Olanzapine Tarbis Farma 7.5 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Olanzapine Tarbis Farma 7.5 mg film-coated tablets EFG

Package leaflet contents

1. What Olanzapina Tarbis Farma is and what it is used for
2. What you need to know before taking Olanzapina Tarbis Farma
3. How to take Olanzapina Tarbis Farma
4. Possible side effects
5. Storage of Olanzapina Tarbis Farma
6. Contents of the pack and other information

1. What Olanzapina Tarbis Farma is and what it is used for

Olanzapina Tarbis Farma belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following conditions:

• Schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this disorder may also experience depression, anxiety, or tension.

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

Olanzapina Tarbis Farma 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 taking Olanzapina Tarbis Farma

Do not take Olanzapina Tarbis Farma

• if you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may present as 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).

Warnings and precautions

Talk to your doctor or pharmacist before starting Olanzapina Tarbis Farma.

• The use of Olanzapina Tarbis Farma is not recommended in elderly patients with dementia, as it may cause serious adverse effects.

• Medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking Olanzapina Tarbis Farma, inform your doctor.

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

• Weight gain has been observed in patients taking Olanzapina Tarbis Farma. 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 Olanzapina Tarbis Farma. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting treatment 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 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 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 transient ischemic attack.

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 of age must not take Olanzapina Tarbis Farma.

Use of Olanzapina Tarbis Farma with other medicines

Only use other medicines together with Olanzapina Tarbis Farma if your doctor has instructed you to do so. You may feel drowsy if Olanzapina Tarbis Farma is combined 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 medicines.

Specifically, tell your doctor if you are taking:

• Medicines for Parkinson's disease
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). Your dose of Olanzapina Tarbis Farma may need to be adjusted.

Use of Olanzapina Tarbis Farma with alcohol

You should not drink alcohol while taking Olanzapina Tarbis Farma, as it may cause drowsiness.

Pregnancy, breastfeeding, and fertility

If you are pregnant, 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 Tarbis Farma may pass into breast milk.

The following symptoms may occur in newborns whose mothers have used Olanzapina Tarbis Farma during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.

Driving and operating machinery

Olanzapine Tarbis Farma may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction capability. These effects, as well as the disease itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your physician has assessed your response to this medication.

Olanzapine Tarbis Farm contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with your doctor before taking this medicine.

3. How to take Olanzapine Tarbis Farma

Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many Olanzapine Tarbis Farma tablets to take and for how long. The daily dose of Olanzapine Tarbis Farma ranges between 5 and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapine Tarbis Farma unless instructed by your doctor.

You should take your Olanzapine Tarbis Farma tablets once daily, as directed by your doctor. Try to take the tablets at the same time every day. You may take them with or without food. Olanzapine Tarbis Farma tablets are for oral use. Swallow the tablets whole with water.

If you take more Olanzapine Tarbis Farma than you should

Patients who have taken more Olanzapine Tarbis Farma than recommended 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 possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing, aspiration, increased or decreased blood pressure, and abnormal heart rhythms.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: (91) 562 04 20, indicating the medication and amount ingested.

If you forget to take Olanzapine Tarbis Farma

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

If you stop taking Olanzapine Tarbis Farma

Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapine Tarbis Farma for as long as your doctor advises.

If you stop taking Olanzapine Tarbis Farma suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, and vomiting may occur. Your doctor may recommend that you 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 attention 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 disturbances, constipation, dry mouth, skin rash, weakness, excessive fatigue, 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 getting up from a lying or sitting position. 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, excessive salivation, absence or reduction of menstrual periods, changes in the breast gland in men and women such as abnormal production of breast milk or abnormal growth, and restless legs syndrome.

Other adverse effects whose frequency cannot be estimated from available data (not known) include allergic reactions (e.g. mouth and throat swelling, itching, skin rash), diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma, decreased normal body temperature, seizures—mostly 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 pain, and prolonged and/or painful erection. Serious allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially presents with flu-like symptoms, facial skin rash spreading to other areas, fever, swollen lymph nodes, 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.

Olanzapina Tarbis Farma may worsen symptoms in patients with Parkinson's disease.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Tarbis Farma

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

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

Olanzapine Tarbis Farma does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Return empty containers and any unused medicines to the SIGRE collection point at your pharmacy. If you are in doubt, please ask your pharmacist how to properly 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 Tarbis Farma 7.5 mg

• The active substance is olanzapine. Each film-coated tablet contains 7.5 mg of active substance.
• The other components are:

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

Tablet coating: polyvinyl alcohol, titanium dioxide E-171, talc, lecithin E-322, and xanthan gum E-415.

Appearance of the product and contents of the pack

Olanzapina Tarbis Farma 7.5 mg film-coated tablets are round, white, and marked with "7.5" on one side.

Olanzapina Tarbis Farma is available in packs of 56 tablets.

Other presentations:

Olanzapina Tarbis Farma 2.5 mg film-coated tablets EFG

Olanzapina Tarbis Farma 5 mg film-coated tablets EFG

Olanzapina Tarbis Farma 10 mg film-coated tablets EFG

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Manufacturer

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of the most recent review of this leaflet: June 2020

Other sources of information

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