Lazapir

Package leaflet: Information for the user

Lazapir 5 mg orodispersible tablets, 10 mg orodispersible tablets

Olanzapine
Generic medicine
Read all of 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 or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 Lazapir is and what it is used for

Lazapir contains the active substance olanzapine. Lazapir 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 experiencing things that do not exist, false beliefs, unjustified suspiciousness, and social withdrawal. People with this illness may also feel depressed, anxious, or tense.
• moderate to severe manic episode, a condition characterised 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 has 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 to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, facial swelling, lip swelling, or shortness of breath. If you have experienced any of these, 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 Lazapir

• The use of Lazapir in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type may cause unusual movements, especially of the face and tongue. If this occurs after you have been given Lazapir, inform your doctor.
• Very rarely, medicines like this may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, contact 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 starting a diet and exercise program.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Lazapir. Your doctor should perform blood tests to check your sugar levels and certain blood fat levels before you start taking Lazapir 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.

Inform your doctor as soon as possible if you have any of the following conditions:

• Stroke or transient ischaemic attack (temporary stroke-like symptoms) (TIA)
• Parkinson’s disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you know you may have excessive salt loss due to severe and prolonged diarrhoea and vomiting (due to illness) or use of diuretics (water tablets)

If you have dementia, you or your caregiver should inform your doctor if you have previously had a stroke or transient ischaemic attack.
As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.
Children and adolescents
Lazapir is not indicated for patients under 18 years of age.
Other medicines and Lazapir
During treatment with Lazapir, take other medicines only after approval from your doctor. You may feel drowsy if Lazapir is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquillisers).
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 stabiliser), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – your dose of Lazapir may need to be adjusted.

Lazapir and alcohol
Do not drink any alcoholic beverages during treatment with Lazapir, as taking Lazapir together with alcohol may cause drowsiness.
Pregnancy, breastfeeding and fertility
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine.
You should not take this medicine while breastfeeding, as small amounts of Lazapir may pass into breast milk.
The following symptoms may occur in newborns of mothers who have taken Lazapir 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 Lazapir, 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 is a source of phenylalanine and may be harmful if you have phenylketonuria, a rare genetic disorder that causes phenylalanine to build up in the body because it cannot be properly metabolised.
Patients who cannot tolerate mannitol should be aware that Lazapir contains mannitol.

3. How to take Lazapir

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 Lazapir tablets to take and for how long you should continue taking them. The daily dose of Lazapir ranges from 5 mg to 20 mg. If your symptoms return, discuss this with your doctor, but do not stop taking Lazapir unless your doctor tells you to do so.
You should take Lazapir tablets once daily, following your doctor’s instructions. Try to take the tablets at the same time each day. It does not matter whether you take them with or without food. Lazapir orodispersible tablets are for oral use.

Lazapir tablets break easily, so handle them with care when taking them in your hand. Do not touch the tablets with wet hands, as they may disintegrate.

1. Hold the blister strip by the edges and separate one blister cavity from the rest of the strip by gently pulling along the perforated line.
2. Carefully remove the backing.
3. Gently push the tablet out.
4. Place the tablet in your mouth. It will dissolve directly in the mouth, allowing it to be swallowed easily.

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

If you take more Lazapir than you should
Patients who have taken more Lazapir than recommended have experienced the following symptoms: increased heart rate, agitation/aggression, speech problems, unusual movements (especially of the face or tongue), and 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, and changes in heart rhythm. Contact your doctor or hospital immediately if any of these symptoms occur. Show your doctor the packaging of your tablets.

If you forget to take Lazapir
Take the missed dose as soon as you remember. Do not take a double dose on the same day.

If you stop taking Lazapir
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue Lazapir treatment for as long as your doctor considers necessary.
If you stop taking Lazapir 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 everyone experiences them.
Tell your doctor immediately if you experience:

• unusual movements (a common side effect that may affect up to 1 in 10 patients), especially of the face or tongue;
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 patients), particularly in the legs (symptoms include swelling, pain, and redness of the leg), which may travel through 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 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 feel dizzy or faint (with a slowed heart rate), 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, circulating fats, and temporary increases in liver enzymes during the initial stages of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased feeling of hunger; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; extreme tiredness; fluid 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 ketones in blood and urine) or coma; seizures, usually occurring in patients with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowed heart rate; sensitivity to sunlight; nosebleeds; abdominal swelling; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and 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; 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.
Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome). DRESS initially presents with flu-like symptoms, a skin rash starting on the face that later becomes widespread, high body temperature, swollen lymph nodes, increased liver enzyme levels observed in blood tests, and an increase in a type of white blood cell (eosinophilia).

During treatment with olanzapine, elderly patients with dementia may be at risk of stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, elevated body temperature, skin redness, and walking disturbances. Fatal cases have been reported in this particular patient group.
In patients with Parkinson's disease, Lazapir may worsen symptoms.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via 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 stated on the pack.
Lazapir should be stored in its original packaging to protect it 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 Lazapir contains

• The active substance is olanzapine. Each orodispersible tablet of Lazapir contains either 5 mg or 10 mg of active substance. The exact amount is indicated on the Lazapir packaging.
• The other components are orange flavour, aspartame, crospovidone, mannitol, anhydrous colloidal silica, sodium stearil fumarate.

Description of the appearance of Lazapir and package contents
Lazapir 5 mg and 10 mg are yellow orodispersible tablets.
Orodispersible tablet is a technical term indicating a tablet that dissolves directly in the mouth, allowing it to be swallowed easily.
Lazapir is available in packages containing 28 tablets.

Marketing Authorization 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