Leaflet: information for the user

Olanzapine ratio 10 mg orally disintegrating tablets EFG

Olanzapine

Olanzapina ratio contains the active ingredient Olanzapina. Olanzapina ratio belongs to a group of medicines called antipsychotics.

Olanzapina ratio is used for:

?treating a condition with symptoms such as hearing, seeing or feeling things that are not real, false beliefs

unusual suspicion and a tendency to withdraw. People who suffer from these conditions may also be depressed, anxious or tense.

?treating a disorder characterized by symptoms such as feeling euphoric, having excessive energy, needing to sleep much less than usual, speaking very quickly with flight of ideas and, sometimes, considerable irritability. It is also a mood stabilizer that prevents the occurrence of extreme variations in mood.

Do not take Olanzapina ratio:

?If you are allergic to the active ingredient or any of the other components of

this medication (listed in section 6). An allergic reaction may manifest as

a rash, itching, swelling of the face or lips, or difficulty breathing. If this

happens, tell your doctor.

?If you have previously been diagnosed with eye problems such as certain types of

glaucoma (increased eye pressure).

Warnings and precautions

Consult your doctor or pharmacist before starting to take Olanzapina ratio

?Olanzapina ratio is not recommended for elderly patients with dementia, as it may

have severe side effects.

?Medications of this type may cause unusual movements, especially in the face or

tongue. If this happens after taking Olanzapina, tell your doctor.

?In rare cases, medications of this type can cause a combination of fever, rapid

breathing, sweating, muscle stiffness, and a state of confusion or somnolence. If this

happens, contact your doctor immediately.

?Patients taking Olanzapina have been observed to gain weight. You and your doctor

should regularly check your weight. If necessary, your doctor can help you plan a

diet or refer you to a nutritionist.

?Patients taking Olanzapina have been observed to have elevated levels of sugar and

fat (triglycerides and cholesterol) in the blood. Your doctor should perform blood

tests to monitor your blood sugar and fat levels before starting Olanzapina and

regularly during treatment.

?If you or a family member has a history of blood clots, consult your doctor, as

medications 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

• Transient cerebral ischemia or stroke symptoms.

If you have dementia, you or your caregiver should inform your doctor if you have ever had a stroke or transient cerebral ischemia.

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 old should not take Olanzapina ratio.

Other medications and Olanzapina ratio

Only use other medications at the same time as Olanzapina ratio if your doctor authorizes it. You may feel drowsy if you combine Olanzapina ratio with antidepressants or medications for anxiety or sleep (tranquilizers).

Inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as your Olanzapina ratio dose may need to be adjusted.

Inform your doctor or pharmacist if you are taking or have recently taken other medications or may need to take another medication.

Inform your doctor especially if you are using:

-Medication for Parkinson's disease.

-Carbamazepine (an antiepileptic and mood stabilizer), fluvoxamine (an antidepressant), or ciprofloxacin (an antibiotic). You may need to change your Olanzapina ratio dose.

Taking Olanzapina ratio with food, drinks, and alcohol

Olanzapina ratio can be taken with or without food.

Do not drink alcohol if you have been given Olanzapina ratio, as the combination of Olanzapina ratio and alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using this medication.

Pregnancy

Newborn babies of mothers who have taken Olanzapina ratio in the last trimester of pregnancy may experience the following symptoms: tremors, muscle stiffness, and/or weakness, somnolence, agitation, breathing difficulties, and feeding problems. If your newborn baby experiences any of these symptoms, contact your doctor.

Breastfeeding

Do not take this medication while breastfeeding, as small amounts of Olanzapina ratio may pass into breast milk.

Driving and operating machinery

Olanzapina ratio may cause symptoms such as drowsiness, dizziness, or visual disturbances, and may impair your ability to react. These effects, as well as the underlying condition, may make it difficult for you to drive vehicles or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities that require special attention, until your doctor assesses your response to this medication.

Olanzapina ratio contains lactose and aspartame

This medication contains lactose. If your doctor has told you that you have a lactose intolerance, consult with them before taking this medication.

This medication contains 4.50 mg of aspartame in each tablet.

Aspartame contains a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it correctly.

Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.consulte a su médico o farmacéutico si tiene dudas.

Your doctor will tell you how many tablets of Olanzapina ratio you should take and for how long.

The daily dose of Olanzapina ratio ranges from 5 mg to 20 mg. Consult with your doctor if you experience symptoms again, but do not stop taking Olanzapina ratio unless your doctor tells you to.

You should take your Olanzapina ratio tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. The tablets are for oral administration. Chew the tablets until they dissolve completely in your mouth.

If you take more Olanzapina ratio than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Patients who have taken more Olanzapina ratio than they should have experienced the following symptoms: rapid heartbeats, agitation/aggressiveness, speech problems, unusual movements (especially of the face and tongue) and a 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 respiratory frequency, aspiration, increased blood pressure or decreased blood pressure,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 interrupt treatment with Olanzapina ratio

Do not stop treatment when you feel better. It is very important that you continue taking Olanzapina ratio as long as your doctor tells you to.

