Introduction

Leaflet: information for the user

Olanzapine cinfa 2.5 mg hard capsules EFG

Read this leaflet carefully before you start taking 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 only, and you must 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.

1. What is Olanzapina cinfa and what is it used for

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

Schizophrenia, a disease whose symptoms are hearing, seeing or feeling unreal things, false beliefs, unusual suspicion, and becoming withdrawn. People who suffer from these diseases may also be depressed, anxious or tense.
Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

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

2. What you need to know before starting to take Olanzapina cinfa

Do not take Olanzapina cinfa

If you are allergic to olanzapina or any of the other components of this medication (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 this medication.

Olanzapina is not recommended for use in elderly patients with dementia as it may have serious adverse effects.
Medications of this type may cause unusual movements, especially in the face or tongue. If this happens after taking olanzapina, tell your doctor.
In very rare cases, medications of this type produce a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness. If this occurs, contact your doctor immediately.
Weight gain has been observed in patients taking olanzapina. You and your doctor should check your weight regularly. If necessary, your doctor may 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 olanzapina. Your doctor should perform blood tests to monitor your blood sugar and fat levels before starting olanzapina and regularly during treatment.
If you or a family member 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 lack of blood flow to the brain)
Parkinson's disease
Prostate problems
Intestinal blockage (paralytic ileus)
Liver or kidney disease
Blood disorders
Heart disease
Diabetes
Seizures
If you think you may have electrolyte loss due to prolonged diarrhea and vomiting or the use of diuretic medications (water pills)

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

Patients under 18 years old should not take olanzapina.

Taking Olanzapina cinfa with other medications

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

Only use other medications at the same time as olanzapina if your doctor authorizes it. You may feel drowsy if you combine olanzapina with antidepressants or medications for anxiety or sleep (tranquilizers).

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 adjust your olanzapina dose.

Taking Olanzapina cinfa with alcohol

You should not drink alcohol if you have been given olanzapina as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

The following symptoms may occur in newborns of mothers who used olanzapina in the last trimester (last three months of pregnancy): tremors, muscle stiffness, and/or weakness, drowsiness, agitation, respiratory problems, and difficulty feeding. If your baby has 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 cinfa contains lactose

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

3. How to Take Olanzapina cinfa

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Your doctor will tell you how many capsules of olanzapina you should take and for how long. The daily dose of olanzapina ranges from 5 mg 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 capsules once a day, following your doctor's instructions. Try to take the capsules at the same time every day. You can take them with or without food. The hard olanzapina capsules are for oral administration. You should swallow the olanzapina capsules whole with water.

If you take more Olanzapina cinfa than you should

Patients who have taken more olanzapina than they should have experienced the following symptoms: rapid heart rate, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and reduced 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 if you notice any of the mentioned symptoms. Show the doctor the packaging with the capsules.

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.

If you forget to take Olanzapina cinfa

Take your capsules as soon as you remember.

Do not take a double dose to make up for the missed dose.

If you interrupt treatment with Olanzapina cinfa

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 stop taking olanzapina suddenly, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea, and vomiting. Your doctor may suggest that you gradually reduce the dose before stopping treatment.

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

4. Possible Adverse Effects

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, seek immediate medical attention.
a combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency unknown (cannot be estimated from available data)).

Frequent side effects (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 sensation usually disappears spontaneously, but if it does not, consult your doctor.

Common side effects (can affect up to 1 in 10 people) include changes in the 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); 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 (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 leg syndrome; speech problems; stuttering; slow pulse; sensitivity to sunlight; nasal bleeding; abdominal distension;excessive salivation;memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; hair loss; absence or decrease of menstrual periods; and changes in the breast gland in men and women such as abnormal milk production or abnormal growth.

Rare side effects (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 include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS by its English acronym). 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 a possible side effect that does not appear in this prospectus. You can also report them directly throughthe Spanish System for the Pharmacovigilance of Medicines for Human Use https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Conservation of Olanzapina cinfa

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

Store below 30°C.

Store the blister pack in the outer packaging to protect it from light.

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

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. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

6. Contents of the packaging and additional information

Composition of Olanzapine cinfa

The active ingredient is olanzapine. Each capsule contains 2.5 mg of active ingredient.
The other components are:

Capule content:microcrystalline cellulose, lactose monohydrate, hydroxypropyl methylcellulose, magnesium stearate.
Capule coating:gelatin, titanium dioxide (E-171), iron oxide black (E-172).
Printing ink:shellac (E-904), propylene glycol (E-1520), strong ammonia solution (E-527), iron oxide black (E-172), potassium hydroxide (E-525).

Appearance of the product and contents of the packaging

Olanzapine cinfa 2.5 mg are hard capsules with a grey cap, with a line and a white body available in aluminium/aluminium blisters with 28 capsules.

Holder of the marketing authorization and responsible manufacturer

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: June 2020

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/85119/P_85119.html

QR code to:https://cima.aemps.es/cima/dochtml/p/85119/P_85119.html