OLAZAX 5 mg Orodispersible Tablet

Зміст інструкції

1. Olazax Disperzi 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets
   1. What Olazax Disperzi is and what it is used for
   2. What you need to know before you take Olazax Disperzi
   3. How to take Olazax Disperzi
   4. Possible side effects
   5. How to store Olazax Disperzi
   6. Contents of the pack and other information

Olazax Disperzi 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets

Olanzapine

Read this leaflet carefully before 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 they have the same symptoms as you, because it may 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 Olazax Disperzi is and what it is used for
• 2. What you need to know before you take Olazax Disperzi
• 3. How to take Olazax Disperzi
• 4. Possible side effects
• 5. How to store Olazax Disperzi
• 6. Contents of the pack and other information

1. What Olazax Disperzi is and what it is used for

Olazax Disperzi contains the active ingredient olanzapine. Olazax Disperzi 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 feeling things that are not there, false beliefs, unjustified suspicion and social withdrawal. People with this illness may also feel depressed, anxious or tense.
• an episode of moderate to severe mania, a condition characterized by symptoms of excitement or euphoria

Olazax Disperzi 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 Olazax Disperzi

Do not take Olazax Disperzi

• 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 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 Olazax Disperzi

• The use of Olazax Disperzi in elderly patients with dementia is not recommended as it may cause serious undesirable effects.
• Medicines of this type can cause unusual movements, especially of the face and tongue. If this happens after you have been given Olazax Disperzi, 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, see your doctor immediately.

accelerated, sweating, muscle rigidity and a state of confusion or drowsiness. If this
happens, consult your doctor immediately.

• Weight gain has been observed in patients taking Olazax Disperzi. 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 Olazax Disperzi. Your doctor should request blood tests to check sugar and certain fat levels in the blood before you start taking Olazax Disperzi and, regularly, during treatment.

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) (TIA)
• Parkinson's disease
• Problems with the prostate
• Bowel obstruction (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Convulsions

If you suffer from dementia, you or your caregiver should 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
Olazax Disperzi is not indicated in patients under the age of 18 years.

Other medicines and Olazax Disperzi
During treatment with Olazax Disperzi, take other medicines only with your doctor's authorization.
You may feel sleepy if Olazax Disperzi is taken in combination with
antidepressants or medicines taken for anxiety or to help you sleep (tranquilizers).
Tell your doctor if you are taking or 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 your dose of Olazax Disperzi.

Olazax Disperzi and alcohol
Do not drink any type of alcohol during treatment with Olazax Disperzi as the simultaneous
intake of Olazax Disperzi 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 Olazax Disperzi may
pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Olazax Disperzi
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 you take Olazax Disperzi there is a risk that you may experience drowsiness. If this
happens, do not drive or operate tools or machinery. Tell your doctor.

Olazax Disperzi contains aspartame
Olazax Disperzi contains a source of phenylalanine which may be harmful to people who suffer
from phenylketonuria.

3. How to take Olazax Disperzi

Take this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will tell you how many Olazax Disperzi orally disintegrating tablets you need to take and for how
long you need to continue taking them. The dose of Olazax Disperzi 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 Olazax Disperzi unless your
doctor tells you to.
You should take the Olazax Disperzi orally disintegrating 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. Olazax Disperzi orally disintegrating tablets
are for oral use. Place the tablet in your mouth where it will dissolve directly and can
be easily swallowed.
It is also possible to put the tablet in a glass or cup filled with water, orange juice,
apple juice, milk or coffee, mixing everything together. Drink it immediately.

If you take more Olazax Disperzi than you should
Patients who have taken more Olazax Disperzi than they should have, have experienced the
following symptoms: acceleration of the heartbeat, agitation/aggressiveness, speech problems,
unusual movements (especially of the face or tongue) and a reduced level of consciousness. Other
symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever,
rapid breathing, sweating, muscle rigidity, stupor or drowsiness, slowing of the respiratory rate,
reduction of the cough reflex, high or low blood pressure, changes in heart rhythm. Contact your doctor or
hospital immediately if you experience any of the above
symptoms. Show your doctor your package of tablets.

If you forget to take Olazax Disperzi
Take the tablets as soon as you remember. Do not take a double dose in one day.

If you stop taking Olazax Disperzi
Do not stop taking the tablets as soon as you start to feel better. It is important that you continue
treatment with Olazax Disperzi for as long as your doctor deems necessary.
If you suddenly stop taking Olazax Disperzi, symptoms may appear
such as sweating, inability to sleep, tremor, anxiety or nausea and vomiting. 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 everyone gets them.
Report to your doctor immediately if you experience:

• unusual movements (a common side effect that can affect up to 1 in 10 patients), especially of the face or tongue;
• blood clots in the veins (an uncommon side effect that can affect up to 1 in 100 patients), especially in the lower legs (symptoms include swelling, pain and redness of the leg), which can 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 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 heart rate), 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; feeling of increased hunger; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; skin rash; loss of strength; extreme fatigue; fluid retention leading to swelling of the hands, ankles or feet; fever; joint pain and sexual dysfunction, such as decreased libido in both 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 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 heart rate; sensitivity to sunlight; nosebleeds; abdominal bloating; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or cessation of menstrual cycles; and changes in 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). 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 redness, gait disturbances. Some fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease Olazax Disperzi may cause a worsening of symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly through the national reporting system listed in Annex V.
By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Olazax Disperzi

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and on the blister after the
wording Exp. The expiry date refers to the last day of the month indicated.
Store at temperatures below 30°C
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 Olazax Disperzi contains

• The active ingredient is olanzapine.
• Each Olazax Disperzi tablet contains 5 mg, 10 mg, 15 mg, 20 mg of olanzapine.
• The other ingredients are: mannitol (E 421), microcrystalline cellulose, aspartame (E 951), crospovidone, magnesium stearate

Description of the appearance of Olazax Disperzi and contents of the pack
Olazax Disperzi is available in:
yellow, circular, orally disintegrating tablets with beveled edges and with the number “B” imprinted
on one side.
Olazax Disperzi 10 mg:
yellow, circular, orally disintegrating tablets with beveled edges and with the letters “OL” imprinted on
one side and the number “D” on the other side.
Olazax Disperzi 15 mg:
yellow, circular, orally disintegrating tablets with beveled edges and with the letters “OL” imprinted on
one side and the number “E” on the other side.
Olazax Disperzi 20 mg:
yellow, circular, orally disintegrating tablets with beveled edges and with the letters “OL” imprinted on
one side and the number “F” on the other side.
Olazax Disperzi 5 mg, 10 mg, 15 mg and 20 mg is available in aluminum blisters of 28 orally
disintegrating tablets

Marketing Authorisation Holder and Manufacturer
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b, 140 78 Praha 4
Czech Republic

Manufacturer
Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b, 140 78 Praha 4
Czech Republic

This leaflet was last updated in {MM/AAAA}.
Detailed information on this product is available on the European Medicines Agency (EMA) website: http://www.ema.europa.eu