OLANZAPINA 2.5 MG Film-coated tablets

Зміст інструкції

1. Olanzapina Accord 2.5 mg film-coated tablets, 5 mg film-coated tablets
   1. What is Olanzapina Accord and what is it 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. Package Contents and Other Information

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

Olanzapina Accord 10 mg film-coated tablets
Olanzapina Accord 20 mg film-coated tablets
Generic medicine

Read this leaflet carefully before you start taking this medicine as 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 pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell 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 you take 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 is Olanzapina Accord and what is it used for

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

• Schizophrenia, a disease characterized by symptoms such as hearing, seeing or perceiving things that have no basis in reality, false beliefs, unusual suspicion and detachment. People affected by this disease 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 other ingredients of this medicine (listed in section 6). An allergic reaction can be recognised as a skin rash, itching, swollen face, swollen lips or difficulty breathing. If this happens to you, tell 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 can cause unusual movements, especially of the face or tongue. If this happens after you have been given Olanzapina Accord, 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, seek immediate medical attention.
• Weight gain has been observed in patients taking Olanzapina Accord. You and your doctor should regularly monitor your weight. Consider consulting a dietitian or help with a diet, if necessary.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking Olanzapina Accord. Your doctor should perform blood tests to check your blood sugar and fat levels before taking Olanzapina Accord and, regularly, during treatment.
• Tell your doctor if you or someone in your family has a history of blood clots, as medicines of this type have been associated with the formation of blood clots.

If you suffer from any of the following conditions, tell your doctor immediately:

• Stroke or “mini”-stroke (transient stroke symptoms)
• Parkinson’s disease
• Problems with the prostate
• Bowel blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorder
• Heart disease
• Diabetes
• Epilepsy

If you suffer from dementia, you or the relative/person assisting you must inform the doctor if you have ever had
a stroke or a “mini”-stroke.
As a general precaution, if you are over 65 years of age, your blood pressure may be monitored by
your doctor.

Children and adolescents
Olanzapina Accord is not indicated for patients under 18 years of age.

Other medicines and Olanzapina Accord:
Only take other medicines while taking Olanzapina Accord if your doctor tells you that you can.
You may feel sleepy if you take Olanzapina Accord with antidepressant medicines, medicines for
anxiety or medicines that help you sleep (sedatives).
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 dose of Olanzapina Accord.

Olanzapina Accord with alcohol:
Do not drink alcoholic beverages if you have been given Olanzapina Accord, because taking
it at the same time as alcohol can cause you to feel sleepy.

Pregnancy and breastfeeding:
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding,
ask your doctor for advice before taking this medicine.
You should not take this medicine during breastfeeding, as small amounts of Olanzapina
Accord can pass into breast milk.
Newborn babies exposed to Olanzapina Accord in the last trimester of pregnancy (the last three months of pregnancy)
may experience the following adverse reactions: tremor, muscle stiffness and/or weakness, drowsiness,
restlessness, difficulty breathing and difficulty feeding. If your baby shows any of these
symptoms, contact your doctor.

Driving and using machines:
There is a risk of feeling sleepy when you are given Olanzapina Accord. If this
happens, do not drive or operate tools or machinery. Tell your doctor.

Olanzapina Accord contains lactose
If your doctor has told you that you have an intolerance to some sugars, talk to your doctor before
taking this medicine.

3. How to take Olanzapina Accord

Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your
doctor or pharmacist.
Your doctor will tell you the number of Olanzapina Accord tablets to take and for how long you should
continue taking them. The daily dose of Olanzapina Accord is between 5 and 20 mg. Consult your
doctor if your symptoms return, but do not stop taking Olanzapina Accord unless your doctor
tells you to.
You must take Olanzapina Accord once a day, following your doctor's instructions. Try to take
the tablets every day at the same time. It does not matter if you take them with or without food. The coated
tablets of Olanzapina Accord are for oral use. You must swallow the Olanzapina Accord tablets whole with water.

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

If you forget to take Olanzapina Accord
Take the tablets as soon as you remember. Do not take two doses in one day.

