Olanzapine Viatris

Package leaflet: Information for the user

Olanzapina Viatris 2.5 mg film-coated tablet, 5 mg film-coated tablet, 7.5 mg film-coated tablet, 10 mg film-coated tablet, 15 mg film-coated tablet, 20 mg film-coated tablet

olanzapine
Read all of this leaflet carefully before taking this medicine because 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 give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Olanzapina Viatris is and what it is used for
2. What you need to know before taking Olanzapina Viatris
3. How to take Olanzapina Viatris
4. Possible side effects
5. How to store Olanzapina Viatris
6. Contents of the pack and other information

1. WHAT Olanzapina Viatris IS and WHAT IT IS USED FOR

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

• schizophrenia, a disorder with symptoms such as hearing, seeing, or experiencing things that do not exist, false beliefs, unjustified suspicion, and social withdrawal. People with this disorder may also feel depressed, anxious, or tense.
• moderate to severe manic episode, a condition characterized by symptoms of excitement or euphoria.

Olanzapina Viatris 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 should know before taking Olanzapine Viatris

Do not take Olanzapine Viatris

• if you are allergic (hypersensitive) to olanzapine, peanuts, soy, or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may include rash, itching, swelling of the face or lips, or difficulty breathing. If you have experienced such a reaction before, inform 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 Olanzapine Viatris.

• The use of Olanzapine Viatris in elderly patients with dementia is not recommended, as it may cause serious side effects.
• Medicines of this type may cause unusual movements, especially of the face and tongue. If this occurs after starting Olanzapine Viatris, inform your doctor.
  • Very rarely, medicines like this may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, confusion, or drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapine Viatris. You and your doctor should monitor your weight regularly. Consideration should be given to referral to a dietitian for a dietary plan or dietary support, if needed.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapine Viatris. Your doctor should order blood tests to check your blood sugar and certain blood fat levels before you start taking Olanzapine Viatris and regularly during treatment.
  • Inform your doctor if you or someone in your family has a history of blood clots, as medicines like this have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

• Stroke or transient ischemic attack (TIA) (temporary stroke-like symptoms)
• Parkinson’s disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you know you may lose excessive amounts of salt due to severe and prolonged diarrhea and vomiting (due to illness) or due to the use of diuretics (water tablets)

If you have dementia, you or your caregiver should inform the doctor if you have previously had a stroke or transient ischemic attack.
As a routine precaution, if you are over 65 years old, have your blood pressure checked regularly by your doctor.
Children and adolescents
Olanzapine Viatris is not indicated for patients under 18 years of age.
Other medicines and Olanzapine Viatris
During treatment with Olanzapine Viatris, take other medicines only after consulting your doctor. You may feel drowsy if Olanzapine Viatris is taken together with antidepressants or medicines used for anxiety or to help you sleep (tranquilizers).
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

• medicines for Parkinson’s disease.
• carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic) – your dose of Olanzapine Viatris may need to be adjusted.

Olanzapine Viatris and alcohol
Do not drink any alcoholic beverages during treatment with Olanzapine Viatris, as taking Olanzapine Viatris together with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant, breastfeeding, suspect you may be pregnant, or are planning to become pregnant, consult your doctor before taking this medicine. You should not take this medicine while breastfeeding, as small amounts of Olanzapine Viatris may pass into breast milk.
The following symptoms may occur in newborns of mothers who have used Olanzapine Viatris during the third trimester (last three months of pregnancy): tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, you may need to contact your doctor.
Driving and using machines
When taking Olanzapine Viatris, you may experience drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
Olanzapine Viatris contains lactose and soy lecithin
If your doctor has informed you that you have an intolerance to certain sugars, contact them before taking this medicine. The tablet coating contains soy lecithin. Do not take this medicine if you are allergic to peanuts or soy.

