Olanzapine Accord

PACKAGE LEAFLET: INFORMATION FOR THE USER

Olanzapina Accord 2.5 mg film-coated tablets, 5 mg film-coated tablets, 10 mg film-coated tablets, 20 mg film-coated tablets

Generic medicine
Please 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Olanzapina Accord is and what it is used for

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

• Schizophrenia, a disorder characterised by symptoms such as hearing, seeing or sensing things that are not real, false beliefs, unusual suspiciousness and withdrawal. People affected by this illness may also feel depressed, anxious or tense.
• Moderate to severe manic episodes, a condition with symptoms of excitement or euphoria.

Olanzapina Accord has been shown to prevent the recurrence of these symptoms in patients with bipolar disorder whose manic episodes have responded to treatment with olanzapine.

2. What you need to know before taking Olanzapina Accord

Do not take Olanzapina Accord

• If you are allergic (hypersensitive) to olanzapine or to any of the ingredients of this medicine (listed in section 6). An allergic reaction may present as a skin rash, itching, swelling of the face, swollen lips or difficulty breathing. If this happens to you, inform your doctor.
• If you have previously been diagnosed with eye problems such as certain types of glaucoma (increased pressure inside the eye).

Warnings and precautions
Talk to your doctor or pharmacist before taking Olanzapina Accord

• The use of Olanzapina Accord in elderly patients with dementia is not recommended, as serious adverse effects may occur.
• Medicines of this type may cause unusual movements, especially of the face or tongue. If this occurs after you have been given Olanzapina Accord, inform your doctor.
• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or sedation. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Accord. You and your doctor should monitor your weight regularly. Consider consulting a dietitian or adopting a diet, if necessary.
• Increased levels of blood glucose and fats (triglycerides and cholesterol) have been observed in patients taking Olanzapina Accord. Your doctor should perform blood tests to monitor your glucose levels and certain fat levels before starting Olanzapina Accord and regularly during treatment.
• Inform your doctor if you or someone in your family has a history of blood clots, as medicines of this type have been associated with blood clot formation.

If you have any of the following conditions, inform your doctor immediately:

• Stroke or "mini"-stroke (transient stroke symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorder
• Heart disease
• Diabetes
• Epilepsy

If you have dementia, you or your caregiver should inform the doctor if you have ever had a stroke or "mini"-stroke.
As a general precaution, if you are over 65 years old, your doctor may monitor your blood pressure.
Children and adolescents
Olanzapina Accord is not indicated for patients under 18 years of age.
Other medicines and Olanzapina Accord:
Take other medicines while using Olanzapina Accord only if your doctor tells you it is safe to do so.
You may experience drowsiness if you take Olanzapina Accord together with antidepressants, anti-anxiety medicines, or medicines that 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 Olanzapina Accord may need to be adjusted.

Olanzapina Accord and alcohol:
Do not drink alcoholic beverages if you have been given Olanzapina Accord, because taking it together with alcohol may cause drowsiness.
Pregnancy and breastfeeding:
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
You must not take this medicine during breastfeeding, as small amounts of Olanzapina Accord may pass into breast milk.
Newborns exposed to Olanzapina Accord during the third trimester of pregnancy (the last three months of pregnancy) may experience the following adverse reactions: tremors, muscle stiffness and/or weakness, drowsiness, restlessness, breathing difficulties, and feeding problems. If your baby shows any of these symptoms, contact your doctor.
Driving and using machines:
There is a risk of drowsiness when taking Olanzapina Accord. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
Olanzapina Accord contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take Olanzapine Accord

Always take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Your doctor will tell you how many Olanzapine Accord tablets to take and for how long you should continue taking them. The daily dose of Olanzapine Accord ranges between 5 and 20 mg. Consult your doctor if symptoms return, but do not stop taking Olanzapine Accord unless your doctor tells you to.
You should take Olanzapine Accord 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. The coated tablets of Olanzapine Accord are for oral use. You must swallow the Olanzapine Accord tablets whole with water.

If you take more Olanzapine Accord than you should
Patients who have taken more Olanzapine Accord than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, difficulty speaking, unusual movements (particularly of the face or tongue), and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity and weakness or drowsiness, slowed breathing, aspiration, high or low blood pressure, or abnormal heart rhythm. Contact your doctor or hospital immediately if you experience any of these symptoms. Show your doctor the package of tablets.

If you forget to take Olanzapine Accord
Take the missed dose as soon as you remember. Do not take a double dose to make up for a forgotten tablet.

