OLANZAPINA 2.5 MG Coated tablet

Зміст інструкції

1. Olanzapina Pensa 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg tablets
   1. WHAT OLANZAPINA PENSA IS AND WHAT IT IS USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLANZAPINA PENSA
   3. HOW TO TAKE OLANZAPINA PENSA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE OLANZAPINA PENSA
   6. CONTENTS OF THE PACK AND OTHER INFORMATION

Olanzapina Pensa 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg tablets

Olanzapina

Read this leaflet carefully before you start taking this medicine as it contains important information for you.

• Keep this leaflet. 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. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What OLANZAPINA PENSA is and what it is used for
• 2. What you need to know before you take OLANZAPINA PENSA
• 3. How to take OLANZAPINA PENSA
• 4. Possible side effects
• 5. How to store OLANZAPINA PENSA
• 6. Contents of the pack and other information

1. WHAT OLANZAPINA PENSA IS AND WHAT IT IS USED FOR

Olanzapina belongs to a group of medicines called antipsychotics.
Olanzapina is used to treat an illness with symptoms such as hearing, seeing or feeling things that do not
exist, false beliefs, unjustified suspicion and social withdrawal. People with
this illness may also feel depressed, anxious or tense.
Olanzapina is used to treat a condition characterized by symptoms such as feeling "revved up",
having an excessive charge, needing much less sleep than usual, talking very
quickly with a rapid succession of ideas and sometimes severe irritability. It is also a
mood stabilizer that prevents the recurrence of debilitating extreme mood swings towards
up and down (depression) that are associated with this condition.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE OLANZAPINA PENSA

Do not take OLANZAPINA PENSA:

• if you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest with skin rash, itching, swelling of the face, swelling of the lips, shortness of breath. If this has happened to you, report it to your doctor.
• if you have previously been diagnosed with an eye problem such as certain types of glaucoma (increased pressure inside the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking OLANZAPINA PENSA.

Pay particular attention with OLANZAPINA PENSA

• If you or someone in your family has a history of blood clots, medicines like these have been associated with the formation of blood clots.
• Medicines of this type can cause unusual movements, especially of the face and tongue. If this happens after you have been given olanzapine, report it to your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness. If this happens, consult your doctor immediately.
• The use of olanzapine in elderly patients with dementia is not recommended as it may cause serious side effects.

If you suffer from any of the following conditions, inform your doctor as soon as possible:

• Diabetes
• Heart disease
• Liver or kidney disease
• Parkinson's disease
• Epilepsy
• Prostate problems
• Bowel obstruction (paralytic ileus)
• Blood disorders
• Stroke or transient ischemic attack (transient stroke symptoms)

If you have dementia, you or your caregiver must inform the doctor if you have
previously had a stroke or transient ischemic attack.
As a routine precaution, if you are over 65 years of age, have your
blood pressure checked periodically by your doctor.

Children
Olanzapine is not indicated in patients under the age of 18 years.

Other medicines and OLANZAPINA PENSA
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.

• During treatment with olanzapine, take other medicines only after your doctor's authorization. You may feel sleepy if olanzapine is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquilizers).
• Report to your doctor if you are taking fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to adjust your dose of olanzapine.
• Inform your doctor if you are taking medicines for Parkinson's disease.

OLANZAPINA PENSA with alcohol
Do not drink any type of alcohol during treatment with OLANZAPINA PENSA as
the simultaneous intake of olanzapine and alcohol can cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant or are breastfeeding with breast
milk, ask your doctor or pharmacist for advice before taking this medicine.
You should not take this medicine when you are pregnant unless you have discussed it with your
doctor.
You should not take this medicine during breastfeeding, as small amounts of
olanzapine can pass into breast milk.
The following symptoms may occur in newborns of mothers who have used olanzapine in the last
trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness,
agitation, breathing problems and difficulty feeding. If your baby develops any of these
symptoms, contact your doctor.

Driving and operating machinery
When you take olanzapine there is a risk that you may experience drowsiness. If this happens
do not drive or operate tools or machinery. Inform your doctor.

OLANZAPINA PENSA contains lactose
This medicine contains lactose. If your doctor has told you that you have an intolerance to some
sugars, contact him before taking this medicine.

3. HOW TO TAKE OLANZAPINA PENSA

• Take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor or pharmacist.
• Your doctor will tell you how many olanzapina tablets you need to take and for how long you need to continue taking them. The recommended dose of olanzapina varies from 5 to 20 mg per day. If your symptoms return, talk to your doctor, but do not stop taking olanzapina unless your doctor tells you to.
• You must take olanzapina tablets once a day, following your doctor's instructions. Try to take the tablets every day at the same time. It does not matter if you take them on a full or empty stomach. OLANZAPINA PENSA is for oral use. Swallow the olanzapina tablets whole, with water.

