Olanzapine EG Stada: detailed information

Patient Information Leaflet

OLANZAPINE EUROGENERICI 5 mg orodispersible tablets

OLANZAPINE EUROGENERICI 10 mg orodispersible tablets
Equivalence medicine
Please read 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their
symptoms are the same as yours, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet,
contact your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:

What OLANZAPINE EUROGENERICI is and what it is used for
What you need to know before taking OLANZAPINE EUROGENERICI
How to take OLANZAPINE EUROGENERICI
Possible side effects
How to store OLANZAPINE EUROGENERICI
Package contents and other information

1. What OLANZAPINE EUROGENERICI is and what it is used for

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

schizophrenia, an illness with symptoms such as hearing, seeing or perceiving things that are not there, false beliefs, unusual suspicions and social withdrawal. People with this illness may feel depressed, anxious or tense;
moderate to severe manic episodes, a condition characterised by symptoms of excitement or euphoria.

OLANZAPINE EUROGENERICI has been shown to prevent the recurrence of these symptoms in
patients with bipolar disorder in whom the manic episode has responded to treatment with
olanzapine.

2. What you should know before taking OLANZAPINE EUROGENERICI

Do not take OLANZAPINE EUROGENERICI
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, lip swelling, or shortness of breath. If you have experienced this,
inform your doctor;
if you have previously been diagnosed with an eye condition such as certain types of glaucoma
(increased pressure inside the eye).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking OLANZAPINE
EUROGENERICI.

The use of OLANZAPINE EUROGENERICI in elderly patients with dementia is not
recommended, as it may cause serious adverse effects.

Medicines of this type may cause unusual movements, especially of the face and
tongue. If this occurs after you have been given OLANZAPINE EUROGENERICI, 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
EUROGENERICI. You and your doctor should monitor your weight regularly. Consider consulting a dietitian or follow a planned diet if necessary.

High levels of blood sugar and fats (triglycerides and cholesterol) have been observed in
patients taking OLANZAPINE EUROGENERICI. Your doctor should perform blood tests to monitor your blood sugar and certain blood fat levels before you start taking OLANZAPINE EUROGENERICI and regularly during treatment.

Inform your doctor if you or anyone else in your family has a history of blood clots, as such medicines have been associated with blood clot formation.

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

Stroke or "mini" stroke (transient ischemic attack)
Parkinson's disease
Prostate problems
Intestinal blockage (paralytic ileus)
Liver or kidney disease
Blood disorders
Heart disease
Diabetes
Seizures

If you suffer from dementia, you or your caregiver should inform your 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
OLANZAPINE EUROGENERICI is not indicated for patients under 18 years of age.

Other medicines and OLANZAPINE EUROGENERICI
During treatment with OLANZAPINE EUROGENERICI, take other medicines only after
obtaining approval from your doctor. You may feel drowsy if OLANZAPINE EUROGENERICI
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 anti-epileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – the dose of OLANZAPINE EUROGENERICI may need to be adjusted.

OLANZAPINE EUROGENERICI and alcohol
Do not drink any alcoholic beverages during treatment with OLANZAPINE EUROGENERICI, as
concurrent use of OLANZAPINE EUROGENERICI and alcohol may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

You must not take this medicine while breastfeeding, as small amounts of OLANZAPINE EUROGENERICI may pass into breast milk.

The following symptoms may occur in newborns whose mothers have taken OLANZAPINE
EUROGENERICI 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 EUROGENERICI, there is a risk of drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

OLANZAPINE EUROGENERICI contains aspartame
It contains a source of phenylalanine. It may be harmful to people with phenylketonuria.

