Olanzapine PensA

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

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

Olanzapine
Please read all of this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Olanzapine belongs to a group of medicines called antipsychotics.
Olanzapine is used to treat an illness with symptoms such as hearing, seeing, or sensing things that do not exist, false beliefs, unjustified suspiciousness, and social withdrawal.
People with this illness may also feel depressed, anxious, or tense.
Olanzapine is used to treat a condition characterised by symptoms such as feeling "overexcited", having excessive energy, needing much less sleep than usual, speaking very rapidly with a racing flow of thoughts, and sometimes severe irritability. It is also a mood stabiliser that prevents the recurrence of disabling extreme mood swings, both highs and lows (depression), associated with this condition.

2. WHAT YOU SHOULD KNOW BEFORE TAKING OLANZAPINE PENSA

Do not take OLANZAPINE 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 as skin rash, itching, facial swelling, swelling of the lips, or shortness of breath. If you have experienced this, inform 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 OLANZAPINE PENSA.
Be especially careful with OLANZAPINE PENSA

• If you or someone in your family has a history of blood clots, medicines like this have been associated with blood clot formation.
• Medicines of this type can cause unusual movements, especially of the face and tongue. If this occurs after you have been given olanzapine, inform your doctor.
• Very rarely, medicines of this type can cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, 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 have 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
• Intestinal blockage (paralytic ileus)
• Blood disorders
• Stroke or transient ischemic attack (temporary stroke-like symptoms)

If you have dementia, you or your caregiver should inform the doctor if you have previously had a stroke or transient ischemic attack.
As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.
Children
Olanzapine is not indicated for patients under 18 years of age.
Other medicines and OLANZAPINE PENSA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

• During treatment with olanzapine, take other medicines only after approval by your doctor. You may feel drowsy if olanzapine is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquilizers).
• Inform your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as your olanzapine dose may need to be adjusted.
• Inform your doctor if you are taking medicines for Parkinson’s disease.

OLANZAPINE PENSA and alcohol
Do not drink any alcoholic beverages during treatment with OLANZAPINE PENSA, as taking olanzapine together with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
You should not take this medicine during pregnancy unless you have discussed it with your doctor.
You should not take this medicine while breastfeeding, as small amounts of olanzapine may pass into breast milk.
The following symptoms may occur in newborns whose mothers have taken olanzapine during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby develops any of these symptoms, contact your doctor.
Driving and using machines
When taking olanzapine, you may experience drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
OLANZAPINE PENSA contains lactose
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine.

3. HOW TO TAKE OLANZAPINE PENSA

• Take this medicine exactly as your doctor has instructed you. If you have any doubts, consult your doctor or pharmacist.
• Your doctor will tell you how many olanzapine tablets you should take and for how long you should continue taking them. The recommended dose of olanzapine ranges from 5 to 20 mg per day. If your symptoms return, discuss this with your doctor, but do not stop taking olanzapine unless your doctor tells you to do so.
• You should take olanzapine tablets once daily, as directed by your doctor. Try to take the tablets at the same time each day. It does not matter whether you take them with or without food. OLANZAPINE PENSA is for oral use. Swallow the tablets whole with water.

If you take more OLANZAPINE PENSA than you should
Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, unusual movements (especially of the face or tongue), and reduced level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, lethargy or drowsiness, slowed breathing, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or hospital immediately. Show the doctor your pack of tablets.

If you forget to take OLANZAPINE PENSA
Take the missed dose as soon as you remember. Do not take a double dose on the same day. Do not take a double dose to make up for the forgotten tablet.

If you stop taking OLANZAPINE PENSA
Do not stop taking the tablets just because you start to feel better. It is important that you continue olanzapine treatment for as long as your doctor considers necessary. If you stop taking olanzapine suddenly, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.

If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.

Very common adverse reactions: may affect more than 1 in 10 people

• Weight gain.
• Drowsiness.
• Increased levels of prolactin in the blood.

Common adverse reactions: may affect up to 1 in 10 people

• Changes in levels of certain blood cells and circulating fats.
• Increased blood and urine sugar levels.
• Increased feeling of hunger.
• Dizziness.
• Restlessness.
• Tremor.
• Muscle stiffness or muscle spasms (including eye movements).
• Speech problems.
• Unusual movements (especially of the face or tongue).
• Constipation.
• Dry mouth.
• Skin rash.
• Loss of strength.
• Extreme tiredness.
• Fluid retention leading to swelling of the hands, hips, or feet.
• In the initial stages of treatment, some people may experience dizziness or fainting (with slowing of the heartbeat), especially when standing up from a lying or sitting position. These symptoms usually resolve spontaneously, but if they do not, inform your doctor.
• Sexual dysfunction, such as decreased libido in males and females or erectile dysfunction in males.

Uncommon adverse reactions: 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 blood and urine) or coma;
• Seizures, usually occurring in patients with a history of seizures (epilepsy);
• Muscle stiffness or spasms (including eye movements);
• Restless legs syndrome;
• Speech problems;
• Slowing of the heartbeat;
• Sensitivity to sunlight;
• Nosebleeds;
• Abdominal swelling;
• Memory loss or forgetfulness;
• Urinary incontinence;
• Inability to urinate;
• Hair loss;
• Absence or reduction of menstrual cycles;
• Breast changes in males and females, such as abnormal growth or abnormal milk secretion.

Other possible adverse reactions: frequency cannot be determined from available data.

• Decreased body temperature.
• Combination of fever, rapid breathing, sweating, and confusion or drowsiness.
• Changes in heart rhythm.
• Unexplained sudden death.
• Blood clots presenting as deep vein thrombosis in the leg or pulmonary embolism.
• Inflammation of the pancreas causing severe stomach pain, fever, and malaise.
• Liver disease manifesting as yellowing of the skin and whites of the eyes.
• Muscle disease presenting as tenderness and unexplained muscle pains.
• Prolonged and/or painful erection.

Very rare adverse reactions include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is initially characterized by flu-like symptoms, such as rash on the face subsequently spreading, high temperature, enlarged lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may be at risk of stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and gait disturbances. In this particular patient group, some fatal cases have been reported.

In patients with Parkinson's disease, olanzapine may worsen symptoms.

After prolonged use of medicines of this type, women may rarely experience milk secretion and absence or irregularity of menstrual cycles. If these symptoms persist, inform your doctor.

Very rarely, newborns whose mothers took olanzapine during the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or apathy.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE OLANZAPINE PENSA

Keep out of the sight and reach of children.
Do not use olanzapine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of that month.
Store in the original packaging.
Do not dispose of any medicine via wastewater 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 PACKAGE AND OTHER INFORMATION

What OLANZAPINA PENSA contains

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

Description of the appearance of OLANZAPINA PENSA and contents of the pack
Olanzapina Pensa is available as tablets.
Description: OLANZAPINA PENSA 2.5 mg, 5 mg, 7.5 mg, 10 mg, and 15 mg tablets are yellow, cylindrical, and biconvex.
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

This patient information leaflet was last approved on