Package leaflet: Information for the patient

Zolafren-Swift, 5 mg, orodispersible tablets
Zolafren-Swift, 10 mg, orodispersible tablets
Zolafren-Swift, 15 mg, orodispersible tablets
Zolafren-Swift, 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 a specific individual. Do not share it with others. This medicine may harm other people, even if their symptoms are the same.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

What Zolafren-Swift is and what it is used for
What you need to know before taking Zolafren-Swift
How to take Zolafren-Swift
Possible side effects
How to store Zolafren-Swift
Contents of the pack and other information

1. What Zolafren-Swift is and what it is used for

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

Schizophrenia – a disorder characterized by hearing, seeing, or sensing things that do not exist in reality, having beliefs that are inconsistent with 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.

Zolafren-Swift has been shown to prevent 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 Zolafren-swift

When not to use Zolafren-swift
if the patient has a known allergy 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, lip swelling, or difficulty breathing. If such symptoms occur,
inform your doctor immediately;
if the patient has eye disorders such as certain types of glaucoma (increased
intraocular pressure).

Warnings and precautions
Before starting treatment with Zolafren-swift, discuss this with your doctor or pharmacist.
Use of Zolafren-swift is not recommended in elderly patients with dementia, as it may lead to very serious adverse effects.
Medicines of this class may cause abnormal movements, especially of the face or tongue. If such symptoms occur after taking Zolafren-swift, inform your doctor.
Very rarely, medicines of this type may cause a group of symptoms including fever, rapid breathing, sweating, muscle stiffness, drowsiness, or lethargy. If any of these symptoms occur, contact your doctor immediately.
Weight gain has been observed in patients treated with Zolafren-swift. 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 glucose levels and elevated lipid levels (triglycerides and cholesterol) have been observed in patients treated with Zolafren-swift. Before initiating and during treatment with Zolafren-swift, your doctor should perform blood tests to monitor blood glucose and certain lipid levels.
Inform your doctor if the patient has ever had blood clots, either personally or in family members, as similar medicines have been associated with blood clot formation.
Inform your doctor immediately if the patient has any of the following conditions:

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 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
Zolafren-swift is not intended for use in patients under 18 years of age.

Zolafren-swift and other medicines
Patients taking Zolafren-swift should use other medicines only under the guidance of a doctor.
Concomitant use of Zolafren-swift with antidepressants, sedatives, or hypnotics may cause drowsiness.
Inform your doctor about all medicines currently or recently taken, as well as any medicines the patient plans to take.
In particular, inform your 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 Zolafren-swift may be necessary.

Zolafren-swift and alcohol
Do not drink alcohol after taking Zolafren-swift, as this medicine in combination with alcohol may cause drowsiness.

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

Driving and operating machinery
Zolafren-swift may cause drowsiness. If drowsiness occurs, do not drive or operate any machinery or equipment. Inform your doctor.

Aspartame
Zolafren-swift 5 mg contains 2.40 mg of aspartame in each orally disintegrating tablet.
Zolafren-swift 10 mg contains 4.80 mg of aspartame in each orally disintegrating tablet.
Zolafren-swift 15 mg contains 7.20 mg of aspartame in each orally disintegrating tablet.
Zolafren-swift 5 mg contains 9.60 mg of aspartame in each orally disintegrating tablet.
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.

Sodium
The medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free."

Benzyl alcohol – ingredient of the flavouring agent (orange flavour)
Zolafren-swift 5 mg contains 0.03 mg of benzyl alcohol in each orally disintegrating tablet.
Zolafren-swift 10 mg contains 0.06 mg of benzyl alcohol in each orally disintegrating tablet.
Zolafren-swift 15 mg contains 0.1 mg of benzyl alcohol in each orally disintegrating tablet.
Zolafren-swift 20 mg contains 0.1 mg of benzyl alcohol in each orally disintegrating tablet.
Benzyl alcohol may cause allergic reactions.
Pregnant or breastfeeding women should consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).
Patients with liver or kidney disease should consult their doctor before using this medicine, as large amounts of benzyl alcohol may accumulate in their body and cause adverse effects (so-called metabolic acidosis).

3. How to take Zolafren-swift
Always take this medicine exactly as prescribed by your doctor. If in doubt, consult your doctor or pharmacist.
Your doctor will decide the number of tablets and duration of treatment with Zolafren-swift. The daily dose of Zolafren-swift ranges from 5 mg to 20 mg. If symptoms reappear, inform your doctor. Do not stop taking Zolafren-swift unless your doctor advises you to do so.
Take Zolafren-swift tablets 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. Orally disintegrating Zolafren-swift tablets should be taken by mouth.
Do not handle Zolafren-swift tablets with wet hands, as they may disintegrate.
The tablet may also be placed in a full glass of water, orange juice, apple juice, milk, or coffee, and then stirred. Some liquids may change color and become cloudy after adding and stirring the tablet. The prepared solution should be consumed immediately.

Taking more Zolafren-swift than prescribed
In patients who have taken more than the prescribed dose of Zolafren-swift, the following symptoms have been reported: rapid heartbeat, agitation or aggressive behavior, difficulty speaking, involuntary movements (especially of facial and tongue muscles), and reduced consciousness. Other symptoms include: acute confusion (disorientation), seizures (epilepsy), coma, concurrent occurrence of fever, rapid breathing, sweating, muscle stiffness, drowsiness or excessive sleepiness, reduced breathing rate, choking, high or low blood pressure, and heart rhythm disturbances. Contact your doctor or go to hospital immediately if any of these symptoms occur. Show the doctor the medicine packaging.

