Olanzapine Sandoz 5 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
Olanzapine Sandoz 5 mg film-coated tablets EFG
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- Keep this leaflet as 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 and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.
Contents of the leaflet
- What Olanzapine Sandoz is and what it is used for
- What you need to know before taking Olanzapine Sandoz
- How to take Olanzapine Sandoz
- Possible side effects
- How to store Olanzapine Sandoz
- Contents of the pack and other information
1. What Olanzapina Sandoz is and what it is used for
Olanzapina Sandoz contains the active substance olanzapine. Olanzapina Sandoz belongs to a group of medicines called antipsychotics, which are 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, unusual suspiciousness, and social withdrawal. People with this condition may also feel depressed, anxious, or tense. -
Moderate to severe manic episodes, a disorder characterized by symptoms such as excitement or euphoria.
Olanzapina Sandoz 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 Sandoz
Do not take Olanzapina Sandoz
- if you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). The allergic reaction may appear as a rash, itching, swelling of the face or 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 in the eye).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Olanzapina Sandoz.
- the use of olanzapine in elderly patients with dementia is not recommended, as it may cause serious adverse reactions,
- medicines of this type may cause unusual movements, especially in the face or tongue. If this happens to you after taking olanzapine, tell your doctor,
- very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, contact your doctor immediately,
- weight gain has been observed in patients taking olanzapine. You and your doctor should monitor your weight regularly. If necessary, your doctor may help you plan a diet or consider referring you to a nutritionist,
- elevated levels of blood sugar and fats (triglycerides and cholesterol) have been observed in patients taking olanzapine. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking olanzapine and regularly during treatment,
- if you or someone in your family has a history of blood clots, consult your doctor, as medicines of this type 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 (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 think you may have salt loss due to prolonged severe diarrhea and vomiting, or from taking diuretic medicines (water tablets).
If you have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient lack of blood flow to the brain.
As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.
Children and adolescents
Olanzapine is not indicated for patients under 18 years of age.
Taking Olanzapina Sandoz with other medicines
Only take any other medicine while taking olanzapine if your doctor tells you it is safe to do so. You may feel dizzy if you take olanzapine together with antidepressants or medicines used to treat anxiety or to help you sleep (tranquilizers).
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
In particular, inform your doctor if you are taking:
- medication for Parkinson's disease,
- carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as it may be necessary to adjust the dose of Olanzapina Sandoz.
Taking Olanzapina Sandoz with food and drink and alcohol
You should not drink alcohol if you are taking Olanzapina Sandoz, as combining it with alcohol may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before taking this medicine.
You should not take this medicine while breastfeeding, as small amounts of Olanzapina Sandoz may pass into breast milk.
The following symptoms may occur in newborns whose mothers have taken Olanzapina Sandoz during the third trimester of pregnancy (last three months of pregnancy): tremors, muscle stiffness and/or weakness, sleep disturbances, agitation, breathing difficulties, feeding problems. If your baby develops any of these symptoms, you may need to contact your doctor.
Driving and using machines
There is a risk of drowsiness when taking Olanzapina Sandoz. If this occurs, do not drive or operate tools or machinery. Discuss this with your doctor.
Olanzapina Sandoz contains lactose.
This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Olanzapine Sandoz
Follow exactly the instructions given by your doctor for taking this medicine. If you have any doubts, consult your doctor or pharmacist.
Your doctor will tell you how many Olanzapine Sandoz tablets to take and for how long. The daily dose of Olanzapine Sandoz ranges from 5 mg to 20 mg.
Contact your doctor if your symptoms return, but do not stop taking Olanzapine Sandoz unless your doctor tells you to.
You should take your Olanzapine Sandoz 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. Olanzapine Sandoz coated tablets are for oral administration. Swallow the tablets with water.
The film-coated tablet may be divided into equal doses.
If you take more Olanzapine Sandoz than you should
Patients who have taken more olanzapine than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech difficulties, unusual movements (especially of the face and tongue), and reduced level of consciousness. Other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing rate, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or hospital immediately if you experience any of the above symptoms. Show the doctor the tablet packaging.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Poison Information Service at 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to take Olanzapine Sandoz
Take your tablet as soon as you remember. Do not take two doses on the same day.
If you stop taking Olanzapine Sandoz
Do not stop taking your tablets just because you feel better. It is important to continue taking olanzapine for as long as your doctor tells you to.
If you suddenly stop taking Olanzapine Sandoz, 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 further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
Contact your doctor immediately if you experience:
-
unusual movements (a common adverse effect that may affect up to 1 in 10 patients), mainly in the face or tongue,
-
blood clots in the veins (an uncommon adverse effect that may affect up to 1 in 100 patients), especially in the legs (symptoms include swelling, pain and redness in the legs), which may travel through the blood vessels to the lungs causing chest pain and difficulty breathing. If you notice any of these symptoms, contact your doctor immediately,
-
a combination of fever, increased breathing rate, sweating, muscle stiffness and dizziness or drowsiness (a rare adverse effect that may affect up to 1 in 1,000 patients).
