ОЛАНЗАПИНА 5 МГ Ородисперсная таблетка

Содержание инструкции

1. Olanzapine Pensa Pharma 5 mg orodispersible tablets
   1. What Olanzapina Pensa Pharma is and what it is used for
   2. What you need to know before you take Olanzapina Pensa Pharma
   3. How to take Olanzapina Pensa Pharma
   4. Possible Undesirable Effects
   5. How to store Olanzapina Pensa Pharma
   6. PACKAGE CONTENTS AND OTHER INFORMATION

Olanzapine Pensa Pharma 5 mg orodispersible tablets

Olanzapine Pensa Pharma 10 mg orodispersible tablets
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Olanzapine Pensa Pharma is and what it is used for
• 2. What you need to know before you take Olanzapine Pensa Pharma
• 3. How to take Olanzapine Pensa Pharma
• 4. Possible side effects
• 5. How to store Olanzapine 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 ingredient olanzapine. Olanzapina Pensa Pharma belongs
to a group of medicines called antipsychotics and is used for the treatment of the
following conditions:

• schizophrenia, an illness with symptoms such as hearing, seeing or experiencing things that do not exist, false beliefs, unjustified suspicion and social withdrawal. People with this illness may also feel depressed, anxious or tense.
• a 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 need to know before you take Olanzapina Pensa Pharma

Do not take Olanzapina Pensa Pharma

• If you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction can manifest with skin rash, itching, swelling of the face, swelling of the lips, shortness of breath. If this has happened to you, tell 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 can cause unusual movements, especially of the face and tongue. If this happens after you have been given Olanzapina Pensa Pharma, tell 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 Pensa Pharma. You and your doctor should check your weight regularly. If necessary, consider consulting a dietitian or getting help with a diet program.
• High levels of sugar and fat (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Pensa Pharma. Your doctor should request blood tests to check sugar and certain fat levels in the blood before you start taking Olanzapina Pensa Pharma and, regularly, during treatment.
• Tell your doctor if you or someone in your family has a history of blood clots, as medicines like these have been associated with the formation of blood clots.

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

• Stroke or transient ischemic attack (temporary symptoms of stroke)
• Parkinson's disease
• Problems with the prostate
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood diseases
• Heart disease
• Diabetes
• Convulsions
• If you think you have a salt depletion as a result of prolonged severe diarrhea and vomiting or following the use of diuretics

If you suffer from dementia, you or your caregiver must inform the doctor if you
have had a stroke or 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 Pensa Pharma is not indicated in patients under the age of 18 years.

Other medicines and Olanzapina Pensa Pharma
During treatment with Olanzapina Pensa Pharma, take other medicines only after
your doctor's authorization. You may feel sleepy if Olanzapina Pensa Pharma is
taken in combination with antidepressants or medicines taken for anxiety or to help you sleep
(sedatives).
Tell your doctor if you are taking, have recently taken or might take any other
medicines.
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), because it may be necessary to adjust your dose of Olanzapina Pensa Pharma.

Olanzapina Pensa Pharma and alcohol
Do not drink any alcohol during treatment with Olanzapina Pensa Pharma because
the simultaneous intake of Olanzapina Pensa Pharma and alcohol can cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning a
pregnancy, ask your doctor for advice before taking this medicine. You should not
take this medicine while breastfeeding, as small amounts of Olanzapina
Pensa Pharma can pass into breast milk.
The following symptoms have been observed in newborns of mothers who have taken Olanzapina Pensa
Pharma during the last trimester (the last three months of pregnancy): tremor, stiffness and/or
muscle weakness, drowsiness, agitation, breathing problems and difficulty in taking
food. If your baby develops any of these symptoms, contact your doctor.

Driving and using machines
When you take Olanzapina Pensa Pharma there is a risk that you may experience drowsiness. If
this happens, do not drive or operate tools or machinery. Tell your doctor.

Olanzapina Pensa Pharma contains lactose
Olanzapina Pensa Pharma contains lactose. If your doctor has told you that you have an intolerance to
some sugars, contact him before taking this medicine.

3. How to take Olanzapina Pensa Pharma

Always take this medicine exactly as your doctor has told you. If you have doubts
consult your doctor or pharmacist.
Your doctor will tell you how many Olanzapina Pensa Pharma tablets you need to take and for how
long you need to continue taking them. The recommended dose of Olanzapina Pensa Pharma to
be taken varies from 5 to 20 mg per day. If your symptoms reappear, talk to your doctor but do not
stop taking Olanzapina Pensa Pharma unless your doctor tells you to do so.
You must take Olanzapina Pensa Pharma tablets once a day, following your
doctor's instructions. Try to take the tablets every day at the same time. It does not
matter if you take them on a full or empty stomach. Olanzapina Pensa Pharma
orodispersible tablets are for oral use.
Olanzapina Pensa Pharma tablets break easily, so be careful
when taking the tablet in your hand. Do not touch the tablets with wet hands as the
tablets may break.

