Olazax Disperzi - patient leaflet, side effects, dosage

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

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

• Schizophrenia, a disease with symptoms such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn. People with this disease may also feel depressed, anxious or tense.
• Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.

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

2. What you need to know before you take Olazax Disperzi

Do not take Olazax Disperzi

• – If you are allergic (hypersensitive) to olanzapine or any of the other ingredients of this medicine

(listed in section 6). An allergic reaction may be recognised as a rash, itching, a swollen face, swollen lips or shortness of breath. If this has happened to you, tell your doctor.

• – If you have been previously diagnosed with eye problems such as certain kinds of glaucoma

(increased pressure in the eye).

Warnings and precautions

Talk to your doctor or pharmacist before you take Olazax Disperzi.

• The use of Olazax Disperzi in elderly patients with dementia is not recommended as it may have serious side effects.
• Medicines of this type may cause unusual movements mainly of the face or 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, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness. If this happens, contact your doctor at once.
• Weight gain has been seen in patients taking Olazax Disperzi. You and your doctor should check your weight regularly. Consider referral to a dietician or help with a diet plan if necessary
• High blood sugar and high levels of fat (triglycerides and cholesterol) have been seen in patients taking Olazax Disperzi. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olazax Disperzi and regularly during treatment.
• Tell the doctor if you or someone else 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 illnesses tell your doctor as soon as possible:

• Stroke or “mini” stroke (temporary symptoms of stroke)
• Parkinson’s disease
• Prostate problems
• A blocked intestine (Paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you know that you may have salt depletion as a result of prolonged severe diarrhoea and

vomiting (being sick) or usage of diuretics (water tablets)

If you suffer from dementia, you or your carer/relative should tell your doctor if you have ever had a stroke or “mini” stroke.

As a routine precaution, if you are over 65 years your blood pressure may be monitored by your doctor.

Children and adolescents

Olazax Disperzi is not for patients who are under 18 years.

Other medicines and Olazax Disperzi

Only take other medicines while you are on Olazax Disperzi if your doctor tells you that you can. You might feel drowsy if Olazax Disperzi is taken in combination with antidepressants or medicines taken for anxiety or to help you sleep (tranquillisers).

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 stabiliser), fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic) – it may be necessary to change your Olazax Disperzi dose.

Olazax Disperzi with alcohol

Do not drink any alcohol if you have been given Olazax Disperzi as together with alcohol it may make you feel drowsy.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you might may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not be given this medicine when breast-feeding, as small amounts of Olazax Disperzi can pass into breast milk.

The following symptoms may occur in newborn babies, of mothers that have used Olazax Disperzi in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding. If your baby develops any of these symptoms you may need to contact your doctor.

Driving and using machines

There is a risk of feeling drowsy when you are given Olazax Disperzi. If this happens do not drive or operate any tools or machines. Tell your doctor.

Olazax Disperzi contains aspartame

Patients who cannot take phenylalanine should note that Olazax Disperzi contains aspartmae, which is a source of phenylalanine. This may be harmful for people with phenylketonuria.

3. How to take Olazax Disperzi

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Your doctor will tell you how many Olazax Disperzi tablets to take and how long you should continue to take them. The daily dose of Olazax Disperzi is between 5 mg and 20 mg. Consult your doctor if your symptoms return but do not stop taking Olazax Disperzi unless your doctor tells you to.

You should take your Olazax Disperzi tablets once a day following the advice of your doctor. Try to take your tablets at the same time each day. It does not matter whether you take them with or without food. Olazax Disperzi tablets are for oral use.

Put the tablet in your mouth. It will dissolve directly in your mouth, so it can be easily swallowed.

You can also place the tablet in a full glass or cup of water orange juice, apple juice, milk or coffee, and stir. Drink it straight away.

If you take more Olazax Disperzi than you should

Patients who have taken more Olazax Disperzi than they should, have experienced the following symptoms: rapid beating of the heart, agitation/aggres­siveness, problems with speech, unusual movements (especially of the face or tongue) and reduced level of consciousness. Other symptoms may be: acute confusion, seizures (epilepsy), coma, a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness, slowing of the breathing rate, aspiration, high blood pressure or low blood pressure, abnormal rhythms of the heart. Contact your doctor or hospital straight away if you experience any of the above symptoms. Show the doctor your pack of tablets.

If you forget to take Olazax Disperzi

Take your tablets as soon as you remember. Do not take two doses in one day.

