging of the tablets.

Missing a dose of Zopridoxin

If the patient forgets to take the next dose of the medicine, they should take it as soon as they remember. The patient should not take a double dose to make up for the missed dose.

Stopping treatment with Zopridoxin

The patient should not stop taking the tablets just because they feel better. It is important to take Zopridoxin for as long as the doctor recommends. If the patient stops taking Zopridoxin suddenly, the following symptoms may occur: sweating, insomnia, trembling, anxiety, nausea, and vomiting. The doctor may recommend gradually reducing the dose of the medicine before completely stopping treatment. If the patient has any further doubts about taking this medicine, they should consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, Zopridoxin can cause side effects, although not everybody gets them. The doctor should be told immediately if the following occur: abnormal movements (a common side effect that may occur in less than 1 in 10 patients), especially in the face or tongue;

• blood clots in the veins (a not very common side effect that may affect up to 1 in 100 patients), especially in the legs (symptoms include swelling, pain, and redness of the leg), which can move through the blood vessels to the lungs, causing chest pain and breathing difficulties. If any of these symptoms occur, the doctor should be contacted immediately;
• simultaneous occurrence of fever, rapid breathing, sweating, muscle stiffness, drowsiness, or excessive sleepiness (the frequency of these side effects cannot be determined from the available data).

Very common side effects (may occur in more than 1 in 10 patients) include: weight gain, drowsiness, 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 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 (may occur in less than 1 in 10 patients) include: changes in the number of some blood cells, blood lipid levels, and initially transient increased activity of liver enzymes; increased blood sugar and urine levels; increased levels of uric acid and creatine phosphokinase 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 (may occur in less than 1 in 100 patients) include: hypersensitivity (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; increased bilirubin levels in the blood, which can be observed in blood tests; seizures, usually in patients with a history of seizures (epilepsy); muscle stiffness or spasm (including eye movements); restless legs syndrome; speech disorders; stuttering; slow heart rate; sensitivity to sunlight; nosebleeds; abdominal bloating; drooling; memory loss or amnesia; urinary incontinence; difficulty urinating; hair loss; absence or decrease of menstruation; breast changes in men and women, such as milk secretion outside of breastfeeding or abnormal breast enlargement. Rare side effects (may occur in less than 1 in 1,000 patients) include: decreased 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; bleeding or bruising that lasts longer than usual or unexpectedly (thrombocytopenia). Side effects with an unknown frequency (frequency cannot be determined from the available data) include: serious 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, elevated liver enzyme activity, and increased levels of a specific type of white blood cell (eosinophilia); withdrawal symptoms in newborns, such as skin spots, diarrhea, excessive sucking or crying, poor feeding, slow weight gain, and hiccup. In elderly patients with dementia taking Zopridoxin, the following may occur: stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. Several fatal cases have been reported in this patient group. In patients with Parkinson's disease taking Zopridoxin, the symptoms of the disease may worsen.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the doctor or pharmacist should be told. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the medicine.

5. How to store Zopridoxin

The medicine should be stored in a place that is out of sight and reach of children. This medicine should not be taken after the expiry date stated on the blister and carton after the words EXP. The expiry date refers to the last day of the month. The medicine should be stored in its original packaging to protect it from moisture. Unused medicine should be returned to the pharmacy. 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 needed. This will help protect the environment.

6. Contents of the packaging and other information

What Zopridoxin contains

• Zopridoxin 5 mg, orally disintegrating tablets: the active substance is olanzapine. Each tablet contains 5 mg of olanzapine.
• Zopridoxin 10 mg, orally disintegrating tablets: the active substance is olanzapine. Each tablet contains 10 mg of olanzapine.
• Zopridoxin 15 mg, orally disintegrating tablets: the active substance is olanzapine. Each tablet contains 15 mg of olanzapine.
• Zopridoxin 20 mg, orally disintegrating tablets: the active substance is olanzapine. Each tablet contains 20 mg of olanzapine.
• Other ingredients are: calcium carbonate, cornstarch, maize starch, lactose monohydrate, crospovidone (type A), aspartame (E 951), and magnesium stearate.

What Zopridoxin looks like and what the pack contains

5 mg: yellow to light yellow, round, biconvex tablet with a diameter of about 6.4 mm, with the inscription "5" on one side. 10 mg: yellow to light yellow, round, biconvex tablet with a diameter of about 9.1 mm, with the inscription "10" on one side. 15 mg: yellow to light yellow, round, biconvex tablet with a diameter of about 10.4 mm, with the inscription "15" on one side. 20 mg: yellow to light yellow, round, biconvex tablet with a diameter of about 12.1 mm, with the inscription "20" on one side. The medicine is available in boxes containing 28 orally disintegrating tablets.

Marketing authorization holder

Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland

Manufacturer

Genepharm S.A., 18 km Marathon Avenue, 153 51 Pallini Attikis, Greece, Bausch Health Poland sp. z o.o., ul. Przemysłowa 2, 35-959 Rzeszów, Bausch Health Poland sp. z o.o., ul. Kosztowska 21, 41-409 Mysłowice

Date of last revision of the leaflet: July 2022