Zolafren 5 mg hard capsules EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Zolafren 5 mg hard capsules EFG

olanzapine

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 only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Zolafren is and what it is used for

2. What you need to know before taking Zolafren

3. How to take Zolafren

4. Possible side effects

5. How to store Zolafren

6. Contents of the pack and other information

1. What Zolafren is and what it is used for

Zolafren 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whose symptoms include hearing, seeing, or feeling unreal things, false beliefs, unusual suspiciousness, and becoming withdrawn. People with this disorder may also experience depression, anxiety, or tension.
• Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.

Zolafren has been shown to prevent 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 Zolafren

Do not take Zolafren:

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

Talk to your doctor or pharmacist before starting to take Zolafren.

• The use of Zolafren 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 Zolafren, inform your doctor.

• Very rarely, medicines of this type cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this occurs, contact your doctor immediately.

• Weight gain has been observed in patients taking Zolafren. 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 Zolafren. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking Zolafren 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:

• Stroke or transient ischemic attack (temporary stroke symptoms)
• Parkinson's disease
• Prostate problems
• Intestinal blockage (paralytic ileus)
• Liver or kidney disease
• Blood disorders
• Heart disease
• Diabetes
• Seizures
• If you think you may have loss of body salts due to prolonged severe diarrhea or vomiting, or due to the use of diuretic medicines (water tablets)

If you have 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 Zolafren.

Other medicines and Zolafren

Only use other medicines together with Zolafren if authorized by your doctor. You may experience drowsiness if Zolafren is combined with antidepressants or medicines for anxiety or sleep (tranquilizers).

Tell 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 dose of Zolafren may need to be adjusted.

Use of Zolafren with alcohol

You should not drink alcohol while taking Zolafren, as it may cause drowsiness.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine. You should not take this medicine while breastfeeding, as small amounts of Zolafren may pass into breast milk.

The following symptoms may occur in newborns of mothers who have used Zolafren during the last 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, contact your doctor.

Driving and using machines

There is a risk of drowsiness while taking Zolafren. If this occurs, do not drive or operate machinery. Discuss this with your doctor.

Zolafren 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 Zolafren

Follow exactly the instructions given by your doctor for the administration of this medicine. If you are unsure, consult your doctor or pharmacist again.

Your doctor will tell you how many Zolafren capsules to take and for how long. The daily dose of Zolafren ranges from 5 to 20 mg. Consult your doctor if your symptoms return, but do not stop taking Zolafren unless instructed by your doctor.

You should take your Zolafren capsules once daily, as directed by your doctor. Try to take the capsules at the same time each day. They may be taken with or without food. Zolafren hard capsules are for oral administration. You must swallow the capsules whole with water.

If you take more Zolafren than you should

Patients who have taken more Zolafren than prescribed have experienced the following symptoms: rapid heartbeat, agitation/aggressiveness, speech problems, 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 pack with the capsules.

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 taken.

If you forget to take Zolafren

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

If you stop taking Zolafren

Do not stop treatment simply because you feel better. It is very important to continue taking Zolafren for as long as your doctor instructs.

If you stop taking Zolafren suddenly, symptoms such as sweating, inability to sleep, tremor, anxiety, or nausea and vomiting may occur. Your doctor may advise you to gradually reduce 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 experiences them.

Contact your doctor immediately if you experience:

• unusual movements (a common adverse effect affecting up to 1 in 10 people), especially of the face or tongue.
• blood clots in the veins (an uncommon adverse effect affecting up to 1 in 100 people), particularly 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 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 (affecting 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 experience dizziness or fainting (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 (affecting 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; abnormal movements (dyskinesia); constipation; dry mouth; skin rash; loss of strength; excessive fatigue; 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 (affecting up to 1 in 100 people) include 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, which in most cases are related to a history of seizures (epilepsy); muscle stiffness or spasms (including eye movements); restless legs syndrome; speech problems; stuttering; slow pulse; 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; and changes in the breast gland in both men and women, such as abnormal production of breast milk or abnormal breast enlargement.

Rare adverse effects (affecting 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 include severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Initially, DRESS manifests with flu-like symptoms and a rash on the face, followed by widespread rash, fever, enlarged lymph nodes, elevated liver enzymes observed in blood tests, and an increase in a type of white blood cells (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 difficulty walking. Some deaths have been reported in this particular group of patients.

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or pharmacist, 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. Storage of Zolafren

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.

This medicine does not require any special storage temperature.

Zolafren should be stored in the original packaging to protect it from light and moisture.

Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE Point in your pharmacy. Ask your pharmacist how to properly discard medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Zolafren

• The active substance is olanzapine. Each capsule contains 5 mg of the active substance.
• The other components are: microcrystalline cellulose (type 112), lactose monohydrate, magnesium stearate, gelatin, and titanium dioxide (E171).

Appearance of the product and contents of the pack

Zolafren 5 mg are hard gelatin capsules of size 3, containing 5 mg of olanzapine, with white body and cap.

They are supplied in PA-Aluminum-PVC/Aluminum blisters in packs of 28 or 56 capsules.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Adamed Laboratorios, S.L.U.

Calle de las Rosas de Aravaca, 31 - 2nd floor

28023 Aravaca – Madrid, Spain

Manufacturer

Adamed Pharma S.A.

Ul. Marszalka Jozefa Pilsudskiego 5

95-200 Pabianice, Poland

This medicinal product is authorized in the Member States of the European Economic Area

under the following names

Date of the last revision of this leaflet: October 2023

The detailed and up-to-date information about this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/