3. How to take OLANZAPINE EUROGENERICI

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 OLANZAPINE EUROGENERICI tablets to take and for how long. The daily dose of OLANZAPINE EUROGENERICI ranges from 5 mg to 20 mg. Consult your doctor if symptoms return, but do not stop taking OLANZAPINE EUROGENERICI unless your doctor tells you to do so.
You should take OLANZAPINE EUROGENERICI tablets once daily as directed by your doctor.
Try to take the tablets at the same time each day. They may be taken with or without food.
OLANZAPINE EUROGENERICI tablets are for oral use.
OLANZAPINE EUROGENERICI tablets break easily, so handle them with care. Avoid touching the tablets with wet hands, as they may break.
Applies exclusively to blister packs with peelable film

Hold the blister at the ends and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.
Carefully peel back the backing.
Gently push the tablet out.
Place the tablet in your mouth. It will dissolve directly in the mouth, allowing it to be swallowed easily.

You may also dissolve the tablet by stirring it in a full glass of water, orange juice, apple juice, milk, or coffee. With some beverages, the mixture may change colour and become opaque. Drink it immediately.
If you take more OLANZAPINE EUROGENERICI than you should
Patients who have taken more OLANZAPINE EUROGENERICI than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech disorders, unusual movements (especially of the face and tongue), and decreased level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid heartbeat, sweating, muscle rigidity and lethargy or drowsiness, reduced breathing rate, aspiration, high or low blood pressure, or abnormal heart rhythm. Contact your doctor or hospital immediately if you experience any of the symptoms listed above. Show the doctor the medicine’s packaging.
If you forget to take OLANZAPINE EUROGENERICI
Take the missed tablet as soon as you remember. Do not take a double dose to make up for the forgotten tablet.
If you stop taking OLANZAPINE EUROGENERICI
Do not stop treatment just because you feel better. It is important that you continue taking OLANZAPINE EUROGENERICI for as long as your doctor prescribes.
If you stop treatment with OLANZAPINE EUROGENERICI suddenly, symptoms such as sweating, difficulty sleeping, tremors, anxiety, nausea, and vomiting may occur. 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 everyone experiences them.
Inform your doctor immediately if you experience:

unusual movements (a common side effect which may affect up to 1 in 10 people), especially of the face or tongue;
blood clots in the veins (an uncommon side effect which may affect up to 1 in 100 people), particularly in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and breathing difficulties. If you notice any of these symptoms, inform a doctor immediately;
a combination of fever, rapid breathing, sweating, muscle stiffness, drowsiness or lethargy (the frequency of this side effect cannot be determined from available data);
severe allergic reactions, for example swelling of the mouth and throat, itching sensation, skin rash (an uncommon side effect which may affect up to 1 in 100 people);
prolonged and/or painful erection (a rare side effect which may affect up to 1 in 1,000 people);
inflammation of the pancreas with severe stomach pain, fever and malaise (a rare side effect which may affect up to 1 in 1,000 people);
muscle disease, for example rhabdomyolysis, presenting as muscle tenderness and unexplained muscle pain (a rare side effect which may affect up to 1 in 1,000 people);
liver disease with nausea, vomiting, loss of appetite, general feeling of illness, fever, itching sensation, yellowing of the skin and whites of the eyes (jaundice), and dark-coloured urine (a rare side effect which may affect up to 1 in 1,000 people).

Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS is initially characterised by flu-like symptoms with a rash on the face, followed by prolonged rash, high temperature, enlarged lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).

Very common side effects (may affect more than 1 in 10 people) include:

weight gain;
drowsiness;
increased levels of prolactin in the blood.

At the beginning of treatment, some people may experience dizziness or fainting (with slowed heart rate), especially when standing up from a lying or sitting position. These symptoms 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 increase in liver enzymes at the beginning of treatment;
increased levels of sugar in the blood and urine;
increased levels of uric acid and creatine phosphokinase in the blood;
increased feeling of hunger;
dizziness;
restlessness;
tremor;
unusual movements (dyskinesia);
constipation;
dry mouth;
skin rash;
loss of strength;
extreme fatigue;
fluid retention leading to swelling of the hands, ankles or feet;
fever, joint pain;
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:

diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine) or coma;
seizures, usually in patients with a history of seizure disorders (epilepsy);
muscle stiffness or repeated muscle contractions (including eye movements);
restless legs syndrome;
speech problems;
slowed heart rate;
sensitivity to sunlight;
nosebleeds;
abdominal distension;
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.

