OLANZAPINE DARI PHARMA 2.5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

OLANZAPINA DARI PHARMA 2.5 mg film-coated tablets EFG

Contents of the package leaflet:

1. What is OLANZAPINA DARI PHARMA and what is it used for
2. What you need to know before you take OLANZAPINA DARI PHARMA
3. How to take OLANZAPINA DARI PHARMA
4. Possible side effects
5. Storage of OLANZAPINA DARI PHARMA
6. Contents of the pack and further information

1. What is OLANZAPINA DARI PHARMA and what is it used for

OLANZAPINA DARI PHARMA belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following diseases:

• Schizophrenia, a disease whose symptoms are hearing, seeing or feeling unreal things, mistaken beliefs, unusual suspicion, and becoming withdrawn. People suffering from these diseases may also be depressed, anxious or tense.

• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

OLANZAPINA DARI PHARMA has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before you take OLANZAPINA DARI PHARMA

Do not take OLANZAPINA DARI PHARMA

• If you are allergic to olanzapine or any of the other ingredients of this medicine (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 to you, tell your doctor.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure in the eye).
• This medicine contains soybean oil. It should not be used in case of allergy to peanuts or soybeans.

Warnings and precautions

Consult your doctor or pharmacist before starting to take OLANZAPINA DARI PHARMA.

• OLANZAPINA DARI PHARMA is not recommended for use in elderly patients with dementia as it may have serious side effects.

• Medicines of this type can cause unusual movements, especially in the face or tongue. If this happens to you after taking OLANZAPINA DARI PHARMA, tell your doctor.
• In very rare cases, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness and a state of confusion or drowsiness. If this happens to you, contact your doctor immediately.
• A weight gain has been observed in patients taking OLANZAPINA DARI PHARMA. You and your doctor should check your weight regularly.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking OLANZAPINA DARI PHARMA. Your doctor should perform blood tests to control your blood sugar and fat levels before you start taking OLANZAPINA DARI PHARMA and regularly during treatment.
• If you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type have been associated with the formation of blood clots.

If you suffer from any of the following diseases, inform your doctor as soon as possible:

• Stroke or transient lack of blood flow in the brain (transient stroke symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or a lack of blood flow in the brain.

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

Children and adolescents

Patient under 18 years should not take OLANZAPINA DARI PHARMA

Use of OLANZAPINA DARI PHARMA with other medicines

Only use other medicines at the same time as OLANZAPINA DARI PHARMA if your doctor authorizes it. You may feel a certain sensation of sleepiness if you combine OLANZAPINA DARI PHARMA with antidepressants or medicines for anxiety or that help you sleep (tranquilizers).

Tell your doctor or pharmacist if you are using, have recently used or may need to use any other medicine.

In particular, 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). Your dose of OLANZAPINA DARI PHARMA may need to be changed.

Use of OLANZAPINA DARI PHARMA with alcohol

You should not drink alcohol if you have been given OLANZAPINA DARI PHARMA because it can cause sleepiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or plan to become pregnant, consult your doctor before using this medicine. You should not take this medicine when you are breastfeeding, as small amounts of OLANZAPINA DARI PHARMA may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used OLANZAPINA DARI PHARMA in the last trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleepiness, agitation, respiratory problems, and difficulty eating. If your baby has any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of sleepiness when taking OLANZAPINA DARI PHARMA. If this happens to you, do not drive vehicles or use machinery. Consult your doctor.

OLANZAPINA DARI PHARMA contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medicine.

3. How to take OLANZAPINA DARI PHARMA

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Consult your doctor or pharmacist if you have doubts.

Your doctor will indicate how many OLANZAPINA DARI PHARMA tablets you should take and for how long. The daily dose of OLANZAPINA DARI PHARMA ranges from 5 to 20 mg. Consult your doctor if you suffer from symptoms again, but do not stop taking OLANZAPINA DARI PHARMA unless your doctor tells you to.

You should take your OLANZAPINA DARI PHARMA 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 OLANZAPINA DARI PHARMA tablets are for oral administration. You should swallow the OLANZAPINA DARI PHARMA tablets whole with water.

If you take more OLANZAPINA DARI PHARMA than you should

Patient who have taken more OLANZAPINA DARI PHARMA than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and a reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness and a state of confusion or drowsiness, slowing of respiratory rate, aspiration, increased or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately if you notice any of the above symptoms. Show the doctor the package with the tablets.

If you forget to take OLANZAPINA DARI PHARMA

Take your tablets as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking OLANZAPINA DARI PHARMA

Do not stop treatment just because you feel better. It is very important that you continue taking OLANZAPINA DARI PHARMA while your doctor tells you to.

If you stop taking OLANZAPINA DARI PHARMA suddenly, symptoms such as sweating, insomnia, tremors, anxiety, or nausea and vomiting may appear. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately 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, go to the doctor immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data)

Very common side effects (may affect more than 1 in 10 people) include

weight gain, sleepiness, and increased prolactin levels in the blood.

Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells and circulating lipids, increased blood sugar and urine levels, increased appetite, dizziness, agitation, tremors, muscle stiffness or spasms (including eye movements), language disorders, constipation, dry mouth.

Skin rash, loss of strength, excessive fatigue, fluid retention that causes swelling of the hands, ankles, or feet, and sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men. In the early stages of treatment, some people experience dizziness or fainting (with slower heartbeats), especially when getting up from lying down or sitting. This sensation usually disappears on its own, but if it does not, inform your doctor.

Rare side effects (may affect up to 1 in 100 people) include slow pulse

sensitivity to sunlight, urinary incontinence, inability to urinate, hair loss, absence or decrease of menstrual periods, and changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth and excessive salivation.

Other side effects whose frequency cannot be estimated from available data (not known) include allergic reaction (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, drop in body temperature, seizures, in most cases related to a history of seizures (epilepsy), muscle spasms in the eye muscles causing circular movements of the eyes, abnormal heart rhythm, sudden unexplained death, pancreatitis, which causes severe stomach pain, fever, and discomfort, liver disease, with yellowing of the skin and the white areas of the eyes, muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

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

OLANZAPINA DARI PHARMA may worsen symptoms in patients with Parkinson's disease.

If you experience side effects, consult your doctor or pharmacist, even if it is a side effect not listed in this leaflet.

5. Storage of OLANZAPINA DARI PHARMA

Keep out of sight and reach of children.

Do not use this medicine after the expiration date that appears on the package after EXP. The expiration date is the last day of the month indicated.

OLANZAPINA DARI PHARMA does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Deposit the packages and medicines you no longer need at the SIGRE point in the pharmacy. If in doubt, ask your pharmacist how to dispose of packages and medicines you no longer need. This way, you will help protect the environment.

6. Contents of the pack and further information

Composition of OLANZAPINA DARI PHARMA 2.5 mg

• The active ingredient is olanzapine. Each film-coated tablet contains 2.5 mg of active ingredient.
• The other ingredients are:

Core of the tablet:lactose monohydrate, microcrystalline cellulose (E-460), low-substituted hydroxypropyl cellulose (E-463a), crospovidone, anhydrous colloidal silica (E-551), and magnesium stearate (E-470b).

Coating of the tablet:polyvinyl alcohol, titanium dioxide (E-171), talc (E-553b), soybean lecithin (E-322), and xanthan gum (E-415).

Appearance of the product and contents of the pack

The film-coated tablets of OLANZAPINA DARI PHARMA 2.5 mg are round, white.

OLANZAPINA DARI PHARMA is available in packages of 28 tablets.

Other presentations:

OLANZAPINA DARI PHARMA 5 mg film-coated tablets

OLANZAPINA DARI PHARMA 7.5 mg film-coated tablets

OLANZAPINA DARI PHARMA 10 mg film-coated tablets

Marketing authorization holder and manufacturer

Marketing authorization holder:

Dari Pharma, S.L.U

Gran Via Carles III, 98, 10th floor

08028 Barcelona – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970, Sant Joan Despi (Barcelona) Spain

Date of last revision of this leaflet:August 2021.

Other sources of information

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