Olanzapine Almus 5 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Olanzapina Almus 5 mg film-coated tablets EFG

Read the entire 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 questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Olanzapina Almus 5 mg film-coated tablets are and what they are used for
2. What you need to know before taking Olanzapina Almus 5 mg film-coated tablets
3. How to take Olanzapina Almus 5 mg film-coated tablets
4. Possible side effects
5. How to store Olanzapina Almus 5 mg film-coated tablets
6. Contents of the pack and other information

1. What Olanzapina Almus 5 mg coated tablets is and what it is used for

Olanzapine belongs to a group of medicines called antipsychotics.

Olanzapina Almus is used to treat

• Schizophrenia, a condition with symptoms such as hearing, seeing, or sensing things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. People with this illness may also feel depressed, anxious, or tense.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Olanzapina Almus 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 starting Olanzapine Almus 5 mg film-coated tablets

Do not take Olanzapine Almus

• If you are allergic (hypersensitive) to olanzapine or to any of the other ingredients of olanzapine (listed in section 6). The allergic reaction may manifest as rash, itching, swelling of the face or lips, or difficulty breathing. If this occurs, 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

Consult your doctor or pharmacist before starting to take Olanzapina Almus 5 mg film-coated tablets.

• Olanzapina Almus is not recommended for use in elderly patients with dementia, as it may cause serious adverse effects.
• Medications of this type may cause unusual movements, especially in the face or tongue. If this occurs after taking olanzapine, inform your doctor.
• Very rarely, medications of this type may cause a combination of fever, rapid breathing, sweating, muscle stiffness, and drowsiness. If this occurs, contact your doctor immediately.
• Weight gain has been observed in patients taking Olanzapina Almus. 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 Olanzapina Almus. Your doctor should perform blood tests to monitor your blood sugar and lipid levels before you start treatment and regularly during treatment.
• If you or a family member has a history of blood clots, consult your doctor, as medications of this type may be associated with blood clot formation.

If you have any of the following conditions, inform your doctor as soon as possible:

• Stroke or transient ischaemic 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 have dementia, you or your caregiver or family member should inform your doctor if you have ever had a stroke or transient ischaemic attack.

As a routine precaution, if you are over 65 years of age, your doctor should monitor your blood pressure.

Children and adolescents under 18 years of age

Olanzapine must not be used in patients under 18 years of age.

Use of Olanzapina Almus with other medicines

Only use other medicines together with Olanzapina Almus if your doctor has approved it. You may feel drowsy if you combine Olanzapina Almus with antidepressants or medicines for anxiety or that help you sleep (tranquilizers).

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Specifically, tell 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 olanzapine dose may need to be adjusted.

Taking Olanzapina Almus with alcohol

You should not drink alcohol while taking olanzapine, as combining olanzapine with alcohol may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. You should not take this medicine during pregnancy unless your doctor advises it.

You should not take this medicine while breastfeeding, as small amounts of olanzapine may pass into breast milk.

Newborns of mothers who have used Olanzapina Almus during the last trimester (last three months) of pregnancy may experience the following symptoms: tremor, muscle stiffness and/or weakness, drowsiness, agitation, breathing difficulties, and feeding problems. If your newborn shows any of these symptoms, contact your doctor.

Driving and operating machinery

There is a risk of experiencing somnolence when taking olanzapine. If this occurs, do not drive vehicles or operate machinery. Consult your doctor.

Olanzapine Almus contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Olanzapina Almus 5 mg film-coated tablets

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

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 instructed by your doctor.

You should take your olanzapine tablets once daily, as directed by your doctor. Try to take the tablets at the same time every day. You may take them with or without food. Olanzapine tablets are for oral use.

You should swallow the tablets whole with water.

If you take more Olanzapina Almus than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount ingested. It is recommended to bring the medicine package and leaflet to the healthcare professional.

Patients who have taken more olanzapine than recommended 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 possible symptoms include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, sweating, muscle rigidity, drowsiness or lethargy, slowed breathing, aspiration, increased or decreased blood pressure, and abnormal heart rhythms. Contact your doctor or go immediately to hospital. Show the doctor the medicine pack and tablets.

If you forget to take Olanzapina Almus

Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.

If you stop taking Olanzapina Almus

Do not stop treatment just because you feel better. It is very important that you continue taking olanzapine for as long as your doctor tells you to.

If you suddenly stop taking olanzapine, you may experience symptoms such as sweating, inability to sleep, tremor, anxiety, nausea or vomiting. Your doctor may suggest 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, this medicine can cause adverse effects, although not everyone will experience them.

Contact your doctor immediately if you experience:

• 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), particularly in the legs (symptoms include swelling, 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 attention 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 people) include weight gain; drowsiness; and increased levels of prolactin in the blood. In the early stages of treatment, some people may feel dizzy or faint (with slower heartbeats), especially when standing up from a lying or sitting position. This sensation usually resolves spontaneously, 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, and temporary increases in liver enzymes at the beginning of treatment; increased blood and urine sugar levels; increased levels of uric acid and creatine phosphokinase in the blood; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); speech disturbances; constipation; dry mouth; skin rash; loss of strength; excessive tiredness; fluid retention causing swelling of the hands, ankles, or feet; fever; joint pain; and 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, 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); restless legs syndrome; speech problems; slow pulse; sensitivity to sunlight; nosebleeds; abdominal distension; memory loss or forgetfulness; urinary incontinence; inability to urinate; hair loss; absence or reduction of menstrual periods; changes in the breast gland in men and women such as abnormal milk production or abnormal growth; and excessive salivation.

Rare adverse effects (may affect up to 1 in 1,000 people) include decreased 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; a muscle disorder presenting as unexplained muscle pain and prolonged and/or painful erection.

Very rare adverse effects (may affect up to 1 in 10,000 people) include severe allergic reactions such as drug reaction with eosinophilia and systemic symptoms (DRESS). DRESS initially presents with flu-like symptoms and a rash on the face, followed by widespread rash, fever, swollen lymph nodes, elevated liver enzymes observed in blood tests, and an increase in 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, elevated body temperature, skin redness, and difficulty walking. Some 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 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 Almus 5 mg Film-coated Tablets

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

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

Do not store above 30 °C. Store in the original packaging to protect from light and moisture.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste containers should be handed over to the SIGRE point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Olanzapine Almus 5 mg

The active substance is olanzapine. Each tablet contains 5 mg of active substance.

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

Appearance of Olanzapine Almus 5 mg and contents of the pack

Olanzapine Almus 5 mg is presented as round, film-coated tablets without a breakline, with a yellow core and white coating.

It is available in blisters containing 28 tablets. Only certain pack sizes may be marketed.

Other presentations:

Olanzapine Almus 10 mg film-coated tablets EFG, 28 tablets
Olanzapine Almus 10 mg film-coated tablets EFG, 56 tablets

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Almus Farmacéutica, S.A.U.
Marie Curie, 54
08840 Viladecans (Barcelona), Spain
Telephone: 93 739 71 80
Email: [email protected]

Manufacturer:

Atlantic Pharma – Produções Farmacêuticas, S.A.
Rua De Tapada Grande 2
Abrunheira, Sintra 2710 – 228
Portugal

Date of latest revision of this leaflet: February 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/