Olanzapine Doc Generici

PATIENT LEAFLET: INFORMATION FOR THE USER

OLANZAPINA DOC Generici 2.5 mg film-coated tablets, 5 mg film-coated tablets, 7.5 mg film-coated tablets, 10 mg film-coated tablets, 15 mg film-coated tablets, 20 mg film-coated tablets

Generic medicinal product
Please read 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 others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist.

Contents of this leaflet:

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

1. What OLANZAPINA DOC Generici is and what it is used for

OLANZAPINA DOC Generici belongs to a group of medicines called antipsychotics and is used to treat the following conditions:

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

OLANZAPINA DOC Generici 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 OLANZAPINA DOC Generici

Do not take OLANZAPINA DOC Generici

• if you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as skin rash, itching, facial swelling, swelling of the lips, or shortness of breath. If you have experienced any of these, 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 DOC Generici.

• The use of OLANZAPINA DOC Generici in elderly patients with dementia is not recommended, as it may cause serious adverse effects.
• Medicines of this type may cause unusual movements, particularly of the face and tongue. If this occurs after you have been given OLANZAPINA DOC Generici, inform your doctor.
• Very rarely, medicines of this type may cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, confusion, or drowsiness. If this occurs, consult your doctor immediately.
• Weight gain has been observed in patients taking OLANZAPINA DOC Generici. You and your doctor should monitor your weight regularly.
• Elevated blood levels of sugar and fats (triglycerides and cholesterol) have been observed in patients taking OLANZAPINA DOC Generici. Your doctor should perform blood tests to monitor your blood sugar and certain fat levels before you start taking OLANZAPINA DOC Generici 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) (transient stroke-like symptoms)
• Parkinson’s disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures

If you have dementia, you or your caregiver should inform your doctor if you have previously had a stroke or transient ischemic attack.
As a routine precaution, if you are over 65 years of age, have your blood pressure checked regularly by your doctor.

Children and adolescents
OLANZAPINA DOC Generici is not indicated for patients under 18 years of age.

Other medicines and OLANZAPINA DOC Generici
During treatment with OLANZAPINA DOC Generici, take other medicines only after obtaining approval from your doctor.
You may feel drowsy if OLANZAPINA DOC Generici 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 OLANZAPINA DOC Generici may need to be adjusted.

OLANZAPINA DOC Generici and alcohol
Do not drink any alcoholic beverages during treatment with OLANZAPINA DOC Generici, as taking OLANZAPINA DOC Generici together with alcohol may cause drowsiness.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, consult your doctor before taking this medicine. You must not take this medicine while breastfeeding, as small amounts of OLANZAPINA DOC Generici may pass into breast milk.
The following symptoms may occur in newborns of mothers who used OLANZAPINA DOC Generici 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 OLANZAPINA DOC Generici, there is a risk of drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.

OLANZAPINA DOC Generici contains lactose
If your doctor has informed you that you have an intolerance to certain sugars, contact your doctor before taking this medicine.

OLANZAPINA DOC Generici contains soya lecithin.
If you are allergic to peanuts or soya, do not take this medicine.

3. How to take OLANZAPINA DOC Generici

Take this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Your doctor will tell you how many OLANZAPINA DOC Generici tablets you should take and for how long
you should continue taking them. The dose of OLANZAPINA DOC Generici varies from 5 to 20 mg per
day. If your symptoms return, discuss this with your doctor, but do not stop taking
OLANZAPINA DOC Generici unless your doctor tells you to do so.
You should take OLANZAPINA DOC Generici tablets once daily, following your doctor's instructions.
Try to take the tablets at the same time each day. It does not matter whether you take them with or
without food. OLANZAPINA DOC Generici coated tablets are for oral use. Swallow the
OLANZAPINA DOC Generici tablets whole with water.

If you take more OLANZAPINA DOC Generici than you should
Patients who have taken more OLANZAPINA DOC Generici than recommended have experienced the
following symptoms: increased heart rate, agitation/aggression, speech problems, unusual movements
(especially of the face or tongue), and decreased level of consciousness. Other possible symptoms include:
acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle
rigidity, drowsiness or lethargy, 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 DOC Generici
Take the missed dose as soon as you remember. Do not take a double dose on the same day.

