ОЛАНЗАПИНА 5 МГ Ородисперсная таблетка

Содержание инструкции

1. OLANZAPINA EUROGENERICI 5 mg orodispersible tablets, 10 mg orodispersible tablets
   1. What OLANZAPINA EUROGENERICI is and what it is used for
   2. What you need to know before taking OLANZAPINA EUROGENERICI
   3. How to take OLANZAPINA EUROGENERICI
   4. Possible side effects
   5. How to store OLANZAPINA EUROGENERICI
   6. Package contents and other information

OLANZAPINA EUROGENERICI 5 mg orodispersible tablets, 10 mg orodispersible tablets

Generic medicine

Read 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, pharmacist or nurse.
This medicine has been prescribed for you only. Do not pass it on to others, even if their
symptoms are the same as yours, as it may be harmful.
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

OLANZAPINA EUROGENERICI contains the active ingredient olanzapine. OLANZAPINA
EUROGENERICI belongs to a group of medicines called antipsychotics and is used for the
treatment of the following conditions:

• schizophrenia, a disease with symptoms such as hearing, seeing or perceiving things that are not there, like false beliefs, unusual suspicions and withdrawn behaviour. People with this disease may feel depressed, anxious or tense;
• moderate to severe manic episodes, a condition characterized by symptoms of excitement or euphoria.

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

2. What you need to know before taking OLANZAPINA EUROGENERICI

Do not take OLANZAPINA 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 with skin rash,
itching, swelling of the face, swelling of the lips, shortness of breath. If this has happened to you,
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, pharmacist or nurse before taking OLANZAPINA
EUROGENERICI
The use of OLANZAPINA EUROGENERICI in elderly patients with dementia is not
recommended as it may cause serious side effects.
Medicines of this type can cause unusual movements, especially of the face and
tongue. If this happens after you have been given OLANZAPINA EUROGENERICI, 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
happens, consult your doctor immediately.
Weight gain has been observed in patients taking OLANZAPINA
EUROGENERICI. You and your doctor should monitor your weight regularly. Consider a referral to a dietitian or seek help with a planned diet, if necessary.
High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in
patients taking OLANZAPINA EUROGENERICI. Your doctor should request blood tests to check your sugar and certain fat levels in the blood before you
start taking OLANZAPINA EUROGENERICI and, regularly, during treatment.
Tell your doctor if you or someone in your family has had a history of blood clot formation, as medicines like these have been associated with the formation of
blood clots.
If you suffer from any of the following conditions, inform your doctor as soon as possible:

• Stroke or “mini” strokes (transient stroke symptoms)
• Parkinson's disease
• Prostate problems
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Convulsions

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

Children and adolescents
OLANZAPINA EUROGENERICI is not indicated in patients under the age of 18 years.

Other medicines and OLANZAPINA EUROGENERICI
During treatment with OLANZAPINA EUROGENERICI, take other medicines only after
your doctor's authorization. You may feel sleepy if OLANZAPINA EUROGENERICI
is taken in combination with antidepressants or medicines taken for anxiety or to help you
sleep (tranquilizers).
Tell your doctor if you are taking, have recently taken or might take any other
medicine.
In particular, tell 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) - it may be necessary to adjust the dose of OLANZAPINA EUROGENERICI.

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

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

Driving and operating machinery
When taking OLANZAPINA EUROGENERICI there is a risk that you may experience
drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

OLANZAPINA EUROGENERICI contains aspartame
Contains a source of phenylalanine. It may cause harm to people with phenylketonuria.

3. How to take OLANZAPINA EUROGENERICI

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 EUROGENERICI tablets you need to take and for
how long you need to take them. The daily dose of OLANZAPINA EUROGENERICI ranges from 5 mg to
20 mg. Consult your doctor if your symptoms return, but do not stop taking OLANZAPINA
EUROGENERICI unless your doctor tells you to.
You should take OLANZAPINA EUROGENERICI tablets once a day, following your
doctor's recommendation.
Try to take the tablets every day at the same time. They can be taken with or without
food.
OLANZAPINA EUROGENERICI tablets must be taken orally.
OLANZAPINA EUROGENERICI tablets are easily broken, so you must handle
the tablets with care. Do not touch the tablets with wet hands as the tablets may
break.

Applicable only to blister packs with tear-open foil

• 1. 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.
• 2. Carefully peel off the backing.
• 3. Gently push the tablet out.
• 4. Place the tablet in your mouth. It will dissolve directly in your mouth, so that it can be swallowed easily.

You can also dissolve the tablet by stirring it in a glass of water, orange juice,
apple juice, milk or coffee. With some drinks, the mixture may change color and become
opaque. Drink it immediately.

If you take more OLANZAPINA EUROGENERICIthan you should
Patients who have taken more OLANZAPINA EUROGENERICI than they should have
experienced the following symptoms: fast heartbeat, agitation/aggression, speech problems,
unusual movements (especially of the face and tongue) and decreased level of consciousness. Other
symptoms may include: acute confusion, seizures (epilepsy), coma, association of fever,
fast heartbeat, sweating, muscle stiffness and stupor or drowsiness, decreased breathing rate,
aspiration, high or low blood pressure, irregular heartbeat. Contact your
doctor or hospital immediately if you experience any of the symptoms
mentioned above. Show the doctor the tablet packaging.

If you forget to take OLANZAPINA EUROGENERICI
Take the tablets as soon as you remember. Do not take a double dose to make up for a
missed dose.

