Zolafren 20 mg orodispersible tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Zolafren Flas 20 mg orodispersible tablets EFG
olanzapine
Read all of this 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, ask 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 they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet:
- What Zolafren Flas is and what it is used for
- What you need to know before taking Zolafren Flas
- How to take Zolafren Flas
- Possible adverse effects
- How to store Zolafren Flas
- Contents of the pack and other information
1. What Zolafren Flas is and what it is used for
Zolafren Flas belongs to a group of medicines called antipsychotics and is indicated for the treatment of the following disorders:
- Schizophrenia, a condition whose symptoms include hearing, seeing, or feeling things that are not real, false beliefs, unusual suspiciousness, and social withdrawal. 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 Flas 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 Flas
Do not take Zolafren Flas:
- if you are allergic to olanzapine or any of the other ingredients of this medicine (listed in section 6). The allergic reaction may present as 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 pressure in the eye).
Warnings and precautions
Talk to your doctor or pharmacist before starting to take Zolafren Flas.
- Use of Zolafren Flas is not recommended in elderly patients with dementia, as it may cause serious adverse effects.
- Medicines of this type may cause unusual movements, mainly of the face or tongue. If this occurs after taking Zolafren Flas, inform your doctor.
- Very rarely, medicines of this type may 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 Flas. 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 Zolafren Flas. Your doctor should perform blood tests to monitor your blood sugar and fat levels before you start taking Zolafren Flas 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 obstruction (paralytic ileus)
- Liver or kidney disease
- Blood disorders
- Heart disease
- Diabetes
- Seizures
- If you think you may have salt loss due to prolonged severe diarrhea and 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 transient lack of 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
Patients under 18 years of age must not take Zolafren Flas.
Other medicines and Zolafren Flas
Only use other medicines together with Zolafren Flas if authorized by your doctor. You may experience increased drowsiness if Zolafren Flas 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 Flas may need to be adjusted.
Alcohol and Zolafren Flas
Do not drink alcohol while taking Zolafren Flas, 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 must not take this medicine while breastfeeding, as small amounts of Zolafren Flas may pass into breast milk.
The following symptoms may occur in newborns of mothers who have taken Zolafren Flas during the third 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 Flas may cause symptoms such as drowsiness, dizziness, or vision disturbances, and may reduce reaction ability. 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 special attention until your doctor has assessed your response to this medicine.
Zolafren Flas contains aspartame and mannitol
This medicine may be harmful for people with phenylketonuria, as it contains aspartame, a source of phenylalanine.
Patients who cannot tolerate mannitol should be aware that Zolafren Flas contains mannitol.
3. How to take Zolafren Flas
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 Zolafren Flas tablets to take and for how long. The daily dose of Zolafren Flas ranges from 5 mg to 20 mg. Consult your doctor if your symptoms return, but do not stop taking Zolafren Flas unless instructed by your doctor.
Zolafren Flas tablets should be taken once daily, as directed by your doctor. Try to take the tablets at the same time every day. They may be taken with or without food. The buccodispersible tablets of Zolafren Flasson are for oral administration.
Zolafren Flas tablets break easily and should therefore be handled with care. Do not handle the tablets with wet hands, as they may disintegrate.
Place the tablet in your mouth. It will dissolve directly in the mouth, making it very easy to swallow.
Alternatively, the tablet may be placed in a cup or glass filled with water, orange juice, apple juice, milk, or coffee, and stirred. With some beverages, the mixture may change color and become cloudy. It should be drunk immediately.
If you take more Zolafren Flas than you should
Patients who have taken more Zolafren Flas 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 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 package and tablets.
If you have taken more Zolafren Flas than you should, contact your doctor, pharmacist, or call the Toxicology Information Service at 91 562 04 20, indicating the medicine and the amount taken. It is recommended to bring the medicine packaging and leaflet to the healthcare professional.
If you forget to take Zolafren Flas
Take your tablet as soon as you remember. Do not take a double dose to make up for forgotten doses.
If you stop taking Zolafren Flas
Do not stop treatment simply because you feel better. It is very important to continue taking Zolafren Flas for as long as your doctor advises.
If you stop taking Zolafren Flas suddenly, symptoms such as sweating, difficulty sleeping, tremor, anxiety, or nausea and vomiting may occur. Your doctor may recommend that you 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 will experience 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, 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).
Other adverse effects:
Very common adverse effects (may affect more than 1 in 10 people) include weight gain, drowsiness, and increased levels of prolactin in the blood. During the initial stages of treatment, some people may experience dizziness or fainting (with slower heartbeats), especially when getting 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 at the beginning of treatment, increases in liver enzymes, 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), 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 (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, mostly 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, excessive salivation, memory loss or forgetfulness, urinary incontinence, inability 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 growth.
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, muscle disorders presenting as unexplained muscle pain, and prolonged and/or painful erection.
Serious allergic reactions such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) have been reported. DRESS initially presents with flu-like symptoms, skin rash which then spreads to other areas, fever, swollen lymph nodes, elevated liver enzymes in blood tests, and increased levels of 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, increased body temperature, skin redness, and difficulty walking. Some deaths have been reported in this particular group of patients.
Zolafren Flas may worsen symptoms in patients with Parkinson's disease.
Reporting of adverse effects
If you experience any adverse effect, talk to 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 Zolafren Flas
Keep this medicine out of 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.
Zolafren Flasse must be stored in the original packaging to protect it from moisture.
Medicines must not be disposed of via wastewater drains or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to properly dispose of containers and medicines you no longer need. This way, you will help protect the environment.
6. Contents of the pack and other information
Composition of Zolafren Flas
- The active substance is olanzapine. Each orodispersible tablet contains 20 mg of the active substance.
- The other components are: mannitol (E421), crospovidone type B, aspartame (E951), orange flavour (flavouring preparations, flavouring substances identical to natural substances, corn maltodextrin, alpha-tocopherol (E307)), colloidal anhydrous silica and sodium stearyl fumarate.
Appearance of the product and contents of the pack
Zolafren Flas are orodispersible tablets. An orodispersible tablet is the technical name for a tablet that dissolves directly in the mouth, allowing it to be swallowed easily.
Zolafren Flas 20 mg orodispersible tablets are yellow, round, smooth, bevelled tablets, 10 mm in diameter, engraved with a "20" on one side.
They are presented in OPA-Al-PVC/Al blisters.
Pack size: 28 orodispersible tablets.
20 mg tablets: 4 blisters of 7 tablets per carton.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Adamed Laboratorios, S.L.U.
C/ de las Rosas de Aravaca, 31 – 2nd floor
28023 Aravaca – Madrid, Spain
Tel.: +34 91 357 11 25
Fax: +34 91 307 09 70
e-mail: [email protected]
Manufacturer
Adamed Pharma, S.A.
Ul. Marszalka Józefa Pilsudskiego 5
95-200 Pabianice, Poland
This medicinal product is authorized in the EEA Member States under the following names:
{Spain} Zolafren Flas 5 mg, 10 mg, 15 mg, 20 mg orodispersible tablets EFG
Date of the most recent review of this leaflet: November 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/