Document: Olanzapine Accord film-coated tablet ENG PL change

• Olanzapine Accord film-coated tablet PL
• Olanzapine Accord film-coated tablet ENG PL

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Package leaflet: Information for the user

Olanzapine Accord 2.5 mg Film-coated Tablets

Olanzapine Accord 5 mg Film-coated Tablets

Olanzapine Accord 7.5 mg Film-coated Tablets

Olanzapine Accord 10 mg Film-coated Tablets

Olanzapine Accord 15 mg Film-coated Tablets

Olanzapine Accord 20 mg Film-coated Tablets

Olanzapine

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you

• Keep this leaflet. You may need to read it again.

• If you have any further questions, please ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See Section 4.

What is in this leaflet

1. What Olanzapine tablets is and what it is used for

2. What you need to know before you take Olanzapine tablets

3. How to take Olanzapine tablets

4. Possible side effects

5. How to store Olanzapine tablets

6. Contents of the pack and other information

1. What Olanzapine tablets is and what it is used for

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such as hearing, seeing or sensing things which are not there, mistaken beliefs, unusual suspiciousness, and becoming withdrawn.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

Do not take Olanzapine tablets

• 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 recognized 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 tablets

• The use of Olanzapine tablets 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 tablets. 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 tablets. 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 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 tablets is not for patients who are under 18 years.

Other medicines and Olanzapine tablets:

Only take other medicines while you are on Olanzapine tablets if your doctor tells you that you can. You might feel drowsy if Olanzapine tablet 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 tablets dose.

Olanzapine tablets 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 tablets 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 lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Olanzapine tablets

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 tablets is between 5 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 coated tablets are for oral use. You should swallow the Olanzapine tablets whole with water.

If you take more Olanzapine tablets than you should

Patients who have taken more Olanzapine tablets 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 tablets

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

If you stop taking Olanzapine tablets

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

If you suddenly stop taking Olanzapine tablets, 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 to 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); problems with speech; slow heart rate; sensitivity to sunlight; bleeding from the nose; abdominal distension; 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.

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 tablets 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 Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Olanzapine tablets

• Keep this medicine out of sight and reach of children.

• Do not use this medicine after expiry date, which is stated on the blister as well as carton after ‘EXP’. The expiry date refers to the last day of that month.

• Do not store above 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 Olanzapine tablets contain

The active substance is olanzapine. Each film-coated tablet contains either 2.5 mg; 5 mg; 7.5 mg; 10 mg; 15 mg or 20 mg of the active substance,

The tablet also contains: Lactose monohydrate, Cellulose microcrystalline, Crospovidone, Hydroxypropylcellulose, Magnesium stearate

Film coating contains: Hypromellose (E464), Titanium dioxide (E171), Macrogol 400, Polysorbate 80 (E433). In addition film coat of 15 mg tablets also contains Indigo carmine aluminium lake (E132) and 20 mg tablets contains iron oxide red ( E172 )

What Olanzapine tablets looks like and content of the pack:

Olanzapine tablets 2.5 mg: White to off white round, biconvex, film-coated tablets plain on both sides

Olanzapine tablets 5 mg: White to off white round biconvex, film coated tablets, debossed with ‘O1’ on one side and plain on other side.

Olanzapine tablets 7.5 mg: White to off white round biconvex, film coated tablets, debossed with ‘O2’ on one side and plain on other side.

Olanzapine tablets 10 mg: White to off white round biconvex, film coated tablets, debossed with ‘O3’ on one side and plain on other side.

Olanzapine tablets 15 mg: Light blue coloured, round, biconvex, film coated tablets plain on both sides

Olanzapine tablets 20 mg: Light pink coloured, round, biconvex, film coated tablets plain on both sides

“The Olanzapine tablets are available in pack sizes of 15, 28, 30, 35, 56 or 70 tablets for the 2.5 mg, 5 mg, 10 mg and 15 mg strengths.

The Olanzapine tablets are available in pack sizes of 28, 30, 35, 56 or 70 tablets for the 7.5 mg and 20 mg strengths.”Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Accord Healthcare Limited, Sage house, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, UK.

Manufacturer:

Wessling Hungary Limited, 1047 Budapest, Fóti út 56,Hungary

Accord Healthcare Limited, Sage House, 319, Pinner Road, North Harrow, Middlesex HA1 4HF, UK.

This medicinal product is authorised in the Member States of the EEA under the following names:

Country	Proposed Name
Bulgaria	Olanzapine Accord 5/10/ mg Film-coated Tablets
Denmark	Olanzapine Accord
Estonia	Olanzapine Accord
Finland	Olanzapine Accord 2.5/5/7.5/10/15/20 mg Kalvopäävysteinen Tabletti
Latvia	Olanzapine Accord 5/10/15/ mg Film-coated Tablets
Lithuania	Olanzapine Accord 5/10/15 mg plėvele dengtos tabletės
Norway	Olanzapine Accord 2.5/5/7.5/10/15/20 mg Film-coated Tablets
Sweden	Olanzapine Accord 2.5/5/7.5/10/15/20 mg Filmdragerad Tabletter
The Netherlands	Olanzapine Accord 2.5/5/10/15/20 mg Filmomhulde Tabletten
UK	Olanzapine 2.5/5/7.5/10/15/20 mg Film-coated Tablets
Austria	Olanzapine Accord 2.5/5/10/15/ mg Filmtabletten
Cyprus	Olanzapine Accord 5/10 mg επικαλυμμένα με λεπτό υμένιοx δισκία
Ireland	Olanzapine Accord 2.5/5/7.5/10/15 mg film-coated Tablets
Italy	Olanzapine Accord 2.5/5/10/20 mg compresse rivestite con film
Malta	Olanzapine Accord 2.5/5/7.5/10/15 mg, pilloli miksija
Slovak republic	Olanzapine Accord 5/10 mg filmom obalené tablety

The leaflet was last revised in 2016-05-11