Package Insert: Information for the User

Zolafren Flas 20 mg Bucodispersable Tablets EFG

olanzapine

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

Zolafren Flas belongs to a group of medications known as antipsychotics and is indicated for the treatment of the following diseases:

• Schizophrenia, a disease characterized by hearing, seeing, or feeling unreal things, holding false beliefs, unusual suspicion, and becoming withdrawn. People suffering from these conditions may also experience depression, anxiety, or tension.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Zolafren Flas has demonstrated the ability to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take Zolafren Flas:

• If you are allergic to olanzapine or any of the other components of this medication (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, tell your doctor.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased eye pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Zolafren Flas.

• Zolafren Flas is not recommended for elderly patients with dementia as it may have severe adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking Zolafren Flas, tell your doctor.
• In rare cases, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Zolafren Flas. You and your doctor should check your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Zolafren Flas. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Zolafren Flas and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medications of this type have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

• Stroke or transient ischemic attack (temporary lack of blood flow to the brain)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you think you may have a loss of electrolytes due to prolonged diarrhea and vomiting or the use of diuretic medications.

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.

As a routine precaution, if you are over 65 years old, it would be a good idea for your doctor to check your blood pressure.

Children and adolescents

Patients under 18 years old should not take Zolafren Flas.

Other medications and Zolafren Flas

Only use other medications at the same time as Zolafren Flas if your doctor authorizes it. You may feel drowsy if you combine Zolafren Flas with antidepressants or medications for anxiety or sleep (tranquilizers).

Inform your doctor or pharmacist if you are using, have used recently, or may use any other medication.

Specifically, tell your doctor if you are taking:

• Medication for Parkinson's disease

• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). You may need to adjust your Zolafren Flas dosage.

Use of Zolafren Flas with alcohol

You should not drink alcohol if you have been administered Zolafren Flas as it may cause drowsiness.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication. Do not take this medication while breastfeeding as small amounts of Zolafren Flas may pass into breast milk.

The following symptoms may occur in newborns of mothers who used Zolafren Flas in the last trimester (last three months of pregnancy): tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your baby has any of these symptoms, contact your doctor.

Driving and operating machinery

Zolafren Flas may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention until your doctor assesses your response to this medication.

Zolafren Flas contains aspartame and mannitol

This medication may be harmful to people with phenylketonuria because it contains aspartame, which is a source of phenylalanine.

Patients who cannot take mannitol should be aware that Zolafren Flas contains mannitol.

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Zolafren Flas tablets to take and for how long. The daily dose of Zolafren Flas ranges from 5 mg to 20 mg. Consult your doctor if you experience the symptoms again, but do not stop taking Zolafren Flas unless your doctor tells you to.

Zolafren Flas tablets should be taken once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. Zolafren Flas tablets are for oral administration.

Zolafren Flas tablets break easily, so they should be handled with care. Do not handle the tablets with wet hands because they may disintegrate.

Place the tablet in your mouth. It will dissolve directly in your mouth, making it very easy to swallow.

You can also pour the tablet into a glass or cup filled with water, orange juice, apple juice, milk, or coffee, stirring it. With some drinks, the mixture may change color and become cloudy. You should drink it immediately.

If you take moreZolafren Flasthan you should

Patients who have taken more Zolafren Flas than they should have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue) and reduced consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased blood pressure or decreased blood pressure, abnormal heart rhythms..Get in touch with your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the packaging with the tablets to the doctor.

If you have taken more Zolafren Flas than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount taken. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

If you forget to takeZolafren Flas

Take your tablets as soon as you remember. Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment withZolafren Flas

Do not stop treatment simply because you feel better. It is very important that you continue taking Zolafren Flas as long as your doctor tells you to.

If you stop taking Zolafren Flas suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact your doctor if you have:

• Unusual movements (a frequent side effect that can affect up to 1 in 10 people), especially of the face or tongue.
• Blood clots in the veins (a rare side effect that can affect up to 1 in 100 people), especially in the legs (symptoms include sweating, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek immediate medical attention.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data).

Other side effects:

Frequent side effects (can affect more than 1 in 10 people) include weight gain, drowsiness, and increased levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying down or sitting. This sensation usually disappears spontaneously, but if it does not, consult your doctor.

Common side effects (can affect up to 1 in 10 people) include changes in levels of some blood cells, circulating lipids, and at the beginning of treatment, increased levels of liver enzymes, increased levels of blood sugar and urine, increased levels of uric acid and creatine phosphokinase in the blood, increased appetite, dizziness, agitation, tremors, strange movements (dyskinesia), constipation, dry mouth, skin rash, loss of strength, excessive fatigue, fluid retention causing inflammation of the hands, ankles, or feet, fever, joint pain, and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Rare side effects (can affect up to 1 in 100 people) include hypersensitivity (e.g., inflammation of the mouth and throat, itching, skin rash), diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in the blood and urine) or coma, seizures, in most cases related to a history of seizures (epilepsy), muscle stiffness or spasms (including eye movements), restless legs syndrome, speech problems, slow pulse, sensitivity to sunlight, nosebleeds, abdominal distension, excessive salivation, memory loss or forgetfulness, urinary incontinence, loss of ability to urinate, hair loss, absence or decrease of menstrual periods, and changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

Rare side effects (can affect up to 1 in 1000 people) include a decrease in normal body temperature, abnormal heart rhythm, sudden death without apparent explanation, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellowing of the skin and white areas of the eye, muscle disorder presenting as unexplained pain, and prolonged and/or painful erection.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially presents with symptoms similar to the flu, with skin rash that then spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.

Zolafren Flas may worsen symptoms in patients with Parkinson's disease.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

Zolafren Flasse must be stored in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition ofZolafren Flas

-The active ingredient is olanzapine. Each buccal dispersible tablet contains 20 mg of the active substance.

-The other components are: mannitol (E421), crospovidone type B, aspartame (E951), orange flavor (aroma preparations, identical natural flavor substances, corn maltodextrin, alpha-tocopherol (E307)), colloidal anhydrous silica, and sodium stearate fumarate.

Appearance of the productandcontents of the packaging

Zolafren Flas are buccal dispersible tablets. A buccal dispersible tablet is the technical term for a tablet that dissolves directly in the mouth, making it easy to swallow.

Zolafren Flas 20 mg buccal dispersible tablets are yellow, rounded, smooth, and beveled tablets, 10 mm in diameter, and engraved on one side with a “20”.

They are presented in OPA-Al-PVC/Al blisters.

Packaging size: 28 buccal dispersible tablets.

20 mg tablets: 4 blisters of 7 tablets per box.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

Adamed Laboratorios, S.L.U.

c/ de las Rosas de Aravaca, 31 – 2nd floor

28023 Aravaca – Madrid, Spain

Tel.: +34 91 357 11 25

Fax: +34 91 307 09 70

e-mail:infoesp@adamed.com

Responsible manufacturer

Adamed Pharma, S.A.

Ul. Marszalka JózefaPilsudskiego 5

95-200 Pabianice, Poland

This medicinal product is approved in the Member States of the EEA under the following names:

{Spain} Zolafren Flas 5 mg, 10 mg, 15 mg, 20 mgbuccal dispersible tablets EFG

Last revision date of this leaflet:November 2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/