Zolafren 10 mg tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Zolafren 10 mg tablets EFG
olanzapine
Read the entire leaflet carefully before you start taking this medicine, as 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 personally. Do not give it to others, 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:
- What Zolafren is and what it is used for
- What you need to know before taking Zolafren
- How to take Zolafren
- Possible side effects
- How to store Zolafren
- Contents of the pack and other information
1. What Zolafren is and what it is used for
Zolafren contains the active substance olanzapine. 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include hearing, seeing, or feeling things that are not real, false beliefs, unusual suspiciousness, and becoming withdrawn. People with this disorder may also feel depressed, anxious, or tense.
- Moderate to severe manic disorder, characterized by symptoms such as excitement or euphoria.
Zolafren 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 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 a 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 can cause a combination of fever, rapid breathing, sweating, muscle stiffness, and mental confusion or drowsiness. If this happens to you, 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 nutritionist.
- Increased 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 starting treatment and regularly during treatment.
- If you or a family member 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-like 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 taking 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 reduced blood flow to the brain.
As a routine precaution, if you are over 65 years old, your doctor should monitor your blood pressure.
Children and adolescents
Zolafren must not be used in patients under 18 years of age.
Taking Zolafren with other medicines
Only use other medicines at the same time as Zolafren if authorized by your doctor. You may feel increased drowsiness if Zolafren is taken together with antidepressants or medicines for anxiety or 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 dose of Zolafren may need to be adjusted.
Drinking alcohol while taking Zolafren
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 are planning 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 taken 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
Zolafren may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction time. These effects, as well as the illness itself, may impair your ability to drive or operate machinery. Therefore, do not drive, operate machinery, or engage in other activities requiring alertness until your doctor has assessed your response to this medicine.
Zolafren contains lactose
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.
Zolafren contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; i.e., essentially "sodium-free".
3. How to take Zolafren
Follow exactly the instructions for using this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.
Your doctor will tell you how many Zolafren tablets to take and for how long. The daily dose of this medicine ranges between 5 mg and 20 mg. Consult your doctor if your symptoms return, but do not stop taking Zolafren unless your doctor tells you to do so.
You should take the 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. The tablets are for oral use. Swallow the tablets whole with water.
If you take more Zolafren than you should
If you have taken more Zolafren than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20 immediately, stating the name of the medicine and the amount taken. It is recommended to bring the medicine pack and leaflet to the healthcare professional.
Patients who have taken more Zolafren than recommended 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 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 medicine pack and tablets.
If you forget to take Zolafren
Take your tablets 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 just because you feel better. It is very important that you continue taking Zolafren for as long as your doctor tells you to.
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 which may affect up to 1 in 10 people), especially of the face or tongue.
- blood clots in the veins (an uncommon adverse effect which may affect up to 1 in 100 people), particularly in the legs (symptoms include sweating, leg pain and redness), 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).
- hypersensitivity (e.g., swelling of the mouth and throat, itching, skin rash) (an uncommon side effect which may affect up to 1 in 100 people).
- severe allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS initially appears as flu-like symptoms with a rash on the face, followed by widespread rash, high fever, swollen lymph nodes, increased liver enzymes observed in blood tests, and an increase in a type of white blood cells (eosinophilia) (the frequency of this side effect 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, 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 alkaline phosphatase; elevated gamma-glutamyl transferase; increased appetite; dizziness; restlessness; tremor; unusual movements (dyskinesia); 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 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; QT interval prolongation; sensitivity to sunlight; nosebleeds; abdominal distension; excessive salivation; memory loss or forgetfulness; urinary incontinence; loss of ability to urinate; difficulty urinating; hair loss; absence or reduction of menstrual periods; and changes in the breast gland in men and women such as abnormal milk production or abnormal growth.
Rare adverse effects (may affect up to 1 in 1,000 people) include low platelet levels in the blood (thrombocytopenia); 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; muscle disorder presenting as unexplained muscle pain, and prolonged and/or painful erection.
Frequency not known (cannot be estimated from available data): neonatal withdrawal syndrome.
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.
Zolafren may worsen symptoms in patients with Parkinson's disease.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may 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. Zolafren Storage
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date shown on the packaging. The expiry date refers to the last day of the month indicated.
Zolafren must be stored in its original packaging to protect it from moisture.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly 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 Zolafren
- The active substance is olanzapine. Each tablet contains 10 mg of olanzapine.
- The other components are: microcrystalline cellulose, lactose monohydrate, sodium carboxymethyl starch from potato (type A, gluten-free), and magnesium stearate.
Appearance of the medicine and contents of the pack
Zolafren 10 mg is presented as yellow, round, biconvex tablets.
It is available in packs of 28 or 56 tablets.
Some pack sizes may not be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed Laboratorios, S.L.U.
C/ de las Rosas de Aravaca, 31 - 2nd floor
28023 Madrid, Spain
Manufacturer
Adamed Pharma S.A.
ul. Marszalka Józefa Pilsudskiego 5
95-200 Pabianice
Poland
This medicine is authorized in the Member States of the European Economic Area under the following names:
{Poland} {Ranofren}
{Spain} {Zolafren}
Date of the most recent review of this leaflet: January 2024
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/