Package Insert: Information for the

Olanzapine TecniGen 5 mg Coated Tablets

Additional Information

Olanzapina belongs to a group of medicines called antipsychotics.

Olanzapina TecniGen is used to treat

-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 this condition may also be depressed, anxious or tense.

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

Do not take Olanzapina TecniGen:

• If you are allergic (hypersensitive) to olanzapina or to any of the other components of Olanzapina. 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 narrow-angle glaucoma.

Be especially careful with Olanzapina TecniGen:

• This type of medication may cause unusual movements, especially in the face or on the tongue. If this happens after taking Olanzapina, tell your doctor.
• Very rarely, this type of medication produces a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness. If this happens, contact your doctor immediately.
• If you or a family member has a history of blood clots, these medications may be associated with the formation of the same.

If you have any of the following diseases, tell 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

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.

Children and adolescents under 18 years

Patients under 18 years should not take Olanzapina

Seniors

The use of Olanzapina in elderly patients with dementia is not recommended as it may have severe adverse effects.

As a routine precaution, if you are over 65 years old, it would be a good idea for your doctor to check your blood pressure.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those purchased without a prescription.

Inform your doctor especially if you are taking medication for Parkinson's disease.

Only take other medications at the same time as Olanzapina if your doctor authorizes it. You may feel a certain sense of drowsiness if you combine olanzapina with antidepressants or medications for anxiety or to help sleep (tranquilizers).

You should inform your doctor if you are taking fluvoxamine (antidepressant) or ciprofloxacin (antibiotic), as it may be necessary to modify your Olanzapina dose.

Taking Olanzapina with food and drinks

Olanzapina can be taken with or without food.

You should not drink alcohol if you have been given Olanzapina because the combination of Olanzapina and alcohol may cause drowsiness.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or think you may be pregnant, consult your doctor before taking this medication. You should not take this medication during pregnancy unless your doctor recommends it.

Newborns of mothers who have used Olanzapina TecniGen in the last trimester of pregnancy may exhibit the following symptoms: tremors, muscle stiffness, and/or weakness, drowsiness, agitation, breathing problems, and feeding difficulties. If your newborn exhibits any of these symptoms, contact your doctor.

You should not take this medication while breastfeeding as small amounts of Olanzapina may pass into breast milk.

Driving and using machines

There is a risk of drowsiness when taking Olanzapina. If this happens, do not drive vehicles or use machinery. Consult your doctor.

Important information about some of the components of Olanzapina

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medication.

Follow exactly the administration instructions for Olanzapina as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will tell you how many Olanzapina tablets to take and for how long. The daily dose of Olanzapina ranges from 5 to 20 mg. Consult your doctor if you experience symptoms again, but do not stop taking Olanzapina unless your doctor tells you to.

You should take your Olanzapina tablets once a day, following your doctor's instructions. Try to take the tablets at the same time every day. You can take them with or without food. Olanzapina tablets are for oral administration.

Swallow the tablets whole with water.

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

If you take more Olanzapina than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested. It is recommended to bring the packaging and the medication leaflet to the healthcare professional.

Patients who have taken more Olanzapina than they should have experienced the following symptoms: rapid heartbeat, agitation/aggression, speech problems, unusual movements (especially of the face and tongue) and reduced 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 or decreased blood pressure, abnormal heart rhythms. Contact your doctor or go to the hospital immediately. Show the doctor the packaging with the tablets.

If you forget to take Olanzapina

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

Do not stop taking Olanzapina unless your doctor tells you to.

If you suddenly stop taking Olanzapina, 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.

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

Like all medications, Olanzapina may cause side effects, although not everyone will experience them.

In this prospectus, when a side effect is defined as “infrequent”, it means it has been reported in more than 1 in 1,000 patients. When a side effect is defined as “rare”, it means it has been reported in more than 1 in 10,000 patients, but less than 1 in 1,000. When a side effect is defined as “very rare”, this means it has been reported in less than 1 in 10,000 patients.