Very common adverse effects (may affect more than 1 in 10 patients):
- weight gain,
- drowsiness,
- increased levels of prolactin in the blood,
- during the initial stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when getting up from lying down or sitting. This sensation usually resolves spontaneously, but if it does not, consult your doctor.
Common adverse effects (may affect up to 1 in 10 patients):
- changes in levels of certain blood cells and circulating lipids,
- temporary increases in liver enzymes at the beginning of treatment,
- increased levels of blood and urine sugar,
- increased levels of uric acid and creatine phosphokinase in the blood,
- increased appetite,
- dizziness,
- restlessness,
- tremor,
- unusual movements (dyskinesia),
- constipation,
- dry mouth,
- skin rash,
- loss of strength,
- excessive tiredness,
- fluid retention causing swelling of the hands, ankles or feet,
- fever,
- joint pain,
- sexual dysfunction such as decreased libido in men and women, or
- erectile dysfunction in men.
Uncommon adverse effects (may affect up to 1 in 100 patients):
- hypersensitivity (e.g. swelling of the mouth and throat, itching, skin rash),
- diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma,
- seizures, which in most cases are related to a history of seizures (epilepsy),
- muscle stiffness or spasms (including eye movements),
- speech problems,
- stuttering,
- slow pulse,
- sensitivity to sunlight,
- nosebleeds,
- abdominal distension,
- excessive salivation,
- memory loss or forgetfulness,
- urinary incontinence, loss of ability to urinate,
- hair loss,
- absence or reduction of menstrual periods,
- changes in the mammary gland in men and women such as abnormal production of breast milk or abnormal growth.
Rare adverse effects (may affect up to 1 in 1,000 patients):
- decrease in normal body temperature,
- abnormal heart rhythm,
- sudden unexplained death,
- inflammation of the pancreas, causing severe stomach pain, fever and malaise,
- liver disease, with yellowing of the skin and whites of the eyes,
- muscle disorder presenting as unexplained muscle pains,
- prolonged and/or painful erection.
During treatment with olanzapine, elderly patients with dementia may experience cerebrovascular adverse effects, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness and difficulty walking. Fatal outcomes have been reported in this particular group of patients.
Olanzapine Sandoz may worsen symptoms in patients with Parkinson's disease.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Olanzapine Sandoz
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and on the blister/label of the HDPE bottle after EXP. The expiry date refers to the last day of the month indicated.
This medicine does not require any special storage conditions.
Storage conditions after first opening of the bottle:
Do not store above 25°C.
Shelf life after first opening of the bottle:
6 months.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and packaging. This will help protect the environment.
6. Pack contents and other information
Composition of Olanzapina Sandoz
The active substance is olanzapine.
Each film-coated tablet contains 5 mg of olanzapine.
The other components are:
Tablet core: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, magnesium stearate.
Tablet coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E 171), and talc.
Appearance of the product and pack contents
Film-coated tablets, white, round, biconvex, approximately 8 mm in diameter, with the inscription "5" in relief on one side and a score line on the other side.
Film-coated tablets are supplied in aluminium/aluminium blisters inserted into cardboard packaging or in HDPE bottles with a desiccant in the cap.
Pack sizes:
Blister: 7, 10, 14, 20, 28, 30, 35, 50, 56, 60, 70, 98, 100, 500 film-coated tablets.
HDPE bottles: 50, 100, 250, 500 film-coated tablets.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Sandoz Farmacéutica, S.A.
Parque Norte Business Centre
Roble Building
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1,
D-39179 Barleben
Germany
or
LEK S.A.
Ul. Podlipie 16 C,
PL-95 010 Strykow
Poland
or
LEK S.A.
Ul. Domaniewska 50 C,
PL-02-672 Warszawa
Poland
or
Lek Pharmaceuticals d.d
Verovskova 57
SI-1526 Ljubljana
Slovenia
or
Lek Pharmaceuticals d.d.
Trimlini 2 D
9220 Lendava
Slovenia
This medicinal product is authorized in the European Economic Area member states under the following names:
Austria: Olanzapin Sandoz 5 mg - Filmtabletten
Belgium: Olanzapine Sandoz 5 mg filmomhulde tabletten
Denmark: Olanzapin “Sandoz”
Finland: Olanzapin Sandoz 5 mg tabletti, kalvopäällysteinen
France: Olanzapine Sandoz 5 mg, comprimé pelliculé
United Kingdom: Olanzapine Sandoz 5 mg Film-coated Tablets
Greece: Olanzapin/Sandoz 5 mg δισκ?α επικαλυμμ?να με λεπτ? υμ?νιο
Iceland: Olanzapin Sandoz 5 mg filmuhúðaðar töflur
Italy: Olanzapina Sandoz 5 mg compresse rivestite con film
Netherlands: Olanzapine Sandoz 5 mg, filmomhulde tabletten
Sweden: Olanzapin Sandoz 5 mg filmdragerade tabletter
Date of the most recent review of this leaflet: November 2019
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/