Olanzapine Sun

Package Leaflet: Information for the User

Olanzapina SUN 2.5 mg tablets, 5 mg tablets, 7.5 mg tablets, 10 mg tablets, 15 mg tablets, 20 mg tablets, 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets

Olanzapine
Generic 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 others, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• schizophrenia, a disorder with symptoms such as hearing, seeing, or experiencing things that do not exist, false beliefs, unjustified suspiciousness, 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 SUN 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 Olanzapine SUN

Do not take Olanzapine SUN

• if you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may present 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 SUN.

• The use of Olanzapine SUN in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type may cause unusual movements, particularly of the face and tongue. If this occurs after you have been given Olanzapine SUN, inform your doctor.
• Very rarely, medicines of this type cause a combination of symptoms including 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 Olanzapine SUN. You and your doctor should monitor your weight regularly. If necessary, consider consulting a dietitian or adopting a dietary management program.
• High blood levels of sugar and fats (triglycerides and cholesterol) have been observed in patients taking Olanzapine SUN. Your doctor should request blood tests to monitor blood sugar and certain blood fat levels before you start taking Olanzapine SUN 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 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 of age, have your blood pressure checked regularly by your doctor.

Children and adolescents
Olanzapine SUN is not recommended for patients under 18 years of age.

Other medicines and Olanzapine SUN
During treatment with Olanzapine SUN, take other medicines only after obtaining approval from your doctor.
You may feel drowsy if Olanzapine SUN 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 medicines.
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) – your dose of Olanzapine SUN may need to be adjusted.

Olanzapine SUN and alcohol
Do not drink any alcoholic beverages during treatment with Olanzapine SUN, as taking Olanzapine SUN together with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking this medicine. You must not take this medicine while breastfeeding, as small amounts of Olanzapine SUN may pass into breast milk.
The following symptoms may occur in newborns whose mothers have used Olanzapine SUN 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 shows any of these symptoms, you may need to contact your doctor.

Driving and using machines
When taking Olanzapine SUN, there is a risk of drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

Olanzapine SUN tablets contain lactose
Olanzapine SUN tablets contain lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact him or her before taking this medicine.

Olanzapine SUN orodispersible tablets contain aspartame
Patients who cannot tolerate phenylalanine should be aware that Olanzapine SUN orodispersible tablets contain aspartame, which is a source of phenylalanine. It may be harmful if you have phenylketonuria.

3. How to take Olanzapina SUN

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or
pharmacist.
Your doctor will tell you how many Olanzapina SUN tablets to take and for how long you should continue
taking them. The recommended dose of Olanzapina SUN ranges from 5 to 20 mg daily. If your
symptoms return, discuss this with your doctor, but do not stop taking Olanzapina SUN unless
your doctor tells you to do so.
You should take Olanzapina SUN 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 SUN tablets are for oral use.

Olanzapina SUN tablets:
Swallow the Olanzapina SUN tablets whole with water.

Olanzapina SUN orodispersible tablets:
Olanzapina SUN orodispersible tablets break easily, so handle them carefully. Avoid touching the tablets with wet hands, as they may disintegrate.

1. Hold the blister strip by the edges and gently separate one blister from the rest along the perforated line.
2. Carefully peel back the backing.
3. Gently push the tablet out.
4. Place the tablet in your mouth. It will dissolve rapidly and can be swallowed easily.

Alternatively, you may place the tablet in a glass or cup containing water, orange juice, apple juice, milk, or coffee, and stir. With some beverages, the mixture may change colour and become slightly cloudy. Drink it immediately.

If you take more Olanzapina SUN than you should
Patients who have taken more Olanzapina SUN than prescribed have experienced the following symptoms:

• increased heart rate
• agitation/aggression
• speech difficulties
• unusual movements (especially of the face or tongue)
• reduced level of consciousness

Other possible symptoms include:

• acute confusion
• seizures (epilepsy)
• coma
• a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing, reduced cough reflex, high or low blood pressure, or changes in heart rhythm.

Contact your doctor or go to a hospital immediately if any of these symptoms occur. Show your doctor the medicine package.