1&2: Hold the blister pack by the edges.
3: Gently push the tablet to avoid breaking it.
4: Put the tablet in your mouth. It can be dissolved directly in your mouth, so that
it can be easily swallowed.
You can also put the tablet in a glass or cup filled with water, orange juice, apple
juice, milk or coffee, mixing everything together. With some drinks, the mixture may change
color and become somewhat opaque. Drink it immediately.

If you take more Olanzapina Pensa Pharma than you should
Patients who have taken more Olanzapina Pensa Pharma than they should have,
have manifested the following symptoms: increased heart rate, agitation/aggression,
speech problems, unusual movements (especially of the face or tongue) and a reduced
level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma,
a combination of fever, rapid breathing, sweating, muscle stiffness, stupor or
drowsiness, slowed breathing rate, reduced cough reflex,
high or low blood pressure, heart rhythm disturbances. Contact your doctor or hospital immediately if any of the above symptoms occur. Show your doctor your
pack of tablets.

If you forget to take Olanzapina Pensa Pharma
Take the tablets 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 to feel better. It is important that you
continue treatment with Olanzapina Pensa Pharma for as long as your doctor deems necessary.
If you suddenly stop taking Olanzapina Pensa Pharma, symptoms such as sweating, inability to sleep, tremor, anxiety or nausea and vomiting may occur. The
doctor may advise you to gradually reduce the dose before stopping treatment.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible Undesirable Effects

Like all medicines, this medicine can cause undesirable effects, although not everyone will experience them.

Report to your doctor immediately if you experience:

• unusual movements (a common undesirable effect that can affect up to 1 in 10 patients), especially of the face or tongue;
• blood clots in the veins (an uncommon undesirable effect that can affect up to 1 in 100 patients), especially in the lower limbs (symptoms include swelling, pain and redness of the leg), which can circulate 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 undesirable effect cannot be estimated based on available data).

Very common undesirable 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 a feeling of dizziness or fainting (with a slowing of the heartbeat), especially when getting up from a lying or sitting position. These effects usually subside spontaneously, but if this does not happen, inform your doctor.

Common undesirable effects(may affect up to 1 in 10 people) include changes in the levels of some blood cells, circulating fats and, in the early stages of treatment, temporary increases in liver enzymes; increases in blood sugar and urine sugar levels; increases in uric acid and creatine phosphokinase levels in the blood; a feeling of increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; extreme fatigue; 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 undesirable 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 associated 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 bloating; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and changes in the breasts in males and females, such as abnormal growth or abnormal milk secretion.

Rare undesirable effects(may affect up to 1 in 1,000 people) include a decrease in body temperature; changes in heart rhythm; sudden unexplained 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 pain; prolonged and/or painful erection. Very rare undesirable 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 more widespread, high temperature, enlarged lymph nodes, elevated liver enzyme levels 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 subject to stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, a rise in body temperature, skin redness, gait disturbances. Some fatal cases have been reported in this particular group of patients. In patients with Parkinson's disease, Olanzapina Pensa Pharma may cause a worsening of symptoms.

Reporting of undesirable effects
If you experience any undesirable effect, including those not listed in this leaflet, tell your doctor or pharmacist. You can also report undesirable effects directly through the national reporting system at the address: www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting undesirable effects you can contribute to providing 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 which is stated on the packaging and blister
after EXP. The expiry date refers to the last day of that month.
Keep this medicine in the original package to protect it from light and moisture.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Olanzapina Pensa Pharma contains

• The active ingredient is olanzapine. Each orally disintegrating tablet of Olanzapina Pensa Pharma contains 5 mg or 10 mg of the active ingredient.
• The excipients are: crospovidone (Type A), lactose monohydrate, colloidal silicon dioxide (anhydrous), hydroxypropylcellulose, mint flavour (composed of: peppermint oil, peppermint oil deterpenated, eucalyptol, menthone, isomenthone, methylene acetate, menthol), talc, magnesium stearate.

Description of the appearance of Olanzapina Pensa Pharma and package contents
Olanzapina Pensa Pharma 5 mg, 10 mg are yellow orally disintegrating tablets
(orally disintegrating tablet is a technical term to indicate a tablet that dissolves
directly in the mouth, so that it can be swallowed easily).
Olanzapina Pensa Pharma 5 mg and 10 mg are available in packs containing:

5 mg:28 tablets

10 mg:28 tablets
Not all pack sizes may be 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 Member States of the European Economic Area
with the following denominations:
Denmark Olanzapin Pensa
Spain Olanzapina Pensa EFG
Italy Olanzapina Pensa Pharma