If you stop taking Olanzapina Accord
Do not stop taking the tablets just because you feel better. It is important that you continue to
take Olanzapina Accord until your doctor tells you to.
If you suddenly stop taking Olanzapina Accord, symptoms such as
sweating, inability to sleep, tremor, anxiety or nausea and vomiting may occur. Your doctor may suggest that you 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 movements (a common side effect that can affect up to 1 in 10 users) particularly of the face or tongue;
• Blood clots in the veins (an uncommon side effect that can affect 1 in 100 users) particularly in the legs (symptoms include swelling, pain and redness of the legs) which can move through the blood vessels to the lungs causing chest pain and difficulty breathing. 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 based on available clinical data).

Very common side effects (may affect more than 1 in 10 users) include weight gain, drowsiness, increases in prolactin levels in the blood. In the early stages of treatment, some people may experience a feeling of dizziness or fainting (with a slowing of the heartbeat), especially when getting up from a lying or sitting position. These symptoms usually pass spontaneously, but if this does not happen, inform your doctor.
Common side effects (may affect up to 1 in 10 users) include changes in the levels of some blood cells, circulating fats in the early stages of treatment a temporary increase in liver enzymes; increases in blood sugar and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; feeling of increased hunger; dizziness; restlessness; tremor; abnormal movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; extreme fatigue; water retention leading to swelling of the hands, ankles or feet; fever; joint pain and sexual dysfunction, such as decreased libido in men and women or erectile dysfunction in men.
Uncommon side effects (may affect up to 1 in 100 users) include allergic reaction (e.g. swelling in the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketones in the blood and urine) or coma; epileptic seizures, usually associated with a history of convulsions (epilepsy); muscle rigidity or spasms (including eye movements); restless legs syndrome; difficulty speaking; slowing of the heart rate; sensitivity to sunlight; nosebleeds; abdominal distension; loss of memory or difficulty remembering; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; changes in the breasts in men and women, such as abnormal milk secretion or abnormal growth.
Rare side effects (may affect up to 1 in 1,000 users) include decreased normal body temperature; heart rhythm abnormalities; sudden unexplained 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 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).
DRESS is initially characterized by flu-like symptoms, such as a rash on the face and then widespread, high temperature, enlarged lymph nodes, high levels of liver enzymes in blood tests and an increase in a type of white blood cells (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may be affected by stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, an increase in body temperature, skin flushing and problems walking. Some fatal cases have been reported in this particular group of patients.
In patients with Parkinson's disease, Olanzapina Accord may worsen symptoms.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through 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 Olanzapina Accord

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the blister and the packaging box after ‘Exp.’. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.
• Medicines should 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 ingredient is olanzapine.
Each film-coated tablet contains 2.5 mg, 5 mg, 10 mg or 20 mg of the active ingredient.
The tablet also contains: lactose monohydrate, microcrystalline cellulose, crospovidone,
hydroxypropylcellulose, magnesium stearate.
The film coating contains: hypromellose (E464), titanium dioxide (E171), macrogol 400, polysorbate 80
(E433). The 20 mg tablets contain red iron oxide (E172).

Description of the appearance of Olanzapina and package contents:
Olanzapina Accord 2.5 mg: Film-coated tablets, of colour from white to off-white, round in shape,
biconvex, smooth on both sides.
Olanzapina Accord 5 mg: Film-coated tablets, of colour from white to off-white, round in shape,
biconvex, with the inscription ‘O1’ embossed on one side and smooth on the other side.
Olanzapina Accord 10 mg: Film-coated tablets, of colour from white to off-white, round in shape,
biconvex, with the inscription ‘O3’ embossed on one side and smooth on the other side.
Olanzapina Accord 20 mg: Film-coated tablets, of light pink colour, round in shape, 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, 10 mg dosages.
Olanzapina Accord is available in packs of 28, 30, 35, 56 or 70 tablets for the 20 mg dosage.
Not all pack sizes may be marketed.

Marketing Authorisation 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 authorised in the Member States of the European Economic Area with the following denominations: