Package Leaflet: Information for the User

Zolafren 5 mg Tablets EFG

olanzapine

1. What Zolafren is and what it is used for

2.What you need to knowbefore you start taking Zolafren

3. How to take Zolafren

4. Possible side effects

5. Storage of Zolafren

6. Contents of the pack and additional information

Zolafren contains the active substance olanzapina. Zolafren belongs to a group of medicines called antipsychoticsand is indicated for the treatment of the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also be depressed, anxious, or tense.
• Moderate to severe manic disorder,characterized by symptoms such as excitement or euphoria.

Zolafren has shown 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:

• If you are allergic to olanzapine or any of the other components of this medication (listed in section 6).The 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.

• Zolafren is not recommended for use in 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, tell your doctor.
• In very 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. 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. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting Zolafren 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 cerebral ischemia (temporary lack of blood flow to the brain)
• Parkinson's disease
• Prostate problems
• Intestinal obstruction (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease

•Diabetes

• Convulsions
• If you think you may be losing electrolytes due to prolonged diarrhea and vomiting or the use of diuretic medications (water pills).

If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or cerebral ischemia.

As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.

Children and adolescents

Patients under 18 years old should not take Zolafren.

Use of Zolafren with other medications

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

Inform your doctor or pharmacist if you areusing, have used recently, or may need to 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 dosage.

Use of Zolafren with alcohol

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

Pregnancy and breastfeeding

If you are pregnant orin the lactation period, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.You should not take this medication while breastfeeding as small amounts of Zolafren may pass into breast milk.

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

Driving and operating machinery

Zolafren may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your reaction time. 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 contains lactose

This medication contains lactose. If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

Zolafren contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per dose unit; it is essentially “sodium-free”.

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

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

Take the tablets 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. The tablets are for oral administration. Swallow the tablets whole with water.

If you take more Zolafren than you should

If you have taken more Zolafren 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.

Patients who have taken more Zolafren than they should have experienced the following symptoms: rapid heartbeats, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue) and a reduced level of 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 or decreased blood pressure, abnormal heart rhythms.Contact your doctor or go to the hospital immediately if you notice any of the mentioned symptoms. Show the doctor the packaging with the tablets.

If you forget to take Zolafren

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

If you interrupt treatment with Zolafren

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

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

If you have any other questions 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 medical attention immediately.
• A combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (the frequency cannot be estimated from the available data).
• Hyper-sensitivity (e.g., swelling of the mouth and throat, itching, skin rash) (a rare side effect that can affect up to 1 in 100 people)
• Severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS for short in English). DRESS initially appears as symptoms similar to the flu with a rash on the face and then with a widespread rash, high fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and elevated levels of a type of white blood cell (eosinophilia) (the frequency of this side effect cannot be estimated from the available data).

Very frequent side effects(that can affect more than 1 in 10 people) include weight gain; drowsiness; and elevated 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 on its own, but if it does not, consult your doctor.

Frequent 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 temporary increases in liver enzymes; elevated levels of blood sugar and urine; elevated levels of uric acid and creatine phosphokinase in the blood;elevated alkaline phosphatase; elevated gamma-glutamyltransferase;elevated appetite; dizziness; agitation; tremor; 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 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; stuttering; slow pulse;prolonged QT interval;sensitivity to sunlight; nasal bleeding; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; difficulty urinating; 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 1,000 people) include low platelet count in the blood (thrombocytopenia); low 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 parts of the eye; muscle disorder that presents as unexplained pain and prolonged and/or painful erection.

Unknown frequency(cannot be estimated from the available data) side effect includes neonatal withdrawal syndrome.

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

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

Reporting of 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.Theexpiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or 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. This will help protect the environment.

Composition of Zolafren

− The active ingredient is olanzapine. Each tablet contains 5 mg of olanzapine.

− The other components are: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl starch (type A) from potato without gluten, and magnesium stearate.

Appearance of the product and content of the container

Zolafren 5 mg is presented in the form of round, biconvex, yellow tablets, scored on one side. The tablets can be divided into two equal parts.

It is presented in containers of 28 or 56 tablets.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Adamed Laboratorios, S.L.U.

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

28023 Madrid, Spain.

Responsible for manufacturing

Adamed Pharma S.A.

ul. Marszalka Józefa Pilsudskiego 5

95-200 Pabianice

Poland

This medicine is authorized in the member states of the European Economic Area with the following names:

European Economic Area with the following names:

{Poland} {Ranofren}

{Spain} {Zolafren}

Last review date of this leaflet: January 2024

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