Zopridoxin

Package leaflet: Information for the user

Zopridoxin, 5 mg, orodispersible tablets
Zopridoxin, 10 mg, orodispersible tablets
Zopridoxin, 15 mg, orodispersible tablets
Zopridoxin, 20 mg, orodispersible tablets
Olanzapine
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, ask your doctor or pharmacist.
• This medicine has been prescribed for you personally. Do not give it 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.

Leaflet contents

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

1. What Zopridoxin is and what it is 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 disorder in which patients hear, see or feel things that do not exist in reality, have beliefs that are not based on reality, are excessively suspicious and withdraw from contact with others. Patients with this disorder may also experience depression, anxiety or tension.
• Moderate to severe manic episodes – states characterized by excitement or euphoria.

Zopridoxin has been shown to prevent recurrence of these symptoms in patients with bipolar affective disorder whose manic episodes have responded to olanzapine treatment.

2. Important information before using Zopridoxin

When not to use Zopridoxin

• if the patient is allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, facial swelling, swollen lips or breathing difficulties. If such symptoms occur, inform the doctor immediately;
• if the patient has previously been diagnosed with eye disorders, for example, a certain type of glaucoma (increased pressure in the eye).

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

• Use of Zopridoxin in elderly patients with dementia is not recommended, as it may cause very serious adverse effects.
• Medicines in this group may cause abnormal movements, mainly affecting the face or tongue. If such symptoms occur after taking Zopridoxin, inform your doctor.
• Very rarely, medicines in this class may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy. If any of these symptoms occur, seek immediate medical attention.
• Weight gain has been observed in patients taking olanzapine. The patient, with support from the doctor, should monitor body weight regularly. If necessary, consider consulting a dietitian or seeking help in establishing an appropriate diet.
• Elevated levels of blood sugar and lipids (cholesterol and triglycerides) have been observed. Your doctor should perform blood tests to check blood sugar and certain lipid levels before starting Zopridoxin and regularly during treatment.
• Inform your doctor if the patient has a history of blood clots, or if there is a family history of blood clots, as medicines like this may increase the risk of thrombosis.

If the patient has any of the following conditions, inform the doctor as soon as possible:

• stroke or "mini" stroke (transient ischemic attack);
• Parkinson's disease;
• prostate gland disorders;
• 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 tablets).

If the patient has dementia, the patient or caregiver should inform the doctor whether the patient has ever had a stroke or "mini" stroke.
As a precautionary measure, doctors may routinely monitor blood pressure in patients over 65 years of age.

Children and adolescents
Zopridoxin is not intended for use in patients under 18 years of age.

Zopridoxin and other medicines
Patients taking Zopridoxin should use other medicines only on the advice of a doctor.
Combining Zopridoxin with antidepressants, sedatives, or sleeping medicines may cause drowsiness.
Inform the doctor about all medicines currently being taken or recently taken, as well as any medicines the patient plans to use.
In particular, inform the doctor 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 adjust the dose of Zopridoxin.

Using Zopridoxin with alcohol
Alcohol must not be consumed during treatment with Zopridoxin, as the medicine combined with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor or pharmacist before using this medicine.
There is insufficient data on use in pregnant women. Olanzapine should be used during pregnancy only if the benefit outweighs the potential risk to the fetus.
Breastfeeding women should not take Zopridoxin, as small amounts of olanzapine may pass into breast milk.
Newborns of mothers who took Zopridoxin during the third trimester of pregnancy (last three months) may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If any of these symptoms occur in the newborn, contact a doctor immediately.

Driving and operating machinery
Drowsiness may occur during treatment with Zopridoxin. If this occurs, the patient must not drive, operate mechanical tools or machinery. Inform the doctor if drowsiness occurs.

Zopridoxin contains aspartame
Each 5 mg orodispersible tablet contains 1.25 mg of aspartame.
Each 10 mg orodispersible tablet contains 2.5 mg of aspartame.
Each 15 mg orodispersible tablet contains 3.75 mg of aspartame.
Each 20 mg orodispersible 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 disorder in which phenylalanine accumulates in the body due to impaired excretion.

Zopridoxin contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking this medicine.

3. How to use Zopridoxin

This medicine should always be taken as prescribed by your doctor. If in doubt, consult your
doctor or pharmacist.
Your doctor will decide how many orally disintegrating tablets of Zopridoxin to take and for how
long. The daily dose of Zopridoxin ranges from 5 to 20 mg. If symptoms recur, inform your doctor.
However, do not stop taking Zopridoxin unless your doctor advises otherwise.
Zopridoxin should be taken 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. The
orally disintegrating tablets of Zopridoxin should be taken by mouth.
The orally disintegrating tablets of Zopridoxin break apart easily, so handle them with care. Do not touch the tablets with wet hands, as they may disintegrate.