The side effects of Olanzapina may include excessive drowsiness or fatigue, weight gain, dizziness, increased appetite, fluid retention, constipation, dry mouth, agitation, unusual movements (especially of the face or tongue), tremors, muscle stiffness or spasms, language alterations, and changes in some circulating blood cells and fats. In some patients, pancreatitis has developed in very rare cases, causing severe stomach pain, fever, and discomfort.

As infrequent side effects, the “restless legs syndrome” and excessive salivation have been reported.

Some people experience dizziness or fainting (with slower heartbeats) in the early stages of treatment, especially when getting up from lying down or sitting. This sensation usually disappears spontaneously, but if it does not, inform your doctor.

Abnormal heart rhythms that can be serious have been reported in very rare cases.

During treatment with olanzapina, elderly patients with dementia may experience strokes, pneumonia, urinary incontinence, falls, extreme fatigue, visual hallucinations, elevated body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.

Olanzapina may worsen symptoms in patients with Parkinson's disease.

In rare cases, Olanzapina could cause an allergic reaction (e.g., inflammation of the mouth and throat, itching, rash), slow heart rate, or sensitivity to sunlight. Liver diseases have also been reported in rare cases. In very rare cases, prolonged and painful erections or difficulty urinating, decreased normal body temperature, blood clots (e.g., deep vein thrombosis in the legs), or muscle disorders (e.g., unexplained pain) have been reported. Some patients, in very rare cases, have experienced high blood sugar levels or initial symptoms of worsening diabetes, with ketoacidosis (acetone in the blood and urine) or coma.

Blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness in the leg), can break loose and travel through the bloodstream to the lungs, causing chest pain and difficulty breathing. If you observe any of these symptoms, consult a doctor immediately.

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 eosinophils.

In rare cases, women taking this type of medication for a long period may experience milk secretion from the mammary gland, irregular or absent menstrual periods, or irregular menstrual periods. If this situation persists, consult your doctor.

Very rarely, babies born to mothers who took Olanzapina in the last stage of pregnancy (third trimester) may experience tremors, drowsiness, or lethargy.

Seizures may occur in rare cases. In most cases, there were pre-existing seizure disorders (epilepsy).

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

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

Do not store at a temperature above 25°C.Store in the original packaging to protect it from light and moisture.

Medicines should not be disposed of through drains or in the trash.Deposit the packaging and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, askyour pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Olanzapina TecniGen 5 mg

The active ingredient is olanzapina. Each tablet contains 5 mg of active ingredient.

The other components are:Core: lactose monohydrate, hydroxypropylcellulose, crospovidone, microcrystalline cellulose, and magnesium stearate.Coating: Hydroxypropylmethylcellulose 6cP, titanium dioxide, and polyethylene glycol 400.

Appearance of Olanzapina TecniGen 5 mg and packaging contents

Olanzapina TecniGen 5 mg is presented in the form of coated tablets with a round, unnotched, yellow core, and white coating.

It is presented in a blister pack with 28 tablets. Some packaging sizes may only be commercially available.

Other presentations:

Olanzapina TecniGen 10 mg tablets EFG, 28 tablets

OlanzapinaTecniGen10 mg tablets EFG, 56 tablets

Marketing Authorization Holder

Tecnimede España Industria Farmacéutica S.A
Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid) SPAIN
Tel: 91 383 51 66
Fax: 91 383 51 67
E-mail: [email protected]

Responsible for Manufacturing

West Pharma - Producções de Especialidades Farmacêuticas, S.A.

Rua João de Deus, nº 11, Venda Nova. 2700 Amadora.

PORTUGAL

Atlantic Pharma – Produções Farmacêuticas SA

Rua da Tapada Grande nº 2, Abrunheira. 2710 – 089 Sintra (Portugal).

This leaflet was revised in January 2020

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