If you take more OLANZAPINA PENSA than you should
Patients who have taken more olanzapina than they should have, have experienced the following symptoms:
increased heart rate, agitation/aggression, speech problems, unusual movements (especially of the face or 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, stupor or drowsiness, slowed breathing rate, reduced cough reflex, high or low blood pressure, changes in heart rhythm. Contact your doctor or hospital immediately. Show your doctor your pack of tablets.

If you forget to take OLANZAPINA PENSA
Take the tablets as soon as you remember. Do not take a double dose in one day.
Do not take a double dose to make up for a missed tablet.

If you stop taking OLANZAPINA PENSA
Do not stop taking the tablets just because you start to feel better. It is important that you continue the treatment with olanzapina for as long as your doctor considers necessary. If you suddenly stop taking olanzapina, symptoms such as sweating, inability to sleep, tremor, anxiety or nausea and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment.
If you have any further questions about this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Very common side effects: may affect more than 1 in 10 people

• Weight gain.
• Drowsiness.
• Increases in prolactin levels in the blood.

Common side effects: may affect up to 1 in 10 people

• Changes in the levels of some blood cells and circulating fats.
• Increases in blood sugar and urine sugar levels.
• Feeling of increased hunger.
• Dizziness.
• Restlessness.
• Tremor.
• Muscle stiffness or muscle spasms (including eye movements).
• Problems with speech.
• Unusual movements (especially of the face or tongue).
• Constipation.
• Dry mouth.
• Skin rash.
• Loss of strength.
• Extreme fatigue.
• Fluid retention leading to swelling of the hands, hips or feet.
• In the early stages of treatment, some people may experience a feeling of dizziness or fainting (with a slowing of the heartbeat), especially when getting up from a lying or sitting position. These symptoms usually resolve spontaneously, but if this does not happen, inform your doctor.
• Sexual dysfunction, such as decreased libido in men and women or erectile dysfunction in men.

Uncommon side effects: may affect up to 1 in 100 people

• hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash);
• diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in the blood and urine) or coma;
• seizures, usually associated with a history of seizures (epilepsy);
• muscle stiffness or spasms (including eye movements);
• restless legs syndrome;
• problems with speech;
• slowing of the heartbeat;
• sensitivity to sunlight;
• nosebleeds;
• abdominal bloating;
• loss of memory or forgetfulness;
• urinary incontinence;
• inability to urinate;
• hair loss;
• absence or reduction of menstrual cycles;
• changes in the breasts in men and women, such as abnormal growth or abnormal milk secretion. Other possible side effects: the frequency cannot be defined based on available data.
• Decrease in body temperature.
• Association of fever, rapid breathing, sweating and confusion or drowsiness.
• Changes in heart rhythm.
• Sudden unexplained death.
• Blood clots that present as deep vein thrombosis in the leg or a blood clot in the lung.
• Inflammation of the pancreas causing severe stomach pain, fever and malaise.
• Liver disease that manifests as yellowing of the skin and whites of the eyes.
• Muscle disease that presents as tenderness and unexplained pain.
• Prolonged and/or painful erection.

Very rare side effects include severe allergic reactions such as drug reaction with
eosinophilia and systemic symptoms (DRESS). DRESS is initially characterized by flu-like symptoms,
such as a rash on the face and then spreading, high temperature, enlarged lymph nodes, high levels of
liver enzymes in blood tests and an increase in a type of white blood cells (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may be subject to stroke,
pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in
temperature, redness of the skin, gait disturbances. Some fatal cases have been reported in this particular
patient group.
In patients with Parkinson's disease olanzapine may worsen symptoms.
After prolonged use with medicines of this type, rarely women may experience
milk secretion and disappearance or irregularity of the menstrual cycle. If these symptoms persist, inform
your doctor. Very rarely, babies born to mothers who had taken olanzapine during
the last stage of pregnancy (3rd trimester) may have tremors, be sleepy or apathetic.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more
information on the safety of this medicine.

5. HOW TO STORE OLANZAPINA PENSA

Keep out of the sight and reach of children.
Do not take olanzapina after the expiry date which is stated on the packaging after SCAD. The expiry
date refers to the last day of that month.
Store in the original packaging.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What OLANZAPINA PENSA contains

• The active ingredient is olanzapine. Each tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg of olanzapine.
• The other ingredients are: microcrystalline cellulose, anhydrous lactose, crospovidone, magnesium stearate

Description of the appearance of OLANZAPINA PENSA and contents of the pack
Olanzapina Pensa is available in tablets.
Description: the OLANZAPINA PENSA 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg tablets are
yellow, cylindrical and biconvex.
The OLANZAPINA PENSA 20 mg tablets are yellow, oval and biconvex.
Olanzapina Pensa tablets are available in packs of 28 and 56 tablets.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:
Pensa Pharma S.p.A.
Via Ippolito Rosellini, 12
20124 Milano
Italy

Manufacturer:
Laboratorios Cinfa, S.A.
C/ Olaz-Chipi, 10 – Polígono Industrial Areta
31620 Huarte-Pamplona (Navarra)
Spain