3. How to take Olanzapina Viatris

Always take this medicine exactly as your doctor has instructed you. If you have any doubts,
you should consult your doctor or pharmacist.
Your doctor will tell you how many Olanzapina Viatris tablets to take and for how long you should
continue taking them. The dose of Olanzapina Viatris to be taken varies from 5 mg to 20 mg per day. If
your symptoms return, discuss this with your doctor, but do not stop taking Olanzapina Viatris unless
your doctor tells you to do so.
You should take Olanzapina Viatris tablets once daily, as directed by your doctor. Try to take the tablets
at the same time each day. It does not matter whether you take them with or without food. Olanzapina Viatris film-coated tablets are for oral use. Swallow the tablets whole with water.
If you take more Olanzapina Viatris than you should
Patients who have taken more Olanzapina Viatris than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face or tongue), and reduced level of consciousness.
Other possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or somnolence, slowed breathing rate, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or hospital immediately if any of these symptoms occur. Show your doctor the package of tablets.
If you forget to take Olanzapina Viatris
Take the missed dose as soon as you remember. Do not take a double dose to make up for the forgotten tablet.
If you stop taking Olanzapina Viatris
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue treatment with Olanzapina Viatris for as long as your doctor considers necessary.
If you suddenly stop taking Olanzapina Viatris, you may experience symptoms 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 completely.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Immediately tell your doctor if you experience:

• unusual movements (a common side effect which may affect up to 1 in 10 patients), especially of the face or tongue;
• blood clots in the veins (an uncommon side effect which may affect up to 1 in 100 patients), particularly 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 breathing. If you notice any of these symptoms, seek medical help immediately;
• a combination of fever, rapid breathing, sweating, muscle stiffness and confusion or drowsiness (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; drowsiness; increased levels of prolactin in the blood. During the initial stages of treatment, some people may feel dizzy or faint (with a slowing of the heartbeat), especially when standing up from a lying or sitting position. This usually resolves spontaneously, but if it does not, inform your doctor.
Common side effects (may affect up to 1 in 10 people) include changes in levels of certain blood cells and circulating fats, and, at the beginning of treatment, temporary increases in liver enzymes; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased feeling of hunger; 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; sexual dysfunction, 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 of the mouth and throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma; seizures, usually in patients with a history of epileptic seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slowing of the heartbeat; sensitivity to sunlight; nosebleeds; abdominal distension; drooling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; breast changes in males and females, such as abnormal growth or abnormal milk secretion.
Rare side effects (may affect up to 1 in 1,000 people) include decreased body temperature; changes in heart rhythm; unexplained sudden death; inflammation of the pancreas causing severe stomach pain, fever and malaise; liver disease manifesting as yellowing of the skin and whites of the eyes; muscle disease presenting as tenderness and unexplained muscle pains; prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS is initially characterized by flu-like symptoms, such as rash on the face later spreading to other parts of the body, high temperature, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may be at risk of stroke, pneumonia, urinary incontinence, falls, extreme tiredness, visual hallucinations, increased body temperature, skin redness, and walking disturbances. In this particular group of patients, some fatal cases have been reported.
In patients with Parkinson's disease, Olanzapina Viatris may worsen symptoms.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 Olanzapine Viatris

Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date stated on the carton and label after Exp.. The expiry date refers to the last day of that month.
Do not store above 25 °C.
Bottles: After first opening, use within 90 days.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. OTHER INFORMATION

What Olanzapina Viatris contains

• The active substance is olanzapine. Each Olanzapina Viatris tablet contains 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg or 20 mg of active substance. The exact amount is indicated on the packaging of Olanzapina Viatris.
• The excipients are: tablet core: monohydrate lactose (see section 2 Olanzapina contains lactose), maize starch, pregelatinized maize starch, crospovidone type A, magnesium stearate; tablet coating: polyvinyl alcohol, titanium dioxide (E171), talc (E553b), soy lecithin (E322) (see section 2 Olanzapina Viatris contains soy lecithin), xanthan gum (E415)

Description of the appearance of Olanzapina Viatris and contents of the pack
Olanzapina Viatris 2.5 mg are film-coated tablets, round, white, biconvex on both sides, marked with "OZ above 2.5" on one side and "G" on the other side.
Olanzapina Viatris 5 mg are film-coated tablets, round, white, biconvex on both sides, marked with "OZ above 5" on one side and "G" on the other side.
Olanzapina Viatris 7.5 mg are film-coated tablets, round, white, biconvex on both sides, marked with "OZ above 7.5" on one side and "G" on the other side.
Olanzapina Viatris 10 mg are film-coated tablets, round, white, biconvex on both sides, marked with "OZ above 10" on one side and "G" on the other side.
Olanzapina Viatris 15 mg are film-coated tablets, oval, white, biconvex on both sides, marked with "OZ 15" on one side and "G" on the other side.
Olanzapina Viatris 20 mg are film-coated tablets, oval, white, biconvex on both sides, marked with "OZ 20" on one side and "G" on the other side.