1. Carefully peel back the bottom layer of the blister pack.
2. Gently push the tablet out of the blister pack.
3. Place the tablet in the mouth. The tablet will dissolve directly in the oral cavity, making it easy to swallow.

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

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

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

Stopping Zopridoxin treatment
The patient should not stop taking the tablets just because they feel better. It is important to continue taking Zopridoxin for as long as your doctor recommends.
If Zopridoxin is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety, nausea, and vomiting. Your doctor may recommend gradually reducing the dose before completely stopping the treatment.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone gets them.
You should inform your doctor immediately if the following occur:
abnormal movements (a commonly reported adverse effect, which may affect fewer than 1 in
10 patients), especially affecting the face or tongue;

• blood clots in the veins (an uncommonly reported adverse effect, which may affect up to 1 in 100 patients), particularly in the legs (symptoms include swelling, pain and redness of the leg), which may travel through blood vessels to the lungs, causing chest pain and difficulty breathing. If any of these symptoms occur, contact your doctor immediately;
• concurrent occurrence of fever, rapid breathing, sweating, muscle stiffness, drowsiness or sleepiness (the frequency of these adverse effects cannot be determined from available data).

Very common adverse effects (may occur in more than 1 in 10 patients) include:
weight gain, drowsiness, increased blood prolactin levels. In the early stages of treatment, dizziness or fainting (with slowed heart function) may occur, particularly when rising from a lying or sitting position. These symptoms usually resolve spontaneously, but if they persist, you should inform your doctor.

Common adverse effects (may occur in fewer than 1 in 10 patients) include: changes in the count 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 blood levels of uric acid and creatine phosphokinase; increased appetite; dizziness; anxiety; tremor; movement disorders (dyskinesias); constipation; dryness of the oral mucosa; rash; loss of strength; extreme fatigue; fluid retention causing swelling of the 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 effects (may occur in fewer than 1 in 100 patients) include:
hypersensitivity (e.g. swelling of the mouth and throat, itching, rash); diabetes mellitus or worsening of pre-existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in blood and urine) or coma; increased blood bilirubin levels, detectable in blood tests; seizures, usually in patients with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech disorders; stuttering; slowed heart function; photosensitivity; nosebleeds; abdominal distension; drooling; memory loss or amnesia; urinary incontinence; difficulty urinating; hair loss; absence or reduction of menstruation; breast changes in men and women, such as milk discharge outside of breastfeeding or unusual breast enlargement.

Rare adverse effects (may occur in fewer than 1 in 1,000 patients) include:
reduced body temperature; heart rhythm disorders; sudden unexplained death; pancreatitis causing severe abdominal pain, fever and nausea; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease presenting as unexplained muscle aches and pains; prolonged and/or painful erection; bleeding or bruising lasting longer than usual or occurring unexpectedly (thrombocytopenia).

Adverse effects with unknown frequency (frequency cannot be determined from available data) include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
In DRESS syndrome, initial symptoms are influenza-like with facial rash, followed by widespread rash, high fever, enlarged lymph nodes, increased liver enzyme activity evident in blood tests, and increased levels of a specific type of white blood cell (eosinophilia); withdrawal symptoms in newborns such as discolored skin patches, diarrhoea, excessive sucking or crying, poor feeding, slow weight gain, sneezing.

In elderly patients with dementia, treatment with Zopridoxin may lead to:
stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and walking difficulties. A number of fatal cases have been reported in this patient group.

In patients with Parkinson's disease, treatment with Zopridoxin may worsen symptoms of the disease.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 effects can also be reported to the marketing authorization holder.
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Zopridoxin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister and carton following the label
EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from moisture.
Unused medicine should be returned to a pharmacy. Medicines should not be disposed of via sewage
or household waste. Ask your pharmacist how to dispose of medicines no longer in use.
This will help protect the environment.

6. Contents of the pack and other information

What Zopridoxin contains

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

What Zopridoxin looks like and contents of the pack
5 mg: yellow to pale yellow, round, biconvex tablet with a diameter of approximately 6.4 mm,
imprinted with the code "5" on one side.
10 mg: yellow to pale yellow, round, biconvex tablet with a diameter of approximately 9.1 mm,
imprinted with the code "10" on one side.
15 mg: yellow to pale yellow, round, biconvex tablet with a diameter of approximately 10.4 mm,
imprinted with the code "15" on one side.
20 mg: yellow to pale yellow, round, biconvex tablet with a diameter of approximately 12.1 mm,
imprinted with the code "20" on one side.
The medicine is available in cartons containing 28 orodispersible tablets.

Marketing Authorisation 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. Kosztowska 21
41-409 Mysłowice
Poland