If you stop taking Olazax Disperzi

Do not stop taking your tablets just because you feel better. It is important that you carry on taking Olazax Disperzi for as long as your doctor tells you.

If you suddenly stop taking Olazax Disperzi, symptoms such as sweating, unable to sleep, tremor, anxiety or nausea and vomiting might occur. Your doctor may suggest you to reduce the dose gradually before stopping treatment.

If you have any further questions on 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.

Tell your doctor immediately if you have:

• unusual movement (a common side effect that may affect up to 1 in 10 people) mainly of the face or tongue;
• blood clots in the veins (an uncommon side effect that may affect up to 1 in 100 people) especially in the legs (symptoms include swelling, pain, and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms seek medical advice immediately;
• a combination of fever, faster breathing, sweating, muscle stiffness and drowsiness or sleepiness (the frequency of this side effect cannot be estimated from the available data).

Very common side effects (may affect more than 1 in 10 people) include weight gain; sleepiness; and increases in levels of prolactin in the blood.. In the early stages of treatment, some people may feel dizzy or faint (with a slow heart rate), especially when getting up from a lying or sitting position. This will usually pass on its own but if it does not, tell 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 early in treatment, temporary increases in liver enzymes; increases in the level of sugars in the blood and urine; increases in levels of uric acid and creatine phosphokinase in the blood; feeling more hungry; dizziness; restlessness; tremor; unusual movements(dys­kinesias); constipation; dry mouth; rash; loss of strength; extreme tiredness; water retention leading to swelling of the hands, ankles or feet; fever; joint pain and sexual dysfunctions 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 in the mouth and throat, itching, rash); diabetes or the worsening of diabetes, occasionally associated with ketoacidosis (ketones 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; problems with speech; stuttering, slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; drooling; memory loss or forgetfulness; urinary incontinence; lack of ability to urinate; hair loss; absence or decrease in menstrual periods and changes in breasts in males and females such as an abnormal production of breast milk or abnormal growth.

Rare side effects (may affect up to 1 in 1000 people) include lowering of normal body temperature; abnormal rhythms of the heart; sudden unexplained death;; inflammation of the pancreas causing severe stomach pain, fever and sickness; liver disease appearing as yellowing of the skin and white parts of the eyes; muscle disease presenting as unexplained aches and pains and prolonged and/or painful erection.

Very rare side effects (may affect up to 1 in 10,000) include serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS appears initially as flu-like symptoms with a rash on the face and then with an extended rash, high temperature, enlarged lymph nodes, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cells (eosinophilia).

While taking olanzapine, elderly patients with dementia may suffer from stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, a rise in body temperature, redness of the skin and have trouble walking. Some fatal cases have been reported in this particular group of patients.

In patients with Parkinson’s disease Olazax Disperzi may worsen the symptoms

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in 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 carton and blister after EXP. The expiry date refers to the last day of that month.

Store below 30 °C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Olazax Disperzi contains

• – The active substance is olanzapine

• – Each tablet contains 5 mg, 10 mg, 15 mg, or 20 mg olanzapine

• – The other ingredients are mannitol (E 421), microcrystalline cellulose, aspartame (E 951),

What Olazax Disperzi looks like and contents of the pack

Olazax Disperzi 5 mg is supplied as a yellow coloured circular flat beveled edge orodispersible tablet with ‘B’ debossed on one side.

Olazax Disperzi 10 mg is supplied as a yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL’ debossed on one side and ‘D’ debossed on other side.

Olazax Disperzi 15 mg is supplied as a yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL’ debossed on one side and ‘E’ debossed on other side.

Olazax Disperzi 20 mg is supplied as a yellow coloured circular flat bevelled edge orodispersible tablets with ‘OL’ debossed on one side and ‘F’ debossed on other side.

Olazax Disperzi 5mg, 10 mg, 15 mg, 20 mg are available in aluminium foil blisters of 28, 56 orodispersible tablets

Marketing Authorisation Holder and Manufacturer

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b, 140 78 Praha 4

Czech Republic

Manufacturer

Glenmark Pharmaceuticals s.r.o.

Hvezdova 1716/2b, 140 78 Praha 4

Czech Republic

This leaflet was last revised in {MM/YYYY}.