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

Stopping Zolafren-swift
Do not stop taking the tablets just because the patient feels better. It is important to continue taking the medicine for as long as your doctor recommends.
If Zolafren-swift is stopped abruptly, the following symptoms may occur: sweating, insomnia, tremor, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose before stopping 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 will experience them.
You should immediately inform your doctor if any of the following occur:

abnormal movements, especially of the face or tongue (a commonly reported adverse effect, which may affect up to 1 in 10 patients);
blood clots in veins (an uncommonly reported adverse effect, 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.
concomitant occurrence of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy (the frequency of this adverse effect cannot be determined from available data).
hypersensitivity (e.g. swelling of the mouth and throat, itching, rash) (an uncommonly reported adverse effect, which may affect up to 1 in 100 patients).
severe allergic reactions, such as drug reaction with eosinophilia and systemic symptoms (DRESS syndrome). In DRESS syndrome, flu-like symptoms with a rash on the face appear initially, followed by widespread rash, high fever, enlarged lymph nodes, increased liver enzyme activity evident in blood tests, and increased count of one type of white blood cells (eosinophilia) (the frequency of this adverse effect cannot be determined from available data).

Very common adverse effects (which may affect more than 1 in 10 patients) include
weight gain, drowsiness, and increased blood prolactin levels. Dizziness or fainting (with reduced heart function), particularly upon standing up from a lying or sitting position, may occur early in treatment. These symptoms usually resolve spontaneously, but if they persist, you should inform your doctor.
Common adverse 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 (especially at the beginning of treatment), increased blood and urine glucose levels, increased blood uric acid and creatine phosphokinase activity, increased alkaline phosphatase activity, elevated gamma-glutamyltransferase activity, increased appetite, dizziness, restlessness, tremor, movement disorders (dyskinesias), constipation, dryness of the oral mucosa, rash, weakness, extreme fatigue, fluid retention 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 adverse effects (which may affect up to 1 in 100 patients) include diabetes mellitus or worsening of pre-existing diabetes, occasionally with ketoacidosis (presence of ketone bodies in blood and urine) or coma, seizures, usually in patients with a previous history of seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech disorders, stuttering, bradycardia, irregular heartbeat (changes in the electrocardiogram), photosensitivity, nosebleeds, abdominal distension, excessive salivation (hypersalivation), memory loss or amnesia, urinary incontinence, difficulty urinating, sensation of urinary urgency, hair loss, absence or reduced intensity of menstrual bleeding, breast changes in men and women such as galactorrhea (milk secretion outside of breastfeeding) or unusual breast enlargement, increased total bilirubin concentration.
Rarely reported adverse effects (which may affect up to 1 in 1000 patients):
thrombocytopenia, hypothermia, neuroleptic malignant syndrome (NMS), withdrawal symptoms, cardiac arrhythmias, sudden unexplained death, pancreatitis causing severe abdominal pain, fever and nausea, liver disease manifesting as yellowing of the skin and whites of the eyes (jaundice), muscle disease presenting as unexplained muscle aches and pains, prolonged and (or) painful erection (priapism).
Adverse effects with unknown frequency include withdrawal syndrome in newborns.
During treatment with olanzapine 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 difficulty walking. Several fatal cases have been reported in this patient group.
In patients with Parkinson's disease, treatment with Zolafren-Swift may worsen symptoms of this disease.
Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse effects can be reported directly to the Department of Monitoring Adverse Drug Reactions, 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 provide more information on the safety of the medicine.

5. How to store Zolafren-Swift

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
Store in the original packaging to protect from moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Zolafren-swift contains

The active substance is olanzapine. Each Zolafren-swift orodispersible tablet contains 5 mg, 10 mg, 15 mg, or 20 mg of the active substance. Exact information on the content of the active substance is provided on the packaging of Zolafren-swift.
Other ingredients are: mannitol, aspartame, crospovidone, orange flavouring (containing, among others, benzyl alcohol), colloidal anhydrous silica, sodium stearyl fumarate.

What Zolafren-swift looks like and contents of the pack
Zolafren-swift, 5 mg: yellow, round, flat orodispersible tablets with the imprint "5" on one side.
Pack contains 28, 84, or 112 orodispersible tablets.
Zolafren-swift, 10 mg: yellow, round, flat orodispersible tablets with the imprint "10" on one side.
Pack contains 28, 84, or 112 orodispersible tablets.
Zolafren-swift, 15 mg: yellow, round, flat orodispersible tablets with the imprint "15" on one side.
Pack contains 28, 84, or 112 orodispersible tablets.
Zolafren-swift, 20 mg: yellow, round, flat orodispersible tablets with the imprint "20" on one side.
Pack contains 28, 84, or 112 orodispersible tablets.
Marketing Authorisation Holder
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów
Tel.: + 48 22 732 77 00
Manufacturer
Adamed Pharma S.A.
Pieńków, ul. M. Adamkiewicza 6A
05-152 Czosnów