Rare side effects (may affect up to 1 in 1,000 people) include:

decreased body temperature;
changes in heart rhythm;
unexplained sudden death.

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 disturbances. Fatal cases have been reported in this particular patient group.

In patients with Parkinson's disease, OLANZAPINA EUROGENERICI 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, pharmacist or nurse. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store OLANZAPINE EUROGENERICI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine 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. Package contents and other information

What OLANZAPINA EUROGENERICI contains

The active substance is olanzapine. Each orodispersible tablet of OLANZAPINA EUROGENERICI contains 5 mg or 10 mg of active substance. The exact amount is indicated on the OLANZAPINA EUROGENERICI packaging.
The other components are magnesium stearate, L-methionine, anhydrous colloidal silica, hydroxypropylcellulose (low substituted), crospovidone (Type B), aspartame, microcrystalline cellulose, guar gum, heavy magnesium carbonate and orange flavour.

Description of the appearance of OLANZAPINA EUROGENERICI and contents of the pack

OLANZAPINA EUROGENERICI 5 mg orodispersible tablets: round, biconvex, yellow tablet with a diameter of 6 mm and marked "O" on one side.
OLANZAPINA EUROGENERICI 10 mg orodispersible tablets: round, biconvex, yellow tablet with a diameter of 8 mm and marked "O1" on one side.

Packs of 5 mg:
Push-through blister packs: 10, 14, 28, 30, 56, 98, 126 and 154 orodispersible tablets.
Peel-to-open blister packs: 10, 14, 28, 30, 56, 98, 126 and 154 orodispersible tablets.

Packs of 10 mg:
Push-through blister packs: 10, 14, 28, 30, 56, 60, 98, 126 and 154 orodispersible tablets.
Peel-to-open blister packs: 10, 14, 28, 30, 56, 60, 98, 126 and 154 orodispersible tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milano, Italy

Manufacturers
Actavis ehf., Reykjavíkurvegur 78, IS-220 Hafnarfjörður (Iceland)
Actavis Ltd., B16, Bulebel Industrial Estate, Zejtun ZTN 08 (Malta)
Centrafarm Services B.V., Nieuwee Donk 9, NL-4879 AC Etten-Leur (Netherlands)
Clonmel Healthcare Ltd., Waterford Road, Clonmel, Co. Tipperary (Ireland)
LAMP S. Prospero S.p.A., Via della Pace 25/A, 41030 San Prospero (Modena), Italy
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
STADA Arzneimittel GmbH, Muthgasse 36/2, A-1190 Wien (Austria)
N.V. Eurogenerics S.A., Heizel Esplanade Heysel b22, 1020 Brussel (Belgium)

This medicinal product is authorised in the European Economic Area countries under the following names:
AT Olanzapin STADA 5 mg/10 mg/15 mg Schmelztabletten
BE Olanzapine Instant EG 5 mg/10 mg orodispergeerbare tabletten
ES Olanzapina Flas STADA 5 mg/10 mg comprimidos bucodispersables EFG
HU Olanzapin STADA 5 mg/10 mg szájban diszpergálódó tabletta
IT OLANZAPINA EUROGENERICI 5 mg/10 mg compresse orodispersibili
LU Olanzapine Instant EG 5 mg/10 mg comprimés orodispersibles
PT Olanzapina Ciclum
SE Olanzapine STADA 5 mg/10 mg/15 mg/20 mg munsönderfallande tabletter
UK Olanzapine Excalibur 5 mg/10 mg/15 mg/20 mg Orodispersible Tablets