Olanzapine Sandoz 5 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Olanzapina Sandoz 5 mg orodispersible tablets EFG
Olanzapina Sandoz 10 mg orodispersible tablets EFG
olanzapine
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 questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Olanzapina Sandoz is and what it is used for
- What you need to know before taking Olanzapina Sandoz
- How to take Olanzapina Sandoz
- Possible side effects
- How to store Olanzapina 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. It belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following conditions:
- Schizophrenia, a disorder whose symptoms include hearing, seeing, or sensing unreal things, false beliefs, unusual suspiciousness, and social withdrawal. People with this condition may also experience depression, tension, or anxiety.
- Moderate to severe manic episodes, a disorder characterized by symptoms of excitement or euphoria.
Olanzapine 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 Olanzapine Sandoz
Do not take Olanzapine Sandoz
- if you are allergic to olanzapine or to any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, tell your doctor immediately,
- 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 Olanzapine Sandoz.
- the use of olanzapine is not recommended in elderly patients with dementia, as they may experience serious adverse effects,
- medicines of this type may cause unusual movements, especially of the face or tongue. If this occurs after taking olanzapine, consult your doctor,
- rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness or lethargy. 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 refer you to a dietitian or help you plan a diet,
- high levels of sugar and fats (triglycerides and cholesterol) in the blood have been observed in patients taking olanzapine. Your doctor should perform blood tests to monitor your blood sugar levels and certain fat levels before starting olanzapine and regularly during treatment,
- consult 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 reduced blood flow to the brain (transient ischemic attack),
- Parkinson's disease,
- prostate problems,
- intestinal blockage (paralytic ileus),
- liver or kidney disease,
- blood disorders,
- heart disease,
- seizures,
- diabetes,
- seizures,
- if you think you may have loss of salts due to diarrhea and vomiting (feeling unwell) or due to the use of diuretic medicines (water tablets).
If you have dementia, you or your caregiver/family member should inform your doctor if you have ever had a stroke or reduced blood flow to the brain.
As a routine precaution, if you are over 65 years of age, your doctor should monitor your blood pressure.
Children and adolescents
Patients under 18 years of age must not take olanzapine.
Taking Olanzapine Sandoz with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Only use other medicines together with olanzapine if your doctor authorizes it, as you may experience increased drowsiness when olanzapine is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).
Specifically, consult your doctor if you are taking:
- medicines for Parkinson's disease,
- carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic), as your olanzapine dose may need to be adjusted.
Taking Olanzapine Sandoz with alcohol
You should not drink alcohol while taking olanzapine, as the combination may cause drowsiness.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine.
You should not take this medicine while breastfeeding, as small amounts of olanzapine may pass into breast milk.
The following symptoms may occur in newborns of mothers who have taken olanzapine 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
There is a risk of dizziness while taking olanzapine. If this occurs, do not drive or operate tools and machinery. Inform your doctor.
Olanzapine Sandoz contains lactose
This medicine contains lactose. If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.
3. How to take Olanzapina Sandoz
Follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again before using this medicine.
Your doctor will tell you how many olanzapine tablets you should take and for how long. The daily dose of olanzapine ranges between 5 and 20 mg.
Consult your doctor if your symptoms return, but do not stop taking olanzapine unless your doctor tells you to.
Olanzapine tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time every day. It does not matter whether you take them with or without food.
Olanzapine tablets are for oral administration.
Olanzapine tablets break easily and should therefore be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.
1 and 2. Hold the blister pack by the edges.
- Gently push the tablet through.
- Place the tablet in the mouth. It will dissolve directly and can be easily swallowed.
Alternatively, the tablet may be placed in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, and stirred. With some drinks, the mixture may change color and become cloudy. It should be drunk immediately.
If you take more Olanzapina Sandoz than you should
Patients who have taken more olanzapine than prescribed 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 blood pressure or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to the hospital if you experience any of the symptoms listed above. Show the doctor the medicine packaging.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, stating the medicine and the amount ingested.
If you forget to take Olanzapina Sandoz
Take your tablet as soon as you remember. Do not take a double dose to make up for the missed dose.
If you stop taking Olanzapina Sandoz
Do not stop treatment with olanzapine even if you feel better.
It is important that you continue taking olanzapine for as long as your doctor advises.
If you stop taking olanzapine suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, and vomiting may occur. Your doctor may recommend gradually reducing the dose before stopping treatment.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, olanzapine can have adverse effects, although not everyone experiences them.
Contact your doctor immediately if you have:
- unusual movements (a common adverse effect that may affect up to 1 in 10 people), especially of the face or tongue,
- blood clots in the veins (an uncommon adverse effect that may affect up to 1 in 100 people), especially in the legs (symptoms include sweating, pain and redness in the leg), which may travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, seek medical help immediately,
- a combination of fever, rapid breathing, sweating, muscle stiffness and a state of mental confusion or drowsiness (rare adverse effects that may affect up to 1 in 1,000 people).
Very common adverse effects (may affect more than 1 in 10 people) include:
- weight gain,
- drowsiness,
- increased levels of prolactin in the blood,
- in the early stages of treatment, some people may feel weak or dizzy (with a slow heart rate), especially when standing up from a sitting position. This usually resolves on its own, but if it does not, consult your doctor.
Common adverse effects (may affect up to 1 in 10 people) include:
- changes in levels of certain blood cells and circulating lipids,
- temporary increases in liver enzymes, especially at the beginning of treatment, increased blood and urine sugar levels,
- increased levels of uric acid and creatine phosphokinase in the blood,
- feeling more irritable,
- dizziness,
- restlessness,
- tremors,
- unusual movements (dyskinesias),
- 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 people) include:
- hypersensitivity (e.g. swelling of the mouth and throat, itching, rash),
- diabetes or worsening of diabetes, usually associated with ketoacidosis (ketones in blood and urine) or coma,
- seizures, usually associated with a history of seizures (epilepsy),
- muscle stiffness or spasms (including eye movements),
- restless legs syndrome,
- speech disorder,
- stuttering,
- slow heart rate,
- 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 breast 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 people) include:
- decrease in normal body temperature,
- abnormal heart rhythm,
- unexplained sudden 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.
Very rare adverse effects including severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially manifests with flu-like symptoms, skin rash on the face that then spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and increased levels of a type of white blood cell (eosinophilia).
During treatment with olanzapine, elderly patients with dementia may experience stroke, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, increased body temperature, skin redness, and walking difficulties. Deaths have been reported in this particular group of patients.
Olanzapine may worsen symptoms in patients with Parkinson's disease.
Reporting of adverse effects
If you experience any type of adverse effect, talk to 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 packaging and blister after EXP. The expiry date is the last day of the month indicated.
Store in the original packaging to protect it from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Package contents and other information
Composition of Olanzapine Sandoz
Olanzapine Sandoz 5 mg:
The active substance is olanzapine. Each orodispersible tablet contains 5 mg of olanzapine.
Olanzapine Sandoz 10 mg:
The active substance is olanzapine. Each orodispersible tablet contains 10 mg of olanzapine.
The other components are: crospovidone (Type A), monohydrate lactose, anhydrous colloidal silica, hydroxypropylcellulose, mint flavour (contains peppermint oil, terpene-free peppermint oil, eucalyptol, menthone, isomenthone, methylene acetate, menthol), talc, magnesium stearate.
Appearance of the product and pack sizes
Olanzapine Sandoz 5 mg are yellow, round, biconvex tablets with a diameter of approximately 6 mm and a thickness of 2.6 mm.
Olanzapine Sandoz 10 mg are yellow, round, flat tablets with a diameter of approximately 8.2 mm and a thickness of 2.4 mm.
Orodispersible tablets are technically defined as tablets that dissolve directly in the mouth, allowing for easy ingestion.
The orodispersible tablets are packaged in PA/ALU/PVC/ALU blisters inserted into cardboard cartons.
Pack sizes:
1, 14, 28, 35, 56, 70 and 98 orodispersible tablets.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz Farmacéutica, S.A.
Centro Empresarial Parque Norte
Edificio Roble
C/ Serrano Galvache, 56
28033 Madrid
Spain
Manufacturer
Pharmathen S.A.
6, Dervenakion str.,
153 51 Pallini Attiki
Greece
or
Salutas Pharma GmbH,
Otto-von-Guericke-Allee 1,
39179 Barleben,
Germany
or
LEK S.A.
ul. Domaniewska 50 C,
02-672 Warszawa,
Poland
or
LEK, S.A.
Ul Podlipie, 16
Strykow - PL95-010
Poland
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany: Olanzapin HEXAL 5 mg Schmelztabletten
Olanzapin HEXAL 10 mg Schmelztabletten
Belgium: Olanzapine Sandoz 5 mg, orodispergeerbare tabletten
Olanzapine Sandoz 10 mg, orodispergeerbare tabletten
France: OLANZAPINE SANDOZ 5 mg, comprimé orodispersible
OLANZAPINE SANDOZ 10 mg, comprimé orodispersible
Portugal: Olanzapina Sandoz
Sweden: Olanzapin Sandoz 5 mg munsönderfallande tabletter
Olanzapin Sandoz 10 mg munsönderfallande tabletter
Date of the most recent revision of this leaflet: June 2020
Detailed and up-to-date 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