If you stop taking Olanzapine Accord
Do not stop treatment with the tablets just because you feel better. It is important that you continue taking Olanzapine Accord until your doctor tells you to stop.
If you suddenly stop treatment with Olanzapine Accord, you may experience symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, and vomiting. Your doctor may advise you to gradually reduce the dose before stopping treatment completely.
If you have any questions about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Speak to your doctor immediately if you have:

• Unusual movements (a common side effect which may affect up to 1 in 10 users), particularly of the face or tongue;
• Blood clots in the veins (an uncommon side effect which may affect up to 1 in 100 users), particularly in the legs (symptoms include swelling, pain and redness of the legs), which may travel through the blood vessels to the lungs causing chest pain and breathing difficulties. If any of these symptoms occur, consult a doctor immediately;
• A combination of fever, rapid breathing, sweating, muscle stiffness and weakness or drowsiness (the frequency of this side effect cannot be estimated from the available clinical data).

Very common side effects (may affect more than 1 in 10 users) include weight gain, drowsiness, increases in blood prolactin levels. In the early stages of treatment, some people may experience dizziness or fainting (with a slowed heartbeat), especially when standing up from a lying or sitting position. These symptoms usually resolve spontaneously, but if they do not, inform your doctor.
Common side effects (may affect up to 1 in 10 users) include changes in levels of certain blood cells, circulating fats, temporary increases in liver enzymes in the early stages of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; abnormal movements (dyskinesia); constipation; dry mouth; rash; loss of strength; extreme tiredness; fluid retention leading to swelling of the hands, ankles or feet; fever; joint pain; and 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 users) include allergic reactions (e.g. swelling of the mouth and throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketones in blood and urine) or coma; seizures, usually in individuals with a history of convulsions (epilepsy); muscle rigidity or spasms (including eye movements); restless legs syndrome; difficulty speaking; slowed heart rate; sensitivity to sunlight; nosebleeds; abdominal distension; memory loss or difficulty remembering; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; breast changes in males and females, such as abnormal milk secretion or abnormal breast growth.
Rare side effects (may affect up to 1 in 1,000 users) include decreased body temperature; heart rhythm abnormalities; 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 pain; and prolonged and/or painful erection.
Very rare side effects include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome).
DRESS is initially characterized by flu-like symptoms, such as rash on the face subsequently spreading to other areas, high temperature, swollen lymph nodes, elevated liver enzymes in blood tests, and an increase in a type of white blood cell (eosinophilia).
In elderly patients with dementia, treatment with olanzapine may be associated with stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and walking difficulties. Fatal cases have been reported in this specific patient group.
In patients with Parkinson’s disease, Olanzapina Accord 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 at https://www.aifa.gov.it/web/guest/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Olanzapine Accord

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and carton after 'Exp.'. The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Olanzapina Accord contains:
The active substance is olanzapine.
Each film-coated tablet contains 2.5 mg, 5 mg, 10 mg, or 20 mg of the active substance.
The tablet also contains: monohydrate lactose, microcrystalline cellulose, crospovidone,
hydroxypropylcellulose, magnesium stearate.
The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80
(E433). The 20 mg tablets additionally contain red iron oxide (E172).

Description of the appearance of Olanzapina Accord and package contents:
Olanzapina Accord 2.5 mg: Film-coated tablets, white to off-white, round, biconvex, smooth on both sides.
Olanzapina Accord 5 mg: Film-coated tablets, white to off-white, round, biconvex, with the code 'O1' engraved on one side and smooth on the other.
Olanzapina Accord 10 mg: Film-coated tablets, white to off-white, round, biconvex, with the code 'O3' engraved on one side and smooth on the other.
Olanzapina Accord 20 mg: Film-coated tablets, light pink, round, biconvex, smooth on both sides.

Olanzapina Accord is available in packs of 15, 28, 30, 35, 56, or 70 tablets for the 2.5 mg, 5 mg, and 10 mg strengths.
Olanzapina Accord is available in packs of 28, 30, 35, 56, or 70 tablets for the 20 mg strength.
Not all pack sizes may be marketed.

Marketing Authorization Holder:
Accord Healthcare S.L.U.
World Trade Center
Moll de Barcelona, s/n
Edificio Este 6ª planta
08039 Barcelona
Spain

Manufacturer:
Wessling Hungary Limited,
Fóti út 56,
Budapest, 1047
Hungary
Accord Healthcare Limited,
Sage House, 319, Pinner Road,
North Harrow,
Middlesex HA1 4HF,
United Kingdom

This medicinal product is authorized in the European Economic Area Member States under the following names:

This patient information leaflet was last approved on