Leaflet: information for the user

Olanzapina Almus 10 mg film-coated tablets

Read this leaflet carefully before you start to take this medicine, because it contains important information for you.

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

Olanzapina belongs to a group of medicines called antipsychotics.

Olanzapina Almus is used to treat

-Schizophrenia, a condition with symptoms such as hearing, seeing or feeling things that are not real, false beliefs, unusual suspicion, and a tendency to withdraw. People who suffer from this condition may also be depressed, anxious or tense.

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

Olanzapina Almus has shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapina.

Do not take Olanzapina Almus

• If you are allergic (hypersensitive) to olanzapina or to any of the other components of olanzapina (listed in section 6). An allergic reaction may manifest as a rash, itching, swelling of the face or lips, or difficulty breathing. If this happens, 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 Olanzapina Almus 10 mg coated tablets.

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

If you have any of the following conditions, tell your doctor as soon as possible:

• Cerebral infarction or transient cerebral ischemia (temporary symptoms of cerebral infarction)
• 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, 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 olanzapina.

Use of 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 to help sleep (tranquilizers).

Inform your doctor or pharmacist if you are using, have used recently, or may need to use 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). You may need to change your olanzapina dose.

Taking Olanzapina Almus with alcohol

You should not drink alcohol if you have been given olanzapina because the combination of olanzapina and alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medicine. Do not take this medicine during pregnancy unless your doctor recommends it.

You should not take this medicine while breastfeeding as small amounts of olanzapina may pass into breast milk.

Newborn babies of mothers who have used Olanzapina Almus in the last trimester (last three months) of pregnancy may experience the following symptoms: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn baby experiences any of these symptoms, contact your doctor.

Driving and operating machinery

There is a risk of drowsiness when taking olanzapina. If this happens, do not drive vehicles or operate machinery. Consult your doctor.

Olanzapina Almus contains lactose

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

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

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

You should take your olanzapina 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. Olanzapina 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Patients who have taken more olanzapina than they should have experienced the following symptoms: rapid heartbeats, 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 rigidity, drowsiness or lethargy, slowed respiratory frequency, aspiration, increased or decreased blood pressure, 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 Olanzapina Almus

Take your tablet as soon as you remember. Do not take a double dose to compensate for the missed dose.

If you interrupt treatment with Olanzapina Almus

Do not stop treatment simply because you feel better. It is very important that you continue taking olanzapina as long as your doctor tells you to.

If you suddenly stop taking olanzapina, you may experience symptoms such as sweating, inability to sleep, 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 medication, ask your doctor or pharmacist.

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

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

Immediately contact your doctor 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 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, see your doctor immediately.

• Combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data).

Frequent side effects (which can affect more than 1 in 10 people) include weight gain; drowsiness; and increased levels of prolactin 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 disappears spontaneously, but if it does not, consult your doctor.

Common side effects (which can affect up to 1 in 10 people) include changes in levels of some blood cells, circulating lipids, and at the beginning of treatment temporary increases in liver enzymes; increased levels of blood sugar and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; agitation; tremor; strange movements (dyskinesia); language alterations; constipation; dry mouth; skin rash; loss of strength; excessive fatigue; fluid retention causing inflammation 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.

Rare side effects (which can 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 the 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; nasal bleeding; abdominal distension; memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; hair loss; absence or decrease of menstrual periods; changes in the breast gland in men and women such as abnormal milk production or abnormal growth; and excessive salivation.

Rare side effects (which can affect up to 1 in 1,000 people) include a decrease in normal body temperature; abnormal heart rhythm; sudden death without apparent explanation; pancreatitis, which causes severe stomach pain, fever, and discomfort; liver disease, with yellowing of the skin and white parts of the eye; muscle disorder that presents as unexplained pain and prolonged and/or painful erection.

Very rare side effects (which can affect up to 1 in 10,000 people) include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS for its acronym in English). Initially, DRESS manifests with symptoms similar to the flu with a rash on the face and later, with extensive rash, fever, swollen lymph nodes, elevated liver enzymes observed 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 walking difficulties. 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 type of side effect, consult your doctor or pharmacist, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use: https://www.notificaram.esBy reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy.Ask your pharmacist if you are unsure how to dispose of packaging and medications you no longer need. This will help protect the environment.

Composition of Olanzapina Almus 10 mg

The active ingredient is olanzapine. Each tablet contains 10 mg of active ingredient.

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

Appearance of Olanzapina Almus 10 mg and content of the container

Olanzapina Almus 10 mg is presented in the form of coated tablets with a film coating, round, without a score, with a yellow core and a white coating.

It is presented in a blister pack with 28 or 56 tablets. Some packaging sizes may only be marketed.

Other presentations:

Olanzapina Almus 5 mg coated tablets, EFG, 28 tablets

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

Almus Farmacéutica, S.A.U.

Marie Curie, 54

08840 Viladecans (Barcelona), Spain

Phone: 93 739 71 80

Email: [email protected]

Responsible manufacturer:

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande, nº 2

Abrunheira. 2710 – 089 Sintra (Portugal).

Last review date of this leaflet: February 2020

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/