Package Insert: Information for the User

Zolafren 5 mg Hard Capsules EFG

olanzapine

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

• Keep this package insert, as you may need to read it again.

If you have any questions, consult your doctor or pharmacist.

• This medicine has been prescribed for you only 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

6. Contents of the pack and additional information

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

• Schizophrenia, a disease characterized by symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also experience depression, anxiety, or tension.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Zolafren 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:

• 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.

• 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 drowsiness or somnolence. 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 refer you to a nutritionist.

• Elevated 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:

• Cerebral infarction or transient cerebral ischemia (temporary symptoms of cerebral infarction).
• 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 electrolyte loss 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 cerebral infarction or cerebral ischemia.

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

Children and adolescents

Patients under 18 years old should not take Zolafren.

Other medications and Zolafren

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 are using, 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 dose.

Use of Zolafren with alcohol

You should not drink alcohol if you have been given Zolafren 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 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 eating. If your baby has any of these symptoms, contact your doctor.

Driving and operating machinery

There is a risk of drowsiness when taking Zolafren. If this happens, do not drive vehicles or operate machinery. Consult your doctor.

Zolafren contains lactose

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

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

You should take your Zolafren capsules once a day, following your doctor's instructions. Try to take the capsules at the same time every day. You can take them with or without food. The hard Zolafren capsules are for oral administration. You should swallow the capsules whole with water.

If you take moreZolafrenthan you should

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 capsules.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken.

If you forget to takeZolafren

Take your capsule as soon as you remember. Do not take a double dose to make up for the missed dose.

If you interrupt treatment withZolafren

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, 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 may 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).

Frequent side effects (which can affect more than 1 in 10 people) include weight gain; drowsiness; and increased blood prolactin levels. 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 (which can affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and at the beginning of treatment, temporary increases in liver enzymes; increased blood sugar and urine levels; increased blood uric acid and creatine phosphokinase levels; increased 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 (which 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 blood and urine) or coma; seizures, in most cases related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless leg syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nasal bleeding; 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 (which 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 that presents as unexplained pain and prolonged and/or painful erection.

Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS by its English acronym). Initially, DRESS manifests with symptoms similar to the flu with a rash on the face and later, with extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed 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 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 the 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.

This medication does not require any special storage temperature.

Zolafren should be stored in the original packaging to protect it from light and humidity.

Medications should not be thrown down the drain or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE drop-off point at the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

Composition of Zolafren

- The active ingredient is olanzapine. Each capsule contains 5 mg of the active substance.

- The other components are: microcrystalline cellulose (type 112), lactose monohydrate, magnesium stearate, gelatin, and titanium dioxide (E171).

Appearance of the product and content of the container

Zolafren 5 mg are hard gelatin capsules of size 3, containing 5 mg of olanzapine, with a white body and cap.

They are presented in PA-Aluminio-PVC/Aluminio blisters in containers of 28 or 56 capsules.

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 Aravaca – Madrid, Spain

Responsible for manufacturing

Adamed Pharma S.A.

Ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice, Poland

This medicine is authorized in the member states of the European Economic Area

with the following names

Last review date of this leaflet: October 2023

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