OLANZAPINE 10 MG ORODISPERSIBLE TABLETS - patient leaflet, side effects, dosage

1 1. what olanzapine is and what it is used for

Olanzapine contains the active substance Olanzapine. Olanzapine 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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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.

Olanzapine 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 olanzapine

Do not take Olanzapine

• If you are allergic 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 Olanzapine.

• The use of Olanzapine 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 Olanzapine 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 Olanzapine. 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 Olanzapine. Your doctor should do blood tests to check blood sugar and certain fat levels before you start taking Olanzapine 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

Olanzapine is not for patients who are under 18 years.

Other medicines and Olanzapine

Only take other medicines while you are on Olanzapine if your doctor tells you that you can.

You might feel drowsy if Olanzapine 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 Olanzapine Torrent dose.

Olanzapine with alcohol

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

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you 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 Olanzapine can pass into breast milk.

The following symptoms may occur in newborn babies, of mothers that have used Olanzapine 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 Olanzapine. If this happens do not drive or operate any tools or machines. Tell your doctor.

Olanzapine contains aspartame

Olanzapine 2.5 mg Orodispersible Tablets contains 0.6 mg aspartame in each orodispersible tablets.

Olanzapine 5 mg Orodispersible Tablets contains 1.2 mg aspartame in each orodispersible tablets.

Olanzapine 7.5 mg Orodispersible Tablets contains 1.8 mg aspartame in each orodispersible tablets.

Olanzapine 10 mg Orodispersible Tablets contains 2.4 mg aspartame in each orodispersible tablets.

Olanzapine 15 mg Orodispersible Tablets contains 3.6 mg aspartame in each orodispersible tablets.

Olanzapine 20 mg Orodispersible Tablets contains 4.8 mg aspartame in each orodispersible tablets.

Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

1 3. how to take olanzapine

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

You should take your Olanzapine 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. Olanzapine orodispersible tablets are for oral use. The score line is not intended for breaking the tablet. Olanzapine tablets break easily, so you should handle the tablets carefully. Therefore please do not push the tablets through the blister foil. Do not handle the tablets with wet hands as the tablets may break up. 1. Hold the blister strip at the edges and separate one blister cell from the rest of the strip by gently tearing along the perforations around it.

• 2. Carefully peel off the backing.

• 3. Gently push the tablet out.

• 4. Put the tablet in your mouth. It will dissolve directly in your mouth, so that 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. With some drinks, the mixture may change colour

and possibly become cloudy. Drink it straight away. If you take more Olanzapine than you should Patients who have taken more Olanzapine 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 Olanzapine

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

If you stop taking Olanzapine

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

If you suddenly stop taking Olanzapine, 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).

1 5. How to store Olanzapine

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. The expiry date refers to the last day of that month.

Do not store above 30 °C.

Store in the original package in order to protect from light.

This medicinal product does not require any special temperature storage conditions.

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.

1 6. Contents of the pack and other information

What Olanzapine contains

The active substance is: olanzapine.

Olanzapine 2.5 mg orodispersible tablet: Each orodispersible tablet contains 2.5 mg of olanzapine. Olanzapine 5 mg orodispersible tablet: Each orodispersible tablet contains 5 mg of olanzapine. Olanzapine 7.5 mg orodispersible tablet: Each orodispersible tablet contains 7.5 mg of olanzapine. Olanzapine 10 mg orodispersible tablet: Each orodispersible tablet contains 10 mg of olanzapine. Olanzapine 15 mg orodispersible tablet: Each orodispersible tablet contains 15 mg of olanzapine. Olanzapine 20 mg orodispersible tablet: Each orodispersible tablet contains 20 mg of olanzapine. The other ingredients are:

mannitol (E 421), aspartame (E 951), crospovidone, microcrystalline cellulose, magnesium stearate.

What Olanzapine looks like and contents of the pack

Olanzapine 2.5mg are yellow coloured, round (Diameter approx. 4.8 mm), flat, bevel edged uncoated tablets, debossed “2.5” on one side and plain on other side.

Olanzapine 5mg are yellow coloured, round (Diameter approx. 6.4 mm), flat, bevel edged uncoated tablets with a score line on one side and debossed “5” on other side.

Olanzapine 7.5mg are yellow coloured, round (Diameter approx. 7.2 mm), flat, bevel edged uncoated tablets with a score line on one side debossed “7.5” on other side.

Olanzapine 10mg are yellow coloured, round (Diameter approx. 8.0 mm), flat, bevel edged uncoated tablets with a score line on one side and debossed “10” on other side.

Olanzapine 15mg are yellow coloured, round (Diameter approx. 9.55 mm), flat, bevel edged uncoated tablets with a score line on one side and debossed “15” on other side.

Olanzapine 20mg are yellow coloured, round (Diameter approx. 10.55 mm), flat, bevel edged uncoated tablets with a score line on one side and debossed “20” on other side.

Pack sizes

Pack sizes: 10, 14, 28, 30, 35, 50, 56, 70 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Torrent Pharma (UK) Ltd. 3rd Floor, Nexus Building, 4 Gatwick Road, Crawley, West Sussex, RH10 9BG, United Kingdom

This leaflet was last revised in 04/2020.

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