OLANZAPINE ALMUS 5 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Almus 5 mg film-coated tablets EFG

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you, do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What Olanzapine Almus 5 mg film-coated tablets are and what they are used for
2. What you need to know before you take Olanzapine Almus 5 mg film-coated tablets
3. How to take Olanzapine Almus 5 mg film-coated tablets
4. Possible side effects
5. Storage of Olanzapine Almus 5 mg film-coated tablets
6. Package contents and further information

1. What Olanzapine Almus 5 mg film-coated tablets are and what they are used for

Olanzapine belongs to a group of medicines called antipsychotics.

Olanzapine Almus is used to treat

• Schizophrenia, a disease with symptoms such as hearing, seeing, or feeling things that are not real, mistaken beliefs, unusual suspicion, and a tendency to withdraw. People suffering from this disease may also be depressed, anxious, or tense.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapine Almus 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 Olanzapine Almus 5 mg film-coated tablets

Do not take Olanzapine Almus

• If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of olanzapine (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).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Olanzapine Almus 5 mg film-coated tablets.

• Olanzapine Almus is not recommended for use in elderly patients with dementia, as it may have serious side effects.
• Medicines of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking olanzapine, tell your doctor.
• Very rarely, medicines of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness. If this happens to you, contact your doctor immediately.
• A weight gain has been observed in patients taking Olanzapine Almus. You and your doctor should check your weight regularly. If necessary, your doctor can help you plan a diet or consider referring you to a nutritionist.
• High levels of sugar and fat (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapine Almus. Your doctor should perform blood tests to check your blood sugar and fat levels before you start taking Olanzapine Almus and regularly during treatment.
• If you or a family member have a history of blood clots, consult your doctor, as medicines of this type may be associated with the formation of blood clots.

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

• Stroke or transient lack of blood flow to the brain (transient symptoms of stroke)
• 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, it would be advisable for your doctor to check your blood pressure.

Children and adolescents under 18 years

Patients under 18 years should not take olanzapine.

Use of Olanzapine Almus with other medicines

Only use other medicines at the same time as Olanzapine Almus if your doctor authorizes it. You may feel drowsy if you combine Olanzapine Almus with antidepressants or medicines for anxiety or sleep aids (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 olanzapine may need to be changed.

Taking Olanzapine Almus with alcohol

Do not drink alcohol if you have been given olanzapine, as the combination of olanzapine and alcohol may cause drowsiness.

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 during pregnancy unless your doctor recommends it.

You should not take this medicine when you are breastfeeding, as small amounts of olanzapine may pass into breast milk.

Newborns of mothers who have used Olanzapine Almus in the last trimester (last three months) of pregnancy may present with the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing problems, and difficulty feeding. If your newborn presents with any of these symptoms, contact your doctor.

Driving and using machines

There is a risk of drowsiness when you are taking olanzapine. If this happens to you, do not drive or use machinery. Consult your doctor.

Olanzapine Almus contains lactose

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

3. How to take Olanzapine Almus 5 mg film-coated tablets

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

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

You should take your olanzapine 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. Olanzapine tablets are for oral administration.

You should swallow the tablets whole with water.

If you take more Olanzapine Almus than you should

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 medicine and the amount ingested. It is recommended to take the packaging and the package leaflet of the medicine to the healthcare professional.

Patient who have taken more olanzapine 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 include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy, slowing of respiratory rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the packaging with the tablets.

If you forget to take Olanzapine Almus

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 Almus

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

If you suddenly stop taking olanzapine, you may experience symptoms such as sweating, insomnia, tremors, anxiety, nausea, or vomiting. Your doctor may suggest gradually reducing 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.

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 may affect up to 1 in 10 people), especially of the face or tongue;
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people), especially in the legs (symptoms include swelling, 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 (the frequency cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include weight gain; drowsiness; and increased prolactin levels in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from a lying or sitting position. This feeling usually disappears on its own, but if it does not, consult your doctor.

Common side effects (may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating lipids, and temporary increases in liver enzymes at the start of treatment; increased blood sugar and urine levels; increased uric acid and creatine phosphokinase levels in the blood; increased appetite; dizziness; agitation; tremors; unusual movements (dyskinesia); language disorders; constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention that causes swelling of the hands, ankles, or feet; fever; joint pain; and sexual dysfunctions such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects (may 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 legs syndrome; speech problems; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; memory loss or forgetfulness; urinary incontinence; loss of urination ability; hair loss; absence or decrease of menstrual periods; changes in the mammary gland in men and women, such as abnormal milk production or abnormal growth; and excessive salivation.

Rare side effects (may affect up to 1 in 1,000 people) include a drop in normal body temperature; 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.

Very rare side effects (may affect up to 1 in 10,000 people) include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). Initially, DRESS manifests with symptoms similar to the flu, with a rash on the face, and later with an extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cell in the blood (eosinophilia).

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: https://www.notificaram.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Olanzapine Almus 5 mg film-coated tablets

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

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

Do not store above 30°C. Store in the original packaging to protect from light and moisture.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to a pharmacy for proper disposal. By doing so, you will help protect the environment.

6. Package contents and further information

Composition of Olanzapine Almus 5 mg

The active substance is olanzapine. Each tablet contains 5 mg of active substance.

The other ingredients are: Core: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, and magnesium stearate. Coating: hydroxypropylmethylcellulose 6cP, titanium dioxide, and polyethylene glycol 400.

Appearance of Olanzapine Almus 5 mg and package contents

Olanzapine Almus 5 mg is presented in the form of film-coated tablets, round, without a score, with a yellow core and white coating.

It is presented in blisters with 28 tablets. Some pack sizes may only be marketed.

Other presentations:

Olanzapine Almus 10 mg film-coated tablets EFG, 28 tablets

Olanzapine Almus 10 mg film-coated tablets EFG, 56 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: farmacovigilancia@almusfarmaceutica.es

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.

Rua De Tapada Grande 2

Abrunheira, Sintra 2710 – 228

Portugal

Date of last revision of this package leaflet: February 2020

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/