OLANZAPINE PENSAPHARMA

Package leaflet: Information for the user

Olanzapina Pensa Pharma 5 mg orodispersible tablets, 10 mg orodispersible tablets

Equivalent medicine
Please 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 questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Olanzapina Pensa Pharma is and what it is used for

Olanzapina Pensa Pharma contains the active substance olanzapine. Olanzapina Pensa Pharma
belongs to a group of medicines called antipsychotics and is used to treat the following
conditions:

• schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, false beliefs, unjustified suspicion, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
• moderate to severe manic episode, a condition characterized by symptoms of excitement or euphoria.

Olanzapina Pensa Pharma has been shown to prevent the recurrence of these symptoms in patients with
bipolar disorder whose manic episode has responded to treatment with olanzapine.

2. What you should know before taking Olanzapina Pensa Pharma

Do not take Olanzapina Pensa Pharma

• If you are allergic to olanzapine or to any of the excipients of this medicine (listed in section 6). An allergic reaction may present as skin rash, itching, facial swelling, lip swelling, or shortness of breath. If you have experienced any of these, 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 Olanzapina Pensa Pharma.

• The use of Olanzapina Pensa Pharma in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type may cause unusual movements, especially of the face and tongue. If this occurs after you have started taking Olanzapina Pensa Pharma, inform your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, consult your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Pensa Pharma. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or starting a diet program.
• High blood levels of sugars and fats (triglycerides and cholesterol) have been observed in patients taking Olanzapina Pensa Pharma. Your doctor should request blood tests to monitor sugar levels and certain blood fat levels before you start taking Olanzapina Pensa Pharma and regularly during treatment.
• Inform your doctor if you or someone in your family has a history of blood clots, as medicines like this have been associated with blood clot formation.

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

• Stroke or transient ischemic attack (temporary stroke-like symptoms)
• 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 salt depletion as a result of prolonged severe diarrhea and vomiting, or due to the use of diuretics

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 and adolescents
Olanzapina Pensa Pharma is not indicated for patients under 18 years of age.
Other medicines and Olanzapina Pensa Pharma
During treatment with Olanzapina Pensa Pharma, take other medicines only after obtaining approval from your doctor. You may feel drowsy if Olanzapina Pensa Pharma is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquilizers).
Inform your doctor if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking:

• Medicines for Parkinson's disease
• Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as your dose of Olanzapina Pensa Pharma may need to be adjusted.

Olanzapina Pensa Pharma and alcohol
Do not drink any alcoholic beverages during treatment with Olanzapina Pensa Pharma, as taking Olanzapina Pensa Pharma together with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, consult your doctor before taking this medicine. You must not take this medicine while breastfeeding, as small amounts of Olanzapina Pensa Pharma may pass into breast milk.
The following symptoms have been observed in newborns whose mothers took Olanzapina Pensa Pharma during the third trimester (the last three months of pregnancy): tremor, 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 Olanzapina Pensa Pharma, there is a risk of drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
Olanzapina Pensa Pharma contains lactose
Olanzapina Pensa Pharma contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Olanzapina Pensa Pharma

Always take this medicine exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many Olanzapina Pensa Pharma tablets to take and for how long you should continue taking them. The recommended dose of Olanzapina Pensa Pharma ranges from 5 to 20 mg per day. If your symptoms return, discuss this with your doctor, but do not stop taking Olanzapina Pensa Pharma unless your doctor tells you to do so.
You should take the Olanzapina Pensa Pharma 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. Olanzapina Pensa Pharma orodispersible tablets are for oral use.

1&2: Hold the blister at the edges.
3: Gently push the tablet to avoid breaking it.
4: Place the tablet in your mouth. It may be allowed to dissolve directly in the mouth so that it can be easily swallowed.
Alternatively, you may place the tablet in a glass or cup filled with water, orange juice, apple juice, milk, or coffee, and stir. With some beverages, the mixture may change colour and become somewhat cloudy. Drink immediately.

If you take more Olanzapina Pensa Pharma than you should
Patients who have taken more Olanzapina Pensa Pharma than recommended 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 stiffness, drowsiness or lethargy, slowed breathing, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or hospital immediately if any of these symptoms occur. Show your doctor the medicine package.

If you forget to take Olanzapina Pensa Pharma
Take the missed dose as soon as you remember. Do not take a double dose to make up for the forgotten tablet.

If you stop taking Olanzapina Pensa Pharma
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with Olanzapina Pensa Pharma for as long as your doctor considers necessary.
If you suddenly stop taking Olanzapina Pensa Pharma, symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Immediately inform your doctor if you experience:

• unusual movements (a common side effect which may affect up to 1 in 10 patients), especially of the face or tongue;
• blood clots in the veins (an uncommon side effect which may affect up to 1 in 100 patients), particularly in the lower limbs (symptoms include swelling, pain and redness of the leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, consult a doctor immediately;
• a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include
weight gain; drowsiness; increased levels of prolactin in the blood. In the initial stages of
treatment, some people may experience dizziness or fainting (with slowing of the heart rate), especially when standing up from a lying or sitting position. These effects usually resolve spontaneously, but if they do not, inform your doctor.
Common side effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating fats, and temporary increases in liver enzymes during the initial stages of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; extreme tiredness; fluid retention leading to swelling of the hands, ankles or feet; fever; joint pain; and sexual dysfunction, such as decreased libido in males and females or erectile dysfunction in males.
Uncommon side effects (may affect up to 1 in 100 people) include
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 heart rate; sensitivity to sunlight; nosebleeds; abdominal swelling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and breast changes in males and females, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 people) include
decreased body temperature; changes in heart rhythm; unexplained sudden death;
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 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, facial rash followed by more widespread rash, high temperature, swollen lymph nodes, elevated liver enzymes 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 be at risk of stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, increased body temperature, skin redness, and walking disturbances. In this particular patient group, some fatal cases have been reported.
In patients with Parkinson's disease, Olanzapina Pensa Pharma may worsen symptoms.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You may also report side effects directly via the national reporting system at: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olanzapina Pensa Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack and blister.
after EXP. The expiry date refers to the last day of that month.
Store this medicine in its original packaging to protect it from light and moisture.
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 Pharma contains

• The active substance is olanzapine. Each orodispersible tablet of Olanzapina Pensa Pharma contains 5 mg or 10 mg of active substance.
• The excipients are: crospovidone (type A), monohydrate lactose, colloidal silicon dioxide (anhydrous), hydroxypropylcellulose, peppermint flavour (composed of: peppermint oil, terpene-free peppermint oil, eucalyptol, menthone, isomenthone, methylene acetate, menthol), talc, magnesium stearate.

Description of the appearance of Olanzapina Pensa Pharma and the contents of the package
Olanzapina Pensa Pharma 5 mg and 10 mg are yellow orodispersible tablets.
(Orodispersible tablet is a technical term indicating a tablet that dissolves directly in the mouth, allowing it to be swallowed easily.)
Olanzapina Pensa Pharma 5 mg and 10 mg are available in cartons containing:
5 mg: 28 tablets
10 mg: 28 tablets
It is possible that not all pack sizes are marketed.

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

Manufacturer
Pharmathen SA
Dervenakion 6
15.351, Pallini, Attica
Greece

This medicinal product is authorised in the European Economic Area Member States under the following names:
Denmark Olanzapin Pensa
Spain Olanzapina Pensa EFG
Italy Olanzapina Pensa Pharma

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