LAZAPIR 5 mg Orodispersible Tablet

Зміст інструкції

1. Lazapir 5 mg orodispersible tablets, 10 mg orodispersible tablets
   1. What is Lazapir and what it is used for
   2. What you need to know before taking Lazapir
   3. How to take Lazapir
   4. Possible side effects
   5. How to store Lazapir
   6. Contents of the pack and other information

Lazapir 5 mg orodispersible tablets, 10 mg orodispersible tablets

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

1. What is Lazapir and what it is used for

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

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

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

2. What you need to know before taking Lazapir

Do not take Lazapir

• If you are allergic (hypersensitive) to olanzapine or 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, report it to 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 Lazapir

• The use of Lazapir 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 Lazapir, report it to 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 Lazapir. You and your doctor should monitor 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 Lazapir. Your doctor should request blood tests to check your sugar and certain fat levels in the blood before you start taking Lazapir and, regularly, during treatment.
• Report to your doctor if you or someone in your family has had 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, inform your doctor as soon as possible:

• Stroke or transient ischemic attack (TIA) (temporary symptoms of stroke)
• Parkinson's disease
• Prostate problems
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood diseases
• Heart disease
• Diabetes
• Convulsions
• If you know you may have excessive salt loss due to severe and prolonged diarrhea and vomiting (being ill) or the use of diuretics (water pills)

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
Lazapir is not indicated in patients under the age of 18 years.

Other medicines and Lazapir
During treatment with Lazapir, take other medicines only with the authorization of your
doctor. You may feel sleepy if Lazapir 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 may 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 your dose of Lazapir.

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

Pregnancy, breastfeeding and fertility
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 during breastfeeding, as small amounts
of Lazapir can pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Lazapir 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 using machines
When you take Lazapir there is a risk that you may experience drowsiness. If this
occurs, do not drive or operate tools or machinery. Inform your doctor.

Lazapir contains aspartame and mannitol
This medicine contains up to 4.8 mg of aspartame per orodispersible tablet. Aspartame, which is a source of phenylalanine, may be harmful to you if you suffer from phenylketonuria, a rare genetic disorder that causes phenylalanine to accumulate because the body cannot
process it correctly.
Patients who cannot take mannitol should be aware that Lazapir contains
mannitol.

3. How to take Lazapir

Take this medicine following exactly the instructions of your doctor. If you have any doubts
consult your doctor or pharmacist.
Your doctor will tell you how many Lazapir tablets you need to take and for how long you need to
continue taking them. The dose of Lazapir to be taken varies from 5 mg to 20 mg per day. If your
symptoms reappear, talk to your doctor but do not stop taking Lazapir unless your doctor tells you to.
You should take Lazapir 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. Lazapir orodispersible tablets are for oral
use.
Lazapir tablets are easily broken, so be careful when you take the
tablet in your hand. Do not touch the tablets with wet hands as the tablets may
break.

• 1. Hold the blister strip by the edges and separate one blister pocket from the rest of the strip by gently pulling along the perforated separation line.
• 2. Carefully remove the backing.
• 3. Gently push the tablet out.
• 4. Place the tablet in your mouth. This will dissolve directly in your mouth, so that it can be swallowed easily.

You can also put the tablet in a glass or cup full of 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 Lazapir than you should
Patients who have taken more Lazapir than they should have, have experienced the
following symptoms: increased heart rate, agitation/aggressiveness, 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 rigidity, stupor or
drowsiness, slowed breathing rate, reduced cough reflex,
high or low blood pressure, changes in heart rhythm. 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 Lazapir
Take the tablets as soon as you remember. Do not take a double dose in one day.

If you stop taking Lazapir
Do not stop taking the tablets as soon as you start to feel better. It is important that you
continue treatment with Lazapir for as long as your doctor deems necessary.
If you suddenly stop taking Lazapir, symptoms such as
sweating, inability to sleep, tremor, anxiety or nausea and vomiting may occur. Your 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 side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Report to your doctor immediately 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 lower legs (symptoms include swelling, pain and redness of the leg), which can 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 based on 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 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 side 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 hunger; 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 men and women or erectile dysfunction in men.
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 a 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; stuttering; slowing of the heartbeat; sensitivity to sunlight; nosebleeds; abdominal bloating; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and changes affecting the breasts in men and women, such as abnormal growth or abnormal milk secretion.
Rare side 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 that manifests as yellowing of the skin and whites of the eyes; muscle disease that presents as tenderness and unexplained pain; and prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome. DRESS initially manifests with flu-like symptoms, with a rash on the face that subsequently becomes widespread, high body temperature, enlarged lymph nodes, increased levels of liver enzymes observed in blood tests and an increase in a type of white blood cells (increased eosinophils).
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 Lazapir may worsen symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through 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 Lazapir

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.
Lazapir must be stored in its original packaging to protect it 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. Contents of the pack and other information

What Lazapir contains

• The active ingredient is olanzapine. Each Lazapir orally disintegrating tablet contains either 5 mg or 10 mg of the active ingredient. The exact amount is reported on the Lazapir packaging.
• The other ingredients are orange aroma, aspartame, crospovidone, mannitol, anhydrous colloidal silica, sodium stearyl fumarate.

Description of the appearance of Lazapir and contents of the pack
Lazapir 5 mg or 10 mg are orally disintegrating tablets of yellow color.
Orally disintegrating tablet is a technical term to indicate a tablet that dissolves
directly in the mouth, in a manner that it can be swallowed easily.
Lazapir is available in packs containing 28 tablets.

Marketing Authorisation Holder
Neuraxpharm Italy S.p.A.
Via Piceno Aprutina, 47
63100 Ascoli Piceno
Italy

Manufacturer:
Adamed Pharma S.A.
Ul. Marszalka J. Pilsudskiego 5
95-200 Pabianice
Poland