If you stop taking OLANZAPINA EUROGENERICI
Do not stop treatment just because you feel better. It is important that you continue to take
OLANZAPINA EUROGENERICI for as long as your doctor prescribes it.
If you suddenly stop treatment with OLANZAPINA EUROGENERICI, symptoms such as sweating, inability to sleep, tremors, anxiety or nausea and vomiting may appear. The
doctor may suggest that you gradually reduce the dose before stopping treatment.
If you have any questions about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

• unusual movements (a common side effect that can affect up to 1 in 10 people), especially of the face or tongue;
• blood clots in the veins (an uncommon side effect that can affect up to 1 in 100 people), especially in the legs (symptoms are swelling, pain and redness in the leg), which can travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, inform your doctor immediately;
• a combination of fever, rapid breathing, sweating, muscle stiffness, stupor or drowsiness (the frequency of this side effect cannot be defined based on available data).
• severe allergic reactions, such as swelling in the mouth and throat, itching, rash (an uncommon side effect that can affect up to 1 in 100 people);
• prolonged and/or painful erection (a rare side effect that can affect up to 1 in 1,000 people);
• inflammation of the pancreas with severe stomach pain, fever and malaise (a rare side effect that can affect up to 1 in 1,000 people);
• muscle disease for example rhabdomyolysis, which presents as unexplained weakness and pain (a rare side effect that can affect up to 1 in 1,000 people);
• liver disease with nausea, vomiting, loss of appetite, general feeling of unwellness, fever, itching, yellowing of the skin and the whites of the eyes (jaundice), and

dark urine (a rare side effect that can affect up to 1 person in

• 1,000).

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 with a rash on the face and subsequently with prolonged rash, high temperature, enlarged lymph nodes, high levels of liver enzymes in blood tests and an increase in a type of white blood cells (eosinophilia).
Very common side effects (may affect more than 1 in 10 people) include

• weight gain;
• drowsiness;
• increases in prolactin levels in the blood; 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.

Common side effects (may affect up to 1 in 10 people) include

• changes in the levels of some blood cells and circulating fats and at the beginning of treatment, temporary increase in liver enzymes;
• increases in blood sugar and urine sugar levels;
• increases in uric acid and creatine phosphokinase levels in the blood;
• feeling of increased hunger;
• dizziness;
• restlessness;
• tremor;
• unusual movements (dyskinesia);
• constipation;
• dry mouth;
• 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 the blood and urine) or coma;
• seizures, usually associated with a history of seizures (epilepsy);
• muscle rigidity or repeated muscle contraction (including eye movements);
• restless legs syndrome;
• problems with speech;
• slowing of the heartbeat;
• sensitivity to sunlight;
• nosebleeds;
• abdominal distension;
• loss of memory or forgetfulness;
• urinary incontinence,
• inability to urinate;
• hair loss;
• absence or reduction of menstrual cycles;
• changes in the breasts 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

• decrease in body temperature;
• changes in heart rhythm;
• sudden, unexplained death.

During treatment with olanzapine, elderly patients with dementia may be subject to
stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise
in body temperature, skin flushing, gait disturbances. Some fatal cases have been reported in
this particular group of patients.
In patients with Parkinson's disease, OLANZAPINA EUROGENERICI may cause a
worsening of symptoms.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
tell your doctor, pharmacist or nurse. You can also report side effects
directly through 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 OLANZAPINA EUROGENERICI

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.
Store in the original package to protect the medicine from light and moisture.
Do not dispose of any medicine in 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 ingredient is olanzapine. Each orodispersible tablet of OLANZAPINA EUROGENERICI contains 5 mg or 10 mg of the active ingredient. The exact amount is reported on the packaging of OLANZAPINA EUROGENERICI.
• The other ingredients are magnesium stearate, L-methionine, anhydrous colloidal silica, hydroxypropylcellulose (low substitution), crospovidone (Type B), aspartame, microcrystalline cellulose, guar gum, heavy magnesium carbonate and orange flavour. Description of the appearance ofOLANZAPINA EUROGENERICI and contents of the pack

OLANZAPINA EUROGENERICI 5 mg orodispersible tablets: round, biconvex tablet,
yellow in colour with a diameter of 6 mm and marking “O” on one side.
OLANZAPINA EUROGENERICI 10 mg orodispersible tablets: round,
biconvex tablet, yellow in colour with a diameter of 8 mm and marking “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 Milan

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)
STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel (Germany)
STADA Arzneimittel GmbH, Muthgasse 36/2, A-1190 Vienna (Austria)
N.V. Eurogenerics S.A., Heizel Esplanade Heysel b22, 1020 Brussels (Belgium)

This medicinal product is authorised in the Member States of the European Economic Area with the
following names:
AT Olanzapin STADA 5 mg/10 mg/15 mg melt tablets
BE Olanzapine Instant EG 5 mg/10 mg orodispersible tablets
ES Olanzapina Flas STADA 5 mg/10 mg dispersible tablets EFG
HU Olanzapin STADA 5 mg/10 mg orally disintegrating tablet
IT OLANZAPINA EUROGENERICI 5 mg/10 mg orodispersible tablets
LU Olanzapine Instant EG 5 mg/10 mg orodispersible tablets
PT Olanzapina Ciclum
SE Olanzapine STADA 5 mg/10 mg/15 mg/20 mg mouth-dissolving tablets
UK Olanzapine Excalibur 5 mg/10 mg/15 mg/20 mg Orodispersible Tablets