Detailed information on this medicine is available on the European Medicines Agency (EMA) website:

Annex IV

Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)

Scientific conclusions

Taking into account the PRAC Assessment Report on the PSUR(s) for olanzapine, the scientific conclusions of CHMP are as follows:

Following the review of case reports in the UK Sentinel database, the EudraVigilance database, and the literature, a signal for salivary hypersecretion with olanzapine was identified on 14 February 2019 by the Medicines and Healthcare products Regulatory Agency (MHRA) and validated by the PRAC.

Based on signal analysis presented by the MAH including mechanistic plausibility, number of dechallenge/recha­llenge cases and strong temporal relationship, the PRAC agrees that salivary hypersecretion may be associated with olanzapine and the adverse reaction salivary hypersecretion should be added to the product information.

The CHMP agrees with the scientific conclusions made by the PRAC.

Grounds for the variation to the terms of the marketing authorisation(s)

On the basis of the scientific conclusions for olanzapine the CHMP is of the opinion that the benefit-risk balance of the medicinal product(s) containing olanzapine is unchanged subject to the proposed changes to the product information

The CHMP recommends that the terms of the marketing authorisation(s) should be varied.

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Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been

reported when olanzapine is stopped abruptly.

Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4). ______

Investigations

Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16

Following short term treatment (median duration 22 days), weight gain > 7 % of baseline body weight (kg) was very common (40.6 %), >15 % of baseline body weight was common (7.1 %) and > 25 % was common (2.5 %). With long-term exposure (at least 24 weeks), 89.4 % gained > 7 %, 55.3 % gained > 15 % and 29.1 % gained > 25% of their baseline body weight.

Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high

(> 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (> 1.016 mmol/l – < 1.467 mmol/l) to high (> 1.467 mmol/l).

Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (> 5.17 mmol/l) were observed commonly. Changes in total fasting cholesterol levels from borderline at baseline (> 4.39 – < 5.17 mmol/l) to high (> 5.17 mmol/l) were very common.

Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4). _______

Investigations

Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16

Following short term treatment (median duration 22 days), weight gain > 7 % of baseline body weight (kg) was very common (40.6 %), >15 % of baseline body weight was common (7.1 %) and > 25 % was common (2.5 %). With long-term exposure (at least 24 weeks), 89.4 % gained > 7 %, 55.3 % gained > 15 % and 29.1 % gained > 25% of their baseline body weight.

Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high (> 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (> 1.016 mmol/l – < 1.467 mmol/l) to high (> 1.467 mmol/l).

Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (> 5.17 mmol/l) were observed commonly. Changes in total fasting cholesterol levels from borderline at baseline (> 4.39 – < 5.17 mmol/l) to high (> 5.17 mmol/l) were very common.

Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4). _______

Investigations

Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16

Following short term treatment (median duration 22 days), weight gain > 7 % of baseline body weight (kg) was very common (40.6 %), >15 % of baseline body weight was common (7.1 %) and > 25 % was common (2.5 %). With long-term exposure (at least 24 weeks), 89.4 % gained > 7 %, 55.3 % gained > 15 % and 29.1 % gained > 25% of their baseline body weight.

Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high

(> 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (> 1.016 mmol/l – < 1.467 mmol/l) to high (> 1.467 mmol/l).

Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (> 5.17 mmol/l) were observed commonly. Changes in total fasting cholesterol levels from borderline at baseline (> 4.39 – < 5.17 mmol/l) to high (> 5.17 mmol/l) were very common.

Acute symptoms such as sweating, insomnia, tremor, anxiety, nausea and vomiting have been

reported when olanzapine is stopped abruptly.

Very common: Elevations of hepatic aminotransferases (ALT/AST; see section 4.4). _______

Investigations

Very common: Decreased total bilirubin, increased GGT, elevated plasma prolactin levels 16

Following short term treatment (median duration 22 days), weight gain > 7 % of baseline body weight (kg) was very common (40.6 %), >15 % of baseline body weight was common (7.1 %) and > 25 % was common (2.5 %). With long-term exposure (at least 24 weeks), 89.4 % gained > 7 %, 55.3 % gained > 15 % and 29.1 % gained > 25% of their baseline body weight.

Observed for fasting normal levels at baseline (< 1.016 mmol/l) which increased to high

(> 1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline (> 1.016 mmol/l – < 1.467 mmol/l) to high (> 1.467 mmol/l).

Changes in total fasting cholesterol levels from normal at baseline (< 4.39 mmol/l) to high (> 5.17 mmol/l) were observed commonly. Changes in total fasting cholesterol levels from borderline at baseline (> 4.39 – < 5.17 mmol/l) to high (> 5.17 mmol/l) were very common.