OLANZAPINE ALMUS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Olanzapine Almus 10 mg film-coated tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this 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 only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What Olanzapine Almus 10 mg film-coated tablets are and what they are used for
2. What you need to know before you take Olanzapine Almus 10 mg film-coated tablets
3. How to take Olanzapine Almus 10 mg film-coated tablets
4. Possible side effects
5. Storage of Olanzapine Almus 10 mg film-coated tablets
6. Contents of the pack and other information

1. What Olanzapine Almus 10 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 there, mistaken beliefs, unusual suspiciousness, and a tendency to withdraw. People with this disease may also feel depressed, anxious or tense.
• Moderate to severe manic episodes, 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 10 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

Consult your doctor or pharmacist before starting to take Olanzapine Almus 10 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 can 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 fats (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 cerebral ischemia (temporary stroke symptoms)
• Parkinson's disease
• Prostate problems
• Paralytic ileus (intestinal blockage)
• 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 of age should not take olanzapine.

Using Olanzapina Almus with other medicines

Only use other medicines at the same time as Olanzapina Almus if your doctor authorizes it. You may feel drowsy if you combine Olanzapina Almus 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 olanzapine may need to be changed.

Taking Olanzapina Almus with alcohol

You should not drink alcohol if you have been given olanzapine because the combination of olanzapine and alcohol can 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 because small amounts of olanzapine can 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 eating. 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 vehicles or use machinery. Consult your doctor.

Olanzapina Almus contains lactose

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

3. How to take Olanzapina Almus 10 mg film-coated tablets

Follow exactly the administration instructions 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 Olanzapina 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 package 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/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 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 package with the tablets.

If you forget to take Olanzapina 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 Olanzapina 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 (which 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 lying down or sitting. This feeling usually goes away on its own, but if it doesn't, consult your doctor.

Common side effects (which 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 dysfunction such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects (which 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 (which 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 parts of the eyes; muscle disorder that presents as unexplained pain and prolonged and/or painful erections.

Very rare side effects (which 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 a widespread 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, skin redness, 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 effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: 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 10 mg film-coated tablets

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

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

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

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

6. Contents of the pack and other information

Composition of Olanzapine Almus 10 mg

The active substance is olanzapine. Each tablet contains 10 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 10 mg and contents of the pack

Olanzapine Almus 10 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 or 56 tablets. Some pack sizes may only be marketed.

Other presentations:

Olanzapine Almus 5 mg film-coated tablets EFG, 28 tablets

Marketing authorization holder and manufacturer

Marketing authorization holder:

Almus Pharmaceutical, 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 the last revision of this 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/