If you suddenly stop taking Olanzapina ratio, you may experience symptoms such as sweating, inability to sleep, tremors, anxiety, nausea or vomiting. Your doctor may suggest gradually reducing the dose before stopping treatment.

Patients under 18 years old should not take Olanzapina ratio.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Immediately contact your doctor if you have:

?Unusual movements (a frequent side effect that can affect up to 1 in 10 patients) especially of the face or tongue

?Blood clots in the veins (a rare side effect that can affect up to 1 in 100 patients), especially in the legs (symptoms include sweating, pain, and redness in the leg), which can travel through the blood to the lungs, causing chest pain and difficulty breathing. If you experience any of these symptoms, see your doctor immediately

?Combination of fever, rapid breathing, sweating, muscle stiffness, and a state of confusion or drowsiness (frequency cannot be estimated from available data)

Side effects very common: (can affect more than 1 in 10 patients)

?Weight gain

?Drowsiness

?Increase in blood prolactin levels

?In the early stages of treatment, some people experience dizziness or fainting (with slower heart rate), especially when getting up from lying down or sitting. This sensation usually disappears spontaneously, but if it did not, report it to your doctor

Side effects common: (can affect up to 1 in 10 patients)

?Changes in levels of some blood cells, circulating lipids, and at the beginning of treatment temporary increases in liver enzymes

?Increase in blood sugar and urine levels

?Increase in uric acid, creatine phosphokinase in blood, and increase in alkaline phosphatase

?Increase in appetite

?Dizziness

?Restlessness

?Tremor

?Strange movements (dyskinesia)

?Constipation

?Dry mouth

?Skin rash

?Joint pain

?Muscle weakness

?Excessive fatigue

?Fluid retention causing inflammation of the hands, ankles, or feet

?Fever

?Sexual dysfunction such as decreased libido in men and women or erectile dysfunction in men

Side effects rare: (can affect up to 1 in 100 patients)

?Hypersensitivity (e.g. inflammation of the mouth and throat, itching, skin rash)

?Diabetes or worsening of diabetes, occasionally related to ketoacidosis (acetone in blood and urine) or coma

?Convulsions, in most cases related to a history of convulsions (epilepsy)

?Muscle stiffness or spasms (including eye movements)

?Restless legs syndrome

?Speech problems

?Slow pulse

?Abnormal heart rhythm

?Sensitivity to sunlight

?Nasal bleeding

?Blood clots such as deep vein thrombosis of the legs and blood clots in the lungs

?Abdominal distension

?Memory loss or forgetfulness

?Urinary incontinence

?Urinary retention

?Difficulty urinating

?Hair loss

?Absence or decrease in menstrual periods

?Changes in breast tissue in men and women such as abnormal milk production or growth

?Increase in total bilirubin

• Excessive salivation

Side effects rare (can affect up to 1 in 1000 patients)

?Decreased platelets

?Decrease in normal body temperature

?Withdrawal syndrome when stopping treatment

?Sudden death without apparent explanation

?Rapid pulse

?Pancreatitis, which causes severe stomach pain, fever, and discomfort

?Liver disease, with yellowing of the skin and white parts of the eyes

?Muscle disorder that presents as unexplained pain

?Prolonged and/or painful erection

Side effects of 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 in elderly patients with dementia treated with antipsychotics has been reported, compared to those who do not receive this treatment.

Olanzapine ratio may worsen symptoms in patients with Parkinson's disease.

In rare cases, women taking this type of medication for a long period may experience milk production by the mammary gland, stop menstruating, or have irregular periods. If this situation persists, consult your doctor. In very rare cases, babies born to mothers who have taken Olanzapine ratio in the last stage of pregnancy (third trimester) may experience tremor, drowsiness, or lethargy.

Severe allergic reactions, such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have been reported. DRESS initially presents with symptoms similar to the flu, with skin rash on the face that spreads to other areas, fever, lymph node swelling, elevated liver enzymes in blood tests, and increased levels of a type of white blood cell (eosinophilia).

Reporting of side effects:

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging and blister after "CAD". The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Olanzapine ratio:

- The active ingredient is olanzapine. Each tablet contains 10 mg of active ingredient.

- The other components are: Mannitol (E421), aspartame (E951), magnesium stearate

(E470B), crospovidone, lactose monohydrate, hydroxypropylcellulose (E463), lemon aroma.

Appearance of the product and contents of the packaging.

Olanzapine ratio 10 mg tablets are yellow, round, 10 mm in diameter.

Olanzapine ratio 10 mg is presented in tablet form. It is presented in packaging of 28 and 56 tablets.

Other presentations

Olanzapine ratio 5 mg: Packaging of 28 tablets.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Teva Pharma, S.L.U.

c/ Anabel Segura, 11, Edificio Albatros B, 1st floor,

Alcobendas, 28108, Madrid

Responsible for manufacturing:

Teva Pharma, S.L.U.

Malpica Industrial Estate c/ C 4,

50016 Zaragoza.

Date of the last review of this leaflet:April 2020

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/