Olanzapine Doc Generici

PACKAGE LEAFLET: INFORMATION FOR THE USER

OLANZAPINE DOC 5 mg orodispersible tablets, 10 mg orodispersible tablets, 15 mg orodispersible tablets, 20 mg orodispersible tablets

Equivalent medicine
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 other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

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

• Schizophrenia, a disorder characterized by symptoms such as hearing, seeing, or sensing things that are not real, false beliefs, unjustified suspiciousness, 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 DOC 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

Do not take OLANZAPINA DOC

• 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 this, 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 OLANZAPINA DOC

• The use of OLANZAPINA DOC in elderly patients with dementia is not recommended, as it may cause serious undesirable effects.
• Medicines of this type may cause unusual movements, especially of the face and tongue. If this occurs after you have been given OLANZAPINA DOC, inform your doctor.
• Very rarely, medicines of this type cause a combination of symptoms including fever, rapid breathing, sweating, muscle stiffness, and confusion or drowsiness. If this occurs, consult your doctor immediately.
• Weight gain has been observed in patients taking OLANZAPINA DOC. You and your doctor should monitor your weight regularly. If necessary, consider seeking advice from a dietitian or starting a diet program.
• High levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking OLANZAPINA DOC. Your doctor must request blood tests to monitor your blood sugar and certain blood fat levels before you start taking OLANZAPINA DOC and regularly during treatment.
• Inform your doctor if you or someone else in your family has a history of blood clots, as medicines like this have been associated with blood clot formation.

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

• Stroke or transient ischemic attack (temporary stroke symptoms) (TIA)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you know you may experience excessive loss of salt due to severe and prolonged diarrhea and vomiting (due to illness) or 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
OLANZAPINA DOC is not indicated for patients under 18 years of age.
Other medicines and OLANZAPINA DOC
During treatment with OLANZAPINA DOC, take other medicines only after obtaining approval from your doctor. You may feel drowsy if OLANZAPINA DOC 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 may need to be adjusted

OLANZAPINA DOC and alcohol
Do not drink any alcoholic beverages during treatment with OLANZAPINA DOC, as taking OLANZAPINA DOC together with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before taking this medicine. You must not take this medicine while breastfeeding, as small amounts of OLANZAPINA DOC may pass into breast milk.
The following symptoms may occur in newborns whose mothers have used OLANZAPINA DOC during the third trimester (last three months of pregnancy): tremor, 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, there is a risk that you may experience drowsiness. If this occurs, do not drive or operate tools or machinery. Inform your doctor.
OLANZAPINA DOC contains aspartame
Patients who cannot tolerate phenylalanine should be aware that OLANZAPINA DOC contains aspartame, which is a source of phenylalanine. It may cause harm to people with phenylketonuria.

3. How to take OLANZAPINE DOC

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 OLANZAPINE DOC tablets to take and for how long you should continue taking them. The daily dose of OLANZAPINE DOC ranges from 5 to 20 mg. If your symptoms return, discuss this with your doctor, but do not stop taking OLANZAPINE DOC unless your doctor tells you to do so.
You should take OLANZAPINE DOC 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. OLANZAPINE DOC orodispersible tablets are for oral use.
OLANZAPINE DOC orodispersible tablets break easily, so handle them with care. Avoid touching the tablets with wet hands, as they may disintegrate.

1. Open with dry hands. Do not push the tablet out of the blister
2. Separate one blister cavity from the rest of the strip
3. Carefully lift the backing foil
4. Remove the tablet from the blister
5. Place the tablet in the mouth. It will dissolve rapidly in the mouth, allowing it to be easily swallowed.

1 2 3 4 5
You may also place the tablet in a glass or cup containing water, orange juice, apple juice, milk, or coffee, and stir. With some beverages, the mixture may change colour and become slightly cloudy. Drink it immediately.
If you take more OLANZAPINE DOC than you should
Patients who have taken more OLANZAPINE DOC than recommended have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, unusual movements (especially of the face or tongue), and decreased level of consciousness. Other possible symptoms include: acute confusion, seizures (epilepsy), coma, or a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing, reduced cough reflex, high or low blood pressure, and changes in heart rhythm. Contact your doctor or go to hospital immediately if any of these symptoms occur. Show your doctor the medicine package.
If you forget to take OLANZAPINE DOC
Take the missed dose as soon as you remember. Do not take a double dose on the same day.
If you stop taking OLANZAPINE DOC
Do not stop taking the tablets as soon as you start feeling better. It is important to continue treatment with OLANZAPINE DOC for as long as your doctor considers necessary.
If you stop taking OLANZAPINE DOC suddenly, you may experience symptoms such as sweating, difficulty sleeping, tremor, anxiety, nausea, or 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 everyone gets them.

Tell your doctor immediately 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 of 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 people) 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 people) include changes in levels of certain blood cells and circulating fats, and temporary increases in liver enzymes during the initial 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; unusual movements (dyskinesias); 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 people) include hypersensitivity (e.g. swelling of the mouth and throat, itching, rash); diabetes or worsening of diabetes, occasionally associated with ketoacidosis (presence of ketone bodies in blood and urine) or coma; seizures, usually in patients with a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; slowing of the heartbeat; sensitivity to sunlight; nosebleeds; abdominal swelling; drooling; 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 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 presenting 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 and subsequently spreading, high fever, 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 tiredness, visual hallucinations, increased body temperature, skin redness, and walking disorders. Fatal cases have been reported in this particular patient group.

In patients with Parkinson's disease, OLANZAPINA DOC may worsen symptoms.

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/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 DOC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack.
OLANZAPINE DOC 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 contains

• The active substance is olanzapine. Each orodispersible tablet of OLANZAPINA DOC contains 5 mg, 10 mg, 15 mg or 20 mg of active substance. The exact amount is indicated on the OLANZAPINA DOC packaging.
• The other components are magnesium stearate, L-methionine, anhydrous colloidal silica, hydroxypropylcellulose (low substituted), crospovidone (Type B), aspartame, microcrystalline cellulose, guar gum, heavy magnesium carbonate and orange flavour.

Description of the appearance of OLANZAPINA DOC and package contents
OLANZAPINA DOC 5 mg orodispersible tablet is round, biconvex, yellow, 6 mm in diameter, with "O" engraved on one side.
OLANZAPINA DOC 10 mg orodispersible tablet is round, biconvex, yellow, 8 mm in diameter, with "O1" engraved on one side.
OLANZAPINA DOC 15 mg orodispersible tablet is round, biconvex, yellow, 9 mm in diameter, with "O2" engraved on one side.
OLANZAPINA DOC 20 mg orodispersible tablet is round, biconvex, yellow, 10 mm in diameter, with "O3" engraved on one side.
Orodispersible tablet is a technical term indicating a tablet that dissolves directly in the mouth, allowing it to be swallowed easily.
Packaging:
OLANZAPINA DOC orodispersible tablets 5 mg: 28 tablets in peelable blisters with press-through opening
OLANZAPINA DOC orodispersible tablets 10 mg: 28 tablets in peelable blisters with press-through opening
OLANZAPINA DOC orodispersible tablets 15 mg: 28 tablets in peelable blisters with press-through opening
OLANZAPINA DOC orodispersible tablets 20 mg: 28 tablets in peelable blisters with press-through opening
Not all pack sizes may be marketed.

Marketing Authorization Holder
DOC Generici Srl, via Turati 40, 20121 Milano

Manufacturer:
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 the EEA Member States under the following names:
IT: OLANZAPINA DOC 5 mg, 10 mg, 15 mg, 20 mg orodispersible tablets