Olanzapine DR Reddys 20 mg orodispersible tablets – patient leaflet, side effects, dosage

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not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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 (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

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

Tablets, 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

Tablets 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 Tablets Only take other medicines while you are taking Olanzapine Tablets 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

stabilizer), fluvoxamine (an antidepressant) or

ciprofloxacin (an antibiotic) - it may be necessary

to change your dose of Olanzapine Tablets.

Olanzapine with alcohol

Do not drink any alcohol if you have been given

Olanzapine Tablets 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 Tablets 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 Tablets. If this happens do not drive or

operate any tools or machines. Tell your doctor.

Olanzapine Tablets contains aspartame and sodium

This medicine 1,5 mg / 3 mg / 4,5 mg / 6 mg aspartame in each orodispersible tablet.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. This medicine contains less than 1 mmol sodium (23 mg) per orodispersible tablet, that is to say essentially ‘sodium-free’.

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 mg and 20 mg. Consult your doctor if your symptoms return but do not stop taking Olanzapine Tablets 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. Olanzapine orodispersible Tablets break easily, so you should handle the tablets carefully. Do not handle the tablets with wet hands as the tablets may break up.

1. 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. 2. Carefully peel off the backing.
3. 3. Gently push the tablet out.
4. 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).

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 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 cell (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, Olanzapine may worsen the symptoms.

Reporting of side effects

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

effects directly via the Yellow Card Scheme website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE OLANZAPINE

Keep this medicine out of sight and reach of children.

Do not use Olanzapine after the expiry date, which is stated on the carton after ‘Expiry:’ and on blister after

‘Exp:’. The expiry date refers to the last day of that month.

Do not store above 25°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 Olanzapine Tablets contain

The active substance is olanzapine. Each orodispersible tablet contains either 5 mg, 10 mg, 15 mg or 20 mg of the active substance. The exact amount is shown on your Olanzapine tablet pack.

The other ingredients are microcrystalline cellulose (E460a), mannitol (E421), pregelatinised maize starch, crospovidone, sodium laurilsulfate, aspartame (E951), guar gum (E412), colloidal anhydrous silica (E551),

magnesium stearate (E572).

What Olanzapine Tablets look like and contents of the pack

The tablets are yellow round tablets that are convex on one side and flat on the other side.

Orodispersible tablet is the technical name for a tablet which dissolves directly in your mouth, so that it can be easily swallowed.

Tablets are blister packed in cartons of 7, 14, 28, 35, 56, 70, 98, 100 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Dr. Reddy’s Laboratories (UK) Ltd., 6 Riverview Road, Beverley, HU17 0LD, UK

This leaflet was last revised in 06/2021

Brand: Dr Reddy’s

Product Name:

Olanzapine

Strength:

5, 10, 15, 20 mg

Form:

Orodispersible Tablets

Leaflet

Pack Size:

N/A

Country:

UK

Date Created:

07/06/2017

Date Modified:

17 JUN 2021

2.2

CC1000045126 9 pt

India

170x375 mm Dimensions:

Project:

Process Black

Dr. Reddy’s Laboratories (UK) Ltd 6 Riverview Road, Beverley, HU17 0LD, UK