If you stop taking OLANZAPINA DOC Generici
Do not stop taking the tablets as soon as you start feeling better. It is important that you continue
treatment with OLANZAPINA DOC Generici for as long as your doctor considers necessary.
If you stop taking OLANZAPINA DOC Generici suddenly, you may experience symptoms such as
sweating, difficulty sleeping, 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 lower limbs (symptoms include swelling, pain and redness in the leg), which may travel through the blood vessels to the lungs causing chest pain and difficulty in breathing. If you notice any of these symptoms, consult a doctor 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 patients) include weight gain; drowsiness; increased levels of prolactin in the blood. In the initial stages of treatment, some people may experience dizziness or fainting (with slowing of the heartbeat), especially when standing up from a lying or sitting position. These effects usually resolve spontaneously, but if they do not, inform your doctor.

Common side effects (may affect up to 1 in 10 patients) include changes in levels of certain blood cells and circulating fats, and temporary increases in liver enzymes during the initial stages of treatment; increased levels of sugar in the blood and urine; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesias); constipation; dry mouth; skin 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 patients) include hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine) or coma; epileptic seizures, usually associated with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); speech problems; slowing of the heartbeat; sensitivity to sunlight; nosebleeds; abdominal swelling; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual cycles; and 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 patients) 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 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 rash on the face subsequently spreading, high temperature, swollen lymph nodes, elevated 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 at risk of stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and walking disorders. In this particular group of patients, some fatal cases have been reported.

In patients with Parkinson's disease, OLANZAPINA DOC Generici may cause worsening of symptoms.

Reporting of side effects

If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store OLANZAPINA DOC Generici

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack.
OLANZAPINA DOC Generici should be stored in its original packaging to protect it from light and moisture.
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. Package contents and other information

What OLANZAPINA DOC Generici contains

• The active substance is olanzapine. Each OLANZAPINA DOC Generici 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 OLANZAPINA DOC Generici packaging.
• The other components are:
• (tablet core): anhydrous lactose, microcrystalline cellulose, crospovidone, magnesium stearate; and
• (coating): polyvinyl alcohol, titanium dioxide (E171), talc, soy lecithin (E322), xanthan gum (E415).
• Additionally, the different strengths of OLANZAPINA DOC Generici contain the following excipients:

TABLET STRENGTH: ADDITIONAL EXCIPIENTS:
OLANZAPINA DOC Generici 15 mg film-coated tablet: indigo carmine (E132)
OLANZAPINA DOC Generici 20 mg film-coated tablet: iron oxide red (E172)

Description of the appearance of OLANZAPINA DOC Generici and contents of the pack
2.5 mg film-coated tablet: round, biconvex, white tablet, 6 mm in diameter, with "O" engraved on one side.
5 mg film-coated tablet: round, biconvex, white tablet, 8 mm in diameter, with "O1" engraved on one side.
7.5 mg film-coated tablet: round, biconvex, white tablet, 9 mm in diameter, with "O2" engraved on one side.
10 mg film-coated tablet: round, biconvex, white tablet, 10 mm in diameter, with "O3" engraved on one side.
15 mg film-coated tablet: oval, biconvex, light blue tablet, 7.35 x 13.35 mm in size, with "O" engraved on one side.
20 mg film-coated tablet: oval, biconvex, light pink tablet, 7.5 x 14.5 mm in size, with "O" engraved on one side.

Pack sizes:
OLANZAPINA DOC Generici 2.5 mg film-coated tablets: 28 tablets
OLANZAPINA DOC Generici 5 mg film-coated tablets: 28 tablets
OLANZAPINA DOC Generici 7.5 mg film-coated tablets: 28 and 56 tablets
OLANZAPINA DOC Generici 10 mg film-coated tablets: 28 and 56 tablets
OLANZAPINA DOC Generici 15 mg film-coated tablets: 28 and 56 tablets
OLANZAPINA DOC Generici 20 mg film-coated tablets: 28 and 56 tablets

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
DOC Generici Srl, Via Turati 40, 20121 Milano, Italy

Responsible manufacturer for batch release:
Actavis Hf., Reykjavikurvegi 78, P.O. Box 420, IS-222 Hafnafjordur, Iceland
Actavis Ltd., B16 Bulebel Industrial Estate, Zejtun ZTN 08, Malta

This medicinal product is authorized in EEA Member States under the following names:
IT: OLANZAPINA DOC Generici
DK: OLANZAPIN DOC Generici