Olanzapine Dari Pharma 2.5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

OLANZAPINE DARI PHARMA 2.5 mg film-coated tablets EFG

Package leaflet contents:

1. What OLANZAPINA DARI PHARMA is and what it is used for
2. What you need to know before taking 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 additional information

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

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

• Schizophrenia, a disorder whose symptoms include hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also feel 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 starting to take OLANZAPINE DARI PHARMA

Do not take OLANZAPINE DARI PHARMA

• If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may appear 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 soya oil. It must not be used if you are allergic to peanuts or soya.

Warnings and precautions

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

• Use of OLANZAPINE DARI PHARMA is not recommended in elderly patients with dementia, as it may cause serious adverse effects.

• Medications of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking OLANZAPINE DARI PHARMA, inform your doctor.

• Very rarely, medications of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If you experience these symptoms, contact your doctor immediately.

• Weight gain has been observed in patients taking OLANZAPINE DARI PHARMA. You and your doctor should monitor your weight regularly.

• Elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking OLANZAPINE DARI PHARMA. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting treatment and at regular intervals during treatment.

• If you or someone in your family 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 stroke-like symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

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, your doctor should monitor your blood pressure.

Children and adolescents

OLANZAPINE DARI PHARMA should not be used in patients under 18 years of age.

Use of OLANZAPINA DARI PHARMA with other medicines

Only use other medicines together with OLANZAPINA DARI PHARMA if your doctor has authorized it. You may feel drowsy if you combine OLANZAPINA DARI PHARMA with antidepressants or medicines for anxiety or sleep (tranquilizers).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicine.

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). Your dose of OLANZAPINA DARI PHARMA may need to be adjusted.

Use of OLANZAPINA DARI PHARMA with alcohol

You should not drink alcohol while taking OLANZAPINA DARI PHARMA, as it may cause drowsiness.

Pregnancy and breastfeeding

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

The following symptoms may occur in newborns of mothers who have taken OLANZAPINA DARI PHARMA during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and difficulty feeding. If your baby shows any of these symptoms, contact your doctor.

Driving and operating machinery

There is a risk of experiencing somnolence when taking OLANZAPINE DARI PHARMA. If this occurs, do not drive vehicles or operate machinery. Consult your doctor.

OLANZAPINE DARI PHARMA contains lactose

This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take OLANZAPINE DARI PHARMA

Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again. Consult your doctor or pharmacist if you have any questions.

Your doctor will tell you how many OLANZAPINE DARI PHARMA tablets to take and for how long. The daily dose of OLANZAPINE DARI PHARMA ranges from 5 to 20 mg. Contact your doctor if your symptoms return, but do not stop taking OLANZAPINE DARI PHARMA unless your doctor tells you to.

You should take your OLANZAPINE DARI PHARMA tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. You may take them with or without food. OLANZAPINE DARI PHARMA tablets are for oral administration. Swallow the tablets whole with water.

If you take more OLANZAPINE DARI PHARMA than you should

Patients who have taken more OLANZAPINE DARI PHARMA than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and 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 breathing rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital if you experience any of the symptoms listed above. Show the doctor the package and tablets.

If you forget to take OLANZAPINE 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 OLANZAPINE DARI PHARMA

Do not stop treatment just because you feel better. It is very important to continue taking OLANZAPINE DARI PHARMA for as long as your doctor tells you to.

If you stop taking OLANZAPINE DARI PHARMA suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment.

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

4. Possible adverse effects

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

Contact your doctor immediately if you have:

• unusual movements (a common adverse effect which may affect up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (an uncommon adverse effect which may affect up to 1 in 100 people), particularly in the legs (symptoms include sweating, pain and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately.
• a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness (frequency cannot be estimated from available data).

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

weight gain, drowsiness, and increased levels of prolactin in the blood.

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

Skin rash, loss of strength, excessive tiredness, fluid retention causing swelling of the hands, ankles or feet, and sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men. In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when standing up from lying or sitting positions. This sensation usually resolves spontaneously, but if it does not, inform your doctor.

Uncommon adverse effects (may affect up to 1 in 100 people) include slow pulse,

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

Other adverse effects where frequency cannot be estimated from available data (not known) include allergic reactions (e.g. swelling of the mouth and throat, itching, skin rash), diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma, decreased body temperature, seizures—most cases are related to a history of seizures (epilepsy)—spasms of the eye muscles causing circular eye movements, abnormal heart rhythm, sudden unexplained death, inflammation of the pancreas causing severe stomach pain, fever and malaise, liver disease with yellowing of the skin and whites of the eyes, muscle disorder presenting as unexplained muscle pains, and prolonged and/or painful erection.

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 difficulty walking. 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

5. Storage of OLANZAPINE DARI PHARMA

Keep out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

OLANZAPINE DARI PHARMA does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Unused containers and medicines should be returned to the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of OLANZAPINA DARI PHARMA 2.5 mg

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

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

Tablet coating: polyvinyl alcohol, titanium dioxide (E-171), talc (E-553b), soya lecithin (E-322) and xanthan gum (E-415).

Appearance of the product and contents of the pack

OLANZAPINA DARI PHARMA 2.5 mg film-coated tablets are round and white.

OLANZAPINA DARI PHARMA is available in packs 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 Manufacturing Responsible Party

Marketing Authorization Holder:

Dari Pharma, S.L.U.

Gran Via Carles III, 98, 10th floor

08028 Barcelona – Spain

Manufacturing Responsible Party:

Neuraxpharm Pharmaceuticals, S.L.

Avda. de Barcelona, 69

08970, Sant Joan Despi (Barcelona), Spain

Date of the most recent review of this leaflet: August 2021.

Other sources of information

Detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.