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

If you stop taking Olanzapina SUN
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with Olanzapina SUN for as long as your doctor recommends.
If you stop taking Olanzapina SUN 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 doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Tell your doctor immediately 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 experience 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 early 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 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 levels of sugar in the blood and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; extreme tiredness; water 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 the blood and urine) or coma; seizures, usually occurring in patients with a history of seizures (epilepsy); muscle stiffness or repeated muscle contractions (including eye movements); 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; and breast-related 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; and prolonged and/or painful erection.

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

In patients with Parkinson's disease, Olanzapina SUN may cause worsening of 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 can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at the website: http://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 SUN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the blister, bottle or carton.
The expiry date refers to the last day of that month.
Olanzapina SUN tablets:
Do not store above 30°C.
Olanzapina SUN orodispersible tablets:
This medicine does not require any special storage conditions.
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 pack and other information

What Olanzapina SUN contains
Olanzapina SUN tablets:

• The active substance is olanzapine. One tablet of Olanzapina SUN contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
• The other ingredients are anhydrous lactose, microcrystalline cellulose, crospovidone type A, low-substituted hydroxypropylcellulose, magnesium stearate, anhydrous colloidal silica.

Olanzapina SUN orodispersible tablets:

• The active substance is olanzapine. One orodispersible tablet of Olanzapina SUN contains 5 mg, 10 mg, 15 mg or 20 mg of olanzapine.
• The excipients are mannitol, microcrystalline cellulose, aspartame (E951), crospovidone type A, low-substituted hydroxypropylcellulose, anhydrous colloidal silica, magnesium stearate.

Description of the appearance of Olanzapina SUN and contents of the pack
Olanzapina SUN tablets:
Olanzapina SUN 2.5 mg tablets: yellow, round, uncoated tablets, marked with '2.5' on one side and smooth on the other.
Olanzapina SUN 5 mg tablets: yellow, oval, uncoated tablets, marked with '5' on one side and smooth on the other.
Olanzapina SUN 7.5 mg tablets: yellow, round, uncoated tablets, marked with '7.5' on one side and smooth on the other.
Olanzapina SUN 10 mg tablets: yellow, oval, uncoated tablets, marked with '10' on one side and smooth on the other.
Olanzapina SUN 15 mg tablets: yellow, oval, uncoated tablets, marked with '15' on one side and smooth on the other.
Olanzapina SUN 20 mg tablets: yellow, oval, uncoated tablets, marked with '20' on one side and smooth on the other.
Olanzapina SUN 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg tablets are available in blisters of 28, 35, 56 and 70 tablets and in HDPE bottles containing 30 or 100 tablets.

Olanzapina SUN orodispersible tablets:
Olanzapina SUN 5 mg orodispersible tablets: yellow, round, uncoated tablets, marked with 'O5' on one side and smooth on the other.
Olanzapina SUN 10 mg orodispersible tablets: yellow, round, uncoated tablets, marked with 'O10' on one side and smooth on the other.
Olanzapina SUN 15 mg orodispersible tablets: yellow, round, uncoated tablets, marked with 'O15' on one side and smooth on the other.
Olanzapina SUN 20 mg orodispersible tablets: yellow, round, uncoated tablets, marked with 'O20' on one side and smooth on the other.
28 x 1, 35 x 1, 56 x 1 and 70 x 1 Olanzapina SUN 5 mg, 10 mg, 15 mg and 20 mg orodispersible tablets in single-dose perforated blisters.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

Legal Representative in Italy:
Sun Pharmaceuticals Italia Srl - Via Luigi Rizzo, 8 - 20151 Milano

Manufacturer
Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132 JH Hoofddorp
The Netherlands

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Olanzapin SUN 2.5/5/7.5/10/15/20 mg Tabletten;
Olanzapin SUN 5/10/15/20 mg Schmelztabletten
Italy: Olanzapina SUN 2.5/5/7.5/10/15/20 mg tablets;
Olanzapina SUN 5/10/15/20 mg orodispersible tablets
The Netherlands: Olanzapine SUN 2.5/5/7.5/10/15/20 mg tabletten;
Olanzapine SUN 5/10/15/20 mg orodispergeerbare tabletten
Sweden: Olanzapin SUN, 2.5/5/7.5/10/15/20 mg tablett;
Olanzapin SUN, 5/10/15/20 mg munsönderfallande tablett
United Kingdom: Olanzapine SUN 2.5/5/7.5/10/15/20 mg tablets;
Olanzapine SUN 5/10/15/20 mg orodispersible tablets