Blister packs:
Olanzapina Viatris 2.5 mg, 5 mg, 7.5 mg, 15 mg and 20 mg are available in packs of 10, 28, 30, 35, 56, 70 (multipack 2 x 35) and 70 film-coated tablets.
Olanzapina Viatris 10 mg is available in packs of 7, 10, 28, 30, 35, 56, 70 (2x35) (multipack) and 70 film-coated tablets.

Unit dose perforated blisters:
Olanzapina Viatris 2.5 mg, 15 mg and 20 mg are available in packs of 28 x 1 film-coated tablets.
Olanzapina Viatris 5 mg and 10 mg are available in packs of 28 x 1 and 98 x 1 film-coated tablets.
Olanzapina Viatris 7.5 mg is available in packs of 28 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets.

Bottles:
Olanzapina Viatris 2.5 mg and 5 mg are available in bottles containing 250 and 500 film-coated tablets.
Olanzapina Viatris 7.5 mg, 15 mg and 20 mg are available in bottles containing 100 film-coated tablets.
Olanzapina Viatris 10 mg is available in bottles containing 100 and 500 film-coated tablets.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland

Manufacturer:
Gerard Laboratories, 35/36 Baldoyle Industrial Estate, Grange Road, Dublin 13, Ireland.
Mylan Hungary Kft., Mylan utca 1., Komárom, 2900, Hungary.

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

België/Belgique/Belgien Lietuva
Viatris Viatris UAB
Tél/Tel: + 32 (0)2 658 61 00 Tel: +370 5 205 1288

България Luxembourg/Luxemburg
Майлан ЕООД Viatris
Тел : +359 2 44 55 400 Tél/Tel: +32 (0)2 658 61 00
(Belgique/Belgien)

Česká republika Magyarország
ViatrisCZ s.r.o. Viatris Healthcare Kft.
Tel: +420 222 004 400 Tel.: + 36 1 465 2100

Danmark Malta
Viatris ApS V.J. Salomone Pharma Ltd
Tlf: +45 28 11 69 32 Tel: + 356 21 22 01 74

Deutschland Nederland
Viatris Healthcare GmbH Mylan BV
Tel: +49 800 0700 800 Tel: +31 (0)20 426 3300

Eesti Norge
Viatris OÜ Tel: + 372 6363 052 Viatris AS
Tlf: + 47 66 75 33 00

Ελλάδα Österreich
Viatris Hellas Ltd Viatris Austria GmbH
Τηλ : +30 2100 100 002 Tel: +43 1 86390

España Polska
Viatris Pharmaceuticals, S.L. Viatris Healthcare Sp. z o.o.
Tel: + 34 900 102 712 Tel.: + 48 22 546 64 00

France Portugal
Viatris Santé Tél: +33 4 37 25 75 00 Mylan, Lda.
Tel: + 351 214 127 200

Hrvatska România
Viatris Hrvatska d.o.o. BGP Products SRL
Tel: +385 1 23 50 599 Tel: +40 372 579 000

Ireland Slovenija
Viatris Limited Viatris d.o.o.
Tel: +353 1 8711600 Tel: + 386 1 23 63 180

Ísland Slovenská republika
Icepharma hf. Viatris Slovakia s.r.o.
Sími: +354 540 8000 Tel: +421 2 32 199 100

Italia Suomi/Finland
Viatris Italia S.r.l. Viatris Oy
Tel: + 39 (0) 02 612 46921 Puh/Tel: +358 20 720 9555

Κύπρος Sverige
GPA Pharmaceuticals Ltd Viatris AB
Τηλ : +357 22863100 Tel: +46 (0)8 630 19 00

Latvija United Kingdom (Northern Ireland)
Viatris SIA Mylan IRE Healthcare Limited
Tel: +371 676 055 80 Tel: +353 18711600

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu