Olanzapine Ratio 10 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Olanzapine ratio 10 mg orodispersible tablets EFG
Olanzapine
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
Contents of the leaflet:
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1. What Olanzapina ratio is and what it is used for
Olanzapina ratio contains the active substance Olanzapina. Olanzapina ratio belongs to a group of medicines called antipsychotics.
Olanzapina ratio is used to:
• treat an illness with symptoms such as hearing, seeing, or feeling things that are not real, false beliefs, unusual suspiciousness, and a tendency to withdraw socially. People with these conditions may also feel depressed, anxious, or tense.
• treat a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing much less sleep than usual, speaking very rapidly with racing thoughts, and sometimes having considerable irritability. It is also a mood stabilizer that helps prevent extreme mood swings.
2. What you need to know before taking Olanzapina ratio
Do not take Olanzapina ratio:
? If you are allergic to the active substance or to any of the other components of
this medicine (listed in section 6). The allergic reaction may manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this happens to you, inform 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
Consult your doctor or pharmacist before starting to take Olanzapina ratio.
? The use of olanzapine is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
? Medicines of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking Olanzapina, inform your doctor.
? Very rarely, medicines of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If you experience these symptoms, 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 dietitian.
? 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 Olanzapina 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:
- Diabetes
- Heart disease
- Liver or kidney disease
- Parkinson's disease
- Epilepsy
- Prostate problems
- Intestinal blockage (paralytic ileus)
- Blood disorders
- Stroke or transient ischemic attack (temporary stroke-like symptoms)
If you suffer from dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischemic attack.
As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.
Children and adolescents
Patients under 18 years of age must not take Olanzapina ratio.
Other medicines and Olanzapina ratio
Only take other medicines together with Olanzapina ratio if authorized by your doctor. You may experience increased drowsiness if Olanzapina ratio is taken together with antidepressants or medications for anxiety or sleep (tranquilizers).
Inform your doctor if you are taking fluvoxamine (an antidepressant) or ciprofloxacin (an antibiotic), as your dose of Olanzapina ratio may need to be adjusted.
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, or if you might need to take another medicine.
Specifically 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). Your dose of Olanzapina ratio may need to be adjusted.
Taking Olanzapina ratio with food, drinks and alcohol
Olanzapina ratio may be taken with or without food.
You must not drink alcohol while taking Olanzapina ratio, as the combination of Olanzapina ratio and alcohol 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.
Pregnancy
Newborns of mothers who have taken Olanzapina ratio during the third trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor.
Breastfeeding
You must not take this medicine while breastfeeding, as small amounts of Olanzapina ratio may pass into breast milk.
Driving and using machines
Olanzapina ratio may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. These effects, as well as the illness itself, may impair your ability to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring special attention until your doctor has assessed your response to this medicine.
Olanzapina ratio contains lactose and aspartame
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.
This medicine contains 4.50 mg of aspartame per tablet.
Aspartame is a source of phenylalanine, which may be harmful in individuals with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot properly eliminate it.
3. How to take Olanzapina ratio
Follow exactly the instructions for use of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Your doctor will tell you how many Olanzapina ratio tablets you should take and for how long.
The daily dose of Olanzapina ratio ranges between 5 mg and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Olanzapina ratio unless instructed by your doctor.
You should take your Olanzapina ratio tablets once daily, as directed by your doctor. Try to take the tablets at the same time every day. The tablets are for oral use. Allow the tablets to dissolve completely in your mouth by sucking on them.
If you take more Olanzapina ratio than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
Patients who have taken more Olanzapina ratio than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue), and reduced 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, aspiration, increased or decreased blood pressure, and abnormal heart rhythms.
If you forget to take Olanzapina ratio
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 ratio
Do not stop treatment just because you feel better. It is very important that you continue taking Olanzapina ratio for as long as your doctor advises.
If you suddenly stop taking Olanzapina ratio, you may experience symptoms such as sweating, inability to sleep, tremor, anxiety, nausea, or vomiting. Your doctor may recommend gradually reducing the dose before stopping treatment.
Olanzapina ratio must not be used in patients under 18 years of age.
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 have:
• Unusual movements (a common adverse effect that may affect up to 1 in 10 patients), especially of the face or tongue
• Blood clots in the veins (an uncommon adverse effect that may affect up to 1 in 100 patients), particularly in the legs (symptoms include sweating, pain, and redness in the leg), which may travel through the blood 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 mental confusion or drowsiness (frequency cannot be estimated from available data)
Very common adverse effects: (may affect more than 1 in 10 patients)
• Weight gain
• Drowsiness
• Increased levels of prolactin in the blood
• In the early stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when standing up from lying or sitting positions. This sensation usually resolves spontaneously, but if it does not, inform your doctor
Common adverse effects: (may affect up to 1 in 10 patients)
• Changes in levels of certain blood cells, circulating lipids, and temporary increases in liver enzymes at the beginning of treatment
• Increased levels of sugar in blood and urine
• Increased levels of uric acid, creatine phosphokinase in blood, and increased alkaline phosphatase
• Increased appetite
• Dizziness
• Agitation
• Tremor
• Unusual movements (dyskinesia)
• Constipation
• Dry mouth
• Skin rash
• Joint pain
• Loss of strength
• Excessive fatigue
• Fluid retention causing swelling of the hands, ankles, or feet
• Fever
• 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., mouth and throat swelling, itching, skin rash)
• Diabetes or worsening of diabetes, occasionally associated with ketoacidosis (ketones in blood and urine) or coma
• Seizures; in most cases, these are related to a history of seizures (epilepsy)
• Muscle stiffness or spasms (including eye movements)
• Restless legs syndrome
• Speech problems
• Slow pulse
• Abnormal heart rhythm
• Sensitivity to sunlight
• Nosebleeds
• Blood clots such as deep vein thrombosis in the legs and blood clots in the lung
• Abdominal distension
• Memory loss or forgetfulness
• Urinary incontinence
• Urinary retention
• Difficulty urinating
• Hair loss
• Absence or reduction of menstrual periods
• Breast gland changes in men and women such as abnormal production of breast milk or abnormal growth
• Increased total bilirubin
• Excessive salivation
Rare adverse effects: (may affect up to 1 in 1000 patients)
• Decreased platelet count
• Decrease in normal body temperature
• Withdrawal syndrome upon discontinuation of treatment
• Sudden unexplained death
• Rapid pulse
• Inflammation of the pancreas, causing severe stomach pain, fever, and discomfort
• Liver disease, with yellowing of the skin and whites of the eyes
• Muscle disorder presenting as unexplained muscle pains
• Prolonged and/or painful erection
Adverse effects with unknown frequency (cannot be estimated from available data)
• Withdrawal syndrome in newborns
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.
A small increase in the number of deaths has been reported in elderly patients with dementia treated with antipsychotics, compared to those not receiving this treatment.
Olanzapina ratio may worsen symptoms in patients with Parkinson's disease.
Rarely, women who take this type of medicine for a long time may experience milk secretion from the breast gland, stop having monthly periods, or have irregular periods. If this situation persists, consult your doctor. Very rarely, babies born to mothers who took Olanzapina ratio during the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.
Severe allergic reactions have been reported, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially manifests with flu-like symptoms, facial rash that spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).
Reporting of adverse effects:
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects 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. Olanzapine ratio Storage
Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging and blister after "EXP". The expiry date refers to the last day of the month indicated.
Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at the SIGRE Point located at your pharmacy. If you are unsure how to dispose of unused medicines and their packaging, please consult your pharmacist. This will help protect the environment.
6. Contents of the pack and other information
Composition of Olanzapine ratio:
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The active substance is olanzapine. Each tablet contains 10 mg of active substance.
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The other components are: Mannitol (E421), aspartame (E951), magnesium stearate (E470B), crospovidone, lactose monohydrate, hydroxypropylcellulose (E463), lemon flavor.
Appearance of the product and contents of the pack
Olanzapine ratio 10 mg tablets are yellow, round, 10 mm in diameter.
Olanzapine ratio 10 mg is presented as tablets. It is available in packs of 28 and 56 tablets.
Other presentations
Olanzapine ratio 5 mg: Pack of 28 tablets.
Marketing Authorisation Holder and Manufacturer:
Marketing Authorisation Holder
Teva Pharma, S.L.U.
C/ Anabel Segura, 11, Edificio Albatros B, 1st floor,
Alcobendas, 28108, Madrid, Spain
Manufacturer:
Teva Pharma, S.L.U.
Polígono Malpica c/ C 4,
50016 Zaragoza, Spain.
Date of the most recent review of this leaflet: April 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/